Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
J Allergy Clin Immunol Pract. 2021 Mar;9(3):1304-1311.e2. doi: 10.1016/j.jaip.2020.09.066. Epub 2020 Nov 9.
Current guidelines for the treatment of asthma and chronic obstructive pulmonary disease overlap (ACO) recommend initial treatment using inhaled corticosteroids (ICSs) plus 1 or more bronchodilators.
To clarify which therapeutic effect is better between the ICS + long-acting β agonist (LABA) and ICS + LABA + long-acting muscarinic antagonist (LAMA) treatment in patients with ACO.
We conducted a multicenter, 48-week, randomized, noninferiority trial. Patients with ACO were enrolled if they were treated with a moderate to high dose of ICS + LABA. In total, 303 patients were involved in the present trial, with 149 receiving ICS + LABA + LAMA. The primary end point was the time to first exacerbation. Secondary outcomes included changes in FEV, forced vital capacity, FEV/forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide.
In the ICS + LABA treatment group, 29 of 154 patients (18.83%) experienced exacerbation, whereas 28 of 149 patients (18.79%) experienced exacerbation in the ICS + LABA + LAMA treatment group. The results of this noninferiority study were ultimately inconclusive (hazard ratio, 1.1; 95% CI, 0.66-1.84). However, the patients treated with the addition of LAMA showed significant improvements in FEV and forced vital capacity (P < .001). Asthma control did not improve in either group.
Although this study was unable to conclude that ICS + LABA treatment is not inferior to ICS + LABA + LAMA in terms of exacerbation, it is obvious that the ICS + LABA + LAMA treatment group had improved lung function in ACO.
目前，哮喘和慢性阻塞性肺疾病重叠（ACO）的治疗指南建议初始治疗采用吸入皮质类固醇（ICS）加 1 种或多种支气管扩张剂。
明确在 ACO 患者中，ICS+长效β激动剂（LABA）与 ICS+LABA+长效毒蕈碱拮抗剂（LAMA）治疗的哪种治疗效果更好。
我们进行了一项多中心、48 周、随机、非劣效性试验。如果 ACO 患者接受中高剂量 ICS+LABA 治疗，则将其纳入研究。本研究共纳入 303 例患者，其中 149 例接受 ICS+LABA+LAMA 治疗。主要终点是首次加重的时间。次要结局包括 FEV1、用力肺活量、FEV1/用力肺活量比值、哮喘控制、血嗜酸性粒细胞计数和呼出气一氧化氮分数的变化。
在 ICS+LABA 治疗组中，154 例患者中有 29 例（18.83%）发生加重，而在 ICS+LABA+LAMA 治疗组中，149 例患者中有 28 例（18.79%）发生加重。这项非劣效性研究的结果最终不确定（危险比，1.1；95%CI，0.66-1.84）。然而，加用 LAMA 的患者的 FEV1 和用力肺活量明显改善（P<0.001）。两组的哮喘控制均未改善。
尽管本研究未能得出 ICS+LABA 治疗在加重方面不劣于 ICS+LABA+LAMA 的结论，但 ICS+LABA+LAMA 治疗组在 ACO 中改善了肺功能是显而易见的。
