摘要
目的:系统评价脑蛋白水解物辅助治疗急性脑梗死的疗效与安全性,为临床提供循证参考。方法:计算机检索SCI、Cochrane图书馆、EMBase、Pub Med、中国期刊全文数据库(CJFD)、中文科技期刊数据库(VIP)、万方数据库,收集脑蛋白水解物联合常规方案(试验组)对比单纯常规方案或联合安慰剂(对照组)治疗急性脑梗死的随机对照试验(RCT),提取资料并按照Cochrane系统评价员手册5.1.0评价质量后,采用Rev Man 5.2统计软件对数据进行Meta分析。结果:最终纳入20项RCT,包括3 313例患者。Meta分析结果显示,试验组患者美国国立卫生研究院卒中量表(NIHSS)评分[MD=-1.77,95%CI(-2.33,-1.21),P<0.001]、有效率[OR=2.85,95%CI(1.75,4.63),P<0.001]、Barthel指数(BI)评分[MD=7.30,95%CI(3.48,11.13),P<0.001]显著高于对照组,差异均有统计学意义;两组患者致残率[OR=0.46,95%CI(0.20,1.03),P=0.06]、死亡率[OR=0.79,95%CI(0.52,1.19),P=0.25]、不良反应发生率[OR=1.04,95%CI(0.85,1.27),P=0.72]和严重不良反应发生率[OR=0.01,95%CI(-0.02,0.04),P=0.51]比较,差异均无统计学意义。结论:脑蛋白水解物辅助治疗急性脑梗死疗效较好,可以显著改善患者神经功能缺损状态和生活质量,且不增加不良反应的发生。
OBJECTIVE：To evaluate the efficacy and safety of cerebrolysin in adjuvant treatmenut of acute cerebral infarction systematically,and to provide evidence-based reference in clinic. METHODS：Retrieved from SCI,Cochrane Library,EMBase,Pub Med,CJFD,VIP and Wanfang Database,RCTs about cerebrolysin combined with routine plan（trial group）vs. routine plan alone or combined with placebo（control group）in adjuvant treatment of acute cerebral infarction were collected. After data extraction and quality evaluation by using Cochrane systematic review manual 5.1.0,Meta-analysis was conducted by using RevMan 5.2 statistical software. RESULTS：A total of 20 RCTs were included,involving 3 313 patients. Meta-analysis showed that NIHSS score [MD=-1.77,95%CI（-2.33,-1.21）,P〈0.001],response rate [OR=2.85,95%CI（1.75,4.63）,P〈0.001] and Barthel index（BI）score [MD=7.30,95%CI（3.48,11.13）,P〈0.001] in trial group were significantly higher than control group,with statistical significance. There was no statistical significance in disability rate [OR=0.46,95%CI（0.20,1.03）,P=0.06],mortality [OR=0.79,95%CI（0.52,1.19）,P=0.25],the incidence of ADR [OR=1.04,95%CI（0.85,1.27）,P=0.72] or the incidence of severe ADR [OR=0.01,95%CI（-0.02,0.04）,P=0.51] between 2 groups. CONCLUSIONS：Cerebrolysin is good for adjanctive therapy of acute cerebral infarction,can significantly improve neurologic impairment and life quality and dosen＇t increase the incidence of ADR.
作者
唐榕
陈沛然
肖利洪
张世洪
勾忠平
李梅
冯萍
TANG Rong CHEN Peiran XIAO Lihong ZHANG Shihong GOU Zhongping LI Mei FENG Ping(West China School of Public Health, Siehuan University, Chengdu 610041, China Dept. of Neurology, West China Hospital, Sichuan University, Chengdu 610041, China National Institution of Drug Clinical Trial, West China Hospital, Sichuan University, Chengdu 610041, China)
出处
《中国药房》
CAS
北大核心
2017年第30期4233-4237,共5页
China Pharmacy
基金
四川省科技支撑计划项目(No.2013SZ0003)
