Comparison Of Efficacy And Safety Between 7-day Vonoprazan-furazolidone-amoxicillin Triple Therapy And 14-day Quadruple Therapy With Bismuth For Helicobacter Pylori Eradication

【Background】Helicobacter pylori（H.pylori）infection is very common,and about44.2%of people in our country are infected with H.pylori.H.pylori infection is closely related to chronic gastritis,peptic ulcer,gastric cancer and other diseases.Eradication of H.pylori can prevent the occurrence of these diseases.In recent years,the antibiotic resistance rate of H.pylori has gradually increased,and the current first-line treatment of H.pylori has many problems such as using high dose of antibiotics,side effects,so the rate of eradication is decreasing.Therefore,it is necessary to find a novel,simple and safe therapy of H.pylori infection.【Objective】to compare the efficacy and safety between 7-day Vonoprazan-furazolidone-amoxicillin triple therapy and 14-day quadruple therapy with bismuth for H.pylori eradication,in order to find a novel,effective and safe treatment for H.pylori eradication.【Methods】A prospective,randomized controlled,single-blinded study was conducted to verify the non-inferiority of 7-day Vonoprazan-furazolidone-amoxicillin triple therapy to 14-day quadruple therapy with bismuth.A total of 336 patients diagnosed with H.pylori infection by ¹³C-urea breath test during November 2022 to March 2023 were enrolled in this study and randomly divided into triple therapy group or quadruple therapy group.Patients of triple therapy group received Vonoprazan 20mg bid with furazolidone100mg bid and amoxicillin 750mg bid for 7 days while the patients of quadruple therapy group received omeprazole 20mg bid with bismuth 200mg bid,amoxicillin 1000mg bid and clarithromycin 500mg bid for 14 days.The ¹³C-urea breath test was repeated at least 4weeks after the end of treatment.The eradication rates and the incidence of adverse effects were compared between two groups.【Results】In the intention-to-treat（ITT）analysis,the eradication rate was 82.74%（139/168,95%CI:76.31%-87.71%）in the triple therapy group and 77.98%（131/168,95%CI:71.31%to 83.58%）in the quadruple therapy group,with a rate difference of 4.76%（95%CI:-3.77%-13.22%）.The lower limit（76.31%）of the 95%CI for eradication rate of the triple therapy was higher than the non-inferiority margin（95%CI 77.98%–6.3%=71.38%）.In the per-protocol（PP）analysis,the eradication rate was 91.45%（139/152,95%CI:85.92%-94.94%）in the triple therapy group and 85.62%（131/153,95%CI:79.19%-90.31%）in the quadruple therapy group,with a rate difference of 5.83%（95%CI:-1.42%-13.14%）.The lower limit（85.92%）of 95%CI for the eradication rate of the triple therapy was higher than the non-inferiority margin（95%CI 85.62%–6.3%=79.32%）.The overall incidence of adverse effects was 27.98%in the triple therapy group and34.52%in the quadruple therapy group,with no statistically significant difference（P=0.195）.【Conclusion】7-day Vonoprazan-furazolidone-amoxicillin triple therapy is effective and safe as the treatment of H.pylori infection.