1 Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
2 Cochin Hospital Group, Assistance Publique-Hôpitaux de Paris, University of Paris Descartes, Paris, France.
Ann Am Thorac Soc. 2015 Jun;12(6):798-806. doi: 10.1513/AnnalsATS.201412-580OC.
Guidelines advocate adding long-acting β-agonist (LABA) to inhaled corticosteroid as the preferred step-up therapy to increasing inhaled corticosteroid dose for patients with uncontrolled asthma on inhaled corticosteroid monotherapy. However, less than 5% of patients with asthma qualify for the randomized controlled trials on which guidelines are based. Thus, real-world data are needed to complement the results of randomized trials with narrow entry criteria.
To compare the effectiveness of stepping up asthma therapy with an increased dose of various types of inhaled corticosteroid as compared with add-on LABA.
We performed a historical matched cohort study using large primary care databases to compare asthma step-up therapy with small- and standard size-particle inhaled corticosteroid versus added LABA for patients 12-80 years old. As outcomes, we examined a composite of asthma control and rates of severe exacerbations.
The odds of asthma control and rates of severe exacerbations over one outcome year were comparable with increased inhaled corticosteroid dose versus added LABA. The adjusted odds ratios (95% confidence interval) for achieving asthma control with increased inhaled corticosteroid dose versus inhaled corticosteroid/LABA were 0.99 (0.88-1.12) for small-particle inhaled corticosteroid (n = 3,036 per cohort) and 0.85 (0.67-1.07) for standard size-particle inhaled corticosteroid (n = 809 per cohort). The adjusted rate ratios (95% confidence interval) for severe exacerbations, compared with inhaled corticosteroid/LABA combination inhaler, were 1.04 (0.91-1.20) and 1.18 (0.92-1.54), respectively. The results were not affected by smoking status.
When applied to a broad primary care population, antiinflammatory therapy using increased doses of small- or standard size-particle inhaled corticosteroid is as effective as adding LABA, as measured by outcomes important to both patients and providers. Real-world populations and outcomes need to be taken into consideration when formulating treatment recommendations.
指南主张在吸入性皮质类固醇基础上添加长效β-激动剂（LABA），作为吸入性皮质类固醇单药治疗控制不佳的哮喘患者逐步升级治疗的首选方案。然而，只有不到 5%的哮喘患者符合指南所依据的随机对照试验的纳入标准。因此，需要真实世界的数据来补充具有严格纳入标准的随机试验结果。
比较增加各种类型吸入性皮质类固醇剂量与添加 LABA 作为哮喘治疗升级方案的疗效。
我们使用大型初级保健数据库进行了一项历史性匹配队列研究，以比较 12-80 岁患者的小粒径和标准粒径吸入性皮质类固醇递增剂量与添加 LABA 的哮喘升级治疗方案。作为结局，我们评估了哮喘控制和重度恶化发作的复合结局。
与添加 LABA 相比，增加吸入性皮质类固醇剂量在一个结局年度时的哮喘控制率和重度恶化发作率相当。与吸入性皮质类固醇/ LABA 相比，增加吸入性皮质类固醇剂量时达到哮喘控制的调整后比值比（95%置信区间）分别为小粒径吸入性皮质类固醇（每个队列 3036 例）0.99（0.88-1.12）和标准粒径吸入性皮质类固醇（每个队列 809 例）0.85（0.67-1.07）。与吸入性皮质类固醇/ LABA 联合吸入器相比，重度恶化发作的调整后率比（95%置信区间）分别为 1.04（0.91-1.20）和 1.18（0.92-1.54）。结果不受吸烟状况的影响。
在广泛的初级保健人群中，使用小粒径或标准粒径吸入性皮质类固醇增加剂量的抗炎治疗与添加 LABA 一样有效，这是患者和提供者都重视的结局。在制定治疗建议时，需要考虑真实世界的人群和结局。
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