Spleen tonifying, middle warmer warming and ulcer healing prescription

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a spleen-tonifying, middle-jiao-warming and ulcer-healing prescription. The formula comprises 15g of radix astragali preparata, 12g of radix codonopsis, 9g of cassia twig, 15g of poria cocos, 15g of roasted rhizoma atractylodis macrocephalae, 12g of pericarpium citri reticulatae, 9g of ginger processed pinellia, 3g of pseudo-ginseng powder, 9g of cuttlebone, 6g of semen oroxyli, 6g of baked ginger, 6g of rhizoma bletillae and 3g of honey-fried licorice root. The spleen-tonifying, middle-jiao-warming and ulcer-healing prescription has the following effects that (1) the curative effect of the spleen-tonifying, middle-jiao-warming and ulcer-healing prescription combined with rabeprazole on spleen-stomach deficiency-cold type PU is better than that of pure rabeprazole, and the effect of improving the overall clinical symptoms of a patient is more remarkable; and (2) the spleen-tonifying middle-jiao-warming ulcer healing prescription is combined with rabeprazole, so that the prescription is superior to rabeprazole in the aspects of promoting the repair of gastrointestinal mucosa of a spleen and stomach deficiency-cold type PU patient and healing of an ulcer surface. And (3) the spleen-tonifying middle-jiao-warming ulcer healing prescription is combined with rabeprazole, so that the relapse rate of the spleen-stomach deficiency-cold type PU patient is lower than that of rabeprazole.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a spleen-strengthening, middle-tonifying and ulcer-healing prescription. Background Art

[0002] Peptic ulcer (PU) is a common disease in the digestive system. It can be divided into gastric ulcer (GU), duodenal ulcer (DU) and combined ulcer according to the location of the ulcer. PU is a multifactorial disease in which the erosion of various substances in the stomach causes an inflammatory reaction in the lower layer and muscular layer of some mucosa, eventually leading to local necrosis and defects.

[0003] Western medicine treatment of PU focuses on controlling and alleviating clinical symptoms, which is reflected in the treatment plan as protection of the gastrointestinal mucosa, inhibition of gastric acid secretion, and elimination of Helicobacter pylori, the inducing factor of PU. However, patients' condition is prone to relapse, and some patients do not show significant improvement in clinical symptoms after taking Western medicine treatment.

[0004] Research results show that Chinese medicine can stimulate the proliferation of gastrointestinal mucosal cells and inhibit gastric acid secretion to achieve the goal of treating PU, and there are relatively few side effects after taking the medicine. The most common syndrome differentiation of PU in clinical practice is spleen and stomach deficiency and cold type. Prescriptions and medicines with the effects of strengthening the spleen, warming the middle and relieving pain have a good effect on the treatment of this disease. After taking Chinese medicine, the side effects and recurrence rate of Western medicine treatment can be significantly reduced. Therefore, in clinical practice, using Chinese medicine to treat PU has greater advantages than Western medicine. There is no "PU" disease name in Chinese medicine, and "stomachache" and "noise" are used as Chinese medicine disease names for PU. Its etiology and pathogenesis are mainly related to the invasion of exogenous evil, improper diet, emotional disorder, and spleen deficiency and weakness.

[0005] The etiology and pathogenesis of PU with spleen-stomach deficiency and coldness are mainly related to spleen yang deficiency. Ningxia Hui Autonomous Region is located in the northwest of China, where the four seasons are dry and the autumn and winter are cold. The dietary habits in the northwest are mainly fatty, sweet, spicy and they like to drink a lot, which is easy to produce dampness. Dampness is a yin evil, which can easily damage yang, causing spleen yang deficiency and eventually forming spleen-stomach deficiency and coldness.

[0006] The inventors have summarized the syndrome differentiation of PU patients in clinical practice, and the results show that more than 60% of them are spleen and stomach deficiency and cold type, and the reasons can be summarized as deficiency of yang, irregular work and rest, greed for cool drinks, abuse of drugs, etc. For further clinical research, provide ideas for syndrome differentiation and treatment, thereby improving the clinical efficacy of PU, reducing the toxic and side effects of Western medicine treatment, reducing the recurrence rate of PU, and improving the quality of life of patients. By developing a spleen-strengthening, warming and ulcer-healing prescription, provide a reference basis for the prevention and clinical diagnosis and treatment of spleen and stomach deficiency and cold type PU in the northwest region. Summary of the invention

[0007] In order to comprehensively solve the above problems, the present invention proposes a spleen-strengthening, middle-heat-warming and ulcer-healing prescription, which is more effective in repairing gastrointestinal mucosa and healing ulcer surface in patients with spleen and stomach deficiency-cold type PU than the existing single use of rabeprazole, and has a lower recurrence rate than rabeprazole.

[0008] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] A prescription for strengthening the spleen, warming the middle and curing ulcers, comprising: roasted astragalus, codonopsis, cinnamon twig, poria, stir-fried atractylodes, tangerine peel, ginger pinellia, notoginseng powder, cuttlebone, oroxylum, roasted ginger, bletilla striata and roasted liquorice.

[0010] Preferably, the amount of the formulated medicine is: 15g of roasted Astragalus, 12g of Codonopsis, 9g of cinnamon twig, 15g of Poria, 15g of stir-fried Atractylodes, 12g of dried tangerine peel, 9g of ginger Pinellia, 3g of Panax notoginseng powder, 9g of cuttlebone, 6g of Oroxylum, 6g of roasted ginger, 6g of Bletilla, and 3g of roasted Licorice.

