CN116747274A - Traditional Chinese medicine composition and preparation for treating gastroesophageal reflux disease with syndrome of liver-stomach stagnation heat and application of traditional Chinese medicine composition and preparation - Google Patents
Traditional Chinese medicine composition and preparation for treating gastroesophageal reflux disease with syndrome of liver-stomach stagnation heat and application of traditional Chinese medicine composition and preparation Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating liver-stomach depression heat syndrome and application thereof, wherein active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight: monarch drug: 10-20 parts of calcined Haematitum and 15-25 parts of cuttlebone; ministerial drugs: 2-10 parts of ginger processed pinellia tuber, 8-16 parts of magnolia officinalis, 2-10 parts of stir-fried coptis chinensis and 1-5 parts of evodia rutaecarpa; adjuvant drug: 2-10 parts of bupleurum, 5-15 parts of baical skullcap root and 10-20 parts of Indian buead; the preparation method comprises the following steps: 2-8 parts of honey-fried licorice root. The beneficial effects of the invention are as follows: 1) Can effectively treat the symptoms of liver-stomach depression and heat, lighten clinical symptoms of patients, and has certain advantages in improving traditional Chinese medicine symptoms such as belch or food regurgitation, irritability, hunger and the like compared with western medicines; 2) Can improve anxiety and depression states of patients with liver-stomach depression heat syndrome, reduce recurrence rate, and has high safety and no obvious adverse reaction.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating gastroesophageal reflux disease with the syndrome of liver-stomach depression and heat, a preparation and application thereof.
Background
Gastroesophageal reflux disease (Gastroesophageal Reflux Disease, GERD) is a digestive system disease that is mainly clinically manifested by symptoms such as regurgitation and heartburn caused by reflux of stomach and duodenal contents into the esophagus. Reflux can also cause tissue damage adjacent to the esophagus, including the mouth, throat, airways, etc., and may cause extra-esophageal manifestations such as asthma, chronic cough, hoarseness, dental erosion, and sphagitis, which can have a serious impact on the patient's life. Modern medicine divides GERD into non-erosive reflux disease, reflux esophagitis, barrett's esophagus. The currently accepted causes of GERD are fatness and smoking, and in addition, factors such as life eating habits, drinking, mental and psychological factors are not ignored. The pathogenesis known at present is mainly dysfunction and structural disorder of the boundary of the gastroesophageal, esophageal clearance dysfunction, esophageal mucosa defense function weakening and the like. Furthermore, delayed gastric emptying, increased esophageal sensitivity, ghrelin, genetic factors, and the like may also be associated with the onset of GERD.
The clinical treatment modes of Western medicine include three aspects of general treatment, drug treatment and operation treatment, and emphasizes that the adjustment of life style is the basis of GERD treatment. The clinical treatment targets mainly comprise relieving symptoms, curing esophagitis, improving life quality, preventing relapse and preventing and curing complications. Western medicine treatment of GERD typically relieves symptoms by inhibiting gastric acid secretion, enhancing LES tone, promoting gastric emptying, protecting gastric mucosa, regulating mood, and the like. Clinically commonly used drugs are Proton Pump Inhibitors (PPI), potassium competitive acid blockers (potassium-competitive acid blockers, P-CABs), H2 receptor antagonists (H2 Receptor Antagonists, H2 RA), gastrointestinal motility-promoting drugs, gastric mucosa protectants, antidepressants, and the like. Wherein, the first three are all the drugs for treating GERD by inhibiting gastric acid secretion, and PPI and P-CABs are the first drugs for treating GERD by Western medicines at present. PPI has the advantages of high specificity, strong acid inhibition effect, quick effect, convenient administration and the like, but the duration of the acid inhibition effect is not long enough, so that the situation of insufficient inhibition of gastric acid at night occurs, and adverse reactions such as diarrhea, nausea, constipation and the like exist. And compared with PPI, the P-CABs is used as a novel acid inhibiting drug, has longer half-life period, is not influenced by food, and has stronger and longer acid inhibiting effect. H2RA promotes esophageal reflux clearance on the basis of acid inhibition, but is resistant. The gastrointestinal motility promoting medicine can promote peristaltic contraction of esophagus, thereby enhancing capacity clearance capability of esophagus, promoting gastric emptying and preventing reflux of gastric contents into esophagus. At the same time, it also increases lower esophageal sphincter (lower esophageal sphincter, LES) pressure, reducing reflux. The gastric mucosa protective agent can reduce esophageal mucosa load caused by reflux and reduce inflammation injury. Aiming at patients with mood disorders such as GERD with anxiety depression, the anti-depression anxiety medicament is added to improve mood and mental state, thereby facilitating symptom relief and reducing oesophageal sensitivity of the patients. In order to improve the curative effect and reduce the influence of adverse reactions clinically, two or more of the above drugs may be used in combination.
The modern traditional Chinese medicine belongs to the categories of acid regurgitation, oesophagitis, and the like, and considers that the disease position of the disease is located in the oesophagus and the stomach and is closely related to the spleen, the liver, the gall bladder and the lung. The principal aspect of the deficiency is the deficiency of the spleen and stomach; the pathogenic excess is the principal sign, and is mainly due to qi depression, phlegm coagulation, food stagnation and blood stasis. The stomach qi failing to descend and the stomach qi flowing upwards are the basic pathogenesis. The Chinese medicine treatment mode comprises Chinese medicine decoction, chinese medicine external treatment and internal and external combination. Modern traditional Chinese medicine divides GERD into six syndromes, including liver and stomach heat stagnation, middle deficiency and qi inversion, gallbladder heat invading stomach, blood stasis and collateral obstruction, qi stagnation and phlegm obstruction and cold and heat obstruction, and adopts corresponding prescription differentiation treatment respectively.
The applicant finds that the disease caused by the liver-stomach depression heat syndrome GERD should be the incoordination between the spleen and stomach, the spleen and stomach is the acquired origin, and the qi movement of the human body is the pivot, so that the qi movement of the spleen and stomach is not smooth, and the qi movement of the spleen and stomach is impaired, and phlegm turbidity is generated. People in the society often have irregular or quantitative meals, hunger and saturation, damage to spleen and stomach and lack of exercise after sitting for a long time, and the inertia of the spleen and the stomach is increased due to the fact that people in the society often have irregular or quantitative meals, hunger and saturation due to working and living reasons. The ascending and descending of the spleen and stomach are orderly dependent on the smooth and normal liver qi, and are affected by the families, and people often have certain pressure, so that the liver is not smooth and is not smooth, the wood is depressed, the soil is obstructed, the heat is transformed into the heat of depression of the liver and the stomach. Disorder of spleen and stomach qi can cause damp-heat accumulation in stomach, upward adverse flow of stomach qi can cause damp-heat to invade esophagus, symptoms such as acid regurgitation, food regurgitation or belch can be clinically seen, gastric acid burns the esophagus, esophagus mucous membrane is damaged, sensitivity is increased, symptoms such as poststernum burning pain and heartburn can be seen, gastric cavity fullness is caused by stomach qi failing to descend, gastric cavity burning pain and hunger are caused by stomach stagnated heat, and dysphoria and irritability are caused by liver qi stagnation.
