CN114470093A - Traditional Chinese medicine preparation for treating gastroesophageal reflux disease and preparation method and application thereof - Google Patents
Traditional Chinese medicine preparation for treating gastroesophageal reflux disease and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which comprises the following raw materials in parts by weight: 20-40 parts of gypsum, 9-15 parts of immature bitter orange, 5-9 parts of mangnolia officinalis, 5-10 parts of scutellaria baicalensis, 10-30 parts of rabdosia rubescens, 3-6 parts of oroxylum indicum, 6-9 parts of blackberry lily, 8-12 parts of thunberg fritillary bulb, 8-12 parts of cuttlebone, 15-30 parts of concha arcae powder, 5-9 parts of rhizoma pinelliae preparata and 10-15 parts of cortex albiziae. Compared with the existing acid-inhibiting medicine, the traditional Chinese medicine preparation can obviously improve the clinical symptoms of patients with gastroesophageal reflux disease, such as heartburn, acid regurgitation, pharyngalgia, pharyngeal blockage, abdominal distension and the like. Obviously improve the damage state of the esophageal mucosa under the gastroscope of the patient with gastroesophageal reflux and improve the healing rate of the esophageal mucosa. Reducing the recurrence rate of gastroesophageal reflux disease.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, and a preparation method and application thereof.
Background
Gastroesophageal reflux disease (GERD) is a common clinical condition with heartburn and reflux as typical symptoms. Epidemiological survey based on population in China shows that the prevalence rate of the heart-fire symptom which is at least 1 time of attack every week is 1.9-7.0%. The treatment of the gastroesophageal reflux disease takes a Proton Pump Inhibitor (PPI) as a first choice medicine, and severe patients and refractory gastroesophageal reflux disease can be treated by endoscopy or surgery. The current therapeutic measures for gastroesophageal reflux disease mainly have the following defects:
1. the treatment time is long. At present, the treatment course of acid inhibition treatment mainly based on PPI drugs is 4-8 weeks, but the healing rate of esophageal mucosa of a patient with the treatment course of 8 weeks is obviously higher than that of a patient with the treatment course of 4 weeks.
2. The recurrence rate is high, and maintenance treatment is required. The recurrence rate of the patients with gastroesophageal reflux disease after taking Lansoprazole 15mg 1 time/d 24 weeks is 25.5%. After the treatment is stopped, patients with severe esophagitis are easy to relapse, and only 58 percent of patients in the treatment group can still maintain the esophageal mucosa healing state according to the requirements after 6 months of treatment.
3. Adverse reactions of long-term acid suppression therapy. With the long-term use of PPI, the pH value in the stomach is increased, which may cause excessive growth of bacteria and increase the chance of Clostridium difficile infection. Some studies suggest that long-term and/or large-dose use may increase the risk of hypomagnesemia, osteoporosis, vitamin B12 deficiency, anemia, pulmonary and intestinal infections, increased polyp formation, community-acquired pneumonia, gastric cancer and chronic kidney disease.
4. Refractory gastroesophageal reflux disease with ineffective acid suppression treatment. Up to 30% of patients, after double standard dose and 8 weeks of treatment with antacids, have no significant improvement in symptoms such as reflux, heartburn, etc., and are defined as refractory GERD. The management of such patients is generally optimized for PPI use, with some patients undergoing endoscopic or surgical treatment.
Therefore, in view of the shortcomings of the existing therapeutic techniques for gastroesophageal reflux disease, there is a need to provide a new therapeutic means which can shorten the treatment time of gastroesophageal reflux disease and reduce the recurrence rate of the disease.
In view of this, the invention is particularly proposed.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which can obviously improve clinical symptoms of heartburn, acid regurgitation, pharyngalgia, pharyngeal congestion, abdominal distension and the like of a gastroesophageal reflux disease patient, obviously improve the damage state of the esophageal mucosa of the gastroesophageal reflux disease patient, improve the healing rate of the esophageal mucosa and reduce the recurrence rate of the gastroesophageal reflux disease.
The second purpose of the invention is to provide a preparation method of the traditional Chinese medicine preparation.
In order to achieve the purpose, the technical scheme of the invention is as follows:
the invention relates to a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which comprises the following raw materials in parts by weight: 20-40 parts of gypsum, 9-15 parts of immature bitter orange, 5-9 parts of mangnolia officinalis, 5-10 parts of scutellaria baicalensis, 10-30 parts of rabdosia rubescens, 3-6 parts of oroxylum indicum, 6-9 parts of blackberry lily, 8-12 parts of thunberg fritillary bulb, 8-12 parts of cuttlebone, 15-30 parts of concha arcae powder, 5-9 parts of rhizoma pinelliae preparata and 10-15 parts of cortex albiziae.
Preferably, the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae.
