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Bayesian network Meta-analysis was performed by using GeMTC 0.14.3 software and Stata 16.0 software. RESULTS：A total of 19
RCTs involving 11 392 patients were included，involving 10 interventions，such as Erenumab 70，140 mg/month；Fremanezumab
675 mg/3 months，225 mg/month；Galcanezumab 120，240，300 mg/month；Eptinezumab 100 mg/3 months，300 mg/3 months
and placebo. Results of Meta-analysis showed that compared with control group，4 kinds of CGRP monoclonal antibodies
significantly reduced the change of mean monthly migraine days （MMD）（P＜0.05）. Among trial groups，compared with
Galcanezumab 300 mg/month [MD＝－1.30，95％CI（－2.59，－0.05），P＜0.05] and Eptinezumab 100 mg/3 months [MD＝－1.18，
95％ CI（－ 2.26，－ 0.03），P＜0.05]，Fremanezumab 225 mg/month could significantly reduce MMD. Network Meta-analysis
ranking showed that Fremanezumab 225 mg/month＞Fremanezumab 675 mg/3 months＞Galcanezumab 120 mg/month＞Erenumab
140 mg/month＞Galcanezumab 240 mg/month＞Eptinezumab 300 mg/3 months＞Erenumab 70 mg/month＞Eptinezumab 100 mg/3
months＞Galcanezumab 300 mg/month＞placebo. Compared with control group，4 kinds of CGRP monoclonal antibodies were
significantly increased of the proportion of patients whose mean monthly migraine days reduction≥50％ compared with baseline
（MMD 50）（P＜0.05）. Among trial groups，compared with Eptinezumab 100 mg/3 months group，MMD 50 of Fremanezumab
675 mg/3 months group [OR＝1.51，95％CI（1.02，2.31），P＜0.05]，Fremanezumab 225 mg/month group [OR＝1.58，95％CI
（1.05，2.44），P＜0.05] were increased significantly. Network Meta-analysis ranking showed that Fremanezumab 225 mg/month＞
Fremanezumab 675 mg/3 months＞Erenumab 140 mg/month＞Galcanezumab 120 mg/month＞Eptinezumab 300 mg/3 months＞
Galcanezumab 240 mg/month＞Erenumab 70 mg/month＞Galcanezumab 300 mg/month＞Eptinezumab 100 mg/3 months＞placebo.
In terms of safety，incidence of total adverse events（AE）of trial groups receiving Fremanezumab 675 mg/3 months [OR＝1.31，
95％ CI（1.05，1.64），P＜0.05]，Galcanezumab 240 mg/month [OR＝1.39，95％ CI（1.09，1.74），P＜0.05] were significantly
higher than control group. Among trial groups，compared with Galcanezumab 240 mg/month group，AE of Erenumab 70 mg/month
group [OR＝0.67，95％CI（0.50，0.93），P＜0.05]，Erenumab 140 mg/month group [OR＝0.70，95％CI（0.51，0.98），P＜0.05]
were decreased significantly. Compared with Fremanezumab 675 mg/3 months group，AE of Erenumab 70 mg/month group [OR＝
0.72，95％CI（0.52，0.98），P＜0.05] were decreased significantly. Network Meta-analysis ranking showed that Galcanezumab 240
mg/month＞ Fremanezumab 675 mg/3 months＞Galcanezumab 120 mg/month＞Galcanezumab 300 mg/month＞Eptinezumab 300
mg/3 months＞Fremanezumab 225 mg/month＞Eptinezumab 100 mg/3 months＞placebo＞Erenumab 140 mg/month＞Erenumab 70
mg/month. CONCLUSIONS：Four kinds of CGRP monoclonal antibodies are effective in the preventive treatment of migraine，
among which Fremanezumab 225 mg/month is most likely to have the best efficacy and Erenumab 70 mg/month is most likely to
have the highest safety.
KEYWORDS Calcitonin gene-related peptide monoclonal antibodies； Preventive treatment；Migraine； Bayesian network
Meta-analysis；Efficacy；Safety

偏头痛是一种以反复发作的偏侧搏动性头痛为特 （以下简称“Ep”）均已获得美国FDA批准上市，上述药物
征的原发性、致残性神经系统疾病，其在世界范围内的 可通过皮下或静脉注射用于偏头痛的预防性治疗 [2，6] 。此
发病率约为 14.7％，在我国的发病率约为 9.3％，且女性 外，Er 和 Ga 也已获得国家药品监督管理局临床试验默
显著高于男性 [1-3] 。偏头痛的治疗主要分为急性期治疗 示许可，正在国内进行临床试验 。
[7]
和预防性治疗，其中预防性治疗的目的是降低偏头痛发
虽然有研究对 CGRP 单克隆抗体对比安慰剂用于
作的频率、严重程度，缩短持续时间 [1，4] 。目前，临床上用
预防性治疗偏头痛的疗效和安全性进行了 Meta 分析，
于预防性治疗偏头痛的药物主要有β受体阻滞药（如普
但这些研究仅为单用CGRP单克隆抗体 [4-5，8] ，未对上述4
萘洛尔、美托洛尔）、抗癫痫药（如丙戊酸、托吡酯）、钙离
种CGRP单克隆抗体的疗效和安全性进行比较，哪种剂
子通道阻滞药（如氟桂利嗪）和三环类抗抑郁药（如阿米
量的 CGRP 单克隆抗体疗效更佳、安全性更高尚未明
[4]
替林）等 。但由于这些药物的特异性不高且不良反应
确。贝叶斯网状Meta分析是基于贝叶斯定理的一种统
较多而致患者的用药依从性较差，因此临床迫切需要一
种安全有效的偏头痛新疗法 [4-5] 。 计学方法，可采用直接或间接比较的方法实现同时对 3
[9]
近年来，靶向拮抗降钙素基因相关肽（CGRP）通路 种及以上干预措施的比较并进行排序 。为此，本研究
已经成为偏头痛治疗药物研发的热点，而CGRP单克隆 采用贝叶斯网状 Meta 分析的方法系统评价了 Er、Fr、
[2]
抗体也成为了预防性治疗偏头痛的新选择 。截至2020 Ga、Ep等4种CGRP单克隆抗体预防性治疗偏头痛的疗
年3月，Erenumab（以下简称“Er”）、Fremanezumab（以下 效和安全性的差异，以期为其在国内上市及临床治疗提
简称“Fr”）、Galcanezumab（以下简称“Ga”）和Eptinezumab 供循证医学证据。

·2276 · China Pharmacy 2020 Vol. 31 No. 18 中国药房 2020年第31卷第18期