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長期氧療可改善COPD患者的生存結局，但是，夜間動脈氧飽和度下降，卻無重度日間低氧血症的患者目前並不符合長期氧療的標準。夜間氧療可否改善患者結局尚不確定。短視頻中總結了新的研究發現。
慢性阻塞性肺疾病患者夜間氧療的隨機試驗
Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease
背景
長期氧療可改善慢性阻塞性肺疾病（COPD）和慢性重度日間低氧血症患者的生存。然而，氧療對單純性夜間低氧血症的療效尚未明確。
Long-term oxygen therapy improves survival in patients with chronic obstructive pulmonary disease (COPD) and chronic severe daytime hypoxemia. However, the efficacy of oxygen therapy for the management of isolated nocturnal hypoxemia is uncertain.方法
我們設計了這項雙盲、安慰劑對照、隨機試驗，目的是在夜間動脈氧飽和度降低，但未達到長期氧療標準的COPD患者中，確定持續3～4年的夜間氧療可否降低死亡率或減少疾病加重（以至於患者符合當前的長期氧療標準）。本研究納入在記錄夜間血氧的時間段內，至少有30%時間的氧飽和度低於90%的患者，我們以1∶1的比例將其隨機分組，一組接受夜間氧療，另一組呼吸來自假制氧機的環境空氣（安慰劑）。主要結局是在意向治療人群中，由全因死亡或者需要長期氧療（根據夜間氧療試驗[Nocturnal Oxygen Therapy Trial，NOTT]的標準定義）構成的複合結局。
We designed this double-blind, placebo-controlled, randomized trial to determine, in patients with COPD who have nocturnal arterial oxygen desaturation without qualifying for long-term oxygen therapy, whether nocturnal oxygen provided for a period of 3 to 4 years would decrease mortality or the worsening of disease such that patients meet current specifications for long-term oxygen therapy. Patients with an oxygen saturation of less than 90% for at least 30% of the recording time on nocturnal oximetry were assigned, in a 1:1 ratio, to receive either nocturnal oxygen or ambient air from a sham concentrator (placebo). The primary outcome was a composite of death from any cause or a requirement for long-term oxygen therapy as defined by the Nocturnal Oxygen Therapy Trial (NOTT) criteria in the intention-to-treat population.結果
本研究原計劃隨機分組600例患者，但28個研究中心隨機分組243例患者之後，由於在招募和保留患者方面存在困難，因此患者招募工作提前停止。3年隨訪時，夜間氧療組39.0%的患者（48/123）和安慰劑組42.0%的患者（50/119）符合NOTT定義的長期氧療標準或已經死亡（差異，－3.0個百分點；95%置信區間［CI］，－15.1～9.1）。
Result
Recruitment was stopped prematurely because of recruitment and retention difficulties after 243 patients, of a projected 600, had undergone randomization at 28 centers. At 3 years of follow-up, 39.0% of the patients assigned to nocturnal oxygen (48 of 123) and 42.0% of those assigned to placebo (50 of 119) met the NOTT-defined criteria for long-term oxygen therapy or had died (difference, −3.0 percentage points; 95% confidence interval, −15.1 to 9.1).
結論
在此項統計學功效不足的試驗中，並無跡象表明夜間氧療會對COPD患者的生存或向長期氧療的進展產生正面或負面影響（由加拿大衛生研究院[Canadian Institutes of Health Research]資助，INOX在ClinicalTrials.gov註冊號為NCT01044628）。
Conclusions
Our underpowered trial provides no indication that nocturnal oxygen has a positive or negative effect on survival or progression to long-term oxygen therapy in patients with COPD. (Funded by the Canadian Institutes of Health Research; INOX ClinicalTrials.gov number, NCT01044628.)關注《NEJM醫學前沿》
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