CN114366790A

CN114366790A - Traditional Chinese medicine composition for preventing and treating tumor and treating after-appetite loss and gastrointestinal reaction

Info

Publication number: CN114366790A
Application number: CN202210097886.0A
Authority: CN
Inventors: 冯利
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-01-27
Filing date: 2022-01-27
Publication date: 2022-04-19
Anticipated expiration: 2042-01-27
Also published as: CN114366790B

Abstract

The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for preventing and treating tumors and treating post-anorexia and gastrointestinal reactions, and a preparation method of the composition. 5-30 parts of codonopsis pilosula, 6-30 parts of bighead atractylodes rhizome, 3-15 parts of ginger processed pinellia, 5-15 parts of poria cocos, 3-15 parts of dried orange peel, 3-12 parts of tsaoko amomum fruit, 1-12 parts of clove, 2-15 parts of magnolia officinalis, 3-15 parts of costustoot, 4-20 parts of fried medicated leaven, 2-15 parts of tribulus terrestris, 3-20 parts of dandelion, 2-15 parts of bletilla and 2-15 parts of honey-fried licorice root. Prolonging life and promoting rehabilitation.

Description

Traditional Chinese medicine composition for preventing and treating tumor and treating after-appetite loss and gastrointestinal reaction

Technical Field

The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for preventing and treating tumors and treating post-anorexia and gastrointestinal reactions, and a preparation method of the composition.

Background

The malignant tumor is a global problem seriously threatening the life and health of human beings, and according to statistics, about 1930 ten thousand new cancer cases and about 1000 ten thousand death cases occur in 2020 world, and the new cancer cases increase by 47% in 2040 year. Cancer is the 1 st or 2 nd leading cause of death in 112 countries worldwide with an age < 70 years. With the increasing attention of people, the wide popularization of high-risk screening and the continuous development of medical technology, the prognosis of cancer is better and better, and the quality of life of cancer patients gradually receives more attention.

Anorexia and gastrointestinal reactions, such as bloating, abdominal distension, nausea and vomiting, are common adverse reactions in malignant tumors and related anti-tumor treatments, severely reducing the quality of life of the patients. The long-term anorexia, gastrectasia, abdominal distention, nausea and vomiting can cause patients to have various physiological or psychological problems such as hypodynamia, anemia, hypoproteinemia, water electrolyte disorder, fear, anxiety, depression, etc., thereby increasing the physical and psychological burden and influencing the overall treatment, thereby influencing the prognosis. According to the symptoms, the traditional Chinese medicine belongs to the categories of 'anorexia', 'fullness in the abdomen', 'vomiting' and the like, and the tumor itself or various anti-tumor treatments are considered to disturb the yin-yang balance and the qi activity of the human body. The spleen and stomach are the middle-jiao hub, descending the yangming stomach and ascending the taiyin spleen, so they can normally transport and transform food; if the yin-yang movement of the spleen and stomach is unbalanced, the qi movement is disordered, the taiyin and spleen do not rise, the yangming stomach does not descend, and food stagnation causes anorexia, gastrectasia, abdominal distension, nausea and vomiting.

Tumor-related anorexia

Tumor-related anorexia refers to anorexia or loss of appetite in patients with malignant tumor, and can reduce the tolerance of treatment. The data show that about 26-58% of patients with advanced tumors experience anorexia and 33% of patients experience loss of appetite. With the increasing symptoms, the nutrition of patients is seriously insufficient, the loss of skeletal muscle and adipose tissue, insulin resistance and basic energy consumption are increased, the cancer cachexia is gradually developed, 20 percent of death events are related, and the prognosis is seriously influenced.

Active substances released by tumor tissues, such as cytokines IL-1 alpha, IL-6, TNF-alpha, GDF15 and the like, act on specific hypothalamic receptors by regulating central nervous system neurotransmitter cascades, promote satiety through downstream neuropeptides and cause anorexia or loss. For example, growth differentiation factor 15(GDF15), a member of the TGF- β superfamily, can produce anorexia by acting directly on the feeding center of the brainstem. The hypothalamic axis is associated with energy intake, and the hypothalamus controls energy expenditure and food intake by coordinating the stimulation of NPY/AgRP and POMC/CART neurons, respectively. Among these, leptin secreted from the arcus nucleus of the hypothalamus acts on the central nervous system to suppress appetite, and leptin, which is also part of the feedback loop regulating several hypothalamic neuropeptides such as NPY and corticotropin releasing factor, causes anorexia due to increased secretion. Serotonin also has key roles, as IL-1 activates POMC/CART neurons by increasing secretion of hypothalamic serotonin, resulting in loss or loss of appetite. In addition, aberrant histamine signaling at the hypothalamic arcuate nucleus, medial nucleus and paraventricular H1 receptors also leads to anorexia. It has been suggested that the parasympathetic nervous system senses tumor characteristics early in the development of cancer and signals human hypothalamic histaminergic neurons, sending out abnormal histamine signals that trigger energy expenditure by activating brown adipose tissue. Thus, tumor-related anorexia may be a common result of alterations in central and peripheral neurohormonal signals that control appetite.

In addition to the tumor itself, tumor-related therapies can also cause loss or loss of appetite, such as dry mouth and tongue, changes in taste or smell, mucositis, diarrhea or constipation, and severe nausea and vomiting caused by chemotherapy, resulting in loss of appetite in patients. The targeted therapy often causes adverse reactions such as oral mucositis and the like, so that the patients feel pain in the oral cavity and the throat when eating, thereby affecting the appetite. Due to the strong expression of PD-1/L1 in normal thyroid tissue, one of the common adverse reactions of immunotherapy is hypothyroidism, and anorexia is an important clinical manifestation.

For anorexia caused by tumors and related treatments, most of the currently recommended pharmacological treatments in guidelines, consensus and clinical practice mainly include the following types of drugs:

(1) progestogens: typified by megestrol acetate. Megestrol acetate can regulate hypothalamic ventral medial nucleus-satiety center, reduce hypothalamic ventral medial nucleus neuron release impulse and inhibit the activity of proinflammatory cytokines such as interleukin-1, interleukin-6 and tumor necrosis factor-alpha, and induce hypothalamus to produce neuropeptide to stimulate appetite. Researches show that megestrol acetate has obvious improvement effect on appetite and life quality of malignant tumor patients, and NCCN palliative treatment clinical guidelines recommend that megestrol acetate is used for treating tumor-related anorexia, can comprehensively improve life treatment of patients, and delay occurrence of cancer cachexia; (2) glucocorticoids: dexamethasone is taken as a representative. Dexamethasone can inhibit accumulation of inflammatory cells, including macrophage and leukocyte, at inflammation site, inhibit release of lysosomal enzyme and synthesis and release of inflammation mediator, relieve and prevent tissue response to inflammation, and exert antiinflammatory effect. It also can inhibit cell-mediated immune reaction, reduce the binding force between immunoglobulin and cell surface receptor, and inhibit synthesis and release of interleukin to exert immunosuppressive effect. Research shows that low-dose dexamethasone can temporarily improve the appetite of cancer patients but cannot increase the weight, and iatrogenic cushing syndrome face and body conditions, osteoporosis, fracture, hypokalemia, nausea and vomiting and the like can occur after long-term application, and the low-dose dexamethasone is mostly applied to late-stage cancer patients; (3) an antidepressant: represented by olanzapine and mirtazapine. Olanzapine is a novel atypical neuroleptic agent that binds to and inhibits dopamine receptors, 5-HT receptors and cholinergic receptors, mirtazapine acts as a central presynaptic alpha 2 receptor antagonist, enhances adrenergic nerve conduction, and modulates 5-HT function by interacting with central 5-hydroxytryptamine receptors. NCCN palliative treatment clinical guidelines recommend olanzapine and mirtazapine for appetite loss or loss in tumor patients; (4) and others: for example, thalidomide is an immunoregulatory drug, and research shows that the thalidomide can improve appetite and is related to reducing the activity degree of inflammatory factors; celecoxib is a non-steroidal anti-inflammatory drug, can resist inflammation and pain, simultaneously reduce the content of IL-1, IL-6 and TNF-alpha in a tumor patient body, and inhibit inflammatory factors to stimulate appetite.

(II) tumor-associated gastrectasia/abdominal distention

The tumor-related gastrectasia/abdominal distension refers to the symptoms that gastrointestinal functions of malignant tumor patients are inhibited due to tumor-related factors such as tumor compression, various anti-tumor treatments and the like, the gastrointestinal peristalsis is slow, the exhaust is reduced, and the stomach and abdominal distension is uncomfortable, seriously influences the life quality of the patients, and is the main reason why the patients refuse to continuously receive treatment.

The primary mechanism responsible for tumor-associated bloating/bloating is the inhibition of vagal excitation as well as the action of the brain-gut axis. The vagus nerve is the 10 th cranial nerve, which is a mixed nerve and contains motor, sensory and parasympathetic fibers, and excitation of the vagus nerve causes gastrointestinal tract motility and increased secretion of digestive juice. Such as a central antiemetic 5-hydroxytryptamine receptor antagonist, can inhibit the excitability of 5-hydroxytryptamine receptor before synapse of peripheral nerve cells in vomiting center, block vagus nerve conduction in gastrointestinal tract, and reduce gastrointestinal motility to cause abdominal distention. Some abdominal surgeries, in which the vagus nerve of the stomach is removed, also cause the stomach to become distended. The brain-intestine axis is a communication pathway connecting the brain and the gastrointestinal tract, participates in various physiological processes of the body, including regulation of hunger sensation and satiety of the body, glucose, fat and bone metabolism, and the like, mainly comprises an autonomic nervous system pathway, a neuroendocrine system pathway, a hypothalamus-pituitary-adrenal axis pathway, a metabolic pathway and an immune system pathway, and is also a hub for interaction of emotion, psychology and gastrointestinal functions. The malignant tumor patient produces anxiety or depression state due to fear of cancer and discomfort of adverse reaction generated by various treatments, which leads to change of internal environment of human body, the signal is transmitted to the center, and after integration treatment, the organism makes adaptive response on one hand, and on the other hand indirectly regulates and controls the digestive tract through neuroendocrine and autonomic nervous system, so that digestive organs and glands are reflexively inhibited and prolonged, and the stomach and abdominal distension are caused.

In addition, patients with malignant tumors often develop electrolyte disorders, such as hyponatremia or hyperkalemia. If hyponatremia is complicated, gastrointestinal reactions such as anorexia, gastrectasia, abdominal distension and the like are obvious; if hyperkalemia is caused, resting potential is reduced, cell membranes are in a depolarized state, nerve conduction excitability of muscles is reduced, and intestinal peristalsis, gastrointestinal dyskinesia and the like are caused, so that stomach and abdomen fullness are caused. The malignant tumor patients often have abdominal dropsy, for example, abdominal malignant tumor or metastatic tumor invades and blocks abdominal blood vessels and lymphatic vessels, so that capillary pressure and lymphatic hydrostatic pressure of the malignant tumor patients rise, lymphatic fluid and interstitial fluid backflow obstacle is retained in the abdominal cavity, and the abdominal dropsy is caused. Malignant tumor of abdomen causes increase of permeability of blood vessel of abdominal cavity, and at the same time, tumor itself secretes liquid, resulting in effusion of abdominal cavity. In late-stage cancer patients, hypoproteinemia is caused by hepatic and renal insufficiency and chronic consumption, so that the plasma colloid osmotic pressure is reduced, and intravascular fluid is externally infiltrated into the abdominal cavity to cause or aggravate the abdominal hydrops. A large amount of abdominal dropsy causes insufficient circulating blood volume, a renin-angiotensin-aldosterone system is excited, water and sodium retention is caused, abdominal dropsy is aggravated, and the abdominal dropsy presses gastrointestinal tracts to cause gastric distention and abdominal distension of patients. The patients with cancer lie in bed for a long time to cause insufficient gastrointestinal motility and also suffer from stomach distension and abdominal distension.

