Chinese Medicine Neuroaid Efficacy on Stroke Recovery A Double-Blind, Placebo-Controlled, Randomized Study
Chinese Medicine Neuroaid Efficacy on Stroke Recovery A Double-Blind, Placebo-Controlled, Randomized Study
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DOI：
10.1161/strokeaha.113.002055
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发表时间：
2013-08-01
期刊：
影响因子：
8.3
通讯作者：
Bousser, Marie-Germaine
中科院分区：
文献类型：
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作者：
Chen, Christopher L. H.;Young, Sherry H. Y.;Bousser, Marie-Germaine
背景和目的先前的临床研究表明，MLC601在卒中发作2周至6个月期间服用有利于卒中后恢复。中医神经辅助对脑卒中恢复的疗效（CHIMES）研究在72小时的时间窗内验证了MLC601在急性、中重度缺血性脑卒中中的疗效优于安慰剂的假设。方法该多中心、双盲、安慰剂对照试验随机选取1100例美国国立卫生研究院卒中量表评分为6 ~ 14分的患者，在发病72小时内，进行为期3个月的药物试验。主要结果是修改后的兰金量表发生了变化。次要结果为改进的Rankin量表二分法、美国国立卫生研究院卒中量表改进、美国国立卫生研究院卒中量表总分和运动评分、Barthel指数和精神状态检查的差异。根据年龄、性别、首次给药时间、基线美国国立卫生研究院卒中量表、皮质体征的存在和抗血小板使用情况进行计划亚组分析。结果经修正Rankin量表移位分析校正的优势比为1.09（95%可信区间为0.86 ~ 1.32）。治疗组间的任何次要结果均未发现统计学差异。亚组分析显示主要结局无统计学异质性；然而，在中风发作后48小时后接受治疗的亚组中有获益的趋势。两组间严重和非严重不良事件发生率相似。结论在中度急性缺血性脑卒中患者中，MLC601在改善3个月预后方面并不优于安慰剂。在未来的研究中可以考虑延长治疗时间和随访48小时后开始治疗的参与者。临床试验注册网址：http://www.clinicaltrials.gov。唯一标识符：NCT00554723。
Background and Purpose Previous clinical studies suggested benefit for poststroke recovery when MLC601 was administered between 2 weeks and 6 months of stroke onset. The Chinese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study tested the hypothesis that MLC601 is superior to placebo in acute, moderately severe ischemic stroke within a 72-hour time window.Methods This multicenter, double-blind, placebo-controlled trial randomized 1100 patients with a National Institutes of Health Stroke Scale score 6 to 14, within 72 hours of onset, to trial medications for 3 months. The primary outcome was a shift in the modified Rankin Scale. Secondary outcomes were modified Rankin Scale dichotomy, National Institutes of Health Stroke Scale improvement, difference in National Institutes of Health Stroke Scale total and motor scores, Barthel index, and mini-mental state examination. Planned subgroup analyses were performed according to age, sex, time to first dose, baseline National Institutes of Health Stroke Scale, presence of cortical signs, and antiplatelet use.Results The modified Rankin Scale shift analysis-adjusted odds ratio was 1.09 (95% confidence interval, 0.86-1.32). Statistical difference was not detected between the treatment groups for any of the secondary outcomes. Subgroup analyses showed no statistical heterogeneity for the primary outcome; however, a trend toward benefit in the subgroup receiving treatment beyond 48 hours from stroke onset was noted. Serious and nonserious adverse events rates were similar between the 2 groups.Conclusions MLC601 is statistically no better than placebo in improving outcomes at 3 months when used among patients with acute ischemic stroke of intermediate severity. Longer treatment duration and follow-up of participants with treatment initiated after 48 hours may be considered in future studies.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00554723.