The principle of the traditional Chinese medicine preparation for realizing the functions is as follows:
the gastroesophageal reflux disease belongs to the categories of symptoms such as esophagus fever, acid regurgitation and gastric upset in traditional Chinese medicine, the disease location is esophagus and stomach, the relationship with liver, spleen and lung is close, and the core pathogenesis of the gastroesophageal reflux disease is summarized as stagnated heat stagnation and adverse rising of stomach qi. The most typical clinical manifestations of gastroesophageal reflux disease are reflux, heartburn. Patients with gastroesophageal reflux disease are often accompanied by adverse rising of stomach qi due to stagnation of liver qi, or dysfunction of qi movement of spleen and stomach, stagnation of qi movement, long-term transformation of fire, endogenous stagnated heat, and heat inflammation. Yuan, Zhu Danxi (Danxi Heart method, six Yu) (Yongyan): "Qi and blood are harmonized, so all diseases are caused by stagnation of liver-heat. The "depression" means that the accumulation is more serious and the ascending person is not ascending, the descending person is not descending, and the changing person is not changing. "Qing, He Meng Yao" (medicine advancing & depression) has a saying: the fire does not occur when the cover is depressed, and the fire does not occur when the cover is depressed. Heat can cause stagnation, and the stagnation turns into heat after long time, both of them coexist, and the heat is stagnated, and the stagnant heat forms, and then the heart is burned and sour regurgitation occurs. As described in the "Nei Jing" (the classic of medicine), vomiting and acid … … all pertain to heat. The stomach descends to direct qi, and the physiological function of the stomach depends on the descending and circulation of stomach qi. The stomach-qi failing to descend and the spleen-qi failing to ascend, so the clear and turbid can not be separated, and in addition, the liver-qi disorder can cause stagnation of qi, and the stagnation of qi can lead to heat transformation due to long-term stagnation, thus forming stagnated heat of liver and stomach, which can cause symptoms of pain after sternum, dysphagia and the like. Liver failure in regulating the flow of qi, stomach failure in descending, lung failure in dispersing and descending, lung qi stagnation, and long-term heat transformation to form stagnated heat in lung and stomach, and "throat is the portal of lung and stomach", so symptoms such as pharyngalgia, pharyngeal blockage, dry throat, etc. appear.
The Chinese medicinal preparation is prepared according to the core pathogenesis of stagnant heat retardation and adverse rise of stomach qi and following the treatment method of clearing, benefiting, regulating and nourishing.
Clearing away heat, namely clearing away stagnated heat, and in the pathogenesis of gastroesophageal reflux disease, the process of heat transformation into acid exists, and the clearing away of the stagnated heat can lead the acid not to be dissolved, thereby relieving the acid regurgitation symptom, reducing the secretion of gastric acid and eliminating the pathological factors. In the formula, gypsum is pungent and sweet in flavor and cold in nature, enters lung and stomach meridians, has bitter taste for clearing heat and purging fire, and pungent flavor for dispersing pathogenic fire, so that it is the essential herb for clearing lung and stomach fire. Therefore, it is a monarch drug.
Baikal skullcap root, bitter in taste and cold in nature, enters lung, stomach, gallbladder and large intestine meridians, and is the key herb for clearing heat, drying dampness and relieving stuffiness. Ben Cao Jing Shu (the book of materia Medica Prime and Dredging): the nature of scutellaria is clear, so that the pathogenic factors are eliminated; bitter taste to dry dampness; cold in yin is predominant in heat, so it is mainly responsible for heat. Those with heat are also the pathogenic heat and damp-heat. Rabdosia rubescens is sweet and bitter in taste and slightly cold in nature, has the effects of clearing heat and removing toxicity, diminishing inflammation, relieving pain, resisting tumors and the like, and is mainly used for treating diseases such as sore throat, tonsillitis, snake and insect bite, esophageal cancer and the like in clinic. Modern pharmacological research finds that the main chemical component of rabdosia rubescens is a diterpenoid compound, can further regulate and control the expression of an inflammation medium by influencing the transcription capability of a nuclear transcription factor kB, exerts the anti-inflammatory activity of the rabdosia rubescens, is even effective to various tumors, and has obvious curative effect on early esophageal cancer. The two medicines are used together to enhance the effects of clearing heat, relieving sore throat and detoxifying.
Zhi Shi and Hou Po can reduce the turbid qi of spleen and stomach. Zhi Shi can break qi and relieve stuffiness, resolve food stagnation and resolve phlegm, enter spleen and stomach meridians. New edition of materia medica cloud: zhi Shi is … … skilled in property and also called Xia Ling Wei. The spleen is also in earth and zang-organs, so it is good at summer qi, so it can descend to promote stagnation in the spleen. Modern pharmacological research shows that the immature bitter orange can regulate gastrointestinal motility, promote gastric motility and accelerate gastric emptying. Magnolia officinalis, which is bitter in flavor, lowers the adverse flow of qi, removes food stagnation, removes fullness, eliminates dampness, and resolves phlegm, as in Yun of Changsha Yao Jie (Long Sha Yao Jie): hou Po, bitter and pungent in flavor, excels in breaking obstruction and relieving fullness and distention. The two medicines are used together to regulate the qi movement of the spleen and the stomach and restore the physiological function of stomach qi circulation and descending.
