Grossman J, Banov C, Bronsky E A, Nathan R A, Pearlman D, Winder J A, Ratner P H, Mendelson L, Findlay S R, Kral K M
Allergy Care Consultants, Ltd, Tucson, AZ 85716.
Pediatrics. 1993 Oct;92(4):594-9.
Fluticasone propionate aqueous nasal spray, a new topical corticosteroid preparation, is effective when given as 200 micrograms once daily in patients (> 12 years of age) with seasonal allergic rhinitis.
To evaluate the efficacy and safety of fluticasone proprionate aqueous nasal spray in children aged 4 to 11 years with seasonal allergic rhinitis.
Multicenter, randomized, double-blind, placebo-controlled, parallel-group.
Two hundred fifty children aged 4 to 11 years with moderate-to-severe nasal symptoms, a positive skin test reaction to a late-summer or autumn allergen, a history of seasonal allergic rhinitis, and documentation of an unsatisfactory response to conventional treatment.
Children were randomly assigned to receive fluticasone propionate, either 100 micrograms or 200 micrograms, or placebo, given by intranasal spray once daily in the morning for 14 days.
Severity of nasal symptoms (obstruction, rhinorrhea, itching, and sneezing) was recorded on visual analog scales by investigators at weekly visits and by patients (or adult guardian) daily in the evening. According to investigator and patient ratings, both fluticasone propionate 100 micrograms/d and 200 micrograms/d lowered total nasal symptom scores when compared with placebo. Both dosages of fluticasone propionate were more effective than placebo on the basis of investigator-rated overall clinical evaluation of efficacy at the end of treatment, with significant improvement (as opposed to moderate or mild improvement, no change or worsening) noted in 21% to 29% of the active-treatment groups vs 9% in the placebo group. There were no significant differences between the two fluticasone propionate dosages in any efficacy measurement. Morning plasma cortisol concentrations and frequency of drug-related adverse events were similar in the fluticasone propionate and placebo groups.
In children as young as 4 years, 100 micrograms of fluticasone propionate aqueous nasal spray given once daily is as effective as 200 micrograms given once daily, the usual adult dose for the treatment of seasonal allergic rhinitis. Both fluticasone propionate dosages were well tolerated and neither dosage appears to interfere with the hypothalamic-pituitary-adrenal axis in children.
丙酸氟替卡松水鼻喷雾剂是一种新型局部用皮质类固醇制剂，对于患有季节性变应性鼻炎的12岁以上患者，每日一次给予200微克时有效。
评估丙酸氟替卡松水鼻喷雾剂对4至11岁季节性变应性鼻炎儿童的疗效和安全性。
多中心、随机、双盲、安慰剂对照、平行组。
250名4至11岁儿童，有中度至重度鼻部症状，对夏末或秋季过敏原皮肤试验反应阳性，有季节性变应性鼻炎病史，且有对传统治疗反应不佳的记录。
儿童被随机分配接受100微克或200微克的丙酸氟替卡松，或安慰剂，通过鼻喷雾剂每天早晨给药一次，共14天。
研究人员每周一次、患者（或成年监护人）每天晚上通过视觉模拟量表记录鼻部症状（鼻塞、流涕、瘙痒和打喷嚏）的严重程度。根据研究人员和患者的评分，与安慰剂相比，100微克/天和200微克/天的丙酸氟替卡松均降低了总鼻部症状评分。在治疗结束时，根据研究人员对疗效的总体临床评估，两种剂量的丙酸氟替卡松均比安慰剂更有效，活性治疗组中有21%至29%的患者有显著改善（与中度或轻度改善、无变化或恶化相反），而安慰剂组为9%。两种丙酸氟替卡松剂量在任何疗效测量中均无显著差异。丙酸氟替卡松组和安慰剂组的早晨血浆皮质醇浓度及药物相关不良事件的发生率相似。
对于年仅4岁的儿童，每日一次给予100微克丙酸氟替卡松水鼻喷雾剂与每日一次给予200微克（治疗季节性变应性鼻炎的常用成人剂量）同样有效。两种丙酸氟替卡松剂量耐受性良好，且两种剂量似乎均不干扰儿童的下丘脑-垂体-肾上腺轴。
