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.).

中文翻译：

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严重低氧血症每天 24 或 15 小时的长期氧疗。


背景每天至少15小时的长期吸氧可延长严重低氧血症患者的生存期。根据非随机比较，建议每天 24 小时进行长期氧疗，这是一种负担较重的治疗方案。方法 为了验证每天 24 小时的长期氧疗不会比每天 15 小时的长期氧疗降低 1 年住院或死亡风险的假设，我们进行了一项多中心、基于登记的随机、对照试验涉及因静息时慢性严重低氧血症而开始氧疗的患者。患者被随机分配接受每天 24 或 15 小时的长期氧疗。通过事件发生时间分析评估的主要结局是一年内住院或全因死亡的综合结果。次要结局包括 3 个月和 12 个月时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日期间，共有241名患者被随机分配接受每天24小时（117名患者）或每天15小时（124名患者）的长期氧疗。没有患者失访。 12 个月时，患者报告的每日氧疗持续时间中位数，24 小时组为 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小时组一年内住院或死亡的风险不低于15小时组（平均每100人年分别有124.7和124.5起事件；风险比为0.99；95%置信度）区间 [CI]，0.72 至 1.36；90% CI，0.76 至 1.29；P = 0.007（非优越性）。 各组在全因住院、全因死亡或不良事件发生率方面没有显着差异。结论 在严重低氧血症患者中，每天 24 小时的长期氧疗并未比每天 15 小时的治疗降低 1 年内住院或死亡的风险。 （由 Crafoord 基金会和其他机构资助；REDOX ClinicalTrials.gov 编号，NCT03441204。）。