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Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma.

机译:支气管热成形术:严重持续性哮喘患者的长期安全性和有效性。

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摘要

BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS: BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS: One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS: These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.
机译:背景:先前已显示,支气管热成形术(BT)可将严重持续性哮喘患者的哮喘控制提高至2年。目的:我们试图评估BT治疗哮喘5年后的有效性和安全性。方法:对来自哮喘干预研究2试验(ClinicalTrials.govNCT01350414)的BT治疗受试者进行了为期5年的年度评估,以评估BT的长期安全性及其治疗效果的持久性。 BT后评估的结果包括严重加重,不良事件,卫生保健使用,肺活量数据和高分辨率计算机断层扫描。结果:哮喘干预研究2试验的190名接受BT治疗的受试者中的一百六十二名(85.3%)完成了5年的随访。经历严重急性发作和急诊就诊的患者比例以及第1至5年每年的事件发生率仍然很低,并且低于BT治疗前12个月的观察值(平均5年降低比例:急性发作的患者占44%,急诊就诊的患者占78%)。与BT后的第一年相比,第2至5年的呼吸不良事件和与呼吸有关的住院治疗保持不变。尽管每日平均吸入皮质类固醇剂量减少了18%,但在BT后1至5年内,支气管扩张剂前FEV₁值保持稳定。从基线到BT后5年的高分辨率计算机断层扫描显示,没有结构异常可归因于BT。结论:这些数据证明了BT的益处在控制哮喘(基于持续减轻严重加重和ED就呼吸道症状进行就诊)方面的5年持久性。 BT已经成为我们治疗武器库的重要补充,对于严重的持续性哮喘患者,即使服用吸入性糖皮质激素和长效β2受体激动剂,也仍然有症状,应考虑使用BT。

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