施普善在缺血性脑卒中急性期的临床疗效研究

目的评价施普善(Cerebrolysin,脑活素)治疗急性期缺血性卒中的临床有效性和安全性。方法研究对象为经磁共振成像或CT确诊为一侧颈动脉系统的缺血性卒中,且神经功能缺损(NIH)评分在8~22分的患者。施普善组(144例)接受施普善50 ml静脉滴注,共10天;对照组(140例)接受非施普善的常规治疗。结果与对照组比较,施普善组患者NIH评分的改善分值和改善率除在治疗后第3天时无显著差异外,在治疗后第112、1、28天时均有显著差异。两组患者的生活能力状态评分均有改善;与对照组比较,施普善组患者生活能力状态评分的改善分值和改善率在治疗后28天时与对照组均有显著差异。结论施普善能改善急性缺血性脑卒中患者的神经功能缺损,是一种安全有效的药物。

The clinical efficacy of Cerebrolysin in the treatment of acute ischemic stroke

Objective To evaluate the efficacy and safety of Cerebrolysin in the treatment of acute ischemic stroke. Methods Two hundred and eighty-seven patients with acute ischemic stroke in the carotid artery territory were eligible for inclusion in the trial, and their NIH stroke scores were between 8 to 22. The patients were randomly assigned to treatment groups with and without Cerebrolysin. One hundred and forty-seven patients in the Cerebrolysin group were given 0.9% sodium chloride injection 500 ml containing Cerebrolysin 50 ml for 10 days, whereas the other 140 patients were treated routinely without Cerebrolysin as the control group. Results The tendency of decrease in NIH stroke scores from the baseline values was observed in patients of both groups during an observation period of 28 days. However, in the Cerebrolysin group, except day 3, the improvement rates of the NIH stroke scores on day 11, day 21, and day 28 were significantly higher than those in the control group. There was also statistically significant difference in the total life score reduction rate between patients treated with Cerebrolysin and routine therapy. Conclusion Cerebrolysin is efficacious and safe in the treatment of acute ischemic stroke due to the improvement of neurological deficits and daily life activity of the patients.