Zhou Yumin, Bruijnzeel Piet L B, McCrae Christopher, Zheng Jinping, Nihlen Ulf, Zhou Rong, Van Geest Marleen, Nilsson Anna, Hadzovic Sinela, Huhn Monika, Taib Ziad, Gu Yi, Xie Jiaxing, Ran Pixin, Chen Rongchang, Zhong Nanshan
1 The State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital, Guangzhou Medical University, Guangzhou 510182, China ; 2 Early Clinical Development, 3 Translational Science, Respiratory, Inflammation and Autoimmunity iMed, AstraZeneca, Mölndal, Sweden ; 4 Translational Science, Asia & Emerging Markets iMed, AstraZeneca, Shanghai 201203, China ; 5 GMED RIA, 6 Statistical Department, 7 Programming Department, AstraZeneca, Mölndal, Sweden.
J Thorac Dis. 2015 Apr;7(4):720-33. doi: 10.3978/j.issn.2072-1439.2015.04.14.
To describe a study design that focuses on risk factors and patterns of chronic obstructive pulmonary disease (COPD) exacerbations.
A 2-year, single centre, observational study was conducted in Guangzhou in China. The study enrolled 318 subjects with COPD aged 40-79 years, stratified into different but equally sized groups according to global initiative for chronic obstructive lung disease (GOLD) stage (including Stage 0) and 86 lung healthy controls. An assessment each year was scheduled including questionnaires, lung function testing, Chest X-ray and blood collection. A sub-group, called sub-group X, consisting of 203 subjects with COPD and 51 lung healthy controls, was selected to answer a symptom questionnaire daily (EXACT-PRO) via a BlackBerry Personal Digital Assistant (PDA) device. Upon an alert that indicated a change in daily symptom pattern, the patients were contacted by the clinic to decide whether they had experienced an exacerbation and should have an extra visit within 24-48 hours. At an extra visit, nasal and throat swabs, induced sputum and blood were collected. Air pollution, temperature and humidity were also monitored daily. A subset of sub-group X, called sub-group M that consisted of 52 COPD patients and 15 healthy controls was dedicated to measure muscle strength and a dexa scan.
More than 78% of the enrolled patients completed the study successfully. There appeared a difference between the patient groups and the controls in gender, age, body mass index (BMI), forced expiratory volume in 1 second (FEV1), FEV1/FVC and smoking at baseline. In sub-group X 90 out of 203 (44.4%) selected COPD patients developed one or more exacerbations in the 2-year observation period. They were more severe COPD patients according to GOLD stage at study start. On average most exacerbations occurred in the month March and the least number of exacerbations occurred in October.
This study with the obtained patient dataset will allow a better insight in many aspects of exacerbations in COPD (e.g., the identification, the risk factors, phenotypes and the biomarkers).
描述一项聚焦于慢性阻塞性肺疾病（COPD）急性加重的危险因素及模式的研究设计。
在中国广州开展了一项为期2年的单中心观察性研究。该研究纳入了318名年龄在40 - 79岁的COPD患者，根据慢性阻塞性肺疾病全球倡议（GOLD）分期（包括0期）分为不同但规模相等的组，以及86名肺部健康对照者。每年安排一次评估，包括问卷调查、肺功能测试、胸部X光检查和血液采集。一个名为X亚组的子组，由203名COPD患者和51名肺部健康对照者组成，通过黑莓个人数字助理（PDA）设备每天回答一份症状问卷（EXACT - PRO）。一旦警报显示每日症状模式发生变化，诊所会联系患者以确定他们是否经历了急性加重以及是否应在24 - 48小时内额外就诊。在额外就诊时，采集鼻和咽拭子、诱导痰和血液样本。同时每天监测空气污染、温度和湿度。X亚组的一个子集，称为M亚组，由52名COPD患者和15名健康对照者组成，专门用于测量肌肉力量和进行双能X线吸收法扫描。
超过78%的入组患者成功完成了研究。患者组和对照组在性别、年龄、体重指数（BMI）、一秒用力呼气容积（FEV1）、FEV1/FVC以及基线吸烟情况方面存在差异。在X亚组中，203名入选的COPD患者中有90名（44.4%）在2年观察期内发生了一次或多次急性加重。根据研究开始时的GOLD分期，他们是病情更严重的COPD患者。平均而言，大多数急性加重发生在3月，而10月急性加重的次数最少。
这项研究以及所获得的患者数据集将有助于更好地洞察COPD急性加重的多个方面（例如，识别、危险因素、表型和生物标志物）。
