Strilciuc Stefan, Vécsei László, Boering Dana, Pražnikar Aleš, Kaut Oliver, Riederer Peter, Battistin Leontino
Department of Neuroscience, Iuliu Hatieganu University of Medicine and Pharmacy, 400364 Cluj-Napoca, Romania.
Department of Neurology, University of Szeged, H-6725 Szeged, Hungary.
Pharmaceuticals (Basel). 2021 Dec 13;14(12):1297. doi: 10.3390/ph14121297.
We performed a systematic search and meta-analysis of available literature to determine the safety profile of Cerebrolysin in acute ischemic stroke, filling existing safety information gaps and inconsistent results. We searched EMBASE, PubMed, and Cochrane Databases of Systematic Reviews and Clinical Trials up to the end of February 2021. Data collection and analysis were conducted using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. All safety outcomes were analyzed based on risk ratios (RR) and their 95% confidence intervals. The meta-analysis pooled 2202 patients from twelve randomized clinical trials, registering non-statistically significant ( > 0.05) differences between Cerebrolysin and placebo throughout main and subgroup analyses. The lowest rate of Serious Adverse Events (SAE), as compared to placebo, was observed for the highest dose of Cerebrolysin (50 mL), highlighting a moderate reduction (RR = 0.6). We observed a tendency of superiority of Cerebrolysin regarding SAE in high dose treatment courses for moderate-severe ischemic stroke, suggesting some effect of the agent against adverse events. This comprehensive safety meta-analysis confirms the safety profile for patients treated with Cerebrolysin after acute ischemic stroke, as compared to placebo.
我们对现有文献进行了系统检索和荟萃分析，以确定脑蛋白水解物在急性缺血性卒中中的安全性概况，填补现有的安全信息空白并解决结果不一致的问题。我们检索了截至2021年2月底的EMBASE、PubMed以及Cochrane系统评价和临床试验数据库。数据收集和分析采用Cochrane干预措施系统评价手册中描述的方法。所有安全性结局均基于风险比（RR）及其95%置信区间进行分析。荟萃分析汇总了来自12项随机临床试验的2202例患者，在主要分析和亚组分析中，脑蛋白水解物与安慰剂之间均未显示出具有统计学意义（>0.05）的差异。与安慰剂相比，脑蛋白水解物最高剂量（50 mL）的严重不良事件（SAE）发生率最低，显示出适度降低（RR = 0.6）。我们观察到在中重度缺血性卒中的高剂量治疗疗程中，脑蛋白水解物在SAE方面有优势倾向，提示该药物对不良事件有一定作用。与安慰剂相比，这项全面的安全性荟萃分析证实了急性缺血性卒中后接受脑蛋白水解物治疗患者的安全性概况。
