Application of Wangshi Bachi Pills in the Treatment of Helicobacter Pylori Infection

Abstract

The application discloses application of Wangshi Baochi pills in treatment of Helicobacter pylori infection and belongs to the technical field of medicines. The application provides the application of the Wangshi Baochi pills in treatment of Helicobacter pylori infection, which can achieve ideal treatment effects under the condition that the dosage of antibiotics is halved and bismuth agents are not used, and can better relieve the clinical symptoms of pain, belching, acid regurgitation and heartburn.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and in particular to the application of Wang's Baochi Pill in the treatment of Helicobacter pylori infection. Background Technology

[0002] Helicobacter pylori (Hp) infection is now primarily treated with anti-Hp drugs. Although Hp is sensitive to many antibiotics in vitro, the effect is not so good when administered in vivo. Single-drug therapy is currently discouraged due to its low cure rate and tendency to develop resistance.

[0003] The principles for selecting a treatment plan are:

[0004] 1. Use combination therapy;

[0005] 2. The eradication rate of Helicobacter pylori should be >80%, preferably above 90%;

[0006] 3. No obvious side effects, and patients tolerate it well;

[0007] 4. The patient's financial affordability.

[0008] The effectiveness of Helicobacter pylori infection treatment should be judged based on the eradication rate of Helicobacter pylori. Eradication means that no bacterial growth is confirmed by bacteriological, histopathological or isotope tracing methods at least one month after the termination of treatment.

[0009] Currently, commonly used anti-Helicobacter pylori drugs both domestically and internationally include Weifuchun tablets, amoxicillin, metronidazole, clarithromycin, doxycycline, furazolidone, organic colloidal bismuth preparations, and omeprazole. For patients with peptic ulcers, a combination of proton pump inhibitors or H2 receptor antagonists with two antibiotics, or a proton pump inhibitor (such as omeprazole) with one antibiotic, can be appropriately used. The course of treatment is generally two weeks.

[0010] Doctors use different medication regimens for patients with primary and recurrent Helicobacter pylori infections. For primary infections, standard triple or quadruple therapy is usually used. For some patients who are not suitable for antibiotic treatment, a combination of traditional Chinese and Western medicine can be used. For eradication therapy in highly drug-resistant individuals, drug sensitivity testing is generally required first, and then a personalized treatment plan is developed based on the results, or traditional Chinese medicine treatment based on syndrome differentiation can be used directly.

[0011] In the 1970s, France and other countries reported cases of bismuth-induced encephalopathy following bismuth administration, leading to widespread panic and concern about its use, and its gradual withdrawal from clinical practice. Since Marshall reported in 1985 that bismuth could kill *Helicobacter pylori* (Hp), its widespread use has resurfaced. Bismuth is now widely accepted as a component of quadruple therapy for Hp eradication. However, the benefits and risks of bismuth in clinical application remain controversial, and its understanding and application are constantly evolving. After absorption, bismuth is primarily distributed in the kidneys, brain, liver, spleen, and bones. It has certain toxic effects on these organs, and its use is particularly risky due to irrational use in primary healthcare settings. Bismuth is mainly metabolized by the kidneys, where it binds to bismuth metal-binding proteins, thus exhibiting nephrotoxicity. Furthermore, long-term use of bismuth can lead to neuropathy, encephalopathy, osteoarthritis, gingivitis, stomatitis, and colitis.

[0012] Due to cultural differences and varying socioeconomic conditions, the current infection rate of *Helicobacter pylori* (Hp) in my country ranges from 40% to 85%, with an average of 59%. A multicenter study in my country showed that the average resistance rates to metronidazole and clarithromycin have reached 75.6% and 27.6%, respectively, and the eradication rate of classic triple therapy has fallen below 80%. Therefore, exploring new first-line eradication regimens has become an urgent priority in clinical practice.

[0013] Wangshi Baochi Pills are a traditional Chinese medicine used to treat infantile malnutrition, phlegm-induced convulsions, wheezing cough, reduced appetite, vomiting, diarrhea, fever, constipation, seasonal colds, and spleen and stomach weakness and developmental delays. It is also effective for adults with intestinal problems and phlegm-related food stagnation. In recent years, the company has conducted a series of pharmacological and evidence-based medical studies on Wangshi Baochi Pills, confirming that they can improve gastrointestinal function, have a bidirectional regulatory effect on gastrointestinal motility, and play a positive role in maintaining intestinal flora homeostasis. They increase the abundance of beneficial bacteria while inhibiting the development of harmful bacteria associated with inflammation, making them suitable for treating functional dyspepsia in adults and children (including infants). Currently, there are no reports on the application of Wangshi Baochi Pills in the treatment of Helicobacter pylori infection. Summary of the Invention

[0014] The purpose of this invention is to provide the application of Wang's Baochi Pill in the treatment of Helicobacter pylori infection, which can achieve ideal therapeutic effects with half the amount of antibiotics and without the use of bismuth.

[0015] The above-mentioned technical objective of the present invention is achieved through the following technical solution:

[0016] Application of Wang's Baochi Pill in the treatment of Helicobacter pylori infection.