Therefore, the key to treat the disease is to regulate qi movement of viscera, liver governs smoothing flow of qi, ascending of its nature, preference for depression, and stomach descending, and coordination of the two results in smooth qi movement of liver and stomach. Liver qi stagnation should be dredged, let out and soft, smooth liver qi, clear heat due to long stagnation, let out fire to calm stomach, and supplement spleen-invigorating and qi-regulating herbs to regulate qi and resolve phlegm, so as to restore ascending and descending of middle energizer. Therefore, the key to treat the disease is to sooth the liver, dispel heat, harmonize stomach and reduce adverse qi. Haematitum has effects of suppressing hyperacidity, lowering adverse qi, neutralizing gastric acid, and cuttlebone can promote gastric mucosa injury healing while suppressing hyperacidity, relieving discomfort symptoms such as acid regurgitation, gastric cavity burning pain, and heartburn, so that the two medicines can effectively relieve symptoms such as acid regurgitation, heartburn, and gastric cavity pain, and can also suppress liver and stomach pathogenic heat.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a traditional Chinese medicine composition for treating gastroesophageal reflux disease with the syndrome of liver-stomach depression and heat and application thereof. The composition can effectively treat liver-stomach depression heat syndrome, lighten clinical symptoms of patients, and has certain advantages in improving traditional Chinese medicine symptoms such as belch or food regurgitation, irritability, hunger and the like compared with western medicines; can improve anxiety and depression states of patients with liver-stomach depression heat syndrome, reduce recurrence rate, and has high safety and no obvious adverse reaction.
In order to achieve the above purpose, the present invention adopts the following technical scheme:
a traditional Chinese medicine composition for treating gastroesophageal reflux disease with liver-stomach stagnation heat syndrome comprises the following active ingredient raw materials in parts by weight:
monarch drug: 10-20 parts of calcined Haematitum and 15-25 parts of cuttlebone;
ministerial drugs: 2-10 parts of ginger processed pinellia tuber, 8-16 parts of magnolia officinalis, 2-10 parts of stir-fried coptis chinensis and 1-5 parts of evodia rutaecarpa;
adjuvant drug: 2-10 parts of bupleurum, 5-15 parts of baical skullcap root and 10-20 parts of Indian buead;
the preparation method comprises the following steps: 2-8 parts of honey-fried licorice root.
Preferably, the active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight:
monarch drug: 15 parts of calcined Haematitum and 20 parts of cuttlebone;
ministerial drugs: 6 parts of ginger processed pinellia tuber, 12 parts of magnolia officinalis, 6 parts of stir-fried coptis chinensis and 3 parts of evodia rutaecarpa;
adjuvant drug: 6 parts of bupleurum, 9 parts of scutellaria baicalensis, and 15 parts of poria cocos;
the preparation method comprises the following steps: 5 parts of honey-fried licorice root.
Preferably, the active ingredient raw materials of the traditional Chinese medicine composition also comprise the following raw materials in parts by weight: 5-15 parts of wrinkled giant hyssop and 5-15 parts of eupatorium.
Preferably, the active ingredient raw materials of the traditional Chinese medicine composition also comprise the following raw materials in parts by weight: 5-15 parts of fried fructus aurantii and 5-15 parts of fried fructus aurantii.
Preferably, the active ingredient raw materials of the traditional Chinese medicine composition also comprise the following raw materials in parts by weight: 5-15 parts of rhizoma corydalis and 5-15 parts of fried costustoot.
Preferably, the active ingredient raw materials of the traditional Chinese medicine composition also comprise the following raw materials in parts by weight: 10-20 parts of fried hawthorn and 10-20 parts of chicken's gizzard-membrane.
Preferably, the Chinese medicinal composition further comprises other Chinese medicinal extracts and/or other raw materials.
Preferably, the traditional Chinese medicine composition preparation comprises a traditional Chinese medicine composition and/or a pharmaceutical adjuvant and/or a food additive.
Preferably, the Chinese medicinal composition preparation is a tablet, a chewable tablet, a powder, a granule, a electuary, a capsule, a paste, a pill or a liquid preparation.
Furthermore, the invention also discloses application of the traditional Chinese medicine composition or the traditional Chinese medicine composition preparation in preparing medicines for treating liver-stomach depression heat syndrome and/or medicines for treating anxiety and depression of patients with gastroesophageal reflux with liver-stomach depression heat syndrome.
The principle of the formula design of the invention:
selecting monarch drugs: the Haematitum has effects of suppressing hyperactive liver and lowering adverse qi, and cuttlebone has effects of regulating stomach and relieving acid, and can effectively relieve symptoms of acid regurgitation, heart burn and gastralgia, and can also suppress pathogenic heat of liver and stomach, so that the two medicines are all monarch medicines;
the ministerial drugs are selected: pinellia tuber can reduce adverse flow of qi and resolve phlegm, magnolia bark can reduce qi and remove fullness, coptis chinensis and fructus evodiae Wen Ganqing are stomach, and the four medicines are ministerial medicines;
selection of adjuvant: the bupleurum is used for soothing liver and relieving depression, and the baical skullcap root is used for reducing turbid and purging fire, so that the qi movement of liver and stomach is smooth, and the stagnated heat is eliminated; poria cocos is sweet and light, excretes dampness and invigorates spleen, eliminates the source of phlegm-dampness, and the three medicines are combined as adjuvant medicines;
selection of the drug: the honey-fried licorice root, radix Glycyrrhizae Praeparata has the effects of strengthening the spleen, eliminating phlegm and harmonizing the drugs, and is used as a guiding drug.
The medicines are combined together to play the roles of dispelling liver-heat, harmonizing stomach, lowering adverse qi, strengthening spleen and reducing phlegm, so that the qi of liver and stomach is smooth, and the heat is removed by self.