The oroxylum indicum is bitter and sweet in taste and cool in nature, enters lung, liver and stomach meridians, can clear stagnated heat of lung and stomach, treat sore throat, sooth liver and harmonize stomach, and harmonize emotion to help recover liver qi failing to disperse and purge.
Belamcanda chinensis, bitter in taste and cold in nature, enters lung meridian, and has the effects of clearing away heat and toxic materials, eliminating phlegm and relieving sore throat. Belamcanda chinensis recorded in Ben Cao gang mu is the key herb for treating pharyngitis and pharyngalgia in ancient prescription, because it can lower fire. Modern pharmacological researches find that the blackberry lily is rich in flavonoids and has various pharmacological activities including oxidation resistance, inflammation resistance, cancer resistance, intestinal flora regulation and the like.
The pharynx is the "mouth" of the stomach and the "exterior syndrome" of the stomach. The meridians run along the middle, the pharynx belongs to the stomach system, and the branch runs from the great front to the lower head, runs through the throat and enters the deficient basin. The study shows that the pharyngeal and gastrointestinal movement is controlled by sympathetic nerves and vagus nerves, and pharyngeal symptoms can occur due to the dysfunction of the gastrointestinal movement and the dysfunction of the sympathetic nerves and the vagus nerves and the involvement of the pharyngeal plexus. Meanwhile, discomfort and stimulation of the pharynx can cause vomiting reflex, so that the intra-abdominal pressure is increased, meanwhile, the pylorus is tightly closed, cardia and esophagus relax, gastric contents such as gastric acid flow back into the esophagus, and damage to esophageal mucosa is caused. Therefore, the three medicines of the rabdosia rubescens, the oroxylum indicum and the blackberry lily can clear and relieve throat symptoms outside the esophagus and relieve repeated stimulation of pathological factors to esophageal mucosa.
Zhe Bei mu is bitter in taste and cold in nature, and enters heart and lung meridians. Has the functions of clearing away lung-heat, eliminating phlegm, resolving masses and relieving swelling. The cuttlebone and the corrugated powder inhibit acid. Modern researches show that cuttlebone has the effects of neutralizing gastric acid, protecting mucous membrane and resisting ulcer. Corrugated powder, salty in taste, neutral in nature, enters lung, stomach and liver meridians, and has the effects of relieving hyperacidity, alleviating pain, eliminating phlegm and removing blood stasis. Zhe Bei mu is combined with Hai Piao Xiao named Wu Bei san as the proved recipe for preparing acid.
Ban Xia is pungent and warm in flavor and warm in nature, and can dry dampness and resolve phlegm, check adverse rise of qi and arrest vomiting, relieve stuffiness and dissipate nodulation. The book of entries is: 'Xiao Xin Fu chest diaphragmatic phlegm-heat and fullness knot, cough and upper qi, urgent pain and mass in the lower heart, vomiting and adverse rising of qi'. In the recipe, it is indicated for strengthening the action of harmonizing stomach and descending adverse qi.
Modern studies have shown that psychosocial factors play an important role in the development of gastroesophageal reflux disease, and that psychosocial factors may exacerbate symptoms by inducing relaxation of the lower esophageal sphincter. Moreover, the disease course is long, the symptoms are repeated, and the patient is easy to generate anxiety state, thus aggravating the disease condition. Therefore, the cortex albiziae and the sweet and neutral products are selected from the formula, have the effects of entering heart and liver channels and soothing the nerves, and are used for treating uneasiness, insomnia and dysphoria, mild action and obvious effect. The book of Shen nong Ben Cao Jing says that cortex Albizziae is mainly used for regulating five internal organs and for harmonizing the mind and making people happy and carefree. Therefore, the cortex albiziae can relieve the emotion of a patient and promote the improvement of gastroesophageal reflux disease.
In summary, the formula takes the gypsum as a monarch drug, the scutellaria baicalensis, the rabdosia rubescens, the immature bitter orange and the mangnolia officinalis as ministerial drugs, and the oroxylum indicum, the blackberry lily, the thunberg fritillary bulb, the cuttlebone, the corrugated powder, the rhizoma pinelliae preparata and the cortex albiziae as assistant drugs, and the effects of clearing away stagnated heat, relieving sore throat, regulating qi, and nourishing heart and spirit are achieved together. The whole formula has strict compatibility, simple and special medicine and exact curative effect aiming at the core pathogenesis.
The invention also relates to a preparation method of the traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which comprises the following steps:
(1) extraction: mixing the raw materials, soaking in water, heating for extraction, and filtering to obtain extractive solution;
preferably, the extraction is carried out in an extraction tank, the weight ratio of the mixed raw materials to water is 1 (5-10), the soaking time is 1-2 hours, the heating extraction time is 0.5-1 hour, the heating temperature is 80-100 ℃, and the extraction can be repeated for 2-3 times.
