Buhl Roland, Criée Carl-Peter, Kardos Peter, Vogelmeier Claus F, Kostikas Konstantinos, Lossi Nadine S, Worth Heinrich
Pulmonary Department, Mainz University Hospital, Mainz,
Department of Sleep and Respiratory Medicine, Evangelical Hospital Goettingen-Weende, Bovenden.
Int J Chron Obstruct Pulmon Dis. 2018 Aug 24;13:2557-2568. doi: 10.2147/COPD.S169958. eCollection 2018.
No observational studies have evaluated the "real-world" effectiveness of dual bronchodilation comprising a long-acting β-agonist plus a long-acting muscarinic antagonist vs that of triple therapy (long-acting β-agonist plus long-acting muscarinic antagonist plus inhaled corticosteroid) in COPD.
DACCORD is a non-interventional, observational clinical study that recruited patients following COPD maintenance therapy initiation or change in maintenance therapy between or within therapeutic class. Given the non-interventional nature of the study, the decision to initiate or change medication had to be made by the patients' physicians prior to inclusion in DACCORD. We used a matched-pairs analysis to compare disease progression in two patient groups: those receiving dual bronchodilation vs those receiving triple therapy (each group n=1,046).
In two subgroups of patients matched according to a broad range of demographic and disease characteristics, over 1 year, fewer patients receiving dual bronchodilation exacerbated than those receiving triple therapy (15.5% vs 26.6%; <0.001), with a greater improvement from baseline in COPD Assessment Test total score at 1 year (mean±SD -2.9±5.8 vs -1.4±5.5;<0.001). When analyzed according to prior therapy, the highest rate of exacerbations was in patients on triple therapy prior to the study who remained on triple therapy. Those changing from mono-bronchodilator to dual bronchodilation had the greatest COPD Assessment Test total score improvement.
In this "real-life" cohort of patients with COPD, most of whom had not exacerbated in the 6 months prior to entry, triple therapy did not seem to improve outcomes compared with dual bronchodilation in terms of either exacerbations or health status. Our analyses clearly demonstrate the potential impact of prior medication on study results, something that should be taken into account when interpreting the results even of controlled clinical trials.
尚无观察性研究评估长效β受体激动剂加长效毒蕈碱拮抗剂的双重支气管扩张疗法与三联疗法（长效β受体激动剂加长效毒蕈碱拮抗剂加吸入性糖皮质激素）在慢性阻塞性肺疾病（COPD）中的“真实世界”疗效。
DACCORD是一项非干预性观察性临床研究，纳入在开始COPD维持治疗或在治疗类别之间或之内改变维持治疗的患者。鉴于该研究的非干预性质，启动或改变药物治疗的决定必须在患者纳入DACCORD之前由其医生做出。我们采用配对分析比较两组患者的疾病进展：接受双重支气管扩张疗法的患者与接受三联疗法的患者（每组n = 1046）。
在根据广泛的人口统计学和疾病特征匹配的两个患者亚组中，超过1年的时间里，接受双重支气管扩张疗法的患者病情加重的人数少于接受三联疗法的患者（15.5%对26.6%；<0.001），1年时慢性阻塞性肺疾病评估测试总分较基线的改善更大（平均值±标准差 -2.9±5.8对 -1.4±5.5；<0.001）。根据先前治疗进行分析时，病情加重率最高的是研究前接受三联疗法且继续接受三联疗法的患者。从单一支气管扩张剂改为双重支气管扩张疗法的患者慢性阻塞性肺疾病评估测试总分改善最大。
在这个“真实生活”的慢性阻塞性肺疾病患者队列中，大多数患者在入组前6个月内未出现病情加重，在病情加重或健康状况方面，三联疗法与双重支气管扩张疗法相比似乎并未改善结局。我们的分析清楚地证明了先前用药对研究结果的潜在影响，在解释甚至是对照临床试验的结果时都应考虑到这一点。
