Non-clinical studies of progesterone.
Non-clinical studies of progesterone.
复制标题
黄体酮的非临床研究。
DOI：
10.1080/13697137.2018.1463982
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发表时间：
2018
期刊：
影响因子：
--
通讯作者：
Sitruk-Ware,R
中科院分区：
文献类型：
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作者：
Sitruk-Ware,R
黄体酮是一种类固醇激素，对生殖功能的调节至关重要。黄体酮已被批准用于几种适应症，包括治疗无排卵月经周期，辅助生殖技术，哺乳期避孕，当与雌激素联合使用时，用于预防绝经后激素治疗中的子宫内膜增生。除了在生殖方面的作用外，黄体酮还在其他组织，特别是神经系统中，调节许多生物学上独特的过程。这种生理激素以晶体形式给药时吸收不良，口服给药时无活性，除非以微粉形式或通过不同的非口服给药系统使给药率更恒定。已经进行了数量有限的临床前研究，以记录不同配方的黄体酮的毒性、致癌性和总体动物安全性，这些相当老的研究没有显示出安全问题。最近，动物实验表明，孕酮及其代谢物异孕酮和结构相关孕激素对神经再生和脑损伤修复以及髓磷脂修复具有积极作用。这些最近的临床前研究结果有可能加速多种未满足的神经学需求的治疗转化。
Progesterone is a steroid hormone that is essential for the regulation of reproductive function. Progesterone has been approved for several indications including the treatment of anovulatory menstrual cycles, assisted reproductive technology, contraception during lactation and, when combined with estrogen, for the prevention of endometrial hyperplasia in postmenopausal hormonal therapy. In addition to its role in reproduction, progesterone regulates a number of biologically distinct processes in other tissues, particularly in the nervous system. This physiological hormone is poorly absorbed when administered in a crystalline form and is not active when given orally, unless in micronized form, or from different non-oral delivery systems that allow a more constant delivery rate. A limited number of preclinical studies have been conducted to document the toxicity, carcinogenicity and overall animal safety of progesterone delivered from different formulations, and these rather old studies showed no safety concern. More recently, it has been shown in animal experiments that progesterone, its metabolite allopregnanolone and structurally related progestins have positive effects on neuroregeneration and repair of brain damage, as well as myelin repair. These recent preclinical findings have the potential to accelerate therapeutic translation for multiple unmet neurological needs.