Meta-analysis of Efficacy and Safety of Edaravone for Amyotrophic Lateral Sclerosis

doi:10.19803/j.1672-8629.2019.12.05

Abstract

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

CLC Number:

R994.11

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.

References

[1] 中华医学会神经病学分会肌电图及临床神经电生理学组,中华医学会神经病学分会神经肌肉病学组.中国肌萎缩侧索硬化诊断和治疗指南[J].中华神经科杂志, 2012, 45(7):531-533.
[2] Hardiman O, van den Berg LH, Kiernan MC. Clinical diagnosis and management of amyotrophic lateral sclerosis[J].Nat Rev Neurol, 2011,7(11):639-649.
[3] Cronin S, Hardiman O, Traynor BJ.Ethnic variation in the incidence of ALS: a systematic review[J]. Neurology, 2007,68(13):1002-1007.
[4] 李海亮,李游嘉,杜潇洒,等.利鲁唑药理学作用研究进展[J].中国药学杂志, 2015(14):1165-1168.
[5] 邹漳钰. 肌萎缩侧索硬化的遗传学和基础研究[D].北京协和医学院中国医学科学院,北京协和医学院,中国医学科学院,清华大学医学部,2013.
[6] Koji A, Yasuto I, Gen S, et al.Confirmatory double-blind,parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients[J]. Amyotroph Lat Scl Fr, 2014(15):610-617.
[7] THE WRITING GROUP ON BEHALF OF THE EDARAVONE(MCI-186) ALS 18 STUDY GROUP. Exploratory double-blind, parallel-group, placebo controlled study of edaravone(MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assistance for eating, excretion or ambulation)[J]. Amyotroph Lat Scl Fr,2017(18):40-止页.
[8] Koji T, Fumihiro T, Shawn L, et al.Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis[J]. Amyotroph Lat Scl Fr, 2017(18):55-63.
[9] THE WRITING GROUP ON BEHALF OF THE EDARAVONE(MCI-186) ALS 19 STUDY GROUP. Safety and efcacy of edaravone in well defned patients with amyotrophic lateral sclerosis: a randomised,double-blind, placebo-controlled trial ALS 19 STUDY GROUP. Safety and efcacy of edaravone in well defned patients with amyotrophic lateral sclerosis: a randomised,double-blind, placebo-controlled trial[J]. Lancet Neurol, 2017 (16):505-512.
[10] THE WRITING GROUP ON BEHALF OF THE EDARAVONE(MCI-186) ALS 17 STUDY GROUP. Exploratory double-blind, parallel-group, placebo controlled extension study of edaravone (MCI-186)in amyotrophic lateral sclerosis ALS 17 STUDY GROUP. Exploratory double-blind, parallel-group, placebo controlled extension study of edaravone (MCI-186)in amyotrophic lateral sclerosis[J].Amyotroph Lat Scl Fr, 2017,18(9):20-31.
[11] 张远锦,张俊,张楠,等.新型自由基清除剂依达拉奉治疗肌萎缩侧索硬化的随机开放临床试验[J].中国现代神经疾病杂志,2007(2):161-164.
[12] 严济春,李婷,刘国胜,等.依达拉奉对肌萎缩侧索硬化的疗效探讨[J].中国医学创新, 2013 (18):129-130.
[13] 王继明,周顺林,陈金亮,等.肌萎缩侧索硬化症临床常用4种评分方法的一致性与协同效应[J].中国临床康复,2005,9(29):24-26.
[14] Cedarbaum JM, Stambler N, Malta E, et al.The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group(Phase Ⅲ)[J]. J Neurol Sci, 1999(169):13-21.
[15] Miano B, Stoddard GJ, Davis S, et al.Inter-evaluator reliability of the ALS Functional Rating Scale[J]. Amyotroph Lateral Sc, 2004,5(4):235-239.
[16] 卢苗,王迎新,宋春莉,等.肌萎缩侧索硬化患者肌电图与ALS-FRS-R的研究[J].脑与神经疾病杂志, 2015, 23(4): 289-291.
[17] Fumihiro T, Koji T, Kikumi T.Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory doubleblind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis[J]. Amyotroph Lat Scl Fr, 2017, (18):32-39.
[18] Petrov D, Mansfield C, Moussy A, et al.ALS clinical trials review: 20 years of failure. are we any closer to registering a new treatment?[J]. Front Aging Neurosci, 2017, 9(68):1-11.
[19] Alexander K, Elvia MP, Kaoru I, et al.A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the doubleblind period in three randomized, placebocontrolled studies[J]. Amyotroph Lat Scl Fr, 2017, (18):71-79.