Hui Jiyuan, Feng Junfeng, Tu Yue, Zhang Weituo, Zhong Chunlong, Liu Min, Wang Yuhai, Long Liansheng, Chen Ligang, Liu Jinfang, Mou Chaohui, Qiu Binghui, Huang Xianjian, Huang Qibing, Zhang Nu, Yang Xiaofeng, Yang Chaohua, Li Lihong, Ma Rong, Wu Xiang, Lei Jin, Jiang Yong, Liu Liang, Gao Guoyi, Jiang Jiyao
Head Trauma Center, Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University/School of Medicine, Shanghai Institute of Head Trauma, Shanghai, China.
Neurological Intensive Care Unit, Beijing Chaoyang Integrative Medicine Emergency Medical Center, Beijing, China.
EClinicalMedicine. 2021 Jan 28;32:100732. doi: 10.1016/j.eclinm.2021.100732. eCollection 2021 Feb.
Therapeutic hypothermia may need prolonged duration for the patients with severe traumatic brain injury (sTBI).
The Long-Term Hypothermia trial was a prospective, multicenter, randomized, controlled clinical trial to examine the safety and efficacy in adults with sTBI. Eligible patients were 18-65, Glasgow Coma Scale score at 4 to 8, and initial intracranial pressure (ICP) ≥ 25 mm Hg, randomly assigned to the long-term mild hypothermia group (34-35 °C for 5 days) or normothermia group at 37 °C. The primary outcome was the Glasgow outcome scale (GOS) at 6 months. Secondary outcomes included ICP control, complications and laboratory findings, the length of ICU and hospital stay, and GOS at 6 months in patients with initial ICP ≥ 30 mm Hg. This trial is registered with ClinicalTrials.gov, NCT01886222.
302 patients were enrolled from June 25, 2013, to December 31, 2018, with 6 months follow-up in 14 hospitals, 156 in hypothermia group and 146 in normothermia group. There was no difference in favorable outcome (OR 1·55, 95%CI 0·91-2·64; = 0·105) and in mortality ( = 0·111) between groups. In patients with an initial ICP ≥ 30 mm Hg, hypothermic treatment significantly increased favorable outcome over normothermia group (60·82%, 42·71%, respectively; OR 1·861, 95%CI 1·031-3·361; = 0·039). Long-term mild hypothermia did not increase the incidences of complications.
Long-term mild hypothermia did not improve the neurological outcomes. However, it may be a potential option in sTBI patients with initial ICP ≥ 30 mm Hg.
: Shanghai municipal government and Shanghai Jiao Tong University/School of Medicine.
对于重度创伤性脑损伤（sTBI）患者，治疗性低温可能需要持续较长时间。
长期低温试验是一项前瞻性、多中心、随机对照临床试验，旨在研究其对成年sTBI患者的安全性和有效性。符合条件的患者年龄在18至65岁之间，格拉斯哥昏迷量表评分为4至8分，初始颅内压（ICP）≥25毫米汞柱，随机分为长期轻度低温组（34 - 35°C，持续5天）或37°C的正常体温组。主要结局指标是6个月时的格拉斯哥预后量表（GOS）。次要结局指标包括ICP控制情况、并发症和实验室检查结果、重症监护病房（ICU）和住院时间，以及初始ICP≥30毫米汞柱患者6个月时的GOS。该试验已在ClinicalTrials.gov注册，注册号为NCT01886222。
2013年6月25日至2018年12月31日共纳入302例患者，在14家医院进行了6个月的随访，低温组156例，正常体温组146例。两组在良好结局（比值比1.55，95%置信区间0.91 - 2.64；P = 0. 105）和死亡率（P = 0.111）方面无差异。在初始ICP≥30毫米汞柱的患者中，低温治疗组的良好结局显著高于正常体温组（分别为60.82%和42.71%；比值比1.861，95%置信区间1.031 - 3.361；P = 0.039）。长期轻度低温并未增加并发症的发生率。
长期轻度低温并未改善神经学结局。然而，对于初始ICP≥30毫米汞柱的sTBI患者，它可能是一个潜在的选择。
上海市政府和上海交通大学医学院
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