Wang Zefeng, Shi Ligen, Xu Shenbin, Zhang Jianmin
Department of Neurosurgery, Second Affiliated Hospital, School of Medicine.
Brain Research Institute.
Drug Des Devel Ther. 2017 Apr 19;11:1273-1282. doi: 10.2147/DDDT.S124273. eCollection 2017.
Cerebrolysin has been shown to have an inconsistent efficacy on functional recovery in patients with acute ischemic stroke (AIS). The present meta-analysis aims to evaluate the value of cerebrolysin and to explore the potential influencing factors. The main electronic databases, including MEDLINE, EMBASE, and the Cochrane Library, were searched. The primary outcome was functional recovery at Day 90. The secondary outcomes included mortality and adverse events. A total of 1,649 patients with AIS were pooled from six randomized controlled trials (RCTs). Cerebrolysin had no significant effect on functional recovery at Day 90 compared with the effect of placebo as shown by the modified Rankin Scale response (relative risk [RR] 1.33, 95% confidence interval [CI] 0.79-2.24, =0.28), National Institutes of Health Stroke Scale response (RR 1.03, 95% CI 0.83-1.28, =0.77), and Barthel Index response (RR 0.95, 95% CI 0.84-1.08, =0.44). In safety analysis, cerebrolysin did not increase the risk of adverse events (RR 0.98, 95% CI 0.88-1.09, =0.67), risk of serious adverse events (RR 1.20, 95% CI 0.86-1.66, =0.29), or the mortality rate (RR 0.86, 95% CI 0.57-1.31, =0.49). In conclusion, routine administration of cerebrolysin to patients with AIS cannot be supported by the available evidence from RCTs.
脑蛋白水解物已被证明对急性缺血性卒中(AIS)患者的功能恢复疗效并不一致。本荟萃分析旨在评估脑蛋白水解物的价值并探索潜在影响因素。检索了包括MEDLINE、EMBASE和Cochrane图书馆在内的主要电子数据库。主要结局是90天时的功能恢复情况。次要结局包括死亡率和不良事件。从六项随机对照试验(RCT)中汇总了总共1649例AIS患者。与安慰剂相比,脑蛋白水解物在90天时对功能恢复没有显著影响,改良Rankin量表反应显示(相对危险度[RR] 1.33,95%置信区间[CI] 0.79 - 2.24,P = 0.28),美国国立卫生研究院卒中量表反应(RR 1.03,95% CI 0.83 - 1.28,P = 0.77),以及Barthel指数反应(RR 0.95,95% CI 0.84 - 1.08,P = 0.44)。在安全性分析中,脑蛋白水解物并未增加不良事件风险(RR 0.98,95% CI 0.88 - 1.09,P = 0.67)、严重不良事件风险(RR 1.20,95% CI 0.86 - 1.66,P = 0.29)或死亡率(RR 0.86,95% CI 0.57 - 1.31,P = 0.49)。总之,RCT的现有证据不支持对AIS患者常规使用脑蛋白水解物。