Ciarleglio Giuseppina, Cameli Paolo, Bennett David, Cekorja Behar, Rottoli Paola, Renzoni Elisabetta A, Sestini Piersante, Bargagli Elena
Department of Medicine, Surgery and Neurosciences, Respiratory Diseases Unit, University of Siena, Siena, Italy.
Interstitial Lung Disease Unit, Royal Brompton and Harefield Clinical Group, Guy's and St Thomas' NHS Foundation Trust, and Margaret Turner Warwick Centre for Fibrosing Lung Disease, National Heart and Lung Institute, Imperial College London, London, UK.
Respirology. 2025 Jul;30(7):644-651. doi: 10.1111/resp.70020. Epub 2025 Mar 11.
The available evidence on the effects of ambulatory oxygen on exercise impairment in patients with fibrotic interstitial lung diseases (F-ILD) is of limited quality.
We conducted a randomised, double-blind, placebo-controlled crossover trial with 32 normoxaemic F-ILD patients, desaturating to ≤ 88% during a baseline 6-minute walk test (6MWT) on ambient air. After determining the oxygen flow needed to prevent desaturation, patients completed two double-blind 6MWTs with either oxygen or placebo (compressed medical air) at the same personalised flow. Objective measures included oxygen saturation, pulse rate, and distance walked. Patient-reported outcomes, assessed via visual analogue scales, included end-of-test dyspnoea, fatigue, and preferences for walking with oxygen or placebo versus each other and ambient air.
Ambulatory oxygen, compared to placebo, prevented desaturation, reduced tachycardia, increased walking distance by 37 m (95% CI: 10-74, p = 0.008), and lessened dyspnoea and fatigue. The mean preference score for oxygen over placebo was 2.6 (95% CI: 1.9-3.2, p < 0.0005), significantly greater than equivalence. The preference score for placebo over ambient air was -1.5 (-2.4 to 0.64, p = 0.005), significantly lower than equivalence, while the score for oxygen over ambient air was 0.4 (-0.7 to 1.5), not significantly different from equivalence.
Our data confirm that ambulatory oxygen provides significant benefits beyond a placebo effect; although in some patients it is associated with a negative perception that may hinder treatment acceptance. This strengthens the evidence supporting current recommendations and suggests that incorporating patient preferences recorded at the time of the 6MWT into clinical discussions can aid shared decision making regarding ambulatory oxygen.
ClinicalTrials.gov identifier: NCT02668029.
关于动态吸氧对纤维化间质性肺疾病（F-ILD）患者运动功能障碍影响的现有证据质量有限。
我们对32名在室内空气中进行基线6分钟步行试验（6MWT）时血氧饱和度降至≤88%的正常血氧F-ILD患者进行了一项随机、双盲、安慰剂对照交叉试验。在确定防止血氧饱和度下降所需的氧流量后，患者以相同的个性化流量完成两次双盲6MWT，一次吸氧，一次吸安慰剂（压缩医用空气）。客观测量指标包括血氧饱和度、脉搏率和步行距离。通过视觉模拟量表评估的患者报告结局包括试验结束时的呼吸困难、疲劳，以及吸氧与吸安慰剂以及与室内空气相比的步行偏好。
与安慰剂相比，动态吸氧可防止血氧饱和度下降，减少心动过速，使步行距离增加37米（95%CI：10-74，p = 0.008），并减轻呼吸困难和疲劳。吸氧相对于安慰剂的平均偏好评分为2.6（95%CI：1.9-3.2，p < 0.0005），显著高于等效值。安慰剂相对于室内空气的偏好评分为-1.5（-2.4至0.64，p = 0.005），显著低于等效值，而吸氧相对于室内空气的评分为0.4（-0.7至1.5），与等效值无显著差异。
我们的数据证实，动态吸氧除了安慰剂效应外还能带来显著益处；尽管在一些患者中，它会带来负面认知，可能会阻碍治疗接受度。这加强了支持当前建议的证据，并表明将6MWT时记录的患者偏好纳入临床讨论有助于就动态吸氧进行共同决策。
ClinicalTrials.gov标识符：NCT02668029。
