The current multicentre observational BR study enrolled 21 patients with CB at six centres in the USA, with bilateral treatment and 2-year follow-up. Entry criteria included elevated cough and sputum scores from COPD Assessment Test (CAT) and forced expiratory volume in one second<80% predicted. Safety was assessed by serious adverse event (SAE) incidence through 24 months. Clinical utility was evaluated using changes in the CAT, the St. George\'s Respiratory Questionnaire (SGRQ) and by comparing exacerbation rates before and following intervention.
No procedure-related or device-related SAEs occurred. Mean (SD) changes from baseline in CAT at 12 and 24 months were -9.0 (6.7) (p<0.0001) and -5.6 (7.1) (p<0.0047) and in SGRQ were -16.6 (13.2) (p<0.0001) and -11.8 (19.2) (p<0.0227), respectively. There was a 34% reduction in moderate and a 64% reduction in severe COPD exacerbation events compared with the year prior to treatment.
This study extends the findings from previous feasibility studies, demonstrating that BR can be performed safely and may significantly improve symptoms and health-related quality of life for patients with CB through 24 months.
NCT03631472.
方法:当前的多中心观察性BR研究在美国六个中心招募了21名CB患者,双侧治疗和2年随访。进入标准包括COPD评估测试(CAT)的咳嗽和痰评分升高,一秒钟的用力呼气量<80%。通过24个月的严重不良事件(SAE)发生率评估安全性。使用CAT的变化评估临床效用,圣乔治呼吸问卷(SGRQ),并通过比较干预前后的恶化率。
结果:未发生手术相关或器械相关的严重不良事件。在12个月和24个月时,CAT相对于基线的平均(SD)变化分别为-9.0(6.7)(p<0.0001)和-5.6(7.1)(p<0.0047),在SGRQ中分别为-16.6(13.2)(p<0.0001)和-11.8(19.2)(p<0.0227),分别。与治疗前一年相比,中度COPD加重事件减少34%,重度COPD加重事件减少64%。
结论:这项研究扩展了以前可行性研究的发现,证明BR可以安全地进行,并且可以显着改善CB患者的症状和与健康相关的生活质量,直至24个月。
背景:NCT03631472。