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中国稳定期 COPD 患者的治疗模式:一项前瞻性、52 周、全国性、观察性队列研究(REAL)的分析。

Treatment patterns in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL).

机构信息

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.

出版信息

Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231158283. doi: 10.1177/17534666231158283.

Abstract

BACKGROUND

Underdiagnosis and undertreatment pose major barriers to optimal management of chronic obstructive pulmonary disease (COPD) in China.

OBJECTIVE

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.

DESIGN

It is a 52-week, prospective, observational, multicentre study.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

REGISTRATION

The trial was registered on 20 March 2017 (ClinicalTrials.gov identifier: NCT03131362; https://clinicaltrials.gov/ct2/show/NCT03131362).

PLAIN LANGUAGE SUMMARY

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.

摘要

背景

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。

目的

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。

设计

这是一项为期 52 周的前瞻性、观察性、多中心研究。

方法

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。

结果

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。

结论

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。

注册

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)。

简单明了的总结

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。

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