长期氧疗：每天 24 小时还是 15 小时？
Long-Term Oxygen Therapy for 24 or 15 Hours per Day in Severe Hypoxemia.
机构信息
From Respiratory Medicine, Allergology, and Palliative Medicine, Department of Clinical Sciences in Lund, Faculty of Medicine, Lund University, Lund (M.E., F.B.), the Department of Medicine, Blekinge Hospital, Karlskrona (M.E.), the COPD Center, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg (A.A.), and the Department of Respiratory Medicine and Allergology, Sahlgrenska University Hospital (S.P.), Gothenburg, Karlstad County Hospital, Karlstad (T.K.), Northern Älvsborg County Hospital, Trollhättan (B.P.), Linköping University Hospital, Linköping (O.K.), Falun Hospital, Falun (P.S.), the Department of Respiratory Medicine and Allergology, Faculty of Medicine, Karolinska University Hospital (M.R.), and Karolinska University Hospital Huddinge (R.H.), Stockholm, the Department of Medical Sciences, Respiratory, Allergy, and Sleep Research, Uppsala University (A.P., E.L., C.J.), and the Uppsala Clinical Research Center (N.H.), Uppsala, the Center for Research and Development, Gävle Hospital, Gävle (A.P.), the Department of Public Health and Clinical Medicine, Umeå University, Umeå (A.B.), Sundsvall-Härnösand County Hospital, Sundsvall (B.S.), and the Department of Respiratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro (J.S.) - all in Sweden; the Institute for Breathing and Sleep and the Department of Respiratory and Sleep Medicine, Austin Health, Melbourne, VIC (C.F.M.), and the Graduate School of Medicine, Faculty of Science, Medicine, and Health, University of Wollongong, Wollongong, NSW (D.C.C.) - both in Australia.
出版信息
N Engl J Med. 2024 Sep 19;391(11):977-988. doi: 10.1056/NEJMoa2402638. Epub 2024 Sep 10.
BACKGROUND
Long-term oxygen supplementation for at least 15 hours per day prolongs survival among patients with severe hypoxemia. On the basis of a nonrandomized comparison, long-term oxygen therapy has been recommended to be used for 24 hours per day, a more burdensome regimen.
METHODS
To test the hypothesis that long-term oxygen therapy used for 24 hours per day does not result in a lower risk of hospitalization or death at 1 year than therapy for 15 hours per day, we conducted a multicenter, registry-based, randomized, controlled trial involving patients who were starting oxygen therapy for chronic, severe hypoxemia at rest. The patients were randomly assigned to receive long-term oxygen therapy for 24 or 15 hours per day. The primary outcome, assessed in a time-to-event analysis, was a composite of hospitalization or death from any cause within 1 year. Secondary outcomes included the individual components of the primary outcome assessed at 3 and 12 months.
RESULTS
Between May 18, 2018, and April 4, 2022, a total of 241 patients were randomly assigned to receive long-term oxygen therapy for 24 hours per day (117 patients) or 15 hours per day (124 patients). No patient was lost to follow-up. At 12 months, the median patient-reported daily duration of oxygen therapy was 24.0 hours (interquartile range, 21.0 to 24.0) in the 24-hour group and 15.0 hours (interquartile range, 15.0 to 16.0) in the 15-hour group. The risk of hospitalization or death within 1 year in the 24-hour group was not lower than that in the 15-hour group (mean rate, 124.7 and 124.5 events per 100 person-years, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.72 to 1.36; 90% CI, 0.76 to 1.29; P = 0.007 for nonsuperiority). The groups did not differ substantially in the incidence of hospitalization for any cause, death from any cause, or adverse events.
CONCLUSIONS
Among patients with severe hypoxemia, long-term oxygen therapy used for 24 hours per day did not result in a lower risk of hospitalization or death within 1 year than therapy for 15 hours per day. (Funded by the Crafoord Foundation and others; REDOX ClinicalTrials.gov number, NCT03441204.).
背景
每天至少 15 小时的长期氧疗可延长严重低氧血症患者的生存时间。基于非随机对照比较，建议每天进行 24 小时的长期氧疗，这是一种更具负担的方案。
方法
为了检验每天 24 小时的长期氧疗不会导致 1 年内住院或死亡风险低于每天 15 小时氧疗的假设，我们进行了一项多中心、基于登记、随机、对照试验，纳入了开始接受慢性、严重静息性低氧血症氧疗的患者。患者被随机分配接受每天 24 或 15 小时的长期氧疗。主要结局是 1 年内因任何原因住院或死亡的复合结局，通过时间事件分析评估。次要结局包括在 3 个月和 12 个月评估的主要结局的各个组成部分。
结果
2018 年 5 月 18 日至 2022 年 4 月 4 日，共有 241 名患者被随机分配接受每天 24 小时（117 名患者）或 15 小时（124 名患者）的长期氧疗。无患者失访。在 12 个月时，24 小时组患者报告的每日氧疗中位时间为 24.0 小时（四分位距，21.0 至 24.0），15 小时组为 15.0 小时（四分位距，15.0 至 16.0）。24 小时组 1 年内住院或死亡的风险并不低于 15 小时组（平均发生率分别为每 100 人年 124.7 和 124.5 例，风险比为 0.99；95%置信区间[CI]为 0.72 至 1.36；90%CI 为 0.76 至 1.29；P=0.007 非劣效性）。两组在任何原因住院、任何原因死亡或不良事件的发生率方面没有显著差异。
结论
在严重低氧血症患者中，每天 24 小时的长期氧疗与每天 15 小时的氧疗相比，1 年内住院或死亡的风险并未降低。（由 Crafoord 基金会等资助；REDOX ClinicalTrials.gov 编号，NCT03441204）。
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