国内序贯疗法对比铋剂四联疗法补救根除幽门螺杆菌感染的Meta分析

Sequential therapy contrasts bismuth containing quadmple therapy to remedy in treatment of Chinese patients with helicobacter pylori infection: a systematic review

目的系统评价序贯疗法与铋剂四联疗法在国内补救根除幽门螺杆菌(Hp)感染的有效性及安全性。方法计算机检索The Cochrance Library(2016年1月)、Pub Med、EMbase、CBM、CNKI、维普、万方数据库,搜集关于含国内序贯疗法与铋剂四联疗法治疗Hp感染的随机对照实验(RCT),检索时限均为建库至2016年1月。由两位评价员按纳入与排除标准独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man5.3软件进行Meta分析。结果最终纳入16项RCT,共1 523例患者,治疗组(序贯疗法组)772例,对照组(铋剂四联疗法组)751例;Meta分析结果显示:与对照组相比,治疗组有利于提高Hp根除率[RR=1.10,95%CI(1.04,1.16),P=0.0004]和降低总的不良反应[RR=0.70,95%CI(0.55,0.90),P=0.006];两组的临床症状缓解率(总有效率)差异无统计学意义[RR=1.07,95%CI(1.00,1.16),P=0.05]。Meta分析结果较稳定,漏斗图显示纳入文献无明显发表偏倚。结论当前证据表明,国内序贯疗法治疗Hp感染的Hp根除率较高,总不良反应发生率较铋剂四联疗法低。但受纳入研究质量和数量的限制,上述结论有待更多高质量的RCT来验证。

Objective To systematically review the efficacy and safety of sequential therapy and bismuth containing quadmple therapy rescue regimen for the eradication of Helicobacter pylori infection in China.Methods We electronically searched Cochrane Central Register of Controlled Trials（CENTRAL）,PubMed,EMbase,CBM,CNKI,WanFang Data and VIP databases from inception to January 2016,to collect randomized controlled trials（RCTs）about sequential therapy and bismuth containing quadmple therapy rescue regimen for the eradication of Helicobacter pylori infection in China.Two reviewers independently screened literature,extracted data,and as-sessed the risk of bias of included studies.Then,meta-analysis was performed by using RevMan 5.3 software.Results Sixteen RCTs involving 1 523 patients were finally included,including 772 patients in the sequential therapy（observation group）and 751 patients in the bismuth containing quadmple therapy（control group）.The results of meta-analysis showed that compared with the control group,se-quential therapy rescue regimen could significantly increase the eradication rate（ITT analysis：86.2% vs.75.1%,RR =1.10,95%CI 1.04 to 1.16,P =0.0004）,decrease the incidence of total adverse reaction（ITT analysis：12.0% vs.17.0%,RR =0.70,95%CI 0.55 to 0.90,P =0.006 ）,and there was no statistical difference in clinical symptom remission rate（total effective rate）between the two groups [RR =1.07,95%CI 1.00 to 1.16,P =0.05）.Sensitivity analysis showed that the result was relatively stable.Publication bias test showed no evidence of substantial publication bias.Conclusions Current evidence indicates that sequential therapy rescue regi-men may contribute to improving eradication rate of Hp infection,and may reduce the occurrence of major gastrointestinal associated ad-verse reaction in China.Due to the limited quality of included studies,more high-quality RCTs are needed to verify the above conclusion.