National Jewish Health, Denver, Colorado, USA.
Allergy Asthma Proc. 2011 Mar-Apr;32(2):127-36. doi: 10.2500/aap.2011.32.3426. Epub 2010 Dec 28.
This 52-week study was designed to assess the safety and efficacy of fluticasone propionate/salmeterol combination (FSC) 250/50 micrograms versus fluticasone propionate (FP) 250 micrograms in subjects with persistent asthma symptomatic on open-label FP 100 micrograms. The primary objective of this study was to show that FSC 250/50 micrograms was superior to FP 250 micrograms at increasing pulmonary function as measured by forced expiratory volume in 1 second over a 52-week treatment period. A secondary objective was to compare the rate of asthma attacks defined as (1) a sustained 2-day decrease in morning peak expiratory flow or increase in albuterol use for 2 consecutive days, (2) an asthma exacerbation requiring systemic corticosteroids, or (3) an unscheduled clinic or hospital visit for acute asthma symptoms. Three hundred six subjects received FSC 250/50 micrograms and 315 subjects received FP 250 micrograms. Both treatments were administered twice daily. Treatment with FSC 250/50 micrograms resulted in a significant improvement in lung function compared with FP 250 micrograms (p < 0.001). Additionally, treatment with FSC 250/50 micrograms resulted in a reduction in the rate of exacerbations of asthma (i.e., requiring systemic corticosteroids or unscheduled urgent care intervention) compared with FP 250 micrograms (0.170 versus 0.273, respectively; p = 0.017). There was no differentiation between treatments for less severe attacks of asthma. FSC 250/50 micrograms showed consistently greater improvement in lung function, symptom control, and decreased albuterol use. In addition, FSC 250/50 micrograms-treated subjects experienced fewer severe asthma exacerbations than subjects treated with FP 250 micrograms.
这项为期 52 周的研究旨在评估丙酸氟替卡松/沙美特罗复方制剂（FSC）250/50 微克与丙酸氟替卡松（FP）250 微克在使用开放标签 FP 100 微克后仍有症状的持续性哮喘患者中的安全性和有效性。该研究的主要目的是证明 FSC 250/50 微克在增加肺功能方面优于 FP 250 微克，具体表现为在 52 周的治疗期间，1 秒用力呼气量（FEV1）的增加。次要目标是比较哮喘发作的发生率，定义为：（1）持续 2 天的晨峰呼气流量降低或连续 2 天沙丁胺醇用量增加；（2）需要全身皮质激素治疗的哮喘恶化；或（3）因急性哮喘症状而未预约的诊所或医院就诊。306 例患者接受 FSC 250/50 微克治疗，315 例患者接受 FP 250 微克治疗。两种治疗方案均每日两次给药。与 FP 250 微克相比，FSC 250/50 微克治疗可显著改善肺功能（p<0.001）。此外，与 FP 250 微克相比，FSC 250/50 微克治疗可降低哮喘恶化的发生率（即需要全身皮质激素或未预约的紧急护理干预）（分别为 0.170 与 0.273，p=0.017）。两种治疗方案对哮喘较轻微发作的疗效无差异。FSC 250/50 微克在改善肺功能、控制症状和减少沙丁胺醇使用方面始终表现出更大的优势。此外，与 FP 250 微克治疗组相比，FSC 250/50 微克治疗组发生严重哮喘恶化的患者更少。
