依达拉奉用于肌萎缩侧索硬化症有效性与安全性的Meta分析

doi:10.19803/j.1672-8629.2019.12.05

摘要/Abstract

摘要： 目的系统评价依达拉奉用于肌萎缩侧索硬化患者的有效性和安全性。方法检索PubMed、Cochrane library、CNKI、万方电子数据库,同时进行手工检索,收集国内外1994年1月至2017年12月公开发表的关于依达拉奉用于治疗肌萎缩侧索硬化的随机对照研究。依据纳入和排除标准筛选文献,对纳入文献进行质量评估,并采用RevMan 5.3软件统计学分析。结果共纳入6个研究（共609例）。Meta分析结果表明,依达拉奉与对照组相比,可改善患者肌萎缩侧索硬化功能等级评分(SMD=0.80,95%CI：0.62~0.98,P <0.00001),但不能减少患者死亡率(RR=0.73,95%CI：0.36~1.46,P =0.37)。与对照组相比,依达拉奉不增加不良反应的发生率(RR=0.91,95%CI：0.70~1.19,P =0.10)。结论依达拉奉有较好的安全性,虽不能减少死亡率的发生,但能够改善ALS患者功能。

关键词: 依达拉奉, 肌萎缩侧索硬化, 肌萎缩侧索硬化功能等级评分, Meta分析

Abstract: Objective To explore the efficacy and safety of edaravone used among patients with amyotrophic lateral sclerosis (ALS). Methods PubMed, Cochrane library, CNKI and Wanfang electronic databases were searched manually. Randomized controlled trials which involved edaravone in the treatment of ALS and published between January 1994 and December 2017 were collected. Citations were extracted according to the predefined inclusion criteria, and the quality of included studies was assessed based on the Cochrane Collaboration’s tool for assessing the risk of bias. RevMan 5.3 software was used for statistical analysis. Results A total of five studies (609 cases) were included. Meta-analysis showed that edaravone significantly improved the revised ALS functional rating score (SMD=0.80, 95%CI: 0.62~0.98, P < 0.00001), but did not reduce mortality (RR=0.73, 95%CI: 0.36~1.46, P =0.37) compared with the control group. The incidence of adverse events in the edaravone group was not significantly different from that of the control group (RR=0.91, 95%CI: 0.70~1.19, P =0.10). Conclusion Edaravone has good safety profiles. Despite its inabiity to reduce the mortality of ALS, it can ameliorate the function of ALS patients.

Key words: edaravone, amyotrophic lateral sclerosis, revised amyotrophic lateral sclerosis functional rating score, Meta-analysis

中图分类号:

R994.11

卫红涛, 李丹丹, 吴汀溪, 程晟. 依达拉奉用于肌萎缩侧索硬化症有效性与安全性的Meta分析[J]. 中国药物警戒, 2019, 16(12): 727-733.

WEI Hongtao, LI Dandan, WU Tingxi, CHENG Sheng. Meta-analysis of Efficacy and Safety of Edaravone for Amyotrophic Lateral Sclerosis[J]. Chinese Journal of Pharmacovigilance, 2019, 16(12): 727-733.

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