含左氧氟沙星和铋剂的四联疗法根除幽门螺杆菌的疗效研究

目的评价含左氧氟沙星和铋剂的四联10d疗法作为一线方案根除治疗幽门螺杆菌感染的有效性和安全性。方法将150例幽门螺杆菌感染的初治患者,随机分配至三联组和四联组,三联组给予埃索美拉唑20mg(2次/d)+克拉霉素500mg,2次/d+阿莫西林1.0g(2次/d)治疗7d,四联组给予埃索美拉唑20mg(2次/d)+胶体果胶铋200mg(2次/d)+左氧氟沙星500mg(1次/d)+阿莫西林1.0g(2次/d)治疗10d。疗程结束6周后行13C-尿素呼气试验检查,判断幽门螺杆菌根除情况,同时观察治疗过程中的不良反应。结果三联组按意向治疗(ITT)分析和按方案(PP)分析H.pylori的根除率分别为73.3%和75.3%,四联组按ITT分析和按PP分析根除率分别为93.3%和95.9%,四联组的按ITT分析和按PP分析H.pylori的根除率均明显高于三联组(P<0.01)。两组不良反应发生率相似,无严重不良反应事件发生。结论含左氧氟沙星和铋剂的四联10d疗法用于幽门螺杆菌感染的初治,疗效高于标准三联7d疗法,是一种可供选择的一线治疗方案。

Efficacy of levofloxacin and bismuth-containing quadruple therapy for the eradication of Helicobacter pylori

Objective To evaluate the efficacy and safety of the 10-day levofloxacin and bismuth-containing quadruple therapy as first-line therapy for the eradication of Helicobacter pylori. Methods A total of 150 patients with H.pylori infection were enrolled and randomly assigned into triple and quadruple group.The patients in the triple therapy group received esomeprazole 20 mg bid,clarithromycin 500 mg bid and amoxicillin 1.0 g bid for seven days.The patients in the quadruple therapy group received esomeprazole 20 mg bid,pectin bismuth 200 mg bid,levofloxacin 500 mg qd,amoxicillin 1.0 g bid for ten days. H. pylori eradication was assessed by 13C-urea breath test six weeks after cessation of therapy,and the safety was also evaluated.Results The intention-to-treat （ITT） and per-protocol （PP）eradication rates were 73.3% and 75.3% in the triple group, and 93.3% and 95.9% in the quadruple group, respectively. The eradication rate was significantly higher in the quadruple group compared with the triple group in both the ITT and PP populations （P〈0.01）, whereas the incidence of adverse events was similar.No serious adverse reactions occurred.Conclusion The 10-day levofloxacin and bismuth-containing quadruple therapy as first-line therapy can achieve a higher eradication rate than the 7-day standard triple therapy in the initial treatment of H.pylori infection.