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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.

DOI:10.1210/clinem/dgae822
PMID:39656185
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11834724/
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
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed8f/11834724/4bcaf8ba586a/dgae822f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed8f/11834724/4bcaf8ba586a/dgae822f1.jpg

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2
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Andrology. 2025 Feb;13(2):302-313. doi: 10.1111/andr.13635. Epub 2024 Mar 28.
3
Dual-release hydrocortisone improves body composition and the glucometabolic profile in patients with secondary adrenal insufficiency.
双释放氢化可的松可改善继发性肾上腺功能不全患者的身体成分和糖代谢谱。
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Effects of Dual-Release Hydrocortisone on Bone Metabolism in Primary and Secondary Adrenal Insufficiency: A 6-Year Study.双释放氢化可的松对原发性和继发性肾上腺皮质功能不全患者骨代谢的影响:一项为期6年的研究。
J Endocr Soc. 2023 Dec 6;8(1):bvad151. doi: 10.1210/jendso/bvad151. eCollection 2023 Dec 1.
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Ultradian hydrocortisone replacement alters neuronal processing, emotional ambiguity, affect and fatigue in adrenal insufficiency: The PULSES trial.超生理剂量氢化可的松替换治疗改变肾上腺皮质功能减退症患者的神经元处理、情绪模糊、情感和疲劳:PULSES 试验。
J Intern Med. 2024 Jan;295(1):51-67. doi: 10.1111/joim.13721. Epub 2023 Oct 19.
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