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慢性阻塞性肺疾病患者夜间氧疗的随机试验
Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease


Yves Lacasse ... 呼吸系统疾病 • 2020.09.17
NEJM 动画解读

COPD应用夜间氧疗
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单纯性夜间低氧的慢阻肺患者难以从夜间氧疗中获益

 

岑来键#,张日兰#,关伟杰*

呼吸疾病国家重点实验室;呼吸疾病国家临床研究中心;广州呼吸健康研究院;广州医科大学附属第一医院

#共同第一作者;*通讯作者

 

慢性阻塞性肺疾病(简称慢阻肺)的疾病负担是全球最重要的公共卫生挑战之一。长期低氧常见于伴有呼吸衰竭或者中重度的慢阻肺患者中。目前,慢阻肺全球倡议对长期氧疗(LTOT)的适应证定义为:动脉血氧分压(PaO2)<55 mm Hg,或介于56~59 mm Hg之间并伴有肺动脉高压、充血性心力衰竭或红细胞增多症的慢阻肺患者。

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摘要


背景

长期氧疗可改善慢性阻塞性肺疾病(COPD)和慢性重度日间低氧血症患者的生存。然而,氧疗对单纯性夜间低氧血症的疗效尚未明确。

 

方法

我们设计了这项双盲、安慰剂对照、随机试验,目的是在夜间动脉氧饱和度降低,但未达到长期氧疗标准的COPD患者中,确定持续3~4年的夜间氧疗可否降低死亡率或减少疾病加重(以至于患者符合当前的长期氧疗标准)。本研究纳入在记录夜间血氧的时间段内,至少有30%时间的氧饱和度低于90%的患者,我们以1∶1的比例将其随机分组,一组接受夜间氧疗,另一组呼吸来自假制氧机的环境空气(安慰剂)。主要结局是在意向治疗人群中,由全因死亡或者需要长期氧疗(根据夜间氧疗试验[Nocturnal Oxygen Therapy Trial,NOTT]的标准定义)构成的复合结局。

 

结果

本研究原计划随机分组600例患者,但28个研究中心随机分组243例患者之后,由于在招募和保留患者方面存在困难,因此患者招募工作提前停止。3年随访时,夜间氧疗组39.0%的患者(48/123)和安慰剂组42.0%的患者(50/119)符合NOTT定义的长期氧疗标准或已经死亡(差异,-3.0个百分点;95%置信区间[CI],-15.1~9.1)。

 

结论

在此项统计学功效不足的试验中,并无迹象表明夜间氧疗会对COPD患者的生存或向长期氧疗的进展产生正面或负面影响(由加拿大卫生研究院[Canadian Institutes of Health Research]资助,INOX在ClinicalTrials.gov注册号为NCT01044628)。





作者信息

Yves Lacasse, M.D., Frédéric Sériès, M.D., François Corbeil, M.D., Marc Baltzan, M.D., Bruno Paradis, M.D., Paula Simão, M.D., Araceli Abad Fernández, M.D., Cristóbal Esteban, M.D., Miguel Guimarães, M.D., Jean Bourbeau, M.D., Shawn D. Aaron, M.D., Sarah Bernard, M.Sc., and François Maltais, M.D. for the INOX Trial Group*
From Institut Universitaire de Cardiologie et de Pneumologie de Québec–Université Laval, Quebec, QC (Y.L., F.S., S.B., F.M.), Centre Hospitalier Affilié Universitaire de Trois-Rivières, Trois-Rivières, QC (F.C.), Mount Sinai Hospital, McGill University (M.B.), and Montreal Chest Institute, Research Institute of the McGill University Health Centre and McGill University (J.B.), Montreal, Centre Intégré de Santé et de Services Sociaux de Laval, Laval, QC (B.P.), and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa (S.D.A.) — all in Canada; Hospital Pedro Hispano–Unidade Local de Saúde de Matosinhos, Matosinhos (P.S.), and Centro Hospitalar Vila Nova de Gaia–Espinho, Vila Nova de Gaia (M.G.) — both in Portugal; and Hospital Universitario de Getafe, Getafe (A.A.F.), and Hospital Galdakao, Servicio Vasco de Salud–Osakidetza, Bizkaia (C.E.) — both in Spain. Address reprint requests to Dr. Lacasse at Centre de Pneumologie, Institut Universitaire de Cardiologie et de Pneumologie de Québec, 2725 Chemin Sainte-Foy, Quebec, QC G1V 4G5, Canada, or at yves.lacasse@med.ulaval.ca. *A complete list of the investigators in the INOX Trial Group is provided in the Supplementary Appendix, available at NEJM.org.

 

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