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抗降钙素基因相关肽单克隆抗体预防慢性偏头痛的疗效与安全性:一项贝叶斯网络荟萃分析

Efficacy and Safety of Anti-CGRP Monoclonal Antibodies in Prevention of Chronic Migraine: A Bayesian Network Meta-analysis.

作者信息

Haridas Mundot Puliappadamb, Tripathy Amruta, Maiti Rituparna, Srinivasan Anand

机构信息

Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, India.

出版信息

Clin Psychopharmacol Neurosci. 2024 Feb 29;22(1):23-32. doi: 10.9758/cpn.23.1109. Epub 2023 Nov 8.

Abstract

Due to the unmet needs in the management of migraine, a primary headache, and disabling disorder, the past decade has focused on developing monoclonal antibodies (mAbs) against the calcitonin-gene-related peptide (CGRP) as migraine prophylactic agents. The objective of the study was to evaluate the efficacy and safety of various anti-CGRP mAbs in the prevention of chronic migraine. Network meta-analysis (NMA) was performed using the Bayesian framework to estimate the efficacy and safety of mAbs after performing a literature search in PubMed, MEDLINE, Cochrane database, and International Clinical Trial Registry Platform (ICTRP). The outcomes calculated were in terms of mean difference (MD) or odds ratio (OR) with a 95% credible interval (95%CrI). Network graphs were constructed and node-split analysis was done to analyze the inconsistency. The NMA included a total of 10 clinical trials. Galacanezumab (120 mg) (MD: -2.7; 95%CrI: -4.8 to -0.83) was found to be better than other mAbs in terms of the difference in mean migraine days (MMD). Fremanezumab quarterly dose administration showed the best response (OR: 2.9; 95%CrI: 1.9 to 4.6) in terms of responder rate. Eptinezumab was found to be safer (OR: 0.88; 95%CrI: 0.61-1.3) as compared to other mAbs in terms of the rate of adverse events. Fremanezumab (quarterly) ranked better in terms of response rate, and eptinezumab was found to be the safest in the prophylactic management of migraine. Galacenequmab was better at reducing MMD. Further studies are needed to evaluate the long-term safety, efficacy, and use of mAbs in migraine patients.

摘要

由于偏头痛(一种原发性头痛和致残性疾病)的管理需求尚未得到满足,过去十年一直专注于开发针对降钙素基因相关肽(CGRP)的单克隆抗体(mAb)作为偏头痛预防药物。本研究的目的是评估各种抗CGRP单克隆抗体预防慢性偏头痛的疗效和安全性。使用贝叶斯框架进行网络荟萃分析(NMA),以在PubMed、MEDLINE、Cochrane数据库和国际临床试验注册平台(ICTRP)中进行文献检索后估计单克隆抗体的疗效和安全性。计算的结果以平均差(MD)或比值比(OR)以及95%可信区间(95%CrI)表示。构建网络图并进行节点拆分分析以分析不一致性。该NMA总共纳入了10项临床试验。就平均偏头痛天数(MMD)的差异而言,发现加卡尼单抗(120 mg)(MD:-2.7;95%CrI:-4.8至-0.83)优于其他单克隆抗体。就缓解率而言,季度剂量给药的夫瑞内单抗显示出最佳反应(OR:2.9;95%CrI:1.9至4.6)。就不良事件发生率而言,发现依普他单抗比其他单克隆抗体更安全(OR:0.88;95%CrI:0.61 - 1.3)。夫瑞内单抗(季度给药)在缓解率方面排名更好,并且发现依普他单抗在偏头痛的预防性管理中是最安全的。加卡尼单抗在降低MMD方面表现更好。需要进一步研究来评估单克隆抗体在偏头痛患者中的长期安全性、疗效和使用情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7386/10811399/8d25d8a43b28/cpn-22-1-23-f1.jpg

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