Comparison Of Efficacy And Safety Between 7-day Low-dose Amoxicillin-vonoprazan Dual Therapy And 14-day Quadruple Therapy With Bismuth For Helicobacter Pylori Eradication

【Background】Helicobacter pylori（H.pylori）is closely related to the occurrence of various digestive diseases,and bismuth quadruple therapy is recommended as the first-line treatment regimen for H.pylori eradication.However,this regimen is associated with a high incidence of adverse effects such as abdominal pain,abdominal distension and diarrhea due to the variety of drugs,high-dose antibiotic,and long course of treatment,which affect the therapeutic effect.It is important to actively explore more simple,effective and safe treatment for H.pylori infection.【Objective】This study was conducted to compare the efficacy and safety between 7-day low-dose amoxicillin-vonoprazan dual therapy and 14-day quadruple therapy with bismuth for H.pylori eradication,in order to find a simple,effective and safe treatment for H.pylori eradication.【Methods】This is a prospective,randomized controlled,single-blind,non-inferiority clinical study,which included 220 patients diagnosed with H.pylori infection without previous eradication therapy in our hospital from August to December 2022.The patients were randomly divided into dual therapy group（110 patients）and quadruple therapy group（110 patients）.In the dual therapy group,patients were given vonoprazan 20mg bid+amoxicillin 500mg tid for 7 days;while in the quadruple therapy group,patients were given omeprazole 20mg bid+bismuth 200mg bid+amoxicillin 1000mg bid+clarithromycin 500mg bid for 14 days.The ¹³C-urea breath test was repeated at least 4weeks after the end of treatment.H.pylori eradication rate and the incidence of adverse effects were compared between two groups.【Results】The H.pylori eradication rates in the intention to treat analysis were 62.7%（69/110,95%CI:53.5%-71.9%）,64.5%（71/110,95%CI:50.2%-68.1%）for the dual therapy and quadruple therapy groups,with a rate difference of 1.82%（95%CI:-14.53%-13.22%）,the lower limit（53.5%）of 95%CI for H.pylori eradication rate with dual therapy was lower than non-inferiority margin（95%CI:64.5%-6.3%=58.2%）,with no statistically significant difference（P=0.779）.The H.pylori eradication rates in the per protocol analysis were 75.8%（69/91,95%CI:66.9%-84.8%）,82.5%（71/86,95%CI:74.4%-90.7%）,with a rate difference of 6.73%（95%CI:-18.64%-5.17%）,the lower limit（66.9%）of 95%CI for H.pylori eradication rate with dual therapy was lower than non-inferiority margin（95%CI:82.5%-6.3%=76.2%）,with no statistically significant difference（P=0.271）.The overall incidence of adverse reactions was 15.4%in the dual therapy group and 31.8%in the quadruple therapy group,with statistically significant difference（P=0.004）.【Conclusion】In China,vonoprazan combined with low-dose amoxicillin dual 7-day therapy failed to provide satisfactory H.pylori eradication rate,but the incidence of adverse reactions was significantly lower in dual therapy than in quadruple therapy.