Tanninen Tiina Helena, Pelkonen Anna Susanna, Malmberg Leo Pekka, Mäkelä Mika Juhani
Department of Allergology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
J Allergy Clin Immunol Glob. 2024 Apr 26;3(3):100268. doi: 10.1016/j.jacig.2024.100268. eCollection 2024 Aug.
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.
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.
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.
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.
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.
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。
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。
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。
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。
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。