Huang Xin, Liu Yu, Bai Shuang, Peng Lidan, Zhang Boai, Lu Hong
Department of Neurology, The First Affiliated Hospital of Zhengzhou University, Henan, China.
PLoS One. 2017 Apr 13;12(4):e0175774. doi: 10.1371/journal.pone.0175774. eCollection 2017.
Granulocyte colony-stimulating factor (G-CSF) is atherapeutic candidate for stroke that has demonstrated anti-inflammatory and neuroprotective properties. Data from preclinical and clinical studies have suggested the safety and efficacy of G-CSF in stroke; however, the exact effects and utility of this cytokine in patients remain disputed. We performed a meta-analysis of randomized controlled trials of G-CSF in ischemic and hemorrhagic stroke to assess its clinical safety and efficacy. Electronic databases were searched for relevant publications in English and Chinese. A total of 14 trials met the inclusion criteria. G-CSF (cumulative dose range, 1-135μg/kg/day) was tested against placebo in a total of 1037 participants. There was no difference in the rate of mortality between groups (odds ratio, 1.23; 95% confidence interval, 0.76-1.97, p = 0.40). Moreover, the rate of serious adverse events did not differ between groups and provided evidence for the safety of G-CSF administration in stroke patients (odds ratio, 1.11; 95% confidence interval, 0.77-1.61, p = 0.57). No significant outcome benefits were noted with respect to the National Institutes of Health Stroke Scale (mean difference, -0.16; 95% confidence interval, -1.02-0.70, p = 0.72); however, improvements were noted with respect to the Barthel Index (mean difference, 8.65; 95% confidence interval 0.98-16.32; p = 0.03). In conclusion, it appears to be safe in administration of G-CSF, but it will increase leukocyte count. G-CSF was weakly significant benefit with improving the BI scores, while there was no improvement in the NIHSS scores. Larger and more robustly designed trials of G-CSF in stroke are needed to confirm the results.
粒细胞集落刺激因子(G-CSF)是一种治疗中风的候选药物,已显示出抗炎和神经保护特性。临床前和临床研究的数据表明G-CSF在中风治疗中的安全性和有效性;然而,这种细胞因子在患者中的确切作用和效用仍存在争议。我们对G-CSF在缺血性和出血性中风中的随机对照试验进行了荟萃分析,以评估其临床安全性和有效性。通过电子数据库检索英文和中文的相关出版物。共有14项试验符合纳入标准。在总共1037名参与者中,将G-CSF(累积剂量范围为1-135μg/kg/天)与安慰剂进行了对比测试。两组之间的死亡率没有差异(优势比,1.23;95%置信区间,0.76-1.97,p = 0.40)。此外,两组之间严重不良事件的发生率没有差异,这为G-CSF用于中风患者的安全性提供了证据(优势比,1.11;95%置信区间,0.77-1.61,p = 0.57)。在国立卫生研究院卒中量表方面未观察到显著的结果益处(平均差异,-0.16;95%置信区间,-1.02-0.70,p = 0.72);然而,在巴氏指数方面有改善(平均差异,8.65;95%置信区间0.98-16.32;p = 0.03)。总之,G-CSF给药似乎是安全的,但会增加白细胞计数。G-CSF在改善巴氏指数评分方面有微弱的显著益处,而国立卫生研究院卒中量表评分没有改善。需要进行更大规模、设计更严谨的G-CSF治疗中风的试验来证实这些结果。