心脏骤停伴可除颤节律患者的低温与正常体温：TTM-2 研究的二次分析。
Hypothermia versus normothermia in patients with cardiac arrest and shockable rhythm: a secondary analysis of the TTM-2 study.
机构信息
Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB), Brussels, Belgium.
After ROSC Network, Paris, France.
出版信息
Crit Care. 2024 Oct 15;28(1):335. doi: 10.1186/s13054-024-05119-3.
BACKGROUND
The aim of this study was to assess whether hypothermia increased survival and improved functional outcome when compared with normothermia in out-of-hospital cardiac arrest (OHCA) patients with similar characteristics than in previous randomized studies showing benefits for hypothermia.
METHODS
Post hoc analysis of a pragmatic, multicenter, randomized clinical trial (TTM-2, NCT02908308). In this analysis, the subset of patients included in the trial who had similar characteristics to patients included in one previous randomized trial and randomized to hypothermia at 33 °C or normothermia (i.e. target < 37.8 °C) were considered. The primary outcome was survival at 6 months; secondary outcomes included favorable functional outcome at 6 months, defined as a modified Rankin scale of 0-3. Time-to-death and the occurrence of adverse events were also reported.
RESULTS
From a total of 1891 included in the TTM-2 study, 600 (31.7%) were included in the analysis, 294 in the hypothermia and 306 in the normothermia group. At 6 months, 207 of the 294 patients (70.4%) in the hypothermia group and 220 of the 306 patients (71.8%) in the normothermia group had survived (relative risk with hypothermia, 0.96; 95% confidence interval [CI], 0.81 to 1.15; P = 0.71). Also, 198 of the 294 (67.3%) in the hypothermia group and 202 of the 306 (66.0%) in the normothermia group had a favorable functional outcome (relative risk with hypothermia, 1.03; 95% CI, 0.87 to 1.23; P = 0.79). There was a significant increase in the occurrence of arrythmias in the hypothermia group (62/294, 21.2%) when compared to the normothermia group (43/306, 14.1%-OR 1.49, 95% CI 1.05-2.14; p = 0.026).
CONCLUSIONS
In this study, hypothermia at 33˚C did not improve survival or functional outcome in a subset of patients with similar cardiac arrest characteristics to patients in whom benefit from hypothermia was shown in prior studies.
背景
本研究旨在评估与先前显示低温治疗获益的随机研究中具有相似特征的院外心脏骤停（OHCA）患者相比，低温治疗是否会增加生存率并改善功能结局。
方法
这是一项实用、多中心、随机临床试验（TTM-2，NCT02908308）的事后分析。在该分析中，将试验中纳入的具有与先前一项随机试验中纳入的患者相似特征并随机分为 33°C 低温组或常规体温组（即目标<37.8°C）的患者亚组纳入分析。主要结局为 6 个月时的生存率；次要结局包括 6 个月时的良好功能结局，定义为改良 Rankin 量表评分为 0-3 分。还报告了死亡时间和不良事件的发生情况。
结果
在 TTM-2 研究中总共纳入了 1891 例患者，其中 600 例（31.7%）纳入了分析，其中低温组 294 例，常规体温组 306 例。6 个月时，低温组 294 例患者中有 207 例（70.4%）存活，常规体温组 306 例患者中有 220 例（71.8%）存活（低温组的相对风险，0.96；95%置信区间[CI]，0.81 至 1.15；P=0.71）。低温组 294 例患者中有 198 例（67.3%）和常规体温组 306 例患者中有 202 例（66.0%）的功能结局良好（低温组的相对风险，1.03；95%CI，0.87 至 1.23；P=0.79）。与常规体温组（43/306，14.1%）相比，低温组（62/294，21.2%）心律失常的发生率显著增加（OR 1.49，95%CI 1.05-2.14；p=0.026）。
结论
在本研究中，33°C 的低温治疗并未改善具有与先前研究中低温治疗获益患者相似特征的患者亚组的生存率或功能结局。
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