Shiqian Zha , Xu Liu , Yan Yao , Yang He , Yixuan Wang , Qingfeng Zhang , Jingyi Zhang , Yaohua Yi , Rui Xiao , Ke Hu
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Six-minute walk distance (6MWD) and spirometry were tested before and after the interventions; the Borg Dyspnea Scale (Borg) and the modified Medical Research Council Dyspnea Scale (mMRC) were used to assess dyspnea; and the Fatigue Assessment Scale (FAS) and the Chalder Fatigue Scale-11 (CFQ-11) were used to assess fatigue. The study was registered in the Chinese Clinical Trial Registry (ChiCTR2300070565).</p></div><div><h3>Findings</h3><p>Ninety-five participants (33 males and 62 females) were recruited between March 1, 2023 and December 30, 2023. Forty-seven patients in the IHE group received 10.0 (9.0, 15.0) days of IHE, and 48 patients in NE group received 10.0 (8.0, 12.0) days of NE. 6MWD, forced vital capacity (FVC), FVC %pred, forced expiratory volume in 1 s (FEV<sub>1</sub>), FEV<sub>1</sub> %pred, tidal volume (V<sub>T</sub>), and dyspnea and fatigue scales markedly improved after IHE (p < 0.05), and improvements were greater than in the NE group (all p < 0.05). 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引用次数: 0
摘要
背景：COVID-19急性后遗症（PASC）给全世界带来了巨大的健康和经济负担。目前还没有针对 PASC 的有效治疗方法或推荐药物：这项前瞻性随机对照研究在中国一家医院进行。方法：这项前瞻性随机对照研究在中国医院进行，研究对象为符合 NICE PASC 定义的患者，探讨间歇性缺氧暴露（IHE；5 分钟缺氧与 5 分钟正常空气交替，重复 5 次）对呼吸困难和疲劳的影响。通过计算随机分配患者接受常氧暴露（NE）和常规治疗，或 IHE 和常规治疗。在干预前后测试了六分钟步行距离（6MWD）和肺活量；使用博格呼吸困难量表（Borg）和改良医学研究委员会呼吸困难量表（mMRC）评估呼吸困难；使用疲劳评估量表（FAS）和Chalder疲劳量表-11（CFQ-11）评估疲劳。该研究已在中国临床试验注册中心注册（ChiCTR2300070565）：2023年3月1日至2023年12月30日期间，共招募了95名参与者（33名男性和62名女性）。IHE 组中的 47 名患者接受了 10.0（9.0，15.0）天的 IHE 治疗，NE 组中的 48 名患者接受了 10.0（8.0，12.0）天的 NE 治疗。IHE后，6MWD、用力呼吸容量（FVC）、FVC%pred、1 s内用力呼气容积（FEV1）、FEV1%pred、潮气量（VT）以及呼吸困难和疲劳量表均有明显改善（P < 0.05），且改善程度高于NE组（所有P < 0.05）。此外，与 NE 组相比，IHE 组患者在呼吸困难和疲劳方面的主观改善效果更好（P < 0.05）。IHE组与NE组相比，FEV1 %pred、VT、FAS和CFQ-11均有改善。无严重不良事件报告：IHE改善了PASC患者的肺活量和6MWD，缓解了呼吸困难和疲劳。现在需要更大规模的前瞻性研究来验证这些发现。
Short-term intermittent hypoxia exposure for dyspnea and fatigue in post-acute sequelae of COVID-19: A randomized controlled study
Background
Post-acute sequelae of COVID-19 (PASC) is incurring a huge health and economic burden worldwide. There is currently no effective treatment or recommended drug for PASC.
Methods
This prospective randomized controlled study was conducted in a hospital in China. The effect of intermittent hypoxia exposure (IHE; 5-min hypoxia alternating with 5-min normal air, repeated five times) on dyspnea and fatigue was investigated in patients meeting the NICE definition of PASC. Patients were computationally randomized to receive normoxia exposure (NE) and routine therapy or IHE and routine therapy. Six-minute walk distance (6MWD) and spirometry were tested before and after the interventions; the Borg Dyspnea Scale (Borg) and the modified Medical Research Council Dyspnea Scale (mMRC) were used to assess dyspnea; and the Fatigue Assessment Scale (FAS) and the Chalder Fatigue Scale-11 (CFQ-11) were used to assess fatigue. The study was registered in the Chinese Clinical Trial Registry (ChiCTR2300070565).
Findings
Ninety-five participants (33 males and 62 females) were recruited between March 1, 2023 and December 30, 2023. Forty-seven patients in the IHE group received 10.0 (9.0, 15.0) days of IHE, and 48 patients in NE group received 10.0 (8.0, 12.0) days of NE. 6MWD, forced vital capacity (FVC), FVC %pred, forced expiratory volume in 1 s (FEV1), FEV1 %pred, tidal volume (VT), and dyspnea and fatigue scales markedly improved after IHE (p < 0.05), and improvements were greater than in the NE group (all p < 0.05). Furthermore, participants in IHE group had better subjective improvements in dyspnea and fatigue than those in the NE group (p < 0.05). Compared with <10 days of IHE, ≥10 days of IHE had a greater impact on 6MWD, FVC, FEV1, FEV1 %pred, VT, FAS, and CFQ-11. No severe adverse events were reported.
Interpretation
IHE improved spirometry and 6MWD and relieved dyspnea and fatigue in PASC patients. Larger prospective studies are now needed to verify these findings.
期刊介绍：
Respiratory Medicine is an internationally-renowned journal devoted to the rapid publication of clinically-relevant respiratory medicine research. It combines cutting-edge original research with state-of-the-art reviews dealing with all aspects of respiratory diseases and therapeutic interventions. Topics include adult and paediatric medicine, epidemiology, immunology and cell biology, physiology, occupational disorders, and the role of allergens and pollutants.
Respiratory Medicine is increasingly the journal of choice for publication of phased trial work, commenting on effectiveness, dosage and methods of action.
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