Air Pollution and Respiratory Health Branch/National Center for Environmental Health/Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30333, USA.
Expert Rev Pharmacoecon Outcomes Res. 2011 Aug;11(4):447-53. doi: 10.1586/erp.11.48.
Asthma is a common chronic disease with underlying inflammation of the airway. Advances in science have led to increased understanding of the heterogeneous nature of asthma and its complex mechanisms. Traditionally, asthma-practice guidelines have focused on optimizing lung function and the US FDA has required increases in lung function and reduction of exacerbation as primary outcomes in clinical trials of new asthma therapeutics. Improved lung function is a critical indicator of bronchodilator therapy, but the importance of long-term asthma control while maintained on controller medication is increasingly emphasized. The NIH asthma guidelines suggest the use of patient-reported outcomes, including health-related quality-of-life measures, to assess asthma control. Clinical practices and research studies concerning asthma can benefit from harmonizing the major outcome measures so that comparisons across studies can be made. In this article, we review common asthma outcome measures with a focus on recent efforts to harmonize outcomes for therapeutic clinical trials in asthma.
哮喘是一种常见的慢性疾病，其气道存在炎症。科学的进步使人们对哮喘的异质性及其复杂机制有了更深入的了解。传统上，哮喘实践指南侧重于优化肺功能，美国 FDA 要求新的哮喘治疗药物临床试验的主要终点为肺功能的提高和恶化的减少。改善肺功能是支气管扩张剂治疗的关键指标，但在使用控制药物的同时长期控制哮喘的重要性越来越受到重视。NIH 哮喘指南建议使用患者报告的结果，包括健康相关生活质量指标，来评估哮喘控制情况。哮喘的临床实践和研究可以从主要结局指标的协调中受益，以便可以进行研究间的比较。在本文中，我们回顾了常见的哮喘结局指标，并重点介绍了最近在哮喘治疗临床试验中协调结局的努力。
