School of Population Health and Environmental Sciences, King's College London, London, UK
School of Population Health and Environmental Sciences, King's College London, London, UK.
BMJ Open Respir Res. 2022 Aug;9(1). doi: 10.1136/bmjresp-2022-001311.
Inhaled corticosteroids (ICS) are frequently prescribed outside guidelines to patients with chronic obstructive pulmonary disease (COPD) with mild/moderate airflow limitation and low exacerbation risk. This primary care trial explored the feasibility of identifying patients with mild/moderate COPD taking ICS, and the acceptability of ICS withdrawal.
Open feasibility trial. Outcome measures included prevalence of suitable participants, feasibility of their identification, their willingness-to-accept open randomisation to ICS withdrawal or continuation over 6 months follow-up.
392 (13%) of 2967 patients with COPD from 20 practices (209 618 population) identified as eligible for ICS withdrawal by electronic search algorithm. After individual patient record review, 243 (62%) were excluded because of: severe airflow limitation (65, 17%); one or more severe or two or more moderate COPD exacerbations in the previous year (86, 22%); asthma (15, 4%); and severe comorbidities (77, 20%). After exclusion, 149 patients with COPD were invited to participate and 61 agreed to randomisation. At clinical assessment, 10 patients exhibited undocumented airflow reversibility (forced expiratory volume in 1 s (FEV) reversibility >12% and >200 mL); 2 had suffered two or more undocumented, moderate exacerbations in the previous year; 7 had severe airflow limitation; and 2 had normal spirometry. Finally, 40 were randomised. One patient died and one was lost to follow-up. 18 (45%) of the 38 (10 withdrawal and 8 usual care) exhibited previously undocumented FEV variability suggestive of asthma, supported in the withdrawal group by significant associations with elevated fractional exhaled nitric oxide (p=0.04), elevated symptom score (p=0.04), poorer quality of life (p=0.04) and atopic status (p=0.01).
Identifying primary care patients with mild/moderate COPD suitable for ICS withdrawal is feasible but requires real-time verification because of unreliable recording of exacerbations and lung function. Suitable patients accepted randomisation to ICS withdrawal or continuation for the purposes of future studies. Follow-up compliance was high. Nearly 50% of participants with a diagnosis of mild/moderate COPD demonstrated previously undocumented FEV variability during follow-up, mandating monitoring for at least 6 months following withdrawal to exclude undiagnosed asthma.
在慢性阻塞性肺疾病（COPD）伴有轻度/中度气流受限和低加重风险的患者中，吸入皮质类固醇（ICS）经常在指南外处方。这项初级保健试验探讨了识别接受 ICS 治疗的轻度/中度 COPD 患者的可行性，以及停止 ICS 治疗的可接受性。
开放性可行性试验。主要结局包括适合的参与者的患病率、他们的识别可行性、他们是否愿意接受为期 6 个月随访的开放性随机分组到 ICS 停药或继续治疗。
从 20 个实践（209618 人）中通过电子搜索算法识别出 2967 例 COPD 患者中有 392 例（13%）适合 ICS 停药。经过患者个体记录审查，由于以下原因排除了 243 例（62%）：严重气流受限（65 例，17%）；过去一年中发生一次或多次严重或两次或更多中度 COPD 加重（86 例，22%）；哮喘（15 例，4%）；和严重合并症（77 例，20%）。排除后，邀请 149 例 COPD 患者参加，其中 61 例同意随机分组。在临床评估时，10 例患者表现出未记录的气流可逆性（用力呼气量 1 秒（FEV1）可逆性>12%和>200 毫升）；2 例患者过去一年中发生两次或更多未记录的中度加重；7 例患者存在严重气流受限；2 例患者的肺功能正常。最后，40 例患者被随机分组。1 例患者死亡，1 例失访。38 例中的 18 例（10 例停药和 8 例常规治疗）表现出先前未记录的 FEV 变异性，提示存在哮喘，在停药组中，与升高的呼气一氧化氮分数（p=0.04）、升高的症状评分（p=0.04）、较差的生活质量（p=0.04）和特应性状态（p=0.01）显著相关。
在初级保健中识别适合 ICS 停药的轻度/中度 COPD 患者是可行的，但由于对加重和肺功能的记录不可靠，需要实时验证。适合的患者接受 ICS 停药或继续治疗的随机分组，以进行未来的研究。随访依从性高。近 50%被诊断为轻度/中度 COPD 的患者在随访期间出现了先前未记录的 FEV 变异性，这需要至少 6 个月的随访来排除未诊断的哮喘。
