Department of Neurology, Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology, Wuhan, 430030, China.
BMC Neurol. 2020 Feb 15;20(1):57. doi: 10.1186/s12883-020-01633-3.
Migraine is one of the most common neurological disorders that leads to disabilities. However, the conventional drug therapy for migraine might be unsatisfactory at times. Therefore, this meta-analysis aimed to evaluate the efficacy and safety of calcitonin-gene-related peptide binding monoclonal antibody (CGRP mAb) for the preventive treatment of episodic migraine, and provide high-quality clinical evidence for migraine therapy.
A systematic electronic database search was conducted to identify the potentially relevant studies. Two independent authors performed data extraction and quality appraisal. Mean difference (MD) and risk ratio (RR) were pooled for continuous and dichotomous data, respectively. The significance levels, weighted effect sizes and homogeneity of variance were calculated.
Eleven high-quality randomized control trials that collectively included 4402 patients were included in this meta-analysis. Compared to placebo group, CGRP mAb therapy resulted in a reduction of monthly migraine days [weighted mean difference (WMD) = - 1.44, 95% CI = (- 1.68,- 1.19)] and acute migraine-specific medication days [WMD = - 1.28, 95% CI = (- 1.66,- 0.90)], with an improvement in 50% responder rate [RR = 1.51, 95% CI = (1.37,1.66)]. In addition, the adverse events (AEs) and treatment withdrawal rates due to AEs were not significantly different between CGRP mAb and placebo groups. Similar efficacy and safety results were obtained for erenumab, fremanezumab, and galcanezumab in subgroup analysis.
The current body of evidence reveals that CGRP mAb is an effective and safe preventive treatment for episodic migraine.
偏头痛是最常见的导致残疾的神经障碍之一。然而，偏头痛的传统药物治疗有时可能并不令人满意。因此，这项荟萃分析旨在评估降钙素基因相关肽结合单克隆抗体（CGRP mAb）用于预防治疗发作性偏头痛的疗效和安全性，为偏头痛治疗提供高质量的临床证据。
系统地进行电子数据库检索以确定潜在相关的研究。两名独立的作者进行了数据提取和质量评估。分别对连续和二分类数据进行了均值差（MD）和风险比（RR）的合并。计算了显著性水平、加权效应量和方差的同质性。
共有 11 项高质量的随机对照试验，共纳入 4402 名患者，纳入了这项荟萃分析。与安慰剂组相比，CGRP mAb 治疗可减少每月偏头痛天数[加权均数差（WMD）= -1.44，95%CI=（-1.68，-1.19）]和急性偏头痛特异性药物使用天数[WMD= -1.28，95%CI=（-1.66，-0.90）]，并提高 50%应答率[RR=1.51，95%CI=（1.37，1.66）]。此外，CGRP mAb 与安慰剂组之间的不良事件（AE）和因 AE 而停药率无显著差异。亚组分析也显示了 CGRP mAb 在依那西普单抗、佛来美尼单抗和加奈珠单抗中的疗效和安全性结果相似。
现有证据表明，CGRP mAb 是一种有效且安全的发作性偏头痛预防治疗方法。