[0017] Preferably, the Wangshi Baochi Pill is used in combination with proton pump inhibitors and antibiotics for treatment.

[0018] Preferably, the ingredients of Wang's Baochi Pill include rhubarb, coptis, prepared arisaema, and fritillaria.

[0019] Preferably, the dosage of Wang's Baochi Pill is 120 pills each time, twice a day.

[0020] In summary, the beneficial effects of this invention are as follows: by using Wang's Baochi Pill in combination with proton pump inhibitors and antibiotics to treat Helicobacter pylori infection, the ideal therapeutic effect can be achieved with half the amount of antibiotics taken and without the need for bismuth preparations, and the clinical symptoms of pain, belching, acid reflux, and heartburn can be better relieved. Detailed Implementation

[0021] The following embodiments are provided to better understand the present invention and are not limited to the preferred embodiments described. They do not constitute a limitation on the content and scope of protection of the present invention. Any product that is the same as or similar to the present invention, derived by any person under the guidance of the present invention or by combining the features of the present invention with other prior art, falls within the protection scope of the present invention.

[0022] For experiments not specifically described in the examples, the procedures or conditions should be followed according to the conventional experimental procedures described in the literature in this field. Reagents or instruments whose manufacturers are not specified are all commercially available conventional reagent products.

[0023] The Wangshi Baochi Pills used in the following experimental examples were provided by Jinghua Pharmaceutical Group Co., Ltd., with a specification of 60 pills * 20 vials / box, and each 120 pills weighing 0.3g.

[0024] Experimental Example

[0025] 1.1 Observation Groups

[0026] This clinical observation included 60 patients with Helicobacter pylori infection, all of whom were strictly screened according to the diagnostic and inclusion criteria. They were randomly divided into an experimental group and a control group using a random number table. The experimental group consisted of 30 patients (18 males and 12 females), aged 35-60 years, with a disease duration of 2-10 months. The control group consisted of 30 patients (14 males and 16 females), aged 36-56 years, with a disease duration of 1-12 months. There were no statistically significant differences in general characteristics between the two groups (p>0.05).

[0027] Inclusion criteria: ① Age 35-60 years; ② First-time Hp infection and no prior Hp eradication therapy; ③ No proton pump inhibitor therapy in the two months prior to enrollment and no antibiotic therapy in the three months prior to enrollment; ④ Electronic gastroscopy showing peptic ulcers or chronic gastritis.

[0028] Exclusion criteria: ① History of malignant tumors, gastric surgery, gastrointestinal bleeding, or gastric perforation; ② Comorbid severe heart, lung, or kidney diseases; ③ Pregnancy or lactation; ④ Allergy to the study drug.

[0029] 1.2 Treatment methods

[0030] The control group received esomeprazole magnesium enteric-coated tablets to inhibit gastric acid secretion, bismuth potassium citrate tablets to promote ulcer repair and healing, and amoxicillin capsules and clarithromycin tablets for antibacterial treatment. The experimental group received esomeprazole magnesium enteric-coated tablets to inhibit gastric acid secretion, amoxicillin capsules for antibacterial treatment, and Wangshi Baochi Pills to treat functional dyspepsia and regulate intestinal flora. [Dosage of each drug: Esomeprazole magnesium enteric-coated tablets (20mg*7 tablets / box) orally, 20mg twice daily; Amoxicillin capsules (0.25g*24 capsules / box) orally, 0.75g twice daily; Clarithromycin tablets (0.25g*6 tablets / box) orally, 500mg twice daily; Wangshi Baochi Pills (60 pills*20 vials / box) orally, 120 pills twice daily.]

[0031] 1.3 Observation indicators and efficacy criteria

[0032] The clinical efficacy, Hp eradication rate, and occurrence of adverse reactions were observed in the two groups. Clinical symptom scores before and after treatment were also observed.

[0033] Efficacy evaluation: Clinical efficacy was evaluated based on the improvement of clinical symptoms and ulceration, categorized into three levels: Markedly effective: All clinical symptoms were significantly relieved after treatment, and electronic gastroscopy showed that the peptic ulcers were basically healed; Effective: All clinical symptoms improved after treatment, and electronic gastroscopy showed that the healed area of ​​the peptic ulcers decreased by more than 50%; Ineffective: No significant improvement in clinical symptoms after treatment, and electronic gastroscopy showed that the healed area of ​​the peptic ulcers was less than 50%. The overall clinical effective rate = (Markedly effective + Effective) / Total number of cases × 100%.

[0034] Clinical symptom scoring: Abdominal pain is graded by severity as follows: 0: no pain (0 points); 1: occasional pain that does not affect daily life or work (1 point); 2: persistent pain that affects daily life and work (2 points); 3: frequent abdominal pain that severely affects daily life and work (3 points). Acid reflux, belching, and heartburn are assessed according to the pain level. The total score is the product of the score and the symptom level.

