哮喘联盟

   摘要
   为期12周的本研究中比较了经干粉吸入器(DPI) (Libbs Farmacêutica, 巴西)吸入丙酸氟替卡松/福莫特罗(FL/F)250/12 μg固定复方制剂每日两次(b.i.d)，与布地奈德/福莫特罗(BD/F) 400/12 μg b.i.d的疗效和安全性。2周导入期后(所有病人治疗仅用布地奈德加福莫特罗)，年龄为12～65岁(N = 196)的哮喘未控制患者被随机纳入有效控制的、非盲、平行组、多中心、III期临床试验研究中。主要目的是通过清晨呼气流量峰值(mPEF) 测定结果确立非劣效性。本研究结果证实了该非劣效性。与基线相比，两组患者肺功能、哮喘控制以及急救药物的使用都得到了统计学上显著的改善。与BD/F 相比，FL/F在肺功能改善(FEV1) (p = 0.01) 和哮喘控制(p = 0.02)方面均显示出统计学上的优势。急性发作率和不良事件的组间差异无统计学意义。在哮喘未控制或部分控制的患者中，经干粉吸入器吸入丙酸氟替卡松/福莫特罗治疗12周改善了FEV1和哮喘控制并且非劣效与布地奈德/福莫特罗。
 

（苏楠 审校）
Respir Med. 2013 Sep;107(9):1330-8. doi: 10.1016/j.rmed.2013.06.018. Epub 2013 Jul 9.


 

Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma.
 

Cukier A, Jacob CM, Rosario Filho NA, Fiterman J, Vianna EO, Hetzel JL, Neis MA, Fiss E, Castro FF, Fernandes AL, Stirbulov R, Pizzichini E; AIR Brazilian Study Group.
 

Abstract
This 12-week study compared the efficacy and safety of a fixed combination of fluticasone propionate plus formoterol (FL/F) 250/12 μg b.i.d. administered via a dry powder inhaler (DPI) (Libbs Farmacêutica, Brazil) to a combination of budesonide plus formoterol (BD/F) 400/12 μg b.i.d. After a 2-week run-in period (in which all patients were treated exclusively with budesonide plus formoterol), patients aged 12-65 years of age (N = 196) with uncontrolled asthma were randomized into an actively-controlled, open-labeled, parallel-group, multicentre, phase III study. The primary objective was to demonstrate non-inferiority, measured by morning peak expiratory flow (mPEF). The non-inferiority was demonstrated. A statistically significant improvement from baseline was observed in both groups in terms of lung function, asthma control, and the use of rescue medication. FL/F demonstrated a statistical superiority to BD/F in terms of lung function (FEV1) (p = 0.01) and for asthma control (p = 0.02). Non-significant between-group differences were observed with regards to exacerbation rates and adverse events. In uncontrolled or partly controlled asthma patients, the use of a combination of fluticasone propionate plus formoterol via DPI for 12-weeks was non-inferior and showed improvements in FEV1 and asthma control when compared to a combination of budesonide plus formoterol.
 

Respir Med. 2013 Sep;107(9):1330-8. doi: 10.1016/j.rmed.2013.06.018. Epub 2013 Jul 9.