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[摘要]
目的 评价丹珍头痛胶囊治疗偏头痛的疗效及安全性。方法 检索中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)、万方数据库和Pubmed数据库有关丹珍头痛胶囊治疗偏头痛的随机对照试验(RCTs),采用Modified Jadad评分量表对纳入文献进行质量评价,应用RevMan 5.3软件进行统计分析。结果 最终纳入9篇RCTs,共891例患者。Meta分析结果显示,丹珍头痛胶囊治疗偏头痛的总有效率高于西药组[RR=1.26,95%CI(1.19,1.35)],差异有统计学意义(P < 0.001)。亚组分析显示,单纯应用丹珍头痛胶囊比单纯使用常规西药总有效率更高[RR=1.28,95%CI(1.19,1.39),P < 0.001],在常规西药基础上加用丹珍头痛胶囊可提高治疗的总有效率[RR=1.22,95%CI(1.10,1.36),P=0.000 3],丹珍头痛胶囊治疗偏头痛总有效率高于盐酸氟桂利嗪[RR=1.26,95%CI(1.17,1.34),P < 0.001]和加巴喷丁[RR=1.32,95%CI(1.10,1.57),P=0.002],差异均有统计学意义(P < 0.05)。丹珍头痛胶囊组未见严重不良反应。结论 丹珍头痛胶囊治疗偏头痛的疗效可能优于常规西药,在常规西药基础上联合丹珍头痛胶囊可提高疗效。为提高结论的可靠性,尚需更多高质量、多中心、大样本的RCTs。
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[Abstract]
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.
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