新型钾离子竞争性酸阻断剂伏诺拉生在Hp根除治疗中的疗效分析

Observation of efficacy of a novel potassium-competitive acid blockers vonoprazan in the treatment of Hp infection

目的:比较新型钾离子竞争性酸阻断剂伏诺拉生铋剂四联方案与雷贝拉唑铋剂四联方案对Hp感染的根除率。方法:选择2022年1月—2022年4月在乐山市人民医院消化内科门诊就诊、初诊为Hp感染的222例患者为研究对象,随机分为研究组(伏诺拉生四联,113例)及对照组(雷贝拉唑四联,109例)。研究组给予伏诺拉生20 mg,1次/d;阿莫西林胶囊1000 mg,2次/d;克拉霉素片500 mg,2次/d;胶体果胶铋0.3 g,2次/d;疗程14 d。对照组给予雷贝拉唑20 mg,2次/d;阿莫西林胶囊1000 mg,2次/d;克拉霉素片500 mg,2次/d;胶体果胶铋0.3 g,2次/d;疗程14 d。疗程结束4周后复查13C尿素呼气试验,比较2组Hp根除率及不良反应发生情况。结果:研究组及对照组的按意向治疗(ITT)根除率分别为85.84%和75.23%,差异有统计学意义(P=0.045),按方案分析(PP)根除率分别为93.27%和83.67%,差异有统计学意义(P=0.032)。研究组、对照组的不良反应发生率分别为21.15%、20.41%,两组不良反应发生率比较按PP分析差异无统计学意义(P=0.896)。结论:新型钾离子竞争性酸阻断剂伏诺拉生铋剂四联方案在Hp感染患者中的根除率更高,安全性较好。

Objective:To compare the effect of a novel potassium-competitive acid blockers(P-CABs)vonoprazan-based and rabeprazole-based bismuth-containing Quadruple therapy in Hp eradication.Methods:From Janurary 2022 to April 2022,a total of 222 patients with Helicopacter pylori admitted to the department of Gastroenterology,People’s Hospital of Leshan were enrolled and randomly assigned into study group(n=113,vonoprazan-based bismuth-containing Quadruple therapy)and controll group(n=109,rabeprazole-based bismuth-containing Quadruple therapy).The patients in study group were given oral administration of vonoprazan 20 mg,once a day,amoxicillin 1000 mg once each 12 hours,clarithromycin 500 mg once each 12 hours,and colloidal bismuth pectin 300 mg once each 12 hours.The patinets in control group were given oral administration of rabeprazole 20 mg,once each 12 hours,amoxicillin 1000 mg once each 12 hours,clarithromycin 500 mg once each 12 hours and colloidal bismuth pectin 300 mg once each 12 hours.The course of treatment for both groups was 14 days.Four weeks after the end of treatment,^(13)C-breath test was performed.Adverse reactions were recorded during the treatment.Results:The eradiction rate of Hp in study group and control group 85.84%and 75.23%,P=0.045 in intention-to-treat(ITT)analysis.The eradiction rate of Hp of study group and control group 93.27%and 83.67%,P=0.032,in per-protocol(PP)analysis.The adverse reaction rate was 21.15%in study group and was 20.41%in control group,P=0.896.No significant difference existed during the two groups.Conclusion:Vonoprazan-based bismuth-containing Quadruple therapy provide higher Hp eradication rates to rabeprazole-based bismuth-containing Quadruple therapy.Both therapy were similar in terms of safety.