For the gastrectasia/abdominal distention caused by tumor and related treatment, most of the current consensus and clinical practices consider that the drug therapy mainly comprises the following types of drugs:

(1) gastrointestinal motility promoting drugs: represented by domperidone and mosapride. Domperidone is a selective action on peripheral D₂The gastrointestinal motility promoting medicine of the receptor is mainly D due to distribution in the gastrointestinal tract₂The receptor, which is stimulated to have inhibitory effect on most of the smooth muscle of gastrointestinal tract, domperidone exerts its prokinetic effect by specifically antagonizing D2 receptor of the smooth muscle of gastrointestinal tract. Mosapride is a benzamide derivative, and increases ACh release of nerve endings by exciting 5-HT4 receptors of myenteric plexus, thereby promoting gastric emptying and exerting the function of promoting gastrointestinal motility. Studies have shown that administration of a prokinetic drug to patients with gastrectasia or abdominal distension can improve clinical symptoms, but with a shorter duration; (2) intestinal flora regulator: takes Bacillus licheniformis capsule and Bifidobacterium triple viable capsule as representatives. The bacteria in the intestinal tract generate gas by fermenting various foods, so the disturbance of the flora in the intestinal tract can cause the abdominal distension of patients, and researches show that the abdominal distension symptom can be effectively improved by adjusting the balance of the strains in the intestinal tract. After entering intestinal tract in the form of live bacteria, the Bacillus licheniformis capsule has antagonistic effect on staphylococcus and yeast, and has effect in promoting growth of Bifidobacterium, lactobacillus, Bacteroides, and Streptococcus digestusCan be used for regulating dysbacteriosis. However, the mechanism of the gastrectasia and abdominal distension of the cancer patient is complex, and researches show that the gastrointestinal tract burden is increased by using medicines such as gastrointestinal motility promoting medicines, intestinal flora regulators and the like, and the treatment of the cancer patient is possibly not facilitated; (3) cathartic agent: lactulose solution and enema are used as representatives. Lactulose solution is converted in the colon by the flora of the digestive tract into low molecular weight organic acids, resulting in a decrease in the pH of the intestinal tract and an increase in the volume of the stool by retaining water, thereby stimulating colonic motility, maintaining bowel movement unobstructed and restoring the circadian rhythm of the colon. Enema can lubricate and irritate the intestinal wall, soften the stool and make it easy to be discharged. Studies have shown that the use of cathartics is beneficial in relieving the bloating and bloating in patients, however, cancer patients are physically weak and should be cautiously administered with cathartics, and not necessarily.

(III) nausea and vomiting associated with tumors

The nausea and vomiting related to tumor refers to nausea and vomiting symptoms of malignant tumor patients caused by tumor self or anti-tumor treatment such as operation, radiotherapy, chemotherapy, targeted therapy, immunotherapy and the like, has obvious negative effects on the emotional, social and physical functions of the patients, reduces the life quality and treatment compliance of the patients, can cause metabolic disorder, malnutrition and weight loss, increases the fear of the patients to the treatment, has to stop the treatment when the serious condition is serious, and seriously affects the prognosis.

In recent years, the mechanism of nausea and vomiting caused by tumors and related therapies has been greatly developed, and the main mechanism is that various stimuli excite the central or Chemoreceptor Trigger Zone (CTZ) of vomiting through peripheral or central pathways. The vomiting center is located at the dorsolateral border of the lateral medullary reticulum, and the CTZ is located in the posterior foramen area of the posterior border of the fourth ventricle adjacent to the vomiting center. The afferent impulses are transmitted to a vomiting center by sensory fibers of vagus nerve and sympathetic nerve, glossopharyngeal nerve and other nerves, and the impulses transmitted by the center are transmitted to the stomach, small intestine, diaphragmatic muscle, abdominal wall muscle and the like along the vagus nerve, the sympathetic nerve, the phrenic nerve, the spinal nerve and the like to cause symptoms of nausea and vomiting; CTZ can receive excitation of various foreign chemicals or endogenous metabolites, and then send out nerve impulses to the vomiting center, causing nausea and vomiting.

The intracranial pressure increase caused by brain tumor, brain metastasis, cerebral edema caused by operation and other conditions can directly stimulate a respiratory center to cause nausea and vomiting; chemotherapeutics stimulate gastric and proximal small intestinal mucosa, and enterochromaffin cells release neurotransmitters to stimulate vagus nerve and visceral nerve afferent fibers on the intestinal wall, transmit signals to the brainstem to directly stimulate nerve nuclei of vomiting centers, or indirectly initiate vomiting reflex through CTZ; the gastrointestinal tract contains rapidly proliferating epithelial cells, is particularly sensitive to radiotherapy, can directly stimulate the afferent nerve fibers of the upper digestive tract to excite the central nervous system to cause nausea and vomiting, and can stimulate CTZ by tissue disintegration products induced by radiotherapy. Targeted therapy also causes nausea and vomiting, and studies have shown that symptoms of nausea and vomiting often occur in more than 15% of patients treated with gefitinib, and in patients treated with erlotinib and imatinib mesylate.

In addition, neurotransmitters and their receptors play an important role in the development of emesis, such as 5-HT, substance P, and dopamine, acetylcholine, histamine, and the like. There are many 5-HT receptors in vagal afferent fibers, CTZ and the nucleus solitary tract, and substance P is the major neurotransmitter in the central nervous system that activates neurokinin-1 (NK-1) and also plays an important role in emesis. The role and importance of different neurotransmitters in different types of emesis differs, for example nausea and vomiting 8-12h after cisplatin chemotherapy are mainly mediated by 5-HT, and emesis after 24h is dominated by substance P.

For nausea and vomiting caused by tumor and related treatment, most of the current guidelines, consensus and clinical practices consider that the prevention and treatment should be mainly carried out by drug intervention, and the current guidelines, consensus and clinical practices mainly include the following types of drugs:

(1)5-HT₃receptor antagonists: represented by ondansetron and granisetron. Chemotherapy can induce 5-HT₃5-HT released from chromaffin cells of the digestive tract and associated with the vagus nerve endings of the digestive tract mucosa₃Receptor binding stimulates the vomiting center to cause emesis. 5-HT₃5-HT of receptor antagonists across the mucosa of the digestive tract₃Receptor binding phaseIn combination, the composition has antiemetic effect. Studies have shown that prophylactic administration prior to treatment can reduce the incidence of emesis, and NCCN guidelines also recommend ondansetron for use in improving emesis symptoms in tumor patients; (2) NK-1 receptor antagonists: represented by aprepitant. The aprepitant can be combined with NK-1 receptors in the brain with high selectivity to antagonize substance P, and researches prove that aprepitant can effectively prevent vomiting, but is not recommended in an NCCN (national center of care) guide; (3) glucocorticoids: dexamethasone is taken as a representative. Dexamethasone is a long-acting glucocorticoid and can be administered orally or intravenously. Clinical studies prove that dexamethasone is an effective drug for preventing acute emesis, and is a basic drug for preventing delayed emesis, and the NCCN guidelines recommend that dexamethasone be used for treating central nervous system involvement of tumor patients; (4) dopamine receptor blockers: represented by metoclopramide. Metoclopramide increases the CTZ threshold by inhibiting the dopamine receptor of CTZ, and exerts a strong central antiemetic effect. The NCCN guidelines recommend that they improve emesis symptoms in tumor patients, and adverse reactions are rare for dystonia and may be restless legs syndrome; (5) psychotropic drugs: including atypical antipsychotics and benzodiazepines

The quasi-drugs are represented by olanzapine and lorazepam. Olanzapine has affinity for a variety of receptors, e.g. 5-HT₂Receptor, 5-HT₃Receptor, 5-HT₆Receptors, dopamine receptors, epinephrine and histamine H₁Receptor and the like, and the research shows that the composition can be used for the rescue treatment of nausea and vomiting caused by chemotherapy; (6) phenothiazines: represented by chlorpromazine, promethazine, diphenhydramine. Chlorpromazine mainly blocks dopamine receptors in brain, can inhibit the dopamine receptors of CTZ in small dose, and directly inhibits vomiting center in large dose. Diphenhydramine has antihistamine effect, and can exert strong antiemetic effect through central inhibition. Promethazine is also an antihistamine, exerts an antiemetic effect by inhibiting CTZ, and all three drugs have sedative effects.

In addition to the above mentioned medications, non-drug treatments are also recommended by current guidelines, consensus and clinical practices for anorexia, bloating, abdominal distension, nausea and vomiting caused by tumors and related treatments, mainly including the following:

(1) acupuncture and moxibustion treatment: acupuncture and moxibustion is a traditional Chinese medicine treatment method, has the characteristics of high safety, small adverse reaction and the like, and is widely accepted in the world as a safe and effective treatment mode. Acupuncture and moxibustion relies on channels and collaterals, and regulates the overall condition of a human body by stimulating target points. Multiple studies show that the compound can improve appetite reduction, gastrectasia, abdominal distension, nausea and vomiting caused by tumors and related treatments, and can be related to ways of regulating the content of substance P in peripheral blood, reducing the level of 5-HT in vivo, increasing the content of nitric oxide synthase and the like; (2) acupoint application: the acupoint application is noninvasive and painless, the operation is simple and convenient, and the acupoint application is widely applied in clinic. Research shows that the acupoint application can prevent and improve the anorexia, the gastrectasia, the abdominal distention and the nausea and vomiting caused by tumor and related treatment, and has exact curative effect, for example, the acupoint application of Zhongwan, Neiguan, Yongquan and the like can reduce the occurrence frequency and the duration of the nausea and vomiting caused by chemotherapy; (3) psychological support: the patients with tumor are often accompanied by anxiety, depression, tension and other adverse emotions, and the adverse emotions are aggravated by anorexia, gastrectasia, abdominal distension, nausea and vomiting caused by the tumor and related treatment. Research shows that attention is paid to psychological dispersion on patients during treatment, the social and psychological conditions of the patients need to be paid attention, the confidence is increased and the attention is transferred through the active psychological dispersion on the patients, the negative psychology brought to the patients by the diseases and the relevant adverse reactions is reduced, the psychosomatic and psychological treatment is realized, and the better clinical curative effect can be obtained; (4) and (3) nutrition support: tumor patients require more energy to maintain their own body mass, which is far more consumed than healthy people, especially for patients with anorexia, bloating, abdominal distension, nausea and vomiting, which require more energy, especially proteins and carbohydrates. Research shows that for tumor patients with insufficient intake or excessive consumption, the administration of high-protein diet through nutrition support treatment has certain curative effect on improving the symptoms of the patients and prolonging the life cycle. (5) And others: such as lifestyle management, including adjustment of dietary structure, daily eating on a regular basis, smoking cessation, alcohol withdrawal, appropriate exercise, etc., can improve the symptoms of the patient; the ear acupuncture point pressing, massage, aromatherapy, hot compress and the like are also used for treatment, and the research shows that the medicine can improve the symptoms of anorexia, gastrectasia, abdominal distension, nausea and vomiting of patients.

The anorexia, the gastrectasia, the abdominal distension, the nausea and the vomiting caused by the tumor and the related treatment bring great negative effects on the physical and mental health of the patient, so that the life quality of the patient is seriously reduced, the treatment of the cancer is not facilitated, the prognosis is influenced, and attention is paid to the symptoms. At present, according to NCCN guideline recommendation and national clinical practice, the evaluation method comprises the following steps:

(1) evaluation of appetite in cancer patients: the evaluation may be made according to the quality of life questionnaire (EORTC QLQ-C30), Visual Analogue Score (VAS) scale, tumor patients anorexia and cachexia function evaluation scale (A/CS-12), tumor patients appetite symptom questionnaire (CASQ) or according to the fifth edition of common adverse event evaluation criteria (CTCAE) of European tumor research and treatment organization; (2) evaluation of the degree of bloating/bloating in cancer patients: at present, no unified standard exists, and the evaluation can be carried out according to the fifth edition of common adverse event evaluation standard (CTCAE), or quantitative evaluation is carried out according to the clinical research guiding principle of new traditional Chinese medicine; (3) evaluation of the extent of nausea and vomiting in cancer patients: nausea and vomiting were graded into 5 grades according to the common adverse event evaluation criteria (CTCAE), fifth edition: level 0: no nausea and vomiting; stage I: no intervention is required; II stage: outpatient vein fluid infusion, medical intervention is needed; grade III: nasal feeding, total parenteral nutrition or hospitalization is required; stage IV: life threatening; and V stage: and death.

