Reddel Helen K, Vestbo Jørgen, Agustí Alvar, Anderson Gary P, Bansal Aruna T, Beasley Richard, Bel Elisabeth H, Janson Christer, Make Barry, Pavord Ian D, Price David, Rapsomaniki Eleni, Karlsson Niklas, Finch Donna K, Nuevo Javier, de Giorgio-Miller Alex, Alacqua Marianna, Hughes Rod, Müllerová Hana, Gerhardsson de Verdier Maria
The Woolcock Institute of Medical Research and the University of Sydney, Sydney, Australia
University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.
Eur Respir J. 2021 Sep 23;58(3). doi: 10.1183/13993003.03927-2020. Print 2021 Sep.
Studies of asthma and chronic obstructive pulmonary disease (COPD) typically focus on these diagnoses separately, limiting understanding of disease mechanisms and treatment options. NOVELTY is a global, 3-year, prospective observational study of patients with asthma and/or COPD from real-world clinical practice. We investigated heterogeneity and overlap by diagnosis and severity in this cohort.
Patients with physician-assigned asthma, COPD or both (asthma+COPD) were enrolled, and stratified by diagnosis and severity. Baseline characteristics were reported descriptively by physician-assigned diagnosis and/or severity. Factors associated with physician-assessed severity were evaluated using ordinal logistic regression analysis.
Of 11 243 patients, 5940 (52.8%) had physician-assigned asthma, 1396 (12.4%) had asthma+COPD and 3907 (34.8%) had COPD; almost half were from primary care. Symptoms, health-related quality of life and spirometry showed substantial heterogeneity and overlap between asthma, asthma+COPD and COPD, with 23%, 62% and 64% of patients, respectively, having a ratio of post-bronchodilator forced expiratory volume in 1 s to forced vital capacity below the lower limit of normal. Symptoms and exacerbations increased with greater physician-assessed severity and were higher in asthma+COPD. However, 24.3% with mild asthma and 20.4% with mild COPD had experienced ≥1 exacerbation in the past 12 months. Medication records suggested both under-treatment and over-treatment relative to severity. Blood eosinophil counts varied little across diagnosis and severity groups, but blood neutrophil counts increased with severity across all diagnoses.
This analysis demonstrates marked heterogeneity within, and overlap between, physician-assigned diagnosis and severity groups in patients with asthma and/or COPD. Current diagnostic and severity classifications in clinical practice poorly differentiate between clinical phenotypes that may have specific risks and treatment implications.
哮喘和慢性阻塞性肺疾病（COPD）的研究通常分别聚焦于这些诊断，限制了对疾病机制和治疗选择的理解。“NOVELTY”是一项针对来自现实临床实践中哮喘和/或COPD患者的全球3年前瞻性观察性研究。我们在该队列中按诊断和严重程度调查了异质性和重叠情况。
纳入由医生诊断为哮喘、COPD或两者皆有（哮喘+COPD）的患者，并按诊断和严重程度进行分层。通过医生指定的诊断和/或严重程度对基线特征进行描述性报告。使用有序逻辑回归分析评估与医生评估的严重程度相关的因素。
在11243例患者中，5940例（52.8%）被医生诊断为哮喘，1396例（12.4%）为哮喘+COPD，3907例（34.8%）为COPD；近一半来自初级保健机构。症状、健康相关生活质量和肺功能检查显示哮喘、哮喘+COPD和COPD之间存在显著的异质性和重叠，支气管扩张剂使用后1秒用力呼气容积与用力肺活量之比低于正常下限的患者分别占23%、62%和64%。症状和急性加重随着医生评估的严重程度增加而增加，且在哮喘+COPD中更高。然而，在过去12个月中，24.3%的轻度哮喘患者和20.4%的轻度COPD患者经历了≥1次急性加重。用药记录表明，相对于严重程度，存在治疗不足和治疗过度的情况。各诊断和严重程度组的血嗜酸性粒细胞计数变化不大，但所有诊断中血中性粒细胞计数均随严重程度增加而升高。
该分析表明，在哮喘和/或COPD患者中，医生指定的诊断和严重程度组内存在明显的异质性，且各诊断和严重程度组之间存在重叠。临床实践中当前的诊断和严重程度分类难以区分可能具有特定风险和治疗意义的临床表型。
