不同疗程铋剂四联疗法在中国根治幽门螺杆菌感染疗效的Meta分析

目的 评价不同疗程(10 d或14 d)铋剂四联疗法在中国幽门螺杆菌感染的根除疗效及安全性.方法 计算机检索2005年1月至2016年11月Pubmed、EMBASE、the Cochrane Central Register of Controlled Trials、中国知网、中国生物医学文献数据库、维普等数据库关于10 d或14 d铋剂四联疗法在中国根除幽门螺杆菌感染的随机对照试验,提取受试者的基本资料、观察指标(根除率及不良反应发生率)、研究质量等相关数据,使用RevMan 5.3软件分析相关指标,计算RR及95％ CI,使用漏斗图行发表偏倚评价.结果 纳入43篇文献,共7 686例患者.合并结果显示:据意向性分析,10 d或14 d铋剂四联疗法和三联疗法根除率分别是88.96％(95％ CI:87.73％ ～90.19％)和74.11％(95％ CI:72.53％ ～75.69％),差异有统计学意义(RR=1.20,95％ CI:1.16％ ～ 1.25％);10 d或14 d铋剂四联疗法和7d铋剂四联疗法相比,根除率分别是87.34％ (95％ CI:84.87％～89.80％)、81.65％(95％ CI:78.76％～ 84.54％)(意向性分析),差异有统计学意义(RR=1.07,95％ CI:1.02％ ～1.12％);10 d或14 d铋剂四联联疗法与序贯疗法(RR=1.02,95％ CI:0.97％～1.07％)及与伴随疗法(RR =1.01,95％ CI:0.95％ ～ 1.07％)差异无统计学意义.结论 10 d或14 d铋剂四联疗法与序贯疗法及伴随疗法疗效相当,三联疗法及7d铋剂四联疗法不作为首选治疗方案.

Efficacy of different durations of bismuth-based quadruple therapy for Helicobacter pylori infection in China: a meta-analysis

Objective To assess the efficacy and safety of bismuth quadruple therapy for 10 or 14 days in eradicating Helicobacter pylori (H.pylori) infections in Chinese patients.Methods The databases including PubMed,Embase,the Cochrane Central Register of Controlled Trials,China National Knowledge Infrastructure Database,Chinese Biomedical Database and VIP database were searched for randomized controlled trials (RCTs) published from the year 2005 to 2016 describing bismuth-based quadruple therapy for 10 or 14 days in Chinese patients.The trails retrieved were examined for clinical features of patients,quality of study,eradication rate of H.pylori and incidence of adverse events.A meta-analysis of the included trials was performed using Revman 5.3 software,and the pooled relative risk (RR) and 95％ confidence intervals (CIs) were calculated;the publication bias was assessed with funnel plot.Results Forty-three trials involving a total of 7 686 patients were eligible for inclusion in the analysis.Intention-to-treat analysis showed that the eradication rate of H.pylori was 88.96％ (95％ CI:87.73％ ～90.19％) with bismuth quadruple therapy for 10 or 14 d and 74.11％ (95％ CI:72.53％ ～75.69％) with triple therapy,showing a significant difference in the efficacy between the 2 therapies (RR =1.20,95％ CI:1.16％ ～1.25％).Analysis of 9 trials comparing bismuth quadruple therapy for 10 or 14 d and for 7 d showed that a treatment duration for 10 or 14 d resulted in an significantly higher eradication rate than a treatment duration of 7 days 87.34％(95％ CI:84.87％ ～89.80％)vs 81.65％ (95％ CI:78.76％ ～84.54％),RR=1.07,95％ CI:1.02％ ～1.12％].The eradication rate produced by bismuth quadruple therapy for 10 or 14 d did not differ significantly from that by sequential therapy (RR =1.02,95％ CI:0.97％ ～1.07％) or concomitant therapy (RR =1.01,95％ CI:0.95％ ～ 1.07％).Conclusion Bismuth-based quadruple therapy for 10 or 14 d has a comparable efficacy in eradicating H.pylori with sequential therapy and concomitant therapy.Triple therapy and bismuth quadruple therapy for 7 d are not recommended as the primary options for treatment of H.pylori infection.