刘多,颜因.Rimegepant治疗急性期偏头痛的Meta分析与GRADE评价[J].四川精神卫生杂志,2021,(4):349-357.
Rimegepant治疗急性期偏头痛的Meta分析与GRADE评价
Meta-analysis and GRADE evidence profile of Rimegepant in the treatment of acute migraine
投稿时间:2021-01-29  
DOI:10.11886/scjsws20210129003
中文关键词:  Rimegepant  急性期偏头痛  有效性  Meta分析  GRADE评价
英文关键词:Rimegepant  Acute migraine  Efficacy  Meta-analysis  GRADE evidence profile
基金项目:
作者单位邮编
刘多 重庆市第九人民医院重庆 400700 400700
颜因 重庆市急救医疗中心重庆 400014 400014
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中文摘要:
      目的 系统评价Rimegepant治疗急性期偏头痛的效果和安全性。方法 计算机检索中国知网、万方、维普数据库、PubMed、Embase、Cochrane Library、ClinicalTrials,收集有关Rimegepant治疗急性期偏头痛的相关文献。以用药后2 h无痛和无最烦人症状(MBS)为主要结局指标,以用药后2 h疼痛缓解等11项指标为次要结局指标,采用RevMan 5.3进行Meta分析,采用GRADE profiler 3.6对结局指标进行证据质量评价。结果 共纳入4项随机对照研究,包括3 827例患者,其中试验组1 840例,对照组1 987例。Meta分析结果显示,在有效性方面,与对照组相比,Rimegepant组用药后2 h无痛(RR=1.67,95% CI:1.44~1.94,P<0.01)、用药后2 h无MBS(RR=1.37,95% CI:1.24~1.51,P<0.01)、用药后2 h疼痛缓解(RR=1.33,95% CI:1.25~1.41,P<0.01)、用药后疼痛缓解持续2~24 h(RR=1.59,95% CI:1.46~1.74,P<0.01)、疼痛缓解持续2~48 h(RR=1.57,95% CI:1.42~1.74,P<0.01)、用药后无痛持续2~24 h(RR=2.27,95% CI:1.62~3.20,P<0.01)、无痛持续2~48 h(RR=2.14,95% CI:1.52~3.02,P<0.01)、用药后2 h无畏光(RR=1.47,95% CI:1.32~1.64,P<0.01)及无恐声(RR=1.40,95% CI:1.19~1.64,P<0.01)的患者比例更高,差异均有统计学意义。在安全性方面,Rimegepant组和对照组出现恶心(RR=1.70,95% CI:0.95~3.02,P=0.07)、尿路感染(RR=1.81,95% CI:0.84~3.91,P=0.13)、头晕(RR=1.14,95% CI:0.49~2.63,P=0.77)以及转氨酶升高(RR=0.76,95% CI:0.45~1.27,P=0.29)的患者比例差异均无统计学意义。GRADE证据质量评价显示,各研究结局指标均为高级或中级证据质量。结论 Rimegepant对急性期偏头痛的效果较好,且毒副反应可耐受。
英文摘要:
      Objective To systematically evaluate the efficacy and safety of Rimegepant in the treatment of acute migraine.Methods The databases of CNKI, Wanfang and VIP database, PubMed, Embase, Cochrane Library, ClinicalTrials were searched to collect relevant literature on the treatment of Rimegepant in acute migraine. The pain freedom and Most Bothersome Symptom (MBS) freedom 2 hours after medication were the primary outcome indicators, and the other 11 indicators including pain relief 2 hours after medication were the secondary outcome indicators. The Meta-analysis was performed using RevMan 5.3, and the quality of evidence was evaluated using GRADE Profiler 3.6 for outcome indicators.Results A total of 4 randomized controlled studies involving 3 827 patients, including 1 840 patients in the experimental group and 1 987 patients in the control group. Meta-analysis results showed that, in terms of effectiveness, compared with the control group, the proportion of patients in the Rimegepant group who were painless 2 hours after medication (RR=1.67, 95 % CI 1.44~1.94, P<0.01), MBS free 2 hours after medication (RR=1.37, 95% CI 1.24~1.51, P<0.01) and pain relief (RR=1.33, 95% CI 1.25~1.41, P<0.01), pain relief lasting 2~24 hours after medication (RR=1.59, 95% CI 1.46~1.74, P<0.01), pain relief lasting 2~48 hours after medication (RR=1.57, 95% CI 1.42~1.74, P<0.01), painless 2~24 hours after medication (RR=2.27, 95% CI 1.62~3.20, P<0.01), painless 2~48 hours after medication (RR=2.14, 95% CI 1.52~3.02, P<0.01), and no fear of light (RR=1.47, 95% CI 1.32~1.64, P<0.01) and no fear of sound 2 hours after medication (RR=1.40, 95% CI 1.19~1.64, P<0.01) was higher, the differences were statistically significant. In terms of safety, the proportion of patients with nausea (RR=1.70, 95% CI 0.95~3.02, P=0.07), urinary tract infection (RR=1.81, 95% CI 0.84~3.91, P=0.13), dizziness (RR=1.14, 95% CI 0.49~2.63, P=0.77) or elevated transaminase (RR=0.76, 95% CI 0.45~1.27, P=0.29) showed no statistically significant differences between the Rimegepant group and the control group. Based on GRADE criteria, evidence for Rimegepant in the treatment of acute migraine was of high or moderate quality.Conclusion Rimegepant is effective for acute migraine, and the toxic effects are tolerable.
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