Papi Alberto, Price David, Sastre Joaquin, Kaiser Kirsten, Lomax Mark, McIver Tammy, Dissanayake Sanjeeva
Department of Clinical and Experimental Medicine, University of Ferrara, Ferrara, Italy.
Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK.
Respir Med. 2015 Feb;109(2):208-17. doi: 10.1016/j.rmed.2014.10.019. Epub 2014 Dec 3.
Fluticasone propionate and formoterol fumarate have been combined in a single inhaler (fluticasone/formoterol; flutiform(®)) for the maintenance treatment of asthma. This pooled analysis assessed the efficacy of fluticasone/formoterol versus fluticasone in patients who previously received inhaled corticosteroids.
Data were pooled from five randomised studies in patients with asthma (aged ≥12 years) treated for 8 or 12 weeks with fluticasone/formoterol (100/10, 250/10 or 500/20 μg b.i.d.; n = 528 delivered via pMDI) or fluticasone alone (100, 250 or 500 μg b.i.d.; n = 527).
Fluticasone/formoterol provided significantly greater increases than fluticasone alone in mean morning forced expiratory volume in 1 second (FEV1) from pre-dose at baseline to 2 hours post-dose at study end (least-squares mean [LSM] treatment difference: 0.146L; p < 0.001) and in pre-dose FEV1 from baseline to study end (LSM treatment difference: 0.048 L; p = 0.043). Compared with fluticasone, fluticasone/formoterol provided greater increases in the percentage of asthma control days (no symptoms, no rescue medication use and no sleep disturbance due to asthma) from baseline to study end (LSM treatment difference: 8.6%; p < 0.001), and was associated with a lower annualised rate of exacerbations (rate ratio: 0.71; p = 0.014).
In summary, fluticasone/formoterol provides clinically significant improvements in lung function and asthma control measures, with a lower incidence of exacerbations than fluticasone alone.
丙酸氟替卡松和富马酸福莫特罗已被联合制成单一吸入器（氟替卡松/福莫特罗；信必可都保(®)）用于哮喘的维持治疗。这项汇总分析评估了氟替卡松/福莫特罗与氟替卡松在先前接受吸入性糖皮质激素治疗的患者中的疗效。
汇总了五项针对哮喘患者（年龄≥12岁）的随机研究数据，这些患者接受氟替卡松/福莫特罗（100/10、250/10或500/20μg，每日两次；n = 528，通过压力定量吸入器给药）或单独使用氟替卡松（100、250或500μg，每日两次；n = 527）治疗8周或12周。
从基线给药前到研究结束后2小时，氟替卡松/福莫特罗使平均清晨第1秒用力呼气容积（FEV1）的增加幅度显著大于单独使用氟替卡松（最小二乘均值[LSM]治疗差异：0.146L；p < 0.001），且从基线到研究结束给药前FEV1的增加幅度也更大（LSM治疗差异：0.048L；p = 0.043）。与氟替卡松相比，从基线到研究结束，氟替卡松/福莫特罗使哮喘控制天数（无症状、未使用缓解药物且无因哮喘导致的睡眠障碍）的百分比增加幅度更大（LSM治疗差异：8.6%；p < 0.001），并且与较低的年化加重率相关（率比：0.71；p = 0.014）。
总之，氟替卡松/福莫特罗在肺功能和哮喘控制指标方面提供了具有临床意义的改善，且加重发生率低于单独使用氟替卡松。
