阿托吉泮预防性治疗偏头痛有效性和安全性的Meta分析  

Efficacy and safety of atogepant in prophylactic treatment of migraine:a Meta-analysis

作　　者：佘浪 蔡俊龙 汤丽芝 史志华 SHE Lang;CAI Junlong;TANG Lizhi;SHI Zhihua(Department of Pharmacy,Hunan University of Medicine General Hospital,Huaihua 418000,Hunan Province,China)

机构地区：[1]湖南医药学院总医院药学部,湖南怀化418000

出　　处：《医学新知》2024年第10期1151-1160,共10页New Medicine

基　　金：湖南省教育厅科研基金(23B1051)。

摘　　要：目的系统评价阿托吉泮预防性治疗偏头痛患者的有效性和安全性。方法系统检索PubMed、Embase、Cochrane Library、CNKI、维普、万方和中国生物医学数据库,收集阿托吉泮治疗偏头痛患者的随机对照试验,试验组给予阿托吉泮,对照组给予安慰剂,检索时限均为建库至2024年4月。由2名研究者独立筛选文献、提取资料并评估纳入研究的偏倚风险,采用RevMan 5.3软件进行Meta分析。结果共纳入5项RCT,包含患者3552例。Meta分析结果显示,有效性方面,阿托吉泮组偏头痛患者平均每月偏头痛天数[SMD=-0.40,95%CI(-0.48,-0.31)]、平均每月头痛天数[SMD=-0.40,95%CI(-0.48,-0.31)]、平均每月急性药物使用天数[SMD=-0.45,95%CI(-0.53,-0.36)]均显著低于安慰剂组;而平均每月偏头痛天数较基线减少50%的患者数[RR=1.83,95%CI(1.40,2.38)]显著高于安慰剂组;安全性方面,两组患者总不良反应发生率[RR=1.02,95%CI(0.88,1.20)]、严重不良反应发生率[RR=1.33,95%CI(0.75,2.33)]的差异均无统计学意义(P>0.05)。结论阿托吉泮预防性治疗偏头痛患者时具有良好的疗效和安全性,受纳入研究数量和质量的限制,上述结论尚需开展更多高质量的研究予以验证。Objective To evaluate the efficacy and safety of atogepant in the prophylactic treatment of migraine.Methods The randomized controlled trials(RCTs)of atogepant in the prophylactic treatment of migraine were collected by searching PubMed,Embase,Cochrane Library,CNKI,VIP,WanFang and the SinoMed database.The experimental group was given atogepant,and the control group was given the placebo.The search time was from the inception to April 2024.Two researchers independently screened the literature,extracted data,and assessed the risk of bias of the included studies.Meta-analysis was performed using RevMan 5.3 software.Results 3,552 patients in a total of 5 RCTs were included.The results of the Meta-analysis showed that compared with placebo,atogepant significantly reduced monthly migraine days[SMD=-0.40,95%CI(-0.48,-0.31)],monthly headache days[SMD=-0.40,95%CI(-0.48,-0.31)],and acute medication use days[SMD=-0.45,95%CI(-0.53,-0.36)],however,atogepant significantly increased the number of patients with≥50%reduction in monthly migraine days[RR=1.83,95%CI(1.40,2.38)].For safety,the total incidence of adverse reactions[RR=1.02,95%CI(0.88,1.20)],and the incidence of serious adverse reactions[RR=1.33,95%CI(0.75,2.33)]between two groups were not statistically significant(P>0.05).Conclusions Atogepant has shown good efficacy and safety in the prophylactic treatment of migraine patients.The above conclusions are limited by the quantity and quality of included studies and need to be verified by more high-quality research.

关 键 词：CGRP抑制剂 阿托吉泮 偏头痛 META分析 有效性 安全性 

分 类 号：R979.9[医药卫生—药品]