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高流量鼻导管氧疗对肺纤维化间质性肺疾病运动能力的影响:概念验证随机对照交叉试验。

The impact of high-flow nasal cannula oxygen therapy on exercise capacity in fibrotic interstitial lung disease: a proof-of-concept randomized controlled crossover trial.

机构信息

Department of Respiratory Medicine and Allergy, Tosei General Hospital, 160 Nishioiwake-cho, Seto, Aichi, 489-8642, Japan.

Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.

出版信息

BMC Pulm Med. 2020 Feb 24;20(1):51. doi: 10.1186/s12890-020-1093-2.

DOI:10.1186/s12890-020-1093-2
PMID:32093665
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7041255/
Abstract

BACKGROUND

Patients with fibrotic interstitial lung disease (FILD) often experience gas exchange abnormalities and ventilatory limitations, resulting in reduced exercise capacity. High-flow nasal cannula (HFNC) oxygen therapy is a novel treatment, whose physiological beneficial effects have been demonstrated in various clinical settings. We hypothesized that HFNC oxygen therapy might be superior to conventional oxygen therapy for improving exercise capacity in FILD patients.

METHODS

We performed a prospective randomized controlled crossover trial with a high-intensity constant work-rate endurance test (CWRET) using HFNC (50 L/min, FiO 0.5) and a venturi mask (VM) (15 L/min, FiO 0.5) for oxygen delivery in FILD patients. The primary outcome variable was endurance time. The secondary outcome variables were SpO, heart rate, Borg scale (dyspnea and leg fatigue), and patient's comfort.

RESULTS

Seven hundred and eleven patients were screened and 20 eligible patients were randomized. All patients completed the trial. The majority of patients were good responders to VM and HFNC compared with the baseline test (VM 75%; HFNC 65%). There was no significant difference in endurance time between HFNC and VM (HFNC 6.8 [95% CI 4.3-9.3] min vs VM 7.6 [95% CI 5.0-10.1] min, p = 0.669). No significant differences were found in other secondary endpoints. Subgroup analysis with HFNC good responders revealed that HFNC significantly extended the endurance time compared with VM (VM 6.4 [95%CI 4.5-8.3] min vs HFNC 7.8 [95%CI 5.8-9.7] min, p = 0.046), while no similar effect was observed in the VM good responders.

CONCLUSIONS

HFNC did not exceed the efficacy of VM on exercise capacity in FILD, but it may be beneficial if the settings match. Further large studies are needed to confirm these findings.

TRIAL REGISTRATION

UMIN-CTR: UMIN000021901.

摘要

背景

纤维化间质性肺疾病(FILD)患者常出现气体交换异常和通气受限,导致运动能力下降。高流量鼻导管(HFNC)氧疗是一种新的治疗方法,其在各种临床环境中的生理有益效果已得到证实。我们假设 HFNC 氧疗可能优于常规氧疗,改善 FILD 患者的运动能力。

方法

我们进行了一项前瞻性随机对照交叉试验,使用 HFNC(50L/min,FiO0.5)和文丘里面罩(VM)(15L/min,FiO0.5)进行高强度恒功耐力试验(CWRET),为 FILD 患者提供氧气输送。主要结局变量为耐力时间。次要结局变量包括 SpO2、心率、Borg 量表(呼吸困难和腿部疲劳)和患者舒适度。

结果

筛选了 711 名患者,20 名符合条件的患者被随机分组。所有患者均完成了试验。与基线测试相比,大多数患者对 VM 和 HFNC 的反应良好(VM 75%;HFNC 65%)。HFNC 与 VM 之间的耐力时间无显著差异(HFNC 6.8[95%CI 4.3-9.3]min 与 VM 7.6[95%CI 5.0-10.1]min,p=0.669)。其他次要终点无显著差异。HFNC 良好反应者的亚组分析显示,HFNC 与 VM 相比显著延长了耐力时间(VM 6.4[95%CI 4.5-8.3]min 与 HFNC 7.8[95%CI 5.8-9.7]min,p=0.046),而 VM 良好反应者则没有类似效果。

结论

HFNC 在 FILD 患者的运动能力方面并未超过 VM 的疗效,但如果设置匹配,可能会有益。需要进一步的大型研究来证实这些发现。

试验注册

UMIN-CTR:UMIN000021901。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ea/7041255/9b63d8240d11/12890_2020_1093_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ea/7041255/ab9b84f0f869/12890_2020_1093_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ea/7041255/9b63d8240d11/12890_2020_1093_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ea/7041255/ab9b84f0f869/12890_2020_1093_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7ea/7041255/9b63d8240d11/12890_2020_1093_Fig2_HTML.jpg

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