[0011] A spleen-strengthening, middle-tonifying and ulcer-healing prescription is used for preparing spleen-strengthening, middle-tonifying and ulcer-healing granules or pills.

[0012] The preparation steps of the spleen-strengthening, middle-tonifying and ulcer-removing granules are as follows:

[0013] Step 1: weigh the following Chinese medicines: roasted Astragalus 15g, Codonopsis pilosula 12g, Cinnamon twig 9g, Poria 15g, stir-fried Atractylodes macrocephala 15g, Tangerine peel 12g, Pinellia ternata 9g, Notoginseng powder 3g, Cuttlebone 9g, Oroxylum indica 6g, Paojiang 6g, Bletilla striata 6g, roasted Licorice root 3g;

[0014] Step 2: Mix the Chinese medicines in step 1, add water and soak for 4 hours, heat and boil twice, each time for 60 minutes, combine the decoctions, let stand for 24 hours, filter, and boil at 80°C. The density of water and concentrated filtrate is 1:1.32-1.35;

[0015] Step 3: Add soluble starch to the concentrated solution obtained in step 2 and mix well. The amount of soluble starch is 10-12% of the original medicinal material. Put it into a microwave vacuum dryer and dry it at 60-80°C and grind it into granules to obtain spleen-strengthening, middle-tonifying and ulcer-healing granules.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] (1) The efficacy of Jianpi Wenzhong Yuyang prescription combined with rabeprazole in the treatment of spleen and stomach deficiency-cold type PU is better than that of rabeprazole alone, and the effect is more significant in improving the overall clinical symptoms of patients.

[0018] (2) The Jianpi Wenzhong Yuyang prescription combined with rabeprazole is superior to rabeprazole in promoting the repair of gastrointestinal mucosa and healing of ulcer surface in patients with spleen and stomach deficiency-cold type PU.

[0019] (3) The Jianpi Wenzhong Yuyang prescription combined with rabeprazole is less effective than rabeprazole in reducing the recurrence rate of patients with spleen and stomach deficiency-cold type PU. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The accompanying drawings are used to provide further understanding of the present invention and constitute a part of the specification. They are used to explain the present invention together with the embodiments of the present invention and do not constitute a limitation of the present invention.

[0021] In the attached picture:

[0022] Figure 1 Gender distribution diagram of the two groups;

[0023] Figure 2 Age distribution (example);

[0024] Figure 3 The flowchart of the preparation method of the Chinese medicine granules of the present invention;

[0025] Figure 4 Review opinion of the Research Ethics Committee of Ningxia Hospital and Institute of Traditional Chinese Medicine. DETAILED DESCRIPTION

[0026] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0027] In order to achieve the above purpose, please refer to the attached Figure 1-4 , the technical solution adopted by the present invention is as follows:

[0028] A prescription for invigorating the spleen, warming the middle and curing ulcers: roasted Astragalus 15g, Codonopsis pilosula 12g, cinnamon twig 9g, Poria 15g, stir-fried Atractylodes macrocephala 15g, tangerine peel 12g, ginger Pinellia 9g, Panax notoginseng powder 3g, cuttlebone 9g, Oroxylum butterflyii 6g, roasted ginger 6g, Bletilla striata 6g, and roasted Licorice root 3g.

[0029] A spleen-strengthening, middle-tonifying and ulcer-healing prescription is used for preparing pills.

[0030] A spleen-strengthening, middle-tonifying and ulcer-healing granule comprising

[0031] Step 1: weigh the following Chinese medicines: roasted Astragalus 15g, Codonopsis pilosula 12g, Cinnamon twig 9g, Poria 15g, stir-fried Atractylodes macrocephala 15g, Tangerine peel 12g, Pinellia ternata 9g, Notoginseng powder 3g, Cuttlebone 9g, Oroxylum indica 6g, Paojiang 6g, Bletilla striata 6g, roasted Licorice root 3g;

[0032] Step 2: Mix the Chinese medicines in step 1, add water and soak for 4 hours, heat and boil twice, each time for 60 minutes, combine the decoctions, let stand for 24 hours, filter, and boil at 80°C. The density of water and concentrated filtrate is 1:1.32-1.35;

[0033] Step 3: Add soluble starch to the concentrated solution obtained in step 2 and mix well. The amount of soluble starch is 10-12% of the original medicinal material. Put it into a microwave vacuum dryer and dry it at 60-80°C and grind it into granules to obtain spleen-strengthening, middle-tonifying and ulcer-healing granules.

[0034] Among them, each component has the following effects:

[0035] Roasted Astragalus: sweet in taste, warm in nature. Enters the lung and spleen meridians. It has the effect of tonifying the middle and replenishing qi. Through the study of the chemical components of Astragalus, it was found that the main chemical components of Astragalus are flavonoids, saponins and polysaccharides. Astragalus flavonoids have the effects of strengthening the spleen and improving gastrointestinal function; Astragalus saponins can effectively inhibit inflammatory reactions and have anti-inflammatory and analgesic effects; Astragalus polysaccharides can improve antioxidant capacity and promote gastric ulcer mucosal repair.

[0036] Codonopsis: sweet, neutral in nature. It enters the spleen and lung meridians. It has the effects of invigorating qi and strengthening the spleen, promoting the production of body fluids and nourishing blood. The main chemical components of Codonopsis include polysaccharides, flavonoids, alkaloids and acids, which have the functions of protecting gastric mucosa, alleviating inflammatory reactions, and regulating the body's immunity.

