Nayak A S, Ellis M H, Gross G N, Mendelson L M, Schenkel E J, Lanier B Q, Simpson B, Mullin M E, Smith J A
J Allergy Clin Immunol. 1998 Feb;101(2 Pt 1):157-62. doi: 10.1016/S0091-6749(98)70379-3.
Suppression of adrenocortical function, a risk associated with oral corticosteroids, is minimized with intranasal corticosteroids. Triamcinolone acetonide (TAA) aqueous nasal spray, at therapeutic doses, has no measurable effect on adrenocortical function in adults with allergic rhinitis.
This double-blind, placebo-controlled study compared the effect of once-daily TAA aqueous nasal spray (220 or 440 microg) with placebo on adrenocortical function after 6 weeks of treatment in pediatric (children 6 to 12 years of age) patients with allergic rhinitis. The pharmacokinetic profile of TAA was examined after once-daily intranasal administration of TAA aqueous nasal spray 440 microg for 6 weeks.
Eighty children received TAA aqueous nasal spray 220 microg or 440 microg or placebo for 6 weeks. Adrenocortical function was assessed by analyzing plasma cortisol levels before stimulation (0 hour) and at 30 and 60 minutes after a rapid 1-hour intravenous cosyntropin stimulation test performed before treatment and after 6 weeks of treatment. Samples for pharmacokinetic evaluation were collected from 19 patients at baseline (0 hour) and at 0.5, 1, 1.5, and 6 hours after the final dose of study medication.
After 6 weeks, no significant effects on adrenocortical function were observed at 30 or 60 minutes after cosyntropin stimulation with either dose of TAA aqueous nasal spray. TAA concentrations in plasma showed rapid elimination of the drug, with little or no accumulation.
TAA aqueous nasal spray (220 or 440 microg/day) has no measurable effect on adrenocortical function in pediatric patients with allergic rhinitis. Pharmacokinetic parameters after 440 microg/day of TAA aqueous nasal spray indicate a rapid decline of plasma drug levels, with little or no systemic accumulation of study drug.
口服皮质类固醇激素存在肾上腺皮质功能抑制的风险，而鼻用皮质类固醇激素可将此风险降至最低。曲安奈德（TAA）水性鼻喷雾剂在治疗剂量下，对患有过敏性鼻炎的成年人肾上腺皮质功能无显著影响。
这项双盲、安慰剂对照研究比较了每日一次使用TAA水性鼻喷雾剂（220或440微克）与安慰剂对患有过敏性鼻炎的儿科（6至12岁儿童）患者治疗6周后肾上腺皮质功能的影响。在每日一次鼻内给予440微克TAA水性鼻喷雾剂6周后，检测了TAA的药代动力学特征。
80名儿童接受220微克或440微克TAA水性鼻喷雾剂或安慰剂治疗6周。在治疗前和治疗6周后进行快速1小时静脉注射促肾上腺皮质激素刺激试验，通过分析刺激前（0小时）以及刺激后30分钟和60分钟时的血浆皮质醇水平来评估肾上腺皮质功能。从19名患者身上采集药代动力学评估样本，分别在基线（0小时）以及最后一剂研究药物后的0.5、1、1.5和6小时采集。
6周后，两种剂量的TAA水性鼻喷雾剂在促肾上腺皮质激素刺激后30分钟或60分钟时，均未观察到对肾上腺皮质功能有显著影响。血浆中TAA浓度显示药物快速消除，几乎没有或没有蓄积。
TAA水性鼻喷雾剂（每日220或440微克）对患有过敏性鼻炎的儿科患者肾上腺皮质功能无显著影响。每日440微克TAA水性鼻喷雾剂的药代动力学参数表明血浆药物水平迅速下降，研究药物几乎没有或没有全身蓄积。
