布地奈德/福莫特罗维持与缓解治疗对比氟替卡松/沙美特罗固定剂量治疗慢性阻塞性肺疾病患者

Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD.

作者信息

Muiser Susan, Imkamp Kai, Seigers Dianne, Halbersma Nynke J, Vonk Judith M, Luijk Bart H D, Braunstahl Gert-Jan, van den Berg Jan-Willem, Kroesen Bart-Jan, Kocks Janwillem W H, Heijink Irene H, Reddel Helen K, Kerstjens Huib A M, van den Berge Maarten

机构信息

Department of Pulmonology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands

Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.

出版信息

Thorax. 2023 May;78(5):451-458. doi: 10.1136/thorax-2022-219620. Epub 2023 Feb 1.

DOI:10.1136/thorax-2022-219620

PMID:36725331

Abstract

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.

摘要

背景

吸入性糖皮质激素（ICS）/福莫特罗维持和缓解治疗（MART）可有效减少哮喘发作。我们旨在研究其与布地奈德/福莫特罗固定剂量疗法相比，在慢性阻塞性肺疾病（COPD）中的疗效。

方法

将过去2年中发生过≥1次加重的COPD患者随机分配至开放标签的MART组（思力华布地奈德/福莫特罗160/4.5μg，每日2次吸入+按需使用1次）或固定剂量疗法组（舒利迭丙酸氟替卡松/沙美特罗联合制剂（FSC）500/50μg，每日2次吸入+沙丁胺醇100μg按需使用），治疗1年。主要结局是中重度加重率，定义为接受口服泼尼松龙和/或抗生素治疗。

结果

总共195例患者被随机分组（MART布地奈德/福莫特罗组n = 103；固定剂量FSC组n = 92）。MART和FSC疗法在加重率方面无显著差异（分别为每年1.32次和1.32次，率比1.05（95%CI 0.79至1.39）；p = 0.741）。未观察到肺功能参数或健康状况的差异。MART组的总ICS剂量显著低于FSC疗法组（布地奈德等效剂量分别为每日928μg和1747μg，p<0.05）。报告不良事件的患者比例相似（MART布地奈德/福莫特罗组：73% vs固定剂量FSC组：68%，p = 0.408），肺炎发生率也相似（MART组：5% vs FSC组：1%，p = 0.216）。