Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, No. 507 Zhengmin Road, Shanghai 200092, China.
Department of Respiratory Medicine, The Sixth People's Hospital of Nantong, Shanghai University, Jiangsu 226001, China.
EBioMedicine. 2021 Oct;72:103587. doi: 10.1016/j.ebiom.2021.103587. Epub 2021 Sep 16.
Persistent cough and large amounts of purulent sputum affects many bronchiectasis patients. No studies have evaluated the efficacy and safety of bronchoscopic airway clearance therapy and bronchoalveolar lavage (B-ACT) for non-cystic fibrosis bronchiectasis patients with acute exacerbation.
A randomised controlled trial was conducted to explore the efficacy and safety of B-ACT among 189 bronchiectasis inpatients from February 1, 2018 to February 28, 2019. The primary outcome was the time to first acute exacerbation. Secondary outcomes included changes of health-related scores, length of hospital stay, hospitalization expenses and incidences of adverse events.
B-ACT therapy significantly prolonged the median days to first acute exacerbation when compared with control group (198 vs 168 days, HR 0·555 (0·322-0·958), p=0·012; effect size(r)= 0·94). Further analysis showed that B-ACT therapy was more beneficial for these patients with severe disease and greater symptoms. COPD Assessment Test (CAT) scores improved significantly on the third day (5·45 vs 4·85, 0·60 (0·09-1·11), p=0·023), and Leicester Cough Questionnaire (LCQ) scores improved obviously on the third and seventh days (1·53 vs 1·23, 0·30 (0·05-0·55), p=0·044; 1·66 vs 1·32, 0·34 (0·08-0·60), p=0·022; respectively) after B-ACT therapy. Adverse events associated with B-ACT were mostly transient and mild. Differences of the lengths of hospital stay and hospitalization expenses in both group was not significant.
B-ACT therapy significantly prolonged the time to first acute exacerbation after discharge, highlighting the importance of B-ACT therapy focused on symptom improvements in preventing exacerbation.
National Natural Science Foundation of China.
ClinicalTrials.gov; No.:NCT03643302; URL: www.clinicaltrials.gov.
持续性咳嗽和大量脓性痰影响许多支气管扩张症患者。目前尚无研究评估支气管镜气道清除治疗和支气管肺泡灌洗(B-ACT)对非囊性纤维化支气管扩张症急性加重患者的疗效和安全性。
一项随机对照试验于 2018 年 2 月 1 日至 2019 年 2 月 28 日纳入了 189 例支气管扩张症住院患者,旨在探索 B-ACT 的疗效和安全性。主要结局是首次急性加重的时间。次要结局包括健康相关评分的变化、住院时间、住院费用和不良事件的发生率。
与对照组相比,B-ACT 治疗显著延长了首次急性加重的中位时间(198 天 vs 168 天,HR 0.555(0.322-0.958),p=0.012;效应量(r)=0.94)。进一步分析表明,B-ACT 治疗对病情较重和症状较重的患者更有益。第 3 天 COPD 评估测试(CAT)评分显著改善(5.45 分 vs 4.85 分,0.60(0.09-1.11),p=0.023),第 3 天和第 7 天莱斯特咳嗽问卷(LCQ)评分明显改善(1.53 分 vs 1.23 分,0.30(0.05-0.55),p=0.044;1.66 分 vs 1.32 分,0.34(0.08-0.60),p=0.022)。B-ACT 治疗后不良事件主要为一过性和轻度。两组住院时间和住院费用的差异无统计学意义。
B-ACT 治疗显著延长了出院后首次急性加重的时间,突出了 B-ACT 治疗在改善症状方面对预防加重的重要性。
国家自然科学基金。
ClinicalTrials.gov;编号:NCT03643302;网址:www.clinicaltrials.gov。