University of California San Francisco, San Francisco, CA, USA.
Respir Res. 2013 Jul 13;14(1):73. doi: 10.1186/1465-9921-14-73.
Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.
Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.
Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.
In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures.
特发性肺纤维化的急性加重已成为临床试验中的一个重要结局指标。本研究旨在探讨疑似急性加重作为结局指标的概念。
三位研究者回顾性分析了在特发性肺纤维化运动能力西地那非试验中出现研究期间呼吸严重不良事件的受试者。根据既定标准，事件被分类为明确的急性加重、疑似急性加重或其他。
确定了 35 起事件。其中 4 起被归类为明确的急性加重，14 起为疑似急性加重，17 起为其他。明确和疑似的急性加重在临床上无法区分。两者在冬季和春季最为常见，且与疾病进展和短期死亡率高的风险相关。
在这项研究中，一半的呼吸严重不良事件归因于明确或疑似的急性加重。疑似急性加重与明确的急性加重在临床上无法区分，代表有临床意义的事件。临床试验研究者应考虑将明确和疑似的急性加重均作为结局指标进行捕获。
