Fokkens W J, Jogi R, Reinartz S, Sidorenko I, Sitkauskiene B, van Oene C, Faris M A, Ellsworth A, Caldwell M F
Academisch Medisch Centrum, Divisie Neurozintuigspecialismen, Polikliniek KNO, Amsterdam, The Netherlands.
Allergy. 2007 Sep;62(9):1078-84. doi: 10.1111/j.1398-9995.2007.01522.x.
Fluticasone furoate is a new enhanced-affinity glucocorticoid with a unique combination of pharmacodynamic and physicochemical properties suitable for topical activity.
In this multicentre, randomized, double-blind, placebo-controlled, parallel-group study, patients [adults and adolescents >or=12 years of age with seasonal allergic rhinitis (SAR)] received once-daily (od) treatment for 2 weeks with either fluticasone furoate nasal spray 110 microg (n = 141) or placebo nasal spray (n = 144) administered in a unique, side-actuated device. Efficacy measures included total nasal symptom score (TNSS) and total ocular symptom score (TOSS). Patients also reported their overall response to therapy and rated their quality of life using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Fluticasone furoate significantly improved the mean change from baseline in daily reflective TNSS compared with placebo (treatment difference of -1.757; P < 0.001). Fluticasone furoate was also significantly more effective in improving the morning predose instantaneous TNSS (treatment difference of -1.898; P < 0.001) and daily reflective TOSS (treatment difference of -0.741; P = 0.001). A significant treatment effect was observed as early as day 1. Compared with placebo-treated patients, fluticasone furoate-treated patients showed significantly greater improvements in overall evaluation of response to therapy (P < 0.001), as well as in overall RQLQ score (P < 0.001). Fluticasone furoate was well tolerated.
Fluticasone furoate nasal spray 110 mug od was effective in improving the nasal symptoms of SAR. It also produced significant improvements in ocular symptoms.
糠酸氟替卡松是一种新型的高亲和力糖皮质激素,具有独特的药效学和物理化学性质组合,适用于局部活性。
在这项多中心、随机、双盲、安慰剂对照、平行组研究中,患者[年龄≥12岁的季节性过敏性鼻炎(SAR)成人和青少年]使用一种独特的侧动装置,接受糠酸氟替卡松鼻喷雾剂110微克(n = 141)或安慰剂鼻喷雾剂(n = 144)每日一次(od)治疗2周。疗效指标包括总鼻症状评分(TNSS)和总眼症状评分(TOSS)。患者还报告了他们对治疗的总体反应,并使用鼻结膜炎生活质量问卷(RQLQ)对他们的生活质量进行评分。
与安慰剂相比,糠酸氟替卡松显著改善了每日反射性TNSS相对于基线的平均变化(治疗差异为-1.757;P < 0.001)。糠酸氟替卡松在改善早晨给药前即时TNSS(治疗差异为-1.898;P < 0.001)和每日反射性TOSS(治疗差异为-0.741;P = 0.001)方面也显著更有效。早在第1天就观察到了显著的治疗效果。与接受安慰剂治疗的患者相比,接受糠酸氟替卡松治疗的患者在对治疗反应的总体评估(P < 0.001)以及总体RQLQ评分(P < 0.001)方面有显著更大的改善。糠酸氟替卡松耐受性良好。
每日一次使用110微克糠酸氟替卡松鼻喷雾剂可有效改善SAR的鼻部症状。它还显著改善了眼部症状。