From the Department of Clinical Science and Education, Division of Cardiology (R.H., N.W., M.F.), and Center for Resuscitation Science (L.S.), Karolinska Institutet, Södersjukhuset, and the Department of Clinical Sciences, Cardiology, Danderyd Hospital, Karolinska Institutet (T.J., R.L., M.E.), Stockholm, the Department of Medical Sciences, Cardiology (S.K.J., B.L., G.A.), and Uppsala Clinical Research Center (S.K.J., O.Ö.), Uppsala University, Uppsala, the Department of Clinical Sciences, Cardiology (D.E., D.S.), and Department of Clinical Sciences, Emergency Medicine (U.E.), Lund University, Lund, the Department of Medical and Health Sciences and Department of Cardiology, Linköping University, Linköping (J.A., L.N.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (A.R.-F., E.O., J.H.), the Department of Cardiology, Örebro University Hospital, Örebro (T.K.), the Department of Internal Medicine, Division of Cardiology, Ryhov Hospital, Jönköping (J.L.), the Department of Cardiology, Karlstad Central Hospital, Karlstad (U.H.), the Department of Cardiology, Karolinska University Hospital (J.P.), and the Department of Medicine, Karolinska Institutet (J.P., L.S.), Solna, and the Department of Health Sciences, University of Borås, Borås (J.H.) - all in Sweden.
N Engl J Med. 2017 Sep 28;377(13):1240-1249. doi: 10.1056/NEJMoa1706222. Epub 2017 Aug 28.
The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infarction who do not have hypoxemia at baseline is uncertain.
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.
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.
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 .).
对于基线时不缺氧的疑似急性心肌梗死患者,常规氧疗的临床效果尚不确定。
本基于登记的随机临床试验中,我们使用了全国性的瑞典患者登记处进行患者招募和数据收集。将疑似心肌梗死且血氧饱和度为 90%或更高的患者随机分为接受补充氧(6 升/分钟,持续 6 至 12 小时,通过开放面罩给予)或环境空气组。
共纳入 6629 例患者。氧疗的中位持续时间为 11.6 小时,接受氧疗的患者在治疗期末的中位血氧饱和度为 99%,而接受环境空气组的患者为 97%。在吸氧组中,有 62 例(1.9%)患者出现低氧血症,而在环境空气组中,有 254 例(7.7%)患者出现低氧血症。在住院期间,最高肌钙蛋白水平的中位数在吸氧组中为 946.5ng/L,在环境空气组中为 983.0ng/L。随机分组后 1 年内任何原因导致的死亡主要终点在接受吸氧的患者中发生率为 5.0%(3311 例中的 166 例),在接受环境空气的患者中发生率为 5.1%(3318 例中的 168 例)(风险比,0.97;95%置信区间[CI],0.79 至 1.21;P=0.80)。在接受吸氧的患者中,1 年内因心肌梗死再次住院的患者有 126 例(3.8%),而在接受环境空气的患者中,有 111 例(3.3%)(风险比,1.13;95%CI,0.88 至 1.46;P=0.33)。所有预先设定的亚组结果一致。
对于基线时不缺氧的疑似心肌梗死患者,常规使用补充氧气并不能降低 1 年全因死亡率。(由瑞典心肺基金会等资助;DETO2X-AMI ClinicalTrials.gov 编号,NCT01787110)。