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在有症状的哮喘患者中,从氟替卡松/沙美特罗或布地奈德/福莫特罗治疗转换为糠酸氟替卡松/维兰特罗后的实际疗效:Relvar Ellipta用于真实哮喘控制研究(RERACS研究)

Real-life effectiveness of fluticasone furoate/vilanterol after switching from fluticasone/salmeterol or budesonide/formoterol therapy in patients with symptomatic asthma: Relvar Ellipta for Real Asthma Control Study (RERACS study).

作者信息

Shimizu Yasuo, Shiobara Taichi, Arai Ryo, Chibana Kazuyuki, Takemasa Akihiro

机构信息

Department of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Mibu, Tochigi, Japan.

出版信息

J Thorac Dis. 2020 May;12(5):1877-1883. doi: 10.21037/jtd-19-3913.

Abstract

BACKGROUND

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.

METHODS

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).

RESULTS

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.

CONCLUSIONS

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.

摘要

背景

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。

方法

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。

结果

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。

结论

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/01a0/7330400/f875b921906e/jtd-12-05-1877-f1.jpg

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