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丙酸氟替卡松/福莫特罗和糠酸氟替卡松/维兰特罗对患有慢性支气管阻塞的青少年的影响。

Effect of fluticasone propionate/formoterol and fluticasone furoate/vilanterol on adolescents with chronic bronchial obstruction.

作者信息

Tanninen Tiina Helena, Pelkonen Anna Susanna, Malmberg Leo Pekka, Mäkelä Mika Juhani

机构信息

Department of Allergology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

出版信息

J Allergy Clin Immunol Glob. 2024 Apr 26;3(3):100268. doi: 10.1016/j.jacig.2024.100268. eCollection 2024 Aug.

Abstract

BACKGROUND

The combination of an inhaled corticosteroid (ICS) and long-acting β-agonist (LABA) (ICS/LABA) has shown superiority in improving lung function (FEV) compared with an ICS alone. The clinical effect of a ICS/LABA combination depends on the fine-particle fraction and the pulmonary deposition.

OBJECTIVE

We sought to compare the efficacy of 2 combinations of an ICS and LABA, namely, fluticasone propionate (FP) and formoterol (FORM) (FP/FORM) and fluticasone furoate (FF) and vilanterol (VI) (FF/VI), in asthmatic adolescents with chronic bronchial obstruction.

METHODS

FP/FORM (125 μg/5 μg, 2 doses twice daily via the k-haler [Mundipharma, Cambridge, UK]) and FF/VI (92 μg/22 μg, once daily via the Ellipta inhaler [GlaxoSmithKline]) were administered to adolescents aged 12 to 17 years who required regular antiasthmatic medication and had a ratio of FEV to forced vital capacity (FEV/FVC) less than -1.65 SD in a 2-sequence, 16-week crossover trial. The primary efficacy end point was change in FEV compared with baseline. Secondary end points were FEV/FVC ratio, maximal expiratory flow at 50% of the FVC, impulse oscillometry indices respiratory resistance at 5 Hz (R5), difference between R5 and respiratory resistance at 20 Hz (R20), area of reactance, and Asthma Control Test score.

RESULTS

Both ICS/LABA combinations resulted in a significant improvement in FEV and maximal expiratory flow at 50% of the FVC scores without any significant difference between FP/FORM and FF/VI, with 40% of patients with either treatment achieving a normal prebronchodilator FEV/FVC score. Neither area of reactance nor difference between R5 and R20 improved significantly with either treatment.

CONCLUSION

Both ICS/LABA combinations demonstrated significant improvements in FEV score. More than one-third of the asthmatic adolescents with prolonged bronchial obstruction achieved a normal prebronchodilator FEV/FVC ratio.

摘要

背景

与单独使用吸入性糖皮质激素(ICS)相比,吸入性糖皮质激素(ICS)与长效β受体激动剂(LABA)联合使用(ICS/LABA)在改善肺功能(FEV)方面显示出优越性。ICS/LABA联合使用的临床效果取决于细颗粒部分和肺部沉积。

目的

我们旨在比较两种ICS与LABA联合制剂,即丙酸氟替卡松(FP)和福莫特罗(FORM)(FP/FORM)以及糠酸氟替卡松(FF)和维兰特罗(VI)(FF/VI),在患有慢性支气管阻塞的哮喘青少年中的疗效。

方法

在一项为期16周的两序列交叉试验中,将FP/FORM(125μg/5μg,通过k-吸入器[英国剑桥Mundipharma公司]每日两次,每次2剂)和FF/VI(92μg/22μg,通过Ellipta吸入器[葛兰素史克公司]每日一次)给予12至17岁需要常规抗哮喘药物治疗且FEV与用力肺活量之比(FEV/FVC)低于-1.65标准差的青少年。主要疗效终点是与基线相比FEV的变化。次要终点包括FEV/FVC比值、FVC的50%时的最大呼气流量、脉冲振荡法指标5Hz时的呼吸阻力(R5)、R5与20Hz时的呼吸阻力之差(R20)、电抗面积和哮喘控制测试评分。

结果

两种ICS/LABA联合制剂均使FEV和FVC的50%时的最大呼气流量评分显著改善,FP/FORM和FF/VI之间无显著差异,两种治疗中40%的患者在支气管扩张剂前FEV/FVC评分达到正常。两种治疗均未使电抗面积或R5与R20之差有显著改善。

结论

两种ICS/LABA联合制剂均使FEV评分显著改善。超过三分之一患有长期支气管阻塞的哮喘青少年在支气管扩张剂前FEV/FVC比值达到正常。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8203/11141437/9fa9ccb4da1b/gr1.jpg

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