枳术宽中胶囊辅助治疗胃食管反流病的Meta分析和试验序贯分析

Meta-analysis and trial sequential analysis of Zhizhukuanzhong capsule for the adjuvant treatment of gastroesophageal reflux disease

目的:基于Meta分析和试验序贯分析(TSA)探究枳术宽中胶囊(ZZKZ)辅助西药治疗胃食管反流病(GERD)的临床疗效和安全性。方法:检索中国知网、万方、维普、中国生物医学文献数据库、中国临床试验注册中心、PubMed、Embase和CochraneLibrary中关于ZZKZ辅助治疗GERD的随机对照试验(RCT),根据纳排标准对文献进行筛选和资料提取,使用Cochranev5.1.0偏倚风险评估工具和改良Jadad量表对纳入文献进行质量评价。采用STATA 15.0软件对胃镜下治疗缓解率、临床症状缓解率和Gerd Q评分结局指标进行Meta分析,应用TSA 0.9.5.10 Beta软件进行TSA。结果:纳入15项RCT,共计1422例患者。Meta分析结果表明ZZKZ辅助西药治疗GERD对比对照组能显著提高胃镜下治疗缓解率(RR=1.19,95%CI:1.09~1.30,P<0.05)和临床症状缓解率(RR=1.20,95%CI:1.15~1.25,P<0.05),并降低Gerd Q评分(WMD=-2.20,95%CI:-2.43~-1.96,P<0.05)且没有增加不良反应发生率。TSA显示纳入研究病例数充足。结论:应用ZZKZ辅助治疗GERD安全有效,但是目前证据力度非常有限,仍需待高质量、多中心的RCT确证。

Objective:To explore the clinical efficacy and safety of Zhizhukuanzhong capsules(ZZKZ)for the adjuvant treatment of gastroesophageal reflux disease(GERD)based on Meta-analysis and trial sequential analysis(TSA).Methods:Randomized controlled trials(RCTs)about ZZKZ for the adjuvant treatment of GERD were retrieved from CNKI,WANFANG,VIP,CBM,ChiCTR,PubMed,Embase and Cochrane Library.According to the inclusion and exclusion criteria,the literature was screened and the data was extracted.Then Cochrane 5.1.0 bias risk assessment tool and improved Jadad scale were used to evaluate the quality of the included studies.After that we performed Meta-analysis on outcome indicators such as treatment remission rateunder gastroscope,the remission rate of clinical symptoms and Gerd Q score with STATA 15.0.Also TSA were made by TSA 0.9.5.10 Beta.Results:Totally 15 studies with 1422 participants were included.There sults of Meta-analysisin dicated that compared with control group ZZKZ had good clinical efficacy for the adjuvant treatment of GERD,which increased the treatment remission rateunder gastroscope(RR=1.19,95%CI:1.09-1.30,P<0.05)and the remission rate of clinical symptoms(RR=1.20,95%CI:1.15-1.25,P<0.05)and also decreased Gerd Q score(WMD=-2.20,95%CI:-2.43--1.96,P<0.05)while there was no increase in the incidence of adverse reactions.TSA showed that the number of cases included in the study were sufficient.Conclusion:The application of ZZKZ for the adjuvant treatment of GERD is safe and effective.However,the strength of evidence is very limited at present,and the conclusion is still to be confirmed by high-quality,multi-center RCT.