Efficacy Of Compound Bismuth Potassium Citrate Capsules Combined With Omeprazole In Eradication Of Helicobacter Pylori Infection With Duodenal Ulcer:A Clinical Study

Background: Helicobacter Pylori(Hp) infection is closely connected with peptic ulcer. Eradication of Hp is essential to the healing of peptic ulcer and can prevent recurrence. Because of the high incidence and drug resistance rate in China, the Hp division of Chinese medical association in digestion proposed that 7-day treatment with proton pump inhibitor(PPI), amoxicilin,clarithromycin can be first choice, and PPI, associated with bismuth,metronidazole, tetracycline is the first rescue therapy. Bismuth is extensively used in eradication of Hp, the effection of bismuth has nothing to do with neutralizing or inhibiting gastric acid, but through forming a oxidized protective coating on the surface of mucous membrane in stomach and the base of ulcer so that the acid would not destruct the mucous and spare time for mucous repairment. Moreover, to some extent, bismuth can kill Hp. Our trial is about a capsule contained bismuth. Each pill of compound bismuth potassium citrate capsules contain bismuth potassium citrate 40 mg, metronidazole0.125 mg, tetracycline 0.125 mg. We found that the compliance of patients is good. The therapy has a bright clinical application, it not only increases the Hp eradication rate, improves healing of peptic ulcer, but also decreases drug resistance.Objective:To investigate the efficacy and safety of compound bismuth potassium citrate capsules in Hp infection patients with duodenal ulcer.Method: After strict selection for Hp infection patients with duendual ulcer from October, 2014 to January 2016, 80 cases were enrolled, and all the patients received a randomized, double-blind, based on standard therapy, placebo-controlled study. 10-14 days after medication, all the patients were respectively followed up including physical examination, blood routine, biochemical examination, urine routine, stool test and electrocardiogram(ECG) as well as recording the signs, symptoms, adverse effects and concomitant drugs. After 45-50 days administration, patients were given a13C-urea breath test and comprehensive assessment of the effectiveness and safety.Result: The eradication rate of control group is 68.5%, while the experimental group is 94.44%(?=0.05, P<0.05), the discrepancy of two groups possess a statistical significance. Moreover, the adverse effects and compliance of both groups do not have any significant differences.Conclusion:Compound bismuth potassium citrate capsules can be used to eradicate of Hp infection in duodenal ulcer patients with effectiveness, safety, and good compliance. In this way, the capsule has a promising clinical application.