Respiratory Medicine, Imperial College, London, UK.
Am J Respir Crit Care Med. 2012 Oct 15;186(8):712-5. doi: 10.1164/rccm.201206-1010PP. Epub 2012 Jul 12.
Idiopathic pulmonary fibrosis causes progressive morbidity and has a worldwide incidence that is increasing. There are a number of promising therapies, one of which has been approved in Europe, parts of Asia, and India, and others that are at various stages of development. Despite this, there continues to be debate about the most appropriate clinical endpoint that should be used in future randomized controlled clinical trials of novel therapies in idiopathic pulmonary fibrosis. In a recent Pulmonary Perspective in this journal, the case for the use of a variety of clinical endpoints was analyzed, and the article concluded that FVC, the endpoint most commonly used recently and in ongoing studies, was not an appropriate option. In this Pulmonary Perspective we present a counterpoint in which we explore the basis on which this conclusion is drawn and present data that strongly and logically support the use of FVC as a valid and robust measure that fulfils the criteria for an ideal clinical endpoint and that is meaningful to patient and clinician alike.
特发性肺纤维化导致进行性发病，全球发病率正在上升。有许多有前途的治疗方法，其中一种已在欧洲、亚洲部分地区和印度获得批准，还有其他一些处于不同的开发阶段。尽管如此，对于特发性肺纤维化新型治疗方法的未来随机对照临床试验中应使用哪种最合适的临床终点，仍存在争议。在最近本刊的一篇 Pulmonary Perspective 中，分析了使用多种临床终点的理由，该文章得出的结论是，FVC（最近和正在进行的研究中最常使用的终点）不是一个合适的选择。在本 Pulmonary Perspective 中，我们提出了一个反驳观点，探讨了得出这一结论的依据，并提供了有力且合乎逻辑的数据，支持将 FVC 作为一种有效的、可靠的测量方法，该方法满足理想临床终点的标准，对患者和临床医生都有意义。
