Chiang Mai University, Amphur Muang, Chiang Mai, Thailand.
University of Santo Tomas Hospital, España Boulevard, Manila, Philippines.
J Stroke Cerebrovasc Dis. 2015 Apr;24(4):823-7. doi: 10.1016/j.jstrokecerebrovasdis.2014.11.017. Epub 2015 Feb 11.
Stroke trials often analyze patients with heterogeneous prognoses using a single definition of outcome, which may not be applicable to all subgroups. We aimed to evaluate the treatment effects of MCL601 among patients stratified by prognosis in the Chinese Medicine Neuroaid Efficacy on Stroke Recovery (CHIMES) study.
Analyses were performed using data from the CHIMES study, an international, randomized, placebo-controlled, double-blind trial comparing MLC601 with placebo in patients with ischemic stroke of intermediate severity in the preceding 72 hours. All subjects with baseline data and the modified Rankin Scale (mRS) score at 3 months were included.
Data from 1006 subjects were analyzed. The predictive variables for mRS score greater than 1 at month 3 were age older than 60 years (P < .001), baseline National Institutes of Health Stroke Scale score 10-14 (P < .001), stroke onset to initiation of study treatment of more than 48 hours (P < .001), and female sex (P = .026). A higher number of predictors was associated with poorer mRS score at month 3 for both placebo (P < .001) and treatment (P < .001) groups. The odds ratio (OR) for achieving a good outcome increased with the number of predictors and reached statistical significance in favor of MLC601 among patients with 2 to 4 predictors combined (unadjusted OR = 1.44, 95% confidence interval, 1.02-2.03; adjusted OR = 1.60, 95% confidence interval, 1.10-2.34).
Age, sex, baseline National Institutes of Health Stroke Scale score, and time to first dose are predictors of functional outcome in the CHIMES study. Stratification by prognosis showed that patients with 2 or more predictors of poorer outcome have better treatment effect with MLC601 than patients with single or no prognostic factor. These results have implications on designing future stroke trials.
中风试验常使用单一的结局定义来分析预后存在差异的患者，这可能不适用于所有亚组。我们旨在评估 MCL601 在中药神经辅助治疗中风恢复疗效（CHIMES）研究中按预后分层的患者中的治疗效果。
分析使用了来自 CHIMES 研究的数据，这是一项国际性、随机、安慰剂对照、双盲试验，比较了 MLC601 与安慰剂在中风发病后 72 小时内处于中等严重程度的患者中的作用。所有具有基线数据和 3 个月时改良 Rankin 量表（mRS）评分的患者均被纳入分析。
对 1006 例患者的数据进行了分析。3 个月时 mRS 评分大于 1 的预测变量为年龄大于 60 岁（P<0.001）、基线国立卫生研究院中风量表评分 10-14 分（P<0.001）、中风发病至开始研究治疗的时间超过 48 小时（P<0.001）和女性（P=0.026）。对于安慰剂（P<0.001）和治疗（P<0.001）组，预测变量数量越多，3 个月时 mRS 评分越差。对于有 2 至 4 个预测因素的患者，与安慰剂相比，使用 MLC601 治疗获得良好结局的可能性更高，这一结果具有统计学意义（调整后比值比[OR]为 1.44，95%置信区间，1.02-2.03；调整后 OR 为 1.60，95%置信区间，1.10-2.34）。
在 CHIMES 研究中，年龄、性别、基线国立卫生研究院中风量表评分和首次用药时间是功能结局的预测因素。按预后分层表明，预后较差的患者有 2 个或更多预后不良的预测因素，与只有单个或没有预后因素的患者相比，使用 MLC601 治疗的效果更好。这些结果对未来的中风试验设计具有意义。
