Efficacy of bronchial thermoplasty in patients with severe asthma and frequent severe exacerbations: A randomized controlled study✰

IF 2.2 4区 医学 Q3 RESPIRATORY SYSTEM
Justine Leroux , Naji Khayath , Cezar Matau , Christophe Marcot , Nicolas Migueres , Cindy Barnig , Anita Molard , Diana Ochea , Mickael Ohana , François Lefebvre , Frédéric de Blay
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Abstract

Background

Bronchial thermoplasty (BT) is a bronchoscopic procedure for patients with severe uncontrolled asthma, but randomized controlled studies of its efficacy in severe asthma with frequent exacerbations are lacking. The current aim was to assess BT efficacy in this patient population.

Methods

Thirty patients with asthma (GINA 5) who had experienced at least four severe exacerbations in the preceding year were randomized to BT (n = 15) or control groups (n = 15). All patients had four follow-up visits over the following 15 months, corresponding to 3, 6, 9, and 12 months after the last procedure for the BT group. The primary outcome was number of exacerbations at 15 months after inclusion (i.e. 12 months after bronchial thermoplasty).

Results

All but three patients had received an asthma biologic without receiving benefit. In the year preceding enrollment, patients in the BT group had an average of five exacerbations, compared with six among controls. For patients in the BT group, oral steroid intake was 9.3 mg/d, compared with 11.0 mg/d among controls. The BT group had 1.58 fewer severe exacerbations (mean, 6.09) compared with controls (mean, 8.28) in the 12-month period after the therapy (p = 0.047). Oral steroid intake during follow-up after BT was significantly lower in the BT group (ratio vs controls: 0.61; p = 0.0002). Quality-of-life measures between inclusion and the last visit were significantly improved in the BT group, but not among controls. Few mild to moderate adverse events were reported, and all were controlled within days.

Conclusion

In patients with severe asthma and frequent severe exacerbations, BT significantly decreased the rate of severe exacerbations and oral steroid intake and led to improved quality of life during the 15 months after inclusion. BT appears to offer a therapeutic option for severe asthma with frequent exacerbations.

支气管热成形术对严重哮喘和频繁严重恶化患者的疗效:随机对照研究
背景支气管热成形术(BT)是一种支气管镜手术,适用于病情未得到控制的重症哮喘患者,但对频繁恶化的重症哮喘患者的疗效缺乏随机对照研究。方法将 30 名哮喘患者(GINA 5)随机分为 BT 组(15 人)和对照组(15 人),这些患者在过去一年中至少经历了四次严重恶化。所有患者在随后的 15 个月中接受了四次随访,分别是 BT 组最后一次治疗后的 3、6、9 和 12 个月。主要结果是入组后15个月(即支气管热成形术后12个月)的病情加重次数。在入组前一年,BT 组患者平均病情加重五次,而对照组为六次。BT 组患者的口服类固醇摄入量为 9.3 毫克/天,而对照组为 11.0 毫克/天。在治疗后的 12 个月内,BT 组患者的严重病情加重次数(平均 6.09 次)比对照组(平均 8.28 次)少 1.58 次(P = 0.047)。在 BT 治疗后的随访期间,BT 组的口服类固醇摄入量明显低于对照组(比值比:0.61;P = 0.0002)。BT组患者在入组和最后一次随访期间的生活质量明显改善,而对照组患者则没有改善。结论 对于严重哮喘且经常严重恶化的患者,BT 能显著降低严重恶化率和口服类固醇的摄入量,并能改善入组 15 个月后的生活质量。BT 似乎为频繁恶化的重症哮喘患者提供了一种治疗选择。
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来源期刊
Respiratory Medicine and Research
Respiratory Medicine and Research RESPIRATORY SYSTEM-
CiteScore
2.70
自引率
0.00%
发文量
82
审稿时长
50 days
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