Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX): a multicentre, randomised, sham-controlled trial.

However, evidence for its efficacy is scarce.

然而，关于其疗效的证据非常有限。

This trial aimed to compare the effects of ambulatory oxygen with ambulatory air on physical activity in daily life over 6 months in people with fibrotic ILD and isolated exertional hypoxaemia.

该试验旨在比较在6个月内，对纤维化间质性肺病伴有单纯运动性低氧血症患者，使用便携式氧气与便携式空气对日常生活活动影响的差异。

Methods

This multicentre, parallel-group, randomised, sham-controlled trial was done at seven hospital sites in Australia and Sweden.

这项多中心、平行组、随机、安慰剂对照试验在澳大利亚和瑞典的七个医院站点进行。

Eligible participants were aged ≥18 years with fibrotic ILD and isolated exertional hypoxaemia (ie, oxyhaemoglobin saturation [SpO2] ≤88% on 6-min walk test).

符合条件的参与者年龄≥18岁，患有纤维化间质性肺病，并且在6分钟步行测试中表现出孤立性运动性低氧血症（即，氧合血红蛋白饱和度[SpO2]≤88%）。

Participants were randomly assigned (1:1) to receive ambulatory oxygen during daily activities delivered using a portable oxygen concentrator (Inogen One G3HF), or air delivered using a device identical in appearance, display, weight, and operation (sham).

参与者被随机分配（1:1），在日常活动中使用便携式氧气浓缩器（Inogen One G3HF）接收行走时的氧气，或使用外观、显示、重量和操作均相同的设备接收空气（安慰剂）。

The primary outcome was change in physical activity (mean steps per day) at 3 months, measured using the StepWatch activity monitor in the intention-to-treatpopulation.

主要结果是3个月时身体活动（每天平均步数）的变化，在意向治疗人群中使用StepWatch活动监测器测量。

The trial is registered with ClinicalTrials.gov (NCT03737409) and is completed.

该试验已在ClinicalTrials.gov注册（NCT03737409），并已完成。

Results

Between Aug 6, 2019, and Jan 10, 2024, 614 individuals were assessed for eligibility. 116 were randomly assigned to ambulatory oxygen (n=59) or ambulatory air (n=57). 79 (68%) of 116 participants were male and 37 (32%) were female.

2019年8月6日至2024年1月10日期间，共有614名个体被评估以确定其是否符合入选资格。其中116名被随机分配至便携式氧气组（n=59）或便携式空气组（n=57）。116名参与者中，79名（占68%）为男性，37名（占32%）为女性。

Mean age was 71 years (SD 10).

平均年龄为71岁（标准差10）。

There was no significant difference between ambulatory oxygen (-271 steps per day, 95% CI -702 to 161) and ambulatory air (64, -377 to 505) for change in mean steps per day at 3 months (-334, -803 to 134).

在3个月时，行走氧疗组（-271步/天，95% 置信区间 -702至161）与行走空气组（64步/天，95% 置信区间 -377至505）在平均每日步数变化上没有显著差异（-334步/天，95% 置信区间 -803至134）。

There were no serious adverse events related to study treatments, and no difference between groups for the number or type of adverse events.

研究治疗期间未发生严重不良事件，两组在不良事件的数量或类型上没有差异。

interpretation

In people with fibrotic ILD and exertional hypoxaemia, ambulatory oxygen delivered using a portable concentrator did not provide benefits over ambulatory air for physical activity in daily life.

在患有纤维化间质性肺病和运动性低氧血症的患者中，使用便携式氧气浓缩器提供的行走氧疗并未比行走空气对日常生活中的体力活动带来益处。

Routine prescription of ambulatory oxygen using a portable oxygen concentrator for people with fibrotic ILD with isolated exertional hypoxaemia might not be indicated.

对于仅在运动时出现低氧血症的纤维化间质性肺病患者，常规使用便携式氧气浓缩器进行行走氧疗可能并不适宜。

These results reinforce the pressing need for innovation in portable oxygen devices to ensure effective oxygen delivery and acceptability to patients.

这些结果强调了对便携式氧气设备进行创新的迫切需求，以确保有效的氧气输送并为患者所接受。

funding

National Health and Medical Research Council (Australia) and Swedish Society of Medicine.

澳大利亚国家健康与医学研究委员会和瑞典医学协会。