[0037] Cinnamon twig: spicy, sweet, warm in nature. It enters the lung, heart, and bladder meridians. It has the effects of dispelling cold and relieving pain, promoting yang and transforming qi. Studies on the chemical components of cinnamon twigs have shown that it mainly includes volatile oils (such as cinnamaldehyde, cinnamyl alcohol, etc.) and organic acids (such as cinnamic acid, methoxycinnamic acid, etc.), which have antifungal, anti-inflammatory and analgesic effects.

[0038] Poria: Sweet, light, neutral in nature. Enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and removing dampness, strengthening the spleen and calming the mind. The chemical active ingredients in Poria are mainly triterpenes and polysaccharides. Its main pharmacological effects include diuresis, liver protection, anti-inflammatory, sedation, etc. In addition, it also has the effects of regulating immunity and improving gastrointestinal function.

[0039] Stir-fried Atractylodes macrocephala: bitter and sweet, warm in nature, and enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. Atractylodes macrocephala contains a variety of volatile oils, polysaccharides, lactones and other chemical components. The various chemical substances contained in Atractylodes macrocephala have a variety of pharmacological effects such as improving gastrointestinal motility, enhancing the body's immunity, inhibiting the occurrence of inflammatory reactions, regulating the body's hormone secretion, effectively inhibiting lipid peroxidation, delaying aging, and enhancing hematopoietic function.

[0040] Tangerine peel: bitter, pungent, warm in nature. Enters the lung and spleen meridians. Mainly has the functions of regulating qi and strengthening spleen, drying dampness and resolving phlegm, inhibiting gastrointestinal smooth muscle, promoting secretion of digestive juice, promoting bile secretion, and resisting shock.

[0041] Pinellia tuber: Spicy, warm, slightly toxic. Enters the spleen, stomach and lung meridians. Has the effects of drying dampness and resolving phlegm, relieving adverse reactions and stopping hiccups. The main chemical components of Pinellia tuber include amino acids, volatile oils, alkaloids, sterols, Pinellia tuber protein, and organic acids. Its main pharmacological effects include anti-inflammatory, antitussive and expectorant, antiemetic, antioxidant, and antibacterial.

[0042] Paojiang: bitter and astringent, warm in nature, it enters the spleen, stomach, and kidney meridians, and has the effect of warming the middle and relieving pain. Paojiang has similar effects to dried ginger, but its warming effect is stronger than dried ginger in treating spleen and stomach deficiency and cold, and Paojiang also has an inhibitory effect on PU, so it can not only treat spleen and stomach deficiency and cold in this prescription, but also assist in the treatment of PU. Paojiang decoction can significantly inhibit acetic acid-induced gastric ulcer, stress gastric ulcer, and pyloric ligation gastric ulcer in rats.

[0043] Bletilla striata: It tastes bitter, sweet and astringent, and is slightly cold in nature. It enters the lung, liver and stomach meridians. It has the effects of astringent, hemostasis, swelling reduction and tissue regeneration. Many modern studies have shown that the Bletilla striata gum contained in Bletilla striata has strong viscosity and can form a protective film on the surface of gastrointestinal ulcers, which can reduce the irritation of food and drugs to the gastrointestinal mucosa, thereby accelerating the healing of the ulcer surface.

[0044] Cuttlebone: salty, astringent, slightly warm, enters the spleen and kidney meridians, has the effects of antacidity and analgesia, removing dampness and promoting tissue regeneration, astringency and hemostasis. Cuttlebone has a good regulatory effect on the content of nitric oxide in the gastrointestinal mucosa, enhances the protective effect of the gastrointestinal mucosal barrier, and promotes the synthesis of prostaglandins in gastrointestinal tissues, thereby accelerating the healing of gastrointestinal mucosal ulcers. Excessive gastric acid secretion is one of the main causes of PU. Cuttlebone can effectively inhibit the secretion of gastric acid, protect the gastrointestinal mucosal tissue, and thus accelerate the healing of ulcers.

[0045] Panax notoginseng: It tastes sweet and slightly bitter, is warm in nature, and enters the liver and stomach meridians. It has the effects of promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding. Panax notoginseng can significantly improve the blood circulation of the gastrointestinal mucosa, accelerate blood circulation, accelerate tissue regeneration, and accelerate metabolism, which can reduce the invasion of inflammatory factors on local damaged mucosa, thereby inhibiting the occurrence of inflammatory reactions and promoting the regeneration of gastrointestinal mucosal tissues. The inflammatory reaction is reduced, and the tissue regeneration ability is strong, then the repair and healing of the ulcer surface is accelerated.

[0046] Oroxylum butterfly: bitter, sweet, cool in nature. Enters the lung, liver, and stomach meridians. It has the effects of clearing the lungs and relieving throat pain, soothing the liver and harmonizing the stomach. Some chemical substances contained in Oroxylum butterfly, such as chrysin, can effectively reduce the expression of genes related to various pro-inflammatory cytokines (such as TNFα, IL-1β, IL-4, IL-6) in mouse wounds, and can effectively inhibit the occurrence of inflammatory reactions. In addition, such compounds can inhibit COX-II and reduce the synthesis of prostaglandins, thereby indirectly inhibiting the occurrence of inflammatory reactions, acting from two aspects at the same time to promote the healing of inflammatory wounds in mice.

[0047] Roasted Licorice: warm in nature, sweet in taste. It enters the heart meridian, lung meridian, stomach meridian, and spleen meridian. It has the effects of tonifying the spleen and stomach and harmonizing various medicines. After being processed into roasted licorice, it can improve the anti-ulcer activity. Its mechanism of action is to improve the body's antioxidant capacity.

