哮喘联盟

   摘要
   在这项为期12周的研究中，比较了固定组合氟替卡松丙酸盐+福莫特罗（FL/F）250/12μg b.i.d.，通过干粉吸入器(DPI)(LibbsFarmacêutica, 巴西) 给药，和布地奈德+福莫特罗(BD/F) 400/12 μg b.i.d的疗效和安全性。2周洗脱期后（其间所有患者都专门接受布地奈德+福莫特罗治疗），12～65岁未控制的哮喘患者（N=196）随机分组进入一个活性药物对照、开放标签、平行分组、多中心的III期研究。研究的主要目的是通过早晨最大呼气流速证明非劣效性。研究证明了非劣效性。两组在肺功能、哮喘控制和使用抢救治疗方面均观察到较基线有统计学显著改善。在肺功能（FEV1）(p=0.01)和哮喘控制(p=0.02)方面，FL/F显著优于BD/F。两组的哮喘发作率和不良反应无显著性差异。对于未控制或部分控制的哮喘患者，与布地奈德+福莫特罗组合相比，氟替卡松丙酸盐+福莫特罗（FL/F）通过干粉吸入(DPI)治疗12周显示出非劣效性，并且在FEV1和哮喘控制方面疗效更佳。
 

（苏楠 审校）
Respir Med. 2013 Jul 9. pii: S0954-6111(13)00230-8. doi: 10.1016/j.rmed.2013.06.018. [Epub ahead of print]

 

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 Jul 9. pii: S0954-6111(13)00230-8. doi: 10.1016/j.rmed.2013.06.018. [Epub ahead of print]