Navarro Jose C, Chen Christopher Lh, Lee Chun F, Gan Herminigildo H, Lao Annabelle Y, Baroque Alejandro C, Hiyadan John Harold B, Chua Carlos L, San Jose Ma Cristina, Advincula Joel M, Venketasubramanian Narayanaswamy
1 University of Santo Tomas Hospital, Manila, Philippines.
2 Department of Pharmacology, Clinical Research Centre, National University of Singapore, Singapore.
Int J Stroke. 2017 Apr;12(3):285-291. doi: 10.1177/1747493016676615. Epub 2016 Oct 26.
Background and Aim A pre-specified country analysis of subjects from the Philippines in the CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) Study showed significantly improved functional and neurological outcomes on MLC601 at month (M) 3. We aimed to assess these effects on long-term functional recovery in the Filipino cohort. Methods The CHIMES-E (extension) Study evaluated subjects who completed three months of randomized placebo-controlled treatment in CHIMES up to two years. Blinding of treatment allocation was maintained and all subjects received standard stroke care and rehabilitation. Modified Rankin Score (mRS) and Barthel Index (BI) were assessed in-person at M3 and by telephone at M6, M12, M18, M24. Odds ratios (OR) with corresponding 95% confidence intervals (CI) for functional recovery using ordinal analysis of mRS and for achieving functional independence (mRS 0-1 or BI ≥ 95) at each time point were calculated, adjusting for age, sex, baseline National Institute of Health Stroke Scale (NIHSS), onset-to-treatment time (OTT) and pre-stroke mRS. Results The 378 subjects (MLC601 192, placebo 186) included in CHIMES-E from the Philippines (mean age 60.2 ± 11.1) had more women ( p < 0.001), worse baseline NIHSS ( p < 0.001) and longer onset to treatment time ( p = 0.002) compared to other countries. Baseline characteristics were similar between treatment groups. The treatment effect of MLC601 seen at M3 peaked at M6 with OR for mRS shift of 1.53 (95% CI 1.05-2.22), mRS dichotomy 0-1 of 1.77 (95% CI 1.10-2.83), and BI ≥ 95 of 1.87 (95% CI 1.16-3.02). The beneficial effect persisted up to M24. Conclusion The beneficial effect of MLC601 seen at M3 in the Filipino cohort is durable up to two years after stroke.
中医药NeuroAiD对中风恢复疗效的中国多中心研究(CHIMES)中对菲律宾受试者进行的一项预先指定的国别分析显示,在第3个月时,MLC601可显著改善功能和神经学预后。我们旨在评估这些对菲律宾队列长期功能恢复的影响。方法:CHIMES-E(扩展)研究对在CHIMES中完成了三个月随机安慰剂对照治疗的受试者进行了长达两年的评估。维持治疗分配的盲法,所有受试者均接受标准的中风护理和康复治疗。在第3个月进行面对面评估改良Rankin量表(mRS)和Barthel指数(BI),并在第6、12、18、24个月通过电话进行评估。使用mRS的有序分析计算每个时间点功能恢复的比值比(OR)及其相应的95%置信区间(CI),以及实现功能独立(mRS 0-1或BI≥95)的比值比,并对年龄、性别、基线美国国立卫生研究院卒中量表(NIHSS)、发病至治疗时间(OTT)和中风前mRS进行校正。结果:CHIMES-E纳入的378名来自菲律宾的受试者(MLC601组192名,安慰剂组186名)(平均年龄60.2±11.1岁)中女性更多(p<0.001),基线NIHSS更差(p<0.001),发病至治疗时间更长(p=0.002),与其他国家相比。治疗组之间的基线特征相似。在第3个月观察到的MLC601的治疗效果在第6个月达到峰值,mRS变化的OR为1.53(95%CI 1.05-2.22),mRS二分法0-1为1.77(95%CI 1.10-2.83),BI≥95为1.87(95%CI 1.16-3.02)。有益效果持续到第24个月。结论:在菲律宾队列中,第3个月观察到的MLC601的有益效果在中风后长达两年都是持久的。