Lancet Neurology：小儿严重颅脑外伤低温治疗不改善总体预后

低温及亚低温治疗常用与脑外伤患者。由于已有研究结果不一致,该研究作者评估了低体温治疗48-72小时后缓慢复温能否改善儿童颅脑损伤后的死亡率.
在这项3期多中心跨国随机对照试验中，作者纳入严重颅脑外伤的病人，年龄小于18岁，发病后6小时内者入组，应用计算机产生的随机性序列将病人随机分配(1:1;根据地点和年龄分层[<6 岁, 6—15岁, 16—17岁])，分别接受低体温治疗（快速低温达到32—33°C，维持48-72小时后每12-24小时复温0.5-1.0°C）或正常体温治疗（保持36·5—37·5°C）。按意向处理分析3个月内的死亡率作为主要结局事件，次要结局事件是运用格拉斯哥预后分级（GOS）及儿科延伸应用评估GOS的损伤后3个月时的总体功能状况，以及发生严重不良反应事件，评估结局的调查者对治疗未知，这项研究在ClinicalTrials.gov的注册号为NCT00222742.
由于中期数据分析发现该研究无用而提前结束，共分析了2007.11.1-2011.2.28期间纳入的77例病人：39例低温治疗组合38例正常体温治疗组，作者发现在损伤后3个月内两组间的死亡率无差异[低温治疗组中6/39例[15%] vs 正常体温治疗组2/38例[5%],p=0.15）；两组间的不良结局也无差异，低温治疗组16[42%]例病人的GOS评分显示不良结局、18[47%]例病人的儿科延伸应用评估GOS评分显示不良结局；正常体温治疗组16 [42%]例病人GOS评分显示不良结局、19/37例[51%]病人的儿科延伸应用评估GOS评分显示不良结局）。作者记录不良反应及严重不良事件的发生率也无组间差异。
低体温治疗48小时后缓慢复温不能降低儿科中严重颅脑外伤患者的死亡率以及改善总体功能结局。
与颅脑外伤相关的拓展阅读：

• Am J Psychiatry ：轻型颅脑外伤后继发成瘾障碍风险随时间变化
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Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomised controlled trial.
BACKGROUND
On the basis of mixed results from previous trials, we assessed whether therapeutic hypothermia for 48-72 h with slow rewarming improved mortality in children after brain injury.
METHODS
In this phase 3, multicenter, multinational, randomised controlled trial, we included patients with severe traumatic brain injury who were younger than 18 years and could be enrolled within 6 h of injury. We used a computer-generated randomisation sequence to randomly allocate patients (1:1; stratified by site and age [<6 years, 6-15 years, 16-17 years]) to either hypothermia (rapidly cooled to 32-33°C for 48-72 h, then rewarmed by 0·5-1·0°C every 12-24 h) or normothermia (maintained at 36·5-37·5°C). The primary outcome was mortality at 3 months, assessed by intention-to-treat analysis; secondary outcomes were global function at 3 months after injury using the Glasgow outcome scale (GOS) and the GOS-extended pediatrics, and the occurrence of serious adverse events. Investigators assessing outcomes were masked to treatment. This trial is registered with ClinicalTrials.gov, number NCT00222742.
FINDINGS
The study was terminated early for futility after an interim data analysis on data for 77 patients (enrolled between Nov 1, 2007, and Feb 28, 2011): 39 in the hypothermia group and 38 in the normothermia group. We detected no between-group difference in mortality 3 months after injury (6 [15%] of 39 patients in the hypothermia group vs two [5%] of 38 patients in the normothermia group; p=0·15). Poor outcomes did not differ between groups (in the hypothermia group, 16 [42%] patients had a poor outcome by GOS and 18 [47%] had a poor outcome by GOS-extended paediatrics; in the normothermia group, 16 [42%] patients had a poor outcome by GOS and 19 [51%] of 37 patients had a poor outcome by GOS-extended paediatrics). We recorded no between-group differences in the occurrence of adverse events or serious adverse events.
INTERPRETATION
Hypothermia for 48 h with slow rewarming does not reduce mortality of improve global functional outcome after paediatric severe traumatic brain injury.
FUNDING
National Institute of Neurological Disorders and Stroke and National Institutes of Health.