中国慢性阻塞性肺疾病的严重程度分布和治疗：一项观察性研究的基线结果。
Severity distribution and treatment of chronic obstructive pulmonary disease in China: baseline results of an observational study.
机构信息
Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, 100029, China.
National Clinical Research Center for Respiratory Diseases, Beijing, 100029, China.
出版信息
Respir Res. 2022 Apr 29;23(1):106. doi: 10.1186/s12931-022-02021-w.
BACKGROUND
Chronic obstructive pulmonary disease (COPD) receives low awareness and is undertreated in China. Understanding the burden and treatment of COPD across the nation is important for improving quality of care for this disease. This study aims to reveal the current situation of COPD severity distribution and management across China.
METHODS
Baseline data from REALizing and Improving Management of Stable COPD in China, a multicentre, prospective, longitudinal, observational study, were analysed. Patients diagnosed with COPD as per Global Initiative for Chronic Obstructive Lung Disease 2016 (GOLD 2016) criteria were enrolled from 50 randomly selected hospitals (tertiary, 25; secondary, 25) across six geographical regions. Data were collected in routine clinical settings.
RESULTS
Between 15 December 2017 and 6 August 2020, 5013 patients were enrolled and 4978 included in the full analysis set. Of these, 2459 (49.4%) reported ≥ 1 exacerbation within 12 months prior to study enrolment, with a mean annual rate of 0.9/patient, including 0.2/patient and 0.5/patient leading to emergency room visits and hospitalisation, respectively. Spirometry graded 458 (10.1%), 1886 (41.7%), 1558 (34.5%), and 616 (13.6%) were GOLD stage I-IV, and 536 (11.4%), 1034 (22.0%), 563 (12.0%), and 2566 (54.6%) were classified as GOLD 2016 Group A-D, respectively, without evident regional variations. Inhaled corticosteroids plus long-acting beta-agonist (ICS/LABA, 1316 [26.4%]), ICS/LABA plus long-acting muscarinic antagonist (ICS/LABA + LAMA, 871 [17.5%]), and LAMA (754 [15.1%]) were prescribed at high rates across all groups and regions. Medications not recommended by GOLD were commonly prescribed (TCM, 578 [11.6%]; others, 951 [19.1%]), and 681 (13.7%) were not given ICS or long-acting bronchodilators.
CONCLUSIONS
Disease burden among Chinese COPD outpatients is high. Improved guideline adherence for COPD treatment is needed. Trial registration ClinicalTrials.gov identifier, NCT03131362.
背景
慢性阻塞性肺疾病（COPD）在中国的知晓率较低，治疗不足。了解全国 COPD 的负担和治疗情况对于改善该疾病的护理质量非常重要。本研究旨在揭示中国 COPD 严重程度分布和管理的现状。
方法
对多中心、前瞻性、纵向、观察性 REALizing and Improving Management of Stable COPD in China 研究的基线数据进行了分析。该研究从六个地理区域的 50 家随机选择的医院（三级 25 家，二级 25 家）招募了符合全球慢性阻塞性肺疾病倡议 2016 年（GOLD 2016）标准的 COPD 患者。数据是在常规临床环境中收集的。
结果
2017 年 12 月 15 日至 2020 年 8 月 6 日，共纳入 5013 例患者，其中 4978 例患者进入全分析集。在这些患者中，2459 例（49.4%）在研究入组前 12 个月内报告有≥1 次急性加重，平均每年发生率为 0.9/患者，包括 0.2/患者和 0.5/患者分别导致急诊就诊和住院治疗。肺功能检查结果显示，458 例（10.1%）、1886 例（41.7%）、1558 例（34.5%）和 616 例（13.6%）患者的 GOLD 分期为 I-IV 期，536 例（11.4%）、1034 例（22.0%）、563 例（12.0%）和 2566 例（54.6%）患者的 GOLD 2016 组分类为 A-D 组，无明显地域差异。在所有组别和地区，吸入性皮质类固醇加长效β激动剂（ICS/LABA，1316 [26.4%]）、ICS/LABA 加长效抗胆碱能药物（ICS/LABA+LAMA，871 [17.5%]）和 LAMA（754 [15.1%]）的处方率均较高。不推荐使用 GOLD 指南的药物（中药，578 [11.6%]；其他药物，951 [19.1%]）也经常开具，681 例（13.7%）患者未使用 ICS 或长效支气管扩张剂。
结论
中国 COPD 门诊患者的疾病负担较高，需要提高 COPD 治疗的指南依从性。临床试验注册ClinicalTrials.gov 标识符，NCT03131362。
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