fremanezumab预防性治疗偏头痛有效性和安全性的Meta分析

Efficacy and safety of fremanezumab in preventive treatment of migraine: a meta-analysis

目的评价fremanezumab预防性治疗偏头痛的有效性和安全性。方法计算机检索PubMed、Embase、 Web of Science (SCI)、 Clinical Trials Website、 Cochrane Library、中国知网、万方、维普等数据库中关于fremanezumab预防性治疗偏头痛有效性和安全性的随机对照试验(RCT),采用Stata 14软件对数据进行Meta分析。结果共纳入4项RCT, 1 715例患者。Meta分析结果显示,与安慰剂组比较,fremanezumab组在每月偏头痛日数、每月头痛日数、每月急性头痛用药日数减少等方面均优于安慰剂组(P <0.05)。fremanezumab组的总不良事件、与治疗相关的不良反应的发生率均高于安慰剂组(P <0.05);与安慰剂组比较, fremanezumab组在严重不良反应、因不良反应终止试验、注射部位疼痛或红斑、上呼吸道感染、尿路感染等方面均无显著差异(P> 0.05)。结论现有证据表明fremanezumab能有效地减少每月偏头痛、头痛和急性头痛用药的时间,不良反应可耐受。

AIM To evaluate the efficacy and safety of fremanezumab in the preventive treatment of migraine.METHODS All randomized controlled trials(RCTs)about the efficacy and safety of fremanezumab in preventive treatment of migraine were searched and retrieved from the databases including PubMed,Embase,Web of Science(SCI),Clinical Trials Website,Cochrane Library,CNKI,Wanfang,and VIP database.Meta-analysis of the data were performed by Stata14 software.RESULTS Four RCTs with 1 715 patients were included.The reduction of migraine-days,headache-days and days of using any acute headache medications in the fremanezumab group were superior to placebo group(P<0.05).The incidence rates of adverse events and the treatment-related adverse reactions in the fremanezumab group were higher than those of placebo group(P<0.05).And there was no statistically significant difference in the incidence rate of serious adverse reactions,reactions leading to discontinuation of the trial,injection-site pain or erythema,upper respiratory tract infection,urinary tract infection,etc.between the fremanezumab group and the placebo group(P>0.05).CONCLUSION Available evidences suggest that fremanezumab is effective in reducing the time of migraine,headache and the time of any acute headache medications per month,and its adverse drug reactions can be tolerated.