From the Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.
Stroke. 2016 Feb;47(2):457-63. doi: 10.1161/STROKEAHA.115.009789. Epub 2015 Dec 22.
We conducted this randomized controlled trial to investigate the effects of therapeutic hypothermia on mortality and neurological outcome in patients with massive cerebral hemispheric infarction.
Patients within 48 hours of symptom onset were randomized to either a hypothermia group or a control group. Patients in the hypothermia group were given standard medical treatment plus endovascular hypothermia with a target temperature of 33 or 34°C. Hypothermia was maintained for a minimum of 24 hours. Patients in the control group were given standard medical treatment only with a target temperature of normothermia. The primary end points were mortality and the modified Rankin Scale score at 6 months.
There were 16 patients in the hypothermia group and 17 patients in the control group. At 6 months, 8 patients had died in the hypothermia group versus 7 patients in the control group (P=0.732). The main cause of death was fatal herniation caused by a pronounced rise in intracranial pressure. Seven patients (43.8%) had a modified Rankin Scale of 1 to 3 in the hypothermia group versus 4 patients (23.5%) in the control group (P=0.282). Additionally, of the survivors, patients in the hypothermia group achieved better neurological outcomes compared with those in the control group (7/8, 87.5% versus 4/10, 40.0%; P=0.066; odds ratio=10.5; 95% confidence interval, 0.9-121.4).
Mild hypothermia seems to not reduce mortality in patients with massive cerebral hemispheric infarction but may improve the neurological outcome in survivors. An adequately powered multicenter randomized controlled trial seems warranted.
URL: http://www.chictr.org.cn. Unique identifier: ChiCTR-TCS-12002680.
本研究旨在探讨治疗性低温对大面积大脑半球梗死患者死亡率和神经功能结局的影响，为此我们开展了这项随机对照试验。
发病后 48 小时内的患者被随机分配到低温组或对照组。低温组患者接受标准治疗加血管内低温治疗，目标温度为 33°C 或 34°C，低温维持至少 24 小时。对照组患者仅接受标准治疗，目标体温为正常体温。主要终点是 6 个月时的死亡率和改良 Rankin 量表评分。
低温组 16 例，对照组 17 例。6 个月时，低温组死亡 8 例，对照组死亡 7 例（P=0.732）。死亡的主要原因是颅内压显著升高导致致命性脑疝。低温组改良 Rankin 量表评分为 1-3 的患者有 7 例（43.8%），对照组有 4 例（23.5%）（P=0.282）。此外，在幸存者中，低温组患者的神经功能结局优于对照组（7/8，87.5% 对 4/10，40.0%；P=0.066；优势比=10.5；95%置信区间，0.9-121.4）。
轻度低温似乎不能降低大面积大脑半球梗死患者的死亡率，但可能改善幸存者的神经功能结局。需要一项足够大样本量的多中心随机对照试验来进一步验证。
Zotero 插件