Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.
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DOI：
10.3109/21678421.2014.959024
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发表时间：
2014-12
影响因子：
2.8
通讯作者：
Edaravone ALS Study Group
中科院分区：
文献类型：
--
作者：
Abe K;Itoyama Y;Sobue G;Tsuji S;Aoki M;Doyu M;Hamada C;Kondo K;Yoneoka T;Akimoto M;Yoshino H;Edaravone ALS Study Group
我们的目的是证实依达拉奉治疗肌萎缩侧索硬化症（ALS）患者的疗效和安全性。我们进行了一项为期36周的验证性研究，包括12周的预观察期和随后的24周治疗期。患者在第1周期的前14天接受安慰剂或依达拉奉静脉输注60分钟以上，在第2 - 6周期的前14天中接受10天。在24周治疗期间，疗效主要终点在修订的ALS功能评定量表（ALSFRS-R）评分中发生变化。患者接受安慰剂（n = 104）和依达拉奉（n = 102）治疗。24周治疗期间，安慰剂组（n = 99）和依达拉奉组（n = 100）的ALSFRS-R变化分别为−6.35 ± 0.84和−5.70 ± 0.85，差异为0.65 ± 0.78（p = 0.411）。安慰剂组不良事件发生率为88.5%（92/104），依达拉奉组为89.2%（91/102）。总之，依达拉奉组ALSFRS-R的降低幅度小于安慰剂组，但依达拉奉治疗ALS的疗效未得到证实。两组报告的不良事件的水平和频率相似。
Our objective was to confirm the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients. We conducted a 36-week confirmatory study, consisting of 12-week pre-observation period followed by 24-week treatment period. Patients received placebo or edaravone i.v. infusion over 60 min for the first 14 days in cycle 1, and for 10 of the first 14 days during cycles 2 to 6. The efficacy primary endpoint was changed in the revised ALS functional rating scale (ALSFRS-R) scores during the 24-week treatment. Patients were treated with placebo (n = 104) and edaravone (n = 102). Changes in ALSFRS-R during the 24-week treatment were −6.35 ± 0.84 in the placebo group (n = 99) and −5.70 ± 0.85 in the edaravone group (n = 100), with a difference of 0.65 ± 0.78 (p = 0.411). Adverse events amounted to 88.5% (92/104) in the placebo group and 89.2% (91/102) in the edaravone group. In conclusion, the reduction of ALSFRS-R was smaller in the edaravone group than in the placebo group, but efficacy of edaravone for treatment of ALS was not demonstrated. Levels and frequencies of reported adverse events were similar in the two groups.
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影响因子：
4.4
作者：
Cedarbaum, JM;Stambler, N;Nakanishi, A
通讯作者：
Nakanishi, A
影响因子：
10.5
作者：
Itoh, K;Wakabayashi, N;Yamamoto, M
通讯作者：
Yamamoto, M
DOI：
10.3109/17482960802566824
发表时间：
2009-10
期刊：
Amyotrophic lateral sclerosis : official publication of the World Federation of Neurology Research Group on Motor Neuron Diseases
影响因子：
--
作者：
Chiò A;Logroscino G;Hardiman O;Swingler R;Mitchell D;Beghi E;Traynor BG;Eurals Consortium
通讯作者：
Eurals Consortium
影响因子：
2.5
作者：
ABE, K;PAN, LH;ITOYAMA, Y
通讯作者：
ITOYAMA, Y
影响因子：
11.2
作者：
Beal, MF;Ferrante, RJ;Brown, RH
通讯作者：
Brown, RH