ICS + LABA与ICS + LABA + LAMA在哮喘-COPD重叠（ACO）治疗中的一项随机非劣性试验：ACO
2020/11/17
ICS + LABA与ICS + LABA + LAMA在哮喘-COPD重叠（ACO）治疗中的一项随机非劣性试验：ACO最佳药物治疗（ATOMIC）研究
摘要背景：当前治疗哮喘和慢性阻塞性肺疾病重叠（ACO）的指南建议使用吸入性糖皮质激素（ICS）加1种或多种支气管扩张药进行初始治疗。
目的：阐明ICS +长效β2激动剂（LABA）和ICS + LABA +长效毒蕈碱拮抗剂（LAMA）治疗ACO患者哪种治疗效果更好。
方法：我们进行了一项多中心，48周，随机，非劣性试验。试验招募了接受中度至高剂量的ICS + LABA治疗的ACO患者。共有303名患者参与了本试验，其中149名患者接受了ICS + LABA + LAMA治疗。研究主要终点是首次加重的时间。次要终点包括FEV1、用力肺活量、FEV1 /用力肺活量、哮喘控制、嗜酸粒细胞计数和呼出气一氧化氮。
结果：在ICS + LABA治疗组中，154例患者中有29例（18.83％）出现急性加重，而在ICS + LABA + LAMA治疗组中149例中有28例（18.79％）出现急性加重。这项非劣性研究的结果是非最终定论的（危险比，1.1； 95％CI，0.66-1.84）。但是，接受LAMA治疗的患者在FEV1和用力肺活量方面有明显改善（P <.001）。两组的哮喘控制均未改善。
结论：尽管本研究无法得出ICS + LABA治疗在急性加重方面并不逊于ICS + LABA + LAMA的结论，但ICS + LABA + LAMA治疗组很明显改善了ACO患者的肺功能。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校)
(J Allergy Clin Immunol Pract. 2020 Nov 9;S2213-2198(20)31120-X. doi: 10.1016/j.jaip.2020.09.066.)
(J Allergy Clin Immunol Pract. 2020 Nov 9;S2213-2198(20)31120-X. doi: 10.1016/j.jaip.2020.09.066.)
A Randomized, Noninferiority Trial Comparing ICS + LABA with ICS + LABA + LAMA in Asthma-COPD Overlap (ACO) Treatment: The ACO Treatment with Optimal Medications (ATOMIC) Study.
So-Young Park, Solmi Kim, Jung-Hyun Kim, Sae-Hoon Kim, Taehoon Lee, Sun-Young Yoon, Min-Hye Kim, Ji-Yong Moon, Min-Suk Yang, Jae-Woo Jung, Joo-Hee Kim, Jeong-Hee Choi, Chan Sun Park, Sujeong Kim, Jaechun Lee, Jae-Woo Kwon, Gyu Young Hur, Sang-Ha Kim, Hee-Kyoo Kim, Yoo Seob Shin, Sang-Hoon Kim, Young-Hee Nam, An-Soo Jang, Seo Young Park, Tae-Bum Kim, Cohort for Reality and Evolution of Adult Asthma in Korea (COREA) Study Group.
Abstract
BACKGROUND: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.
OBJECTIVE:To clarify which therapeutic effect is better between the ICS + long-acting β2 agonist (LABA) and ICS + LABA + long-acting muscarinic antagonist (LAMA) treatment in patients with ACO.
METHODS: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 FEV1, forced vital capacity, FEV1/forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide.
RESULTS: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 FEV1 and forced vital capacity (P < .001). Asthma control did not improve in either group.
CONCLUSIONS: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.
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