Double-Blind And Randomaized Controlled Trial Of Cerebrolysin In The Teatment Of Acute Cerebral Infarction

Background Multiple neuroprotective agents have been used in the treatment of acute cerebral infarction, and confirmed to be effective in the experimental study of animal models, but many relative clinical trials failed. Cerebrolysin, a preparation derived from porcine brain, has a direct impact on the nerve cells through the blood-brain barrier. It has been widely used in the treatment of cerebrovascular diseases, traumatic brain injuries, Alzheimer's diseases and other encephalopathy, due to its neurotrophic and neuroprotective effects.Objective To evaluate the efficacy and safety of Cerebrolysin in the treatment of acute cerebral infarction and to explore the influence of Cerebrolysin on serum calcium and magnesium.Methods A double-blind and randomized controlled clinical trial was conducted for treating acute cerebral infarction. Forty cases with acute cerebral infarction were randomly assigned to Cerebrolysin group and Placebo group. Cerebrolysin and placebo were administered lasting for 10 days by intravenous injection. The indexes of clinical efficacy, which included NIH, mRS and BI scores, were observed on day 14, 21 and 28 after treatment. Adverse reaction and the changes of serum calcium and magnesium before and after treatment were also studied.Results The tendency of decrease in NIH stroke scores from the baseline values was observed in patients of both groups during observation periods of 10 days and 30 days. However, in the Cerebrolysin group, except day 5, the improvement rates of the NIH stroke scores on day 10 and day 30 were significantly higher than those in Placebo group (P<0.05, P<0.05). Compared with Placebo group, the improvement rates of BI scores on day 30 was significantly higher (P<0.05). On day 30, the effective and improved rates of Cerebrolysin group were 25 % and 60 %, respectively. There was a statistically significant difference in therapeutic efficacy and total effective rate between the two groups (P=0.0416, P=0.041, respectively). Compared with Placebo group, the efficacy and total effective rate of severe patients were significantly higher in Cerebrolysin group (P=0.0219, P=0.029, respectively). In the Cerebrolysin group, serum calcium and magnesium concentration increased significantly after administration (P=0.006, P=0.014, respectively), but there was no significant difference before and after therapy in Placebo group (P>0.05). No adverse drug reaction was observed in both groups.Conclusion Cerebrolysin is efficacious and safe in the improvement of neurological function of patients with acute cerebral infarction, and can decrease the encephalic injury by increasing the concentration of serum calcium and magnesium.