The single medicine analysis of the formula of the invention:
haematitum is bitter in flavor, sweet and slightly cold in nature, and can calm liver and reduce adverse qi, cool blood and stop bleeding, and "Ben Cao Zheng" is called as it can "descend qi and reduce adverse qi, clear fire", and "Changsha Yao Jie" is recorded as it can "descend adverse qi of lung and stomach, remove belching and relieve depression heat", so it can stop vomiting due to regurgitation. Related researches show that the Haematitum can be used for astringing gastrointestinal wall and protecting mucosa. Therefore, haematitum is added into the prescription to achieve the effects of suppressing hyperactive liver, lowering adverse qi, and neutralizing gastric acid.
Cuttlebone is salty and astringent in taste, can relieve hyperacidity and pain, astringe and stop bleeding, is called as "antacid king", contains calcium carbonate in ingredients, can neutralize gastric acid and promote acidity and basicity in stomach. Studies show that cuttlebone has the effects of reducing the damage index of gastric mucosa and reducing the damage area of gastric mucosa. So the cuttlebone can promote gastric mucosa injury healing while inhibiting acid, and relieve discomfort symptoms such as acid regurgitation, gastric cavity burning pain, heartburn and the like.
Ban Xia is pungent and warm in nature and enters spleen, stomach and lung meridians. The drug theory states that it can "eliminate phlegm and saliva", promote appetite and invigorate spleen, stop vomiting, and eliminate phlegm and fullness in chest ". Pharmacological studies show that pinellia ternate has the effects of relieving cough, relieving vomiting, eliminating phlegm, resisting ulcer and the like. Therefore, ban Xia in this formula can dry dampness and resolve phlegm and stabilize the stomach qi of the adverse rising energy.
Magnolia officinalis, cortex Magnolia officinalis, bitter in flavor, can dry energy, dry dampness, lower qi and remove fullness, is called as "in Ming Yi Bie Lu" in its main temperature, tonifying qi, resolving phlegm and descending qi, and treating cholera and abdominal pain, distention and fullness, cold in the stomach and vomiting in the chest. Pharmacological studies show that magnolol can reduce inflammatory reaction and can play a bidirectional regulation role on gastrointestinal motility. The magnolia officinalis can promote gastric emptying, relieve gastrectasia and reduce gastric acid rising.
Huang Lian is bitter and cold in nature, good at drying dampness and purging fire, and indicated for incoordination between liver and stomach, vomiting and acid regurgitation. Medicine type statue carrying: "purging heart fire, removing damp-heat in spleen and stomach, treating dysphoria and nausea, stagnated heat in middle energizer, and being abrupt to induce vomiting. It is also indicated for the treatment of heart stuffiness and fullness. The modern pharmacological research shows that berberine as the effective component in coptis root has the functions of clearing heat, inhibiting helicobacter pylori, resisting ulcer and the like. Rhizoma Coptidis may be added to help clear heat of liver and stomach stagnation.
Evodia rutaecarpa has the effects of relieving pain by dissipating cold and qi, lowering turbid yin and treating vomiting, and is pungent and liver qi and bitter and stomach qi, as described in Ben Cao gang mu: zhu Yu, with pungent heat energy and warm energy and bitter heat energy and dry energy and hard mass, all indicated for this condition have the actions of dispelling cold and warming middle energizer, drying dampness and resolving depression. The related research indicates that the medicine has the functions of inhibiting bacteria, promoting ulcer healing, controlling gastric acid secretion, preventing vomiting and the like. The traditional compatibility of the evodia rutaecarpa and the coptis chinensis for forming the left golden pill can prevent the coptis chinensis from bitter and cold to hurt the stomach, and simultaneously has the functions of clearing liver and purging fire, and lowering adverse qi and preventing vomiting.
Bupleuri radix is bitter and slightly cold, and is good at soothing liver, relieving depression, eliminating pathogenic factors and relieving fever. Shennong Ben Cao Jing (Shennong's herbal medicine book): the accumulation of food and drink, accumulation of pathogenic cold and heat, and promotion of aging. "Bencao zheng" is also called: being cool in nature, it can pacify liver fire and heat, pungent and dispersed, and dispel liver meridian stagnation. The related pharmacological research shows that it has antipyretic, anti-inflammatory and liver injury resisting effects.
Baical skullcap root is bitter and cold, good at clearing heat and drying dampness, and "Ben Cao Zheng" has the following meanings: the dry person can clear the fire of upper energizer, remove phlegm and promote qi circulation. "Ben Cao Jing Jie" as follows: bitter and flat with heart-fire clearing, so it is mainly used for treating various fever. Modern pharmacological researches have the effects of relieving fever, protecting liver, promoting bile flow, inhibiting intestinal peristalsis, resisting tumor, etc.
Poria is sweet, light and flat, and has effects of invigorating spleen, eliminating dampness, inducing diuresis and relieving edema. "Shibu zhai medical book" records: poria is a principal drug for treating phlegm, and it can be used for treating phlegm. Poria also can be used for damp-heat due to phlegm movement and damp-heat. The modern pharmacological research shows that it can inhibit gastric ulcer, reduce gastric secretion, protect liver, etc.
Roasted licorice has the actions of keeping the qi of spleen and stomach in middle energizer, warming and tonifying middle energizer, and regulating and alleviating all herbs. The "Bie Ji" carries: warming middle-jiao and descending qi, dysphoria with short qi … …, dredging meridians, li Xieqi, and relieving the toxicity of drugs. "drug theory" states that: cold pain in the main abdomen, treating convulsive epilepsy and removing abdominal distention and fullness; tonify five viscera; making into various medicinal toxins. The related researches show that the medicine has the effects of resisting inflammation, eliminating phlegm, improving heart failure, promoting ulcer healing and the like, wherein the flavone as an active ingredient also has the effects of diminishing inflammation, spasmolysis and acid resistance.
The beneficial effects of the invention are as follows: 1) Can effectively treat the symptoms of liver-stomach depression and heat, lighten clinical symptoms of patients, and has certain advantages in improving traditional Chinese medicine symptoms such as belch or food regurgitation, irritability, hunger and the like compared with western medicines; 2) Can improve anxiety and depression states of patients with liver-stomach depression heat syndrome, reduce recurrence rate, and has high safety and no obvious adverse reaction.
Drawings
Fig. 1 is a case completion scenario.
Figure 2 is a comparison of the RDQ scores before treatment of the two groups.
Figure 3 is a comparison of the integral of the symptoms of the traditional Chinese medicine prior to treatment of two groups.
Figure 4 is a comparison of the HAMA scores before treatment for the two groups.
FIG. 5 is a comparison of HAMD scores before treatment for two groups.
Fig. 6 is a comparison of overall efficacy.
Figure 7 is a comparison of RDQ total integral after two groups of treatments.
