University of Manchester, Medicines Evaluation Unit, Manchester University NHS Foundation Trust, Manchester, UK.
Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.
Respir Res. 2020 Jun 2;21(1):134. doi: 10.1186/s12931-020-01387-z.
Given the heterogeneity of chronic obstructive pulmonary disease (COPD), personalized clinical management is key to optimizing patient outcomes. Important treatment goals include minimizing disease activity and preventing disease progression; however, quantification of these components remains a challenge. Growing evidence suggests that decline over time in forced expiratory volume in 1 s (FEV), traditionally the key marker of disease progression, may not be sufficient to fully determine deterioration across COPD populations. In addition, there is a lack of evidence showing that currently available multidimensional COPD indexes improve clinical decision-making, treatment, or patient outcomes. The composite clinically important deterioration (CID) endpoint was developed to assess disease worsening by detecting early deteriorations in lung function (measured by FEV), health status (assessed by the St George's Respiratory Questionnaire), and the presence of exacerbations. Post hoc and prospective analyses of clinical trial data have confirmed that the multidimensional composite CID endpoint better predicts poorer medium-term outcomes compared with any single CID component alone, and that it can demonstrate differences in treatment efficacy in short-term trials. Given the widely acknowledged need for an individualized holistic approach to COPD management, monitoring short-term CID has the potential to facilitate early identification of suboptimal treatment responses and patients at risk of increased disease progression. CID monitoring may lead to better-informed clinical management decisions and potentially improved prognosis.
鉴于慢性阻塞性肺疾病(COPD)的异质性,个性化临床管理是优化患者结局的关键。重要的治疗目标包括最小化疾病活动度和预防疾病进展;然而,这些成分的量化仍然是一个挑战。越来越多的证据表明,传统上作为疾病进展关键标志物的 1 秒用力呼气量(FEV)随时间的下降,可能不足以充分确定 COPD 人群的恶化情况。此外,目前尚无证据表明现有的多维 COPD 指数可改善临床决策、治疗或患者结局。复合临床重要恶化(CID)终点的开发是为了通过检测肺功能(通过 FEV 测量)、健康状况(通过圣乔治呼吸问卷评估)和加重情况的早期恶化来评估疾病恶化。临床试验数据的事后和前瞻性分析证实,多维复合 CID 终点比任何单一 CID 成分单独预测更差的中期结局更好,并且它可以在短期试验中显示治疗效果的差异。鉴于 COPD 管理需要广泛认可的个体化整体方法,监测短期 CID 有可能促进对治疗反应不佳和疾病进展风险增加的患者的早期识别。CID 监测可能会导致更明智的临床管理决策,并可能改善预后。