Observation Of The Efficiency And Safety Of Acute Cerebral Infarction Cured With Cerebrolysin

Objectives:To observe the curative effect and security about Cerebro-lysin (by Austria EBEWE corporation production) to treat acute cerebral infarction onset within 12 hour.Methods:The patients with acute cerebral infarction in the carotid artery territory were eligible for inclusion in the trial were randomly assigned to 2 groups, whose NIHSS stroke scores were between 6 to 22, and onset within 12 hours:1. Cerebrolysin group:patients were given 0.9% sodium chloride injection 100ml containing Cerebrolysin 30 ml for 10 days; 2. Placebo group:patients were given 0.9% sodium chloride injection 100ml for 10 days. The patients in the two groups took orally Bayaspirin 100 mg every day for 90 days. All patients accepted the conventional treatment. The modified Rankin scale (mRS) and the Activity of Daily Living Scale (ADL or Barthel Index, BI) at 3 months to be the main curative effect target:mRS (0-1) divides as well as the Barthel index≥95 divides into effectively; and uses the National Institutes of Health Stroke Scale (NIHSS) as the secondary target. Adverse events were recorded according to the adverse scale (DOTES and TWIS) within the treatment period and mortality at 3 months were used as the target of the validity and the security. Carries on the data analysis using the SPSS 11.5 statistics software, the measurement material with X±S the expression, carries on the T-test; Uses Chi-square examination to the counting material, P values<0.05 has statistics significance.Results:1. Among the 50 patients enrolled, excluded 1 patient exit, there are 49 patients participated in the final statistical analysis. 2. Two groups can be effective in improving neurological function, two groups except 5 day after treatment 10 day,30 day, and 3 months NIHSS score compared with the pre-treatment significantly differences. At 3 months, the favourable outcome (mRS score 0 or 1) were 14 cases of Cerebrolysin group for 58.33%, Placebo group 7 cases were for 28.00%; the restoration of a satisfactory (Barthel index≥95) Cerebrolysin group of 15 cases were for 62.50%, Placebo group 8 cases were for 32.00%, this difference has the significance.4 cases of death During the 3 months, cause of death all were acute myocardial infarction, Cerebrolysin group of 1 cases were for 4.17%.Placebo group 3 cases, were for 12.00%, mortality rates were not significantly different.Conclusions:1. The effection of Cerebrolysin is efficacious and safe in the improve-ment of neurological function of patients within 12 hours of stroke onset.2. It will be needed to further expand the sample size to discuss the mechanism, safety and efficacy of Cerebrolysin for treating acute cerebral infarction onset within 12 hours.