Hebert Adelaide A, Friedlander Sheila Fallon, Allen David B
Department of Dermatology, University of Texas-Houston Medical School, 6655 Travis Street, Houston, TX 77030, USA.
J Pediatr. 2006 Sep;149(3):378-82. doi: 10.1016/j.jpeds.2006.05.008.
To establish the absence of adrenal suppression of fluticasone propionate (FP) 0.05% lotion when applied extensively to children (3 months to 6 years), with moderate to severe atopic dermatitis (AD).
Open-label, conducted at 6 US centers; 44 subjects (3 to 71 months) with widespread AD (mean body surface area treated, 65%) received FP lotion twice daily for up to 4 weeks.
No significant differences in mean cortisol levels were detected before or after treatment. At baseline, mean (+/-standard deviation) cortisols before and after cosyntropin (CST) stimulation were 13 +/- 6 microg/dL and 35 +/- 6 microg/dL, respectively. End-treatment, pre-CST, and post-CST cortisols were 12 +/- 6 microg/dL and 33 +/- 8 microg/dL, respectively. All 42 subjects with end-treatment post-CST cortisols demonstrated a normal adrenal response to CST (>18.0 microg/dL). FP lotion was well tolerated. Subjects who had blood drawn for bioavailability showed no correlation between FP levels and end-treatment post-CST cortisols.
In patients as young as 3 months, FP lotion had no effect on HPA axis function and did not cause skin thinning even when used extensively over widespread, severe inflammatory disease. These results, together with others from studies using cream and ointment, provide further evidence of the safety of FP.
确定0.05%丙酸氟替卡松（FP）洗剂广泛应用于3个月至6岁患有中度至重度特应性皮炎（AD）的儿童时，是否不存在肾上腺抑制作用。
在美国6个中心进行的开放标签研究；44名3至71个月患有广泛AD（平均治疗体表面积为65%）的受试者，每天两次使用FP洗剂，持续4周。
治疗前后平均皮质醇水平未检测到显著差异。基线时，促肾上腺皮质激素（CST）刺激前后的平均（±标准差）皮质醇分别为13±6μg/dL和35±6μg/dL。治疗结束时，CST刺激前和刺激后的皮质醇分别为12±6μg/dL和33±8μg/dL。所有42名治疗结束时CST刺激后皮质醇的受试者对CST均表现出正常的肾上腺反应（>18.0μg/dL）。FP洗剂耐受性良好。抽取血样检测生物利用度的受试者，其FP水平与治疗结束时CST刺激后的皮质醇之间无相关性。
在3个月大的患者中，即使在广泛的严重炎症性疾病上广泛使用，FP洗剂对下丘脑-垂体-肾上腺（HPA）轴功能也无影响，且不会导致皮肤变薄。这些结果与使用乳膏和软膏的其他研究结果一起，进一步证明了FP的安全性。
