大剂量双联疗法治疗幽门螺杆菌随机对照试验的Meta分析

A Meta analysis of randomized controlled trials of high-dose dual therapy for the treatment of Helicobacter pylori infection

目的:评价大剂量双联疗法作为一线方案治疗幽门螺杆菌的有效性和安全性。方法:检索PubMed、Cochrane Library、Embase、万方数据库、维普、中国知网(CNKI),纳入符合要求的随机对照试验。采用STATA 12.0版本进行统计学分析,主要结果是幽门螺杆菌的根除率,次要结果是不良事件发生率和患者的依从性。结果:共有9个随机对照试验2519例患者符合纳入条件。大剂量双联疗法的根除率(OR=1.12,95%CI 0.77~1.64,P=0.555)和依从性(OR=1.20,95%CI 0.71~2.03,P=0.487)与目前一线推荐方案如三联疗法、含铋剂四联疗法的差异无统计学意义。大剂量双联疗法能明显降低不良事件的发生率,差异具有统计学意义(OR=0.36,95%CI 0.22~0.59,P<0.001)。通过敏感性分析,确定这一结果是稳定可靠的。结论:大剂量双联疗法和目前一线治疗方案相比,具有相同的疗效和依从性,并能减少不良事件的发生。

Objective:To evaluate the effectiveness and safety of high-dose dual therapy(HDDT)as a first-line treatment for Helicobacter pylori.Methods:The major databases of PubMed,Cochrane Library,Embase,Wanfang Data,VIP and CNKI were searched.Randomized controlled trials that meet the requirements were included.Using STATA version 12.0 for statistical analysis,the main result was the eradication rate of Helicobacter pylori.The secondary results were the incidence of sad effects and compliance.Results:A total of 2519 patients from 9 randomized controlled trials were eligible for inclusion.The eradication rate of HDDT(OR=1.12,95%CI0.77-1.64,P=0.555)and compliance(OR=1.20,95%CI 0.71-2.03,P=0.487)were not significantly different from the current first-line recommended regimens such as triple therapy and bismuth quadruple therapy.HDDT can significantly reduce the incidence of sad effects(OR=0.36,95%CI0.22-0.59,P<0.001).Sensitivity analysis confirmed that the result was robust and reliable.Conclusion:Compared with the current first-line therapies,HDDT program has the same efficacy and compliance,and show few sad effects.