Buhl Roland, Criée Carl-Peter, Kardos Peter, Vogelmeier Claus, Lossi Nadine, Mailänder Claudia, Worth Heinrich
Pulmonary Department, Mainz University Hospital, Mainz.
Department of Sleep and Respiratory Medicine, Evangelical Hospital Göttingen-Weende, Bovenden.
Int J Chron Obstruct Pulmon Dis. 2016 Jul 20;11:1639-46. doi: 10.2147/COPD.S112110. eCollection 2016.
Randomized interventional trials generally recruit highly selected patients. In contrast, long-term, noninterventional studies can reflect standard of care of real-life populations. DACCORD (Die ambulante Versorgung mit langwirksamen Bronchodilatatoren: COPD-Register in Deutschland [Outpatient Care With Long-Acting Bronchodilators: COPD Registry in Germany]) is an ongoing observational study, conducted in primary and secondary care in Germany, aiming to describe the impact of disease and treatments on real-life patients with chronic obstructive pulmonary disease (COPD).
Patients had a clinical and spirometry diagnosis of COPD, were aged ≥40 years, and were initiating or changing COPD maintenance medication. The only exclusion criteria were asthma and participation in a randomized clinical trial. Exacerbation data were collected every 3 months. COPD medication, COPD Assessment Test, and forced expiratory volume in 1 second (FEV1) were recorded at the end of the 1 year period.
In the 6 months prior to baseline, 26.5% of the 3,974 patients experienced ≥1 exacerbation, compared with 26.1% over the 1-year follow-up (annualized rate 0.384). Importantly, only previous exacerbations and not poor lung function alone predicted an increased exacerbation risk. There was a general shift to lower disease severity from baseline to 1 year, predominantly as a consequence of a lower proportion of patients considered at high risk due to exacerbations. COPD Assessment Test mean change from baseline was -1.9, with 48.9% of patients reporting a clinically relevant improvement. Overall persistence to medication was high, with 77.2% of patients still receiving the same class of medication at 1 year.
DACCORD suggests that in clinical practice, the large majority of COPD patients are symptomatic but seldom exacerbate and that widely used tools and treatment recommendations do not reflect this fully.
随机干预试验通常招募经过严格筛选的患者。相比之下，长期非干预性研究能够反映现实生活中人群的医疗标准。DACCORD（德国慢性阻塞性肺疾病长效支气管扩张剂门诊治疗登记研究）是一项正在进行的观察性研究，在德国的初级和二级医疗保健机构开展，旨在描述疾病和治疗对现实生活中慢性阻塞性肺疾病（COPD）患者的影响。
患者经临床和肺功能检查诊断为COPD，年龄≥40岁，且正在开始或改变COPD维持治疗药物。唯一的排除标准是哮喘和参与随机临床试验。每3个月收集一次急性加重数据。在1年研究期结束时记录COPD药物使用情况、COPD评估测试结果和第1秒用力呼气容积（FEV1）。
在基线前的6个月里，3974例患者中有26.5%经历了≥1次急性加重，而在1年的随访期内这一比例为26.1%（年化率0.384）。重要的是，仅既往急性加重而非单纯的肺功能差可预测急性加重风险增加。从基线到1年，疾病严重程度总体上有所下降，主要原因是因急性加重而被视为高危的患者比例降低。COPD评估测试结果相对于基线的平均变化为-1.9，48.9%的患者报告有临床相关改善。总体药物依从性较高，7年后仍有77.2%的患者使用同一类药物。
DACCORD研究表明，在临床实践中，大多数COPD患者有症状但很少急性加重，而广泛使用的工具和治疗建议并未充分反映这一点。
