Granulocyte-colony stimulating factor (G-CSF) in stroke patients with concomitant vascular disease--a randomized controlled trial.
Granulocyte-colony stimulating factor (G-CSF) in stroke patients with concomitant vascular disease--a randomized controlled trial.
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DOI：
10.1371/journal.pone.0019767
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发表时间：
2011
期刊：
影响因子：
3.7
通讯作者：
Schäbitz WR
中科院分区：
文献类型：
--
作者：
Floel A;Warnecke T;Duning T;Lating Y;Uhlenbrock J;Schneider A;Vogt G;Laage R;Koch W;Knecht S;Schäbitz WR
G-CSF已在中风动物模型中显示出促进中枢神经系统的功能和结构再生。因此，它可能是一种促进中风后慢性阶段恢复的治疗方法。在此，我们评估了G-CSF在伴有血管疾病的慢性卒中患者中的安全性和耐受性，并探讨了疗效数据。采用双盲、随机化方法对41例患者进行了研究，接受10天G-CSF（10 µg/kg体重/天）或安慰剂。主要入选标准是入选前缺血性梗死>4个月，MRI显示白色高信号。主要终点是不良事件的数量。在研究过程中，我们还探讨了日常生活活动、运动和语言学习以及手指敲击速度的手部运动功能的变化。不良事件（AE）在G-CSF组中更常见，但通常分级为轻度或中度，并且来自G-CSF的已知副作用谱。白细胞计数在G-CSF给药第2天后升高，在第8天达到最大值（平均42/nl），并在治疗停止后1周恢复至基线水平。对于主要疗效终点（手运动功能测试），未检测到显著的治疗效果。这些结果证明了皮下注射G-CSF在慢性卒中患者中的可行性、安全性和合理耐受性。本研究为探讨G-CSF改善慢性脑卒中相关功能障碍的疗效提供了基础。ClinicalTrials.gov NCT00298597
G-CSF has been shown in animal models of stroke to promote functional and structural regeneration of the central nervous system. It thus might present a therapy to promote recovery in the chronic stage after stroke. Here, we assessed the safety and tolerability of G-CSF in chronic stroke patients with concomitant vascular disease, and explored efficacy data. 41 patients were studied in a double-blind, randomized approach to either receive 10 days of G-CSF (10 µg/kg body weight/day), or placebo. Main inclusion criteria were an ischemic infarct >4 months prior to inclusion, and white matter hyperintensities on MRI. Primary endpoint was number of adverse events. We also explored changes in hand motor function for activities of daily living, motor and verbal learning, and finger tapping speed, over the course of the study. Adverse events (AEs) were more frequent in the G-CSF group, but were generally graded mild or moderate and from the known side-effect spectrum of G-CSF. Leukocyte count rose after day 2 of G-CSF dosing, reached a maximum on day 8 (mean 42/nl), and returned to baseline 1 week after treatment cessation. No significant effect of treatment was detected for the primary efficacy endpoint, the test of hand motor function. These results demonstrate the feasibility, safety and reasonable tolerability of subcutaneous G-CSF in chronic stroke patients. This study thus provides the basis to explore the efficacy of G-CSF in improving chronic stroke-related deficits. ClinicalTrials.gov NCT00298597
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影响因子：
8.3
作者：
Fisher M;Feuerstein G;Howells DW;Hurn PD;Kent TA;Savitz SI;Lo EH;STAIR Group
通讯作者：
STAIR Group
影响因子：
3.2
作者：
Anderlini P
通讯作者：
Anderlini P
影响因子：
5.7
作者：
Johansen-Berg H;Della-Maggiore V;Behrens TE;Smith SM;Paus T
通讯作者：
Paus T
影响因子：
2.9
作者：
Basile, Anna Maria;Pantoni, Leonardo;Inzitari, Domenico
通讯作者：
Inzitari, Domenico
影响因子：
14.5
作者：
Hummel, F;Celnik, P;Cohen, LG
通讯作者：
Cohen, LG