(2) Concentration: concentrating the extracting solution under reduced pressure to obtain an extract;
preferably, the reduced pressure concentration is carried out in a multi-effect energy-saving evaporation concentration device, wherein the temperature is 80-85 ℃ in the first effect, 75-80 ℃ in the second effect and 65-75 ℃ in the third effect; the vacuum degree is-0.04 to-0.05 MPa, the secondary effect is-0.05 to-0.06 MPa, the tertiary effect is-0.06 to-0.07 MPa, the steam pressure is 0.2 to 0.5MPa, and the relative density of the extract at 55 ℃ is 1.08 to 1.10 (the density of water at 4 ℃ is 1g/cm3 as a reference density).
(3) Spray drying: and spray drying the extract to obtain the traditional Chinese medicine preparation.
Preferably, the spray drying is carried out in a spray dryer, the air inlet temperature of the spray drying is 130-160 ℃, and the air outlet temperature of the spray drying is 80-100 ℃.
The invention also relates to application of the traditional Chinese medicine preparation in preparing a medicine for treating gastroesophageal reflux disease, and specific clinical effects are shown in the embodiment.
The invention has the beneficial effects that:
aiming at the defects of the prior art for treating gastroesophageal reflux disease, the invention provides a traditional Chinese medicine preparation for treating gastroesophageal reflux disease, which can achieve the following technical effects:
1. obviously improve the clinical symptoms of patients with gastroesophageal reflux disease. Compared with the single administration of rabeprazole, the combined use of the preparation can obviously improve clinical symptoms such as heartburn, acid regurgitation, pharyngalgia, pharyngeal blockage, abdominal distension and the like.
2. Obviously improve the esophageal mucosa state of patients with gastroesophageal reflux and improve the healing rate of the esophageal mucosa. After the preparation is combined with rabeprazole for treating for 8 weeks, the effective rate of improving esophageal mucosa under a gastroscope of a patient is 83.33%, and the healing rate is 60.00%. The effective rate of pure rabeprazole taken at the same period is 73.33 percent, and the healing rate is 33.33 percent.
3. Reducing the recurrence rate of gastroesophageal reflux disease. After the treatment of the preparation is stopped, the symptom recurrence rate at 4 weeks is 11.11%, and the symptom recurrence rate of the simple rabeprazole administration at the same period is 34.78.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the examples given herein without any inventive step, are within the scope of the present invention.
Examples
A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following components in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae.
The preparation method of the traditional Chinese medicine preparation comprises the following steps:
(1) extraction: mixing the raw materials, placing in an extraction tank, soaking in water for 1 hr at a weight ratio of 1:8, heating and extracting at 90 deg.C for 40 min, repeating the extraction for 2 times, and filtering to obtain extractive solution;
(2) concentration: carrying out reduced pressure concentration on the extracting solution in a multi-effect energy-saving evaporation concentration device, wherein the temperature is 80-85 ℃ in one effect, 75-80 ℃ in two effects and 65-75 ℃ in three effects; the vacuum degree is-0.04 to-0.05 MPa, the secondary effect is-0.05 to-0.06 MPa, the tertiary effect is-0.06 to-0.07 MPa, the steam pressure is 0.2 to 0.5MPa, and an extract is obtained, wherein the relative density of the extract at 55 ℃ is 1.08 to 1.10;
(3) spray drying: and (3) carrying out spray drying on the extract in a spray dryer, wherein the air inlet temperature is 150 ℃, and the air exhaust temperature is 90 ℃, so as to obtain the traditional Chinese medicine preparation.
The clinical effect observation results of the Chinese medicinal preparation in the examples are as follows:
1. clinical data
1.1 general clinical data
In the study, 60 patients in the study were diagnosed in famous physicians' offices of TCM in Hebei province from 12 months to 7 months in 2021 in 2020, and confirmed to be reflux esophagitis. The patients are numbered according to the treatment sequence, and are divided into 2 groups of 30 patients by adopting a random number table method.
1.2 case selection
1.2.1 Western medicine diagnosis Standard reference "China gastroesophageal reflux disease experts' consensus in 2020":
(one) clinical manifestations
(1) Typical symptoms are: heartburn and reflux
(2) Atypical symptoms: chest pain (excluding cardiogenic chest pain), epigastric pain, epigastric distention, belch, nausea and other digestive tract symptoms; asthma, cough, pharyngolaryngitis, odontopathy, foreign body sensation or obstruction in pharynx, hoarseness after sleep, otitis media, etc.;
(II) upper digestive tract endoscope
The upper gastrointestinal endoscope finds reflux esophagitis, and the severity of the reflux esophagitis adopts the los angeles classification method, and the standard is as follows:
the clinical symptom coincidence person can be preliminarily diagnosed as the reflux esophagitis, and the endoscopic examination coincidence person can be definitely diagnosed as the reflux esophagitis.
1.2.2 inclusion criteria
(1) The kit meets the western medicine diagnosis standard of reflux esophagitis;
(2) the age is 18-65 years, and the nature is not limited;
(3) the medicine and non-medicine means for treating reflux esophagitis are not received within 2 weeks, and the medicine which changes the gastrointestinal function is not taken;
(4) voluntarily participate in the research and investigation, sign an informed consent, follow medical advice and have high reliability.
