论文部分内容阅读
睾酮是维持男性生长发育和雄性特征的一种非常重要的激素。在性腺机能减退男性中,睾酮水平异常偏低,影响了正常的性发育。睾酮药品通过弥补体内缺乏的睾酮,有助于恢复男性正常的睾酮水平,以确保男性正常的性发育、成熟。目前,我国上市的睾酮药品包括甲睾酮片、丙酸睾酮注射液、十一酸睾酮胶丸、十一酸睾酮注射液、十一酸睾酮软胶囊、睾酮贴剂等。其中甲睾酮片、丙酸睾酮注射液为《国家基本药物目录(2012年版)》品种。一、国外监管部门发布的关于睾酮的安全性信息2014年以来,美国食品药品监督管理局(FDA)、欧洲药品管理局(EMA)、
Testosterone is a very important hormone that sustains male growth and development and males. In hypogonadal men, testosterone levels are abnormally low, affecting normal sexual development. Testosterone drugs help to restore normal male testosterone levels by making up for lack of testosterone in the body to ensure normal sexual development and maturation in men. Currently, testosterone drugs listed in China include testosterone tablets, testosterone propionate injection, testosterone undecanoate capsules, testosterone undecanoate injection, testosterone undecanoate capsules, and testosterone patch. One of the testosterone tablets, testosterone propionate injection for the “National Essential Drug List (2012 Edition)” varieties. First, the foreign regulatory agencies on the safety of testosterone Information Since 2014, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA)