Department of Neurology, Affiliated Xiaolan Hospital, Southern Medical University, Zhongshan, China.
Neurol Sci. 2019 Feb;40(2):235-241. doi: 10.1007/s10072-018-3653-2. Epub 2018 Nov 27.
Based on the results of randomized, double-blind, placebo-controlled trials, the benefit and safety of edaravone in the treatment of amyotrophic lateral sclerosis remain controversial. We performed a meta-analysis to evaluate the efficacy and safety of edaravone in the treatment of this disease.
We searched PubMed, the Cochrane Library, and Embase from the inception of electronic data to April 2018. We included randomized, double-blind, placebo-controlled trials reporting amyotrophic lateral sclerosis patients receiving 60-mg intravenous edaravone or intravenous saline placebo for 24 weeks. The primary efficacy evaluation was changed in Amyotrophic Lateral Sclerosis Functional Rating Scale score from baseline to after the trial. Measure of safety was the frequency of investigated adverse events and serious adverse events. Data synthesis and analysis and evaluation of risk of bias were performed using RevMan 5.3 software. Heterogeneity among studies was evaluated with the I statistic.
A total of 367 patients were analyzed across three randomized controlled trials (183 patients receiving intravenous edaravone; 184 receiving placebo). A difference in ALSFRS-R score between groups at 24 weeks was found (mean difference [MD] = 1.63, 95% confidence interval [CI] 0.26-3.00, P = .02). No differences in the frequency of adverse events (odds ratio [OR] = 1.22, 95% CI 0.68-2.19, P = .50) or serious adverse events (OR = 0.71, 95% CI 0.43-1.19, P = .20) were found.
Intravenous edaravone is efficacious in amyotrophic lateral sclerosis patients, with no severe adverse effects. Additional reliable randomized controlled trials with larger sample sizes will further assess the efficacy and safety of edaravone in amyotrophic lateral sclerosis.
The systematic review and meta-analysis was registered in the international prospective register of systematic reviews. (PROSPERO registration number: CRD42018096191; http://www.crd.york.ac.uk/PROSPERO .).
基于随机、双盲、安慰剂对照试验的结果，依达拉奉治疗肌萎缩侧索硬化症的疗效和安全性仍存在争议。我们进行了一项荟萃分析，以评估依达拉奉治疗该病的疗效和安全性。
我们检索了 PubMed、Cochrane 图书馆和 Embase 从电子数据的开始到 2018 年 4 月。我们纳入了报告肌萎缩侧索硬化症患者接受 60mg 静脉依达拉奉或静脉生理盐水安慰剂治疗 24 周的随机、双盲、安慰剂对照试验。主要疗效评估指标为从基线到试验后的肌萎缩侧索硬化功能评定量表评分变化。安全性测量指标为研究不良事件和严重不良事件的频率。使用 RevMan 5.3 软件进行数据综合分析和偏倚风险评估。使用 I ² 统计评估研究间的异质性。
共有 367 名患者来自三项随机对照试验（183 名接受静脉依达拉奉治疗；184 名接受安慰剂治疗）进行了分析。24 周时组间 ALSFRS-R 评分差异有统计学意义（平均差 [MD] = 1.63，95%置信区间 [CI] 0.26-3.00，P = 0.02）。不良事件（比值比 [OR] = 1.22，95%CI 0.68-2.19，P = 0.50）或严重不良事件（OR = 0.71，95%CI 0.43-1.19，P = 0.20）的频率无差异。
静脉用依达拉奉治疗肌萎缩侧索硬化症有效，无严重不良反应。需要进一步进行更大样本量的可靠随机对照试验，以评估依达拉奉治疗肌萎缩侧索硬化症的疗效和安全性。
该系统评价和荟萃分析已在国际前瞻性系统评价注册库中注册。（PROSPERO 注册号：CRD42018096191；http://www.crd.york.ac.uk/PROSPERO.）。