Although there are many methods for preventing and treating tumor and treating anorexia, gastrectasia, abdominal distention, nausea and vomiting, the symptoms of some patients are still difficult to relieve clinically, for the following reasons: (1) the non-drug therapy mainly aims at coordination and adjuvant drug therapy, generally has slow effect, needs a patient to insist and coordinate for a long time, and is rarely used alone in clinic as a treatment method; (2) the existing clinically common medicament with better curative effect, such as megestrol acetate, is used for improving the appetite of patients, and can cause adverse reactions such as peripheral edema, vaginal bleeding, male erectile dysfunction, adrenal insufficiency and the like, even increase the risk of venous thrombosis, and the serious adverse reactions can counteract the benefit of increasing the appetiteAt least one of (1) and (b); domperidone has few adverse reactions, including depression, anxiety, decreased libido, dry mouth, rash, headache, diarrhea, lethargy, etc., but because of the metabolism of intestinal wall and the first pass effect of liver, the oral bioavailability of domperidone is very low; mosapride can cause adverse reactions such as diarrhea, abdominal pain, dry mouth, rash, lassitude and dizziness; 5-HT₃Receptor antagonists often cause headache, constipation, elevated transaminase, abdominal distension and pain, and in severe cases, may also cause prolonged QT interval and fatal malignant arrhythmia; metoclopramide can cause untoward effects such as lethargy, dysphoria, fatigue, weakness, orthostatic hypotension and the like, and can cause extrapyramidal reactions, muscle tremor, dysarthria, ataxia and the like after long-term application of a large dose; (3) the anorexia, the gastrectasia, the abdominal distension, the nausea and the vomiting caused by the tumor and the related treatment are complex problems related to multiple causes, multiple systems and multiple mechanisms, the symptoms are difficult to solve by one medicament, the combined application of multiple medicaments has the possibility of increasing the risk of adverse reaction, and the caused harm is far more than the improvement of the symptoms.

The symptoms of anorexia, gastrectasia, abdominal distention, nausea and vomiting caused by tumors and related treatment not only can influence the body function, daily life and psychological health of patients, reduce the living quality of the patients, but also can influence the normal treatment of the cancers, and influence the prognosis of the patients, thereby being a major problem to be solved, and the traditional Chinese medicine has no mode which has quick effect, small side effect and wide application range and can effectively prevent and treat the cancers.

The pharmaceutical composition of the invention effectively solves the problems.

Disclosure of Invention

In order to solve the technical problems, the invention provides a traditional Chinese medicine composition for preventing and treating tumor and treating anorexia and gastrointestinal reaction after tumor treatment and a preparation method thereof.

The invention also provides a preparation method of the traditional Chinese medicine composition.

The invention provides a traditional Chinese medicine composition for preventing and treating tumors and treating anorexia and gastrointestinal reactions after tumor treatment, which is realized by the following technical scheme: 5-30 parts of codonopsis pilosula, 6-30 parts of bighead atractylodes rhizome, 3-15 parts of ginger processed pinellia, 5-15 parts of poria cocos, 3-15 parts of dried orange peel, 3-12 parts of tsaoko amomum fruits, 1-12 parts of clove, 2-15 parts of mangnolia officinalis, 3-15 parts of elecampane, 4-20 parts of fried medicated leaven, 2-15 parts of tribulus terrestris, 3-20 parts of dandelion, 2-15 parts of rhizoma bletillae and 2-15 parts of honey-fried licorice roots.

Preferably, the composition comprises the following components in parts by weight: 9-15 parts of codonopsis pilosula, 10-20 parts of bighead atractylodes rhizome, 5-10 parts of ginger processed pinellia, 5-12 parts of poria cocos, 3-12 parts of dried orange peel, 5-10 parts of tsaoko amomum fruit, 3-10 parts of clove, 2-12 parts of mangnolia officinalis, 4-10 parts of elecampane, 6-12 parts of fried medicated leaven, 5-10 parts of tribulus terrestris, 6-15 parts of dandelion, 6-12 parts of rhizoma bletillae and 5-10 parts of honey-fried licorice root.

More preferably, the composition comprises the following components in parts by weight: 10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 10 parts of ginger processed pinellia tuber, 10 parts of poria cocos, 10 parts of dried orange peel, 6 parts of amomum tsao-ko, 6 parts of clove, 10 parts of magnolia officinalis, 10 parts of elecampane, 10 parts of fried medicated leaven, 10 parts of tribulus terrestris, 10 parts of dandelion, 10 parts of rhizoma bletillae and 10 parts of honey-fried licorice root.

The preparation method of the traditional Chinese medicine composition for preventing and treating tumors and treating after-appetite reduction and gastrointestinal reaction can be divided into decoction and granules, and comprises the following steps:

preparation method of water decoction 1

(1) Mixing 10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 10 parts of ginger processed pinellia tuber, 10 parts of poria cocos, 10 parts of dried orange peel, 6 parts of amomum tsao-ko, 6 parts of clove, 10 parts of mangnolia officinalis, 10 parts of elecampane, 10 parts of fried medicated leaven, 10 parts of tribulus terrestris, 10 parts of dandelion, 10 parts of bletilla striata and 10 parts of honey-fried licorice root, and then adding water to soak for half an hour. Wherein, the weight ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2) to (10-15), and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(2) Decocting all the materials for 40 min. Wherein, the weight ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2) to (10-15), and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(3) Filtering the decoction to obtain filtrate and residue, and finishing the first decoction.

(4) Taking out the filter residue, and adding water again for decocting for 25 minutes. Wherein, the weight ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2) to (5-10), and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(5) Filtering the decoction to obtain filtrate and residue, and finishing the second decoction.

(6) Mixing the filtrate obtained by the first decoction and the filtrate obtained by the second decoction to obtain the decoction of the traditional Chinese medicine composition.

The preparation method is suitable for decocting at home for individual to take.

Preparation method of water decoction 2

(1) Mixing 10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 10 parts of ginger processed pinellia tuber, 10 parts of poria cocos, 10 parts of dried orange peel, 6 parts of amomum tsao-ko, 6 parts of clove, 10 parts of mangnolia officinalis, 10 parts of elecampane, 10 parts of fried medicated leaven, 10 parts of tribulus terrestris, 10 parts of dandelion, 10 parts of bletilla striata and 10 parts of honey-fried licorice root, and then adding water to decoct for three times.

(2) Decocting in water for 1 hr. Wherein, the weight ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2) to (10-20), and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(3) Decocting in water for 1 hr for the second time. Wherein, the weight ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2) to (5-10), and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(4) Decocting in water for 0.5 hr. Wherein, the weight ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2) to (5-10), and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(5) Concentrating the obtained medicinal liquid under reduced pressure until the relative density is 1.1-1.15 at 60 deg.C, refrigerating, and standing for 24 hr.

(6) Filtering to obtain filtrate, adding water to 500ml, bottling, and sterilizing to obtain the Chinese medicinal composition decoction.

The preparation method is suitable for decoction preparation in pharmacy, pharmaceutical factory, and institution, and has long shelf life.

Preparation of granules

(1) Mixing 10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 0 part of ginger processed pinellia, 10 parts of poria cocos, 10 parts of dried orange peel, 6 parts of amomum tsao-ko, 6 parts of clove, 10 parts of mangnolia officinalis, 10 parts of elecampane, 10 parts of fried medicated leaven, 10 parts of tribulus terrestris, 10 parts of dandelion, 10 parts of bletilla striata and 10 parts of honey-fried licorice root, and soaking the mixture in water for 30 minutes. Wherein, the weight ratio of the total weight of the Chinese medicinal materials to the weight of the water can be (1-2) to (5-10), and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(2) Decocting in water for three times, and decocting in water for 1.5 hr for the first time. Wherein, the weight ratio of the total weight of the Chinese medicinal materials to the water is 1: 10, and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(3) Decocting in water for 1.5 hr for the second and third times. Wherein the weight ratio of the total weight of the Chinese medicinal materials to the water is 1: 8, and the specific water addition amount can be determined according to the weight of the Chinese medicinal materials.

(4) And combining the filtrates obtained by the three times of filtration, and filtering by a 200-mesh filter to obtain a filtrate.

(5) Concentrating under vacuum degree of-0.06-0.08 MPa and temperature of 70-80 deg.C to relative density of 1.20-1.25(50 deg.C) to obtain fluid extract.

(6) Adopting a one-step granulation method, taking dextrin and mannitol as base materials at a ratio of 8: 1, spraying the clear paste to obtain granules, and subpackaging to obtain the traditional Chinese medicine composition granules.

The preparation method is suitable for decocting in pharmacy, pharmaceutical factory, and institution to prepare into granule, and has the advantages of long storage time, simple use, and easy transportation and carrying.

In addition, each Chinese medicinal material in the composition can be directly replaced by commercially available Chinese medicinal formula granules with corresponding equivalent crude drug amount. The application method comprises mixing the Chinese medicinal granules directly, and dissolving in hot water.

Meanwhile, the traditional Chinese medicine composition for preventing and treating tumors, treating after-appetite reduction and gastrointestinal reactions, which is prepared by taking the traditional Chinese medicine composition provided by the invention as an active ingredient, also belongs to the protection scope of the invention.

The traditional Chinese medicinal materials adopted by the invention have the following effects and pharmacological effects:

radix Codonopsis is dried root of radix Codonopsis, radix Codonopsis Lanceolatae or radix Codonopsis Pilosulae belonging to Campanulaceae family. Has effects in invigorating spleen, replenishing qi, quenching thirst, invigorating spleen, benefiting lung, nourishing blood, and promoting fluid production, and can be used for treating deficiency of spleen-lung qi, anorexia, listlessness, cough, asthma, deficiency of qi and blood, sallow complexion, palpitation, short breath, thirst due to body fluid consumption, internal heat, diabetes, etc. Modern pharmacology indicates that the codonopsis pilosula mainly contains chemical components such as alkaloids, polyacetylenes, lignans, flavonoids, polysaccharides and the like, and can protect nerves, resist tumors, oxidation, inflammation, stress, liver and the like.

Atractylodis rhizoma is dried rhizome of Atractylodes macrocephala Koidz of Compositae. Has effects of invigorating spleen, invigorating qi, eliminating dampness, promoting diuresis, arresting sweating, and preventing miscarriage, and can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion. Modern pharmacology indicates that the bighead atractylodes rhizome mainly contains chemical components such as volatile oil, polysaccharide and amino acid, and can regulate immunity, improve gastrointestinal tract function, regulate intestinal flora, promote healing of intestinal mucosal ulcer, resist tumors, protect nerves, resist inflammation, inhibit bacteria, improve glycometabolism and the like.

