Agustí Alvar, Hughes Rod, Rapsomaki Eleni, Make Barry, Del Olmo Ricardo, Papi Alberto, Price David, Benton Laura, Franzen Stefan, Vestbo Jørgen, Mullerova Hana
University of Barcelona, Respiratory Institute - Clinic Barcelona, IDIBAPS, and CIBERES, Barcelona, Spain.
These authors contributed equally.
ERJ Open Res. 2024 Feb 12;10(1). doi: 10.1183/23120541.00895-2023. eCollection 2024 Jan.
The diagnosis of COPD requires the demonstration of non-fully reversible airflow limitation by spirometry in the appropriate clinical context. Yet, there are patients with symptoms and relevant exposures suggestive of COPD with either normal spirometry (pre-COPD) or preserved ratio but impaired spirometry (PRISm). Their prevalence, clinical characteristics and associated outcomes in a real-life setting are unclear.
To investigate them, we studied 3183 patients diagnosed with COPD by their attending physician included in the NOVELTY study (clinicaltrials.gov identifier NCT02760329), a global, 3-year, observational, real-life cohort that included patients recruited from both primary and specialist care clinics in 18 countries.
We found that 1) approximately a quarter of patients diagnosed with (and treated for) COPD in real life did not fulfil the spirometric diagnostic criteria recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), and could be instead categorised as pre-COPD (13%) or PRISm (14%); 2) disease burden (symptoms and exacerbations) was highest in GOLD 3-4 patients (exacerbations per person-year (PPY) 0.82) and lower but similar in those in GOLD 1-2, pre-COPD and PRISm (exacerbations range 0.27-0.43 PPY); 3) lung function decline was highest in pre-COPD and GOLD 1-2, and much less pronounced in PRISm and GOLD 3-4; 4) PRISm and pre-COPD were not stable diagnostic categories and change substantially over time; and 5) all-cause mortality was highest in GOLD 3-4, lowest in pre-COPD, and intermediate and similar in GOLD 1-2 and PRISm.
Patients diagnosed COPD in a real-life clinical setting present great diversity in symptom burden, progression and survival, warranting medical attention.
慢性阻塞性肺疾病（COPD）的诊断需要在适当的临床背景下通过肺量计证明存在不完全可逆的气流受限。然而，有一些患者虽有症状且有提示COPD的相关暴露因素，但肺量计检查结果正常（COPD前期）或比值保留但肺量计检查受损（PRISm）。在现实生活环境中，他们的患病率、临床特征及相关结局尚不清楚。
为了对这些情况进行研究，我们对参加新颖性研究（clinicaltrials.gov标识符NCT02760329）的3183例由主治医生诊断为COPD的患者进行了研究。该研究是一项全球性、为期3年的观察性现实生活队列研究，纳入了来自18个国家的基层医疗诊所和专科医疗诊所招募的患者。
我们发现：1）在现实生活中，约四分之一被诊断为（并接受治疗）COPD的患者不符合慢性阻塞性肺疾病全球倡议（GOLD）推荐的肺量计诊断标准，而是可归类为COPD前期（13%）或PRISm（14%）；2）疾病负担（症状和急性加重）在GOLD 3 - 4级患者中最高（每人年急性加重次数（PPY）为0.82），在GOLD 1 - 2级、COPD前期和PRISm患者中较低但相似（急性加重次数范围为0.27 - 0.43 PPY）；3）肺功能下降在COPD前期和GOLD 1 - 2级患者中最高，在PRISm和GOLD 3 - 4级患者中则明显较轻；4）PRISm和COPD前期不是稳定的诊断类别，且随时间变化很大；5）全因死亡率在GOLD 3 - 4级患者中最高，在COPD前期患者中最低，在GOLD 1 - 2级和PRISm患者中处于中间水平且相似。
在现实临床环境中被诊断为COPD的患者在症状负担、病情进展和生存方面存在很大差异，值得医学关注。
