METHODS: A total of 15 patients with severe asthma were enrolled in this prospective, single-center pilot study. Patients underwent bifurcated BCD treatment at a 30-day interval after baseline assessment. Follow-up through 12 months included assessment of adverse events, technical feasibility, and changes in pulmonary function; asthma control questionnaire-7 (ACQ-7); and asthma control test (ACT).
RESULTS: BCD was performed on all 15 severe asthma patients, with technical feasibility of 96.7%. There were no device-related and 2 procedure-related serious adverse events through 12 months, which resolved without sequelae. The most frequent nonserious procedure-related adverse event was increased cough in 60% (9 of 15) patients. Pulmonary function remained unchanged, and significant improvements from baseline ACQ-7 (mean, -1.19, p = 0.0032) and ACT (mean, 3.18, p = 0.0011) scores were observed since the first month\'s follow-up after a single lung airway treatment, with similar trends till the end of the 12-month follow-up.
CONCLUSIONS: This study provides the first clinical evidence of the safety, feasibility, and initial efficacy of BCD in patients with severe asthma.
方法:本次前瞻性研究共纳入15例重度哮喘患者,单中心试点研究。患者在基线评估后30天间隔接受分叉BCD治疗。12个月的随访包括不良事件的评估,技术可行性,和肺功能的变化;哮喘控制问卷-7(ACQ-7);和哮喘控制测试(ACT)。
结果:对所有15名重度哮喘患者进行了BCD,技术可行性为96.7%。在12个月内,没有发生与设备相关的严重不良事件和2起与手术相关的严重不良事件。没有后遗症。最常见的非严重手术相关不良事件是60%(15人中有9人)的咳嗽增加。肺功能保持不变,与基线ACQ-7相比有显著改善(平均值,-1.19,p=0.0032)和ACT(平均值,自单肺气道治疗后第一个月随访以来,观察到3.18,p=0.0011)评分,在12个月的随访结束之前,趋势相似。
结论:这项研究提供了第一个安全性的临床证据,可行性,和BCD在重症哮喘患者中的初始疗效。