瑞典布莱金医院Magnus Ekström团队比较了严重低氧血症患者每天接受24小时或15小时长期吸氧对临床预后的影响。相关论文于2024年9月10日发表在《新英格兰医学杂志》上。

每天长期补氧至少15小时可以延长严重低氧血症患者的生存期。非随机比较结果建议每天24小时使用长期氧气治疗，这是一种更繁重的治疗方案。

为了验证每天24小时的长期氧气治疗不会比每天15小时的治疗在1年内降低住院或死亡风险的假设，研究组进行了一项多中心、基于登记的随机对照试验，招募在休息时开始接受慢性严重低氧血症氧气治疗的患者。患者被随机分配接受每天24或15小时的长期氧气治疗。在事件发生时间分析中评估的主要结局是1年内全因住院或死亡的综合结果。次要结局包括在3个月和12个月时评估的主要结局的各个组成部分。

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）或每天15小时（124名患者）的长期氧气治疗。没有患者失访。在12个月时，24小时组患者报告的每日氧疗持续时间中位数为24.0小时（四分位数间距，21.0至24.0），15小时组为15.0小时（五分位数间距：15.0至16.0）。24小时组1年内住院或死亡的风险不低于15小时组（平均发生率分别为每100人年124.7和124.5起事件；风险比为0.99；95%置信区间[CI]为0.72至1.36；90%置信区间为0.76至1.29；非优先性P=0.007）。两组在全因住院、全因死亡或不良事件的发生率方面没有实质性差异。

研究结果表明，在严重低氧血症患者中，每天24小时的长期氧气治疗与每天15小时的治疗相比，并没有导致1年内住院或死亡的风险降低。

附：英文原文

Title: Long-Term Oxygen Therapy for 24 or 15 Hours per Day in Severe Hypoxemia

Author: Magnus Ekstrm, Anders Andersson, Savvas Papadopoulos, Taivo Kipper, Bo Pedersen, Ozren Kricka, Pierre Sobrino, Michael Runold, Andreas Palm, Anders Blomberg, Ranjh Hamed, Eva Lindberg, Bjrn Sundberg, Nermin Hadziosmanovic, Filip Bjrklund, Christer Janson, Christine F. McDonald, David C. Currow, Josefin Sundh

Issue&Volume: 2024-09-10

Abstract:

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.

DOI: NJ202409100000001

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2402638