Tashkin Donald P
Division of Pulmonary and Critical Care Medicine, Department of Medicine, David Geffen School of Medicine at UCLA, University of California-Los Angeles, Los Angeles, California 90095-1690, USA.
Am J Med. 2006 Oct;119(10 Suppl 1):63-72. doi: 10.1016/j.amjmed.2006.08.009.
In chronic obstructive pulmonary disease (COPD), the rate of decline in forced expiratory volume in 1 second (FEV1) and progression to disability and death are accelerated. COPD management goals include preventing or slowing the progressive loss of lung function, relieving symptoms, improving exercise tolerance and the patient's health status, preventing and treating exacerbations and complications, minimizing side effects of treatment, and reducing mortality. Although lung function is important for diagnosis of COPD and classification of its severity, clinicians and patients are also very interested in symptoms, ability to function, and general well-being (health status). Consequently, increasing attention is being given to these patient-centered outcomes. It is possible to modify patient-centered outcomes; however, it remains to be seen whether doing so can also alter the natural course of the disease and reduce mortality. Two long-term clinical trials--Towards a Revolution in COPD Health (TORCH) and Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT)--will help to answer the question of whether pharmacologic interventions are effective in changing the clinical course of COPD. The TORCH study examines the long-term effects of combination therapy with an inhaled long-acting beta-agonist (salmeterol) and a corticosteroid (fluticasone) on reduction of all-cause mortality over 3 years. The 4-year UPLIFT study examines the effects of maintenance treatment with the once-daily anticholinergic bronchodilator tiotropium on the yearly rate of decline in trough FEV1 and the yearly rate of decline in FEV1 90 minutes after maximal or near-maximal bronchodilator administration. This article examines the rationale for each of these studies and provides an overview of study methodology as well as preliminary demographic data.
在慢性阻塞性肺疾病（COPD）中，1秒用力呼气容积（FEV1）的下降速率以及发展为残疾和死亡的进程均会加速。COPD的管理目标包括预防或减缓肺功能的进行性丧失、缓解症状、提高运动耐量和患者的健康状况、预防和治疗急性加重及并发症、将治疗的副作用降至最低以及降低死亡率。尽管肺功能对于COPD的诊断及其严重程度分级很重要，但临床医生和患者也非常关注症状、功能能力和总体健康状况（健康状态）。因此，以患者为中心的这些结局正受到越来越多的关注。有可能改变以患者为中心的结局；然而，这样做是否也能改变疾病的自然病程并降低死亡率仍有待观察。两项长期临床试验——慢性阻塞性肺疾病健康革命研究（TORCH）和噻托溴铵对功能的潜在长期影响研究（UPLIFT）——将有助于回答药物干预在改变COPD临床病程方面是否有效的问题。TORCH研究考察了吸入长效β受体激动剂（沙美特罗）和皮质类固醇（氟替卡松）联合治疗在3年内降低全因死亡率的长期效果。为期4年的UPLIFT研究考察了每日一次使用抗胆碱能支气管扩张剂噻托溴铵进行维持治疗对最低FEV1年下降率以及最大或接近最大支气管扩张剂给药90分钟后FEV1年下降率的影响。本文探讨了每项研究的基本原理，并概述了研究方法以及初步的人口统计学数据。