Figure 8 is a comparison of the single integral of RDQ after two sets of treatments.
Fig. 9 is a comparison of total integral of the symptoms of the traditional Chinese medicine after two groups of treatments.
FIG. 10 is a graph showing the single integral comparison of the symptoms of the traditional Chinese medicine after two groups of treatments.
Figure 11 is a HAMA integral comparison after two treatment groups.
FIG. 12 is a comparison of HAMD scores after two sets of treatments.
Fig. 13 is a comparison of recurrence rates for the two groups.
Detailed Description
The technical solutions in the embodiments are clearly and completely described below in connection with the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight:
monarch drug: 15 parts of calcined Haematitum and 20 parts of cuttlebone;
ministerial drugs: 6 parts of ginger processed pinellia tuber, 12 parts of magnolia officinalis, 6 parts of stir-fried coptis chinensis and 3 parts of evodia rutaecarpa;
adjuvant drug: 6 parts of bupleurum, 9 parts of scutellaria baicalensis, and 15 parts of poria cocos;
the preparation method comprises the following steps: 5 parts of honey-fried licorice root.
Adding water, and decocting to obtain liquid preparation.
The beneficial effects of the invention prove that:
1. research data and method
Study data (I)
1. Study object
The GERD cases from 11 months 2021 to 11 months 2022 are selected and treated at the department of gastroenterology in Hospital of Lithode, zhejiang province, 106 cases are taken.
2. Diagnostic criteria and syndrome differentiation criteria
(1) Western diagnostic criteria
With reference to the recommendations of the national gastroesophageal reflux disease expert consensus (2020), the following criteria are formulated:
(1) typical symptoms, such as acid regurgitation and heartburn; atypical symptoms such as poststernal pain, burning sensation in the epigastrium, epigastric pain, etc.; extraesophageal symptoms such as cough, chronic pharyngitis, hoarseness, asthma, etc.;
(2) endoscopic examination: reflux esophagitis can be diagnosed with distal esophageal mucosa injury using gastrointestinal endoscopy, with reference to los Angeles classification (LA classification) criteria; the tooth line can be seen to move upwards regularly or irregularly or to show island change, and can be diagnosed as Barrett esophagus;
(3) esophageal reflux monitoring: transesophageal 24h pH monitoring indicates reflux presence, and/or bile reflux presence;
(4) the score of the reflux disease questionnaire (Reflux disease questionnaire, RDQ) is more than or equal to 12.
GERD may be diagnosed in conformity with any one of the first, second, and fourth strips described above.
The los Angeles classification criteria are as follows:
class a: one or more mucous membranes of the esophagus are damaged, and the diameter of each mucous membrane is smaller than 5mm;
b level: the diameter of the damage is larger than 5mm, and one or more mucous membranes can be damaged, but no fusion phenomenon exists;
c level: more than 2 folds, but less than 75% of the esophageal circumference is damaged by mucofusion;
d stage: the damaged mucous membranes are mutually fused, and the damaged range is accumulated to at least 75% of the esophageal circumference.
(2) Diagnostic criteria for traditional Chinese medicine
Based on the consensus opinion (2017) of traditional Chinese medicine diagnosis and treatment expert of gastroesophageal reflux disease, and combined with clinic, the diagnosis standard of the liver-stomach depression heat syndrome GERD in the study is formulated as follows:
mainly comprises (1) burning heart; (2) acid is reversed.
The secondary symptoms are (1) poststernal burning pain; (2) burning pain in the gastric cavity; (3) abdominal distention and fullness; (4) belching or regurgitation; (5) irritability; (6) is easy to hunger.
A red tongue with yellow coating; (2) the pulse is wiry.
The main symptoms and at least two secondary symptoms need to be satisfied, and the tongue pulse condition is consulted.
3. Inclusion criteria
(1) GERD patients who meet western medical diagnostic standards and traditional Chinese medical science symptoms;
(2) age 18-75 years old;
(3) no drugs affecting the study, including acid inhibitors, gastric motility drugs, etc. were taken within one month prior to the visit;
(4) the questionnaire can be completed by oneself or with help if the independent questionnaire and understanding capability is normal;
(5) voluntary group entering and signing an informed consent form;
(6) no other clinical trial was engaged in the last march that could affect the study.
4. Exclusion criteria
(1) Endoscopic or other examinations suggest other diseases that lead to reflux symptoms;
(2) combining other digestive diseases such as digestive tract malignant tumor, digestive tract ulcer, drug or mycotic esophagitis, etc.; major digestive tract surgery was performed;
(3) those with liver and kidney dysfunction; other serious diseases such as severe cardiovascular and cerebrovascular diseases, blood system diseases, tumors and the like are combined;
(4) a patient with a history of allergy to the drug involved in the study;
(5) women during pregnancy or lactation;
(6) the syndrome differentiation of traditional Chinese medicine is ambiguous or inconsistent;
(7) a person without voluntary behavior ability;
(8) other conditions judged by the researcher not to meet the inclusion criteria;
(9) the test group should exclude patients who use anti-reflux western medicines simultaneously, and the control group should exclude patients who use traditional Chinese medicines simultaneously.
The method is suitable for the above-mentioned one to be excluded.
5. Reject criteria
(1) Adverse reactions occur during the administration period and the study treatment regimen cannot be continued;
(2) the patients with aggravated illness or other diseases after receiving the treatment need to take other medicines, which affects the evaluation of curative effect;
(3) compliance is poor and treatment cannot be accepted as required and efficacy assessment is completed.
6. Drop criteria
(1) Patients with treatment periods which are not half of the clinical observation period or incomplete observation records;
(2) naturally falls off and lost to the visit.
7. Ethical requirements
The research has obtained the ethical inspection department standard of Lithode Hospital in Zhejiang province (ethical inspection batch number: zhejiang De Lun inspection 2022 research No. 018) (second) research method
1. Sample size estimation
The study is a random control test, the total effective rate of the two groups is taken as a main outcome index of observation, and the adopted sample size calculation formula is as follows:
wherein n represents sample size, Z represents bilateral, let a=0.05 on bilateral, the degree of certainty be 90%, look up table can know Z α ＝1.96，Z β ＝1.28。P 1 And P 2 Respectively representing the predicted total effective rate of the test group and the control group, and obtaining P by early clinical observation and reference of related documents, wherein the predicted total effective rate of the test group is 90 percent, and the control group is 70 percent 1 ＝0.9，P 2 =0.7. Wherein P means P 1 And P 2 Q means 1-P 1 And 1-P 2 N.apprxeq.48 cases can be obtained by calculation. According to the requirements of the 'guiding principle of clinical research of new traditional Chinese medicines', the shedding rate is inferred to be not more than 10% by combining the consultation and follow-up condition of the prior outpatient, so 53 patients in the test group and the control group can be obtained through final calculation, and 106 patients are required to be included.
