对慢性偏头痛的预防性治疗的风险差异元分析
Michalis Kodounis1,2, Theodoros S Constantinidis3, Konstantina Rizonaki2,4
1First Neurology Department, Eginitio Hospital, School of Medicine, National & Kapodistrian University of Athens, Athens, GRC.
Cureus
|July 18, 2024
概括
新的单克隆抗体 (mAbs) 针对色素基因相关 (CGRP) 显示了与慢性偏头痛 (CM) 标准治疗相比的有效性和安全性. 这些CGRP mAbs提供了一个有前途的,偏头痛特定的预防方案,具有类似的治疗效益.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 慢性偏头痛 (CM) 给全球健康带来了巨大的负担,从历史上来看,只有有限的特定预防性治疗方法可用.
- 向色素基因相关 (CGRP) 的单克隆抗体 (mAbs) 已成为一种针对偏头痛的新,向的预防疗法.
- 现有的CGRP mAbs (erenumab, fremanezumab, galcanezumab, eptinezumab) 缺乏与已建立的抗偏头痛治疗方法进行直接对比.
研究的目的:
- 间接比较抗CGRP mAbs与标准CM预防治疗的疗效和安全性.
- 利用基于绝对风险差异 (ARD) 的交叉试验间接模型来计算需要治疗的数量 (NNT) 和需要伤害的数量 (NNH).
主要方法:
- 在MEDLINE和CENTRAL数据库中对CM预防的3期和2b期随机对照试验 (RCT) 进行了系统搜索.
- 采用了包含和排除标准来选择符合条件的RCT.
- 对于50%的响应率 (每月偏头痛日减少),不良事件 (AE),严重不良事件 (SAE) 和退出的ARD,计算了NNT和NNH.
主要成果:
- 在分析中包括了8个RCT. 抗CGRP mAbs与类似的NNTs (范围从5到8) 显示出统计学上显著的有效性.
- 无毒毒素A (oBTA) 显示非显著的ARD与更高的NNT (56).
- 托皮拉在研究中产生了矛盾的结果,NNT分别为2和22. CGRP mAbs的有效性和安全性概况与标准治疗方法相似.
结论:
- 所有四种研究的抗CGRP mAbs都在CM预防方面表现出一致的高疗效,与标准治疗方法相比.
- 这些发现表明CGRP mAbs是CM管理的有价值和有效的选择,提供与现有疗法相似的好处.
- 需要进一步进行对比试验,以确定相对有效性和安全性.
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