序贯与三联疗法根除幽门螺杆菌的临床应用比较

Comparison of Sequential Therapy Versus Standard Triple-drug Therapy for Helicobacter pylori Eradication

目的比较由雷贝拉唑联合阿莫西林、克拉霉素以及替硝唑组成的10d序贯疗法与三联疗法根除幽门螺杆菌的疗效、依从性、安全性及经济学比较。方法将幽门螺杆菌阳性的90例消化性溃疡患者随机分为以雷贝拉唑为基础的10d序贯疗法组(n=45)和三联疗法组(n=45),治疗结束4周后复查14C-UBT,评估幽门螺杆菌根除情况,并对各方案进行成本-效果分析。结果共85例患者按方案完成治疗。10 d序贯疗法组幽门螺杆菌根除率按意向治疗(ITT)和按方案(PP)分析均高于三联疗法组(ITT:91.1%对73.3%,P<0.05;PP:95.3%对78.6%,P<0.05);10d序贯疗法组不良反应发生率(PP:14.0%对11.9%,P<0.05)与三联疗法组相似;成本-效果分析显示,序贯治疗组的成本-效果比值(C/E)低于对照组。结论以雷贝拉唑为基础的10 d序贯疗法具有疗效高、可提高幽门螺杆菌根除率等优势。

OBJECTIVE To compare the efficacy, compliance, safety and economics of standard triple therapy and 10-day se- quential therapy consisting of rabeprazole, clarithromyein, amoxieillin and tinidazole for Helicobacter pylori eradication. METHODS A total of 90 pepticulcer patients who were Helicobacter pylori positive proved by 14 C-urea breath test（ 14 C-UBT） were randomly divided into two groups. Forty-five patients received rabeprazole-based 10-day sequential therapy and the other forty-five patients received rabe- prazole-based 7-day standard triple therapy. 14 C-UBT was carried out 4 weeks after a course of treatment to evaluate the eradication of Helicobacter pylori. The two regimens were evaluated by cost-effectiveness analysis. RESULTS Eighty-five patients completed the study. The Helicobacter pylori eradication rates by intention-to-treat（IT＇F） analysis and by per-protocol（PP） analysis in 10-day sequen- tial therapy group were higher than those in 7-day standard triple therapy group （ ITT ： 91.1% vs. 73.3 %, P 〈 0.05 ; PP ： 95.3 % vs. 78.6%, P 〈 0.05 ）. The incidences of adverse reactions （ PP ： 14. 0% vs. 11.9%, P 〈 0.05 ） were similar in the two groups. The cost-effectiveness analysis showed that the C/E value of the 10-day sequential therapy were lower. CONCLUSION Rabeprazole- based 10-day sequential therapy is more effective for eradication of Helicobacter pylori.