Abstract: Background　Chronic constipation has become a common gastrointestinal motility disease，which may be associated with negative effect of some social factors，exerting a great impact on the life quality of patients. Most common treatments are laxatives，which may lead to drug dependence and adverse reactions. Comparatively speaking，TCM treatment using holistic approach for chronic constipation has certain advantages. But there is no research on Shouhui Tongbian Capsules for chronic constipation. Objective　To systematically evaluate the efficacy and safety of Shouhui Tongbian Capsules in treating chronic constipation. Methods　Literature retrieval was performed through databases of PubMed，EMBase，The Cochrane Library，CNKI，SinoMed，CQVIP and Wanfang Data from inception to May 25，2020 to select randomized controlled trials（RCT）investigating the efficacy and safety of Shouhui Tongbian Capsules in the treatment of chronic constipation. Data extraction was performed，including the first author's name，publication time，sample size，sample age，intervention measures，course of treatment，and outcome indices（defecation frequency，clinical response rate，defecation difficulty，incidence of constipation，occurrence of adverse reactions）. The quality of the included studies was evaluated using the Cochrane risk-of-bias tool. Meta-analysis was conducted with RevMan 5.3. Results　In all，three RCT were included，involving 241 patients. All were evaluated with relatively low quality. Meta-analysis demonstrated that the improvement in bowel movement frequency〔SMD=0.73，95%CI（0.31，1.15），P=0.000 6〕，and defecation difficulty〔SMD=0.50，95%CI（-0.01，1.00），P=0.06〕and clinical response rate〔RR=1.20，95%CI（1.07，1.34），P=0.002〕 in experimental group were superior to those in the control group. Moreover，the frequency of constipation in experimental group（9%）was lower than that of control group（48%）. All these RCT studied the safety of treatment，but no adverse effects were identified. Conclusion　Compared to routine western medicine treatment alone，its combination with Shouhui Tongbian Capsules improves defecation frequency and difficulty in chronic constipation patients more significantly，indicating that the combination therapy has better efficacy. Furthermore，the incidence of adverse reactions related to the combination therapy is low，indicating that the therapy has good safety. However，due to limited number and low quality of included RCT，more high-quality clinical RCT are needed to verify the above conclusion. As for outcome indices，internationally recognized ones are recommended.

Key words: Constipation, Chronic constipation, Shouhui Tongbian Capsules, Meta-analysis, Effectiveness, Security, Systematic review

摘要： 背景　受到社会因素影响，慢性便秘成了常见的胃肠动力疾病，对患者生活质量造成较大影响。慢性便秘的常规治疗药物多为导泻剂，可能存在药物依赖及不良反应情况，中医药运用整体观念治疗慢性便秘具有一定优势，但目前关于首荟通便胶囊治疗慢性便秘的研究少见。目的　系统评价首荟通便胶囊治疗慢性便秘的有效性与安全性。方法　计算机检索PubMed、EMBase、The Cochrane Library、中国知网（CNKI）、中国生物医学文献数据库（SinoMed）、维普网、万方数据知识服务平台，检索时间均从建库至2020-05-25。检索收集关于首荟通便胶囊治疗慢性便秘的随机对照试验，提取第一作者姓名、发表时间、样本量、研究对象年龄、干预措施、疗程、结局指标（排便频率、临床有效率、排便困难程度、便秘发生率、不良反应发生情况）等信息。采用Cochrane风险偏倚评估工具，对纳入研究进行质量评价。采用RevMan 5.3软件进行Meta分析。结果　共纳入3篇文献，241例患者，研究质量普遍偏低。Meta分析结果显示，试验组改善排便频率的效果〔SMD=0.73，95%CI（0.31，1.15），P=0.000 6〕、临床有效率〔RR=1.20，95%CI（1.07，1.34），P=0.002〕、改善排便困难程度的效果〔SMD=0.50，95%CI（-0.01，1.00），P=0.06〕优于对照组。试验组便秘发生率（9%）低于对照组（48%）（P<0.05）。3篇文献均报道了不良反应发生情况，但均报道无不良反应发生。结论　首荟通便胶囊联合西医常规治疗慢性便秘的临床疗效可能优于西医常规治疗，其可能会改善患者排便频率与排便困难程度，且不良反应发生率较低，具有良好的有效性与安全性。但现有临床研究数量较少，质量偏低，为了进一步验证上述结论，还需开展更多高质量的临床随机对照试验，且选择国际公认的结局指标进行研究。

关键词: 便秘, 慢性便秘, 首荟通便胶囊, Meta 分析, 有效性, 安全性, 系统评价