目的 系統(tǒng)評價少腹逐瘀湯治療寒凝血瘀型原發(fā)性痛經(jīng)（PD）的療效和安全性，比較其與化學(xué)藥或其他中成藥的優(yōu)勢，為臨床用藥提供依據(jù)。方法 計算機輔以手工檢索1997年3月-2015年7月在PubMed、Cochrane圖書館、EMbase、中國期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫、中文科技期刊全文數(shù)據(jù)庫（VIP）、中國生物醫(yī)學(xué)文獻數(shù)據(jù)庫（CBM）發(fā)表的以少腹逐瘀湯治療PD的隨機對照試驗，按照Cochrane系統(tǒng)評價方法，應(yīng)用RevMan 5.2軟件進行Meta分析。結(jié)果 最終納入17篇文獻計1 591例；Meta分析結(jié)果顯示少腹逐瘀湯改善PD癥狀及體征的總有效率優(yōu)于芬必得布洛芬緩釋膠囊、月月舒痛經(jīng)寶顆粒、消炎痛片、吲哚美辛；缺乏對少腹逐瘀湯不良反應(yīng)及長期副作用的報告；3組療效差異有統(tǒng)計學(xué)意義，吲哚美辛亞組沒有統(tǒng)計學(xué)意義。結(jié)論 少腹逐瘀湯治療PD的療效優(yōu)于芬必得布洛芬緩釋膠囊、月月舒痛經(jīng)寶顆粒、消炎痛片、吲哚美辛等藥物，但由于納入文獻質(zhì)量不高且存在較大的偏倚風(fēng)險，以后需要開展全球范圍內(nèi)高質(zhì)量的臨床研究，以評價少腹逐瘀湯的遠期療效和安全性。

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.