Background Galcanezumab is a novel monoclonal antibody that target to calcitonin gene-related peptide (CGRP). It has been tested for the preventive treatment of migraine and episodic cluster headache by multiple randomized clinical trials (RCTs) and have been found to reduce headache frequency. Methods We systematically searched PubMed and Embase on Cochrane Central Register of Controlled Trials (CENTRAL) from the earliest date to August 1, 2019. Relative risk (RR) and weighted mean difference (WMD) were used to evaluate clinical outcomes. Results Seven studies were pooled with 3889 patients. Subcutaneous injection of Galcanezumab at 120 mg, 240 mg leads to a statistically significant response rate for the treatment of migraine compared with placebo (120 mg: RR = 1.51; 95% CI, 1.33 to 1.70; P < 0.001; 240 mg: RR = 1.58; 95% CI, 1.43 to 1.76; P < 0.001). Among them, 120 mg group has the same treatment efficacy with 240 mg group (50% response: RR = 1.06; 95% CI, 0.92 to 1.22; P = 0.425; 75% response: RR = 1.07; 95% CI, 0.94 to 1.23; P = 0.301; 100% response; RR = 1.06; 95% CI, 0.81 to 1.37; P = 0.682; MHD: RR = − 0.08; 95% CI, − 0.55 to − 0.40; P = 0.748) while related to a lower risk for adverse events for the treatment of migraine (120 mg RR = 1.06; 95% CI, 0.99 to 1.14; P = 0.084; 240 mg: RR = 1.17; 95% CI, 1.09 to 1.25; P < 0.001). 300 mg per month galcanezumab is effective for the prevention of episodic cluster headache measured by at least 50% reduction of cluster headache frequency at week 3 (RR = 1.36; 95% CI, 1.00–1.84; P = 0.048). Conclusions Use of galcanezumab is related to a significantly reduced monthly headache frequency compared with placebo for the treatment of migraine and episodic cluster headache, 120 mg has the same treatment efficacy with 240 mg group while related to a lower risk for adverse effects for the treatment of migraine. 300 mg per month galcanezumab is effective for the prevention of episodic cluster headache with no significantly increased adverse events.

中文翻译：

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偏头痛和丛集性头痛患者不同剂量的 galcanezumab 与安慰剂：随机对照试验的荟萃分析

背景 Galcanezumab 是一种新型单克隆抗体，靶向降钙素基因相关肽 (CGRP)。多项随机临床试验 (RCT) 已对其预防性治疗偏头痛和发作性丛集性头痛进行了测试，并发现其可降低头痛频率。方法 我们系统地检索了最早至 2019 年 8 月 1 日的 PubMed 和 Embase on Cochrane Central Register of Controlled Trials (CENTRAL)。使用相对风险 (RR) 和加权平均差 (WMD) 来评估临床结果。结果 7 项研究共纳入 3889 名患者。与安慰剂相比，皮下注射 120 毫克、240 毫克的 Galcanezumab 导致偏头痛治疗的显着缓解率（120 毫克：RR = 1.51；95% CI，1.33 至 1.70；P < 0.001；240 毫克：RR = 1.58；95% CI，1.43 至 1.76；P < 0.001)。其中，120mg组与240mg组疗效相同（50%反应：RR=1.06；95%CI，0.92～1.22；P=0.425；75%反应：RR=1.07；95%CI，0.94～ 1.23；P = 0.301；100% 反应；RR = 1.06；95% CI，0.81 至 1.37；P = 0.682；MHD：RR = - 0.08；95% CI，- 0.55 至 - 0.40；48) 与 0.7 相关偏头痛治疗的不良事件风险较低（120 mg RR = 1.06；95% CI，0.99 至 1.14；P = 0.084；240 mg：RR = 1.17；95% CI，1.09 至 1.25；P < 0.001）。每月 300 毫克 galcanezumab 可有效预防发作性丛集性头痛，测量结果为第 3 周丛集性头痛频率降低至少 50%（RR = 1.36；95% CI，1.00–1.84；P = 0.048）。结论 与安慰剂相比，使用 galcanezumab 与治疗偏头痛和发作性丛集性头痛的每月头痛频率显着降低有关，120 mg 与 240 mg 组的治疗效果相同，但与治疗偏头痛的不良反应风险较低有关。偏头痛。每月 300 毫克 galcanezumab 可有效预防发作性丛集性头痛，且不良事件没有显着增加。