[0048] Clinical Research:

[0049] 1. Clinical Data

[0050] 1.1 Case source

[0051] A total of 72 cases that met the trial criteria were included. All of them were PU patients with spleen and stomach deficiency and cold syndrome who visited the outpatient and inpatient departments of the Hepatobiliary Spleen and Stomach Department of Ningxia Hospital of Traditional Chinese Medicine and Institute of Traditional Chinese Medicine from January 2022 to January 2023.

[0052] 1.2 Diagnostic criteria

[0053] 1.2.1 Western medicine diagnostic criteria

[0054] The Western medicine diagnostic standards were formulated with reference to the "Guidelines for the Diagnosis and Treatment of Peptic Ulcer" and the ninth edition of "Internal Medicine".

[0055] (1) Symptoms: Chronic, rhythmic, cyclical upper abdominal distension, dull pain or burning pain are the main clinical symptoms. The pain of gastric ulcer GU is characterized by pain on the left side of the upper abdomen after meals, which is relieved before the next meal; the pain of duodenal ulcer DU is characterized by pain on the upper abdomen before meals or at night, the pain is generally on the right side, and the symptoms are relieved after eating. In addition to the main symptoms, it is often accompanied by other symptoms such as acid reflux, poor appetite, and belching.

[0056] (2) Signs: Mainly upper abdominal pain. Depending on the site of the peptic ulcer, the pain may be slightly to the left or right, and there may be local tenderness.

[0057] (3) Gastroscopy may reveal gastrointestinal ulcer lesions, such as localized ulcer lesions in the stomach and / or duodenum, and endoscopic pathological biopsy may exclude severe dysplastic changes in the gastric mucosa.

[0058] 1.2.2 Endoscopic staging diagnostic criteria

[0059] Endoscopic examination showed PU, and the staging method of Takao Kirara was used.

[0060] Table 1 Takao Shita staging

[0061]

[0062] 1.2.3 TCM diagnostic criteria

[0063] The TCM diagnostic standards were formulated in reference to the "Consensus on the Diagnosis and Treatment of Peptic Ulcer with Integrated Traditional Chinese and Western Medicine".

[0064] Clinical symptoms of PU in TCM due to spleen and stomach deficiency and coldness:

[0065] The main symptoms are: ① pain in the stomach, which prefers warmth and pressure; ② pain that is more severe when the stomach is empty and is relieved after eating.

[0066] The secondary symptoms are: ① fatigue and listlessness; ② vomiting clear saliva; ③ loss of appetite; ④ pale complexion; ⑤ cold limbs; ⑥ loose stools.

[0067] The tongue is pale red, with a thin white coating and teeth marks on the edges; the pulse is deep and thin or slow.

[0068] Diagnosis conditions: The main symptom item ① plus 2 secondary symptoms, or all the main symptoms plus any secondary symptoms, while referring to the tongue coating and pulse.

[0069] 1.3 Inclusion criteria

[0070] (1) Meet the above-mentioned PU Chinese and Western medicine diagnostic criteria;

[0071] (2) Patients aged between 18 and 75 years, regardless of gender;

[0072] (3) Have not taken any medication that may affect the test results within 1 month;

[0073] (4) Willing to accept corresponding treatment and sign the informed consent form.

[0074] 1.4 Exclusion criteria

[0075] (1) Those who have recently participated in other experimental studies and become research subjects;

[0076] (2) Patients with severe complications such as upper gastrointestinal bleeding or pyloric obstruction;

[0077] (3) Those with a history of allergy to Chinese herbal decoctions or PPIs;

[0078] (4) Women who are preparing for pregnancy, pregnant, or breastfeeding;

[0079] (5) Those who have bad habits such as smoking and drinking;

[0080] (6) PU caused by other causes such as tumors;

[0081] (7) Those who have undergone gastrointestinal surgery;

[0082] (8) Patients with serious diseases of cardiovascular, encephalopathy, immune system, etc.;

[0083] 1.5 Elimination criteria

[0084] (1) Patients were included due to misdiagnosis during the initial visit;

[0085] (2) Failure to take medication regularly as required by the trial;

[0086] (3) Taking drugs that may affect the experimental results during the experiment;

[0087] (4) Failure to conduct relevant inspections according to test requirements.

[0088] 1.6 Shedding Standard

[0089] (1) The patient withdraws from the trial due to personal reasons;

[0090] (2) Poor compliance or loss to follow-up.

[0091] 1.7 Termination criteria

[0092] (1) Severe complications occurred during the trial;

[0093] (2) The patient's symptoms continue to worsen and are not suitable for this trial;

[0094] 1.8 Handling of case dropout

[0095] If a patient participating in the trial study drops out, the researcher should contact the patient in a timely manner, using telephone, text messaging or other online methods, or directly visiting the patient at the registered address, asking the patient why they dropped out, and recording the treatment status and evaluation items according to the last treatment time.

[0096] 1.9 Measures to improve subject compliance

[0097] (1) It is necessary to establish a good doctor-patient relationship and demonstrate the doctor’s professional ethics.

[0098] (2) Try to select patients who have a strong willingness to participate in the trial.

[0099] (3) Use telephone, WeChat and other communication methods to remind patients to actively seek treatment.

[0100] 1.10 Informed Consent

[0101] Researchers need to fully communicate with patients participating in the trial and have the patients sign an informed consent form.

