摘要
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。
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.
出处
《华南国防医学杂志》
CAS
2005年第2期4-6,共3页
Military Medical Journal of South China