PDF(Pubmed)
Abstract：
Chronic bronchitis (CB), a phenotype of chronic obstructive pulmonary disease (COPD) characterised by persistent cough and mucus hypersecretion, is associated with poor outcomes despite guideline-based treatment. Bronchial rheoplasty (BR) with the RheOx system delivers non-thermal pulsed electric fields to the lower airway epithelium and submucosa to reduce mucus producing cells. Early phase clinical trials including 1-year follow-up have demonstrated reduction in airway goblet cell hyperplasia and improvement in CB symptoms.
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.
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.
摘要：
背景：慢性支气管炎（CB），慢性阻塞性肺疾病（COPD）的表型，以持续咳嗽和粘液分泌过多为特征，尽管以指南为基础的治疗，但与不良结局相关。使用RheOx系统的支气管流变成形术（BR）将非热脉冲电场传递到下气道上皮和粘膜下层，以减少粘液产生细胞。包括1年随访在内的早期临床试验表明，气道杯状细胞增生减少，CB症状改善。
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。
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。
