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40岁以上气流受限中国患者中哮喘-慢性阻塞性肺疾病重叠综合征(ACOS)的现状:一项多中心横断面试验的基本原理与设计(研究方案)

Current situation of asthma-COPD overlap syndrome (ACOS) in Chinese patients older than 40 years with airflow limitation: rationale and design for a multicenter, cross-sectional trial (study protocol).

作者信息

Kang Jian, Yao Wanzhen, Cai Baiqiang, Chen Ping, Ling Xia, Shang Hongyan

机构信息

The First Hospital of China Medical University, Shenyang 110001, China.

Department of Respiratory Medicine, Peking University Third Hospital, Beijing 100191, China.

出版信息

J Thorac Dis. 2016 Dec;8(12):3744-3751. doi: 10.21037/jtd.2016.12.108.

DOI:10.21037/jtd.2016.12.108
PMID:28149573
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5227279/
Abstract

BACKGROUND

Asthma and chronic obstructive pulmonary disease (COPD) are the frequently occurring chronic airway diseases, and the overlapping syndrome observed in the majority of patients has been recently defined as asthma-COPD overlap syndrome (ACOS) by the Global Initiative for Chronic Obstructive Lung (GOLD, 2014) and Global initiative for Asthma (GINA, 2015). The proportion, features, and clinical practice of ACOS still remain elusive in China. We are conducting this multicenter, cross-sectional, observational study (NCT02600221) to investigate the distributions of chronic obstructive diseases in patients >40 years of age with chronic airflow limitation in China along with determination of the main clinical practice and features of these diseases. The study will also explore the factors that may influence the exacerbations and severity of ACOS in Chinese patients (>40 years of age).

METHODS

A total of 2,000 patients (age, ≥40 years; either sex) who are clinically diagnosed as having asthma, COPD/chronic bronchitis/emphysema, or ACOS for at least 12 months with airflow limitation [post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV/FVC): <0.7] will be enrolled from approximately 20 sites in China between December 2015 and December 2016. The proportion of ACOS among patients older than 40 years based on GINA 2015 and GOLD 2014 definitions is the primary variable. Following were the secondary variables: the proportions of COPD and asthma among the patients, distributions of the severity of airflow limitation, distribution of groups according to GOLD 2011 group definition (A, B, C, D), and the distribution of medication by drug class in patients with ACOS, asthma, and COPD. Acute exacerbation history, hospitalization, and severity of ACOS as evaluated using COPD Assessment Test, Asthma Control Questionnaire-5, and Modified British Medical Research Council in patients with ACOS were also assessed.

IMPLICATIONS

This will be the first study to disseminate scientific knowledge on the current situation, main clinical practice, and features of ACOS, asthma, and COPD conditions in Chinese patients. The insights will be helpful in designing optimal management strategies for ACOS and redefining the healthcare development programs.

摘要

背景

哮喘和慢性阻塞性肺疾病(COPD)是常见的慢性气道疾病,全球慢性阻塞性肺疾病倡议组织(GOLD,2014)和全球哮喘防治创议组织(GINA,2015)最近将大多数患者中观察到的重叠综合征定义为哮喘-COPD重叠综合征(ACOS)。在中国,ACOS的比例、特征及临床实践仍不明确。我们正在开展这项多中心、横断面、观察性研究(NCT02600221),以调查中国40岁以上慢性气流受限患者中慢性阻塞性疾病的分布情况,并确定这些疾病的主要临床实践及特征。该研究还将探索可能影响中国患者(年龄>40岁)ACOS急性加重和严重程度的因素。

方法

2015年12月至2016年12月期间,将从中国约20个地点招募2000例患者(年龄≥40岁,性别不限),这些患者临床诊断为哮喘、COPD/慢性支气管炎/肺气肿或ACOS至少12个月且存在气流受限[支气管扩张剂后1秒用力呼气容积/用力肺活量(FEV/FVC)<0.7]。基于GINA 2015和GOLD 2014定义的40岁以上患者中ACOS的比例是主要变量。次要变量如下:患者中COPD和哮喘的比例、气流受限严重程度的分布、根据GOLD 2011组定义(A、B、C、D)的分组分布,以及ACOS、哮喘和COPD患者按药物类别划分的用药分布。还评估了ACOS患者的急性加重病史、住院情况,以及使用慢性阻塞性肺疾病评估测试、哮喘控制问卷-5和改良英国医学研究委员会评估的ACOS严重程度。

意义

这将是第一项传播关于中国患者ACOS、哮喘和COPD现状、主要临床实践及特征的科学知识的研究。这些见解将有助于设计ACOS的最佳管理策略并重新定义医疗保健发展计划。

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本文引用的文献

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Asthma-chronic obstructive pulmonary disease overlap syndrome in the urban Chinese population: prevalence and disease burden using the 2010, 2012, and 2013 China National Health and Wellness Surveys.中国城市人群中的哮喘-慢性阻塞性肺疾病重叠综合征:基于2010年、2012年和2013年中国国民健康与营养调查的患病率及疾病负担
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What is asthma-COPD overlap syndrome? Towards a consensus definition from a round table discussion.哮喘-慢阻肺重叠综合征是什么?圆桌会议上的共识定义。
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