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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。
Objective To evaluate the efficacy and safety of recombinant human granulocyte colony-stimulating factor (rhG-CSF) in the treatment of acute cerebral infarction in a randomized, placebo-controlled clinical study. Methods Fifty patients with acute cerebral infarction who developed for 1 week were randomly divided into rhG-CSF treatment group and control group. Among them, 25 cases were treated with rhG-CSF, and 2μg / kg rhG-CSF was injected subcutaneously for 5 days. Control group of 25 patients, the same way given placebo. Outcome measures included NIHSS score and side effects on neurological deficit scores 10 and 20 after acute cerebral infarction. Results After treatment, the NIHSS score of the 20th day in rhG-CSF treatment group was significantly different from that before treatment (P = 0.004, P <0.01). On the 20th day, there was significant difference between the two groups in the treatment group and the control group (P = 0.007, P <0.01). Conclusion rhG-CSF treatment of acute cerebral infarction in a short period of time to observe the effective, no adverse reactions. Its indications, therapeutic dose and duration of treatment and other aspects of the relationship between the efficacy needs further study.