Kaiser Harold B, Naclerio Robert M, Given John, Toler Tom N, Ellsworth Anna, Philpot Edward E
Clinical Research Institute, Minneapolis, MN 55402, USA.
J Allergy Clin Immunol. 2007 Jun;119(6):1430-7. doi: 10.1016/j.jaci.2007.02.022. Epub 2007 Apr 5.
Fluticasone furoate (USAN-approved name) is a novel, enhanced-affinity glucocorticoid administered in a unique side-actuated device for the management of seasonal allergic rhinitis (SAR).
We sought to evaluate the efficacy and safety of once-daily fluticasone furoate nasal spray, 110 microg, in patients aged 12 years or older with fall SAR.
Patients (n = 299) received fluticasone furoate or placebo for 2 weeks in this double-blind, parallel-group randomized study. Patients evaluated nasal and ocular symptoms using a 4-point categoric scale. Efficacy was assessed on the basis of the mean change from baseline in reflective and instantaneous total nasal symptom scores and reflective total ocular symptom scores.
Fluticasone furoate produced significantly greater improvements than placebo in daily reflective total nasal symptom score (-1.473, P < .001; primary end point), morning predose instantaneous total nasal symptom score (-1.375, P < .001), daily reflective total ocular symptom score (-0.600, P = .004), and patient-rated overall response to therapy (P < .001). The onset of therapeutic effect occurred at 8 hours after initial administration. Fluticasone furoate was well tolerated.
Fluticasone furoate, 110 microg once daily, was effective and well tolerated for the treatment of nasal symptoms of SAR in patients aged 12 years and older. Treatment also produced significant improvements in ocular symptoms. Fluticasone furoate was fast acting, as indicated by an 8-hour onset of action, and provided 24-hour symptom control.
New treatments for the bothersome symptoms of SAR are needed. One such treatment, fluticasone furoate nasal spray, provides effective relief of the symptom profile of SAR.
糠酸氟替卡松(美国采用名称)是一种新型的、亲和力增强的糖皮质激素,通过独特的侧动式装置给药,用于治疗季节性变应性鼻炎(SAR)。
我们旨在评估110微克每日一次的糠酸氟替卡松鼻喷雾剂在12岁及以上秋季患SAR患者中的疗效和安全性。
在这项双盲、平行组随机研究中,299例患者接受了2周的糠酸氟替卡松或安慰剂治疗。患者使用4分分类量表评估鼻和眼症状。疗效根据反射性和即时性总鼻症状评分以及反射性总眼症状评分相对于基线的平均变化进行评估。
糠酸氟替卡松在每日反射性总鼻症状评分(-1.473,P <.001;主要终点)、晨起给药前即时性总鼻症状评分(-1.375,P <.001)、每日反射性总眼症状评分(-0.600,P =.004)以及患者评定的治疗总体反应方面(P <.001)比安慰剂有显著更大的改善。治疗效果在首次给药后8小时出现。糠酸氟替卡松耐受性良好。
每日一次110微克的糠酸氟替卡松对治疗12岁及以上患者的SAR鼻症状有效且耐受性良好。治疗对眼症状也有显著改善。糠酸氟替卡松起效迅速,8小时开始起效,并能提供24小时症状控制。
需要针对SAR烦人的症状的新治疗方法。一种这样的治疗方法,糠酸氟替卡松鼻喷雾剂,可有效缓解SAR的症状。