[0102] 2 Research Methods

[0103] 2.1 Sample size estimation

[0104] According to the sample content estimation formula for comparison of independent two-sample design rates, considering the 20% dropout rate, the final conclusion of this study is

[0105] 72 cases need to be included, 36 in each group, and the formula used is as follows:

[0106]

[0107] 2.2 Sample grouping method

[0108] ① The enrolled patients were numbered in sequence from 1 to 72; ② SPSS25.0 software was used to generate 72 numbers with a sequence of 1-72; ③ The generated random numbers were randomly assigned to 2 groups at a ratio of 1:1, starting from the first one, corresponding to the treatment group and the control group; ④ Patients who drew even numbers were in the treatment group, and patients who drew odd numbers were in the control group.

[0109] 3 Treatment options

[0110] 3.1 Basic treatment

[0111] (1) During the trial treatment period, patients are advised to avoid cold weather, relax their emotions, avoid eating raw, cold, greasy, or spicy foods, maintain a normal work and rest schedule, and have a regular daily routine.

[0112] (2) If the patient has HP infection, he or she should first be treated with rabeprazole sodium enteric-coated tablets 20 mg (National Medicine Standard No. H20110160 Shuanghe) orally once a day, and potassium citrate bismuth 220 mg (National Medicine Standard No. H10900086 Lizhu Dele), clarithromycin 0.5 g (National Medicine Standard No. H20059139 Yishu), and amoxicillin capsules 1.0 g (National Medicine Standard No. H50021364 Dikang) orally twice a day. The anti-HP treatment course is 2 weeks.

[0113] 3.2 Control group

[0114] The patient was given oral administration of rabeprazole sodium enteric-coated tablets (specification: 10 mg, national medicine standard number H20110160 Shuanghe) once a day, 2 tablets each time, before breakfast every day.

[0115] 3.3 Treatment groups

[0116] On the basis of the control group, the Jianpi Wenzhong Yuyang prescription was added: roasted Astragalus 15g, Codonopsis pilosula 12g, Cinnamon twig 9g, Poria 15g, stir-fried Atractylodes macrocephala 15g, Tangerine peel 12g, Pinellia ternata 9g, Panax notoginseng powder 3g, Cuttlebone 9g, Oroxylum indica 6g, Paojiang 6g, Bletilla striata 6g, roasted Licorice root 3g. The decoction machine was used to decoct the medicine to obtain about 400mL of juice, which was taken twice a day in the morning and evening.

[0117] Chinese medicine is decocted uniformly by the Chinese medicine pharmacy of our hospital (electric decocting machine: Huadong original decocting machine product, model: YIX20 / 1±1(50-250)D)

[0118] 4 Observation indicators

[0119] 4.1 Safety indicators

[0120] (1) Monitor the patient's vital signs (respiration, pulse, body temperature, blood pressure) and routine blood tests, liver function, kidney function, urine routine, stool routine, and electrocardiogram before and after treatment.

[0121] (2) If the patient experiences severe allergic reactions or adverse reactions during medication treatment, the trial should be stopped immediately, the patient's condition should be questioned, and symptomatic treatment should be given.

[0122] 4.2 Endoscopic examination

[0123] By comparing and analyzing the changes in patients' gastroscopy stages and ulcer area before and after treatment, the comprehensive efficacy of Western medicine was obtained.

[0124] Note: Ulcer area (mm 2 )=π×ulcer length (mm)×ulcer width (mm)÷4

[0125] 4.3 Quantification of TCM symptom scores

[0126] (1) According to the TCM Symptom Score Scale for Peptic Ulcer of Spleen and Stomach Deficiency and Cold Type and the Consensus on the Diagnosis and Treatment of Peptic Ulcer with Integrated Traditional Chinese and Western Medicine, the clinical symptoms of patients were divided into four levels from mild to severe: none, mild, moderate, and severe. The main symptoms were scored as 0, 2, 4, and 6 points respectively, and the minor symptoms were scored as 0, 1, 2, and 3 points respectively.

[0127] (2) Observe and ask the patient about symptoms and signs before and after treatment and record them in the scoring table, Table 2.

[0128] Table 2 Gastroscopy and 14C breath test

[0129]

[0130] Note: Please fill in and tick “√” in the corresponding position.

[0131] 5. Efficacy evaluation criteria

[0132] 5.1 Comprehensive Western Medicine Therapeutic Effect Evaluation Criteria

[0133] According to the 2017 Consensus on the Diagnosis and Treatment of Peptic Ulcer with Integrated Traditional Chinese and Western Medicine, the overall efficacy evaluation criteria are as follows:

[0134] (1) Clinical cure: All symptoms of the patient disappear, and the endoscopic stage is S stage;

[0135] (2) Significantly effective: The patient's symptoms basically disappeared, and the endoscopic stage was H2;

[0136] (3) Effective: The patient's symptoms were alleviated and the endoscopic stage was H1;

[0137] (4) Ineffective: There was no improvement in the patient's symptoms and endoscopic staging.

[0138] 5.2 TCM efficacy evaluation criteria

[0139] Efficacy score = (total symptom score before treatment - total symptom score after treatment) ÷ total symptom score before treatment × 100%

[0140] (1) Clinical recovery: symptoms basically disappear after treatment, and the efficacy score is ≥95%

[0141] (2) Significantly effective: The patient showed significant improvement after treatment, with efficacy score > 75%

[0142] (3) Effective: The patient has improved after treatment, with an efficacy score of ≥50%

[0143] (4) Ineffective: The patient showed no significant improvement after treatment, and the efficacy score was <50%

[0144] 5.3 Ulcer healing rate

[0145] Ulcer healing rate = (ulcer area before treatment - ulcer area after treatment) ÷ ulcer area before treatment × 100%

[0146] 5.4 Recurrence rate index

[0147] The subjects were re-examined by gastroscopy 6 months after treatment, and the PU recurrence rate was calculated.

