Chang Won Hyuk, Lee Jungsoo, Shin Yong-Il, Ko Myoung-Hwan, Kim Deog Young, Sohn Min Kyun, Kim Jinuk, Kim Yun-Hee
Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.
Department of Rehabilitation Medicine, Pusan National University College of Medicine, Pusan National University Yangsan Hospital, Yangsan 50612, Korea.
J Pers Med. 2021 Jun 11;11(6):545. doi: 10.3390/jpm11060545.
The objective of this study was to evaluate whether Cerebrolysin combined with rehabilitation therapy supports additional motor recovery in stroke patients with severe motor impairment. This study analyzed the combined data from the two phase IV prospective, multicenter, randomized, double-blind, placebo-controlled trials. Stroke patients were included within seven days after stroke onset and were randomized to receive a 21-day treatment course of either Cerebrolysin or placebo with standardized rehabilitation therapy. Assessments were performed at baseline, immediately after the treatment course, and 90 days after stroke onset. The plasticity of the motor system was assessed by diffusion tensor imaging and resting state fMRI. In total, 110 stroke patients were included for the full analysis set (Cerebrolysin = 59, placebo = 51). Both groups showed significant motor recovery over time. Repeated-measures analysis of varianceshowed a significant interaction between time and type of intervention as measured by the Fugl-Meyer Assessment ( < 0.05). The Cerebrolysin group demonstrated less degenerative changes in the major motor-related white matter tracts over time than the placebo group. In conclusion, Cerebrolysin treatment as an add-on to a rehabilitation program is a promising pharmacologic approach that is worth considering in order to enhance motor recovery in ischemic stroke patients with severe motor impairment.
本研究的目的是评估脑蛋白水解物联合康复治疗是否有助于重度运动功能障碍的中风患者实现额外的运动功能恢复。本研究分析了两项IV期前瞻性、多中心、随机、双盲、安慰剂对照试验的合并数据。中风患者在中风发作后7天内纳入研究,并随机接受为期21天的脑蛋白水解物或安慰剂治疗疗程,同时接受标准化康复治疗。在基线、治疗疗程结束后即刻以及中风发作后90天进行评估。通过弥散张量成像和静息态功能磁共振成像评估运动系统的可塑性。总共110例中风患者纳入全分析集(脑蛋白水解物组 = 59例,安慰剂组 = 51例)。两组均随时间推移显示出显著的运动功能恢复。重复测量方差分析显示,以Fugl-Meyer评估量表衡量,时间与干预类型之间存在显著交互作用(P < 0.05)。与安慰剂组相比,脑蛋白水解物组随时间推移在主要运动相关白质束中的退行性变化较少。总之,脑蛋白水解物治疗作为康复计划的补充,是一种有前景的药物治疗方法,对于改善重度运动功能障碍的缺血性中风患者的运动功能恢复值得考虑。