2. Research method
2.1 methods of treatment
2.1.1 basic treatment
Educating two groups of subjects to respect diet, mood, lifestyle adjustments, such as: avoid eating before sleep, avoid strong tea, coffee, chocolate, mint, spicy or acidic food, high-fat diet and the like; avoid the bad emotional states of anxiety, dysphoria and the like for a long time; reducing weight, raising the head of the bed, giving up (limiting) smoking, giving up (limiting) drinking, etc.
2.1.2 drug treatment
Control group: rabeprazole sodium enteric-coated tablets: each tablet is 10 mg, 1 tablet for 1 time, 1 time for 1 day, and is taken once before breakfast. [ Productivity units ] Jiangsu Haisen pharmaceutical industry Co., Ltd; [ approval document ] national drug standard H20020330.
Treatment groups: the formulation of the Chinese medicinal preparation (granule of example 1) was administered on the basis of the control group treatment: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae. The application method comprises the following steps: the medicine is taken 1 day with boiling water, 200 ml in the morning and evening respectively.
According to the consensus of China gastroesophageal reflux disease experts in 2020, 8 weeks are determined as 1 course of treatment, and the standard treatment of the 2 groups of subjects is carried out for 8 weeks.
2.2 Observation index
2.2.1 general criteria: sex, age, course of disease, etc.
2.2.2 therapeutic index
(1) Traditional Chinese medicine syndrome integration: the score before and after treatment is recorded by respectively giving 0, 2, 4 and 6 points to the main symptoms and 0, 1, 2 and 3 points to the minor symptoms according to the absence, light, medium and heavy symptoms in the traditional Chinese medicine syndrome score table.
(2) The RDQ scale score records the frequency and the severity of four symptoms of heartburn, regurgitation, non-cardiogenic chest pain and acid regurgitation in the past four weeks, each item is divided into 0-5 points, and the total points exceed 12 points and are divided into positive points. Pre-treatment and post-treatment scores were recorded.
(3) Changes in the mucosa under the gastroscope before and after treatment.
(4) Relapse of patients after 4 weeks of drug withdrawal
2.2.3 safety index
Performing electrocardiographic examination; blood, urine and excrement are used as conventional materials; liver and kidney function; adverse drug reactions.
2.3 therapeutic efficacy assessment criteria
2.3.1 evaluation Standard of curative Effect of traditional Chinese medicine syndrome
According to the clinical research guiding principle of the new traditional Chinese medicine (2002 edition), the nimodipine method is adopted for calculation: efficacy index ═ (pre-treatment score-post-treatment score)/pre-treatment score × 100%
The principle of judging the traditional Chinese medicine syndrome and effect
2.3.2 RDQ integral efficacy assessment
Referring to 'the combined diagnosis and treatment consensus opinion of gastroesophageal reflux disease in 2017', the curative effect is evaluated according to a total score ratio (score before treatment-score after treatment)/score before treatment × 100%, and the specific standards are as follows:
RDQ integral efficacy assessment
2.3.3 the curative effect is judged according to the integral of the gastroscope reexamination:
(1) and (3) healing: the volume of the endoscope after treatment is 0 point.
(2) The effect is shown: the endoscope integral was reduced by 2 points.
(3) The method has the following advantages: the endoscopic integral was reduced by 1 point.
(4) And (4) invalidation: no change or increase in endoscopic integral. The specific criteria are as follows:
2.3.4 evaluation of Long term efficacy
The RDQ questionnaire scale is filled in after 4 weeks of treatment, and the score is larger than the score at the end of the treatment course and is more than 12 points, namely the relapse is determined.
2.3.5 adverse reactions
If adverse reactions occur in the research process, recording the time, the ending time, the specific conditions and the treatment measures of the adverse reactions, and if the adverse reactions are determined to be related to the test drugs, exiting the research.
2.3.6 statistical analysis method
All data in the study are statistically analyzed by SPSS 26.0 statistical software, and the measurement data are expressed by mean plus or minus standard deviation (X plus or minus S); before and after the same group of treatment, matched sample t test is adopted, independent sample t test is adopted for comparison among different groups, and the significant difference is that P is less than 0.05, which shows that the method has statistical significance; p > 0.05 is no significant difference and is comparable.
3. Therapeutic results
3.1 comparison of the two basic data before treatment
3.1.1 two group gender comparison
TABLE 1 two groups of patients sex comparison table
As shown in Table 1, gender comparisons of the two groups were performed using Chi-Square test, chi20.300, 0.584, P > 0.05, indicating no statistical difference in gender between the two groups of patients and comparability.
3.1.2 age comparison of groups
TABLE 2 age distribution chart for two groups of patients
As shown in table 2, the ages of the two groups of patients were not normally distributed, and compared by rank-sum test, wherein Z is-0.533, P is 0.594, and P > 0.05, indicating that there was no significant difference in the ages of the two groups of patients.
3.1.3 comparison of the course of disease
TABLE 3 comparison of the course of disease for two groups of patients
As shown in table 3, the disease course time of the two groups did not follow normal distribution, and the sum of ranks test was used, Z is-0.187, P is 0.852, P > 0.05, and the difference between the disease courses of the two groups was not statistically significant and comparable.
