Shimizu Yasuo, Shiobara Taichi, Arai Ryo, Chibana Kazuyuki, Takemasa Akihiro
Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Mibu, Tochigi, Japan.
J Thorac Dis. 2020 May;12(5):1877-1883. doi: 10.21037/jtd-19-3913.
This study evaluated the efficacy of switching therapy from fluticasone propionate/salmeterol (FP/SM) or budesonide/formoterol (BD/FM) to fluticasone furoate and vilanterol (FF/VI) at the equivalent corticosteroid dose in a real-world setting.
A prospective, 3-month, open-label, parallel group, switching therapy trial was performed in symptomatic asthma patients under routine management. Patients using 1 puff of FP 250 µg/SM 50 µg b.i.d or 2 puffs of BD 160 µg/FM 4.5 µg b.i.d were switched to FF 100 µg/VI 25 µg once daily, while patients using 1 puff of FP 500 µg/SM 50 µg b.i.d or 4 puffs of BD 160/FM b.i.d was switched to FF 200 µg/VI 25 µg once daily. The primary outcome was improvement of the predicted forced expiratory volume in 1 second % (%FEV1), while secondary outcomes were improvement of asthma symptoms evaluated by the asthma control test (ACT) and fractional exhaled nitric oxide (FeNO).
The %FEV1 was improved at 4 weeks after switching, and the improvement was maintained until 12 weeks. ACT also improved after switching. Patients with ACT <20 before switching showed greater improvement of symptoms at 4 weeks and 62% had an ACT score >20. FeNO decreased from 8 weeks.
In symptomatic asthma patients showing insufficient control, improvement of asthma was obtained by switching to FF/VI at the equivalent corticosteroid dose accompanied with the improvement of biomarkers. FF/VI can be a useful option for better control of asthma because of its high efficacy, long duration of action, and delivery via a single-action device.
本研究在真实环境中评估了在等效皮质类固醇剂量下,将丙酸氟替卡松/沙美特罗(FP/SM)或布地奈德/福莫特罗(BD/FM)转换为糠酸氟替卡松和维兰特罗(FF/VI)的治疗效果。
对接受常规管理的症状性哮喘患者进行了一项为期3个月的前瞻性、开放标签、平行组转换治疗试验。使用1吸250μg FP/50μg SM每日两次或2吸160μg BD/4.5μg FM每日两次的患者转换为每日一次100μg FF/25μg VI,而使用1吸500μg FP/50μg SM每日两次或4吸160μg BD/FM每日两次的患者转换为每日一次200μg FF/25μg VI。主要结局是预测的1秒用力呼气量百分比(%FEV1)的改善,次要结局是通过哮喘控制测试(ACT)和呼出一氧化氮分数(FeNO)评估的哮喘症状的改善。
转换后4周时%FEV1得到改善,且这种改善持续至12周。转换后ACT也有所改善。转换前ACT<20的患者在4周时症状改善更明显,62%的患者ACT评分>20。FeNO从8周开始下降。
在控制不佳的症状性哮喘患者中,在等效皮质类固醇剂量下转换为FF/VI可改善哮喘,并伴有生物标志物的改善。FF/VI因其高效、长效作用以及通过单剂量装置给药,可能是更好控制哮喘的有用选择。