福莫特罗
医学
沙美特罗
丙酸氟替卡松
氟替卡松
布地奈德
慢性阻塞性肺病
恶化
布地奈德/福莫特罗
支气管扩张剂
皮质类固醇
内科学
哮喘
麻醉
胃肠病学
作者
Susan Muiser,Kai Imkamp,Dianne Seigers,Nynke J Halbersma,Judith M. Vonk,Bart H D Luijk,Gert‐Jan Braunstahl,Jan Willem van den Berg,Bart‐Jan Kroesen,Janwillem Kocks,Irene H. Heijink,Helen K. Reddel,Huib A.M. Kerstjens,Maarten van den Berge
出处
期刊:Thorax
[BMJ]
日期:2023-02-01
卷期号:78 (5): 451-458
被引量:9
标识
DOI:10.1136/thorax-2022-219620
摘要
Background Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). Methods Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax budesonide/formoterol 160/4.5 µg 2 inhalations twice daily+1 prn) or fixed-dose therapy (Diskus fluticasone propionate/salmeterol combination (FSC) 500/50 µg 1 inhalation twice daily+salbutamol 100 µg prn) for 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. Results In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 µg/day vs 1747 µg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). Conclusions This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety.
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