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一项在家中使用便携式氧气治疗 COPD 患者呼吸困难但无静息性低氧血症的随机试验。

A randomised trial of domiciliary, ambulatory oxygen in patients with COPD and dyspnoea but without resting hypoxaemia.

机构信息

Institute for Breathing and Sleep, Austin Hospital, Heidelberg, Victoria, Australia.

出版信息

Thorax. 2011 Jan;66(1):32-7. doi: 10.1136/thx.2009.132522. Epub 2010 Sep 29.

Abstract

BACKGROUND

Patients with chronic obstructive pulmonary disease (COPD) who are not severely hypoxaemic at rest may experience significant breathlessness on exertion, and ambulatory oxygen is often prescribed in this circumstance despite a lack of conclusive evidence for benefit. This study aimed to determine whether such patients benefit from domiciliary ambulatory oxygen and, if so, which factors may be associated with benefit.

METHODS

This was a 12 week, parallel, double-blinded, randomised, placebo-controlled trial of cylinder air versus cylinder oxygen, provided at 6 l/min intranasally, for use during any activity provoking breathlessness. Patients underwent baseline measurements of arterial blood gases and lung function. Outcome measures assessed dyspnoea, health-related quality of life, mood disturbance, functional status and cylinder utilisation. Data were analysed on an intention-to-treat basis, p≤0.05.

RESULTS

143 subjects (44 female), mean±SD age 71.8±9.8 years, forced expiratory volume in 1 s (FEV(1))1.16±0.51 litres, Pao(2) 9.5±1.1 kPa (71.4±8.5 mm Hg) were randomised, including 50 patients with exertional desaturation to ≤88%. No significant differences in any outcome were found between groups receiving air or oxygen. Statistically significant but clinically small improvements in dyspnoea and depression were observed in the whole study group over the 12 weeks of the study.

CONCLUSION

In breathless patients with COPD who do not have severe resting hypoxaemia, domiciliary ambulatory oxygen confers no benefits in terms of dyspnoea, quality of life or function. Exertional desaturation is not predictive of outcome. Intranasal gas (either air or oxygen) may provide a placebo benefit.

CLINICAL TRIAL NUMBER

ACTRN12605000457640.

摘要

背景

休息时不严重低氧血症的慢性阻塞性肺疾病(COPD)患者在运动时可能会出现明显的呼吸困难,尽管没有确凿的证据表明吸氧有益,但在这种情况下通常会开处家庭用便携式吸氧。本研究旨在确定此类患者是否受益于家庭用便携式吸氧,如果有,哪些因素可能与获益相关。

方法

这是一项为期 12 周、平行、双盲、随机、安慰剂对照试验,比较了在任何引起呼吸困难的活动中以 6L/min 经鼻吸入的空钢瓶与氧钢瓶的疗效。患者在基线时进行了血气和肺功能测量。评估的终点包括呼吸困难、健康相关生活质量、情绪障碍、功能状态和钢瓶使用情况。数据分析采用意向治疗原则,p≤0.05。

结果

共纳入 143 例患者(44 例女性),平均年龄 71.8±9.8 岁,1 秒用力呼气容积(FEV1)1.16±0.51 升,动脉血氧分压(Pao2)9.5±1.1kPa(71.4±8.5mmHg)。其中 50 例患者在运动时出现了≤88%的血氧饱和度下降。接受空气或氧气的两组患者在任何结局上均无显著差异。在整个研究组中,在 12 周的研究期间,呼吸困难和抑郁均出现了有统计学意义但临床意义较小的改善。

结论

在不伴有严重静息性低氧血症的 COPD 呼吸困难患者中,家庭用便携式吸氧在呼吸困难、生活质量或功能方面没有益处。运动性血氧饱和度下降不能预测结局。经鼻吸入气体(空气或氧气)可能提供安慰剂效应。

临床试验注册号

ACTRN12605000457640。

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