Murray Lindsey T, Leidy Nancy K
1-Evidera, Bethesda, Maryland.
Chronic Obstr Pulm Dis. 2018 Jan 24;5(1):27-37. doi: 10.15326/jcopdf.5.1.2017.0166.
This study examined the short-term effects of symptom-defined exacerbation recovery on health status and pulmonary function in moderate to severe chronic obstructive pulmonary disease (COPD) patients. Secondary analyses of pooled data from two 12-week Phase II international, randomized controlled trials using the cerbations of hronic Pulmonary Disease ool (EXACT) to identify symptom-defined exacerbations were conducted. Recovery was categorized as recovered, unrecovered (persistent worsening), or censored. Multiple regression analyses were used to test the effect of recovery status on change in the St George's Respiratory Questionnaire (SGRQ) and forced expiratory volume in 1 second (FEV) from baseline to Week 12. Evaluating Respiratory Symptom scale (E-RS) scores were used to evaluate change in stable-state respiratory symptoms from baseline to Week 12. Of 1346 eligible patients, 414 (31%) experienced ≥1 symptom-defined exacerbation; 260 patients recovered from their events, 80 experienced an unrecovered event (persistent worsening), 74 patients had only censored events (excluded). Groups were similar at baseline, with the recovered group reporting significantly worse symptoms (<0.01). Recovery group and baseline SGRQ were significant predictors of change in health status over 12 weeks (=0.04; <0.01); no effects were observed for lung function. Significant between-group differences in change in respiratory symptom severity from baseline to Week 12 were observed (<0.01), with the persistent worsening group experiencing clinically meaningful deterioration in breathlessness and chest symptoms. Results suggest some patients have difficulty recovering from symptom-defined exacerbations, leading to a deterioration in health status, dyspnea, and chest symptoms without short-term effects on lung function. Further study of symptom-defined exacerbation recovery and health outcomes is warranted.
本研究调查了症状定义的急性加重恢复对中重度慢性阻塞性肺疾病(COPD)患者健康状况和肺功能的短期影响。对两项为期12周的国际II期随机对照试验的汇总数据进行了二次分析,这些试验使用慢性肺病加重期(EXACT)来识别症状定义的急性加重。恢复情况分为已恢复、未恢复(持续恶化)或截尾。使用多元回归分析来测试恢复状态对从基线到第12周圣乔治呼吸问卷(SGRQ)和一秒用力呼气量(FEV)变化的影响。使用评估呼吸症状量表(E-RS)评分来评估从基线到第12周稳态呼吸症状的变化。在1346名符合条件的患者中,414名(31%)经历了≥1次症状定义的急性加重;260名患者从急性加重事件中恢复,80名经历了未恢复事件(持续恶化),74名患者仅有截尾事件(排除)。各组在基线时相似,已恢复组报告的症状明显更严重(<0.01)。恢复组和基线SGRQ是12周内健康状况变化的显著预测因素(=0.04;<0.01);未观察到对肺功能的影响。观察到从基线到第12周呼吸症状严重程度变化的组间显著差异(<0.01),持续恶化组在呼吸困难和胸部症状方面出现了具有临床意义的恶化。结果表明,一些患者从症状定义的急性加重中恢复困难,导致健康状况、呼吸困难和胸部症状恶化,而对肺功能无短期影响。有必要进一步研究症状定义的急性加重恢复情况和健康结局。