Brusselle Guy, Blasi Francesco, Gessner Christian, Kuna Piotr, Wark Peter, Cappellini Glauco, Oosterom Emilie, Van Der Deijl Marielle, Bucchioni Enrica, Topole Eva
Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
Pulmonology and Cystic Fibrosis Unit, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy.
ERJ Open Res. 2024 Sep 30;10(5). doi: 10.1183/23120541.00174-2024. eCollection 2024 Sep.
Inhaled corticosteroid/formoterol fumarate (ICS/FF) as needed is recommended by the Global Initiative for Asthma (GINA) as sole therapy in adults with mild asthma, with low-dose maintenance ICS plus short-acting β-agonist (SABA) as an alternative. SABA alone is no longer recommended. Given these changes in recommendations, the observational PRIME study aimed to describe real-world treatment patterns in mild asthma in Europe.
Adults with asthma receiving low-dose maintenance ICS, or as needed ICS/FF or SABA were followed for 6 months. Data collected included Asthma Control Test (ACT), Asthma Control Questionnaire 5-item (ACQ-5), forced expiratory volume in 1 s (FEV) and asthma exacerbations.
The study was conducted in 883 patients in Germany, Italy, Poland and Spain; 833 (94.3%) completed follow-up. At enrolment, 32.2% received maintenance ICS, 56.3% ICS/FF as needed and 11.6% SABA as needed; 57.4%, 61.2% and 54.9%, respectively, had well-controlled asthma (ACQ-5/ACT definition). After 6 months, changes in mean FEV were small in the maintenance ICS and ICS/FF as needed groups, whereas there was a decline in FEV in the SABA as needed group. ACQ-5 total score improved from baseline in all three groups; 0.4%, 0.4% and 2.0% patients, respectively, had a severe exacerbation during the study.
More patients received ICS/FF as needed than SABA as needed, suggesting that physicians are aware of the latest treatment recommendations. This real-world study provides additional support to the use of ICS/FF as needed as preferred treatment for patients with mild asthma, whereas SABA as needed was associated with a fall in lung function and more severe exacerbations.
全球哮喘防治创议（GINA）推荐按需使用吸入性糖皮质激素/富马酸福莫特罗（ICS/FF）作为轻度哮喘成人患者的单一疗法，低剂量维持性ICS加短效β受体激动剂（SABA）作为替代方案。不再推荐单独使用SABA。鉴于这些推荐的变化，观察性PRIME研究旨在描述欧洲轻度哮喘的实际治疗模式。
对接受低剂量维持性ICS、按需使用ICS/FF或SABA的成年哮喘患者进行为期6个月的随访。收集的数据包括哮喘控制测试（ACT）、5项哮喘控制问卷（ACQ-5）、1秒用力呼气量（FEV）和哮喘急性加重情况。
该研究在德国、意大利、波兰和西班牙的883例患者中进行；833例（94.3%）完成随访。入组时，32.2%的患者接受维持性ICS，56.3%的患者按需使用ICS/FF，11.6%的患者按需使用SABA；分别有57.4%、61.2%和54.9%的患者哮喘得到良好控制（根据ACQ-5/ACT定义）。6个月后，维持性ICS组和按需使用ICS/FF组的平均FEV变化较小，而按需使用SABA组的FEV有所下降。所有三组的ACQ-5总分均较基线有所改善；在研究期间，分别有0.4%、0.4%和2.0%的患者发生严重急性加重。
按需使用ICS/FF的患者比按需使用SABA的患者更多，这表明医生了解最新的治疗推荐。这项真实世界研究为按需使用ICS/FF作为轻度哮喘患者的首选治疗方法提供了额外支持，而按需使用SABA与肺功能下降和更严重的急性加重相关。
