亚洲人群中序贯疗法与三联疗法根除幽门螺旋杆菌临床疗效的Meta分析

Meta analysis of the eradication rate of Helicobacter pylori of sequential therapy and triple therapy in Asian population

目的 评价在亚洲人群中序贯疗法与三联疗法根除幽门螺旋杆菌（Helicobacter pylori,H.pylori）临床疗效的差异.方法 计算机检索中文数据库和外文数据库包括万方数据库、中国知网、维普数据库、中国生物医学文献数据库（CBM）、Medline/Pubmed、Embase、Wiley、Springer和Elsevier;手工检索《中华消化杂志》、《世界华人消化杂志》和会议记录.查找与此研究相关的临床随机对照试验（RCT）文献,采用Cochrane系统评价员手册5.0.2版推荐的方法纳入文献,并对其进行Meta分析.结果 共纳入19篇临床随机对照（RCT）文献,纳入患者2 854例,其中采用序贯疗法的患者1 282例,采用三联疗法的患者1 572例.对19篇RCT研究进行Meta分析的结果显示：序贯疗法根除幽门螺旋杆菌（H.pylori）的疗效优于三联疗法,差异具有统计学意义（P＜0.05）.序贯疗法和三联疗法根除率的意向处理（ITT）分析分别为86.91％和73.47％ （OR=2.43,95％ CI：1.83 ～ 3.22,P＜0.05）,序贯疗法与三联疗法根除率的试验方案（PP）分析分别为89.85％和77.32％（OR=2.51,95％CI：1.91～3.30,P＜0.05）.对于溃疡显效情况、疼痛缓解情况和不良反应发生情况等,由于条件所限未能进行Meta分析,仅进行了描述性分析.结论 在亚洲人群中,序贯疗法较传统三联疗法具有较高的H.pylori根除率,为当前由于H.pylori抗生素耐药性提高而引起的三联疗法治疗成功率降低提供了一种新的选择,在临床上具有很好的应用前景.但目前相关RCT研究样本量少,且普遍质量较低.上述结论尚需要高质量、多中心、大样本量的随机双盲试验加以证实.

Objective To evaluate the efficacy difference between sequential therapy and triple therapy for eradication of Helicobacter pylori （H.pylori） in Asian population.Methods Computer-based online was used to retrieve Chinese and foreign language databases：Wanfang data,CNKI,VIP database,Chinese Biomedical Literature Database （CBM）,Medline/Pubmed,Embase,Wiley,Springer and Elsevier ; ＂Chinese Journal of Digestion＂,＂World Journal of Gastroenterology＂ and meeting records were retrieved manually.The literatures relevant with randomized controlled trials （RCT） were collected.Literatures were included in accordance with Cochrane systematic review guideline 5.0.2.Meta analysis was performed to evaluate the data.Results A total of 19 randomized controlled （RCT） literatures were included,involving 2 854 cases,including 1 282 cases receiving the sequential therapy and 1 572 cases receiving the triple therapy.Meta analysis results showed that sequential therapy was superior to the conventional triple therapy and the difference was statistically significant （P ＜ 0.05）.The results of the Intention To Treat （ITT） analysis of eradication rate of sequential therapy and triple therapy were 86.91％ and 73.47％ （OR =2.43,95％ CI：1.83 ～ 3.22,P ＜ 0.01）.The results of Per Protocol （PP） analysis of eradication rate of sequential therapy and triple therapy were 89.85 ％ and 77.32％ （OR =2.51,95 ％ CI：1.91 ～ 3.30,P ＜ 0.01）.Due to the limited conditions,the author failed to perform Meta analysis for the ulcer cases,pain relief and adverse events,only conducting descriptive analysis to them.Conclusion Compared with triple therapy,H.pylori eradication rate of sequential therapy was higher in Asian population.Helicobacter pylori eradication rate of conventional triple therapy has declined because of antibiotic resistance.Sequential therapy provides a new and prospective therapeutic method for H.pylori infection.However,the sample sizes of current RCT stuies are relatively less,and the studies are generally of lower quality.This conclusion has to be further verified by high quality,multi-center,large scale and double blinded RCTs.