Early Clinical Research & Experimental Medicine, Schering-Plough Research Institute, 2015 Galloping Hill Road (K-15-4, 4455), Kenilworth, NJ 07033, USA.
Chest. 2010 Jan;137(1):115-21. doi: 10.1378/chest.09-0235. Epub 2009 Sep 11.
Inhaled corticosteroids can suppress the hypothalamic-pituitary-adrenal (HPA) axis with long-term exposure. This study reports the effects of moderate-dose (400 microg) mometasone furoate administered via dry powder inhaler (MF-DPI) once daily in the evening on the HPA axis in adults with mild to moderate asthma.
In this randomized, investigator-blind, placebo-controlled trial, nonsmoking adults aged 18 to 50 years with mild-to-moderate asthma received once-daily MF-DPI 400 microg (2 x 200 microg/inhalation; treatment A), MF-DPI 400 microg (1 x 400 microg/inhalation; treatment B), or placebo (two inhalations, treatment C), delivered at approximately 8:00 pm, for 42 days. Primary end points were area under the serum cortisol concentration-vs-time curve over 24 h (AUC(0-24)), 24-h urinary free cortisol (creatinine corrected) on day 42, maximum serum cortisol concentration (C(max)), time to C(max) (T(max)), and 8 :00 am serum cortisol concentration. This study was initiated April 16, 2001 and completed June 14, 2001.
Serum cortisol AUC(0-24), C(max), and 24-h urinary free cortisol levels decreased with all treatments by day 42 with no significant differences between groups. For treatment B, the change in 8:00 am serum cortisol from baseline to day 42 was significantly less than placebo (P = .04), attributed to a large baseline difference between these treatments. A significant difference in T(max) change from baseline by day 42 for treatment B compared with the other treatments (P = .019) was also attributed to significant baseline differences between groups. Actual values at day 42 for T(max) and 8:00 am serum cortisol were not significantly different between treatment groups (P > or = .275).
Once-evening moderate dosing (400 microg) MF-DPI does not suppress HPA axis function in adults with mild to moderate asthma.
长期使用吸入性皮质类固醇会抑制下丘脑-垂体-肾上腺（HPA）轴。本研究报告了每日晚间通过干粉吸入器（MF-DPI）给予中等剂量（400μg）糠酸莫米松对轻至中度哮喘成人 HPA 轴的影响。
在这项随机、研究者盲法、安慰剂对照试验中，年龄在 18 至 50 岁之间、患有轻至中度哮喘的非吸烟成人接受每日一次 MF-DPI 400μg（2×200μg/吸；治疗 A）、MF-DPI 400μg（1×400μg/吸；治疗 B）或安慰剂（2 吸，治疗 C）治疗，大约在晚上 8 点给药，共 42 天。主要终点是 24 小时内血清皮质醇浓度-时间曲线下面积（AUC（0-24））、第 42 天 24 小时尿游离皮质醇（肌酐校正）、最大血清皮质醇浓度（C（max））、达峰时间（T（max））和 8：00 点血清皮质醇浓度。这项研究于 2001 年 4 月 16 日开始，于 2001 年 6 月 14 日完成。
所有治疗组在第 42 天血清皮质醇 AUC（0-24）、C（max）和 24 小时尿游离皮质醇水平均下降，组间无显著差异。对于治疗 B，与基线相比，第 42 天 8：00 点血清皮质醇的变化显著低于安慰剂（P =.04），这归因于这些治疗组之间基线存在较大差异。与其他治疗相比，治疗 B 的 T（max）变化的差异也具有统计学意义（P =.019），这也归因于组间基线存在显著差异。治疗组间第 42 天 T（max）和 8：00 点血清皮质醇的实际值无显著差异（P≥.275）。
每日晚间给予中等剂量（400μg）糠酸莫米松不会抑制轻至中度哮喘成人的 HPA 轴功能。