3.2 comparison of therapeutic Effect
3.2.1 Total integral comparison of Chinese medicine symptoms before and after treatment
TABLE 4 Total integral comparison chart of TCM symptoms of two groups of patients before and after treatment
Note: the P is less than 0.05 after the treatment; in addition, compared with the control group, P is less than 0.05.
As shown in Table 4, the total integrals of TCM symptoms of two groups of patients before and after treatment are in accordance with the normal distribution and the variances are uniform, so t test is adopted. The total integration of the traditional Chinese medicine symptoms of the first two groups of patients treated by the t test has no statistical difference and is comparable (t is 1.116, P is 0.269, and P is more than 0.05). After treatment, the total integral of the traditional Chinese medicine symptoms of the two groups of patients is obviously reduced compared with that before treatment, and the difference has statistical significance (P is less than 0.05). Compared with the total traditional Chinese medicine symptom scores of two groups of patients after treatment, the treatment group is obviously lower than the control group, and the difference has statistical significance (t is 7.393, P is 0.00, and P is less than 0.05).
3.2.2 comparison of Chinese medicine symptom integrals before and after treatment
TABLE 5 Chinese medicine symptom score comparison table for two groups of patients before and after treatment
Note: compared with the tangle, P is less than 0.05; in addition, compared with the control group, P is less than 0.05.
As shown in Table 5, the scores of the Chinese medical symptoms of the two groups of patients before and after treatment do not conform to the normal distribution, so the rank-sum test is adopted. Through the rank sum test, the Chinese medicine symptom scores of the two groups of patients before treatment are not statistically different and have comparability. After the treatment of each Chinese medicine symptom score of the control group of patients, compared with the treatment before the treatment, the loose stool score has no obvious difference (P is more than 0.05). The scores of other symptoms are obviously reduced, and the difference has statistical significance (P is less than 0.05). After the treatment of each Chinese medicine symptom score of the patients in the treatment group, the Chinese medicine symptom scores are obviously reduced compared with the Chinese medicine symptom scores before the treatment, and the difference has statistical significance (P is less than 0.05). After the treatment of the two groups of patients, the scores of symptoms of heartburn, acid regurgitation, pharyngalgia, pharyngeal congestion, abdominal distention, lassitude and hypodynamia and loose stool of the treatment group are obviously smaller than those of the control group, the difference has statistical significance (P is less than 0.05), and the scores of symptoms of chest distress and anorexia have no obvious difference (P is more than 0.05).
3.2.3 comparison of therapeutic effects of the Chinese medicine symptoms before and after treatment
TABLE 6 comparison of the therapeutic effects of TCM symptoms in two groups of patients after treatment
As shown in Table 6, the therapeutic effect of the Chinese medicine syndromes of the two groups of patients after treatment is tested by rank-sum, wherein Z is-2.779, P is 0.005, and P is less than 0.05, and the difference has statistical significance. The total effective rate of 93.33 percent in the treatment group is higher than 83.33 percent in the control group.
3.2.4 comparison of RDQ scores before and after treatment
TABLE 7 RDQ scores in two groups of patients before and after treatment
Note: compared with the tangle, P is less than 0.05; in addition, compared with the control group, P is less than 0.05.
As shown in table 7, both groups of patients had both pre-and post-treatment RDQ scores that were in the normal distribution and were equally varied, so the t-test was used. Through t-test, the difference of RDQ scores of two groups of patients before treatment has no statistical significance (P is more than 0.05), which indicates that the scores of two groups of patients before treatment have no obvious difference and can be compared. The post-treatment RDQ scores for both groups of patients were significantly lower than pre-treatment, with statistical significance for the differences (P < 0.05). The RDQ score after treatment was significantly lower in the treatment groups than in the control group, with statistical differences (t 5.839, P < 0.05).
3.2.5 comparison of before and after treatment RDQ integral efficacy
TABLE 8 RDQ-score efficacy in two groups of patients
As shown in table 8, the RDQ score efficacy of the two groups of patients after treatment was tested by rank-sum, Z-2.440, P-0.015, P < 0.05, and the difference was statistically significant. The total effective rate of the treatment group is 90.00 percent higher than that of the control group by 76.67 percent.
3.2.6 comparison of before and after treatment with gastroscope
TABLE 9 comparison of the curative effects of the two groups of gastroscopes
As shown in table 9, the gastroscope curative effect showed that the total effective rate of the treatment group was 83.33% and the total effective rate of the control group was 73.33%. Through the rank sum test, Z is-2.039, P is 0.041, and P is less than 0.05, and the differences have statistical significance.
3.2.7 gastroscope grading comparison before and after treatment
TABLE 10 gastroscopic grading of two groups of patients before and after treatment
Note: compared with the tangle, P is less than 0.05; in addition, compared with the control group, P is less than 0.05.
