MLC601（NeuroAiDTM）与康复联合治疗对中风后恢复的影响：CHIMES和CHIMES-E研究。
Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies.
作者信息
Suwanwela Nijasri C, Chen Christopher L H, Lee Chun Fan, Young Sherry H, Tay San San, Umapathi Thirugnanam, Lao Annabelle Y, Gan Herminigildo H, Baroque Ii Alejandro C, Navarro Jose C, Chang Hui Meng, Advincula Joel M, Muengtaweepongsa Sombat, Chan Bernard P L, Chua Carlos L, Wijekoon Nirmala, de Silva H Asita, Hiyadan John Harold B, Wong Ka Sing Lawrence, Poungvarin Niphon, Eow Gaik Bee, Venketasubramanian Narayanaswamy
机构信息
Chulalongkorn University, Chulalongkorn Stroke Centre, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Memory Aging and Cognition Centre, Department of Pharmacology, National University of Singapore, Singapore, Singapore.
出版信息
Cerebrovasc Dis. 2018;46(1-2):82-88. doi: 10.1159/000492625. Epub 2018 Sep 5.
BACKGROUND AND PURPOSE
MLC601 has been shown in preclinical studies to enhance neurorestorative mechanisms after stroke. The aim of this post hoc analysis was to assess whether combining MLC601 and rehabilitation has an effect on improving functional outcomes after stroke.
METHODS
Data from the CHInese Medicine NeuroAiD Efficacy on Stroke (CHIMES) and CHIMES-Extension (CHIMES-E) studies were analyzed. CHIMES-E was a 24-month follow-up study of subjects included in CHIMES, a multi-centre, double-blind placebo-controlled trial which randomized subjects with acute ischemic stroke, to either MLC601 or placebo for 3 months in addition to standard stroke treatment and rehabilitation. Subjects were stratified according to whether they received or did not receive persistent rehabilitation up to month (M)3 (non- randomized allocation) and by treatment group. The modified Rankin Scale (mRS) and Barthel Index were assessed at month (M) 3, M6, M12, M18, and M24.
RESULTS
Of 880 subjects in CHIMES-E, data on rehabilitation at M3 were available in 807 (91.7%, mean age 61.8 ± 11.3 years, 36% female). After adjusting for prognostic factors of poor outcome (age, sex, pre-stroke mRS, baseline National Institute of Health Stroke Scale, and stroke onset-to-study-treatment time), subjects who received persistent rehabilitation showed consistently higher treatment effect in favor of MLC601 for all time points on mRS 0-1 dichotomy analysis (ORs 1.85 at M3, 2.18 at M6, 2.42 at M12, 1.94 at M18, 1.87 at M24), mRS ordinal analysis (ORs 1.37 at M3, 1.40 at M6, 1.53 at M12, 1.50 at M18, 1.38 at M24), and BI ≥95 dichotomy analysis (ORs 1.39 at M3, 1.95 at M6, 1.56 at M12, 1.56 at M18, 1.46 at M24) compared to those who did not receive persistent rehabilitation.
CONCLUSIONS
More subjects on MLC601 improved to functional independence compared to placebo among subjects receiving persistent rehabilitation up to M3. The larger treatment effect of MLC601 was sustained over 2 years which supports the hypothesis that MLC601 combined with rehabilitation might have beneficial and sustained effects on neuro-repair processes after stroke. There is a need for more data on the effect of combining rehabilitation programs with stroke recovery treatments.
背景与目的
临床前研究表明，MLC601可增强中风后的神经修复机制。本事后分析的目的是评估MLC601与康复治疗相结合是否对改善中风后的功能结局有影响。
方法
分析了中药脑脉利对中风疗效（CHIMES）和CHIMES扩展研究（CHIMES-E）的数据。CHIMES-E是一项对CHIMES纳入受试者进行的为期24个月的随访研究，CHIMES是一项多中心、双盲、安慰剂对照试验，除标准中风治疗和康复外，将急性缺血性中风患者随机分为MLC601组或安慰剂组，治疗3个月。受试者根据在第3个月（M3）是否接受持续康复治疗（非随机分配）和治疗组进行分层。在第3个月（M3）、第6个月（M6）、第12个月（M12）、第18个月（M18）和第24个月（M24）评估改良Rankin量表（mRS）和Barthel指数。
结果
在CHIMES-E的880名受试者中，807名（91.7%，平均年龄61.8±11.3岁，36%为女性）有M3时的康复数据。在调整了预后不良因素（年龄、性别、中风前mRS、基线美国国立卫生研究院卒中量表和中风发作至研究治疗时间）后，在mRS 0-1二分法分析（M3时OR为1.85，M6时为2.18，M12时为2.42，M18时为1.94，M24时为1.87）、mRS序数分析（M3时OR为1.37，M6时为1.40，M12时为1.53，M18时为1.50，M24时为1.38）和BI≥95二分法分析（M3时OR为1.39，M6时为1.95，M12时为1.56，M18时为1.56，M24时为1.46）中，接受持续康复治疗的受试者在所有时间点上均显示出对MLC601更有利的治疗效果，与未接受持续康复治疗的受试者相比。
结论
在接受持续康复治疗至M3的受试者中，与安慰剂相比，更多接受MLC601治疗的受试者改善至功能独立。MLC601更大的治疗效果持续了2年，这支持了MLC601与康复治疗相结合可能对中风后的神经修复过程具有有益且持续影响的假设。需要更多关于康复计划与中风恢复治疗相结合效果的数据。
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