EBioMedicine ( IF 9.7 ) Pub Date : 2021-09-16 , DOI: 10.1016/j.ebiom.2021.103587 Yang Liu 1 , Hai-Wen Lu 1 , Shu-Yi Gu 1 , Wen-Wen Wang 1 , Juan Ge 2 , Zhi-Jun Jie 3 , Jin-Guang Jia 4 , Zhi-Ting Gao 5 , Jun Li 6 , Jing-Yun Shi 7 , Shuo Liang 1 , Ke-Bing Cheng 1 , Jiu-Wu Bai 1 , Jie-Ming Qu 8 , Jin-Fu Xu 1
Background
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.
Methods
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.
Findings
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.
Interpretation
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.
Funding
National Natural Science Foundation of China.
Trial registry
ClinicalTrials.gov; No.:NCT03643302; URL: www.clinicaltrials.gov.
中文翻译:
支气管扩张急性加重期支气管镜气道清除治疗
背景
持续咳嗽和大量脓痰影响许多支气管扩张症患者。没有研究评估支气管镜气道清除疗法和支气管肺泡灌洗 (B-ACT) 对非囊性纤维化支气管扩张急性加重患者的疗效和安全性。
方法
在 2018 年 2 月 1 日至 2019 年 2 月 28 日期间,对 189 名支气管扩张症住院患者进行了一项随机对照试验,以探讨 B-ACT 的疗效和安全性。主要结果是首次急性发作的时间。次要结局包括健康相关评分、住院时间、住院费用和不良事件发生率的变化。
发现
与对照组相比,B-ACT 治疗显着延长了首次急性发作的中位天数(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 疗法对这些病情严重、症状更严重的患者更有益。第三天 COPD 评估测试 (CAT) 分数显着提高(5·45 vs 4·85、0·60 (0·09-1·11), p=0·023)和莱斯特咳嗽问卷 (LCQ) 分数第三天和第七天明显好转(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;分别) 在 B-ACT 治疗后。与 B-ACT 相关的不良事件大多是短暂的和轻微的。两组住院时间和住院费用差异不显着。
解释
B-ACT 治疗显着延长了出院后首次急性加重的时间,突出了 B-ACT 治疗的重要性,重点是改善症状以预防急性加重。
资金
国家自然科学基金委。
试验登记处
临床试验.gov;编号:NCT03643302;网址:www.clinicaltrials.gov。