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加卡尼单抗预防性治疗偏头痛的疗效与安全性:一项系统评价和荟萃分析

Efficacy and safety of galcanezumab for preventive treatment of migraine: a systematic review and meta-analysis.

作者信息

Zhao Xiuyuan, Xu Xiaolin, Li Qingyun

机构信息

Tianjin Medical University, Tianjin, China.

Neurology, Tianjin Huanhu Hospital, Tianjin, China.

出版信息

J Neurol. 2021 Jul;268(7):2364-2376. doi: 10.1007/s00415-020-09707-5. Epub 2020 Jan 31.

Abstract

OBJECTIVE

This meta-analysis aimed to systematically evaluate the effectiveness and safety of galcanezumab in the prophylactic treatment of adult migraine.

METHODS

A systematic literature search was performed to identity randomized-controlled trials (RCTs). The primary outcome was the decline in the number of monthly migraine days (MMDs). Secondary outcomes included the reduction of monthly acute migraine‑specific medication days (MSMDs), the number of participants showing a reduction in MMDs from baseline of ≥ 50%, ≥ 75%, and 100%, the incidence of adverse events (AEs), and the number of participants developing anti-drug antibodies (ADAs) to galcanezumab. We calculated the mean difference (MD), relative risk (RR), and 95% confidence intervals (CIs) for these outcomes.

RESULTS

Among the five included trials, galcanezumab given at doses of 120, 150, 240, and 300 mg was superior to placebo for both MMDs and secondary outcomes. The degree of AEs in all group was mild. Notably, no significant differences were found in the occurrence of AEs and ADAs between the galcanezumab and placebo groups.

CONCLUSION

Galcanezumab is a safe and effective treatment for adult patients with episodic and chronic migraine.

摘要

目的

本荟萃分析旨在系统评价加卡尼单抗预防性治疗成人偏头痛的有效性和安全性。

方法

进行系统文献检索以确定随机对照试验(RCT)。主要结局是每月偏头痛天数(MMD)的减少。次要结局包括每月急性偏头痛特异性药物治疗天数(MSMD)的减少、MMD从基线减少≥50%、≥75%和100%的参与者数量、不良事件(AE)的发生率以及产生加卡尼单抗抗药物抗体(ADA)的参与者数量。我们计算了这些结局的平均差(MD)、相对风险(RR)和95%置信区间(CI)。

结果

在纳入的五项试验中,剂量为120、150、240和300mg的加卡尼单抗在MMD和次要结局方面均优于安慰剂。所有组的AE程度均为轻度。值得注意的是,加卡尼单抗组和安慰剂组在AE和ADA的发生方面未发现显著差异。

结论

加卡尼单抗是治疗发作性和慢性偏头痛成年患者的一种安全有效的疗法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d72/8217057/cab1232d815b/415_2020_9707_Fig1_HTML.jpg

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