Zhang Danfeng, Dong Yan, Li Ya, Chen Jigang, Wang Junyu, Hou Lijun
Department of Neurosurgery, Shanghai Institute of Neurosurgery, PLA Institute of Neurosurgery, Changzheng Hospital, Second Military Medical University, Shanghai, China.
Biomed Res Int. 2017;2017:4191670. doi: 10.1155/2017/4191670. Epub 2017 Jun 5.
Cerebrolysin was reported to be effective in the neurological improvement of patients with acute ischemic stroke (AIS) in experimental models, while data from clinical trials were inconsistent. We performed a meta-analysis to explore the efficacy and safety of cerebrolysin for AIS. PubMed, EMBASE, and Cochrane Library were searched for randomized controlled trials, which intervened within 72 hours after the stroke onset. We investigated the efficacy and safety outcomes, respectively. Risk ratios and mean differences were pooled with fixed-effects model or random-effects model. Seven studies were identified, involving 1779 patients with AIS. The summary results failed to demonstrate significant superiority of cerebrolysin in the assessment of efficacy outcomes of mRS and BI. Similarly, administration of cerebrolysin had neutral effects on safety outcomes compared with placebo, including mortality and SAE. However, the number of included studies was small, especially in the analysis of efficacy outcomes, which might cause publication bias and inaccurate between-studies variance in the meta-analysis. Conclusively, although it seemed to be safe, routine use of cerebrolysin to improve the long-term rehabilitation after stroke could not be supported by available evidence.
据报道，在实验模型中，脑活素对急性缺血性卒中（AIS）患者的神经功能改善有效，但临床试验数据并不一致。我们进行了一项荟萃分析，以探讨脑活素治疗AIS的疗效和安全性。检索了PubMed、EMBASE和Cochrane图书馆中的随机对照试验，这些试验在卒中发作后72小时内进行干预。我们分别调查了疗效和安全性结果。风险比和均值差采用固定效应模型或随机效应模型进行汇总。共纳入7项研究，涉及1779例AIS患者。汇总结果未能显示脑活素在改良Rankin量表（mRS）和巴氏指数（BI）疗效评估方面具有显著优势。同样，与安慰剂相比，脑活素给药对安全性结果（包括死亡率和严重不良事件）的影响呈中性。然而，纳入研究数量较少，尤其是在疗效结果分析方面，这可能导致荟萃分析中出现发表偏倚和研究间方差不准确的情况。总之，尽管脑活素似乎是安全的，但现有证据不支持常规使用脑活素改善卒中后的长期康复。
