ORIGINAL ARTICLE
Oxygen Therapy in Suspected Acute Myocardial Infarction
Robin Hofmann, M.D., Stefan K. James, M.D., Ph.D., Tomas Jernberg, M.D., Ph.D., Bertil Lindahl, M.D., Ph.D., David Erlinge, M.D., Ph.D., Nils Witt, M.D., Ph.D., Gabriel Arefalk, M.D., Mats Frick, M.D., Ph.D., Joakim Alfredsson, M.D., Ph.D., Lennart Nilsson, M.D., Ph.D., Annica Ravn-Fischer, M.D., Ph.D., Elmir Omerovic, M.D., Ph.D., Thomas Kellerth, M.D., David Sparv, B.Sc., Ulf Ekelund, M.D., Ph.D., Rickard Linder, M.D., Ph.D., Mattias Ekström, M.D., Ph.D., Jörg Lauermann, M.D., Urban Haaga, B.Sc., John Pernow, M.D., Ph.D., Ollie Östlund, Ph.D., Johan Herlitz, M.D., Ph.D., and Leif Svensson, M.D., Ph.D., for the DETO2X–SWEDEHEART Investigators
August 28, 2017
DOI: 10.1056/NEJMoa1706222
BACKGROUND 背景
The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infarction who do not have hypoxemia at baseline is uncertain.
可疑急性心梗患者未合并低氧血症时常规氧疗的临床效果并不明确。
METHODS 方法
In this registry-based randomized clinical trial, we used nationwide Swedish registries for patient enrollment and data collection. Patients with suspected myocardial infarction and an oxygen saturation of 90% or higher were randomly assigned to receive either supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered through an open face mask) or ambient air.
在这项基于注册的随机临床试验中，我们采用瑞典全国注册系统进行患者入选及数据收集。可疑心梗且氧饱和度90%以上的患者被随机分为氧疗（通过面罩吸氧6 L/min，6-12小时）或吸入空气。
RESULTS 结果
A total of 6629 patients were enrolled. The median duration of oxygen therapy was 11.6 hours, and the median oxygen saturation at the end of the treatment period was 99% among patients assigned to oxygen and 97% among patients assigned to ambient air. Hypoxemia developed in 62 patients (1.9%) in the oxygen group, as compared with 254 patients (7.7%) in the ambient-air group. The median of the highest troponin level during hospitalization was 946.5 ng per liter in the oxygen group and 983.0 ng per liter in the ambient-air group. The primary end point of death from any cause within 1 year after randomization occurred in 5.0% of patients (166 of 3311) assigned to oxygen and in 5.1% of patients (168 of 3318) assigned to ambient air (hazard ratio, 0.97; 95% confidence interval [CI], 0.79 to 1.21; P=0.80). Rehospitalization with myocardial infarction within 1 year occurred in 126 patients (3.8%) assigned to oxygen and in 111 patients (3.3%) assigned to ambient air (hazard ratio, 1.13; 95% CI, 0.88 to 1.46; P=0.33). The results were consistent across all predefined subgroups.
共入选6629名患者。氧疗持续中位时间为11.6个小时，治疗结束时，氧疗组患者氧饱和度中位数位99%，空气组患者为97%。氧疗组62名(1.9%)患者发生低氧血症，空气组254名(7.7%)发生低氧。氧疗组患者在住院期间肌钙蛋白最高水平中位数为946.5 ng/L，空气组为983.0 ng/L。主要预后终点为随机分组后一年内的全因病死率，氧疗组患者为5.0% (166/33110)，空气组为5.1% (168/3318)（风险比0.97; 95% 可信区间 [CI], 0.79 to 1.21; P=0.80）。氧疗组一年内因心梗再次住院患者126名(3.8%)，空气组为111名(3.3%)（风险比1.13; 95% CI, 0.88 to 1.46; P=0.33）。所有预先确定的亚组分析结果一致。
CONCLUSIONS 结论
Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality. (Funded by the Swedish Heart–Lung Foundation and others; DETO2X-AMI ClinicalTrials.gov number, NCT01787110.)
对于未合并低氧血症的可疑心梗患者，常规氧疗不能降低一年的全因病死率。
