围产期缺氧缺血性脑病亚低温治疗 18 个月时的神经学结局：试验数据的综合分析和荟萃分析。

Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data.

机构信息

Institute of Clinical Sciences, Faculty of Medicine, Imperial College London, London SW7 2AZ.

出版信息

BMJ. 2010 Feb 9;340:c363. doi: 10.1136/bmj.c363.

DOI:10.1136/bmj.c363

PMID:20144981

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2819259/

Abstract

OBJECTIVE

To determine whether moderate hypothermia after hypoxic-ischaemic encephalopathy in neonates improves survival and neurological outcome at 18 months of age.

DESIGN

A meta-analysis was performed using a fixed effect model. Risk ratios, risk difference, and number needed to treat, plus 95% confidence intervals, were measured.

DATA SOURCES

Studies were identified from the Cochrane central register of controlled trials, the Oxford database of perinatal trials, PubMed, previous reviews, and abstracts. Review methods Reports that compared whole body cooling or selective head cooling with normal care in neonates with hypoxic-ischaemic encephalopathy and that included data on death or disability and on specific neurological outcomes of interest to patients and clinicians were selected. Results We found three trials, encompassing 767 infants, that included information on death and major neurodevelopmental disability after at least 18 months' follow-up. We also identified seven other trials with mortality information but no appropriate neurodevelopmental data. Therapeutic hypothermia significantly reduced the combined rate of death and severe disability in the three trials with 18 month outcomes (risk ratio 0.81, 95% confidence interval 0.71 to 0.93, P=0.002; risk difference -0.11, 95% CI -0.18 to -0.04), with a number needed to treat of nine (95% CI 5 to 25). Hypothermia increased survival with normal neurological function (risk ratio 1.53, 95% CI 1.22 to 1.93, P<0.001; risk difference 0.12, 95% CI 0.06 to 0.18), with a number needed to treat of eight (95% CI 5 to 17), and in survivors reduced the rates of severe disability (P=0.006), cerebral palsy (P=0.004), and mental and the psychomotor developmental index of less than 70 (P=0.01 and P=0.02, respectively). No significant interaction between severity of encephalopathy and treatment effect was detected. Mortality was significantly reduced when we assessed all 10 trials (1320 infants; relative risk 0.78, 95% CI 0.66 to 0.93, P=0.005; risk difference -0.07, 95% CI -0.12 to -0.02), with a number needed to treat of 14 (95% CI 8 to 47).

CONCLUSIONS

In infants with hypoxic-ischaemic encephalopathy, moderate hypothermia is associated with a consistent reduction in death and neurological impairment at 18 months.

摘要

目的

确定新生儿缺氧缺血性脑病后亚低温治疗是否能改善 18 个月时的存活率和神经结局。

设计

使用固定效应模型进行荟萃分析。测量风险比、风险差异和需要治疗的人数，以及 95%置信区间。

数据来源

研究从 Cochrane 对照试验中心注册库、牛津围产期试验数据库、PubMed、以前的综述和摘要中确定。综述方法：报告比较了全身冷却或选择性头部冷却与缺氧缺血性脑病新生儿常规治疗，并包括死亡或残疾以及对患者和临床医生有意义的特定神经结局数据的研究。

结果

我们发现了三项试验，共纳入了 767 名婴儿，这些试验包括了至少 18 个月随访后的死亡和主要神经发育残疾的信息。我们还发现了另外七项具有死亡率信息但没有适当神经发育数据的试验。亚低温治疗显著降低了三项有 18 个月结局的试验中死亡和严重残疾的联合发生率（风险比 0.81，95%置信区间 0.71 至 0.93，P=0.002；风险差异 -0.11，95%置信区间 -0.18 至 -0.04），需要治疗的人数为 9（95%置信区间 5 至 25）。亚低温治疗增加了神经功能正常的存活率（风险比 1.53，95%置信区间 1.22 至 1.93，P<0.001；风险差异 0.12，95%置信区间 0.06 至 0.18），需要治疗的人数为 8（95%置信区间 5 至 17），在幸存者中降低了严重残疾的发生率（P=0.006）、脑瘫（P=0.004）和精神运动发育指数低于 70（P=0.01 和 P=0.02）。未发现脑病严重程度与治疗效果之间存在显著的交互作用。当我们评估所有 10 项试验（1320 名婴儿；相对风险 0.78，95%置信区间 0.66 至 0.93，P=0.005；风险差异 -0.07，95%置信区间 -0.12 至 -0.02）时，死亡率显著降低，需要治疗的人数为 14（95%置信区间 8 至 47）。