儿童院外心脏骤停后的治疗性低温
Therapeutic hypothermia after out-of-hospital cardiac arrest in children.
作者信息
Moler Frank W, Silverstein Faye S, Holubkov Richard, Slomine Beth S, Christensen James R, Nadkarni Vinay M, Meert Kathleen L, Clark Amy E, Browning Brittan, Pemberton Victoria L, Page Kent, Shankaran Seetha, Hutchison Jamie S, Newth Christopher J L, Bennett Kimberly S, Berger John T, Topjian Alexis, Pineda Jose A, Koch Joshua D, Schleien Charles L, Dalton Heidi J, Ofori-Amanfo George, Goodman Denise M, Fink Ericka L, McQuillen Patrick, Zimmerman Jerry J, Thomas Neal J, van der Jagt Elise W, Porter Melissa B, Meyer Michael T, Harrison Rick, Pham Nga, Schwarz Adam J, Nowak Jeffrey E, Alten Jeffrey, Wheeler Derek S, Bhalala Utpal S, Lidsky Karen, Lloyd Eric, Mathur Mudit, Shah Samir, Wu Theodore, Theodorou Andreas A, Sanders Ronald C, Dean J Michael
机构信息
The authors' affiliations are listed in the Appendix.
出版信息
N Engl J Med. 2015 May 14;372(20):1898-908. doi: 10.1056/NEJMoa1411480. Epub 2015 Apr 25.
BACKGROUND
Therapeutic hypothermia is recommended for comatose adults after witnessed out-of-hospital cardiac arrest, but data about this intervention in children are limited.
METHODS
We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest.
RESULTS
A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% confidence interval [CI], 0.86 to 2.76; P=0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P=0.13) and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P=0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality.
CONCLUSIONS
In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; THAPCA-OH ClinicalTrials.gov number, NCT00878644.).
背景
对于院外心脏骤停后昏迷的成年人，推荐进行治疗性低温治疗，但有关该干预措施在儿童中的数据有限。
方法
我们在38家儿童医院对38名院外心脏骤停后仍昏迷的儿童进行了两种目标温度干预的试验。在恢复循环后6小时内，将年龄大于2天且小于18岁的昏迷患者随机分配至治疗性低温组（目标温度33.0°C）或治疗性正常体温组（目标温度36.8°C）。主要疗效结局为心脏骤停后12个月存活且Vineland适应性行为量表第二版（VABS-II）得分≥70分（评分范围为20至160分，分数越高功能越好），在心脏骤停前VABS-II得分至少为70分的患者中进行评估。
结果
共有295例患者进行了随机分组。在260例可评估数据且心脏骤停前VABS-II得分至少为70分的患者中，低温组和正常体温组的主要结局无显著差异（20%对12%；相对可能性，1.54；95%置信区间[CI]，0.86至2.76；P = 0.14）。在所有可评估数据的患者中，从基线到12个月VABS-II得分的变化无显著差异（P = 0.13），1年生存率相似（低温组为38%，正常体温组为29%；相对可能性，1.29；95% CI，0.93至1.79；P = 0.13）。两组感染和严重心律失常的发生率相似，血液制品的使用情况和28天死亡率也相似。
结论
在院外心脏骤停后存活的昏迷儿童中，与治疗性正常体温相比，治疗性低温在1年时并未在存活且具有良好功能结局方面带来显著益处。（由美国国立心肺血液研究所等资助；THAPCA-OH ClinicalTrials.gov编号，NCT00878644。）
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