Pinellia is dried tuber of pinellia tuber of Araceae. Has effects of eliminating dampness and phlegm, lowering adverse qi and relieving vomit, and relieving oppression and masses, and can be used for treating damp phlegm cold phlegm, cough and asthma excessive phlegm, phlegm retention and dizziness and palpitation, wind phlegm giddiness, phlegm syncope and headache, emesis and regurgitation, chest distress, globus hystericus, etc. Modern pharmacology indicates that pinellia ternata mainly contains chemical components such as alkaloid, volatile oil, organic acid, sterols, amino acid, inorganic elements and the like, and has the effects of relieving cough, eliminating phlegm, stopping vomiting, resisting early pregnancy, resisting ulcer, resisting tumor, reducing blood fat, reducing blood pressure and the like. The ginger processed pinellia is prepared by soaking raw pinellia in water, decocting with fresh ginger and alum, taking out, drying, moistening and slicing, and has reduced toxicity, warm and dry nature, and good effects in eliminating dampness and phlegm, lowering adverse qi and relieving vomit.

Poria is dried sclerotium of Poria cocos (Schw.) wolf of Polyporaceae. Has effects in promoting diuresis, eliminating dampness, invigorating spleen, and calming heart, and can be used for treating edema, oliguria, phlegm and fluid retention, dizziness, palpitation, spleen deficiency, anorexia, loose stool, diarrhea, uneasiness, palpitation, and insomnia. Modern pharmacology indicates that the poria cocos mainly contains chemical components such as polysaccharides, triterpenes, sterols and volatile oil, and has the effects of promoting urination, protecting the liver, tranquilizing, regulating immunity, resisting inflammation, resisting tumors, reducing blood fat and the like.

Pericarpium Citri Tangerinae, which is dried mature pericarp of Rutaceae plant fructus Citri Tangerinae and its cultivar. Has effects of regulating qi-flowing, invigorating spleen, eliminating dampness and phlegm, and can be used for treating abdominal distention, anorexia, vomiting, diarrhea, cough, excessive phlegm, etc. Modern pharmacology indicates that the dried orange peel mainly contains chemical components such as vitamin B, vitamin C, nobiletin, flavonoid compounds, volatile oil and the like, and can resist tumor, relieve cough and asthma, eliminate phlegm, resist shock, resist aging, promote secretion of digestive juice and the like.

Fructus Tsaoko is dry mature fruit of Tsaoko of Zingiberaceae. Has effects of eliminating dampness, warming middle warmer, preventing malaria, and eliminating phlegm, and can be used for treating cold-dampness retention, abdominal distention and pain, distention and fullness, emesis, malaria, fever, plague, etc. Modern pharmacology indicates that tsaoko amomum fruits mainly contain chemical components such as volatile oil, polyphenols, diphenyl heptane, bicyclononane, sterols and the like, and can regulate gastrointestinal dysfunction, resist oxidation, bacteria, tumors, lose weight, reduce blood fat, reduce blood sugar and the like.

Flos Caryophylli is the dried bud of flos Caryophylli of Myrtaceae. Has effects of warming middle-jiao, lowering adverse qi, invigorating kidney, and tonifying yang, and can be used for treating deficiency cold of spleen and stomach, singultus emesis, anorexia, emesis, diarrhea, psychroalgia of heart and abdomen, and sexual impotence due to kidney deficiency. Modern pharmacology indicates that the clove mainly contains chemical components such as clove oil, eugenol, flavonoid, steroids, triterpenes, tannin and the like, and can resist oxidation, inflammation, fever and pain, tumors, memory and the like.

Cortex Magnolia officinalis is dry bark, root bark and branch bark of Magnolia officinalis or Magnolia officinalis of Magnoliaceae. Has effects of eliminating dampness, eliminating phlegm, descending qi and relieving fullness, and can be used for treating damp stagnation, distention and fullness, vomiting and diarrhea, food stagnation, abdominal distention, constipation, phlegm retention, asthma, cough, etc. Modern pharmacology indicates that the mangnolia officinalis mainly contains chemical components such as phenolic compounds, alkaloids and volatile oil, and can resist diarrhea, improve gastrointestinal dyskinesia, epilepsy, depression, dementia, blood pressure and heart-lung function, reduce blood sugar, resist inflammation, pain, bacteria, tumors and oxidation and the like.

Radix aucklandiae is dried root of radix aucklandiae of Compositae. Has effects in activating qi-flowing, relieving pain, invigorating spleen, and resolving food stagnation, and can be used for treating chest and hypochondrium, abdominal distention and pain, diarrhea, dysentery, food stagnation, and anorexia. Modern pharmacology indicates that the costustoot mainly contains terpenes, alkaloids, anthraquinone, flavone and other chemical components, and can resist cardiovascular diseases, inflammation, tumors, ulcers, pathogenic microorganisms, spasmolysis, pain and the like.

Medicated leaven is prepared by adding flour into herba Polygoni Hydropiperis, herba Artemisiae Annuae, and semen Armeniacae amarum, mixing, and fermenting. Has effects of invigorating spleen, regulating stomach function, resolving food stagnation, and regulating middle warmer, and can be used for treating weakness of spleen and stomach, dyspepsia, emesis, and diarrhea. Modern pharmacology indicates that medicated leaven mainly contains digestive enzyme, volatile oil, glycosides and other chemical components, and can promote secretion of digestive juice, improve intestinal dysbacteriosis and the like. The medicated leaven is prepared by uniformly spreading bran in a hot pot or parching the medicated leaven to yellow without bran, and has effects of invigorating spleen and stomach, and resolving food stagnation.

Tribulus terrestris, dried mature fruit of Tribulus terrestris of Zygophyllaceae. Has effects of suppressing hyperactive liver, resolving stagnation, promoting blood circulation, dispelling pathogenic wind, improving eyesight, and relieving itching, and can be used for treating headache, giddiness, chest and hypochondrium distending pain, breast closed mastitis, conjunctival congestion, nebula, rubella, pruritus, etc. Modern pharmacology indicates that the caltrop mainly contains chemical components such as saponins, flavonoids, alkaloids, polysaccharides and the like, and can enhance sexual function, resist aging, bacteria and tumors, regulate blood fat, treat cardiovascular system diseases and the like.

Herba Taraxaci is dried whole plant of Taraxacum officinale Kitag of Compositae, Taraxacum sinicum Kitag or plants of the same genus. Has effects of clearing away heat and toxic materials, relieving swelling, resolving hard mass, inducing diuresis, and treating stranguria, and can be used for treating furuncle, swelling, acute mastitis, scrofula, conjunctival congestion, pharyngalgia, pulmonary abscess, intestinal abscess, damp-heat jaundice, stranguria with astringency, etc. Modern pharmacology indicates that the dandelion mainly contains chemical components such as flavonoids, phenolic acids, sterols, polysaccharides and the like, and can inhibit bacteria, diminish inflammation, regulate blood sugar, resist aging, enhance immunity, resist tumors and the like.

Rhizoma Bletillae is dried tuber of bletilla striata of Orchidaceae. Has effects of astringing, stopping bleeding, relieving swelling, and promoting granulation, and can be used for treating hemoptysis, hematemesis, traumatic hemorrhage, pyocutaneous disease, toxic swelling, and chapped skin. Modern pharmacology indicates that the bletilla striata mainly contains chemical components such as saccharides, bibenzenes and derivatives thereof, phenanthrenes, dihydrophenanthrenes, dihydrophenanthrene furans, diphenanthrene ethers, steroids and triterpenes, and the like, and can stop bleeding, regulate immunity, promote wound healing, resist bacteria, inflammation, tumors, oxidation and ulcer, promote hematopoiesis, resist viruses and the like.

The Glycyrrhrizae radix is dried root and rhizome of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat or Glycyrrhiza glabra L of Leguminosae. Has effects of invigorating spleen and replenishing qi, clearing away heat and toxic materials, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the drugs, and can be used for treating weakness of spleen and stomach, listlessness debilitation, cardiopalmus short breath, cough with excessive phlegm, abdominal cavity and limbs spasm pain, carbuncle swelling and sore toxin, etc. Modern pharmacology indicates that the liquorice mainly contains chemical components such as triterpenes, flavonoids, polysaccharides, coumarins, volatile oils, amino acids and the like, and can resist tumors, bacteria, viruses, inflammation, immunity, oxidation, aging, fibrosis and the like. The prepared licorice is warm in nature, is prepared by adding honey into raw licorice, and is better in warming, tonifying and harmonizing.

The traditional Chinese medicine composition for preventing and treating tumors, and treating anorexia and gastrointestinal reactions is prepared from the traditional Chinese medicinal materials. The whole prescription takes the codonopsis pilosula as monarch drug for tonifying middle-jiao, replenishing qi and strengthening spleen; the atractylodes macrocephala is mainly used for eliminating dampness and phlegm, tonifying spleen and replenishing qi, and the ginger processed pinellia is mild and dry and is used as a key medicine for eliminating damp-phlegm, and is used for calming adverse-rising energy, harmonizing stomach, preventing vomiting, tonifying spleen and eliminating dampness, and the atractylodes macrocephala and the pinellia are used as ministerial medicines; poria cocos, dried orange peel and tsaoko amomum fruit can regulate qi movement to remove stuffiness and stuffiness in the chest and stomach, can descend adverse rise of stomach qi to arrest vomiting, dry dampness and resolve phlegm to eliminate phlegm caused by dampness accumulation, so called qi is smooth and phlegm is self-eliminated. Clove and magnolia officinalis regulate qi movement, regulate qi and transport spleen, costustoot dispels dampness with aromatics, enlivens spleen and harmonizes middle warmer, and simultaneously helps amomum tsao-ko and dried orange peel to dispel dampness and eliminate phlegm, medicated leaven enters spleen and stomach channels, stir-fried to enhance the effects of promoting digestion, stimulating appetite, regulating qi, eliminating dampness, strengthening spleen and harmonizing middle warmer, tribulus terrestris regulates qi movement, dandelion and bletilla are used together for clearing heat and removing toxicity, dissipating blood stasis and relieving swelling, and removing blood stasis and obstruction caused by toxin, and are used as adjuvant drugs; prepared licorice root, radix Glycyrrhizae Praeparata, with a slightly warm nature, is used to harmonize the various drugs as a guiding drug. The combination of the whole formula can ensure that phlegm dampness is removed, spleen and stomach are nourished, toxin stasis is eliminated, and qi movement is smooth, thereby having the effects of strengthening spleen and tonifying stomach, regulating qi and regulating the middle warmer, eliminating turbid pathogen and detoxifying, eliminating dampness and phlegm, resisting cancer and removing blood stasis.

The functions are as follows: invigorating spleen and stomach, regulating qi-flowing, regulating the middle warmer, eliminating turbid pathogen and toxic substance, eliminating dampness and phlegm, resisting cancer and removing blood stasis.

The main treatment is as follows: tumor and treating anorexia, or abdominal distention, nausea, emesis, sallow complexion, listlessness, debilitation, low voice, pale tongue, thin and white tongue coating, and soft-superficial and thready pulse; or pale and tasteless, sticky and greasy mouth, lassitude or edema of limbs, constipation or diarrhea, pale tongue with white or white greasy coating, and soft and slow pulse; or dry mouth, bitter taste, halitosis, retching, heavy sensation in the body, scanty and yellow urine, red tongue with yellow and greasy coating, soft-superficial and rapid pulse.

The invention has the advantages that:

(1) preventing the occurrence of anorexia, gastrointestinal distension, abdominal distension, nausea and vomiting: according to the symptoms, the traditional Chinese medicine belongs to the categories of ' anorexia ', ' fullness and vomiting ', and the like, wherein ' stomach qi is the main of health preservation, stomach is strong, stomach is weak and weak, stomach is healthy, stomach is dead without stomach, spleen qi is communicated with mouth, spleen and mouth can know five cereals ', and the five internal organs are qi-endowing in stomach, and the basis of five internal organs and six internal organs of stomach is also ' said that the traditional Chinese medicine considers that the spleen and stomach are weak and phlegm-dampness stasis is the basis. Therefore, the invention is taken by a cancer patient before symptoms appear, is beneficial to preventing the diseases in the bud and also conforms to the idea of preventing the diseases in the traditional Chinese medicine.

