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干粉吸入器与压力定量吸入器递送沙美特罗/氟替卡松联合制剂的临床效果比较。

Comparison of the clinical effects of combined salmeterol/fluticasone delivered by dry powder or pressurized metered dose inhaler.

作者信息

Hojo Masayuki, Shirai Toshihiro, Hirashima Junko, Iikura Motoyasu, Sugiyama Haruhito

机构信息

Division of Respiratory Medicine, National Center for Global Health and Medicine, Japan.

Department of Respiratory Medicine, Shizuoka General Hospital, Japan.

出版信息

Pulm Pharmacol Ther. 2016 Apr;37:43-8. doi: 10.1016/j.pupt.2016.02.004. Epub 2016 Feb 17.

Abstract

The salmeterol/fluticasone combination (SFC) inhaler is currently the most widely used maintenance drug for asthmatics worldwide. Although the effectiveness of SFC as either a dry powder inhaler (DPI) or a pressurized metered dose inhaler (pMDI) is well documented, there is limited data comparing the clinical efficacies of the two devices. To address this issue, we carried out a randomized crossover trial in which asthmatic patients (n = 47; mean age, 62.5 ± 16.5 years old) received a 12-week treatment of SFC DPI (50/250 μg twice daily) or SFC pMDI (four puffs of 25/125 μg daily). After a 4-week washout period, patients received another crossover treatment for 12 weeks. Respiratory resistance and reactance were measured by forced oscillation technique (MostGraph-01), spirometry, fractional exhaled nitric oxide (FeNO), and an asthma control test (ACT) every 4 weeks. The mean forced expiratory volume1.0 at the baseline was 2.16 ± 0.86 (L). Respiratory system resistance at 5 Hz (R5), the difference between R5 and R at 20 Hz (R5 - R20), and FeNO improved in both treatment groups, while reactance at 5 Hz (X5) and ACT score improved only in the pMDI group. In patients >70 years old (n = 21), R5, R5 - R20, ΔX5, and FeNO improved only in the pMDI group. These results suggest that SFC by pMDI produces a stronger anti-inflammatory and bronchodilatory effect even in patients whose asthma is well controlled by SFC delivered by DPI.

摘要

沙美特罗/氟替卡松联合制剂(SFC)吸入器是目前全球哮喘患者使用最广泛的维持治疗药物。尽管SFC作为干粉吸入器(DPI)或压力定量吸入器(pMDI)的有效性已有充分记录,但比较这两种装置临床疗效的数据有限。为解决这一问题,我们进行了一项随机交叉试验,哮喘患者(n = 47;平均年龄62.5±16.5岁)接受为期12周的SFC DPI(50/250μg,每日两次)或SFC pMDI(25/125μg,每日4喷)治疗。经过4周的洗脱期后,患者接受另一轮为期12周的交叉治疗。每4周通过强迫振荡技术(MostGraph-01)、肺功能测定、呼出一氧化氮分数(FeNO)和哮喘控制测试(ACT)测量呼吸阻力和电抗。基线时的平均第1秒用力呼气量为2.16±0.86(L)。两个治疗组的5Hz时呼吸系统阻力(R5)、R5与20Hz时R的差值(R5 - R20)以及FeNO均有所改善,而5Hz时的电抗(X5)和ACT评分仅在pMDI组有所改善。在70岁以上的患者(n = 21)中,仅pMDI组的R5、R5 - R20、ΔX5和FeNO有所改善。这些结果表明,即使在哮喘通过DPI给予的SFC得到良好控制的患者中,pMDI给予的SFC也能产生更强的抗炎和支气管扩张作用。

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