目的 系統(tǒng)評(píng)價(jià)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(shì)，為臨床用藥提供依據(jù)。方法 計(jì)算機(jī)輔以手工檢索1997年3月-2015年7月在PubMed、Cochrane圖書(shū)館、EMbase、中國(guó)期刊全文數(shù)據(jù)庫(kù)（CNKI）、萬(wàn)方數(shù)據(jù)庫(kù)、中文科技期刊全文數(shù)據(jù)庫(kù)（VIP）、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)（CBM）發(fā)表的以少腹逐瘀湯治療PD的隨機(jī)對(duì)照試驗(yàn)，按照Cochrane系統(tǒng)評(píng)價(jià)方法，應(yīng)用RevMan 5.2軟件進(jìn)行Meta分析。結(jié)果 最終納入17篇文獻(xiàn)計(jì)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(duì)少腹逐瘀湯不良反應(yīng)及長(zhǎng)期副作用的報(bào)告；3組療效差異有統(tǒng)計(jì)學(xué)意義，吲哚美辛亞組沒(méi)有統(tǒng)計(jì)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(xiàn)質(zhì)量不高且存在較大的偏倚風(fēng)險(xiǎn)，以后需要開(kāi)展全球范圍內(nèi)高質(zhì)量的臨床研究，以評(píng)價(jià)少腹逐瘀湯的遠(yuǎn)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.