Withdrawal of high-dose inhaled corticosteroids in COPD patients with mild or moderate airflow limitation: a feasibility study in primary care

P. White, G. Gilworth, M. Thomas, C. Corrigan, Patrick J. Murphy, N. Hart, Leslie A. Hamilton, T. Harries
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Abstract

Background: High-dose inhaled corticosteroids (HD-ICS) are prescribed frequently outside guidelines in COPD, especially with mild or moderate airflow limitation. The acceptability and safety of withdrawal of HD-ICS in these patients is unknown. Aim: Feasibility study of a trial of the safe withdrawal of HD-ICS prescribed outside guidelines in COPD patients with mild or moderate airflow limitation. Method: COPD patients with mild or moderate airflow limitation using HD-ICS were invited to participate by their GPs. The challenges of identifying those suitable for inclusion have been described elsewhere. Participants were randomised to withdrawal from or continued use of HD-ICS. Impact of withdrawal was assessed through measures of lung function, quality of life, exacerbations, cellular and molecular biomarkers and neural respiratory drive. Measures were repeated at 3 and 6 months. Results: 61 patients attended. All agreed to undertake HD-ICS withdrawal. 21 patients were excluded due to: FEV1 reversibility (49%), severe airflow limitation (29%), no airflow obstruction (10%), frequent exacerbations in past year (4%), hospital admission for exacerbation (4%), BMI >35 (4%). 40 patients were recruited to the feasibility study. 20 were randomised to withdraw from HD-ICS use, 20 to continue HD-ICS use. Among the withdrawal arm, 5 resumed HD-ICS because of a decline in lung function or patient choice. Conclusions: A trial of the withdrawal of HD-ICS is feasible and acceptable to eligible patients responding to invitation. Of priority are identification of suitable patients and careful monitoring to detect a decline in lung function following withdrawal.
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轻度或中度气流受限的COPD患者停用大剂量吸入皮质类固醇:一项初级保健的可行性研究
背景:大剂量吸入性皮质类固醇(HD-ICS)经常在COPD指南之外使用,特别是轻度或中度气流受限的患者。这些患者停用HD-ICS的可接受性和安全性尚不清楚。目的:对轻度或中度气流受限COPD患者安全停用指南外HD-ICS的可行性研究。方法:由全科医生邀请轻度或中度气流受限的COPD患者使用HD-ICS进行参与。在其他地方已经描述了确定那些适合纳入的挑战。参与者被随机分配到停止或继续使用HD-ICS。通过测量肺功能、生活质量、恶化情况、细胞和分子生物标志物以及神经呼吸驱动来评估停药的影响。在3个月和6个月时重复测量。结果:61例患者就诊。所有国家都同意撤出HD-ICS。21例患者因FEV1可逆性(49%)、严重气流受限(29%)、无气流阻塞(10%)、过去一年频繁加重(4%)、因加重住院(4%)、BMI >35(4%)被排除。选取40例患者进行可行性研究。20人随机退出HD-ICS使用,20人继续使用HD-ICS。在停药组中,5例因肺功能下降或患者选择恢复HD-ICS。结论:对于响应邀请的符合条件的患者,撤销HD-ICS的试验是可行和可接受的。优先考虑的是确定合适的患者,并仔细监测停药后肺功能的下降。
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