特立氟胺治疗多发性硬化的有效性及安全性的Meta分析

Efficacy and safety of teriflunomide in multiple sclerosis: a meta-analysis

目的评价特立氟胺治疗多发性硬化的有效性及安全性。方法通过检索Pubmed、EMbase、Web of Science、Cochrane图书馆、万方、中国知网等电子数据库获取文献,收集关于特立氟胺治疗多发性硬化的所有文献,检索时间为2019年7月截止。使用检索关键词"多发性硬化"、"特立氟胺"、"multiple sclerosis"、"MS""Teriflunomide"进行检索。由两名研究者严格按照纳入与排除标准独立检索以及提取数据。使用RevMan 5. 3软件对提取资料进行统计分析。结果共8篇文献、2875名患者纳入研究。特立氟胺7 mg(RR=0. 69,95%CI 0. 56~0. 85,P=0. 0007)和特立氟胺14 mg(RR=0. 67,95%CI 0. 54~0. 84,P=0. 0004)在降低疾病复发率方面均优于安慰剂组。在安全性方面,接受特立氟胺的受试者发生任何不良反应的风险与接受安慰剂的受试者相似[特立氟胺7 mg(RR=1. 00,95%CI0. 97~1. 03,P=0. 94);特立氟胺14 mg(RR=1. 03,95%CI 0. 99~1. 06,P=0. 12)]。接受特立氟胺的受试者发生严重不良反应的风险与接受安慰剂的受试者相似[特立氟胺7 mg(RR=1. 03,95%CI 0. 84~1. 25,P=0. 81);特立氟胺14mg(RR=1. 13,95%CI 0. 92~1. 38,P=0. 24)]。然而,两种剂量的特立氟胺均增加了因不良反应导致研究药物停用的风险[特立氟胺7 mg(RR=1. 35,95%CI 1. 06~1. 71,P=0. 02);特立氟胺14 mg(RR=1. 51,95%CI 1. 01~2. 26,P=0. 04)]。结论特立氟胺与安慰剂相比在有效性方面更占有优势,且其安全性与安慰剂相似。

Objective To evaluate the efficacy and safety of Teriflunomide in the treatment of multiple sclerosis through systematic review. Methods The databases including Pub Med,EMbase,Web of Science,Cochrane Library,Wanfang and CNKI were retrieved. The studies published up to July 2019 were collected. We use the keywords: multiple sclerosis or MS and the drug name: Teriflunomide to search. Two authors independently selected the articles and extracted the data with inclusion and exclusion criteria. RevMan 5. 3 software was used to conduct statistical analysis. Results Eight papers with a total of 2875 patients were selected. Teriflunomide 7 mg( RR = 0. 69,95% CI 0. 56 ~ 0. 85,P = 0. 0007) and teriflunomide 14 mg( RR = 0. 67,95% CI 0. 54 ~ 0. 84,P = 0. 0004) were better than placebo in reducing the annualized relapse rate. In terms of safety,the risk of any adverse reactions in subjects receiving teriflunomide was similar to that in subjects receiving placebo[Teriflunomide 7 mg( RR = 1. 00,95% CI 0. 97 ~ 1. 03,P = 0. 9). Teriflunomide 14 mg( RR =1. 03,95% CI 0. 99 ~ 1. 06,P = 0. 12)]. There was no significant difference in the occurrence rates of serious adverse events[Teriflunomide 7 mg( RR = 1. 03,95% CI 0. 84 ~ 1. 25,P = 0. 81). Teriflunomide 14 mg( RR = 1. 13,95% CI 0. 92 ~1. 38,P = 0. 24)]. However,both doses of teriflunomide increased the risk of discontinuation of studies due to adverse reactions[Teriflunomide 7 mg( RR = 1. 35,95% CI 1. 06 ~ 1. 71,P = 0. 02). Teriflunomide 14 mg( RR = 1. 51,95% CI 1. 01 ~2. 26,P = 0. 04)]. Conclusion Teriflunomide significantly reduces annualized relapse rates and disability progression with a similar safety profile to placebo.