2. Grouping method
106 patients meeting the standard are respectively marked as numbers 1-106 according to the order of treatment, the patients with the number 1 are included in the test group, and the patients with the number 2 are included in the control group by grouping the patients with the number 1 by using an SPSS25.0 software random number table to generate 53 patients with the number 1 and 2.
3. Treatment regimen
(1) Test group
The traditional Chinese medicine composition takes 15g of calcined Haematitum, 20g of cuttlebone, 6g of ginger processed pinellia tuber, 12g of magnolia officinalis, 6g of stir-fried coptis chinensis, 3g of evodia rutaecarpa, 6g of bupleurum, 9g of baical skullcap root, 15g of Indian buead and 5g of honey-fried licorice root) as a basic prescription, and is modified and dosed according to the individual clinical symptoms on the basis of dialectical treatment: for patients with severe damp-heat and thick greasy tongue fur, 10g of herba Pogostemonis and 10g of herba Eupatorii are added; for patients with abdominal distention, 10g of stir-fried fructus aurantii and 10g of stir-fried fructus aurantii are added; for severe pain in the gastric cavity, 10g of rhizoma corydalis and 10g of stir-fried costustoot are added; for patients with poor appetite, 15g of fried hawthorn and 15g of chicken's gizzard-skin are added. The traditional Chinese medicine decoction is decocted for the first generation, each dose is decocted into 200ml of 2 bags, and the decoction is taken after half an hour after breakfast and supper.
(2) Control group
The rabeprazole sodium enteric-coated tablet (Rebaud, specification 10mg, jiangsu Haoshen pharmaceutical Co., ltd., lot number: H20020330) was taken once daily, 20mg each time, half an hour before breakfast each day.
(3) Treatment course and follow-up
The treatment course was 8 weeks, and each patient was followed 4 weeks after the end of the course.
4. Observation index
(1) Case demographics
Basic information such as patient gender, age, course of disease, history of tobacco and alcohol, and BMI is recorded.
(2) Efficacy evaluation index
The efficacy evaluation index mainly comprises clinical symptoms, traditional Chinese medicine symptoms and mental states, and is evaluated by adopting RDQ integral, traditional Chinese medicine symptoms integral and anxiety depression scale.
(1) RDQ integration: counting the integration condition of the first day of treatment, 8 weeks of treatment and 4 weeks of drug withdrawal, and carrying out concurrent statistical treatment;
(2) the Chinese medicine syndromes are integrated: referring to the guidelines of clinical research on new traditional Chinese medicines, the symptoms of GERD liver-stomach depression heat syndrome are classified and quantified according to main symptoms and secondary symptoms, each symptom is classified into four grades of no, light, medium and heavy, the main symptoms are respectively marked as 0, 2, 4 and 6, and the secondary symptoms are respectively marked as 0, 1, 2 and 3. The integration of the first day of visit, 8 weeks of treatment, and 4 weeks of withdrawal was compared.
(3) Mental state evaluation: the total score was calculated using hamilton anxiety scale (Hamilton Anxiety Scale, HAMA) and hamilton depression scale (Hamilton depression scale, HAMD), 14 total entries for HAMA, 24 total entries for HAMD, each entry being 0, 1, 2, 3, 4 points according to none, mild, moderate, severe, and very severe, respectively. The higher the score, the more severe the anxiety or depression state.
(3) Index of recurrence rate
Patients who are cured, effective and effective are followed up after the treatment course is ended for 4 weeks, RDQ integral is again evaluated, and the integral at the end of the treatment course is compared to judge the recurrence condition.
(4) Safety observation index
Recording vital signs such as heart rate, blood pressure, respiration and the like of a patient before and after treatment, and auxiliary examination results including blood convention, urine convention, stool convention, liver and kidney functions and electrocardiogram; observing whether adverse reaction occurs in the course of treatment, if so, timely recording related symptoms, occurrence time, treatment method and the like, and if necessary, terminating the study.
5. Evaluation criteria
(1) Efficacy evaluation criteria
Overall efficacy assessment by integral changes in symptoms before and after treatment according to the "nimodipine method:
efficacy index (%) = (pre-treatment symptom score-post-treatment symptom score)/pre-treatment symptom score x 100%.
(1) Clinical recovery: symptoms and signs disappear or disappear basically, and the curative effect index is more than or equal to 95%;
(2) the effect is shown: the symptoms and the physical signs are obviously improved, and the curative effect index is more than or equal to 70% and less than 95%;
(3) the method is effective: the symptoms and the physical signs are improved, and the curative effect index is less than 70% and is more than or equal to 30%;
(4) invalidation: the symptoms and signs are not obviously improved or even aggravated, and the curative effect index is less than 30 percent.
Total effective rate = (number of cure cases + number of significant cases + number of effective cases)/total case number x 100%
(2) Recrudescence rate evaluation criterion
Symptom score and recurrence index at follow-up of both groups of patients were calculated, with recurrence index greater than 30% being recurrence, and both groups of recurrence rates were calculated.
Recurrence index = (total score for follow-up-total score at end of course)/total score for follow-up x 100%,
recurrence rate = number of recurrence/number of follow-up cases x 100%.
(3) Safety evaluation criterion
The preparation is formulated by referring to 2002 edition of guidelines for clinical study of New Chinese medicine:
(1) stage I: safety, no adverse reaction occurs during treatment;
(2) stage II: the medicine is safer, and if adverse reaction occurs, the medicine can be subjected to subsequent administration treatment without any special treatment;
(3) III grade: the safety problem exists, certain adverse reaction occurs in the test process, and the subsequent test can be carried out after corresponding treatment is adopted;
(4) grade IV: serious adverse reactions occur and the clinical trial should be ended.
(III) statistical methods
The statistical data in the study are processed by SPSS25.0 software, the counting data are tested by a chi-square test, the metering data which accord with approximate normal distribution are expressed by mean (X) +/-standard deviation (S), the counting data are tested by t-test, and the grading data are analyzed by rank sum test. The statistical significance level was set at α=0.05, P > 0.05, and no statistical difference was considered for the tested groups, P < 0.05, and statistical difference was considered for the tested groups.
