Howland W C, Hampel F C, Martin B G, Ratner P H, van Bavel J H, Field E A
HealthQuest Therapy and Research Institute, Inc., Austin, Texas, USA.
Clin Ther. 1996 Nov-Dec;18(6):1106-17. doi: 10.1016/s0149-2918(96)80065-8.
Fluticasone propionate aqueous nasal spray is an intranasal corticosteroid for the treatment of patients with allergic rhinitis. This double-masked, double-dummy, parallel-group study was conducted to confirm that the efficacy of fluticasone propionate nasal spray is attributable to topical rather than systemic effects. A total of 304 patients with documented seasonal allergic rhinitis were randomly assigned to receive fluticasone propionate nasal spray 200 micrograms once daily (n = 77), oral fluticasone propionate 5 mg once daily (n = 73), oral fluticasone propionate 10 mg once daily (n = 77), or placebo (n = 77) for 14 days. Plasma fluticasone propionate concentrations were determined at baseline and after 14 days of treatment (day 15). Nasal symptoms were recorded daily by patients and assessed weekly by clinicians. On day 15, more patients in the oral fluticasone propionate 5-mg or 10-mg groups, compared with patients in the fluticasone propionate nasal spray group or the placebo group, had detectable plasma fluticasone propionate concentrations, and mean concentrations were higher in the oral fluticasone propionate groups. Both clinician- and patient-rated total and individual nasal symptom scores for obstruction, rhinorrhea, sneezing, and itching were significantly lower in the fluticasone propionate nasal spray group compared with either of the oral fluticasone propionate groups or the placebo group. With few exceptions, oral fluticasone propionate (5 mg or 10 mg) was not significantly different from placebo on any measures of efficacy. These findings indicate that the efficacy of fluticasone propionate nasal spray (200 micrograms once daily) in the treatment of allergic rhinitis results from direct topical effects rather than from indirect effects after systemic absorption.
丙酸氟替卡松水性鼻喷雾剂是一种用于治疗过敏性鼻炎患者的鼻用皮质类固醇药物。本双盲、双模拟、平行组研究旨在证实丙酸氟替卡松鼻喷雾剂的疗效归因于局部作用而非全身作用。共有304例有季节性过敏性鼻炎记录的患者被随机分配，分别接受每日一次200微克丙酸氟替卡松鼻喷雾剂（n = 77）、每日一次口服5毫克丙酸氟替卡松（n = 73）、每日一次口服10毫克丙酸氟替卡松（n = 77）或安慰剂（n = 77）治疗14天。在基线和治疗14天（第15天）后测定血浆丙酸氟替卡松浓度。患者每天记录鼻部症状，临床医生每周进行评估。在第15天，与丙酸氟替卡松鼻喷雾剂组或安慰剂组的患者相比，口服5毫克或10毫克丙酸氟替卡松组中有更多患者的血浆丙酸氟替卡松浓度可检测到，且口服丙酸氟替卡松组的平均浓度更高。与口服丙酸氟替卡松组或安慰剂组相比，丙酸氟替卡松鼻喷雾剂组临床医生和患者评定的鼻塞、流涕、打喷嚏和瘙痒的总鼻部症状评分及单项鼻部症状评分均显著更低。除少数例外情况外，口服丙酸氟替卡松（5毫克或10毫克）在任何疗效指标上与安慰剂均无显著差异。这些研究结果表明，丙酸氟替卡松鼻喷雾剂（每日一次200微克）治疗过敏性鼻炎的疗效源于直接局部作用，而非全身吸收后的间接作用。
