Jones Paul, Higenbottam Tim
St. George's, University of London, Cranmer Terrace, London, SW17 0RE, UK.
Proc Am Thorac Soc. 2007 Dec;4(8):597-601. doi: 10.1513/pats.200707-115TH.
Exacerbations of chronic obstructive pulmonary disease (COPD) offer a considerable clinical challenge for clinical practice and drug development. The underlying pathobiology of these characteristic events is unclear. We are far behind other disease areas, such as cardiology, where there are effective approaches for diagnosing and managing acute and potentially fatal events. A joint initiative has begun between the pharmaceutical industry, academia, and the Food and Drug Administration to produce a valid diary card measure of exacerbation severity: the EXAcerbations of Chronic pulmonary disease Test-Patient-Reported Outcome (EXACT-PRO). This article describes the background to this initiative, using the consensus definition of a COPD exacerbation as the starting point from which to propose a new method for quantifying the severity of the event. This approach takes into account the relationships between the symptoms that make up an exacerbation and shows that they can be used in a single continuous severity scale. Methods for defining exacerbation onset and cessation are also proposed.
慢性阻塞性肺疾病（COPD）急性加重给临床实践和药物研发带来了巨大的挑战。这些特征性事件的潜在病理生物学尚不清楚。在心脏病学等其他疾病领域，我们远远落后，在这些领域有有效的方法来诊断和处理急性及潜在致命事件。制药行业、学术界和美国食品药品监督管理局（FDA）已经启动了一项联合计划，以制定一种有效的用于衡量急性加重严重程度的日记卡：慢性肺病急性加重测试 - 患者报告结局（EXACT - PRO）。本文以COPD急性加重的共识定义为出发点，描述了该计划的背景，在此基础上提出一种量化该事件严重程度的新方法。这种方法考虑了构成急性加重的各种症状之间的关系，并表明它们可以用于单一的连续严重程度量表。还提出了定义急性加重开始和结束的方法。
