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院外心脏骤停后进行靶向低温管理并不优于正常体温管理
2021-06-20 16:28

瑞典赫尔辛堡医院Niklas Nielsen团队比较了院外心脏骤停后进行靶向低温与常温管理的效果。该研究成果发表在2021年6月16日出版的《新英格兰医学杂志》上。

心脏骤停后患者通常被建议采用靶向温度管理,但支持证据尚不明确。

在一项盲法评估结果的开放性试验中,研究组招募了1900名昏迷成人,均曾有过心脏或未知原因导致的院外心脏骤停,将其随机分组,分别接受33°C的靶向低温管理,之后控制缓慢复温;或接受早期发热(体温,≥37.8°C)治疗的靶向正常体温管理。

主要结局是6个月时的全因死亡。次要结局包括6个月时使用改良Rankin量表评估的功能结局。根据性别、年龄、初始心律、自主循环恢复时间以及入院时是否休克来确定预先分组。预先指定的不良事件包括肺炎、脓毒症、出血、导致血流动力学损害的心律失常以及与温度管理装置相关的皮肤并发症。

研究组共对1850例患者进行了主要预后评估。6个月后,低温组925名患者中有465名(50%)死亡,常温组925名患者中有446人(48%)死亡。在1747例评估功能结局的患者中,低温组881例患者中有488例(55%)患有中度或更严重的残疾(改良Rankin评分≥4),而常温组866例患者中有479例(55%)。在预先指定的亚组中上述结果也一致。低温组中心律失常导致的血流动力学损害发生率为24%,显著高于常温组(17%)。其他不良事件发生率两组间无显著差异。

研究结果表明,对于院外心脏骤停后昏迷的患者,与采用靶向常温治疗相比,靶向低温管理治疗6个月后的死亡率并未显著降低。

附:英文原文

Title: Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest

Author: Josef Dankiewicz, M.D., Ph.D.,, Tobias Cronberg, M.D., Ph.D.,, Gisela Lilja, O.T., Ph.D.,, Janus C. Jakobsen, M.D., Ph.D.,, Helena Levin, M.Sc.,, Susann Ullén, Ph.D.,, Christian Rylander, M.D., Ph.D.,, Matt P. Wise, M.B., B.Ch., D.Phil.,, Mauro Oddo, M.D.,, Alain Cariou, M.D., Ph.D.,, Jan Bělohlávek, M.D., Ph.D.,, Jan Hovdenes, M.D., Ph.D.,, Manoj Saxena, M.B., B.Ch., Ph.D.,, Hans Kirkegaard, M.D., D.M.Sc.,, Paul J. Young, M.D., Ph.D.,, Paolo Pelosi, M.D.,, Christian Storm, M.D., Ph.D.,, Fabio S. Taccone, M.D., Ph.D.,, Michael Joannidis, M.D.,, Clifton Callaway, M.D., Ph.D.,, Glenn M. Eastwood, R.N., Ph.D.,, Matt P.G. Morgan, M.B., B.Ch., Ph.D.,, Per Nordberg, M.D., Ph.D.,, David Erlinge, M.D., Ph.D.,, Alistair D. Nichol, Ph.D.,, Michelle S. Chew, M.D., Ph.D.,, Jacob Hollenberg, M.D., Ph.D.,, Matthew Thomas, M.B., B.Ch.,, Jeremy Bewley, M.B., B.Ch.,, Katie Sweet, R.N., B.Sc.,, Anders M. Grejs, M.D., Ph.D.,, Steffen Christensen, M.D., Ph.D.,, Matthias Haenggi, M.D.,, Anja Levis, M.D.,, Andreas Lundin, M.D.,, Joachim Düring, M.D.,, Simon Schmidbauer, M.D.,, Thomas R. Keeble, M.B., B.S., M.D.,, Grigoris V. Karamasis, M.D.,, Claudia Schrag, M.D.,, Edith Faessler, M.D.,, Ondrej Smid, M.D., Ph.D.,, Michal Otáhal, M.D., Ph.D.,, Marco Maggiorini, M.D.,, Pedro D. Wendel Garcia, M.Sc.,, Paul Jaubert, M.D.,, Jade M. Cole, R.N., B.Sc.,, Miroslav Solar, M.D., Ph.D.,, Ola Borgquist, M.D., Ph.D.,, Christoph Leithner, M.D.,, Samia Abed-Maillard, M.Sc.,, Leanlove Navarra, R.N., B.Sc.,, Martin Annborn, M.D., Ph.D.,, Johan Undén, M.D., Ph.D.,, Iole Brunetti, M.D.,, Akil Awad, M.D.,, Peter McGuigan, M.B., B.Ch.,, Roy Bjrkholt Olsen, M.D., Ph.D.,, Tiziano Cassina, M.D., Ph.D.,, Philippe Vignon, M.D., Ph.D.,, Halvor Langeland, M.D.,, Theis Lange, Ph.D.,, Hans Friberg, M.D., Ph.D.,, and Niklas Nielsen, M.D., Ph.D.

Issue&Volume: 2021-06-16

Abstract:

Background

Targeted temperature management is recommended for patients after cardiac arrest, but the supporting evidence is of low certainty.

Methods

In an open-label trial with blinded assessment of outcomes, we randomly assigned 1900 adults with coma who had had an out-of-hospital cardiac arrest of presumed cardiac or unknown cause to undergo targeted hypothermia at 33°C, followed by controlled rewarming, or targeted normothermia with early treatment of fever (body temperature, ≥37.8°C). The primary outcome was death from any cause at 6 months. Secondary outcomes included functional outcome at 6 months as assessed with the modified Rankin scale. Prespecified subgroups were defined according to sex, age, initial cardiac rhythm, time to return of spontaneous circulation, and presence or absence of shock on admission. Prespecified adverse events were pneumonia, sepsis, bleeding, arrhythmia resulting in hemodynamic compromise, and skin complications related to the temperature management device.

Results

A total of 1850 patients were evaluated for the primary outcome. At 6 months, 465 of 925 patients (50%) in the hypothermia group had died, as compared with 446 of 925 (48%) in the normothermia group (relative risk with hypothermia, 1.04; 95% confidence interval [CI], 0.94 to 1.14; P=0.37). Of the 1747 patients in whom the functional outcome was assessed, 488 of 881 (55%) in the hypothermia group had moderately severe disability or worse (modified Rankin scale score ≥4), as compared with 479 of 866 (55%) in the normothermia group (relative risk with hypothermia, 1.00; 95% CI, 0.92 to 1.09). Outcomes were consistent in the prespecified subgroups. Arrhythmia resulting in hemodynamic compromise was more common in the hypothermia group than in the normothermia group (24% vs. 17%, P<0.001). The incidence of other adverse events did not differ significantly between the two groups.

Conclusions

In patients with coma after out-of-hospital cardiac arrest, targeted hypothermia did not lead to a lower incidence of death by 6 months than targeted normothermia.

DOI: 10.1056/NEJMoa2100591

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2100591

 

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home


本期文章:《新英格兰医学杂志》:Vol.384 No.24

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