厄瑞奴单抗预防性治疗成人偏头痛有效性和安全性的系统评价

Efficacy and safety of erenumab in the preventive treatment of migraine in adults: a systematic review

目的系统评价厄瑞奴单抗预防性治疗成人偏头痛的有效性和安全性。方法以Erenumab OR AMG334 AND Migraine、厄瑞奴单抗AND偏头痛计算机检索2001年1月1日-2018年8月1日美国国立医学图书馆生物医学信息检索系统(PubMed)、Cochrane图书馆和中国知网中国知识基础设施工程、万方数据库、维普数据库,以及Google Scholar互联网检索关于厄瑞奴单抗预防性治疗成人偏头痛的随机对照临床试验,采用Jadad量表评价文献质量。结果共获得68篇英文文献,经剔除重复和不符合纳入与排除标准的文献,最终纳入4篇高质量(Jadad评分≥4分)文献共2682例成年偏头痛患者(厄瑞奴单抗组1626例,对照组1056例)。结果显示:(1)厄瑞奴单抗70 mg组和140 mg组治疗有效率(每月偏头痛天数减少≥50%比例)、每月偏头痛减少天数、每月应用特异性药物减少天数以及偏头痛物理功能影响日记-日常生活部分和身体影响部分评分均优于对照组。(2)厄瑞奴单抗组与对照组药物不良反应发生率差异无统计学意义,且不良反应较轻微,主要包括注射部位疼痛、上呼吸道感染、鼻咽炎等,因药物不良反应而中断试验的病例数极少。结论厄瑞奴单抗预防性治疗成人偏头痛安全、有效。

Objective To systematically evaluate the clinical efficacy and safety of erenumab in the preventive treatment of migraine in adults.Methods Taking Erenumab or AMG334 AND Migraine as search terms,retrieve in databases such as PubMed,Cochrane Library,China National Knowledge Infrastructure（CNKI）,Wanfang Data and VIP,and search engines such as Google Scholar,in order to collect randomized controlled trials（RCTs）of erenumab in the preventive treatment of adult migraine from January 1,2001 to August 1,2018.Jadad Scale was used to evaluate the quality of literatures.Results A total of 68 English articles were enrolled after preliminary searching,and 4 high-quality RCTs（Jadad score≥4）with a total of 2682 cases（1626 cases in erenumab group and 1056 cases in placebo group）were finally included after excluding duplicates and those not meeting the inclusion criteria.The results were as follows：1）compared with placebo,erenumab（70 mg/4 weeks or monthly,140 mg/4 weeks）was more effective（effective defined as≥50%reduction from baseline migraine days per month）and showed significantly higher efficacy in reducing migraine days per month,the use of migraine-specific medication,Migraine Physical Function Impact Diary on Everyday Activities and Physical Impairment（MPFID-EA and MPFID-PI）in treating migraine patients.2）The incidence of adverse reactions was low and mild,and there was no significant difference compared with placebo.Common adverse reactions included injection site pain,upper respiratory tract infection,nasopharyngitis,etc.There were very few patients who discontinued treatment due to adverse drug reactions.ConclusionsErenumab is safe and effective in the preventive treatment of migraine in adults.