Zephyr支气管内膜瓣(EBV)治疗的单中心随机对照试验已证明对严重异质性肺气肿有益。这是第一个评估这种治疗方法的多中心研究。
评估ZephyrEBV在异质性肺气肿和无侧支通气患者中的疗效和安全性。
这是一个前景,多中心2:1例EBV加标准护理或标准单独护理(SoC)的随机对照试验。术后3个月的主要结果是FEV1从基线改善12%或更高的受试者的百分比。FEV1、剩余体积、6分钟步行距离,圣乔治呼吸问卷评分,在3个月和6个月时评估了修改后的医学研究理事会评分,3个月时胸部计算机断层扫描显示目标肺叶体积减少。
97名受试者随机接受EBV(n=65)或SoC(n=32)。3个月时,55.4%的EBV和6.5%的SoC受试者的FEV1改善为12%或更多(P<0.001)。6个月时仍有改善:EBV为56.3%,SoC为3.2%(P<0.001),6个月时FEV1的平均±SD变化为20.7±29.6%和-8.6±13.0%,分别。共有89.8%的EBV受试者的靶叶体积减少大于或等于350ml,平均1.09±0.62L(P<0.001)。6个月时变化的组间差异具有统计学和临床意义:残余体积的ΔEBV-SoC,-700毫升;6分钟步行距离,+78.7米;圣乔治呼吸问卷评分,-6.5分;修改医学研究理事会呼吸困难评分,-0.6分;和BODE(体重指数,气流阻塞,呼吸困难,和运动能力)指数,-1.8分(均P<0.05)。气胸是最常见的不良事件,发生在65例EBV受试者中的19例(29.2%)。
在没有侧支通气的异质性肺气肿患者中,EBV治疗在肺功能方面具有临床意义的益处。呼吸困难,运动耐受力,和生活质量,具有可接受的安全性。在www上注册的临床试验。临床试验。gov(NCT02022683)。
Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter
study evaluating this treatment approach.
To evaluate the efficacy and safety of Zephyr EBVs in patients with heterogeneous emphysema and absence of collateral ventilation.
This was a prospective, multicenter 2:1 randomized controlled
trial of EBVs plus standard of care or standard of care alone (SoC). Primary outcome at 3 months post-procedure was the percentage of subjects with FEV1 improvement from baseline of 12% or greater. Changes in FEV1, residual volume, 6-minute-walk distance, St. George\'s Respiratory Questionnaire score, and modified Medical Research Council score were assessed at 3 and 6 months, and target lobe volume reduction on chest computed tomography at 3 months.
Ninety seven subjects were randomized to EBV (n = 65) or SoC (n = 32). At 3 months, 55.4% of EBV and 6.5% of SoC subjects had an FEV1 improvement of 12% or more (P < 0.001). Improvements were maintained at 6 months: EBV 56.3% versus SoC 3.2% (P < 0.001), with a mean ± SD change in FEV1 at 6 months of 20.7 ± 29.6% and -8.6 ± 13.0%, respectively. A total of 89.8% of EBV subjects had target lobe volume reduction greater than or equal to 350 ml, mean 1.09 ± 0.62 L (P < 0.001). Between-group differences for changes at 6 months were statistically and clinically significant: ΔEBV-SoC for residual volume, -700 ml; 6-minute-walk distance, +78.7 m; St. George\'s Respiratory Questionnaire score, -6.5 points; modified Medical Research Council dyspnea score, -0.6 points; and BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, -1.8 points (all P < 0.05). Pneumothorax was the most common adverse event, occurring in 19 of 65 (29.2%) of EBV subjects.
EBV treatment in hyperinflated patients with heterogeneous emphysema without collateral ventilation resulted in clinically meaningful benefits in lung function, dyspnea, exercise tolerance, and quality of life, with an acceptable safety profile. Clinical
trial registered with www.clinicaltrials.gov (NCT02022683).