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降钙素基因相关肽单克隆抗体与肉毒杆菌毒素预防慢性偏头痛的疗效比较:间接治疗比较的证据

Calcitonin Gene-Related Peptide Monoclonal Antibody Versus Botulinum Toxin for the Preventive Treatment of Chronic Migraine: Evidence From Indirect Treatment Comparison.

作者信息

Lu Jiajie, Zhang Quanquan, Guo Xiaoning, Liu Wei, Xu Chunyang, Hu Xiaowei, Ni Jianqiang, Lu Haifeng, Zhao Hongru

机构信息

Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, China.

Department of Neurology, Traditional Chinese Medicine Hospital of Kunshan, Kunshan, China.

出版信息

Front Pharmacol. 2021 May 3;12:631204. doi: 10.3389/fphar.2021.631204. eCollection 2021.

Abstract

The previously approved botulinum toxin and nowadays promising calcitonin gene-related peptide (CGRP) monoclonal antibody have shown efficacy for preventing chronic migraine (CM). However, there is no direct evidence for their relative effectiveness and safety. In this study, we conducted an indirect treatment comparison to compare the efficacy and safety of CGRP monoclonal antibody with botulinum toxin for the preventive treatment of chronic migraine. Up to August 31, 2020, we systematically searched PubMed, Embase, and Cochrane Library Central Register of Controlled Trials (Central). Weighted mean difference (WMD) and relative risk (RR) were used to evaluate clinical outcomes. Indirect treatment comparison (ITC) software was used to conduct indirect treatment comparison. Ten studies were pooled with 6,325 patients in our meta-analysis. Both botulinum toxin and CGRP monoclonal antibody demonstrated favorable efficacy in the change of migraine days, headache days, HIT-6 score, and 50% migraine responder rate compared with placebo. In indirect treatment comparison, CGRP monoclonal antibody was superior to botulinum toxin in the frequency of acute analgesics intake (WMD = -1.31, 95% CI: -3.394 to 0.774, = 0.02113), the rate of treatment-related adverse events (AEs) (RR = 0.664, 95% CI: 0.469 to 0.939, = 0.04047), and the rate of treatment-related serious adverse events (RR = 0.505, 95% CI: 0.005 to 46.98, < 0.001). For chronic migraine patients, CGRP monoclonal antibody was slightly better than botulinum toxin in terms of efficacy and safety. In the future, head-to-head trials would be better to evaluate the efficacy and safety between different medications in the prevention of chronic migraine.

摘要

先前已获批的肉毒杆菌毒素以及当下颇具前景的降钙素基因相关肽(CGRP)单克隆抗体已显示出预防慢性偏头痛(CM)的疗效。然而,尚无关于它们相对有效性和安全性的直接证据。在本研究中,我们进行了间接治疗比较,以比较CGRP单克隆抗体与肉毒杆菌毒素在慢性偏头痛预防性治疗中的疗效和安全性。截至2020年8月31日,我们系统检索了PubMed、Embase和Cochrane图书馆对照试验中央注册库(Central)。采用加权平均差(WMD)和相对危险度(RR)来评估临床结局。使用间接治疗比较(ITC)软件进行间接治疗比较。在我们的荟萃分析中纳入了10项研究,共6325例患者。与安慰剂相比,肉毒杆菌毒素和CGRP单克隆抗体在偏头痛天数、头痛天数、HIT-6评分以及50%偏头痛缓解率的变化方面均显示出良好疗效。在间接治疗比较中,CGRP单克隆抗体在急性镇痛药服用频率(WMD = -1.31,95%CI:-3.394至0.774,P = 0.02113)、治疗相关不良事件(AE)发生率(RR = 0.664,95%CI:0.469至0.939,P = 0.04047)以及治疗相关严重不良事件发生率(RR = 0.505,95%CI:0.005至46.98,P < 0.001)方面均优于肉毒杆菌毒素。对于慢性偏头痛患者,CGRP单克隆抗体在疗效和安全性方面略优于肉毒杆菌毒素。未来,进行直接对比试验将更有助于评估不同药物在预防慢性偏头痛方面的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2ed/8126691/a9f414cf3e14/fphar-12-631204-g001.jpg

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