Modified-release Hydrocortisone Therapy as a Treatment for CAH

完成了16例典型CAH成人（8例女性）的2期交叉药代动力学和药效学研究，比较了新开发的氢化可的松缓释制剂与常规氢化可的松。这种新开发的氢化可的松制剂，Chronocort，被设计用来模仿正常的皮质醇昼夜节律。每日两次的时可酮被发现近似生理性皮质醇分泌。与基线时的常规治疗相比，在6个月时，Chronocort显示全天雄激素水平的改善，雄激素的降低是在较低或相似的平均日糖皮质激素剂量下实现的。虽然身体质量指数没有显著变化，但对身体成分的研究表明，女性的瘦质量增加了，男性的脂肪质量减少了。这种新型氢化可的松制剂代表了一种潜在的治疗CAH患者的新方法，目前正在一项国际多中心3期临床试验中进行研究。三期研究现已完成，数据分析正在进行中。

A Phase 2, crossover pharmacokinetic and pharmacodynamic study in 16 adults (8 females) with classic CAH, comparing a newly-developed modifed-release formulation of hydrocortisone with conventional hydrocortisone, was completed. This newly developed formulation of hydrocortisone, Chronocort, was designed to mimic the normal cortisol circadian rhythm. Twice daily Chronocort was found to approximate physiologic cortisol secretion. Compared to conventional therapy at baseline, Chronocort at 6 months showed improved androgen levels throughout the day and this lowering of androgens was achieved with a lower or similar average daily glucocorticoid dose. Although there were no significant changes in body mass index, studies of body composition showed an increase in lean mass (females) and a decrease in fat mass (males). This novel hydrocortisone formulation represents a potential new treatment approach for patients with CAH and is currently being studied in an international multi-center phase 3 clinical trial. The phase 3 study is now completed and data analysis is underway.