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研究方案:使用序列分析(PICCS)研究慢性阻塞性肺疾病中的肺炎和吸入皮质类固醇治疗模式。

Study protocol: pneumonia and inhaled corticosteroid treatment patterns in chronic obstructive pulmonary disease - a cohort study using sequence analysis (PICCS).

机构信息

Department of Internal Medicine, Lillebaelt Hospital, Vejle, Denmark

Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.

出版信息

BMJ Open. 2023 Jun 1;13(6):e072685. doi: 10.1136/bmjopen-2023-072685.

Abstract

INTRODUCTION

Treatment with inhaled corticosteroids (ICS) is a widely used treatment in chronic obstructive pulmonary disease. The main effects include a reduction in the number of exacerbations and, for some patients, an increase in expected mortality. Unfortunately, the treatment is also linked to an increased risk of pneumonia, and very little is known about which patients experience this increased risk. There is a need for identification of patient characteristics associated with increased risk of pneumonia and treatment with ICS.

METHODS AND ANALYSIS

This is a register-based cohort study that uses the nationwide Danish registers. Data from several registers in the years 2008-2018 will be merged on an individual level using the personal identification numbers that are unique to every citizen in Denmark. Clusters based on pneumonia incidence and ICS treatment patterns will be explored with a sequence analysis in a 3-year follow-up period.

ETHICS AND DISSEMINATION

This is a register-based study and research ethics approval is not required according to Danish Law and National Ethics Committee Guidelines. The results will be submitted to peer-reviewed journals and reported at appropriate national and international meetings.

摘要

简介

吸入皮质类固醇(ICS)治疗是慢性阻塞性肺疾病的常用治疗方法。主要疗效包括减少恶化次数,并且对于某些患者,增加预期死亡率。不幸的是,该治疗还与肺炎风险增加相关,并且对于哪些患者存在这种风险增加知之甚少。需要确定与肺炎和 ICS 治疗相关的增加风险的患者特征。

方法和分析

这是一项基于登记的队列研究,使用全国性的丹麦登记处。将在 2008-2018 年期间使用个人识别号码(丹麦每位公民的唯一号码)在个体层面上合并来自多个登记处的数据。将使用序列分析在 3 年的随访期间探索基于肺炎发生率和 ICS 治疗模式的聚类。

伦理和传播

这是一项基于登记的研究,根据丹麦法律和国家伦理委员会指南,不需要进行研究伦理批准。研究结果将提交给同行评议的期刊,并在适当的国家和国际会议上报告。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/12b3/10254891/c9570b3589f6/bmjopen-2023-072685f01.jpg

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