| 제목 |
Effects of Cerebrolysin with Rehabilitation in Stroke Patients with Severe Motor Involvement |
| 소속 |
Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Department of Physical and Rehabilitation Medicine1, Pusan National University College of Medicine, Pusan National University Yangsan Hospital, Pusan, Korea, Department of Rehabilitation Medicine2, Research Institute of Clinical Medicine of Chonbuk National University, Biomedical Research Institute of Chonbuk National University Hospital, Jeonbuk, Korea, Department of Physical Medicine and Rehabilitation3, Yonsei University College of Medicine, Seoul, Korea, Department and Research Institute of Rehabilitation Medicine4, School of Medicine, Chungnam National University, Department of Rehabilitation Medicine5, SAIHST, Sungkyunkwan University, Seoul, Korea, Department of Health Sciences and Technology6 |
| 저자 |
Yu Jin Im1*, Won Hyuk Chang1, Jungsoo Lee1, Yong-Il Shin2, Myoung-Hwan Ko3, Deog Young Kim4, Min Kyun Sohn5, Jinuk Kim1,6, Yun-Hee Kim1,6† |
Objective: The objective of this study was to evaluate whether Cerebrolysin on top of rehabilitation therapy provides additional motor recovery in subacute stroke patients with severe motor impairment.
Materials and Methods: This phase IV trial was designed as a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Stroke patients with severe motor function impairment (Fugl-Meyer assessment (FMA) 0-50) were included within 7 days after stroke onset. They were randomized to receive a 21-day treatment course (Days 8-28) of either Cerebrolysin or placebo, given in addition to standardized rehabilitation therapy. Assessments were performed at baseline, immediately after treatment, and 3 months after stroke onset. The plasticity of the motor system was assessed by diffusion tensor imaging (DTI) and resting-state functional magnetic resonance imaging (rsfMRI).
Results: A total of 122 patients (Cerebrolysin n=62, placebo n=60) were enrolled, and 110 patients completed the study protocol (Cerebrolysin n=59, placebo n=51). Each group showed significant motor recovery over time. Repeated measures ANOVA showed a significant interaction effect between time and type of intervention as measured by FMA (p<0.05). rsfMRI analysis also showed a significant interaction between intervention time and type in ipsilesional functional connectivity. In DTI analysis, patients treated with Cerebrolysin demonstrated less degenerative white matter changes in major vertical, longitudinal, and lateral white matter tracts over time than the control group.
Conclusions: Cerebrolysin treatment as an add-on to a rehabilitation program is a pharmacologic approach that is worth considering to improve motor recovery in ischemic stroke patients with severe motor impairment. |
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