(2) The curative effect is obvious and lasting: clinical practices show that the Chinese medicinal composition can improve symptoms of anorexia, gastrointestinal distension, abdominal distension, nausea and vomiting of patients after tumors and related treatments by oral administration, and has the advantages of quick response, lasting effect and relatively small side effect.

(3) The quality of life is improved: the patients with anorexia, gastrectasia, abdominal distention, nausea and vomiting after tumor and related treatment seriously affect the quality of life due to symptoms of reduced food intake, discomfort in the stomach and abdomen, nausea and vomiting and the like, and cause huge burden on the physiology and even the psychology of the patients, so that the cancer treatment of the patients can not be normally and effectively carried out, and the prognosis of the patients is affected. When the traditional Chinese medicine composition is used for treating patients with symptoms of anorexia, gastrointestinal distension, abdominal distension, nausea and vomiting after tumors and related treatment, the effectiveness of the drug therapy can be improved, the immunity is enhanced, the life quality of the patients is improved, and the prognosis is improved.

(4) Matching with western medicine treatment: the traditional Chinese medicine composition has the effects of strengthening body resistance, eliminating pathogenic factors and resisting cancer, and clinically shows that the traditional Chinese medicine composition can prevent and relieve appetite decrease, gastrectasia, abdominal distension, nausea and vomiting of patients, improve the life quality of the patients and relieve adverse reactions of western medicine treatment when being matched with surgical treatment, radiotherapy, chemotherapy, targeted treatment and immunotherapy, so that the clinical treatment effect is enhanced and the prognosis of the patients is improved.

(5) The side effect is small: the current commonly used medicines have certain adverse reactions, for example, megestrol acetate can cause the adverse reactions such as peripheral edema, incomplete adrenal gland function and the like, and even increase the risk of venous thrombosis; mosapride can cause adverse reactions such as diarrhea, abdominal pain, dry mouth, rash, lassitude and dizziness; 5-HT₃Receptor antagonists often cause headache, constipation, elevated transaminase, abdominal distension and pain, and in severe cases, may also cause prolongation of the QT interval; metoclopramide may cause adverse reactions such as lethargy, dysphoria, fatigue, weakness, orthostatic hypotension and the like, and long-term application of a large dose may cause extrapyramidal reactions, muscle tremor, dysarthria, ataxia and the like. One of the advantages of the invention in improving tumor and treating anorexia, gastrectasia, abdominal distention, nausea and vomiting after tumor treatment is that adverse reaction is relatively small.

The innovation of the invention is that compared with other traditional Chinese medicine compositions for treating tumors and related treatments, the traditional Chinese medicine composition causes anorexia, gastrectasia, abdominal distension, nausea and vomiting, and has the following differences and innovations:

(1) the traditional Chinese medicine composition has the effects of eliminating phlegm dampness, eliminating stasis and toxin, tonifying spleen and stomach, promoting qi and blood circulation, strengthening body resistance and eliminating evil, strengthening spleen and tonifying stomach, regulating qi and regulating the middle warmer, eliminating turbidity and detoxifying, resisting cancer and removing blood stasis, recovering the ascending and descending of the spleen and stomach, dredging qi stagnation and eliminating phlegm dampness evil. The whole formula treats both principal and secondary aspect of disease, relieves the anorexia, the gastrectasia, the abdominal distension, the nausea and the vomiting of patients, treats the cancer, and has good clinical curative effect;

(2) the invention can play a role in quickly, obviously and durably relieving symptoms of patients with anorexia, gastrectasia, abdominal distension, nausea and vomiting after tumor and related treatment, and clinical research and practice show that the traditional Chinese medicine composition can also improve the traditional Chinese medicine symptoms, improve the life quality and enhance the immune function, thereby improving the clinical treatment effect of the patients with anorexia, gastrectasia, abdominal distension, nausea and vomiting without adverse reaction. The composition can be used for preventing or relieving anorexia, flatulence, abdominal distention, nausea and emesis of patients, improving life quality of patients, and relieving adverse reaction of western medicine treatment, and has synergistic effect.

In conclusion, the traditional Chinese medicine composition has exact curative effect on patients with anorexia and gastrointestinal reaction after tumor prevention and treatment and related treatment, has synergistic enhancement effect with western medicine treatment, can relieve clinical symptoms, improve traditional Chinese medicine symptoms, improve life quality, enhance immune function and improve patient prognosis, has no obvious adverse reaction, and is worthy of development and clinical popularization.

Detailed Description

The following will further describe the Chinese medicinal composition of the present invention with reference to specific examples to make those skilled in the art understand the present invention, but the present invention is not limited thereto.

The Chinese medicinal materials used in the following examples are identified before feeding, and the actual objects of the Chinese medicinal materials are consistent with the names of the Chinese medicinal materials.

Example 1: a Chinese medicinal decoction 1 for preventing and treating tumor, anorexia and gastrointestinal reaction

The composition comprises the following components in parts by weight: 10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 10 parts of ginger processed pinellia tuber, 10 parts of poria cocos, 10 parts of dried orange peel, 6 parts of tsaoko amomum fruit, 6 parts of clove, 10 parts of magnolia officinalis, 10 parts of costustoot, 10 parts of fried medicated leaven, 10 parts of tribulus terrestris, 10 parts of dandelion, 10 parts of rhizoma bletillae and 10 parts of honey-fried licorice root

Weighing 137g of the decoction pieces of the twelve medicinal materials according to the prescription, mixing, adding 1000ml of water, soaking for half an hour, and adding 1000ml of water to all the medicinal materials, and decocting for 40 minutes.

Filtering the decoction to obtain filtrate and residue, and finishing the first decoction. Taking out the filter residue, adding water again, decocting for 25 minutes, filtering the decoction to obtain filtrate and filter residue, and finishing the second decoction.

Mixing the filtrate obtained by the first decoction and the filtrate obtained by the second decoction to obtain the Chinese medicinal composition decoction 1, which is taken warmly when in use.

Example 2: preparation of a Chinese medicinal composition decoction 2 for preventing and treating tumor and anorexia and gastrointestinal reaction after treatment

The composition comprises the following components in parts by weight: 5 parts of codonopsis pilosula, 8 parts of bighead atractylodes rhizome, 5 parts of rhizoma pinelliae preparata, 5 parts of poria cocos, 5 parts of dried orange peel, 3 parts of tsaoko amomum fruit, 3 parts of clove, 5 parts of magnolia officinalis, 5 parts of elecampane, 5 parts of fried medicated leaven, 5 parts of tribulus terrestris, 5 parts of dandelion, 5 parts of rhizoma bletillae and 5 parts of honey-fried licorice root

69g of the traditional Chinese medicine decoction pieces of the twelve medicinal materials are weighed according to the prescription, mixed and decocted with water for three times. The first time is decocted for 1 hour by adding 700ml of water, the second time is decocted for 1 hour by adding 300ml of water, and the third time is decocted for 0.5 hour by adding 300ml of water.

Concentrating the obtained medicinal liquid under reduced pressure until the relative density is 1.1-1.15 at 60 deg.C, refrigerating, and standing for 24 hr.

Filtering to obtain filtrate, adding water to 500ml, bottling, and sterilizing to obtain the Chinese medicinal composition decoction 2 for warm administration.

Example 3: a Chinese medicinal decoction 3 for preventing and treating tumor, anorexia and gastrointestinal reaction

The composition comprises the following components in parts by weight: 30 parts of codonopsis pilosula, 30 parts of bighead atractylodes rhizome, 15 parts of rhizoma pinelliae preparata, 15 parts of poria cocos, 15 parts of dried orange peel, 12 parts of tsaoko amomum fruit, 12 parts of clove, 15 parts of mangnolia officinalis, 15 parts of elecampane, 20 parts of fried medicated leaven, 15 parts of tribulus terrestris, 20 parts of dandelion, 15 parts of rhizoma bletillae and 15 parts of honey-fried licorice root

244g of the decoction pieces of the twelve medicinal materials are weighed according to the prescription, 2000ml of water is added after the decoction pieces are mixed for soaking for half an hour, and 2000ml of water is added to all the medicinal materials for decocting for 40 minutes.

Mixing the filtrate obtained by the first decoction and the filtrate obtained by the second decoction to obtain the Chinese medicinal composition decoction 3, which is taken warmly when in use.

Example 4: a Chinese medicinal granule 1 for preventing and treating tumor, anorexia and gastrointestinal reaction

Weighing 137g of the decoction pieces of the twelve medicinal materials according to the prescription, mixing, adding 1000ml of water, and soaking for 30 minutes. 1300ml of water is added for the first time and decocted for 1.5 hours, and 1000ml of water is added for the second time and the third time and decocted for 1.5 hours. And combining the filtrates obtained by the three times of filtration, and filtering by a 200-mesh filter to obtain a filtrate. Concentrating under vacuum degree of-0.06-0.08 MPa and temperature of 70-80 deg.C to relative density of 1.20-1.25(50 deg.C) to obtain fluid extract.

Adopting a one-step granulation method, taking dextrin and mannitol at a ratio of 8: 1 as base materials, spraying the clear paste to obtain granules, subpackaging to obtain the traditional Chinese medicine composition granules 1, and taking the traditional Chinese medicine composition granules with hot water when in use.

Example 5: preparing a Chinese medicinal composition granule 2 for preventing and treating tumor and treating anorexia and gastrointestinal reaction

The composition comprises the following components in parts by weight: 5 parts of codonopsis pilosula, 6 parts of bighead atractylodes rhizome, 3 parts of rhizoma pinelliae preparata, 5 parts of poria cocos, 6 parts of dried orange peel, 3 parts of tsaoko amomum fruit, 3 parts of clove, 3 parts of magnolia officinalis, 3 parts of elecampane, 5 parts of fried medicated leaven, 3 parts of tribulus terrestris, 3 parts of dandelion, 5 parts of rhizoma bletillae and 5 parts of honey-fried licorice root

58g of the decoction pieces of the twelve medicinal materials are weighed according to the prescription, mixed and soaked in 500ml of water for 30 minutes. 580ml of water is added for the first time and decocted for 1.5 hours, and 460ml of water is added for the second time and the third time and decocted for 1.5 hours. And combining the filtrates obtained by the three times of filtration, and filtering by a 200-mesh filter to obtain a filtrate. Concentrating under vacuum degree of-0.06-0.08 MPa and temperature of 70-80 deg.C to relative density of 1.20-1.25(50 deg.C) to obtain fluid extract.

Adopting a one-step granulation method, taking dextrin and mannitol at a ratio of 8: 1 as base materials, spraying the clear paste to obtain granules, and subpackaging to obtain the traditional Chinese medicine composition granules 2 which are taken with hot water when in use.

Example 6: a Chinese medicinal granule 3 for preventing and treating tumor, anorexia and gastrointestinal reaction

Weighing the traditional Chinese medicine formula granules of the medicinal materials corresponding to the crude drugs according to the prescription amount of the medicinal materials, namely weighing the traditional Chinese medicine formula granules with the following weight:

30g of codonopsis pilosula, 30g of bighead atractylodes rhizome, 15g of ginger processed pinellia tuber, 15g of poria cocos, 15g of dried orange peel, 12g of tsaoko amomum fruit, 12g of clove, 15g of magnolia officinalis, 15g of costustoot, 20g of fried medicated leaven, 15g of tribulus terrestris, 20g of dandelion, 15g of rhizoma bletillae and 15g of honey-fried licorice root

Mixing the above Chinese medicinal granules directly to obtain Chinese medicinal composition granule 3, which can be administered with hot water.

