Nihon University, Itabashi-ku, Tokyo, Japan.
Hibiya Kokusai Clinic, Chiyoda-ku, Tokyo, Japan.
Adv Ther. 2021 Feb;38(2):1168-1184. doi: 10.1007/s12325-020-01573-x. Epub 2020 Dec 23.
Patients with asthma-chronic obstructive pulmonary disease (COPD) overlap (ACO) present with chronic respiratory symptoms with features of both asthma and COPD. New ACO diagnostic criteria (2018) were suggested by the Japanese Respiratory Society (JRS). This prospective, multicenter, observational cohort study was conducted to investigate the proportion of patients who meet the JRS ACO diagnostic criteria among COPD patients in clinical practice.
This 2-year ongoing study enrolled consecutive outpatients aged ≥ 40 years with COPD who visited one of 27 Japanese centers at which the medical examinations/tests required for ACO diagnosis were routinely conducted. At registration, the proportion of ACO or non-ACO patients was determined using the JRS diagnostic criteria, and the characteristics of the two groups were compared using analysis of variance and chi-square test.
Of 708 COPD patients analyzed at registration, 396 (55.9%) had the data necessary for ACO diagnosis to be conducted, and 312 (44.1%) were lacking these data. Of the 396 patients who had the data necessary for ACO diagnosis, 101 (25.5%) met the diagnostic criteria for ACO, and 295 (74.5%) did not (non-ACO patients). ACO patients were younger, had a greater rate of asthma based on a physician's diagnosis, and used more medications, including inhaled corticosteroids (p < 0.05), compared with non-ACO patients.
We have determined the proportion of patients with the data necessary to diagnose ACO using the JRS criteria, and the proportion of these who met the ACO criteria among the COPD population at the time of registration. Patients, including those lacking necessary examination/test data at registration, will continue to undergo follow-up to explore changes in their testing and ACO diagnostic status over time. Analyses of study data over 2 years will provide relevant information on the ACO symptoms, clinical course, and real-world treatment patterns.
ClinicalTrials.gov identifier, NCT03577795.
哮喘-慢性阻塞性肺疾病（COPD）重叠（ACO）患者表现为慢性呼吸系统症状，具有哮喘和 COPD 的特征。日本呼吸学会（JRS）提出了新的 ACO 诊断标准（2018 年）。本前瞻性、多中心、观察性队列研究旨在调查临床实践中 COPD 患者符合 JRS ACO 诊断标准的患者比例。
这项正在进行的 2 年研究纳入了年龄≥40 岁的连续门诊 COPD 患者，他们在进行 ACO 诊断所需的医学检查/测试的 27 个日本中心之一就诊。在登记时，使用 JRS 诊断标准确定 ACO 或非 ACO 患者的比例，并使用方差分析和卡方检验比较两组的特征。
在登记时分析的 708 例 COPD 患者中，有 396 例（55.9%）有进行 ACO 诊断所需的数据，有 312 例（44.1%）缺乏这些数据。在有 ACO 诊断所需数据的 396 例患者中，有 101 例（25.5%）符合 ACO 的诊断标准，295 例（74.5%）不符合（非 ACO 患者）。与非 ACO 患者相比，ACO 患者年龄较小，根据医生的诊断，哮喘发生率更高，使用的药物更多，包括吸入皮质类固醇（p<0.05）。
我们已经确定了使用 JRS 标准诊断 ACO 所需数据的患者比例，以及在登记时 COPD 人群中符合 ACO 标准的患者比例。包括在登记时缺乏必要检查/测试数据的患者在内，将继续进行随访，以探讨随时间推移其检查和 ACO 诊断状况的变化。对 2 年研究数据的分析将提供有关 ACO 症状、临床过程和真实世界治疗模式的相关信息。
ClinicalTrials.gov 标识符，NCT03577795。
