目的 系统评价痛泻宁颗粒治疗肠易激综合征（IBS）的疗效及安全性。方法 以痛泻宁、肠易激综合征、随机对照试验为关键词，检索PubMed、e Cocheane Library、中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、中文科技期刊全文数据库（VIP）、万方数据库中有关痛泻宁治疗IBS的随机对照试验（RCT），检索时限为建库至2013年10月，并追溯纳入研究的参考文献。由2名研究人员按纳入与排除标准独立筛选试验，并对纳入研究的文献进行方法学质量评价、提取资料，用Review Manger 5.0软件进行数据管理与Meta分析，用漏斗图分析发表性偏倚。结果 共有符合纳入标准的5个随机对照试验，共788例患者。痛泻宁颗粒组总有效率优于对照组（固定效应模型）[比值比（OR）=6.28，95 %置信区间（CI）（4.28，9.22），P＜0.00001]；腹泻改善优于对照组[OR=4.58，95 % CI（3.04，6.88），P＜0.0001]；腹痛改善优于对照组[OR=5.87，95 % CI（3.87，8.90），P＜0.0001]。2组不良反应发生率[OR=0.30，95 % CI（0.05，1.79），P=0.19]差异无统计学意义。对纳入的5个研究作倒漏斗图，直观上形状近似于1个倒置的漏斗。由于纳入研究的原始数据样本量较少，无国外研究文献，提示存在发表语种、样本量等发表偏倚。结论 基于现有临床证据，痛泻宁颗粒治疗IBS有效，安全性较好。但由于纳入研究的RCT数量较少，研究质量参差不齐，无外文研究，本结论尚需更多大样本、高质量的临床RCT予以更新和证实。

Objective To evaluate curative effect and safety of Tongxiening granule for the treatment of irritable bowel syndrome. Methods Using“Tongxiening”，“irritable bowel syndrome”，“randomized controlled trial”as the key words，research articles in domestic and foreign database of PubMed，LiBRARY，eCocheane，China journal full text database（CNKI），Chinese biomedical literature database（CBM），and Chinese science and technology periodical full text database（VIP） were retrieved for the screening of randomized controlled trials（RCT） of Tongxiening in treating irritable bowel syndrome. The retrieval time ranged from the time of database founded to October of 2013，and trace of the related references was also carried out. Two researchers were independently in charge of TCT screening，methodological quality evaluation and data extraction according to the inclusion criteria and exclusion criteria. Data management and Meta analysis were performed by using Review Manger 5.0 software，and publication bias was judged by funnel plot. Results A total of 5 RCT accorded with the inclusion criteria，involving 788 patients. Tongxiening granule group had better total effectiveness than the control group（by fixed effect model），with OR=6.28，95 % CI（4.28，9.22）（P＜0.00001）. Tongxiening granule group had better effect on relieving diarrhea symptom[OR=4.58，95 % CI（3.04，6.88），P＜0.0001] and on relieving abdominal pain [OR=5.87，95 % CI（3.87，8.90），P＜0.0001]. The difference of the incidence of adverse reaction between the two groups was insignificant[OR=0.30，95 % CI（0.05，1.79），P=0.19]. Funnel plot of the 5 included RCT presented as intuitive shape of the inverted funnel. For the small sample size and the absence of foreign literatures，publication bias of publication languages and sample size existed obviously. Conclusion Based on the current clinical evidence，Tongxiening granule is effective and safe for the treatment of irritable bowel syndrome. However，the conclusion should be verified by large sample size and high quality RCT for the current RCT are with small sample size，uneven quality and absence of foreign literatures.

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