一项关于使用 ICS/LABA 进行拯救干预以减少北京严重空气污染（SIRCAP）下慢性阻塞性肺疾病恶化的前瞻性研究：一项多中心随机对照试验方案。
A prospective study of salvational intervention with ICS/LABA for reducing chronic obstructive pulmonary disease exacerbation under severe air pollution (SIRCAP) in Beijing: protocol of a multi-center randomized controlled trial.
机构信息
Department of Respiratory and Critical Care Medicine, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, 100034, China.
Department of Medical Statistics, Peking University First Hospital, Beijing, China.
出版信息
BMC Pulm Med. 2019 Jan 25;19(1):22. doi: 10.1186/s12890-018-0771-9.
BACKGROUND
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality all over the world. Acute exacerbation of COPD (AECOPD) not only accelerates the progression of disease, but also causes hospital administration and death events. Epidemiologic studies have shown air pollution is a high risk factor of AECOPD. However, there are rare technics or treatment strategies recommended to reduce severe air pollution related AECOPD.
METHODS
This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial. Seven hundred sixty-four stable COPD patients in group B, C and D according to GOLD 2017 will be recruited and equally divided into two parallel groups, salvational intervention (SI group) and control group (CT group). Original treatments for participants include tiotropium (18μg once q.d), budesonide/formoterol (160μg/4.5μg once or twice b.i.d) or budesonide/formoterol (160μg/4.5μg once or twice b.i.d) with tiotropium (18μg once q.d). The savational intervention for SI group is routine treatment plus budesonide/formoterol (160μg/4.5μg once b.i.d) from the first day after severe air pollution (air quality index, AQI ≥200) to the third day after AQI < 200. CT group will maintain the original treatment. The intervention will last for 2 years. Primary outcome is the frequency of AECOPD per year and the secondary outcomes include the incidence of unplanned outpatient visits, emergency visits, hospitalization, medical cost and mortality associated with AECOPD per year.
DISCUSSION
The salvational intervention is a novel strategy for COPD management under severe air pollution. Results of the present study will provide reference information to guide clinical practice in reducing the air pollution related exacerbation of COPD.
TRIAL REGISTRATION
This study has been registered at www.ClinicalTrials.gov (registration identifier: NCT03083067 ) in 17 March, 2017.
背景
慢性阻塞性肺疾病（COPD）是全世界发病率和死亡率的主要原因。COPD 急性加重（AECOPD）不仅加速了疾病的进展，还导致医院管理和死亡事件。流行病学研究表明，空气污染是 AECOPD 的一个高危因素。然而，目前几乎没有技术或治疗策略被推荐用于减少严重空气污染相关的 AECOPD。
方法
这是一项多中心、前瞻性、随机、标准治疗平行对照临床试验。根据 GOLD 2017 指南，将招募 764 例稳定期 COPD 患者（B、C 和 D 组），并将其分为两组，即拯救干预（SI）组和对照组（CT）组。参与者的原始治疗包括噻托溴铵（18μg 每日一次）、布地奈德/福莫特罗（160μg/4.5μg 每日一次或两次）或布地奈德/福莫特罗（160μg/4.5μg 每日一次或两次）加噻托溴铵（18μg 每日一次）。SI 组的拯救干预是从严重空气污染（空气质量指数，AQI≥200）后第一天到 AQI<200 后第三天，常规治疗加布地奈德/福莫特罗（160μg/4.5μg 每日一次）。CT 组将维持原治疗。干预将持续 2 年。主要结局是每年 AECOPD 的发生频率，次要结局包括每年与 AECOPD 相关的非计划性门诊就诊、急诊就诊、住院、医疗费用和死亡率。
讨论
拯救干预是一种在严重空气污染下管理 COPD 的新策略。本研究的结果将为指导临床实践提供参考信息，以减少 COPD 与空气污染相关的加重。
试验注册
本研究于 2017 年 3 月 17 日在 www.ClinicalTrials.gov 注册（注册号：NCT03083067）。
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