单唾液酸四已糖神经节苷脂钠注射液治疗急性脑梗死的有效性和安全性研究

目的评价齐鲁制药有限公司开发的GM-1注射液治疗急性脑梗死的有效性和安全性。方法采用双盲、随机、阳性药对照的方法,48例患者随机分入A组(试验组:使用齐鲁制药有限公司生产的单唾液酸四己糖神经节苷脂钠注射液)和B组(对照组:使用阿根廷TRB Pharma S.A公司生产的”施捷因”注射液)。A组:GM-1注射液100mg,稀释于250ml生理盐水中,静脉滴注,1/d,连续使用14天;B组:“施捷因”100mg,稀释于250ml生理盐水,静脉滴注,1/d,连续使用14天。结果两组治疗NIHSS评分和BI指数评分组内前后比较均有显著性差异(P<0.05),但两组前后差值组间比较无显著性差异(P>0.05);NIHSS评分变化率(NIHSS评分治疗后减少)和BI指数变化率(BI指数治疗后增加)两组之间比较无显著性差异(P>0.05);两组在整个试验过程中没有发生不良反应。结论国产GM-1注射液和进口同类产品疗效和安全性相同。

Curative Effect of GM-1 on Acute Cerebral Infarction and Its Safety

Objective To evaluate the curative effect of GM-1 injection on acute cerebral infarction and its safety. Methods The method of double - blindness random positive control was used in the present study. Forty - eight patients with cerebral infarction were divideded into two groups, i. e. treatment group with GM-1 produced in China and control group receiveng GH - l injection produced by TRB pharma S. A Co. in Argentina. The curative effects were evaluated by NIHSS and Barthel index. Results There was significant difference in NIHSS and Barthel mdex of both groups between before and after treatment ( P <0.05),but before and after the treatment NIHSS and Barthel index in the treatment group were insignificantly different from that in the control groups ( P > 0.05) . There were no abnormal responses in the two groups. Conclusion The curative effect of GM-1 injection produced in China on acute cerebral infarction and its safety is similar to that produced in Argentina.