As shown in Table 10, gastroscopic grading compares attribute rating data, so a rank sum test is used. Before treatment, the gastroscopic grading of two groups of patients has no obvious difference and no statistical significance (Z is-0.779, P is 0.436, and P is more than 0.05), and the comparability exists. After treatment, the gastroscopic grading of both groups differed from the pretreatment, with statistical significance (control group: Z-4.125, P-0.000, P < 0.05; treatment group: Z-4.769, P-0.000, P < 0.05). After treatment, the treatment groups were clearly lower gastroscopically graded than the control group, with statistical differences (Z ═ 2.131, P ═ 0.033, P < 0.05).
3.2.8 comparison of recurrence rates after treatment
TABLE 11 comparison of relapse rates 4 weeks after the end of treatment in both groups
As shown in Table 11, the follow-up visit was carried out 4 weeks after the two groups had stopped taking the drug, the recurrence rate of 3 patients was 11.11%, the recurrence rate of 8 patients was 11.78%, the recurrence rate of 34.78% was determined by continuous chi-square test24.056, P0.044, P < 0.05, the difference being statistically significant.
The amounts of Rabdosia Rubescens (Hemsl.) Hara, semen Oroxyli and Belamcanda chinensis added were varied on the basis of the examples to obtain comparative examples 1 to 3. Replacing Rabdosia rubescens with Prunellae Spica, comparative example 4 was obtained.
Comparative example 1
A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of magnolia officinalis, 12 parts of scutellaria baicalensis, 20 parts of rabdosia rubescens, 9 parts of oroxylum indicum, 6 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae, and the preparation method is the same as that in example 1.
Comparative example 2
A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 20 parts of rabdosia rubescens, 9 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae, and the preparation method is the same as that of example 1.
Comparative example 3
A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 12 parts of scutellaria baicalensis, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 6 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae. The preparation method is the same as example 1.
Comparative example 4
A traditional Chinese medicine preparation for treating gastroesophageal reflux disease comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 15 parts of selfheal, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae. The preparation method is the same as example 1.
Clinical trials were repeated for the Chinese medicinal preparations of examples and comparative examples, following the same procedure as for the Chinese medicinal preparation of the foregoing examples. The results of the observation of the clinical efficacy of the comparative example Chinese medicinal preparation are as follows:
1. clinical data
1.1 general clinical data
In comparative study, 90 patients selected from the study were diagnosed in famous hospital of traditional Chinese medicine of Hebei province from 6 months to 10 months of 2020, and confirmed to be reflux esophagitis. The patients are numbered according to the treatment sequence and divided into 6 groups by adopting a random number table method, and each group comprises 15 patients.
1.2 case selection
The same as section 1.2 in the clinical efficacy observation of the Chinese medicinal preparation in the example.
2. Research method
2.1 methods of treatment
2.1.1 basic treatment
The same as section 2.1.1 in the clinical efficacy observation of the Chinese medicinal preparation in the example.
2.1.2 drug treatment
Control group: rabeprazole sodium enteric-coated tablets: each tablet is 10 mg, 1 tablet for 1 time, 1 time for 1 day, and is taken once before breakfast. [ Productivity units ] Jiangsu Haisen pharmaceutical industry Co., Ltd; [ approved article ] national drug standard H20020330.
Comparative example 1 group: the formula of the Chinese medicinal preparation (granule of comparative example 1) was administered on the basis of the control group treatment: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 12 parts of scutellaria baicalensis, 20 parts of rabdosia rubescens, 9 parts of oroxylum indicum, 6 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae. The use method comprises the following steps: the medicine is taken 1 day with boiling water, 200 ml in the morning and evening respectively.
Comparative example 2 group: the formula of the Chinese medicinal preparation (granule of comparative example 2) was administered on the basis of the control group treatment: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 20 parts of rabdosia rubescens, 9 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae. The use method comprises the following steps: the medicine is taken 1 day with boiling water, 200 ml in the morning and evening respectively.
Comparative example 3 group: the formula of the Chinese medicinal preparation (the granule of the comparative example 3) is given on the basis of the treatment of the control group: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 12 parts of scutellaria baicalensis, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 6 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae. The use method comprises the following steps: the medicine is taken 1 day with boiling water, 200 ml in the morning and evening respectively.
Comparative example 4 group: the formula of the Chinese medicinal preparation (the granule of the comparative example 4) is given on the basis of the treatment of the control group: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 15 parts of selfheal, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae. The use method comprises the following steps: the medicine is taken 1 day with boiling water, 200 ml in the morning and evening respectively.
Example set: the formula of the Chinese medicinal preparation (granule in the example) is given on the basis of the treatment of the control group: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae. The use method comprises the following steps: the medicine is taken 1 day with boiling water, 200 ml in the morning and evening respectively.
According to the consensus of China gastroesophageal reflux disease experts in 2020, 8 weeks are determined as 1 course of treatment, and the standard treatment of the 2 groups of subjects is carried out for 8 weeks.
2.2 Observation index
(1) Traditional Chinese medicine syndrome integration: the score before and after treatment is recorded by respectively giving 0, 2, 4 and 6 points to the main symptoms and 0, 1, 2 and 3 points to the minor symptoms according to the absence, light, medium and heavy symptoms in the traditional Chinese medicine syndrome score table.
