逍遥散加减治疗肠易激综合征的Meta分析和试验序贯分析

Meta-analysis and Trial Sequential Analysis of the Treatment of Irritable Bowel Syndrome with Modified Xiaoyao Powder

目的系统评价逍遥散加减治疗肠易激综合征(IBS)的疗效。方法计算机检索Pub Med,Cochrane Library,中国知网(CNKI)、万方数据资源系统,中国生物医学文献数据库(CBM)以及中文科技期刊全文数据库(VIP)。检索时间从各数据库建立时间截止至2020年5月2日。检索出所有逍遥散加减治疗IBS的随机对照试验,由两名研究员各自独立严格进行纳入研究的质量评价和资料提取,使用Review Manager 5.3软件进行Meta分析,使用TSA 0.9软件进行试验序贯分析。结果共纳入14篇文献,1240例患者。Meta分析结果显示,逍遥散加减方治疗IBS在总有效率(RR=1.25;95%CI 1.18,1.32;P<0.000 01)方面优于常规西药治疗,可显著降低患者腹痛积分(SMD=-0.71;95%CI-1.08,-0.35;Z=3.88;P=0.000 1)及腹胀积分(SMD=-0.93;95%CI-1.39,-0.48;Z=4.01;P<0.000 1),不良反应较少发生。试验序贯分析(TSA)结果显示,临床有效率累积纳入的研究穿过了传统界值和TSA界值,进一步肯定了试验组的临床疗效。结论逍遥散加减治疗IBS疗效优于常规西药治疗,且不良反应较少,但仍需要更多高质量、大样本、多中心的随机对照试验进行验证。

Objective To systematically evaluate the efficacy and safety of modified Xiaoyao Powder in the treatment of irritable bowel syndrome(IBS).Methods We searched Pub Med,Cochrane Library,CNKI,Wanfang Data,CBM,and VIP.The retrieval time was from the establishment time of each database to May 02,2020.After retrieving all the randomized controlled trials of modified xiaoyao powder therapy for IBS,two researchers independently and strictly evaluated the quality of the included studies and extracted the data.Review Manager 5.3 software was used for meta-analysis,and TSA 0.9 software was used for sequential analysis of the trials.Results A total of 14 articles and 1240 patients were included.The results of meta-analysis showed that modified Xiaoyao Powder was superior to conventional western medicine in terms of total effective rate(RR = 1.25;95% CI 1.18,1.32;P<0.000 01),and could significantly reduce the abdominal pain score(SMD =-0.71;95% CI-1.08,-0.35;Z = 3.88;P = 0.000 1) and abdominal distension score(SMD =-0.93;95% CI-1.39,-0.48;Z = 4.01;P<0.000 1) of patients.Adverse reactions were rare.The trial sequential analysis(TSA) results showed that the clinical effectiveness was cumulative across the traditional and TSA thresholds,further confirming the clinical efficacy of the trial group.Conclusion Modified Xiaoyao Powder was more effective than conventional western medicine in the treatment of IBS,with fewer adverse reactions.However,more high-quality,large-sample,multi-center randomized controlled trials were still needed or verification.