脑蛋白水解物治疗新生儿缺氧缺血性脑病的系统评价  

Cerebrolysin for patients with HIE：a systematic review

作　　者：麦泳瑶 刘毅[2] 程国华[1] 陈琳[3] 王霆[1,4] 

机构地区：[1]暨南大学药学院,广东广州510632 [2]首都儿科研究所附属儿童医院,北京100021 [3]暨南大学附属第一医院,广东广州510632 [4]广州一品红制药有限公司,广东广州510760

出　　处：《中国生化药物杂志》2017年第3期310-315,319,共7页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的 系统评价脑蛋白水解物治疗新生儿缺氧缺血性脑病的有效性。方法 计算机检索Cochrane图书馆、EMBase、Pub Med、中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、万方数据库（各数据库检索时间均从其创建至2016年5月）关于脑蛋白水解物治疗新生儿缺氧缺血性脑病的随机对照临床试验。按文献的纳入与排除标准进行筛选,并对纳入研究的方法学质量进行评价、提取资料;用Rev Man5.3软件对数据进行Meta分析。结果 共纳入41篇RCT,合计3695例患者,其中试验组为1932例,对照组为1763例。Meta分析结果显示,脑蛋白水解物治疗新生儿缺氧缺血性脑病的有效率显著高于对照组[OR=3.85,95%CI（3.15,4.70）,P〈0.000001];对于临床症状的影响方面,脑蛋白水解物治疗组新生儿缺氧缺血性脑病的原始反射恢复天数[MD=-1.22,95%CI（-2.06,-0.38）,P=0.004]、肌张力恢复天数[MD=-1.69,95%CI（-1.80,-1.58）,P〈0.00001]、意识状态恢复天数[MD=-1.32,95%CI（-2.25,-0.40）,P=0.005]、惊厥恢复天数[MD=-2.36,95%CI（-3.70,-1.03）,P=0.0005]等指标均短于对照组,试验组与对照组比较差异有统计学意义。结论 脑蛋白水解物治疗新生儿缺氧缺血性脑病疗效显著。Objective Systematic evaluation of cerebrolysin in the treatment of neonatal hypoxic -ischemic encephalopathy.Methods Computer search Cochrane Library, EMBase, PubMed, Chinese Journal Full-text Database （CNKI）, Chinese Biomedical Literature Database （CBM）, Wanfang Database （ each database retrieval time from its creation to May 2016 ） About cerebrolysin Randomized controlled clinical trial of neonatal hypoxic -ischemic encephalopathy.According to the inclusion and exclusion criteria of the literature, the methodological quality of the included research was evaluated and the data were extracted.Metadata was analyzed by RevMan 5.3 software.Results A total of 41 RCT patients were enrolled, with a total of 3695 patients, the experimental group was 1932 cases, the control group was 1763 cases.Meta analysis showed, the efficacy of cerebrolysin in the treatment of neonatal hypoxic-ischemic encephalopathy was significantly higher than that in the control group [OR=3.85, 95% CI （3.15,4.70）, P〈0.000001], for the impact of clinical symptoms, the number of primitive reflexes of neonatal hypoxic-ischemic encephalopathy in the treatment group was significantly higher than that in the control group [MD=-1.22, 95% CI （ -2.06,-0.38）, P=0.004], muscle tension recovery days[MD=-1.69, 95% CI （ -1.80,-1.58）, P〈0.00001], conscious state recovery days[MD=-1.32, 95% CI （ -2.25,-0.40）, P=0.005], seizure recovery days [MD=-2.36, 95% CI （ -3.70, -1.03）, P =0.0005], and other indicators were shorter than the control group, the difference between the experimental group and the control group was statistically significant.Conclusion Cerebrolysin havean effective in treating HIE.

关 键 词：脑蛋白水解物 新生儿缺氧缺血性脑病 随机对照试验 系统评价 

分 类 号：R722.1[医药卫生—儿科]