四逆散加减治疗腹泻型肠易激综合征疗效的系统评价

Systematic Review of Sinisan Prescription in Treatment of Irritable Bowel Syndrome with Predominant Diarrhea

目的:评价四逆散加减治疗腹泻型肠易激综合征(IBS-D)的临床疗效与安全性。方法:检索数据库中国期刊全文数据库(CNKI)、重庆维普中文科技期刊数据库(VIP)、万方数据库(Wanfang Database)、PubMed、Embase、Cochranelibrary和Sino Med中收录的2019年3月前发表的关于四逆散加减治疗IBS-D的临床随机对照试验(RCTs)。由研究人员对文献进行筛选和数据提取,应用Cochrane评价手册进行方法质量学偏倚风险评估,Revman5.3软件对临床疗效和安全性进行Meta分析,TSA0.9软件进行试验序贯分析。结果:共纳入8项RCTs,683例患者,Meta分析结果显示:四逆散加减治疗IBS-D的临床疗效总有效率(n=683,OR=6.01,95%CI:3.71~9.72,P<0.00001)、治疗后腹痛积分(n=118,MD=-1.16,95%CI:-1.59^-0.73,P<0.00001)、治疗后排便次数积分(n=118,MD=-0.74,95%CI:-1.20^-0.28,P=0.002)、治疗后大便性状积分(n=118,MD=-0.63,95%CI:-0.97^-0.28,P=0.0004)均优于对照组;四逆散加减组治疗后血清炎症因子IL-1β较对照组减少,差异具有统计学意义(n=122,MD=-0.13,95%CI:-0.16^-0.10,P<0.00001);所纳入的研究仅1项研究提及不良反应,表现为轻微恶心、头晕和乏力,两组差异无统计学意义。TSA分析进一步肯定了四逆散加减治疗IBS-D的疗效。结论:四逆散加减治疗IBS-D的临床疗效优于西药常规疗法,但由于所纳入文献总体质量较低、样本量较少,需更多高质量的多中心、大样本、随机双盲等严格设计的RCT来验证其疗效与安全性。

Objective: To evaluate the efficacy and safety of sinisan prescription in treatment of irritable bowel syndrome with predominant diarrhea (IBS-D).Methods: The China National Knowledge Infrastructure (CNKI), Chongqing Weipu Database for Chinese Technical Periodicals (VIP), Wan-fang Database, PubMed, EMBASE, Cochrane Library, and SinoMed were searched from their inception to March 2019 for randomized controlled trials (RCTs) about sinisan prescription in treatment of IBS-D.All relevant articles were searched and selected to extract data.Article quality was evaluated by Cochrane Risk Bias Tool in the Cochrane Handbook.Meta analysis of clinical efficacy and safety was performed by RevMan 5.3.TSA 0.9 software was used for trial sequential analysis.Results: There were eight studies including 683 participants.Compared to the control group, sinisan prescription increased clinical efficacy ( n =683, OR=6.01,95%CI:3.71 to 9.72 , P <0.000 01), and reduced score of abdominal pain after treatment( n =118, MD=-1.16,95%CI:-1.59 to -0.73, P <0.000 01), and score of frequency of defecation after treatment( n =118, MD=-0.74,95%CI:-1.20 to -0.28, P =0.002), and score of stool trait after treatment( n =118, MD=-0.63,95%CI:-0.97 to -0.28, P =0.0004).Compared to the control group, serum inflammatory factor IL-1β was reduced in sinisan group after treatment, with a statistically difference ( n =122, MD=-0.13,95%CI:-0.16 to -0.10 , P <0.000 01).There was only one study mentioned adverse reactions, which performed mild nausea, dizziness and fatigue.There was no statistical difference between the two groups in adverse reactions.TSA analysis further confirmed the efficacy of sinisan prescription in treatment of IBS-D.Conclusion: Sinisan prescription has higher clinical efficacy in treatment of IBS-D when compared with the conventional therapy of western medicine.However, due to the low quality and small sample size of studies in the included literature, higher quality of multi-center, large sample, random double-blind and strictly designed RCTs are needed to verify its efficacy and safety in future.