2. Results of the study
Case completion
The study included 106 patients, randomized into the test and control groups, 53 each. In the course of the study, 4 patients who had lost their natural follow-up in each of the test group and the control group, and 1 patient in the control group had taken other drugs affecting the study and had been rejected. The study was completed in 49 patients from the final total trial and 48 patients from the control group, see table 1 and fig. 1:
table 1 case completion status
| Grouping | Inclusion cases (examples) | Reject cases (examples) | Case of falling (example) | Completion case (example) |
| Test group | 53 | 0 | 4 | 49 |
| Control group | 53 | 1 | 4 | 48 |
(II) case basic data comparison
The statistics of the basic data of 97 patients finally included is carried out, the ages, the disease courses and the BMI of the two groups of patients are approximately in normal distribution, the t test is adopted, the gender, the smoking history and the drinking history of the two groups of patients are tested by the chi-square test, and the statistical results show that P is more than 0.05, so that the difference of the basic data of the two groups has no statistical significance and is comparable, and the table 2 is shown:
table 2 comparison of two patient profiles
(III) comparison of Pre-treatment clinical symptom score and anxiety depression
1. RDQ integral comparison before treatment of two groups
The RDQ integral before treatment of two groups of patients is counted, the total integral before treatment and the single integral before treatment of the two groups are approximately normally distributed, and the statistical result shows that P is more than 0.05 by adopting t test, so that the difference between the two groups on the RDQ total integral and each integral has no statistical significance and is comparable. See table 3 below and fig. 2:
table 3 two sets of pre-treatment RDQ integral comparisons
2. Integral comparison of traditional Chinese medicine symptoms before treatment
The statistics is carried out on the traditional Chinese medicine syndrome integral before the treatment of two groups of patients, the total syndrome integral before the treatment and each syndrome integral are approximately normally distributed, and the statistical results show that P is more than 0.05 by adopting t test, so that the difference between the two groups of traditional Chinese medicine syndrome integral and each syndrome integral has no statistical significance and is comparable. See table 4 below and fig. 3:
table 4 comparison of the integral of the symptoms of the two groups of pre-treatment chinese medicine
3. Two sets of pre-treatment HAMA integral comparisons
The statistics of the HAMA integral before the treatment of two groups of patients is carried out, the HAMA integral before the treatment of two groups approximates to normal distribution, and the statistical result shows that P=0.529 is more than 0.05 by adopting t test, so that the difference of the two groups on the HAMA integral has no statistical significance and is comparable. See table 5 below and fig. 4:
table 5 comparison of two sets of pre-treatment HAMA integrals
4. Comparison of HAMD score before treatment of two groups
The HAMD integral before treatment of two groups of patients is counted, the HAMD integral before treatment of two groups approximates to normal distribution, and the statistical result shows that P=0.676 > 0.05 by adopting t test, so that the difference of the two groups on the HAMD integral has no statistical significance and is comparable. See table 6 below and fig. 5:
TABLE 6 comparison of two sets of pre-treatment HAMD integral
Fourth, efficacy and safety comparison
1. Overall efficacy comparison
After 8 weeks of treatment, the total effective rate of the test group is 89.79%, the control group is 75%, the two groups of effective rates are compared by using chi-square test, and the P=0.032 is less than 0.05, the difference has statistical significance, and the overall curative effect of the test group is better than that of the control group. See table 7 below and fig. 6:
table 7 overall efficacy comparison
RDQ integral comparison
(1) RDQ total integral comparison
The total integral of RDQ after treatment of two groups of patients is counted, the total integral of RDQ after treatment of two groups of patients is approximately normally distributed, the statistical result shows that P=0.676 is more than 0.05, the difference has no statistical significance, the total integral before and after treatment of two groups of patients is respectively compared in groups, P is less than 0.01, the difference has statistical significance, the two groups of medicines are indicated to obviously improve the total integral of RDQ, and the comparison between the two groups has no obvious difference, see the following table 8 and figure 7.
Table 8 comparison of RDQ total integral before and after treatment for two groups
(2) RDQ single-phase integral comparison
Statistics of RDQ single integral after treatment of two groups of patients shows that the integral P of symptoms of anti-acid, heartburn and non-heart chest pain is more than 0.05, the difference has no statistical significance, the integral of symptoms of anti-eating is less than 0.05, the difference has statistical significance, the single integral before and after treatment is respectively compared in groups, and the P is less than 0.05, the difference has statistical significance, and both groups of medicines are indicated to obviously improve the RDQ single integral, wherein, in the aspects of improving anti-acid, heartburn and non-heart chest pain, the two groups have no obvious difference, in the aspect of improving anti-eating, the test group is better than the control group, and the following table 9 and figure 8 are referred to:
table 9 two sets of pre-and post-treatment RDQ single integral comparisons
Note that: * the statistical difference (P < 0.05) between the two groups before and after treatment, the statistical difference (P < 0.05) between the two groups after treatment, # the difference between the two groups before and after treatment is statistically different (P < 0.05)
3. Integral comparison of syndrome of Chinese medicine
(1) Total integral comparison of syndrome of Chinese medicine
Statistics is carried out on total integral of traditional Chinese medicine symptoms after treatment of two groups of patients, the total integral of the traditional Chinese medicine symptoms after treatment of the two groups of patients is approximately normally distributed, the statistical result shows that P is less than 0.05, the difference has statistical significance, the total integral before and after treatment of the two groups of patients is respectively compared in groups, P is less than 0.05, the difference has statistical significance, the two groups of medicines are prompted to improve the total integral of the traditional Chinese medicine symptoms, wherein the experimental group is superior to the control group, see the following table 10 and fig. 9:
table 10 comparison of total integral of traditional Chinese medicine syndromes before and after treatment
(2) Single integral comparison of Chinese medicine syndrome
Statistics is carried out on the single integral of the traditional Chinese medicine symptoms after treatment of two groups of patients, the result shows that the integral P of the chest pain symptoms with acid regurgitation, heart burning and non-heart origin is more than 0.05, the difference has no statistical significance, the chest pain with acid regurgitation, abdominal distention, belch or regurgitation, irritability and hunger-prone symptoms, the P is less than 0.05, the difference has statistical significance, the integral P of the single symptoms before and after treatment is respectively compared in groups, the P of the test group is less than 0.05, the P of the control group is less than 0.05 except for the chest pain with acid regurgitation and hunger prone to hunger, the traditional Chinese medicine composition can be used for obviously improving the integral except for the chest pain with acid regurgitation, heart burning and non-heart origin chest pain, the two groups have no obvious difference, and the advantages of improving the chest pain with acid regurgitation, the abdominal distention, the gas regurgitation or the chest pain with acid regurgitation and the irritability and the hunger, the test group are superior to the control group, see the table 11 and fig. 10 below:
