目的 評(píng)價(jià)丹珍頭痛膠囊治療偏頭痛的療效及安全性。方法 檢索中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)（CBM）、中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)（CNKI）、維普中文科技期刊數(shù)據(jù)庫(kù)（VIP）、萬(wàn)方數(shù)據(jù)庫(kù)和Pubmed數(shù)據(jù)庫(kù)有關(guān)丹珍頭痛膠囊治療偏頭痛的隨機(jī)對(duì)照試驗(yàn)（RCTs），采用Modified Jadad評(píng)分量表對(duì)納入文獻(xiàn)進(jìn)行質(zhì)量評(píng)價(jià)，應(yīng)用RevMan 5.3軟件進(jìn)行統(tǒng)計(jì)分析。結(jié)果 最終納入9篇RCTs，共891例患者。Meta分析結(jié)果顯示，丹珍頭痛膠囊治療偏頭痛的總有效率高于西藥組[RR=1.26，95%CI（1.19，1.35）]，差異有統(tǒng)計(jì)學(xué)意義（P < 0.001）。亞組分析顯示，單純應(yīng)用丹珍頭痛膠囊比單純使用常規(guī)西藥總有效率更高[RR=1.28，95%CI（1.19，1.39），P < 0.001]，在常規(guī)西藥基礎(chǔ)上加用丹珍頭痛膠囊可提高治療的總有效率[RR=1.22，95%CI（1.10，1.36），P=0.000 3]，丹珍頭痛膠囊治療偏頭痛總有效率高于鹽酸氟桂利嗪[RR=1.26，95%CI（1.17，1.34），P < 0.001]和加巴噴丁[RR=1.32，95%CI（1.10，1.57），P=0.002]，差異均有統(tǒng)計(jì)學(xué)意義（P < 0.05）。丹珍頭痛膠囊組未見(jiàn)嚴(yán)重不良反應(yīng)。結(jié)論 丹珍頭痛膠囊治療偏頭痛的療效可能優(yōu)于常規(guī)西藥，在常規(guī)西藥基礎(chǔ)上聯(lián)合丹珍頭痛膠囊可提高療效。為提高結(jié)論的可靠性，尚需更多高質(zhì)量、多中心、大樣本的RCTs。

Objective To evaluate the efficacy and safety of Danzhen Headache Capsules in treatment of migraine. Methods Published randomized controlled trials (RCTs) about Danzhen Headache Capsules in treatment of migraine were identified through a systematic search through CBM, CNKI, VIP, Wanfang, and Pubmed. Quality was assessed according to the Modified Jadad scale for RCTs, and the statistical software RevMan 5.3 was used for data analysis. Results Nine RCTs with 891 patients were involved totally. Meta analysis results showed that the total effective rate of Danzhen Headache Capsules was significantly higher than that of ordinary western medicine group in treatment of migraine[RR=1.26, 95%CI (1.19, 1.35), (P < 0.001)]. Simple Danzhen headache capsules subgroups had a significantly higher total effective rate compared with simple ordinary western medicine subgroups[RR=1.28, 95%CI(1.19, 1.39), P < 0.001]. Danzhen Headache Capsules combined with ordinary western medicine significantly increased the total effective rate of treating migraine[RR=1.22, 95%CI(1.10, 1.36), P=0.000 3]. Danzhen Headache Capsules had a significantly higher total effective rate compared with flunarizine hydrochloride capsules[RR=1.26, 95%CI(1.17, 1.34), P < 0.001] and gabapentin[RR=1.32, 95%CI(1.10, 1.57), P=0.002] in treatment of migraine. No serious adverse reaction was reported in the Danzhen Headache Capsules group. Conclusion The therapeutic effect of Danzhen Headache Capsules might better than ordinary western medicine. The combination treatment of ordinary western medicine and Danzhen Headache Capsules might improve therapeutic efficacy of patients with migraine. Moreover, this conclusion remains to be validated by high quality, multicenter and large scale RCTs.