Berlin School of Public Health, Charité Universitätsmedizin Berlin, Berlin, Germany.
Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Comprehensive Pneumology Center Munich (CPC-M), Ludwig-Maximilians-Universität München, Munich, Germany.
BMC Pulm Med. 2024 Mar 1;24(1):103. doi: 10.1186/s12890-024-02902-4.
Randomized controlled trials described beneficial effects of inhaled triple therapy (LABA/LAMA/ICS) in patients with chronic obstructive pulmonary disease (COPD) and high risk of exacerbations. We studied whether such effects were also detectable under continuous treatment in a retrospective observational setting.
Data from baseline and 18-month follow-up of the COPD cohort COSYCONET were used, including patients categorized as GOLD groups C/D at both visits (n = 258). Therapy groups were defined as triple therapy at both visits (triple always, TA) versus its complement (triple not always, TNA). Comparisons were performed via multiple regression analysis, propensity score matching and inverse probability weighting to adjust for differences between groups. For this purpose, variables were divided into predictors of therapy and outcomes.
In total, 258 patients were eligible (TA: n = 162, TNA: n = 96). Without adjustments, TA patients showed significant (p < 0.05) impairments regarding lung function, quality of life and symptom burden. After adjustments, most differences in outcomes were no more significant. Total direct health care costs were reduced but still elevated, with inpatient costs much reduced, while costs of total and respiratory medication only slightly changed.
Without statistical adjustment, patients with triple therapy showed multiple impairments as well as elevated treatment costs. After adjusting for differences between treatment groups, differences were reduced. These findings are compatible with beneficial effects of triple therapy under continuous, long-term treatment, but also demonstrate the limitations encountered in the comparison of controlled intervention studies with observational studies in patients with severe COPD using different types of devices and compounds.
随机对照试验描述了吸入三联疗法（LABA/LAMA/ICS）在慢性阻塞性肺疾病（COPD）和高加重风险患者中的有益作用。我们研究了在连续治疗下，这种作用在回顾性观察性研究中是否也能被检测到。
使用 COPD 队列 COSYCONET 的基线和 18 个月随访数据，包括两次就诊时均被归类为 GOLD 组 C/D 的患者（n=258）。治疗组定义为两次就诊时均接受三联疗法（三联始终，TA）与非三联疗法（三联不始终，TNA）。通过多元回归分析、倾向评分匹配和逆概率加权来调整组间差异进行比较。为此，将变量分为治疗和结局的预测因素。
共有 258 名患者符合条件（TA：n=162，TNA：n=96）。未经调整，TA 患者的肺功能、生活质量和症状负担明显受损（p<0.05）。调整后，大多数结局的差异不再显著。总直接医疗费用降低，但仍处于较高水平，住院费用大幅降低，而总药物和呼吸药物费用仅略有变化。
未经统计学调整，接受三联疗法的患者表现出多种损害以及治疗费用升高。在调整治疗组之间的差异后，差异有所减少。这些发现与连续、长期治疗下三联疗法的有益作用一致，但也表明在使用不同类型装置和化合物的严重 COPD 患者中，对照干预研究与观察性研究之间的比较存在局限性。
