Lack of effect of induction of hypothermia after acute brain injury.
Lack of effect of induction of hypothermia after acute brain injury.
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DOI：
10.1056/nejm200102223440803
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发表时间：
2001-02-22
影响因子：
158.5
通讯作者：
Schwartz, M
中科院分区：
文献类型：
--
作者：
Clifton, GL;Miller, ER;Schwartz, M
背景：在小型临床研究中显示，在脑损伤患者中诱导低温可以改善预后，但结果并不确定。为了研究这一问题，我们进行了一项多中心试验，比较了低温和常温对急性颅脑损伤患者的疗效。方法：研究对象为392例16~65岁闭合性颅脑损伤后昏迷的患者，他们被随机分配到亚低温(体温，33℃)治疗，亚低温在伤后6小时内开始，通过体表降温或常温维持48小时。所有患者均接受标准治疗。结果：两组患者的平均年龄、损伤类型和严重程度相似。从损伤到随机化的平均(+/-SD)时间亚低温组为4.3+/-1.1小时，常温组为4.1+/-1.2小时；亚低温组从损伤到达到33℃的目标温度的平均时间为8.4+/-3.0小时。两组中57%的患者预后不佳(定义为严重残疾、植物状态或死亡)。亚低温组死亡率为28%，常温组为27%(P=0.79)。亚低温组出现并发症的住院天数明显多于常温组。结论：重型颅脑损伤患者伤后8h内体温达33℃的亚低温治疗不能有效改善预后。(N Engl J Med 2001；344：556-63)版权所有(C)2001年马萨诸塞州医学会。
Background: Induction of hypothermia in patients with brain injury was shown to improve outcomes in small clinical studies, but the results were not definitive. To study this issue, we conducted a multicenter trial comparing the effects of hypothermia with those of normothermia in patients with acute brain injury.Methods: The study subjects were 392 patients 16 to 65 years of age with coma after sustaining closed head injuries who were randomly assigned to be treated with hypothermia (body temperature, 33 degreesC), which was initiated within 6 hours after injury and maintained for 48 hours by means of surface cooling, or normothermia. All patients otherwise received standard treatment. The primary outcome measure was functional status six months after the injury.Results: The mean age of the patients and the type and severity of injury in the two treatment groups were similar. The mean (+/-SD) time from injury to randomization was 4.3+/-1.1 hours in the hypothermia group and 4.1+/-1.2 hours in the normothermia group, and the mean time from injury to the achievement of the target temperature of 33 degreesC in the hypothermia group was 8.4+/-3.0 hours. The outcome was poor (defined as severe disability, a vegetative state, or death) in 57 percent of the patients in both groups. Mortality was 28 percent in the hypothermia group and 27 percent in the normothermia group (P=0.79). The patients in the hypothermia group had more hospital days with complications than the patients in the normothermia group. Fewer patients in the hypothermia group had high intracranial pressure than in the normothermia group.Conclusions: Treatment with hypothermia, with the body temperature reaching 33 degreesC within eight hours after injury, is not effective in improving outcomes in patients with severe brain injury. (N Engl J Med 2001;344:556-63.) Copyright (C) 2001 Massachusetts Medical Society.