Ubrogepant和Rimegepant治疗急性期偏头痛疗效与安全性的Meta分析

Efficacy and Safety of Ubrogepant and Rimegepant in the Treatment of Acute Migraine:A Meta-analysis

目的:系统评价Ubrogepant和Rimegepant治疗急性期偏头痛的疗效和安全性,旨在为临床用药提供循证参考。方法:计算机检索PubMed、Embase、Cochrane图书馆、中国知网、维普网、万方数据及临床试验注册网站等,检索时限均为建库起至2020年1月,收集Ubrogepant和Rimegepant(试验组)对比安慰剂(对照组)治疗急性期偏头痛的随机对照试验(RCT)。筛选文献、提取资料后,采用Cochrane系统评价员手册5.1.0提供的偏倚风险评估工具评价文献质量,采用Stata 16.0软件进行Meta分析。结果:共纳入8项RCT,共计7989例患者。Meta分析结果显示,Ubrogepant组[RR=1.65,95%CI(1.38,1.98),P<0.001]、Rimegepant组[RR=1.69,95%CI(1.46,1.95),P<0.001]服药后2 h无痛患者比例,Ubrogepant组[RR=1.35,95%CI(1.20,1.53),P<0.001]、Rimegepant组[RR=1.37,95%CI(1.24,1.51),P<0.001]服药后2 h无最烦人症状患者比例及其他次要结局指标(服药后2 h内疼痛缓解患者比例、服药后2~24 h持续无痛患者比例、服药后2~24 h持续疼痛缓解患者比例、服药后2 h无畏光患者比例、服药后2 h无恐声患者比例、服药后2 h无恶心患者比例)均显著优于对照组(P<0.05)。安全性方面,Ubrogepant组患者总不良反应发生率与对照组比较,差异无统计学意义[RR=1.04,95%CI(0.87,1.25),P=0.646],Rimegepant组患者总不良反应发生率显著高于对照组[RR=1.23,95%CI(1.01,1.50),P=0.043];两组患者其他安全性指标(恶心、头晕、口干、嗜睡、尿路感染发生率)与对照组比较,差异均无统计学意义(P>0.05)。结论:Ubrogepant和Rimegepant治疗急性期偏头痛的疗效显著;Ubrogepant的安全性较高,而Rimegepant可能会增加不良反应的发生。

OBJECTIVE:To systematically evaluate the efficacy and safety of Ubrogepant and Rimegepant in the treatment of acute migraine,and to provide evidence-based reference for the clinical treatment.METHODS:Retrieved from PubMed,Embase,Cochrane Library,CNKI,VIP,Wanfang database and Clinicaltrials.gov,randomized controlled trials(RCTs)about the Ubrogepant and Rimegepant(trial group)versus placebo(control group)in the treatment of acute migraine were collected during the inception to Jan.2020.After literature screening and data extraction,quality assessment was performed using the bias risk assessment tool provided by the Cochrane system evaluator manual 5.1.0.Meta-analysis was performed by using Stata 16.0 software.RESULTS:Eight RCTs with a total of 7989 patients were included.The results of Meta-analysis showed that the proportion of patients who were free from pain at 2 h postdose in Ubrogepant group[RR=1.65,95%CI(1.38,1.98),P<0.001]and Rimegepant group[RR=1.69,95%CI(1.46,1.95),P<0.001],the proportion of patients who were free from the most bothersome symptom at 2 h postdose in Ubrogepant group[RR=1.35,95%CI(1.20,1.53),P<0.001]and Rimegepant group[RR=1.37,95%CI(1.24,1.51),P<0.001],and other secondary outcome indicators(i.e.the proportion of patients with pain relief at 2 h postdose,the proportion of patients with sustained freedom from pain from 2-24 h postdose,the proportion of patients with sustained pain relief from 2-24 h postdose,the proportion of patients without photophobia at 2 h postdose,the proportion of patients without phonophobia at 2 h postdose,the proportion of patients without nausea at 2 h postdose)were all significantly better than control group(P<0.05).In terms of safety,there was no statistical significance in the incidence of total ADR between Ubrogepant group and control group[RR=1.04,95%CI(0.87,1.25),P=0.646],but the incidence of total ADR in Rimegepant group were significantly higher than control group[RR=1.23,95%CI(1.01,1.50),P=0.043].There was no statistical significance in other security indicators(i.e.incidence of nausea,dizziness,dry mouth,somnolence,urinary tract infection)in 2 groups(P>0.05).CONCLUSIONS:Ubrogepant and Rimegepant are effective in the treatment of acute migraine.Ubrogepant is safe,while Rimegepant may increase the incidence of ADR.