与安慰剂相比,弗雷曼祖马布在预防发作性偏头痛方面的作用:随机临床试验
David W Dodick1, Stephen D Silberstein2, Marcelo E Bigal3
1Mayo Clinic Arizona, Phoenix.
JAMA
|May 26, 2018
概括
在偶发性偏头痛患者中,Fremanezumab显著减少了每月偏头痛的几天. 这种单克隆抗体提供了一个新的治疗选择,在12周的试验中显示出有效性.
科学领域:
- 神经学
- 免疫学
- 药理学
背景情况:
- 偶发性偏头痛是一种衰弱的神经疾病.
- 素基因相关 (CGRP) 是偏头痛预防的关键目标.
- 弗雷曼祖马布是一种针对CGRP的单克隆抗体.
研究的目的:
- 评估弗雷曼祖马布与安慰剂的疗效,以预防发作性偏头痛.
- 评估每月和每季度使用弗雷曼祖马布的剂量方案.
主要方法:
- 这是一项随机,双盲,安慰剂对照试验,涉及875名患有偏头痛的患者.
- 参与者每月接受一次较高剂量的弗雷曼祖马布或安慰剂,持续12周.
- 主要终点是每月偏头痛天数的平均变化.
主要成果:
- 与安慰剂相比,每月服用弗雷曼祖马布可以减少每月偏头痛的1.5天 (P < 0. 001).
- 与安慰剂相比,Fremanezumab单次较高剂量每月的偏头痛日减少了1. 3天 (P < 0. 001).
- 这些不良事件通常是轻微的,注射部位反应是最常见的.
结论:
- 弗雷曼祖马布在减少每月偏头痛日数方面表现出显著的统计效果.
- 这项研究支持弗雷曼祖马布作为偶发性偏头痛的潜在预防性治疗方法.
- 建议对长期的安全性和疗效进行进一步的研究,并对以前治疗失败的患者群进行进一步的研究.
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