[0148] 6 Statistical analysis

[0149] (1) After the clinical trial, the test results were statistically analyzed using SP25.0 statistical software.

[0150] (2) When the data are quantitative data, first perform a normality test on the data. If the data do not conform to the normal distribution, use the rank sum test. If the data conform to the normal distribution, use the t test. For different groups, use the independent sample t test, and for the same group, use the paired t test. When the data are count data, use the χ2 test. If any of the tables has an expected theoretical number T < 1 or a total sample size n < 40, use the Fisher exact probability method. For ordinal data, use the rank sum test.

[0151] (3) The test level was α = 0.05, and the difference was statistically significant when P ≤ 0.05.

[0152] Research findings:

[0153] 1 General data analysis

[0154] A total of 72 cases from Ningxia Hui Autonomous Region Traditional Chinese Medicine Hospital and Institute of Traditional Chinese Medicine were included in this study, of which 2 cases dropped out of the treatment group due to non-cooperation with the examination, 2 cases dropped out of the control group, 1 case did not cooperate with the examination, and 1 case was lost to follow-up. Finally, 68 patients completed effective observation and statistical tests, 34 cases in each group.

[0155] 1.1 Gender distribution

[0156] A total of 68 patients completed this trial study, including 15 males and 19 females in the treatment group and 18 males and 16 females in the control group. Figure 1 .

[0157] After the chi-square test, the gender of the two groups 2 =0.530, P=0.467>0.05, there was no significant difference in gender distribution between the two groups, and they were comparable.

[0158] Table 3 Group*Gender Cross Table (Example)

[0159]

[0160] 1.2 Age distribution

[0161] like Figure 2 The two groups of patients were divided into three age groups for statistics: the youth group (18-40 years old), the middle-aged group (41-65 years old), and the elderly group (66-80 years old).

[0162] The normality test showed that both groups obeyed the normal distribution. The independent sample t test showed that there was no statistically significant difference between the two groups (P>0.05), indicating that the two groups were comparable.

[0163] Table 4 Independent sample t test for age

[0164]

[0165] 2 Comparison of efficacy indicators before treatment

[0166] 2.1 Gastroscopy

[0167] Fisher's exact probability method showed no significant difference between the two groups (P>0.05), indicating that the two groups were comparable.

[0168] Table 5 Endoscopic PU staging (examples)

[0169]

[0170] 2.2 TCM symptom score

[0171] The normality test showed that both groups obeyed the normal distribution. The independent sample t test showed that there was no statistically significant difference between the two groups (P>0.05), indicating that the two groups were comparable.

[0172] Table 6 TCM symptom score

[0173]

[0174] 3 Comparison of efficacy

[0175] 3.1 Comparison of TCM efficacy between the two groups

[0176] The rank sum test showed that Z=-2.362, P=0.018<0.05, which was statistically significant.

[0177] Table 7 Comparison of TCM efficacy between two groups (examples)

[0178]

[0179] 3.2 Comparison of the comprehensive efficacy of Western medicine between the two groups

[0180] The rank sum test showed that Z=-2.445, P=0.014<0.05, which was statistically significant.

[0181] Table 8 Comparison of the efficacy of comprehensive western medicine in two groups (examples)

[0182]

[0183] 4 Analysis of efficacy before and after treatment

[0184] 4.1 Gastroscopy

[0185] According to the rank sum test, the treatment group before and after treatment Z = -5.865, P = 0.000 < 0.05, which was statistically significant; the control group before and after treatment Z = -4.031, P = 0.000 < 0.05, which was statistically significant; after treatment, the two groups Z = -2.423, P = 0.015 < 0.05, which was statistically significant.

[0186] Table 9 Comparison of gastroscopic staging between the two groups before and after treatment (cases)

[0187]

[0188] 4.2 Ulcer area

[0189] After normality test, the difference of ulcer area before and after treatment and the ulcer area of ​​the two groups after treatment were in accordance with normal distribution. Paired t test was used within the group and independent sample t test was used between the groups. Before and after treatment, t = 9.677, P = 0.000 < 0.05 in the treatment group, which was statistically significant; before and after treatment, t = 8.051, P = 0.000 < 0.05 in the control group, which was statistically significant; after treatment, t = -12.250 in the two groups, P = 0.000 < 0.05, which was statistically significant. The average ulcer healing rate in the treatment group was 79.59%> 67.69% in the control group.

[0190] Table 10 Comparison of ulcer area between the two groups before and after treatment (mm 2 )(X±S)

[0191]

[0192] 4.3 Comparison of single symptom scores in TCM

[0193] The single TCM symptom scores of the two groups did not conform to the normal distribution, so the rank sum test was used.

[0194] 4.3.1 Comparison of TCM single symptom scores between the two groups

[0195] As shown in Table 11, after test and calculation, there was no statistically significant difference in the scores of single TCM symptoms between the two groups before treatment (P>0.05); as shown in Table 12, after test and calculation, in the comparison of the scores of single TCM symptoms between the two groups after treatment, there was a statistically significant difference in the scores of anorexia and vomiting clear saliva (P<0.05), and the scores of the treatment group were lower than those of the control group after treatment, proving that the treatment group was better than the control group in improving these two symptoms; while there was no significant difference in the scores of the four symptoms of epigastric pain, loose stools, fatigue, and cold limbs (P>0.05), indicating that the efficacy in improving these four symptoms was equivalent.

