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长效氢化可的松制剂——是否具有临床显著益处?

Extended-release Hydrocortisone Formulations-Is There a Clinically Meaningful Benefit?

作者信息

Steintorsdottir Sandra D, Øksnes Marianne, Jørgensen Anders P, Husebye Eystein S

机构信息

Department of Clinical Medicine, University of Bergen, Bergen N-5020, Norway.

Department of Medicine, Haukeland University Hospital, Bergen N-5021, Norway.

出版信息

J Clin Endocrinol Metab. 2025 Feb 18;110(3):e566-e573. doi: 10.1210/clinem/dgae822.

Abstract

Despite best practice replacement therapy with corticosteroids, patients with adrenal insufficiency report diminished quality of life and face increased mortality and morbidity. Conventional formulations of hydrocortisone have short half-lives (about 90 minutes) requiring multiple dosing during the day. Since 2011, extended-release hydrocortisone (ER-HC) formulations have been available enabling once-, sometimes twice-daily dosing. Most studies comparing ER-HC formulations with conventional hydrocortisone therapy report reduction in body weight, blood pressure and glucose levels, and improved quality of life. However, it is still unclear if the reported beneficiary effects are due to differences in cortisol exposure or alterations in pharmacokinetics. Here, we review studies comparing conventional and ER-HC treatment in adrenal insufficiency and discuss whether these novel formulations are safe and offer clinically significant benefits.

摘要

尽管采用皮质类固醇进行最佳替代治疗,但肾上腺功能不全患者的生活质量仍会下降,且死亡率和发病率会增加。传统氢化可的松制剂的半衰期较短(约90分钟),需要在一天内多次给药。自2011年以来,已有缓释氢化可的松(ER-HC)制剂可供使用,可实现每日一次,有时每日两次给药。大多数比较ER-HC制剂与传统氢化可的松治疗的研究报告称,患者体重、血压和血糖水平有所降低,生活质量得到改善。然而,目前尚不清楚所报告的有益效果是由于皮质醇暴露量的差异还是药代动力学的改变。在此,我们回顾了比较肾上腺功能不全患者传统治疗与ER-HC治疗的研究,并讨论了这些新型制剂是否安全以及是否具有临床显著益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed8f/11834724/4bcaf8ba586a/dgae822f1.jpg

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