Dahl Ronald, Chuchalin Alexander, Gor Dee, Yoxall Sally, Sharma Raj
Department of Respiratory Diseases, University Hospital Arhus, Nørrebrogada 44, DK 8000 Arhus C, Denmark.
Respir Med. 2006 Jul;100(7):1152-62. doi: 10.1016/j.rmed.2006.03.001. Epub 2006 May 3.
This multicentre, parallel group, double-blind, double-dummy, randomised 24-week study was designed to compare the efficacy of salmeterol/fluticasone propionate combination (SFC) 50/250 microg one inhalation twice daily (bid) with formoterol/budesonide combination (FBC) 6/200 microg two inhalations bid in patients with persistent asthma, currently receiving 1000-2000 microg/day of inhaled corticosteroids.
The intent-to-treat population comprised 694 patients in the SFC group and 697 patients in the FBC group.
The primary endpoint, mean rate of all exacerbations over 24 weeks, was similar in both treatment groups (SFC: 2.69; FBC: 2.79; SFC/FBC ratio 0.96; 95% CL 0.84, 1.10; P=0.571). A reduction in the rate of exacerbations over time was observed in both treatment groups. Overall, there was a 30% lower annual rate of moderate/severe exacerbations in the SFC group compared with the FBC group (95% CI 0-49%, 52% reduction vs. 1% increase; P=0.059). This effect increased with time: in weeks 17-24 the moderate/severe exacerbation rate was 57% lower in the SFC group compared with the FBC group (95% CI 21-77% reduction; P=0.006). Similar improvements in lung function, asthma symptoms and rescue medication usage were seen with both treatments and both were well tolerated.
Twice-daily treatment with SFC and FBC over 6 months significantly improved asthma symptoms and lung function in patients with persistent asthma. The rate of exacerbations was significantly reduced over time on both treatments but SFC was found to be significantly superior to FBC in reducing the rate of moderate/severe exacerbations with sustained treatment.
本多中心、平行组、双盲、双模拟、随机化的24周研究旨在比较沙美特罗/丙酸氟替卡松联合制剂（SFC）50/250微克每日吸入两次（bid）与福莫特罗/布地奈德联合制剂（FBC）6/200微克每日吸入两次bid对持续性哮喘患者的疗效，这些患者目前正在接受每日1000 - 2000微克的吸入性糖皮质激素治疗。
意向性治疗人群包括SFC组的694例患者和FBC组的697例患者。
主要终点，即24周内所有加重发作的平均发生率，在两个治疗组中相似（SFC：2.69；FBC：2.79；SFC/FBC比值0.96；95%置信区间0.84, 1.10；P = 0.571）。两个治疗组均观察到随着时间推移加重发作率降低。总体而言，SFC组中度/重度加重发作的年发生率比FBC组低30%（95%置信区间0 - 49%，降低52% vs. 增加1%；P = 0.059）。这种效应随时间增加：在第17 - 24周，SFC组中度/重度加重发作率比FBC组低57%（95%置信区间降低21 - 77%；P = 0.006）。两种治疗在肺功能、哮喘症状和急救药物使用方面均有相似改善，且耐受性良好。
SFC和FBC每日两次治疗6个月显著改善了持续性哮喘患者的哮喘症状和肺功能。两种治疗随着时间推移均显著降低了加重发作率，但发现SFC在持续治疗中降低中度/重度加重发作率方面显著优于FBC。
