Department of Epidemiology, Epidemiology, Biostatistics, and Prevention Institute, University of Zurich, Zurich, Switzerland.
Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands; Urban Vitality Centre of Expertise, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, Netherlands.
Lancet Digit Health. 2021 Oct;3(10):e644-e653. doi: 10.1016/S2589-7500(21)00130-8. Epub 2021 Aug 24.
Since the benefit-harm balance of adding inhaled corticosteroids to long-acting β-agonists (LABA) and long-acting muscarinic antagonists (LAMA) for patients with chronic obstructive pulmonary disease is unclear, we evaluated this addition for a range of patient profiles.
Analyses considered the effects of low-to-moderate doses of inhaled corticosteroids, LABA, and LAMA compared with LABA and LAMA alone, outcome incidences, and preference weights assigned to averted moderate-to-severe exacerbations (benefit) and severe pneumonia, candidiasis, and dysphonia (harm). Using exponential models, we estimated the preference weight-adjusted 2-year net clinical benefit (ie, benefits outweighing harms) indices. Exacerbation risk thresholds for triggering inhaled corticosteroids, LABA, and LAMA were established when the probability of a 2-year net clinical benefit reached 60%. We estimated the proportion of patients benefiting from added inhaled corticosteroids using an externally validated prediction model for acute exacerbations in primary care.
Adding low-to-moderate dose inhaled corticosteroids to LABA and LAMA provided a net clinical benefit in patients with a 2-year baseline exacerbation risk of 54-83%. Low-dose inhaled corticosteroids showed a net clinical benefit if the baseline risk was 40-91%, but not at higher doses. The benefit was modified by blood eosinophil count (BEC) and age. Although no net benefit was associated with a BEC of less than 150 cells per μL, patients with a BEC of 150 cells per μL or more had a net benefit from low-dose inhaled corticosteroids with a 2-year exacerbation risk of 32-95% in those aged 40-79 years and 41-93% in those older than 80 years. A moderate dose of inhaled corticosteroids showed a net benefit in patients younger than 80 years with a BEC of 150 cells per μL or more at 52-86% 2-year exacerbation risk. Depending on the subgroups, the proportion of patients with a net benefit from added inhaled corticosteroids ranged from 0 to 68%.
The net clinical benefit of adding different inhaled corticosteroid doses to LABA and LAMA varies greatly with exacerbation risk, BEC, and age. Personalised treatment decisions based on these factors and predicted exacerbation risks might reduce overtreatment and undertreatment with inhaled corticosteroids.
None.
由于慢性阻塞性肺疾病患者加用吸入性皮质类固醇与长效β-激动剂（LABA）和长效抗胆硷能药物（LAMA）的获益-危害平衡尚不清楚，我们评估了这一联用对各种患者特征的效果。
分析比较了低-中剂量吸入皮质类固醇、LABA 和 LAMA 与 LABA 和 LAMA 单用的效果，结果发生率以及对预防中度至重度加重（获益）和严重肺炎、念珠菌病和发音困难（危害）的回避偏好权重。采用指数模型，我们估计了偏好权重调整后的 2 年净临床获益（即获益超过危害）指数。当 2 年净临床获益概率达到 60%时，确定了触发吸入皮质类固醇、LABA 和 LAMA 的加重风险阈值。我们使用初级保健中急性加重的外部验证预测模型估计了加用吸入皮质类固醇获益的患者比例。
在 2 年基线加重风险为 54-83%的患者中，低-中剂量吸入皮质类固醇联合 LABA 和 LAMA 具有净临床获益。如果基线风险为 40-91%，则低剂量吸入皮质类固醇具有净临床获益，但剂量更高则没有获益。疗效还受血嗜酸性粒细胞计数（BEC）和年龄的影响。虽然 BEC 小于 150 细胞/μL 时无净获益，但 BEC 为 150 细胞/μL 或更高时，40-79 岁患者 2 年加重风险为 32-95%，80 岁以上患者 2 年加重风险为 41-93%时，低剂量吸入皮质类固醇具有获益。在 BEC 为 150 细胞/μL 或更高且年龄小于 80 岁的患者中，中剂量吸入皮质类固醇的获益在 2 年加重风险为 52-86%时出现。根据亚组情况，加用吸入皮质类固醇获益的患者比例为 0 至 68%。
加用不同剂量的吸入皮质类固醇与 LABA 和 LAMA 的净临床获益随加重风险、BEC 和年龄的不同而有很大差异。基于这些因素和预测的加重风险制定个体化治疗决策，可能会减少皮质类固醇的过度治疗和治疗不足。
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