Example 7: typical cases

Typical case 1

Wangzhi, female, age 75, confirmed more than half a year of bladder malignancy, with multiple metastases. The local hospital is diagnosed in 8 months in 2020 because of the continuous unrelieved abdominal pain and abdominal distension. CT shows that: malignant tumor on right side of bladder, invade serosa surface, accumulate opening of right ureter, expand hydrops of secondary right urine collecting system; lower right lung nodule foci, metastasis is considered. ECT shows: the bone metabolism abnormality of the whole body is considered as bone destruction, the bone metabolism abnormality of long bones of the skull and limbs and the osteoporosis. The first cycle of chemotherapy, which was a GC regimen, gemcitabine + cisplatin, was initiated at the local hospital on month 12 2020. The patients who have vomit of II grade during chemotherapy can relieve the vomit after symptomatic treatment. After 1 cycle of chemotherapy, patients have anorexia, reduced appetite, stomach distention and abdominal distention, and aggravation after eating, accompanied by dry mouth, bitter taste, halitosis, vomiturition, heavy body, asthenia, yellow urine, red tongue with yellow and greasy coating, and soft-superficial and rapid pulse. Differentiation of symptoms and signs include weakness of spleen and stomach and retention of phlegm-heat in the interior, and treatment with the actions of invigorating spleen, removing dampness, clearing heat and resolving phlegm. After evaluation, the patient was rated II for anorexia, 9 for bloating and bloating, I for nausea and vomiting, and 75 for KPS.

The decoction of example 1 was taken for 1 course of treatment, i.e. 1 dose daily, divided into morning and evening for 14 days, and the patient was instructed to apply the obtained residue externally around the umbilicus. After 14 days, the symptoms are improved, the disease condition is relieved, the anorexia is graded as 0 grade, the gastrectasia and abdominal distension are graded as 4 grades, the nausea and vomiting are graded as 0 grade, and the KPS is graded as 80 grades. The subsequent treatment is continued for 14 days with the previous consolidation treatment, and all the following symptoms are removed.

After chemotherapy of bladder cancer, the patient is older, has deficiency of vital qi, suffers from chemotherapy, loses vital qi, damages spleen and stomach, causes imbalance of ascending and descending of the spleen and stomach, has no right to transport and transform, and has the symptoms of anorexia, reduced appetite, stomach distension and abdominal distension, and aggravation after eating; spleen governs transportation and transformation of water, so dysfunction of spleen and stomach can lead to failure of body fluid to go up and cause dryness of mouth, and water retention and accumulation of water can lead to generation of damp-phlegm; phlegm-dampness transforming into heat for a long time, and the heat is urgent and fumigating on the upper part, so the mouth is bitter and the halitosis is caused; dampness is a yin pathogen and tends to block qi, so the body is heavy and weak. Dampness obstructing heat and steaming inside it can cause scanty and yellow urine. A red tongue with yellow and greasy coating and a soft and rapid pulse, which is the condition of damp-heat accumulation in the interior. Radix codonopsitis, rhizoma atractylodis macrocephalae and pinellia ternate are used for tonifying qi, strengthening spleen, drying dampness, lowering adverse qi, harmonizing stomach, preventing vomiting, and having aromatic costustoot property, and can activate spleen to eliminate dampness, and medicated leaven is stir-fried to enhance the effects of regulating qi, eliminating dampness, strengthening spleen and regulating stomach, and can digest food and harmonizing stomach to assist transportation and digestion. For the good treatment of phlegm, qi is treated instead of treating phlegm, and qi is smooth and phlegm is eliminated, so Poria cocos, dried orange peel and fructus tsaoko are added to regulate qi movement, dry dampness and resolve phlegm, tribulus terrestris, clove and magnolia officinalis are added to regulate qi movement and regulate qi and spleen, dandelion and rhizoma bletillae are used for clearing heat and removing toxicity, and honey-fried licorice root is used for regulating qi movement and warming middle-jiao.

Typical case 2

One who is a male, 52 years old, has confirmed diagnosis of colon cancer for more than 2 months and 1 month after surgery. Before 2 months, patients are in a local hospital for treatment due to epigastric pain and unsmooth defecation, and are subjected to abdominal CT: left lower abdominal intussusception is not completely obstructed, considering colon cancer. Laparoscopic colectomy after admission examination, postoperative pathology reporting: myxoma adenocarcinoma, 6cm × 3cm × 2cm in volume, cancer tissue infiltrating the entire layer of intestinal wall, periintestinal lymph node metastasis: 7/12. Patients refused postoperative adjuvant chemotherapy for their own reasons. The physician needs to diagnose the disease in our family in 11 months in 2020, and the disease is manifested by poor appetite, listlessness, fullness and distention of stomach and abdomen, sallow complexion, lassitude, hypodynamia, low voice, emaciation, 8 jin of weight reduction after operation, pale tongue with white and greasy coating, and soft-superficial and thready pulse. It is manifested as weakness of the spleen and stomach accompanied by phlegm-dampness. For the treatment, it can strengthen spleen, resolve phlegm, regulate qi and harmonize middle energizer. After evaluation, the patient rated a loss of appetite on a scale of III, a bloating rating of 15 and a KPS rating of 70.

The decoction of example 3 was taken for 3 courses of treatment, i.e. 1 dose daily, divided into morning and evening for 7 days, and the patient was instructed to apply the obtained residue externally around the umbilicus. After 7 days, the symptoms are improved, the disease condition is relieved, the appetite loss is graded as I grade, the gastrectasia and abdominal distension are graded as 3, and the KPS is graded as 80. The decoction 1 of example 1 was used for 14 days, and all the following symptoms were removed. The patients had improved self-consciousness, received postoperative adjuvant chemotherapy, and started chemotherapy in local hospitals in 12 months in 2020 with oxaliplatin in combination with capecitabine, and no vomiting during chemotherapy.

The large intestine is one of six fu organs, and it is transported but not stored. The transmission and transformation of food by the large intestine, which requires continuous reception, digestion, conduction and excretion, is a process of alternating deficiency and excess, moving but not living, and is suitable for dredging but not stagnating. When the spleen and stomach are injured due to improper diet and occasional daily life, water will be damp, food will be stagnated, and essential qi cannot be transformed. For patients with postoperative intestinal cancer, deficiency of qi and blood, deficiency of spleen qi, stagnation of qi in middle energizer, and retention of phlegm-dampness, the main purpose of invigorating spleen and reducing phlegm should be taken, and the auxiliary purpose of regulating qi and harmonizing the middle warmer should be taken. The patient suffers from anorexia accompanied with weight loss, so codonopsis pilosula and bighead atractylodes rhizome are used for tonifying middle-jiao and qi, strengthening spleen and eliminating dampness, poria cocos and pinellia ternate ginger are added for better eliminating dampness and reducing phlegm, dried orange peel, tsaoko amomum fruits, clove, mangnolia officinalis and tribulus terrestris used for regulating qi activity, regulating qi and activating spleen, elecampane is used for activating spleen and regulating stomach, medicated leaven is fried for strengthening spleen and promoting appetite, dandelion and bletilla are used for dissipating blood stasis and detoxifying, and honey-fried licorice is used for regulating the effects of the other drugs. The combination of the whole formula can tonify spleen and stomach, remove phlegm-dampness, and smooth qi movement, and the dosage is reduced after the symptoms are improved so as to consolidate the curative effect.

Typical case 3

Shang-Zeng, male, 65 years old, dry cough with hoarse voice for more than 2 months. The patient is diagnosed in local hospital at 8 months in 2021, lung puncture examination is carried out, lung cancer is diagnosed, lung adenocarcinoma is suggested as pathological indication, and PET-CT examination shows that the lung cancer is left central lung cancer, and is accompanied with bilateral pulmonary portal and supraclavicular lymph node metastasis and bone metastasis. The gene detection result shows that PD-L1 is more than or equal to 50 percent, and the rest genes are wild. In 2021, 9 months, the hospital starts to carry out immune single-drug treatment, the treatment medicine is a Pabolizumab injection (trade name: Coprina) and nausea and vomiting occur during the treatment, grade II adverse reactions are evaluated according to CTCAE, and the treatment process normally proceeds after symptomatic support treatment. After the immunotherapy is finished, the patient is diagnosed in the department of China, nausea and retching, gastric cavity and abdomen fullness and discomfort, poor appetite, tastelessness and tastelessness, sticky and greasy mouth, edema of limbs, pale tongue with white coating and soft and slow pulse are seen. Syndrome differentiation includes spleen deficiency with dampness and adverse rising of stomach-qi. It is indicated for strengthening spleen, drying dampness, checking adverse rise of qi and arresting vomiting. After evaluation, the patient was rated II for anorexia, 13 for bloating and bloating, II for nausea and vomiting, and 75 for KPS.

The granules of example 4 were taken for one treatment course, i.e. 1 dose per day, divided into morning and evening, and continued for 14 days. After 14 days, the symptoms are improved, the disease condition is relieved, the anorexia is graded as 0 grade, the gastrectasia and abdominal distension are graded as 2 grades, the nausea and vomiting are graded as 0 grade, and the KPS is graded as 80 grades. The decoction 2 of example 5 was used for 14 days of consolidation treatment, all the following symptoms were removed, and the patient continued to the next cycle of immunotherapy without any symptoms during treatment.

After the patient is subjected to the lung cancer immunotherapy, the lung is a organ of the heart, mainly disperses and descends, tumors injure the vital qi of the human body, the lung is gathered to easily block the qi activity, the qi of the whole body is influenced, the immunotherapy restores the immune monitoring and immune clearing functions of the body, the vital qi is stimulated to resist the pathogenic factors, the autoimmune balance state is broken, and the body dysfunction is aggravated. Lung disease and spleen, child disease and mother disease cause spleen and stomach deficiency, abnormal ascending and descending, water-dampness stagnation, stomach qi descending and ascending of the stomach qi. The main cause of vomiting is the ascending, descending, transportation and transformation of the spleen and stomach, which is characterized by the failure of spleen qi to transport and transform food, retention of phlegm and fluid retention in the middle warmer, ascending of inflammation with heat and vomiting with cold accumulation. Therefore, codonopsis pilosula is used for strengthening spleen and tonifying lung, mothers and children are used for tonifying, bighead atractylodes rhizome, poria cocos and dried orange peel are used for strengthening spleen and drying dampness, pinellia ternate and ginger are better used for drying dampness and resolving phlegm, calming adverse-rising energy and stopping vomiting, tsaoko amomum and clove are used for warming middle-jiao and calming adverse-rising energy, magnolia officinalis, tribulus terrestris and elecampane are used for regulating qi movement, medicated leaven is fried for strengthening spleen and stomach, dandelion and bletilla are used for dissipating blood stasis and detoxifying, and the effect of astringing is achieved, and honey-fried licorice root is used for regulating the effects of the medicines.

Typical case 4

Zhangzhi, male, 90 years old, confirmed the esophagus malignant tumor for more than 1 month. The local hospital is visited for 20 days due to the occurrence of progressive dysphagia in 10 months in 2020, and the barium meal examination result of the upper digestive tract is shown as follows: middle and upper esophageal cancer; the pathological cytological examination confirms the diagnosis of esophageal squamous cell carcinoma. Since the patient is high in age, the doctor and the family refuses the operation, and the Chinese medicine treatment is sought. The doctor visits my family in 12 months in 2020, and the family members complain: before 2 months, there is no obvious reason to cause progressive dysphagia, nausea and vomiting after eating, after taking antiemetic, the symptoms are relieved, and the symptoms appear discontinuously. The following symptoms are shown: poor appetite, obstructed food intake, vomiting immediately after drinking or eating, vomiting of white phlegm and saliva, abdominal distension, mental fatigue, loose stool, pale tongue with thin and white coating and soft-superficial and slow pulse. Syndrome differentiation is the syndrome of phlegm-dampness in the spleen. For treatment, it can tonify qi, invigorate spleen, dry dampness and resolve phlegm. After evaluation, the patient was rated for anorexia as grade III, stomach and abdominal fullness as 10, nausea and vomiting as grade II, and KPS as 65.

