Muresanu Dafin F, Heiss Wolf-Dieter, Hoemberg Volker, Bajenaru Ovidiu, Popescu Cristian Dinu, Vester Johannes C, Rahlfs Volker W, Doppler Edith, Meier Dieter, Moessler Herbert, Guekht Alla
From the Department of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania (D.F.M.); Max Planck Institute for Metabolism Research, Cologne, Germany (W.-D.H.); Department of Neurology, SHR Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany (V.H.); Department of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania (O.B.); Department of Neurology, "Grigore T. Popa" University of Medicine and Pharmacy, Iasi, Romania (C.D.P.); Department of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Krailling, Germany (J.C.V., V.W.R.); Department of Clinical Research, EVER Neuro Pharma GmbH, Unterach, Austria (E.D., D.M., H.M.); Department of Neurology, Neurosurgery and Genetics, Russian National Research Medical University, Moscow City Hospital No. 8 for Neuropsychiatry, Moscow, Russia (A.G.); and "RoNeuro" Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania (D.F.M.).
Stroke. 2016 Jan;47(1):151-9. doi: 10.1161/STROKEAHA.115.009416. Epub 2015 Nov 12.
The aim of this trial was to investigate whether stroke patients who receive Cerebrolysin show improved motor function in the upper extremities at day 90 compared with patients who receive a placebo.
This study was a prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study. Patients were treated with Cerebrolysin (30 mL/d) or a placebo (saline) once daily for 21 days, beginning at 24 to 72 hours after stroke onset. The patients also participated in a standardized rehabilitation program for 21 days that was initiated within 72 hours after stroke onset. The primary end point was the Action Research Arm Test score on day 90.
The nonparametric effect size on the Action Research Arm Test score on day 90 indicated a large superiority of Cerebrolysin compared with the placebo (Mann-Whitney estimator, 0.71; 95% confidence interval, 0.63-0.79; P<0.0001). The multivariate effect size on global status, as assessed using 12 different outcome scales, indicated a small-to-medium superiority of Cerebrolysin (Mann-Whitney estimator, 0.62; 95% confidence interval, 0.58-0.65; P<0.0001). The rate of premature discontinuation was <5% (3.8%). Cerebrolysin was safe and well tolerated.
Cerebrolysin had a beneficial effect on function and global outcome in early rehabilitation patients after stroke. Its safety was comparable with that of the placebo, suggesting a favorable benefit/risk ratio. Because this study was exploratory and had a relatively small sample size, the results should be confirmed in a large-scale, randomized clinical trial.
URL: http://www.clinicaltrialsregister.eu. Unique identifier: 2007-000870-21.
本试验旨在研究与接受安慰剂的患者相比，接受脑蛋白水解物的中风患者在第90天时上肢运动功能是否得到改善。
本研究为前瞻性、随机、双盲、安慰剂对照、多中心、平行组研究。患者在中风发作后24至72小时开始，每天接受一次脑蛋白水解物（30 mL/d）或安慰剂（生理盐水）治疗，持续21天。患者还参与了一项标准化康复计划，为期21天，在中风发作后72小时内启动。主要终点是第90天的动作研究臂测试评分。
第90天动作研究臂测试评分的非参数效应大小表明，与安慰剂相比，脑蛋白水解物具有显著优势（曼-惠特尼估计值，0.71；95%置信区间，0.63 - 0.79；P<0.0001）。使用12种不同结局量表评估的整体状态的多变量效应大小表明，脑蛋白水解物具有小到中等程度的优势（曼-惠特尼估计值，0.62；95%置信区间，0.58 - 0.65；P<0.0001）。提前停药率<5%（3.8%）。脑蛋白水解物安全且耐受性良好。
脑蛋白水解物对中风后早期康复患者的功能和整体结局有有益影响。其安全性与安慰剂相当，提示有利的效益/风险比。由于本研究为探索性研究且样本量相对较小，结果应在大规模随机临床试验中得到证实。
网址：http://www.clinicaltrialsregister.eu。唯一标识符：2007 - 000870 - 21。
