Washington University, St. Louis, MO, USA.
Ann Allergy Asthma Immunol. 2011 Jul;107(1):65-70. doi: 10.1016/j.anai.2011.03.005. Epub 2011 Apr 14.
Bronchial thermoplasty (BT) has been demonstrated to be safe and effective in the treatment of severe persistent asthma out to at least 1 year. Preclinical studies have demonstrated that the reduction in airway smooth muscle after bronchial thermoplasty persists out to at least 3 years.
To examine the persistence of effectiveness of BT 2 years posttreatment in subjects with severe asthma.
Subjects participating in the long-term safety follow-up phase of the Asthma Intervention Research 2 (AIR2) Trial were evaluated by comparing the proportion of subjects who experienced exacerbations, adverse events, or healthcare utilization during the first year (year 1) after BT treatment with the proportion of subjects who experienced the same during the subsequent 12 months (year 2).
Severe exacerbations, respiratory adverse events, emergency department visits for respiratory symptoms, and hospitalizations for respiratory symptoms (proportion of subjects experiencing and rates of events), and stability of pre- and post-bronchodilator forced expiratory volume in 1 second (FEV(1)), were comparable between years 1 and 2. The proportion of subjects experiencing severe exacerbations in year 2 after BT was 23.0%, compared with 30.9% in year 1.
The reduction in the proportion of subjects experiencing severe exacerbations after BT is maintained for at least 2 years. Bronchial thermoplasty provides beneficial long-term effects on asthma outcomes in patients with severe asthma.
clinicaltrials.gov, Identifier: NCT00231114.
支气管热成形术(BT)已被证明在治疗严重持续性哮喘方面是安全有效的,至少可维持 1 年。临床前研究表明,支气管热成形术后气道平滑肌的减少至少可维持 3 年。
检查 BT 治疗后 2 年严重哮喘患者疗效的持久性。
参与哮喘干预研究 2(AIR2)试验长期安全性随访阶段的患者,通过比较 BT 治疗后第一年(第 1 年)和随后 12 个月(第 2 年)发生加重、不良事件或医疗保健利用的患者比例,来评估疗效的持久性。
严重加重、呼吸道不良事件、因呼吸道症状急诊就诊和因呼吸道症状住院(经历事件的患者比例和事件发生率)以及支气管扩张剂后用力呼气量第一秒(FEV(1))的稳定性在第 1 年和第 2 年之间是可比的。BT 治疗后第 2 年经历严重加重的患者比例为 23.0%,而第 1 年为 30.9%。
BT 治疗后严重加重患者比例的降低至少可维持 2 年。支气管热成形术为严重哮喘患者的哮喘结局提供了有益的长期效果。
clinicaltrials.gov,标识符:NCT00231114。