重症哮喘患者支气管热成形术后的远期疗效:两个前瞻性多中心研究的3年随访结果比较
2017/12/29
摘要
背景：支气管热成形术是一种以内镜治疗重症哮喘的方法。此前一项随机的以假手术作为对照的试验AIR2 (哮喘干预研究 2)表明, 支气管热成形术后，重度哮喘的急性加重, 急诊访视和住院次数均显著降低。但更加贴近“真实世界”的临床疗效仍需再进一步地评估。
方法：在正在进行的批准上市应用后的PAS2研究中（经FDA批准后的评估支气管热成形术在重症持续性哮喘中疗效的临床试验），我们对经历过支气管热成形术的病人进行了3年的随访。并将该项实验的结果与在AIR2试验中的结果进行了比较。
结果：在PAS2研究中,共有279位患者接受了支气管热成形术。我们将PAS2研究中的前190位患者与AIR2研究中接受了支气管热成形术的190位患者进行了比较，并比较了患者的3年随访结果。PAS2研究中的病人年龄更大(平均年龄45.9 vs 40.7 岁)，更加肥胖(平均体重指数BMI 32.5 vs 29.3 kg·m−2)，吸入糖皮质激素的剂量也更高（平均剂量2301 vs 1961 μg·day−1）。在接受支气管热成形术治疗的前12个月里，PAS2研究中有更多的的病人经历了哮喘急性加重(74% vs 52%)和住院治疗(15.3% vs 4.2%) 。在支气管热成形术后的3年，PAS2研究中具有哮喘急性加重史，急诊访视史和住院治疗史的患者比例分别为45%, 55% 和40%，这与在AIR2研究中的结果相近似。
结论：尽管PAS2研究中所纳入的患者在之前有着更糟糕的哮喘控制状态，但在经支气管热成形术治疗后，在哮喘控制状态方面，PAS2研究中的患者取得了与AIR2研究中的患者相近似的改善。
Long-term outcomes of bronchial thermoplasty in subjects with severe asthma: a comparison of 3-year follow-up results from two prospective multicentre studies.
Chupp G, Laviolette M, Cohn L, et al.
Abstract
BACKGROUND:Bronchial thermoplasty is an endoscopic therapy for severe asthma. The previously reported, randomised sham-controlled AIR2 (Asthma Intervention Research 2) trial showed a significant reduction in severe asthma exacerbations, emergency department visits and hospitalisations after bronchial thermoplasty. More “real-world” clinical outcome data is needed.
Methods:This article compares outcomes in bronchial thermoplasty subjects with 3 years of follow-up from the ongoing, post-market PAS2 (Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma) study with those from the AIR2 trial.
Results:279 subjects were treated with bronchial thermoplasty in the PAS2 study. We compared the first 190 PAS2 subjects with the 190 bronchial thermoplasty-treated subjects in the AIR2 trial at 3 years of follow-up. The PAS2 subjects were older (mean age 45.9 versus 40.7 years) and more obese (mean body mass index 32.5 versus 29.3 kg·m−2) and took higher doses of inhaled corticosteroids (mean dose 2301 versus 1961 μg·day−1). More PAS2 subjects had experienced severe exacerbations (74% versus 52%) and hospitalisations (15.3% versus 4.2%) in the 12 months prior to bronchial thermoplasty. At year 3 after bronchial thermoplasty, the percentage of PAS2 subjects with severe exacerbations, emergency department visits and hospitalisations significantly decreased by 45%, 55% and 40%, respectively, echoing the AIR2 results.
Conclusions：The PAS2 study demonstrates similar improvements in asthma control after bronchial thermoplasty compared with the AIR2 trial despite enrolling subjects who may have had poorer asthma control.
背景：支气管热成形术是一种以内镜治疗重症哮喘的方法。此前一项随机的以假手术作为对照的试验AIR2 (哮喘干预研究 2)表明, 支气管热成形术后，重度哮喘的急性加重, 急诊访视和住院次数均显著降低。但更加贴近“真实世界”的临床疗效仍需再进一步地评估。
方法：在正在进行的批准上市应用后的PAS2研究中（经FDA批准后的评估支气管热成形术在重症持续性哮喘中疗效的临床试验），我们对经历过支气管热成形术的病人进行了3年的随访。并将该项实验的结果与在AIR2试验中的结果进行了比较。
结果：在PAS2研究中,共有279位患者接受了支气管热成形术。我们将PAS2研究中的前190位患者与AIR2研究中接受了支气管热成形术的190位患者进行了比较，并比较了患者的3年随访结果。PAS2研究中的病人年龄更大(平均年龄45.9 vs 40.7 岁)，更加肥胖(平均体重指数BMI 32.5 vs 29.3 kg·m−2)，吸入糖皮质激素的剂量也更高（平均剂量2301 vs 1961 μg·day−1）。在接受支气管热成形术治疗的前12个月里，PAS2研究中有更多的的病人经历了哮喘急性加重(74% vs 52%)和住院治疗(15.3% vs 4.2%) 。在支气管热成形术后的3年，PAS2研究中具有哮喘急性加重史，急诊访视史和住院治疗史的患者比例分别为45%, 55% 和40%，这与在AIR2研究中的结果相近似。
结论：尽管PAS2研究中所纳入的患者在之前有着更糟糕的哮喘控制状态，但在经支气管热成形术治疗后，在哮喘控制状态方面，PAS2研究中的患者取得了与AIR2研究中的患者相近似的改善。
(复旦大学附属中山医院 呼吸科 胡湘麟 摘译 杨冬 审校)
(European Respiratory Journal 2017,50(2))
(European Respiratory Journal 2017,50(2))
Long-term outcomes of bronchial thermoplasty in subjects with severe asthma: a comparison of 3-year follow-up results from two prospective multicentre studies.
Chupp G, Laviolette M, Cohn L, et al.
Abstract
BACKGROUND:Bronchial thermoplasty is an endoscopic therapy for severe asthma. The previously reported, randomised sham-controlled AIR2 (Asthma Intervention Research 2) trial showed a significant reduction in severe asthma exacerbations, emergency department visits and hospitalisations after bronchial thermoplasty. More “real-world” clinical outcome data is needed.
Methods:This article compares outcomes in bronchial thermoplasty subjects with 3 years of follow-up from the ongoing, post-market PAS2 (Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma) study with those from the AIR2 trial.
Results:279 subjects were treated with bronchial thermoplasty in the PAS2 study. We compared the first 190 PAS2 subjects with the 190 bronchial thermoplasty-treated subjects in the AIR2 trial at 3 years of follow-up. The PAS2 subjects were older (mean age 45.9 versus 40.7 years) and more obese (mean body mass index 32.5 versus 29.3 kg·m−2) and took higher doses of inhaled corticosteroids (mean dose 2301 versus 1961 μg·day−1). More PAS2 subjects had experienced severe exacerbations (74% versus 52%) and hospitalisations (15.3% versus 4.2%) in the 12 months prior to bronchial thermoplasty. At year 3 after bronchial thermoplasty, the percentage of PAS2 subjects with severe exacerbations, emergency department visits and hospitalisations significantly decreased by 45%, 55% and 40%, respectively, echoing the AIR2 results.
Conclusions：The PAS2 study demonstrates similar improvements in asthma control after bronchial thermoplasty compared with the AIR2 trial despite enrolling subjects who may have had poorer asthma control.
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