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<p>Chronic obstructive pulmonary disease (COPD) represents a significant global health burden necessitating optimized therapeutic interventions. Contemporary guidelines advocate for individualized bronchodilator therapy, yet comparative real-world effectiveness data remain limited, particularly in Chinese populations. To evaluate the comparative effectiveness and safety of umeclidinium/vilanterol (UMEC/VI) dual bronchodilator therapy versus tiotropium monotherapy and budesonide/formoterol combination in patients with stable COPD over a 12-month observation period. This prospective observational cohort study enrolled 171 patients with stable COPD from February 2020 to February 2022 at a tertiary respiratory center. Participants were allocated to treatment groups based on clinical discretion following GOLD guidelines: UMEC/VI (<i>n</i> = 57), tiotropium (<i>n</i> = 57), or budesonide/formoterol (<i>n</i> = 57). The primary outcome was change in forced expiratory volume in one second (FEV<sub>1</sub>) from baseline to 12 months. Secondary outcomes included functional capacity, symptom burden, inflammatory biomarkers, exacerbation rates, and adverse events. Statistical analysis employed multivariable mixed-effects models with propensity score adjustment to control for confounding. All treatment groups demonstrated significant improvements from baseline, with UMEC/VI showing superior outcomes. The adjusted mean change in FEV<sub>1</sub> was 12.6% (95% CI: 9.2–15.9%) for UMEC/VI versus 8.1% (95% CI: 5.4–10.8%) for tiotropium and 5.3% (95% CI: 2.8–7.8%) for budesonide/formoterol (<i>p</i> &lt; 0.001). UMEC/VI was associated with greater improvements in exercise tolerance (6-minute walking distance: +4 5.7&#xa0;m, 95% CI: 32.5–58.9&#xa0;m), symptom control (CAT score reduction: −&#xa0;4.2 points, 95% CI: -5.1 to -3.3), and inflammatory markers. Exacerbation rates were lowest with UMEC/VI (0.42 vs. 0.61 vs. 0.89 events per patient-year, respectively). Adverse event incidence was significantly lower in the UMEC/VI group (8.8%, 95% CI: 3.7–19.6%) compared to budesonide/formoterol (29.8%, 95% CI: 19.2–42.9%). This observational study suggests that UMEC/VI dual bronchodilator therapy is associated with superior clinical outcomes and a favorable safety profile in patients with stable moderate COPD. However, these findings require validation through adequately powered randomized controlled trials before definitive therapeutic recommendations can be established.</p>

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Impact of umeclidinium/vilanterol dual bronchodilator therapy on pulmonary function and inflammatory responses in stable COPD patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月13日

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  • Rongbin Jiang,
  • Weijie Zhan,
  • Xiaoyun Jian,
  • Jiachun Li

摘要

Chronic obstructive pulmonary disease (COPD) represents a significant global health burden necessitating optimized therapeutic interventions. Contemporary guidelines advocate for individualized bronchodilator therapy, yet comparative real-world effectiveness data remain limited, particularly in Chinese populations. To evaluate the comparative effectiveness and safety of umeclidinium/vilanterol (UMEC/VI) dual bronchodilator therapy versus tiotropium monotherapy and budesonide/formoterol combination in patients with stable COPD over a 12-month observation period. This prospective observational cohort study enrolled 171 patients with stable COPD from February 2020 to February 2022 at a tertiary respiratory center. Participants were allocated to treatment groups based on clinical discretion following GOLD guidelines: UMEC/VI (n = 57), tiotropium (n = 57), or budesonide/formoterol (n = 57). The primary outcome was change in forced expiratory volume in one second (FEV1) from baseline to 12 months. Secondary outcomes included functional capacity, symptom burden, inflammatory biomarkers, exacerbation rates, and adverse events. Statistical analysis employed multivariable mixed-effects models with propensity score adjustment to control for confounding. All treatment groups demonstrated significant improvements from baseline, with UMEC/VI showing superior outcomes. The adjusted mean change in FEV1 was 12.6% (95% CI: 9.2–15.9%) for UMEC/VI versus 8.1% (95% CI: 5.4–10.8%) for tiotropium and 5.3% (95% CI: 2.8–7.8%) for budesonide/formoterol (p < 0.001). UMEC/VI was associated with greater improvements in exercise tolerance (6-minute walking distance: +4 5.7 m, 95% CI: 32.5–58.9 m), symptom control (CAT score reduction: − 4.2 points, 95% CI: -5.1 to -3.3), and inflammatory markers. Exacerbation rates were lowest with UMEC/VI (0.42 vs. 0.61 vs. 0.89 events per patient-year, respectively). Adverse event incidence was significantly lower in the UMEC/VI group (8.8%, 95% CI: 3.7–19.6%) compared to budesonide/formoterol (29.8%, 95% CI: 19.2–42.9%). This observational study suggests that UMEC/VI dual bronchodilator therapy is associated with superior clinical outcomes and a favorable safety profile in patients with stable moderate COPD. However, these findings require validation through adequately powered randomized controlled trials before definitive therapeutic recommendations can be established.