Bhat Salman Z, Dobs Adrian S
Department of Endocrinology, Diabetes and Metabolism, Johns Hopkins Hospital, Baltimore, MD, USA.
touchREV Endocrinol. 2022 Nov;18(2):133-140. doi: 10.17925/EE.2022.18.2.133. Epub 2022 Aug 24.
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.
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。