The granules of example 6 were taken for 3 courses, i.e. 1 dose per day, divided into morning and evening, for 7 days. After 7 days, the symptoms are improved, the disease condition is relieved, the anorexia is graded as I grade, the stomach and abdomen fullness is graded as 3 grade, the nausea and vomiting are graded as 0 grade, and the KPS is graded as 75 grade. The granule 1 of example 4 is used for the second treatment after 14 days of consolidation treatment, the symptoms are improved, and the last treatment is continued for more than 2 months without other special discomfort.

The patients with senile weakness, deficiency of vital qi, spleen deficiency, and weakness in transportation and transformation cause water-dampness to stop accumulating, accumulate dampness to form phlegm, retain viscera, cause phlegm-dampness internal resistance, disorder of middle-jiao qi activity, and stomach disorder, so the patients have symptoms of food intake obstruction, poor appetite, nausea and vomiting, abdominal distention, loose stool, mental fatigue and hypodynamia, and should be treated with the effects of tonifying qi and strengthening spleen, eliminating dampness and resolving phlegm. The formula has the effects of tonifying middle-jiao and spleen, eliminating dampness and phlegm, lowering adverse qi and stopping vomiting, regulating qi movement, lowering adverse qi and harmonizing stomach, and has the effects of eliminating dampness and warming middle-jiao, clove, magnolia officinalis, amomum tsao-ko and costus root, and the prepared licorice root has the effects of tonifying spleen and qi and harmonizing the medicines.

Example 8: clinical trial 1

According to literature research and investigation, patients with digestive system malignant tumor, especially patients with stomach and esophagus malignant tumor, often suffer from various gastrointestinal adverse reactions and anorexia. On the basis that the traditional Chinese medicine composition achieves good clinical curative effects on anorexia and gastrointestinal reactions after tumor treatment and related treatment, the inventor explores the way that the traditional Chinese medicine composition can be used for preventively treating patients with gastrointestinal malignant tumors, evaluates whether the traditional Chinese medicine composition can improve the symptoms of the anorexia, the gastrectasia, the abdominal distension, the gastrointestinal reactions of nausea and vomiting of the patients with the gastrointestinal tumors or reduce the degree of the symptoms, and pays attention to whether the quality of life of the patients is improved accordingly.

1. Case selection criteria

1.1 case inclusion criteria

According to the diagnosis standard of ' standard for diagnosis and treatment of common malignant tumor ' issued by Ministry of health of the people's republic of China, the malignant tumor of the digestive system is diagnosed clearly through pathology, and the clinical stages are II-IV stages;

② patients who do not receive any operation, radiotherapy, chemotherapy, targeted therapy and immunotherapy during the observation period;

③ Karnofsky functional status score (KPS) is more than or equal to 60 points, and the function insufficiency of the gravity, liver, kidney and bone marrow is not strict;

fourthly, the life is 18 to 80 years old, and the estimated survival time is more than or equal to 3 months;

voluntarily receiving the treatment by the scheme, having good compliance and signing an informed consent;

and complete clinical data.

1.2 case exclusion criteria

Situations that may prevent a subject from completing a clinical trial process, including but not limited to severe, difficult to control organic lesions or infections, etc.;

② there is gastrointestinal bleeding or there is mechanical eating disorder such as chewing, swallowing difficulty or digestive tract obstruction;

③ those suffering from uncontrollable mental diseases or mental disorders;

fourthly, the patients with metabolic diseases, such as diabetes, hyperthyroidism, hypothyroidism and the like, need to use hormone for a long time to treat the diseases and influence the weight and the metabolic level;

the patients who participate in other drug testers or take other drugs related to appetite improvement at the same time, or use oral administration and/or intravenous nutrition support therapentic people;

sixthly, the curative effect cannot be judged or other factors influence the judgment of the curative effect or the judgment of the safety;

the researcher considers that the researcher can not cooperate with the subject who completes the clinical investigation.

1.3 case knockout and termination criteria

Firstly, the patient newly develops other serious diseases in the implementation process of the research, and the experimenter cannot continue to test the diseases;

② patients with serious adverse reactions in the treatment process;

thirdly, the testee requires or must quit for various reasons;

patients receive other treatments which have influence on the research result due to various reasons or self-add medicines and reduce medicines in the research implementation process, and the compliance is too high (> 120%) or too low (< 80%).

2. Design of research

A randomized, double-blind, placebo-controlled study was used. All groups of patients 70 were treated as per 1: 1 was randomly assigned to the control group and the treatment group, 35 cases each.

Both groups were given routine care, but did not include nutritional support therapy.

The control group was treated with placebo prepared by: 1/10 dosage of example 4 granule 1, made with dextrin. Treatment group granules 1 of example 4 were used. The two groups of medicines are used as follows: dissolving the medicine with hot water, diluting with hot water to 500ml, and warm-taking once every morning and evening, with a treatment course of 14 days.

3. Observation index

The occurrence and severity of anorexia, bloating, abdominal distension, nausea and vomiting were recorded in two groups 14 days after treatment and the quality of life of the patients was assessed.

Evaluation index of appetite decrease:

the appetite loss was rated on 5 scales according to the evaluation criteria for common adverse events (CTCAE), fifth edition: level 0: no appetite loss; stage I: appetite declined, but dietary habits were unchanged; II stage: changes in eating, not accompanied by weight loss or malnutrition, but requiring supplementation by oral administration; grade III: significant weight loss or malnutrition symptoms (e.g., insufficient calories and/or fluid volume by oral feeding), requiring nasal feeding or total parenteral nutrition; stage IV: life threatening, requiring emergency treatment; and V stage: death was caused by death

Evaluation indexes of gastrectasia and abdominal distension:

a scale is drawn up for evaluation according to the clinical research guiding principle of the new traditional Chinese medicine and the evaluation standard (CTCAE) of common adverse events, the items of the scale comprise 6 items including the existence of the gastric distention, the decrease of food intake, abdominal circumference, anus exhaust frequency, bowel sound and abdominal percussion, each item is divided into 0 to 4 points, 0 point is the no gastric distention and abdominal distention, 1 to 8 points are mild, 9 to 16 points are moderate, and 17 to 24 points are severe.

Evaluation index of nausea and vomiting:

nausea and vomiting were divided into 5 grades, evaluated according to the common adverse event evaluation criteria (CTCAE), fifth edition: level 0: no nausea and vomiting; stage I: no intervention is required; II stage: outpatient vein fluid infusion, medical intervention is needed; grade III: nasal feeding, total parenteral nutrition or hospitalization is required; stage IV: life threatening; and V stage: and death.

Evaluation index of quality of life:

the evaluation is carried out according to the Ka-Shi score (KPS), the KPS score is weakened when the KPS score is reduced by more than or equal to 10 compared with before-treatment, the KPS score is stable when the KPS score is reduced or increased by less than 10 compared with before-treatment, and the KPS score is improved when the KPS score is increased by more than or equal to 10 compared with before-treatment. Wherein, the effective rate is (stable case number + improved case number)/total case number × 100%.

4. Results

Incidence and extent of anorexia: 6 cases of the control group are normal, and 29 cases of the control group have anorexia with the incidence rate of 82.9 percent; 23 cases of the treatment group are normal, 12 cases of the treatment group have anorexia, the incidence rate is 34.3 percent, and the comparison difference of the two groups has statistical significance (P is less than 0.05); 18 cases in the control group were grade I (51.4%), 9 cases in the treatment group were grade I (25.7%), and the comparison between the two groups was statistically significant (P < 0.05); 7 cases in the control group were grade II (20.0%), 3 cases in the treatment group were grade II (8.6%), and the comparison between the two groups was not statistically significant (P > 0.05); control 3 cases were grade III (8.6%), treatment 0 cases were grade III (0.0%), and the comparison between the two groups was not statistically significant (P > 0.05). Control group 1 was grade IV (2.9%), treatment group 0 was grade IV (0.0%), and the differences between the two groups were not statistically significant (P > 0.05).

Occurrence and degree of bloating and abdominal distension: 8 cases of the control group are normal, 27 cases of the control group have stomach and abdomen fullness, and the incidence rate is 77.1 percent; 25 cases of the treatment group are normal, 10 cases of the treatment group have stomach and abdomen fullness, the incidence rate is 28.6 percent, and the comparison difference of the two groups has statistical significance (P is less than 0.05); control 18 cases were mild (51.4%), treatment 9 cases were mild (25.7%), and the differences were statistically significant (P < 0.05) in comparison between the two groups; control 6 cases were moderate (17.1%), treatment 1 cases were moderate (2.9%), and the difference between the two groups was not statistically significant (P > 0.05); control 3 cases were severe (8.6%), treatment 0 cases were severe (0.0%), and the comparison between the two groups was not statistically significant (P > 0.05).

Occurrence and extent of nausea and vomiting: the control group had 20 normal cases and 15 cases with 42.9% incidence of vomiting; in the treatment group, 34 patients had normal disease,

1 case had vomiting with incidence of 2.9%, and the two groups had statistical differences (P < 0.05); 11 cases in the control group were grade I (31.4%), 1 case in the treatment group was grade I (2.9%), and the comparison between the two groups was statistically significant (P < 0.05); 4 cases in the control group were grade II (11.4%), 0 cases in the treatment group were grade II (0.0%), and the comparison between the two groups was not statistically significant (P > 0.05); there were 0 cases in each of the two groups, class III, class IV and class V, and the comparison between the two groups was not statistically significant (P > 0.05).

Quality of life: 19 of the control group were attenuated (54.3%), 2 of the treatment group were attenuated (5.7%), and the comparative differences between the two groups were statistically significant (P < 0.05); 12 cases in the control group were stable (34.3%), 5 cases in the treatment group were stable (14.3%), and the difference between the two groups was not statistically significant (P > 0.05); 4 cases in the control group improved (11.4%), 28 cases in the treatment group improved (80.0%), and the comparison difference between the two groups has statistical significance (P < 0.05); the effective rate of the control group is 45.7%, the effective rate of the treatment group is 94.3%, and the comparison difference of the two groups has statistical significance (P is less than 0.05).

Research results show that the traditional Chinese medicine composition can reduce incidence rates of anorexia, gastrectasia, abdominal distention, nausea and vomiting of patients with digestive tract malignant tumors, and improve life quality of the patients.

Example 9: clinical trial 2

At present, random, double-blind and placebo-controlled clinical research is carried out, aiming at observing the effectiveness of the traditional Chinese medicine composition in treating anorexia and gastrointestinal reaction after malignant tumor chemotherapy, evaluating whether the traditional Chinese medicine composition can improve the symptoms of anorexia, gastrectasia, abdominal distension, nausea and vomiting, reducing the degree of the symptoms and improving the life quality of patients.

1. Western diagnostic criteria:

firstly, according to the diagnosis standard of ' standard for diagnosing and treating common malignant tumor ' issued by Ministry of health of the people's republic of China, the malignant tumor is clearly diagnosed through pathology;

② diagnosing anorexia: evaluated according to the common adverse event evaluation criteria (CTCAE), grade I and above is considered to be anorexia;

③ diagnosis of stomach and abdominal distension: drawing up a scale for evaluation according to the clinical research guiding principle of the new traditional Chinese medicine and the evaluation standard (CTCAE) of common adverse events, and considering that the stomach and abdominal distension exist at 1 point or more;

fourthly, diagnosis of vomiting: emesis was considered to be present on grade I and above, assessed according to the common adverse event evaluation criteria (CTCAE).

2. The traditional Chinese medicine diagnosis standard is as follows: the Chinese medicine is formulated according to the internal science of traditional Chinese medicine and the clinical research guiding principle trial of new traditional Chinese medicines, the following 2 main symptoms and more than 1 secondary symptom are met, and the tongue coating pulse condition can be distinguished.