table 11 comparison of the single integral of the symptoms of the traditional Chinese medical science before and after the two treatments
Note that: * it means that there is a statistical difference (P < 0.05) between before and after treatment, △ the comparison between the two groups after treatment is statistically different (P < 0.05), # the difference between the two groups before and after treatment is statistically different (P < 0.05)
4. Anxiety depression state score comparison
(1) HAMA integral comparison
Statistics are carried out on HAMA integral after treatment of two groups of patients, the HAMA integral after treatment of two groups is approximately in normal distribution, t test is adopted, statistical results show that P is less than 0.05, difference has statistical significance, the HAMA integral before treatment and after treatment of two groups are respectively compared in groups, P is less than 0.05, difference has statistical significance, and both groups of medicines are indicated to improve anxiety states, wherein the test group is superior to the control group, and the following table 12 and fig. 11 are adopted:
table 12 comparison of HAMA integral before and after two treatment groups
(2) HAMD integral comparison
Statistics is carried out on HAMD integral after treatment of two groups of patients, the HAMD integral after treatment of two groups of patients is approximately normally distributed, the statistical result shows that P is less than 0.05, the difference has statistical significance, the HAMD integral before treatment and after treatment of two groups of patients are respectively compared in groups, P is less than 0.05, the difference has statistical significance, and the two groups of medicines are prompted to improve depression state, wherein the experimental group is superior to the control group, and the following table 13 and fig. 12 are provided:
TABLE 13 comparison of HAMD score before and after treatment of two groups
5. Comparison of recurrence rates
After the treatment course is ended for 4 weeks, the test group and the control group are followed by curing, developing and effective patients, wherein the test group is followed by 44 patients according to the plan, 2 patients are not visited, and 42 patients are finally visited, wherein 5 patients relapse; the control group should follow up 36 cases on schedule, 3 patients were not visited, and finally 33 cases were visited, of which 10 cases were relapsed. The recurrence rates of the two groups were compared and statistically different (P < 0.05), see Table 14 below and FIG. 13:
table 14 comparison of recurrence rates for two groups
6. Safety and adverse reaction comparison
In the research process, no obvious adverse reaction occurs to the patient, and vital signs and auxiliary examination results of the patient are not changed obviously before and after treatment. The two groups of treatment schemes are both safe and reliable.
3. Analysis of study results
1. Case profile analysis
The study is carried out by taking 106 GERD patients together, and finally 97 cases are completed, wherein 59 cases of men and 38 cases of women are more men, which may be related to that the probability of male dinner, smoking and drinking is greater than that of women, and foreign scholars study finds that the probability of female suffering from non-erosive GERD is higher than that of men, and the probability of male suffering from organic diseases such as erosive esophagitis, barrett esophagus and esophageal cancer is higher than that of women. The average age of the study group is 42.43 +/-13.191 years, the average age of the control group is 47.38+/-12.385 years, epidemiology shows that the disease incidence of GERD increases with the age, and the age of 40-60 years is the disease incidence peak age, which can be related to the physical function decline, lack of exercise and irregular diet of middle-aged and old people. In addition to age, sex, smoking, alcohol consumption, obesity are important risk factors for GERD, so this study included these three factors in the analysis. Various studies have shown that BMI is positively correlated with the prevalence of GERD, which may be associated with damp-heat in obese people who are more fat, sweet, and greasy, and in addition, more prone to hiatal hernias and transient LES relaxation than normal people.
2. Overall efficacy comparative analysis
After 8 weeks of treatment, the total effective rate of the test group is 89.79%, the control group is 75%, the two groups are compared by adopting chi-square test, and the P=0.032 is less than 0.05, so that the difference has statistical significance. The two treatment methods are proved to have the effect of improving the clinical symptoms of the GERD with the symptoms of liver-stomach depression and heat, and the total curative effect of the traditional Chinese medicine composition is better than that of western medicines.
RDQ integral comparison analysis
The total integral of RDQ after treatment of two groups of patients is counted, and the result shows that P=0.676 is more than 0.05, the difference has no statistical significance, the total integral before and after treatment of two groups of patients is respectively compared in groups, P is less than 0.01, the difference has statistical significance, and the two groups of medicines are indicated to obviously improve the total integral of RDQ, and the comparison between the two groups has no obvious difference. The statistics of RDQ single integral after treatment of two groups of patients shows that the integral P of symptoms of chest pain of acid regurgitation, heart burning and non-heart origin is more than 0.05, the difference has no statistical significance, the integral of symptoms of acid regurgitation, P is less than 0.05, the difference has statistical significance, the single integral before and after treatment is respectively compared in groups, P is less than 0.05, the difference has statistical significance, and the two groups of medicines are indicated to obviously improve the RDQ single integral, wherein, in the aspect of improving the chest pain of acid regurgitation, heart burning and non-heart origin, the two groups have no obvious difference, and in the aspect of improving the food regurgitation, the test group is better than the control group. The traditional Chinese medicine composition has the effects of lowering adverse flow of qi and preparing acid by using the Haematitum and the cuttlebone, and meanwhile, the classical compatibility of the pinellia ternate and the magnolia officinalis has the effects of promoting qi circulation and eliminating phlegm, descending qi and removing fullness, and can promote gastric emptying and enhance oesophageal motility, so that the combination of all the medicines can effectively improve clinical symptoms. The rabeprazole used in the control group is PPI of the second generation, has stronger acid inhibiting effect than the first generation, is applicable to digestive tract ulcers, reflux related diseases and the like, has the main pharmacological effect of inhibiting gastric acid secretion, and has better curative effects on acid regurgitation, heartburn and non-cardiogenic chest pain caused by gastric hyperacidity or overrising and slightly inferior curative effects on symptoms of overeating.
