目的 系统评价少腹逐瘀汤治疗寒凝血瘀型原发性痛经（PD）的疗效和安全性，比较其与化学药或其他中成药的优势，为临床用药提供依据。方法 计算机辅以手工检索1997年3月-2015年7月在PubMed、Cochrane图书馆、EMbase、中国期刊全文数据库（CNKI）、万方数据库、中文科技期刊全文数据库（VIP）、中国生物医学文献数据库（CBM）发表的以少腹逐瘀汤治疗PD的随机对照试验，按照Cochrane系统评价方法，应用RevMan 5.2软件进行Meta分析。结果 最终纳入17篇文献计1 591例；Meta分析结果显示少腹逐瘀汤改善PD症状及体征的总有效率优于芬必得布洛芬缓释胶囊、月月舒痛经宝颗粒、消炎痛片、吲哚美辛；缺乏对少腹逐瘀汤不良反应及长期副作用的报告；3组疗效差异有统计学意义，吲哚美辛亚组没有统计学意义。结论 少腹逐瘀汤治疗PD的疗效优于芬必得布洛芬缓释胶囊、月月舒痛经宝颗粒、消炎痛片、吲哚美辛等药物，但由于纳入文献质量不高且存在较大的偏倚风险，以后需要开展全球范围内高质量的临床研究，以评价少腹逐瘀汤的远期疗效和安全性。

Objective To evaluate the efficacy and safety of Shaofu Zhuyu Decoction in treatment of primary dysmenorrhea (PD) with cold-coagulation blood-stasis. Methods The related literatures till July, 2015 in PubMed, Embase, Cochrane Librar, CNKI, CBM, Wanfang Database, and VIP Database were searched. The randomized controlled trials involving Shaofu Zhuyu Decoction for the treatment of PD were collected. According to Cochrane system evaluation method, study quality was evaluated and extracted the available information, and then performed Meta-analysis by Revman 5.2 software. Results Finally into 17 documents, involving 1591 patients, Meta-analysis showed that symptoms and signs of Shaofu Zhuyu Decoction improving PD with cold-coagulation blood-stasis were better than Ibuprofen Sustained Release Capsules, Yueyueshu Granules, Indometacin Tablets, and Indocin in the total efficiency. The long term efficacy and safety of Shaofu Zhuyu Decoction cannot be evaluated. Indomethacin subgroup had no statistical significance. Conclusions Effect of Shaofu Zhuyu Decoction is better than Ibuprofen Sustained Release Capsules, Yueyueshu Granules, Indometacin Tablets, and Indocin. Due to the quality of the included studies are not high and have a bias of risk. In the future, additional and high-quality studies on patients across the world might be required to validate the findings.