Wang Lai-shuan, Cheng Guo-qiang, Zhou Wen-hao, Sun Jin-qiao, Cao Yun, Shao Xiao-mei
Department of Neonatology, Children's Hospital of Fudan University, Shanghai 201102, China.
Zhonghua Yi Xue Za Zhi. 2012 May 29;92(20):1400-4.
To determine the effects of therapeutic hypothermia (TH) in encephalopathic asphyxiated newborn infants on mortality, long-term neurodevelopmental disability and side effects by summarizing the data of hypoxic-ischemic encephalopathy(HIE) newborns undergoing mild hypothermia using meta-analysis.
The standard searching strategy of the Neonatal Review Group as outlined in the Cochrane Library was used to retrieve all clinical literatures about TH on HIE. RevMan 5.1 software was used to perform the meta-analysis of target papers. The primary outcome measure was a combination of death and severe major neurodevelopmental disabilities at 18 - 24 months of age. Secondary outcomes included mortality, cerebral palsy (CP), neurodevelopmental delay, blindness, deafness and main side effects of cooling therapy.
A total of 276 papers fulfilled the search strategy and 11 trials were included. Overall TH resulted in a statistically significant and clinically important reduction in the combined outcome of death or major neurodevelopmental disabilities to 18-24 months of age (RR = 0.76, 95%CI: 0.68 - 0.84, P < 0.01). Moreover, as compared with the control group, TH significantly decreased the incidence of mortality (RR = 0.76, 95%CI: 0.65 - 0.90, P < 0.01), psychomotor development index(RR = 0.69, 95%CI: 0.55 - 0.87, P < 0.01), mental development index (RR = 0.66, 95%CI: 0.53 - 0.83, P < 0.01), CP (RR = 0.70, 95%CI: 0.54 - 0.91, P < 0.01) and blindness (RR = 0.54, 95%CI: 0.33 - 0.90, P < 0.05)except for severe hearing loss (deafness) (RR = 0.69, 95%CI: 0.35 - 1.34, P = 0.3000) in survivors. Adverse effects included significant thrombocytopenia in the TH group (P = 0.0400) but without deleterious consequences. There were no significant differences in arrhythmia, coagulopathy, hypotension requiring inotropic supports, sepsis and pulmonary hypertension between the TH and control groups (all P > 0.05).
Mild hypothermia is effective in reducing death and major disabilities in infants with moderate-to-severe HIE without significant side effects. Infants presenting within the first hours after birth with the signs and symptoms of moderate-to-severe encephalopathy should be cooled in accordance with the established protocols of previous randomized controlled trials.
通过对接受亚低温治疗的缺氧缺血性脑病（HIE）新生儿的数据进行Meta分析，确定治疗性低温（TH）对患脑病的窒息新生儿死亡率、长期神经发育残疾和副作用的影响。
采用Cochrane图书馆中概述的新生儿回顾组标准检索策略，检索所有关于TH治疗HIE的临床文献。使用RevMan 5.1软件对目标论文进行Meta分析。主要结局指标为18至24个月时死亡和严重主要神经发育残疾的综合情况。次要结局包括死亡率、脑瘫（CP）、神经发育延迟、失明、失聪以及降温治疗的主要副作用。
共有276篇论文符合检索策略，纳入11项试验。总体而言，TH导致18至24个月时死亡或主要神经发育残疾的综合结局在统计学上有显著且具有临床意义的降低（RR = 0.76，95%CI：0.68 - 0.84，P < 0.01）。此外，与对照组相比，TH显著降低了死亡率（RR = 0.76，95%CI：0.65 - 0.90，P < 0.01）、精神运动发育指数（RR = 0.69，95%CI：0.55 - 0.87，P < 0.01）、智力发育指数（RR = 0.66，95%CI：0.53 - 0.83，P < 0.01）、CP（RR = 0.70，95%CI：0.54 - 0.91，P < 0.01）和失明（RR = 0.54，95%CI：0.33 - 0.90, P < 0.05），但幸存者中严重听力损失（失聪）除外（RR = 0.69，95%CI：0.35 - 1.34，P = 0.3000）。不良反应包括TH组有显著的血小板减少（P = 0.0400），但无有害后果。TH组和对照组在心律失常、凝血病、需要使用血管活性药物支持的低血压、败血症和肺动脉高压方面无显著差异（所有P > 0.05）。
亚低温可有效降低中重度HIE婴儿的死亡和主要残疾，且无明显副作用。出生后数小时内出现中重度脑病体征和症状的婴儿应按照先前随机对照试验的既定方案进行降温治疗。
