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COPD 临床试验中肺炎诊断标准不一致:综述

Discordant diagnostic criteria for pneumonia in COPD trials: a review.

机构信息

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Nuffield Dept of Medicine, University of Oxford, Oxford, UK.

出版信息

Eur Respir Rev. 2021 Nov 17;30(162). doi: 10.1183/16000617.0124-2021. Print 2021 Dec 31.

Abstract

Inhaled corticosteroids (ICS) have a class effect of increasing pneumonia risk in patients with COPD. However, pneumonia incidence varies widely across clinical trials of ICS use in COPD. This review clarifies methodological differences in defining and recording pneumonia events in these trials and discusses factors that could contribute to the varying pneumonia incidence. Literature searches and screening yielded 40 relevant references for inclusion. Methods used to capture pneumonia events in these studies included investigator-reported pneumonia adverse events, standardised list of signs or symptoms, radiographic confirmation of suspected cases and/or confirmation by an independent clinical end-point committee. In general, more stringent pneumonia diagnosis criteria led to lower reported pneumonia incidence rates. In addition, studies varied in design and population characteristics, including exacerbation history and lung function, factors that probably contribute to the varying pneumonia incidence. As such, cross-trial comparisons are problematic. A minimal set of standardised criteria for diagnosis and reporting of pneumonia should be used in COPD studies, as well as reporting of patients' pneumonia history at baseline, to allow comparison of pneumonia rates between trials. Currently, within-trial comparison of ICS-containing non-ICS-containing treatments is the appropriate method to assess the influence of ICS on pneumonia incidence.

摘要

吸入性皮质类固醇(ICS)具有增加 COPD 患者肺炎风险的类别效应。然而,ICS 在 COPD 中的应用临床试验中,肺炎的发生率差异很大。本综述阐明了这些试验中定义和记录肺炎事件的方法学差异,并讨论了可能导致肺炎发生率变化的因素。文献检索和筛选产生了 40 篇相关参考文献。这些研究中用于捕获肺炎事件的方法包括研究者报告的肺炎不良事件、标准化的体征或症状列表、疑似病例的放射学确认和/或独立临床终点委员会的确认。一般来说,更严格的肺炎诊断标准导致报告的肺炎发生率较低。此外,研究在设计和人群特征方面存在差异,包括加重史和肺功能,这些因素可能导致肺炎发生率的变化。因此,临床试验间的比较存在问题。应在 COPD 研究中使用一套标准化的诊断和报告肺炎的标准,以及报告患者在基线时的肺炎病史,以允许在试验之间比较肺炎发生率。目前,对包含 ICS 和不包含 ICS 的治疗方案进行临床试验内比较是评估 ICS 对肺炎发生率影响的适当方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a767/9488621/876190735736/ERR-0124-2021.01.jpg

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