亚低温对新生儿缺氧缺血性脑损伤的保护作用——随机对照试验Meta分析  

Protective effects of mild bypotbermia on neonatal bypoxic-iscbemic brain injury-Meta-analysis of randomized-controlled trails

作　　者：汤亚南[1] 赵凤临[1] 陈白羽[2] 王波[3] 

机构地区：[1]北京大学第三医院儿科,100083 [2]北京大学基础医学院解剖学系 [3]北京大学公共卫生学院流行病学教研室

出　　处：《中华围产医学杂志》2008年第2期101-106,共6页Chinese Journal of Perinatal Medicine

摘　　要：目的评价亚低温对新生儿缺氧缺血性脑损伤的保护作用。方法计算机检索Medline／PubMed（1977-2006年）医学数据库、荷兰医学文摘（Embase，1989～2006年）和OVID全文数据库、Cochrane系统评价数据库（2006年）、中国学术期刊网全文数据库（CNKI，1994-2006年）、中国生物医学文献数据库（CBMdisc，1978-2006年）和国家科技图书文献中心等文献数据库，收集亚低温治疗新生儿缺氧缺血性脑损伤的临床研究和系统评价，进行质量评价，并对符合纳入标准的临床研究进行Meta分析。结果共查阅到国内外相关临床研究18篇，纳入随机对照研究4篇，其中国外3篇，国内1篇，均为高质量研究（Jadad评分均为3分）。纳入研究均描述了随机化方法，但均未使用盲法。各组研究随访12～18个月，报道了病死率和严重伤残的发生率，均描述了失访情况。合并分析表明，与普通治疗组比较，亚低温组病死率OR=0．64，95％CI为0．46～0．90，P=0．01；严重伤残发生率OR=0．57，95％CI为0．37-0．86，P=0．008；严重伤残和病死的合并发生率OR=0．50，95％CI为0．369～0．69，P〈0．01，差异均有统计学意义。结论从现有临床证据看，亚低温可降低新生儿缺氧缺血性脑损伤后严重伤残发生率和病死率，但仍需大规模、高质量、随访结局统一的临床试验进一步验证。Objective To assess the efficacy of mild hypothermia in treatment of neonatal hypoxic-ischemic brain injury. Methods According to the requirements of Cochrane systematic review, a thorough literature search was performed among Medline/PubMed （1977- 2006）, Embase （1989-2006）, OVID, Cochrane（2006）, Chinese Digital Hospital Library （www. chkd. cnki. net） and Chinese Biomedical Literature Disk Database （CBMdisk）. Quality assessments of clinical trials were carried out. Randomized controlled trials （RCTs） with fatality rate and the incidence rate of severe disability were selected for meta-analysis. Results A total of 725 patients involved in 4 papers which met the inclusion criteria were enrolled in this meta-analysis. Four RCTs with Jadad score was 3 were included, 3 papers were done in overseas and 1 papers was done in China. All of the 4 RCTs described the method of randomization and allocation concealment. But none of the 4 RCTs mentioned whether blindness was used. Comparing with the control group, the OR of the fatality rate in mild hypothermia group was 0.64 with 95% CI 0. 46-0.90, P= 0.01. The OR of the incidence rate of severe disability was 0.57 with 95% CI 0. 3740.86, P=0. 008. The OR of the overall incidence rate of severe disability and death was 0.50 with 95 % CI 0. 36-0.69, P-0.01. Conclusions The clinical evidences available so far indicated that mild hypothermia could reduce the fatality rate and the incidence rate of severe disability resulted from neonatal hypoxic-ischemic brain injury. The quality of most RCTs on mild hypothermia in China for HIE was not in good quality. Scientifically designed RCTs are still needed to evaluate the value of mild hypothermia in the treatment of HIE.

关 键 词：缺氧缺血 脑 低温 人工 婴儿 新生 随机对照试验 META分析 

分 类 号：R722.12[医药卫生—儿科] R651.15[医药卫生—临床医学]