Vargas R, Dockhorn R J, Findlay S R, Korenblat P E, Field E A, Kral K M
Clinical Research Center, New Orleans, LA 70112, USA.
J Allergy Clin Immunol. 1998 Aug;102(2):191-7. doi: 10.1016/s0091-6749(98)70085-5.
Fluticasone propionate is a glucocorticoid with negligible oral bioavailability and very low intranasal bioavailability that is used as an intranasal spray for the treatment of rhinitis.
The purpose of this study was to evaluate the hypothalamic-pituitary-adrenal (HPA)axis effects of fluticasone propionate aqueous nasal spray (FP ANS) compared with oral prednisone and placebo by using a 6-hour cosyntropin infusion test.
In a 4-week, randomized, double-blind, double-dummy, placebo-controlled parallel-group study, 105 adult patients with allergic rhinitis were randomly assigned to receive FP ANS 200 microg once daily, FP ANS 400 microg twice daily, oral prednisone 7.5 mg once daily, oral prednisone 15 mg once daily, or placebo. HPA-axis function was assessed at the screening visit and after 4 weeks of treatment by measuring morning plasma cortisol concentrations and poststimulation concentrations of plasma and urinary cortisol.
There was no evidence of altered HPA-axis response to cosyntropin by the end of treatment with FP ANS 200 microg once daily or FP ANS 400 microg twice daily when compared with placebo. In contrast, 4 weeks of treatment with oral prednisone 7.5 or 15 mg once daily was associated with significant (p < 0.05 vs placebo) reduction in HPA-axis function, as evidenced by lower plasma cortisol concentrations (area under the plasma concentration-time curve and peak concentrations) after cosyntropin stimulation and reduced mean 24-hour urinary cortisol excretion. FP ANS 400 microg twice daily and both prednisone regimens were associated with a significant (p < 0.05 vs placebo) reduction in mean morning plasma cortisol concentrations.
These results indicate that a 4-week course of FP ANS at four times the recommended dose does not suppress adrenal function in response to a 6-hour cosyntropin stimulation test.
丙酸氟替卡松是一种糖皮质激素，口服生物利用度可忽略不计，鼻内生物利用度极低，用作鼻喷雾剂治疗鼻炎。
本研究的目的是通过6小时促肾上腺皮质激素输注试验，评估丙酸氟替卡松水基鼻喷雾剂（FP ANS）与口服泼尼松及安慰剂相比对下丘脑-垂体-肾上腺（HPA）轴的影响。
在一项为期4周的随机、双盲、双模拟、安慰剂对照平行组研究中，105例成年变应性鼻炎患者被随机分配接受每日一次200μg的FP ANS、每日两次400μg的FP ANS、每日一次7.5mg的口服泼尼松、每日一次15mg的口服泼尼松或安慰剂。在筛查访视时以及治疗4周后，通过测量早晨血浆皮质醇浓度以及血浆和尿皮质醇的刺激后浓度来评估HPA轴功能。
与安慰剂相比，每日一次200μg的FP ANS或每日两次400μg的FP ANS治疗结束时，没有证据表明HPA轴对促肾上腺皮质激素的反应发生改变。相比之下，每日一次7.5mg或15mg的口服泼尼松治疗4周与HPA轴功能显著降低（与安慰剂相比，p<0.05）相关，促肾上腺皮质激素刺激后血浆皮质醇浓度较低（血浆浓度-时间曲线下面积和峰值浓度）以及24小时尿皮质醇平均排泄量降低证明了这一点。每日两次400μg的FP ANS以及两种泼尼松治疗方案均与早晨平均血浆皮质醇浓度显著降低（与安慰剂相比，p<0.05）相关。
这些结果表明，在推荐剂量的四倍下进行为期4周的FP ANS疗程，在6小时促肾上腺皮质激素刺激试验中不会抑制肾上腺功能。