4. Integral comparison analysis of traditional Chinese medicine syndrome
The total integral of the traditional Chinese medicine symptoms after the treatment of the two groups of patients is counted, the result shows that P is less than 0.05, the difference has statistical significance, the total integral before and after the treatment of the two groups of patients is respectively compared in groups, P is less than 0.05, the difference has statistical significance, and the two groups of medicines are indicated to be capable of improving the total integral of the traditional Chinese medicine symptoms, wherein the test group is superior to the control group. The statistics of the single integral of the traditional Chinese medicine symptoms after the treatment of two groups of patients shows that the integral P of the chest pain symptoms caused by acid regurgitation, heart burning and non-heart is more than 0.05, the difference has no statistical significance, the chest pain caused by acid regurgitation, epigastric distension and fullness, belch or regurgitation, irritability and hunger symptoms integral, the P is less than 0.05, the difference has statistical significance, the integral of the single symptoms before and after the treatment are respectively compared in groups, the P is less than 0.05 in test groups, the P is less than 0.05 in comparison groups except for the chest pain caused by acid regurgitation and hunger, the integral of the rabeprazole can be obviously improved, and the two groups have no obvious difference in the aspects of improving the chest pain caused by acid regurgitation, heart burning and non-heart and chest pain caused by non-heart, and are better than the comparison groups. The traditional Chinese medicine for treating GERD has the advantages that the syndrome differentiation treatment can be carried out according to individual differences, and the syndrome differentiation treatment is modified along with the syndrome, and the combination of four medicines of coptis chinensis, evodia rutaecarpa, bupleurum and scutellaria baicalensis in the traditional Chinese medicine composition can effectively clear away stagnated heat and smooth liver qi, so that the traditional Chinese medicine composition is superior to single rabeprazole in improving traditional Chinese medicine syndrome caused by stagnated heat of liver and stomach.
5. Anxiety depression state score comparison analysis
Statistics is carried out on HAMA and HAMD integral after treatment of two groups of patients, the result shows that P is less than 0.05, the difference has statistical significance, the HAMA and HAMD integral before and after treatment of two groups of patients are respectively compared in groups, P is less than 0.05, the difference has statistical significance, and the two groups of medicines are indicated to be capable of improving anxiety states, wherein the test group is superior to the control group. Anxiety and depression emotion of GERD patients are closely related to clinical symptoms, and both groups of medicines can effectively improve clinical symptoms, so that the emotional state can also be improved. Rabeprazole has no mental-related pharmacological action, so it is less preferred. The Chinese medicinal composition has the effects of soothing liver, relieving depression, calming the heart and tranquilizing the mind, and has good curative effects on anxiety and depression.
6. Recurrence rate comparative analysis
After the treatment course is ended for 4 weeks, the test group and the control group are visited for curing, developing and effective patients, wherein the test group is visited for 44 patients according to the plan, 2 patients are not visited, and 42 patients are visited finally, wherein the recurrence rate is 11.90% and the recurrence rate is 5; the control group should follow up 36 cases according to the plan, 1 case of patients is not visited, and finally 35 cases of patients are visited, wherein 10 cases of recurrence are recurrent, and the recurrence rate is 30.30%. The recurrence rates of the two groups were compared and statistically different (P < 0.05). Pharmacological researches of a plurality of traditional Chinese medicines in the traditional Chinese medicine composition show that the traditional Chinese medicine composition has the effects of promoting gastric mucosa healing and promoting gastrointestinal motility, and the traditional Chinese medicines are taught to treat diseases and solve the root cause of the diseases while improving clinical symptoms, so that the problem is solved from the etiology, and the long-term curative effect of a test group is better.
7. Security comparison analysis
In the research process, no obvious adverse reaction occurs to the patient, and vital signs and auxiliary examination results of the patient are not changed obviously before and after treatment. The two groups of treatment schemes are both safe and reliable.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art. The generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (10)
1. The traditional Chinese medicine composition for treating gastroesophageal reflux disease with the syndrome of liver-stomach stagnation heat is characterized by comprising the following active ingredient raw materials in parts by weight:
monarch drug: 10-20 parts of calcined Haematitum and 15-25 parts of cuttlebone;
ministerial drugs: 2-10 parts of ginger processed pinellia tuber, 8-16 parts of magnolia officinalis, 2-10 parts of stir-fried coptis chinensis and 1-5 parts of evodia rutaecarpa;
adjuvant drug: 2-10 parts of bupleurum, 5-15 parts of baical skullcap root and 10-20 parts of Indian buead;
the preparation method comprises the following steps: 2-8 parts of honey-fried licorice root.
2. The traditional Chinese medicine composition for treating gastroesophageal reflux disease with the syndrome of liver-stomach heat according to claim 1, wherein the active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight:
monarch drug: 15 parts of calcined Haematitum and 20 parts of cuttlebone;
ministerial drugs: 6 parts of ginger processed pinellia tuber, 12 parts of magnolia officinalis, 6 parts of stir-fried coptis chinensis and 3 parts of evodia rutaecarpa;
adjuvant drug: 6 parts of bupleurum, 9 parts of scutellaria baicalensis, and 15 parts of poria cocos;
the preparation method comprises the following steps: 5 parts of honey-fried licorice root.
3. The traditional Chinese medicine composition for treating gastroesophageal reflux disease with the syndrome of liver-stomach heat according to claim 1, wherein the active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight: 5-15 parts of wrinkled giant hyssop and 5-15 parts of eupatorium.
4. The traditional Chinese medicine composition for treating gastroesophageal reflux disease with the syndrome of liver-stomach heat according to claim 1, wherein the active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight: 5-15 parts of fried fructus aurantii and 5-15 parts of fried fructus aurantii.
5. The traditional Chinese medicine composition for treating gastroesophageal reflux disease with the syndrome of liver-stomach heat according to claim 1, wherein the active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight: 5-15 parts of rhizoma corydalis and 5-15 parts of fried costustoot.
6. The traditional Chinese medicine composition for treating gastroesophageal reflux disease with the syndrome of liver-stomach heat according to claim 1, wherein the active ingredient raw materials of the traditional Chinese medicine composition comprise the following raw materials in parts by weight: 10-20 parts of fried hawthorn and 10-20 parts of chicken's gizzard-membrane.
7. The traditional Chinese medicine composition for treating gastroesophageal reflux disease with liver-stomach heat syndrome according to any one of claims 1-6, wherein the traditional Chinese medicine composition further comprises other traditional Chinese medicine extracts and/or other raw materials.
8. A Chinese medicinal composition preparation for treating gastroesophageal reflux disease with liver-stomach stagnation heat syndrome, which is characterized by comprising the Chinese medicinal composition according to any one of claims 1-7 and/or adding medicinal auxiliary materials and/or adding food additives.
9. The traditional Chinese medicine composition preparation for treating gastroesophageal reflux disease with the syndrome of liver-stomach stagnation heat according to claim 8, wherein the traditional Chinese medicine composition preparation is a tablet, a chewable tablet, a powder, a granule, a capsule, a paste, a pill or a liquid preparation.
10. Use of a Chinese medicinal composition according to any one of claims 1 to 7 or a Chinese medicinal composition preparation according to any one of claims 8 to 9 in the preparation of a medicament for treating gastroesophageal reflux disease with the syndrome of liver-stomach depression and/or a medicament for treating anxiety depression in patients with gastroesophageal reflux disease with the syndrome of liver-stomach depression.
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