Department of Pulmonary and Critical Care Medicine, National Clinical Research Centre for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.
Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China.
Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231158283. doi: 10.1177/17534666231158283.
Underdiagnosis and undertreatment pose major barriers to optimal management of chronic obstructive pulmonary disease (COPD) in China.
The REAL trial was performed to generate reliable information on real-world COPD management, outcomes and risk factors among Chinese patients. Here, we present study outcomes related to COPD management.
It is a 52-week, prospective, observational, multicentre study.
Outpatients (aged ⩾40 years) enrolled from 50 secondary and tertiary hospitals across six geographic regions of China were followed up for 12 months, with two onsite visits and by telephone every 3 months following baseline.
Between June 2017 and January 2019, 5013 patients were enrolled and 4978 included in the analysis. Mean [standard deviation (SD)] age was 66.2 (8.9) years, the majority of patients were male (79.5%) and mean (SD) time since COPD diagnosis was 3.8 (6.2) years. The most common treatments at each study visit were inhaled corticosteroids/long-acting beta-agonists (ICSs/LABAs; 28.3-36.0%), long-acting muscarinic antagonists (LAMAs; 13.0-16.2%) and ICS/LABA + LAMA (17.5-18.7%), but up to 15.8% of patients at each visit received neither ICS nor long-acting bronchodilators. The use of ICS/LABA, LAMA and ICS/LABA + LAMA differed across regions and hospital tiers; up to fivefold, more patients received neither ICS nor long-acting bronchodilators in secondary (17.3-25.4%) tertiary hospitals (5.0-5.3%). Overall, rates of nonpharmacological management were low. Direct treatment costs increased with disease severity, but the proportion of direct treatment costs incurred due to maintenance treatment decreased with disease severity.
ICS/LABA, LAMA and ICS/LABA + LAMA were the most frequently prescribed maintenance treatments for patients with stable COPD in China, although their use differed between region and hospital tier. There is a clear need for improved COPD management across China, particularly in secondary hospitals.
The trial was registered on 20 March 2017 (ClinicalTrials.gov identifier: NCT03131362; https://clinicaltrials.gov/ct2/show/NCT03131362).
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease characterized by progressive and irreversible airflow limitation. In China, many patients with this disease do not receive a diagnosis or appropriate treatment. This study aimed to generate reliable information on the treatment patterns among patients with COPD in China to help inform future management strategies. Patients (aged ⩾40 years) were enrolled from 50 hospitals across 6 regions of China and physicians collected data over the course of 1 year during routine outpatient visits. The majority of patients were receiving long-acting inhaled treatments, which are recommended to prevent worsening of the disease. Up to 16% of patients in this study, however, did not receive any of these recommended treatments. The proportion of patients who received long-acting inhaled treatments differed across regions and hospital tiers; there were about five times more patients in secondary hospitals (about 25%) who did not receive these treatments compared with those in tertiary hospitals (about 5%). Guidelines recommend that pharmacological treatment should be complemented by nondrug treatment, but this was only received by a minority of patients in this study. Patients with higher disease severity incurred greater direct treatment costs compared with those with milder disease. Maintenance treatment costs made up a smaller proportion of overall direct costs for patients with higher disease severity (60-76%) compared with patients with milder disease (81-94%). Long-acting inhaled treatments were the most frequently prescribed maintenance treatments among patients with COPD in China, but their use differed between region and hospital tier. There is a clear need to improve disease management across China, especially in secondary hospitals.
在中国，慢性阻塞性肺疾病（COPD）的诊断不足和治疗不足是实现其优化管理的主要障碍。
REAL 试验旨在为中国 COPD 患者的实际管理、结局和风险因素提供可靠信息。在这里，我们呈现与 COPD 管理相关的研究结果。
这是一项为期 52 周的前瞻性、观察性、多中心研究。
从中国六个地理区域的 50 家二级和三级医院招募门诊患者（年龄 ⩾40 岁），随访 12 个月，在基线后每 3 个月通过电话进行两次现场随访。
2017 年 6 月至 2019 年 1 月，共纳入 5013 例患者，其中 4978 例患者纳入分析。患者的平均（标准偏差）年龄为 66.2（8.9）岁，大多数患者为男性（79.5%），COPD 诊断后的平均（标准偏差）时间为 3.8（6.2）年。每次研究访视时最常用的治疗方法是吸入皮质激素/长效β-激动剂（ICSs/LABAs；28.3-36.0%）、长效毒蕈碱拮抗剂（LAMAs；13.0-16.2%）和 ICS/LABA+LAMA（17.5-18.7%），但每次访视时有多达 15.8%的患者既未接受 ICS 也未接受长效支气管扩张剂治疗。ICS/LABA、LAMA 和 ICS/LABA+LAMA 的使用在不同地区和医院级别之间存在差异；在二级（17.3-25.4%）和三级（5.0-5.3%）医院中，有多达五倍的患者既未接受 ICS 也未接受长效支气管扩张剂治疗。总的来说，非药物治疗的比例较低。直接治疗费用随着疾病严重程度的增加而增加，但随着疾病严重程度的增加，维持治疗的直接治疗费用比例下降。
在中国，ICS/LABA、LAMA 和 ICS/LABA+LAMA 是稳定期 COPD 患者最常使用的维持治疗方法，但在地区和医院级别之间使用情况存在差异。中国需要改进 COPD 管理，特别是在二级医院。
该试验于 2017 年 3 月 20 日在 ClinicalTrials.gov 注册（临床试验标识符：NCT03131362；https://clinicaltrials.gov/ct2/show/NCT03131362）。
慢性阻塞性肺疾病（COPD）是一种慢性炎症性肺部疾病，其特征为进行性和不可逆转的气流受限。在中国，许多患有这种疾病的患者没有得到诊断或适当的治疗。本研究旨在为中国 COPD 患者的治疗模式提供可靠信息，以帮助制定未来的管理策略。从中国 6 个地区的 50 家医院招募年龄 ⩾40 岁的患者，医生在常规门诊就诊期间收集了 1 年期间的数据。大多数患者正在接受长效吸入治疗，这是预防疾病恶化的推荐治疗方法。然而，在这项研究中，多达 16%的患者没有接受任何这些推荐的治疗。在本研究中，接受长效吸入治疗的患者比例在不同地区和医院级别之间存在差异；在二级医院（约 25%）中，没有接受这些治疗的患者比例约为三级医院（约 5%）的五倍。指南建议药物治疗应辅以非药物治疗，但在这项研究中，只有少数患者接受了这种治疗。与病情较轻的患者相比，病情较重的患者直接治疗费用更高。对于病情较重（60-76%）的患者，维持治疗费用占总直接费用的比例较小（81-94%）。在中国，长效吸入治疗是 COPD 患者最常使用的维持治疗方法，但在地区和医院级别之间存在差异。中国需要改善疾病管理，特别是在二级医院。
