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评估 CGRP mAbs 和 gepants 用于偏头痛预防治疗的疗效:3 期随机对照试验的系统评价和网络荟萃分析。

Evaluating the efficacy of CGRP mAbs and gepants for the preventive treatment of migraine: A systematic review and network meta-analysis of phase 3 randomised controlled trials.

机构信息

The George Institute for Global Health, University of New South Wales, Sydney, Australia.

Headache Group, Wolfson CARD, SLaM Biomedical Research Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College Hospital, London, United Kingdom.

出版信息

Cephalalgia. 2023 Apr;43(4):3331024231159366. doi: 10.1177/03331024231159366.

DOI:10.1177/03331024231159366
PMID:36855951
Abstract

BACKGROUND

Several novel treatments targeting the calcitonin gene-related peptide pathway have been developed for migraine. We evaluated the efficacy of these medications, including atogepant, rimegepant, erenumab, eptinezumab, fremanezumab, and galcanezumab, for the prevention of migraine via network meta-analysis.

METHODS

Databases, including MEDLINE via PubMed, EMBASE, and Cochrane central, were systematically reviewed, and all eligible phase 3 randomised controlled trials were included.

RESULTS

Nineteen studies (n = 14,584 participants) were included. Studies included episodic (n = 11) and chronic (n = 4) migraine or both (n = 4). All interventions, except for eptinzumab 30mg, significantly reduced mean monthly migraine days compared to placebo. All medications had a higher ≥50% responder rate than placebo and results were statistically significant in those with the subcutaneous or intravenous route of administrations, but not with the oral one. All medications significantly reduced mean monthly headache days, although no data for this outcome was available for rimegepant, and mean monthly acute medication days, with no data for eptinezumab.

CONCLUSION

The results show that medications targeting calcitonin gene-related peptide were effective in preventing migraine compared to placebo. Considering limitations of single studies, different populations such as episodic and chronic migraine, and the absence of head-to-head trials, all novel treatments decreased mean monthly migraine and headache days, and showed higher 50%, 75% and 100% responder rates than placebo. PROSPERO registration: CRD42022310579.

摘要

背景

已有几种针对降钙素基因相关肽途径的新型偏头痛治疗药物被开发出来。我们通过网络荟萃分析评估了这些药物(包括 atogepant、rimegepant、erenumab、eptinezumab、fremanezumab 和 galcanezumab)预防偏头痛的疗效。

方法

系统检索了包括 MEDLINE 在内的多个数据库(通过 PubMed 检索)、EMBASE 和 Cochrane 中心,并纳入了所有符合条件的 3 期随机对照试验。

结果

共纳入 19 项研究(n=14584 名参与者)。这些研究包括发作性(n=11)和慢性(n=4)偏头痛或两者均包括(n=4)。与安慰剂相比,除了 eptinezumab 30mg 外,所有干预措施均显著减少了平均每月偏头痛天数。与安慰剂相比,所有药物的≥50%应答率更高,且结果在皮下或静脉给药途径的药物中具有统计学意义,但在口服给药途径的药物中则没有。所有药物均显著减少了平均每月头痛天数,但 rimegepant 无该结局数据,且平均每月急性用药天数也无 eptinezumab 的数据。

结论

结果表明,与安慰剂相比,靶向降钙素基因相关肽的药物在预防偏头痛方面是有效的。考虑到单个研究的局限性、不同人群(如发作性和慢性偏头痛)以及缺乏头对头试验,所有新型治疗方法均降低了平均每月偏头痛和头痛天数,并且显示出比安慰剂更高的 50%、75%和 100%应答率。PROSPERO 注册号:CRD42022310579。

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