[0196] Table 11 Comparison of TCM single symptom scores between the two groups before treatment [P 50 (P 25 ,P 75 )]

[0197]

[0198] Table 12 Comparison of TCM single symptom scores between the two groups after treatment [P 50 (P 25 ,P 75 )]

[0199]

[0200] 4.3.2 Intra-group comparison of TCM single symptom scores between the two groups

[0201] As shown in Tables 13 and 14, after testing and calculation, the intra-group comparison of the TCM single symptom scores between the treatment group and the control group before and after treatment was statistically significant (P < 0.05). The scores of both groups after treatment were lower than those before treatment, indicating that the symptoms of both groups were improved after treatment.

[0202] Table 13 Comparison of TCM single symptom scores before and after treatment in the treatment group [P 50 (P 25 ,P 75 )]

[0203]

[0204] Table 14 Comparison of TCM single symptom scores before and after treatment in the control group [P 50 (P 25 ,P 75 )]

[0205]

[0206] 4.4 Comparison of TCM total symptom scores

[0207] After normality test, the difference of symptom scores before and after treatment in the treatment group conformed to normal distribution, while the difference of symptom scores before and after treatment in the control group and the symptom scores of the two groups after treatment did not conform to normal distribution. The symptom scores of the treatment group before and after treatment were tested by paired t test. t=20.512, P=0.000<0.05, which was statistically significant; the symptom scores of the control group before and after treatment were tested by signed rank test, P=0.000<0.05, which was statistically significant; the symptom scores of the two groups after treatment were tested by rank test, Z=-2.237, P=0.025<0.05, which was statistically significant; the average efficacy score of the treatment group was 76.76%>63.10% of the control group.

[0208] Table 15 Comparison of total TCM symptom scores between the two groups before and after treatment (X±S)

[0209]

[0210] 5. Recurrence Rate

[0211] Six months later, the gastroscopy was repeated and the recurrence rate of patients was as follows:

[0212] Table 16 Relapse rate after half a year (cases)

[0213]

[0214] 6 Safety indicators

[0215] The patients' vital signs (respiration, pulse, body temperature, blood pressure) and routine blood tests, liver function, kidney function, urine routine, stool routine, and electrocardiogram were monitored before and after treatment. The results showed no obvious abnormalities, and no adverse reactions or allergic reactions occurred during the trial.

[0216] 7. Basis for the selection of treatment drugs for the control group

[0217] Excessive secretion of gastric acid is the main cause of PU, and inhibiting gastric acid secretion is the main way to treat PU. Therefore, the most widely used PPI in clinical practice with the best effect of inhibiting gastric acid secretion is selected. Commonly used PPIs include omeprazole, rabeprazole, esomeprazole, etc. Among them, rabeprazole is the latest generation of PPI, which has better gastric inhibition effect than the previous two generations, and has faster onset and longer drug effect. Therefore, the present invention selects rabeprazole sodium enteric-coated tablets as the treatment drug for the control group.

[0218] 8 Analysis of research results

[0219] 8.1 General Data Analysis

[0220] 8.1.1 Inclusion and Dropout

[0221] A total of 72 patients with spleen-stomach deficiency-cold type PU were included in this trial, of which 4 dropped out (2 in the treatment group and 2 in the control group). Finally, 68 patients completed the trial, with 34 in each group.

[0222] 8.1.2 Gender

[0223] There were 68 patients in this trial, including 15 males and 19 females in the treatment group; 18 males and 16 females in the control group. Statistical analysis of the gender of the two groups of patients showed no significant difference (P>0.05), which is comparable and will not affect the trial.

[0224] 8.1.3 Age

[0225] The two groups of patients were divided into three age groups for statistical analysis, namely the youth group (18-40 years old), the middle-aged group (41-65 years old), and the elderly group (66-80 years old). Among them, there were 3 cases in the youth group, 25 cases in the middle-aged group, and 6 cases in the elderly group in the treatment group, and 3 cases in the youth group, 24 cases in the middle-aged group, and 5 cases in the elderly group in the control group. There was no significant difference in the age of the two groups of patients (P>0.05), which was comparable and would not affect the experiment. All patients participating in the experiment were divided into three age groups, namely 8 cases in the youth group, 59 cases in the middle-aged group, and 11 cases in the elderly group. Among the 68 patients, the majority were middle-aged and elderly patients. The possible reasons are: (1) Weak organs and decreased function. (2) Long-term history of smoking and drinking. (3) Drugs taken to treat other underlying diseases damage the stomach.

[0226] 8.2 Pre-treatment efficacy indicators

[0227] Before treatment, the gastroscopic staging and TCM symptom scores of the two groups of patients were statistically analyzed, and no significant difference was found (P>0.05), which proved that there was no significant difference between the two groups of patients and they were comparable.

[0228] 8.3 Total Effectiveness

[0229] Comparison of TCM symptom efficacy: After treatment, the total effective rate of the treatment group was 97.06%; the total effective rate of the control group was 88.24%, and there was a significant difference between the treatment group and the control group (P < 0.05), proving that the treatment group had a higher efficacy than the control group. Comparison of Western medicine comprehensive efficacy: After treatment, the total effective rate of the treatment group was 94.12%; the total effective rate of the control group was 85.29%, and there was a significant difference between the treatment group and the control group (P < 0.05), proving that the treatment group had a higher efficacy than the control group.

[0230] 8.4 Endoscopic staging

[0231] Statistical analysis of the gastroscopic staging of the two groups after treatment showed significant differences between the treatment group and the control group (P < 0.05), proving that the treatment group had a higher efficacy than the control group.