[0035] Statistical methods: Data were analyzed using SPSS software. Quantitative data were expressed as (X±S) and analyzed using the t-test for two independent samples; categorical data were expressed as rates and analyzed using the chi-square test; ordinal data were analyzed using the rank-sum test. P<0.05 was considered statistically significant.

[0036] 1.4 Results

[0037] The clinical efficacy, clinical symptom scores, Hp eradication rate, and adverse reactions were compared between the two groups.

[0038] Comparison of clinical efficacy between the two groups: After treatment, there was no significant difference in clinical efficacy between the experimental group and the control group (P>0.05), and the efficacy of the two groups was comparable.

[0039] Table 1 Comparison of clinical efficacy between the two groups [n(%)]

[0040]

[0041] Comparison of clinical symptom scores between the two groups: After treatment, the clinical symptom scores of pain, belching, acid reflux, and heartburn in the experimental group were significantly lower than those in the control group (P<0.05). This suggests that compared with the control group, Wang's Baochi Pills combined with proton pump inhibitors and antibiotics can better alleviate clinical symptoms of Helicobacter pylori infection.

[0042] Table 2 Comparison of clinical symptom scores between the two groups (X±S)

[0043]

[0044] Clinical Cases:

[0045] Case 1

[0046] Ms. Liu, 49 years old, was admitted to the hospital due to upper abdominal pain, dry mouth, and bitter taste in her mouth for one week. After undergoing gastrointestinal endoscopy, she was diagnosed with Helicobacter pylori infection. She was treated with drugs to protect the gastric mucosa, reduce inflammation, and fight Helicobacter pylori infection for 14 days. Her symptoms of abdominal pain, dry mouth, and bitter taste disappeared, and her Helicobacter pylori test turned negative. A follow-up examination two months later showed no recurrence.

[0047] Treatment: Esomeprazole magnesium enteric-coated tablets (20mg*7 tablets / box) orally, 20mg twice daily; Amoxicillin capsules (0.25g*24 capsules / box) orally, 0.75g twice daily; Wang's Baochi Pills (60 pills*20 vials / box) orally, 120 pills twice daily.

[0048] Case 2

[0049] Ms. Zhang, 57 years old, female, had experienced bloating, acid reflux, and heartburn for 3 years, which had worsened over the past six months. She was prone to diarrhea after eating cold food or large meals, experienced dry mouth and bitter taste in the morning, and her acid reflux and heartburn worsened in the afternoon. Her stools were loose. Gastroscopy confirmed chronic non-atrophic gastritis and a positive Helicobacter pylori infection. She received 14 days of treatment with medications to protect the gastric mucosa, reduce inflammation, and treat Helicobacter pylori infection. Afterward, her acid reflux and bloating disappeared, her dry mouth and bitter taste disappeared, and her stools became formed. A follow-up examination showed that Helicobacter pylori had become negative, and a follow-up examination two months later showed no recurrence.

[0050] Treatment: Rabeprazole sodium enteric-coated tablets (10mg*7 tablets / box) orally, 10mg twice daily; Amoxicillin capsules (0.25g*24 capsules / box) orally, 0.75g twice daily; Wang's Baochi Pills (60 pills*20 vials / box) orally, 120 pills twice daily.

[0051] Case 3

[0052] Mr. Yu, male, 60 years old, underwent a carbon-14 H1N1 breath test for Helicobacter pylori at a local tertiary hospital in June 2023, and the result was positive. The patient also experienced stomach pain, burning sensation in the stomach, bloating, and acid reflux. He was treated for 14 days with medications to protect the gastric mucosa, reduce inflammation, and combat Helicobacter pylori infection. After treatment, the patient's abdominal pain, bloating, and acid reflux symptoms disappeared, and the Helicobacter pylori test returned to negative. A follow-up examination two months later showed no recurrence.

[0053] Treatment: Rabeprazole sodium enteric-coated tablets (10mg*7 tablets / box) orally, 10mg twice daily; Amoxicillin capsules (0.25g*24 capsules / box) orally, 0.75g twice daily; Wang's Baochi Pills (60 pills*20 vials / box) orally, 120 pills twice daily.

[0054] This invention utilizes Wang's Baochi Pills combined with proton pump inhibitors and antibiotics to treat Helicobacter pylori infection. It can achieve ideal therapeutic effects with half the amount of antibiotics and without the need for bismuth preparations, and can better relieve clinical symptoms such as pain, belching, acid reflux, and heartburn.

[0055] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. The application of Wangshi Baochi Pill in the preparation of drugs for treating Helicobacter pylori infection, characterized in that: The Wangshi Baochi Pill is used in combination with proton pump inhibitors and antibiotics for treatment.

2. The application of Wangshi Baochi Pill according to claim 1 in the preparation of a drug for treating Helicobacter pylori infection, characterized in that: The ingredients of Wang's Baochi Pill include rhubarb, coptis, prepared arisaema, and fritillaria.

3. The application of Wangshi Baochi Pill according to claim 1 in the preparation of a drug for treating Helicobacter pylori infection, characterized in that: The dosage of Wang's Baochi Pills is 120 pills each time, twice a day.

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