摘要
简介慢性阻塞性肺疾病（AECOPD）严重急性加重期的患者在 30 天内的再入院率为 20%。本研究评估了开展随机对照试验的可行性，以评估除常规药物治疗外，家庭高流量疗法（HFT）对优生优育的 AECOPD 恢复期患者的临床、患者报告和生理影响，从而为 3 期试验的设计提供支持：一项混合方法可行性随机对照试验（定量为主，同时嵌入定性评估）（ISRCTN15949009）招募了连续住院的非肥胖 AECOPD 患者，这些患者不需要急性无创通气。参与者被随机分配接受常规护理或常规护理和家庭 HFT（37°C、30 L/min），每周进行为期 4 周的家庭随访，以收集以下方面的数据：设备使用情况、呼吸困难程度（改良博格量表、视觉模拟量表、多维呼吸困难量表）、健康相关生活质量（慢性阻塞性肺病评估测试 (CAT)、临床慢性阻塞性肺病问卷）、脉搏血氧饱和度、肺活量和吸气能力、胸骨旁肌电图和运动肌电图。第 4 周进行了半结构化访谈。试验进展标准为：符合条件的随机患者比例≥40%，自然减员比例≤20%，完整数据≥70%，未发生与设备相关的严重不良事件（SAE）：45名符合条件的患者中有18名接受了随机治疗（年龄69±5岁，44%为女性，体重指数23±5 kg/m2，1秒用力呼气量32±12%）。一名患者因非呼吸道疾病住院而退出。在超过 90% 的家庭评估中收集了完整的结果测量数据。没有发生与设备相关的 SAE。第 1 周，每天使用 HFT 的时间为 2.7±2.2 小时，第 4 周降至 2.3±1.4 小时。有 6 例患者的温度和流量设置进行了调整，以提高舒适度。较高的 HFT 使用率与较低的症状负担相关（CAT p=0.01）。访谈强调了设备的易用性、沙丁胺醇用量的减少以及痰液产生和清除率的提高：这项可行性研究的数据支持开展第三阶段随机临床试验，调查家用（HFT）对严重恶化后恢复期慢性阻塞性肺病患者免住院生存期的影响：该研究已获得伦理批准（REC19/LO/0194），并进行了前瞻性注册（ISRCTN15949009）。Introduction: Patients recovering from severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a 30-day readmission rate of 20%. This study evaluated the feasibility of conducting a randomised controlled trial to evaluate clinical, patient-reported and physiological effects of home high-flow therapy (HFT) in addition to usual medical therapy, in eucapnic patients recovering from AECOPD to support the design of a phase 3 trial.
Methods: A mixed-methods feasibility randomised controlled trial (quantitative primacy, concurrently embedded qualitative evaluation) (ISRCTN15949009) recruiting consecutive non-obese patients hospitalised with AECOPD not requiring acute non-invasive ventilation. Participants were randomised to receive usual care or usual care and home HFT (37°C, 30 L/min) with weekly home-based follow-up for 4 weeks to collect data on: device usage, breathlessness (modified Borg scale, visual analogue scale, Multidimensional Dyspnoea Profile), health-related quality of life (COPD Assessment Test (CAT), Clinical COPD Questionnaire), pulse oximetry, spirometry and inspiratory capacity, parasternal electromyography and actigraphy. Semistructured interviews were conducted in week 4. Trial progression criteria were: ≥40% of eligible patients randomised, ≤20% attrition, ≥70% complete data, and no device-related serious adverse events (SAE).
Results: 18 of 45 eligible patients were randomised (age 69±5 years, 44% female, body mass index 23±5 kg/m2, forced expiratory volume in 1 second 32±12%). One withdrew following non-respiratory hospitalisation. Complete outcome measures were collected in >90% of home assessments. There were no device-related SAE. Daily HFT usage was 2.7±2.2 hours in week 1, falling to 2.3±1.4 hours by week 4. Temperature and flow settings were modified for comfort in 6 cases. Higher HFT usage was associated with lower symptom burden (CAT p=0.01). Interviews highlighted ease of device use, reduced salbutamol usage, and improved sputum production and clearance.
Conclusions: The data from this feasibility study support the progression to a phase 3 randomised clinical trial investigating the effect of home (HFT) on admission-free survival in COPD patients recovering from a severe exacerbation.
Trial registration number: The study received ethical approval (REC19/LO/0194) and was prospectively registered (ISRCTN15949009).
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