Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy
Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy
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DOI：
10.1056/nejmcps050929
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发表时间：
2005-10-13
影响因子：
158.5
通讯作者：
Jobe, AH
中科院分区：
文献类型：
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作者：
Shankaran, S;Laptook, AR;Jobe, AH
背景：在动物模型中，低温可预防窒息后的脑损伤。然而，对患有脑病的足月儿进行低温治疗的安全性和有效性尚不确定。 方法：我们对胎龄至少 36 周的婴儿进行了一项随机低温试验，这些婴儿在 6 小时或之前入院，患有严重酸中毒或围产期并发症并在出生时进行复苏，并且患有中度或重度脑病。婴儿被随机分配到常规护理组（对照组）或全身降温至食道温度 33.5 摄氏度 72 小时，然后缓慢复温（低温组）。在 18 至 22 个月大时评估神经发育结果。主要结局是死亡或中度或重度残疾的综合终点。 结果：在 239 名符合条件的婴儿中，102 名被分配到低温组，106 名被分配到对照组。在 72 小时的降温过程中，两组的不良事件相似。可获得 205 名婴儿的主要结果数据。低温组 102 名婴儿中有 45 名（44%）发生死亡或中度或重度残疾，对照组 103 名婴儿中有 64 名（62%）发生死亡或中度或重度残疾（风险比，0.72；95% 置信区间，0.54 至 0.95；P=0.01）。低温组有 24 名婴儿 (24%) 死亡，对照组有 38 名婴儿 (37%) 死亡（风险比，0.68；95% 置信区间，0.44 至 1.05；P=0.08）。幸存者的严重残疾没有增加；低温组的脑瘫发生率为 77 例中的 15 例（19%），而对照组的脑瘫发生率为 64 例中的 19 例（30%）（风险比为 0.68；95% 置信区间为 0.38 至 1.22；P=0.20）。结论：全身低温可降低中度或重度缺氧缺血婴儿的死亡或残疾风险脑病。
BACKGROUND:Hypothermia is protective against brain injury after asphyxiation in animal models. However, the safety and effectiveness of hypothermia in term infants with encephalopathy is uncertain.METHODS:We conducted a randomized trial of hypothermia in infants with a gestational age of at least 36 weeks who were admitted to the hospital at or before six hours of age with either severe acidosis or perinatal complications and resuscitation at birth and who had moderate or severe encephalopathy. Infants were randomly assigned to usual care (control group) or whole-body cooling to an esophageal temperature of 33.5 degreesC for 72 hours, followed by slow rewarming (hypothermia group). Neurodevelopmental outcome was assessed at 18 to 22 months of age. The primary outcome was a combined end point of death or moderate or severe disability.RESULTS:Of 239 eligible infants, 102 were assigned to the hypothermia group and 106 to the control group. Adverse events were similar in the two groups during the 72 hours of cooling. Primary outcome data were available for 205 infants. Death or moderate or severe disability occurred in 45 of 102 infants (44 percent) in the hypothermia group and 64 of 103 infants (62 percent) in the control group (risk ratio, 0.72; 95 percent confidence interval, 0.54 to 0.95; P=0.01). Twenty-four infants (24 percent) in the hypothermia group and 38 (37 percent) in the control group died (risk ratio, 0.68; 95 percent confidence interval, 0.44 to 1.05; P=0.08). There was no increase in major disability among survivors; the rate of cerebral palsy was 15 of 77 (19 percent) in the hypothermia group as compared with 19 of 64 (30 percent) in the control group (risk ratio, 0.68; 95 percent confidence interval, 0.38 to 1.22; P=0.20).CONCLUSIONS:Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.