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睾酮替代疗法:一篇侧重于新型口服制剂的叙述性综述。

Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations.

作者信息

Bhat Salman Z, Dobs Adrian S

机构信息

Department of Endocrinology, Diabetes and Metabolism, Johns Hopkins Hospital, Baltimore, MD, USA.

出版信息

touchREV Endocrinol. 2022 Nov;18(2):133-140. doi: 10.17925/EE.2022.18.2.133. Epub 2022 Aug 24.

Abstract

Male hypogonadism affects 10-30% of the male population and is often under-recognized and under-treated. Different replacement formulations exist, each with specific benefits and limitations. These replacements include gels, patches and short- and long-acting injectables. JATENZO® (oral testosterone undecanoate; Clarus Therapeutics Inc., Northbrook, IL, US) is the first oral formulation of testosterone approved by the US Food and Drug Administration. TLANDO® (oral testosterone undecanoate; Lipocine Inc., Salt Lake City, UT, US), another oral testosterone formulation, has also recently been approved by the US Food and Drug Administration. Based on unique chemistry using a self-emulsifying drug delivery system and lymphatic absorption, JATENZO and TLANDO address some of the limitations of other dosing routes while providing a safe option without evidence of liver dysfunction. This review discusses various testosterone treatment options, focusing on the role and pharmacokinetics of the new oral formulations.

摘要

男性性腺功能减退影响10%至30%的男性人群,且常常未得到充分认识和治疗。目前有不同的替代制剂,每种都有其特定的益处和局限性。这些替代制剂包括凝胶、贴片以及短效和长效注射剂。JATENZO®(十一酸睾酮口服制剂;美国伊利诺伊州北布鲁克的Clarus Therapeutics公司)是美国食品药品监督管理局批准的首个睾酮口服制剂。TLANDO®(十一酸睾酮口服制剂;美国犹他州盐湖城的Lipocine公司)是另一种睾酮口服制剂,最近也获得了美国食品药品监督管理局的批准。基于使用自乳化药物递送系统和淋巴吸收的独特化学性质,JATENZO和TLANDO在提供无肝功能障碍证据的安全选择的同时,解决了其他给药途径的一些局限性。本综述讨论了各种睾酮治疗选择,重点关注新型口服制剂的作用和药代动力学。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9052/9835814/9c28b97e04db/touchendo-18-133-g001.jpg

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