Choi Hye Sook, Park Yong Bum, Shin Kyeong Cheol, Jang Seung Hun, Choe Kang Hyeon, Kim Young Sam, Kyung Sun Young, Yoon Sung Ho, Kim Ju Sang, Jung Sung Soo
Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital-Kangdong, Seoul, Republic of Korea.
Int J Chron Obstruct Pulmon Dis. 2019 Feb 25;14:471-478. doi: 10.2147/COPD.S189300. eCollection 2019.
The Exacerbations of Chronic Obstructive Pulmonary Disease Tool-Patient-Reported Outcomes (EXACT-PRO) has been suggested as a reliable and valid measure for early assessment of COPD exacerbations and perceived recovery. However, there has been no evidence for EXACT-PRO efficacy in assessing recovery from treatment in a randomized controlled trial. The study evaluated the reliability, validity, and responsiveness of EXACT-PRO for the evaluation of the efficacy of acute treatment in patients with COPD exacerbation.
In a Phase III randomized controlled study for assessing the efficacy of antibiotic treatment on COPD exacerbation, EXACT-PRO was evaluated in the responders and non-responders.
A total of 295 patients were analyzed (259 responders and 37 non-responders). Cronbach's α was 0.96 for EXACT total, 0.96 for the breathlessness domain, 0.89 for the cough and sputum domain, and 0.93 for the chest symptoms domain. The EXACT score correlated with the COPD assessment test (CAT) score (=0.8, <0.01). A stronger decrease in the EXACT score was found in the responder group than in the non-responder group from the fifth day after treatment. The difference in the EXACT score from exacerbation onset to recovery was -6.3 in responders and -1.9 in non-responders (=0.01).
EXACT-PRO is a comprehensive and sensitive method for assessing symptomatic resolution of COPD exacerbations during treatment.
慢性阻塞性肺疾病急性加重期工具-患者报告结局（EXACT-PRO）已被认为是早期评估慢性阻塞性肺疾病急性加重及感知恢复的可靠且有效的指标。然而，尚无证据表明EXACT-PRO在随机对照试验中评估治疗恢复情况的疗效。本研究评估了EXACT-PRO在评估慢性阻塞性肺疾病急性加重期患者急性治疗疗效方面的可靠性、有效性及反应性。
在一项评估抗生素治疗慢性阻塞性肺疾病急性加重期疗效的III期随机对照研究中，对有反应者和无反应者进行了EXACT-PRO评估。
共分析了295例患者（259例有反应者和37例无反应者）。EXACT总分的Cronbach's α为0.96，呼吸困难领域为0.96，咳嗽和咳痰领域为0.89，胸部症状领域为0.93。EXACT评分与慢性阻塞性肺疾病评估测试（CAT）评分相关（=0.8，<0.01）。治疗后第5天起，有反应者组的EXACT评分下降幅度大于无反应者组。从急性加重发作到恢复，有反应者的EXACT评分差异为-6.3，无反应者为-1.9（=0.01）。
EXACT-PRO是评估慢性阻塞性肺疾病急性加重期治疗期间症状缓解的一种全面且敏感的方法。