(2) The mucosa under the gastroscope changes before and after treatment.
3 results
TABLE 12 Total integral comparison chart of TCM symptoms of each group of patients before and after treatment
Note: the P is less than 0.05 after the treatment; as compared with the control group, P is less than 0.05; and compared with the comparative examples 1-4, P is less than 0.05.
As shown in Table 12, the total integrals of TCM symptoms of each group of patients before and after treatment are in accordance with the normal distribution and the variances are uniform, so t test is adopted. Through t test, the total traditional Chinese medicine symptom scores of all groups of patients before treatment have no statistical difference and are comparable (P is more than 0.05). After treatment, the total integral of the traditional Chinese medicine symptoms of each group of patients is obviously reduced compared with that before treatment, and the difference has statistical significance (P is less than 0.05). After treatment, the total traditional Chinese medicine symptom integral of the patients in the comparative examples 1-4 is obviously smaller than that of the control group, and the difference has statistical significance (P is less than 0.05). The total integral of traditional Chinese medicine symptoms of patients in the example group after treatment is obviously smaller than that of the control group and the proportion group of 1-4, and the difference has statistical significance (P is less than 0.05).
TABLE 13 gastroscopic therapeutic comparison of the groups
As shown in table 13, the gastroscopic effect showed that the treatment effect was superior to that of the control group in the example group, and the difference was statistically significant (Z ═ 2.083, P ═ 0.037, P < 0.05). The curative effect of the example group is better than that of the comparative examples 1-4 groups, and the difference has clinical significance and no statistical significance (P is more than 0.05). The curative effect of the comparative examples 1-4 is better than that of the control group, and the difference has clinical significance and no statistical significance (P is more than 0.05).
The curative effect results of the comparative examples show that the total effective rate is reduced to different degrees by changing the dosage or the components of the raw materials in the components of the invention.
The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present invention, and all the changes or substitutions should be covered within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.
Claims (10)
1. The traditional Chinese medicine preparation for treating gastroesophageal reflux disease is characterized by comprising the following raw materials in parts by weight: 20-40 parts of gypsum, 9-15 parts of immature bitter orange, 5-9 parts of mangnolia officinalis, 5-10 parts of scutellaria baicalensis, 10-30 parts of rabdosia rubescens, 3-6 parts of oroxylum indicum, 6-9 parts of blackberry lily, 8-12 parts of thunberg fritillary bulb, 8-12 parts of cuttlebone, 15-30 parts of concha arcae powder, 5-9 parts of rhizoma pinelliae preparata and 10-15 parts of cortex albiziae.
2. The traditional Chinese medicine preparation for treating gastroesophageal reflux disease according to claim 1, wherein the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 30 parts of gypsum, 15 parts of immature bitter orange, 9 parts of mangnolia officinalis, 9 parts of scutellaria baicalensis, 15 parts of rabdosia rubescens, 6 parts of oroxylum indicum, 9 parts of blackberry lily, 12 parts of thunberg fritillary bulb, 12 parts of cuttlebone, 30 parts of concha arcae powder, 9 parts of rhizoma pinelliae preparata and 15 parts of cortex albiziae.
3. The method for preparing a chinese medicinal preparation for the treatment of gastroesophageal reflux disease according to claim 1 or 2, wherein the method comprises the steps of:
(1) extraction: mixing the raw materials, soaking in water, heating for extraction, and filtering to obtain extractive solution;
(2) concentration: concentrating the extracting solution under reduced pressure to obtain an extract;
(3) spray drying: and spray drying the extract to obtain the traditional Chinese medicine preparation.
4. The preparation method according to claim 3, wherein in the step (1), the weight ratio of the mixed raw materials to the water is 1 (5-10).
5. The method according to claim 3, wherein in the step (1), the soaking time is 1 to 2 hours, the heating and extracting time is 0.5 to 1 hour, and the heating temperature is 80 to 100 ℃.
6. The method according to claim 3, wherein the extraction in the step (1) is repeated 2 to 3 times.
7. The preparation method according to claim 3, wherein in the step (2), the concentration under reduced pressure is carried out in a multi-effect energy-saving evaporation concentration device.
8. The preparation method according to claim 3, wherein in the step (2), the first-effect temperature is 80-85 ℃, the second-effect temperature is 75-80 ℃, and the third-effect temperature is 65-75 ℃; the primary vacuum degree is-0.04 to-0.05 MPa, the secondary vacuum degree is-0.05 to-0.06 MPa, the tertiary vacuum degree is-0.06 to-0.07 MPa, and the steam pressure is 0.2 to 0.5 MPa.
9. The preparation method according to claim 3, wherein in the step (3), the inlet air temperature of the spray drying is 130-160 ℃, and the outlet air temperature is 80-100 ℃.
10. Use of a Chinese medicinal preparation according to claim 1 or 2 in the manufacture of a medicament for the treatment of gastroesophageal reflux disease.
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