在布地奈德/福莫特罗/格隆溴铵固定三联组合治疗下，现实生活中慢性阻塞性肺疾病患者小气道功能障碍的管理：MASCOT真实世界证据研究
Managing Small Airways Dysfunction in COPD Patients in Real Life Under Fixed Triple Combination of Beclomethasone/Formoterol/Glycopyrronium: The MASCOT Real World Evidence Study.
作者信息
Gogali Athena, Kostikas Konstantinos, Kyriakopoulos Christos, Potonos Dimitrios, Porpodis Konstantinos, Tsiouprou Ioanna, Fouka Evangelia, Tryfon Stavros, Papadopoulou Efthymia, Kipourou Maria, Katsoulis Konstantinos
机构信息
Respiratory Medicine Department, University of Ioannina, Ioannina, Greece.
Pulmonology Department, G. Papanikolaou Hospital, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
出版信息
Int J Chron Obstruct Pulmon Dis. 2025 May 23;20:1651-1663. doi: 10.2147/COPD.S513350. eCollection 2025.
INTRODUCTION
The efficacy of the fixed extrafine combination of beclomethasone/formoterol/glycopyrronium (BDP/FF/G 87/5/9 μg) has been evaluated in randomized controlled trials of patients with chronic obstructive pulmonary disease (COPD). However, only few data exist on its effectiveness on small airways dysfunction (SAD).
METHODS
The MASCOT (MAnaging Small airways dysfunction in COPD patients in real life on the fixed Triple combination of BDP/FF/G 87/5/9 μg pMDI) prospective observational study evaluated the effectiveness of this combination on SAD in a period of 4 weeks, after direct switch from long-acting β-agonists (LABA) and long-acting muscarinic antagonists (LAMA) in COPD patients with SAD (forced expiratory flow at 25-75% of the vital capacity, FEF25-75% <60% predicted). The primary endpoint was improvement in R5-19 in oscillometry; secondary endpoints included other oscillometry parameters, lung function and health status (COPD assessment test-CAT, Saint-George's Respiratory Questionnaire-SGRQ).
RESULTS
Between May 2022 and July 2023 we recruited 93 COPD patients (mean age 68.5 years, 82% men) with forced expiratory volume in 1 second (FEV, mean ± SD) 1.53 ± 0.47L (53.4 ± 14.5% predicted) and small airways dysfunction (FEF25-75% predicted 27.7 ± 15.4%). We observed statistically significant improvement in R5-19 between baseline (V1) and follow-up (V2) visits [median (IQR) V2 0.70 (0.41-1.10) vs V1 0.90 (0.60-1.83); mean change (95% CI) -0.49, -0.66 to -0.33 cmHO/L/sec, p < 0.0001). There were improvements in multiple parameters, including FEF25-75% (3.43, 1.20% to 5.66%, p = 0.0005), FEV (0.142, 0.078 to 0.205 L, p < 0.0001) and RV/TLC (-6.09, -9.61% to -2,56% predicted, p < 0.0001), as well as improvement in CAT score -4.09 (-5.09 to -3.08) και SGRQ total score (-8.75, -11.58 to -5.93 points, p < 0.0001).
CONCLUSION
Extrafine triple therapy improved SAD and spirometric parameters, leading to improvement in health status at 4 weeks. These results need to be confirmed in longer studies.
引言
布地奈德/福莫特罗/格隆溴铵固定超细组合制剂（BDP/FF/G 87/5/9μg）的疗效已在慢性阻塞性肺疾病（COPD）患者的随机对照试验中得到评估。然而，关于其对小气道功能障碍（SAD）有效性的数据却很少。
方法
MASCOT（在现实生活中使用BDP/FF/G 87/5/9μg pMDI固定三联组合治疗COPD患者的小气道功能障碍）前瞻性观察研究评估了该组合制剂在4周内对SAD的有效性，这些患者为患有SAD（肺活量25%-75%时的用力呼气流量，FEF25-75%<预测值的60%）的COPD患者，他们直接从长效β受体激动剂（LABA）和长效毒蕈碱拮抗剂（LAMA）转换而来。主要终点是振荡法中R5-19的改善；次要终点包括其他振荡法参数、肺功能和健康状况（COPD评估测试-CAT、圣乔治呼吸问卷-SGRQ）。
结果
在2022年5月至2023年7月期间，我们招募了93例COPD患者（平均年龄68.5岁，82%为男性），其1秒用力呼气容积（FEV，平均值±标准差）为1.53±0.47L（预测值的53.4±14.5%），存在小气道功能障碍（FEF25-75%预测值为27.7±15.4%）。我们观察到在基线（V1）和随访（V2）就诊之间R5-19有统计学意义的改善[V2的中位数（IQR）为0.70（0.41-1.10），而V1为0.90（0.60-1.83）；平均变化（95%CI）为-0.49，-0.66至-0.33cmH₂O/L/秒，p<0.0001]。多个参数得到改善，包括FEF25-75%（3.43，1.20%至5.66%，p=0.0005）、FEV（0.142，0.078至0.205L，p<0.0001）和残气量/肺总量（-6.09，-9.61%至-2.56%预测值，p<0.0001），以及CAT评分改善-4.09（-5.09至-3.08）和SGRQ总分改善（-8.75，-11.58至-5.93分，p<0.0001）。
结论
超细三联疗法改善了SAD和肺量计参数，在4周时改善了健康状况。这些结果需要在更长时间的研究中得到证实。
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