Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen AB25 2ZD, UK.
Respir Med. 2013 Jul;107(7):987-1000. doi: 10.1016/j.rmed.2013.03.009. Epub 2013 May 3.
Beclometasone dipropionate is an inhaled corticosteroid (ICS) available in both extrafine and larger-particle hydrofluoroalkane formulations. Extrafine beclometasone has greater small airway distribution and inhalation technique tolerance than larger-particle beclometasone; therefore, its use may be associated with improved asthma outcomes at population levels. The study objective was to compare real-life effectiveness of extrafine and larger-particle beclometasone.
Retrospective matched cohort study including primary care patients with asthma (ages 12-60 and non-smokers 61-80 years) prescribed extrafine or larger-particle beclometasone by metered-dose inhaler. We studied patients receiving their first ICS (initiation population, n = 11,289) or switched from another ICS without dose change (switch population, n = 19,065). The extrafine and larger-particle beclometasone cohorts were matched in each population for demographic and database measures of asthma control during a baseline year; and endpoints assessed during 1 outcome year were adjusted for residual confounding factors.
The odds of no loss of asthma control (no asthma-related hospital attendance, consultation for lower respiratory tract infection, or oral corticosteroids) were significantly higher in the extrafine beclometasone cohorts of both initiation population (adjusted odds ratio [aOR] 1.12; 95% CI 1.02-1.23) and switch population (aOR 1.10; 95% CI 1.01-1.19). The odds of better adherence to ICS therapy were also significantly higher in both extrafine beclometasone cohorts (initiation population, aOR 1.64; 95% CI 1.52-1.75 and switch population, aOR 1.35; 95% CI 1.27-1.43).
These findings are consistent with the hypothesis that delivery of beclometasone in extrafine particle size produces real-life asthma treatment benefits. Clinical trials no. NCT01400217.
倍氯米松二丙酸酯是一种吸入性皮质类固醇（ICS），有超细颗粒和较大颗粒的氢氟烷烃两种制剂。与较大颗粒的倍氯米松相比，超细颗粒的倍氯米松在小气道分布和吸入技术方面的耐受性更好；因此，其在人群中的使用可能与改善哮喘结局有关。本研究的目的是比较超细颗粒和较大颗粒的倍氯米松的实际疗效。
这是一项回顾性匹配队列研究，纳入了接受以计量吸入器给药的超细颗粒或较大颗粒倍氯米松治疗的初级保健患者（年龄 12-60 岁，非吸烟者 61-80 岁）。我们研究了首次接受 ICS 治疗的患者（起始人群，n=11289）或未改变剂量而从其他 ICS 转换的患者（转换人群，n=19065）。在起始人群和转换人群中，对每个人群中的超细和较大颗粒倍氯米松队列，根据哮喘控制的基线年度的人口统计学和数据库指标进行匹配；在 1 年的随访期间评估终点，并对残余混杂因素进行调整。
在起始人群（调整后的比值比[aOR]1.12；95%CI 1.02-1.23）和转换人群（aOR 1.10；95%CI 1.01-1.19）中，超细颗粒倍氯米松队列中，哮喘控制不丢失（无哮喘相关的住院治疗、下呼吸道感染就诊或口服皮质类固醇治疗）的可能性显著更高。在两个超细颗粒倍氯米松队列中，ICS 治疗依从性更好的可能性也显著更高（起始人群，aOR 1.64；95%CI 1.52-1.75；转换人群，aOR 1.35；95%CI 1.27-1.43）。
这些发现与假设一致，即倍氯米松的超细颗粒粒径可带来现实生活中的哮喘治疗获益。临床试验注册号 NCT01400217。