[0232] 8.5 Ulcer area

[0233] The ulcer area under gastroscope in the treatment group was (96.12±54.60) mm before treatment. 2 After treatment, it decreased to (19.12±13.1) mm 2 The ulcer healing rate was (79.59±21.79)%. The ulcer area under gastroscope in the control group was (91.71±53.31)mm before treatment. 2 After treatment, it decreased to (25.77±16.44) mm 2 The ulcer healing rate was (67.69±29.36)%. There was a significant difference in the ulcer area between the two groups before and after treatment (P<0.05). There was a significant difference in the ulcer area between the two groups after treatment (P<0.05), which proved that both groups were effective in healing the ulcer surface, but the ulcer healing rate of the treatment group (79.59%) was greater than that of the control group (67.69%), which proved that the treatment group had a higher therapeutic effect than the control group.

[0234] 8.6 TCM symptom score

[0235] 8.6.1 TCM Single Symptom Score

[0236] According to statistical analysis, there was no significant difference in the TCM single symptom scores between the two groups before treatment (P>0.05). After treatment, the TCM single symptom scores of the two groups were compared, and the difference in the scores of anorexia and vomiting clear saliva was significant (P<0.05), proving that the treatment group was better than the control group in improving these two symptoms; while there was no significant difference in the scores of epigastric pain, loose stools, fatigue, and cold limbs (P>0.05), indicating that the two groups had equivalent efficacy in improving these four symptoms. The TCM single symptom scores of the treatment group and the control group before and after treatment were significantly different within the group (P<0.05), proving that the symptoms of both groups were improved after treatment.

[0237] 8.6.2 TCM total symptom score

[0238] The total TCM symptom score of the treatment group decreased from 7.79±1.30 to 1.79±1.37, and the efficacy score was (76.76±18.39)%. The total TCM symptom score of the control group decreased from 7.59±1.65 to 2.71±1.61, and the efficacy score was (63.10±23.65)%. There was a significant difference in the total symptom scores of the two groups after treatment (P<0.05), which proved that the treatment group was better than the control group in improving overall symptoms.

[0239] 8.7 Relapse Rate

[0240] A gastroscopy was performed again six months later, and the recurrence rate in the treatment group was 6.25%, while the recurrence rate in the control group was 17.24%, proving that the recurrence rate in the treatment group was lower.

[0241] 8.8 Safety indicators

[0242] The patients' vital signs (respiration, pulse, body temperature, blood pressure) and routine blood tests, liver function, kidney function, urine routine, stool routine, and electrocardiogram were monitored before and after treatment. The results showed no obvious abnormalities, and no adverse reactions or allergic reactions occurred during the trial.

[0243] 9. Conclusion

[0244] (1) The efficacy of Jianpi Wenzhong Yuyang prescription combined with rabeprazole in the treatment of spleen and stomach deficiency-cold type PU is better than that of rabeprazole alone, and the effect is more significant in improving the overall clinical symptoms of patients.

[0245] (2) The Jianpi Wenzhong Yuyang prescription combined with rabeprazole is superior to rabeprazole in promoting the repair of gastrointestinal mucosa and healing of ulcer surface in patients with spleen and stomach deficiency-cold type PU.

[0246] (3) The Jianpi Wenzhong Yuyang prescription combined with rabeprazole is less effective than rabeprazole in reducing the recurrence rate of patients with spleen and stomach deficiency-cold type PU.

[0247] The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments, and the above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention to be protected. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A spleen-strengthening, middle-tonifying and ulcer-healing prescription, characterized in that: The prescription includes: roasted Astragalus, Codonopsis pilosula, cinnamon twig, Poria cocos, stir-fried Atractylodes macrocephala, tangerine peel, Pinellia ternata with ginger, Panax notoginseng powder, cuttlebone, Oroxylum indica, roasted ginger, Bletilla striata and roasted licorice.

2. A spleen-strengthening, middle-tonifying and ulcer-healing prescription according to claim 1, characterized in that: The amount of the prescription drugs is: roasted Astragalus 15g, Codonopsis pilosula 12g, cinnamon twig 9g, Poria 15g, stir-fried Atractylodes macrocephala 15g, tangerine peel 12g, ginger Pinellia 9g, Panax notoginseng powder 3g, cuttlebone 9g, Oroxylum butterfly 6g, roasted ginger 6g, Bletilla striata 6g, and roasted Licorice root 3g.

3. A spleen-strengthening, middle-heat-warming and ulcer-healing prescription as claimed in claim 1 or 2, which is used to prepare spleen-strengthening, middle-heat-warming and ulcer-healing granules or pills.

4. The method for preparing the spleen-strengthening, middle-tonifying and ulcer-healing granules according to claim 3, characterized in that: include Step 1: weigh the following Chinese medicines: roasted Astragalus 15g, Codonopsis pilosula 12g, Cinnamon twig 9g, Poria 15g, stir-fried Atractylodes macrocephala 15g, Tangerine peel 12g, Pinellia ternata 9g, Notoginseng powder 3g, Cuttlebone 9g, Oroxylum indica 6g, Paojiang 6g, Bletilla striata 6g, roasted Licorice root 3g; Step 2: Mix the Chinese medicines in step 1, add water and soak for 4 hours, heat and boil twice, each time for 60 minutes, combine the decoctions, let stand for 24 hours, filter, and boil at 80°C. The density of water and concentrated filtrate is 1:1.32-1.35; Step 3: Add soluble starch to the concentrated solution obtained in step 2 and mix well. The amount of soluble starch is 10-12% of the original medicinal material. Put it into a microwave vacuum dryer and dry it at 60-80°C and grind it into granules to obtain spleen-strengthening, middle-tonifying and ulcer-healing granules.

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