The main symptoms are: poor appetite, or distending and uncomfortable feeling in the gastric cavity and abdomen, or nausea and vomiting;

the secondary symptoms are as follows: after eating, the stomach and abdomen is distended and aggravated, the complexion is sallow, the people are listless and hypodynamia, the voice is low, or the mouth is light and tasteless, the mouth is sticky and greasy, the limbs are sleepy or are swollen, the stool is not smooth or the people are diarrhea, or the mouth is dry and bitter, the halitosis is retching, the body is sleepy and the urine is short and yellow;

tongue coating and pulse: pale tongue with thin, white or white greasy coating and soft, thready or slow-superficial pulse; or a red tongue with yellow and greasy coating and a soft and rapid pulse.

3. Case selection criteria

3.1 case inclusion criteria

The first one is in accordance with the first + second/third/fourth of the above-mentioned Chinese medicine and Western medicine diagnosis standards;

secondly, after single or combined chemotherapy with platinum-containing drugs within one week, the course of the chemotherapy is not limited;

age 18-80 years, estimated survival time is more than or equal to 3 months;

karnofsky functional status score (KPS) is not less than 60 points, and the function insufficiency of the center of gravity, liver, kidney and bone marrow is avoided;

fifthly, complete clinical data are obtained.

3.2 case exclusion criteria

Those not meeting the inclusion criteria;

② may prevent subjects from completing clinical trial procedures including but not limited to severe, difficult to control organic lesions or infections;

③ gastrointestinal bleeding, or mechanical eating disorder such as chewing difficulty and swallowing difficulty, or obstruction of digestive tract;

(iv) those suffering from a psychiatric disease or disorder which is not readily controllable;

patients with metabolic diseases, such as diabetes, hyperthyroidism, hypothyroidism and the like, who need to use hormone for a long time to treat the diseases and influence the weight and the metabolic level;

sixthly, the patient is participating in other drug tests;

seventhly, the curative effect cannot be judged or other factors influence the curative effect judgment or the safety judgment;

the investigator considers that the investigator can not cooperate with the subject who completes the clinical investigation.

3.3 criteria for case rejection and shedding

secondly, the patient with serious adverse reaction in the treatment process is not suitable for continuously receiving the observer, and the adverse reaction is recorded;

thirdly, the testee requires or must quit for various reasons;

For the case of exfoliation, researchers need to contact patients as much as possible, fill out the cause of exfoliation, complete the completed evaluation items, fill out and withdraw from the test record table, and record the treatment time of the last traditional Chinese medicine as much as possible.

4. Design of research

Random, double blind control studies were used. 64 patients in all groups were randomly assigned 1: 1 to the control and treatment groups, 32 in each group, according to a random number table. Four of the control groups were dropped, and the study was finally completed in 28 cases.

The control group was treated with a combination of regular care and placebo, which were prepared by: 1/10 dosage of example 5 granule 2, made with dextrin.

The treatment group is based on the conventional nursing, and the granules 2 in the example 5 are applied, one dose is taken every day, and the granules are taken with warm water when being used. The treatment course of the two groups of medicines is 14 days.

5. Observation index

Classifying appetite reduction symptoms and judging curative effect: the appetite loss was rated on 5 scales according to the evaluation criteria for common adverse events (CTCAE), fifth edition: level 0: no appetite loss; stage I: appetite declined, but dietary habits were unchanged; II stage: changes in eating, not accompanied by weight loss or malnutrition, but requiring supplementation by oral administration; grade III: significant weight loss or malnutrition symptoms (e.g., insufficient calories and/or fluid volume by oral feeding), requiring nasal feeding or total parenteral nutrition; stage IV: life threatening, requiring emergency treatment; and V stage: and death. After treatment, the effect is reduced by 2 grades or more or reduced to 0 grade compared with before treatment; the reduction of grade 1 after treatment compared with before treatment is effective; the symptoms were not reduced or exacerbated to be ineffective. Total effective rate (%) (effective + effective)/total number of cases × 100%;

② grading the symptoms of gastrectasia and abdominal distension and judging the curative effect: a scale is drawn up for evaluation according to the clinical research guiding principle of the new traditional Chinese medicine and the evaluation standard (CTCAE) of common adverse events, the items of the scale comprise 6 items including the existence of the conscious gastrectasia, the existence of the reduction of food intake, abdominal circumference, anus exhaust frequency, bowel sound and abdomen percussion, each item is divided into 0-4 points, 1-8 points are mild points, 9-16 points are moderate points, and 17-24 points are severe points. After treatment, the temperature is reduced by 2 degrees or 0 degrees compared with the temperature before treatment; effective after treatment, 1 degree lower than before treatment; the symptoms were not reduced or exacerbated to be ineffective. Total effective rate (%) (effective + effective)/total number of cases × 100%;

thirdly, grading nausea and vomiting symptoms and judging curative effect: nausea and vomiting were divided into 5 grades, evaluated according to the common adverse event evaluation criteria (CTCAE), fifth edition: level 0: no nausea and vomiting; stage I: no intervention is required; II stage: outpatient vein fluid infusion, medical intervention is needed; grade III: nasal feeding, total parenteral nutrition or hospitalization is required; stage IV: life threatening; and V stage: and death. After treatment, the temperature is reduced by 2 degrees or 0 degrees compared with the temperature before treatment; effective after treatment, 1 degree lower than before treatment; the symptoms were not reduced or exacerbated to be ineffective. Total effective rate (%) (effective + effective)/total number of cases × 100%;

fourthly, traditional Chinese medicine syndrome scoring and curative effect judgment: according to the diagnosis standard of traditional Chinese medicine, one main symptom is scored as 0, 2, 4 and 6 according to the severity degree, and one secondary symptom is scored as 0, 1, 2 and 3 according to the severity degree. Clinical symptoms and physical signs disappear or basically disappear, and the clinical recovery is realized when the syndrome score is reduced by more than or equal to 90 percent; clinical symptoms and physical signs disappear and are obviously improved, and the reduction of syndrome integral is more than or equal to 70 percent, so that the effect is obvious; the clinical symptoms and physical signs are improved, and the reduction of the syndrome integral by more than or equal to 30 percent is effective; clinical symptoms and signs disappear without obvious improvement or even aggravation, and the reduction of syndrome score by less than 30 percent is ineffective. The calculation formula (nimodipine method) is: [ (pre-treatment score-post-treatment score) ÷ pre-treatment score ] × 100%;

quality of life score and therapeutic effect judgment standard: the evaluation is carried out by adopting Ka's score (KPS), the KPS score is weakened when the KPS score is reduced by more than or equal to 10 compared with the KPS score before treatment, the KPS score is stable when the KPS score is reduced or increased by less than 10 compared with the KPS score before treatment, and the KPS score is improved when the KPS score is increased by more than or equal to 10 compared with the KPS score before treatment. Wherein, the effective rate is (stable case number + improved case number)/total case number × 100%.

Sixthly, safety observation: before treatment and after the treatment course, the blood routine, the urine routine, the stool routine and the liver and kidney functions are respectively checked. The grading is referenced to the following criteria: normal, within normal/standard range, none is level 0; mild/mild toxicity was grade 1; moderate/moderate toxicity was grade 2; severe/severe toxicity was grade 3; toxicity of life threatening or immobility was grade 4; death (with causality) was grade 5.

6. Results

In the aspect of appetite reduction: 7 cases of the control group are invalid, 14 cases are valid, 4 cases are valid, and the total effective rate is 72.0 percent; 1 case of the treatment group is invalid, 7 cases are valid, 23 cases are valid, the total effective rate is 96.8 percent, the comparison difference of the two groups has statistical significance, and P is less than 0.05;

stomach distension and abdominal distension: 13 cases of the control group are invalid, 4 cases are valid, 5 cases are valid, and the total effective rate is 41.0 percent; 2 cases of treatment groups are invalid, 6 cases are effective, 19 cases are effective, the total effective rate is 92.6 percent, the comparison difference of the two groups has statistical significance, and P is less than 0.05;

nausea and vomiting: 4 cases of the control group are invalid, 7 cases are valid, 2 cases are effective, and the total effective rate is 69.2%; 1 case of the treatment group is invalid, 3 cases are valid, 12 cases are valid, the total effective rate is 93.75%, the comparison difference of the two groups has no statistical significance, and P is more than 0.05; on the aspect of significant efficiency, the control group is 15.4 percent, the treatment group is 75.0 percent, the comparison difference of the two groups has statistical significance, and P is less than 0.05.

The traditional Chinese medicine syndrome curative effect aspect is as follows: the control group has 11 cases of no effect, 4 cases of effect and 13 cases of effect, 0 case of cure, and the total effective rate is 60.7 percent; 2 cases of treatment groups are ineffective, 8 cases are effective, 22 cases are effective, 0 case is healed, the total effective rate is 93.75 percent, the comparison difference of the two groups has statistical significance, and P is less than 0.05;

quality of life scoring: 13 cases in the control group are weakened, 12 cases are stable, 3 cases are improved, and the total effective rate is 53.6%; 4 cases of treatment groups are weakened, 5 cases are stable, 23 cases are improved, the total effective rate is 87.5 percent, the comparison difference of the two groups has statistical significance, and P is less than 0.05;

and (3) safety aspect: no adverse reaction occurred in 32 patients in the treatment group during the treatment process of the invention.

And (4) conclusion: the invention can prevent and treat tumors and related gastrointestinal reaction symptoms of anorexia, gastrectasia, abdominal distention, nausea and vomiting after treatment, improve the traditional Chinese medicine symptoms, improve the life quality of patients and have no adverse reaction.

Claims

1. A traditional Chinese medicine composition for preventing and treating tumor and treating post-anorexia and gastrointestinal reaction is characterized by comprising the following components in parts by weight: 5-30 parts of codonopsis pilosula, 6-30 parts of bighead atractylodes rhizome, 3-15 parts of ginger processed pinellia, 5-15 parts of poria cocos, 3-15 parts of dried orange peel, 3-12 parts of tsaoko amomum fruits, 1-12 parts of clove, 2-15 parts of mangnolia officinalis, 3-15 parts of elecampane, 4-20 parts of fried medicated leaven, 2-15 parts of tribulus terrestris, 3-20 parts of dandelion, 2-15 parts of rhizoma bletillae and 2-15 parts of honey-fried licorice roots.

2. The traditional Chinese medicine composition for preventing and treating tumor and treating after-appetite decrease and gastrointestinal reaction as claimed in claim 1, wherein the composition comprises the following components in parts by weight: 9-15 parts of codonopsis pilosula, 10-20 parts of bighead atractylodes rhizome, 5-10 parts of ginger processed pinellia, 5-12 parts of poria cocos, 3-12 parts of dried orange peel, 5-10 parts of tsaoko amomum fruit, 3-10 parts of clove, 2-12 parts of mangnolia officinalis, 4-10 parts of elecampane, 6-12 parts of fried medicated leaven, 5-10 parts of tribulus terrestris, 6-15 parts of dandelion, 6-12 parts of rhizoma bletillae and 5-10 parts of honey-fried licorice root.

3. The traditional Chinese medicine composition for preventing and treating tumor and treating after-appetite decrease and gastrointestinal reaction as claimed in claim 1, wherein the composition comprises the following components in parts by weight: 10 parts of codonopsis pilosula, 15 parts of bighead atractylodes rhizome, 10 parts of ginger processed pinellia tuber, 10 parts of poria cocos, 10 parts of dried orange peel, 6 parts of amomum tsao-ko, 6 parts of clove, 10 parts of magnolia officinalis, 10 parts of elecampane, 10 parts of fried medicated leaven, 10 parts of tribulus terrestris, 10 parts of dandelion, 10 parts of rhizoma bletillae and 10 parts of honey-fried licorice root.

4. A Chinese medicinal composition for preventing and treating tumor and anorexia and gastrointestinal reaction, wherein the active ingredient of the Chinese medicinal composition is as claimed in any one of claims 1-3.

5. Use of a Chinese medicinal composition according to any one of claims 1 to 3 for the preparation of a Chinese medicinal decoction/granule for the prevention and treatment of tumours and related post-treatment anorexia and gastrointestinal reactions.