【摘要】 目的通过随机、安慰剂对照的临床研究,对人重组粒细胞集落刺激因子(rhG—CSF)治疗急性脑梗死的有效性及安全性进行客观评价。方法将50例发病1周的急性脑梗死患者随机分为rhG-CSF治疗组和对照组。其中rhG—CSF治疗组为25例,给予rhG—CSF皮下注射2μg／kg,连续使用5d。对照组25例,按同样方式给予安慰剂。评定的终点指标包括急性脑梗死治疗后第10天、第20天的神经功能缺损评分NIHSS评分以及副作用。结果经治疗后,rhG-CSF治疗组第20天NIHSS评分与治疗前有显著性差异(P=0．004,P<0．01)、第20天治疗组和对照组两组间差异有显著性(P=0．007,P<0．01)。结论 rhG—CSF治疗急性脑梗死在短时间内观察有效,未见不良反应。其在适应证、治疗剂量及用药时限等方面与临床疗效的关系有待进一步研究。更多还原

【Abstract】 Objective To assess the safety and efficacy of recombinant human granulocyte colony-stimulating factor(rhG-CSF)in the treatment of acute cerebral infarction by a randomized and placebo-controlled clinical trial. Method 50 cases with acute cerebral infarction were randomly allocated to receive treatment by either rhG-CSF or placebo within 1 week of stroke onset. The former included 25 cases were consecutively given rhG-CSF 2μg/kg for 5 days by subcutaneous injection. The other 25 cases were treated with placebo. The end points included NIH Stroke Scale and adverse reaction. Result In treatment group,there were statistically significant difference at NIH Stroke Scale on the 20th days of treatment (P=0. 004, P<0. 01). There were also remarkable difference between two groups(P = 0. 007,P<0. 01). Conclusions This study shows that rhG-CSF appears safe and effective for a-cute cerebral infarction during short time. It is necessary to have further study on the relations between its clinical efficacy and the dose,protocol of drugadministration and indication.更多还原