Corona G, Rastrelli G, Reisman Y, Sforza A, Maggi M
a Endocrinology Unit, Medical Department , Maggiore-Bellaria Hospital, Azienda-Usl Bologna , Bologna , Italy.
b Sexual Medicine and Andrology Unit, Department of Experimental, Clinical and Biomedical Sciences , University of Florence , Florence , Italy.
Expert Opin Drug Saf. 2018 Mar;17(3):277-292. doi: 10.1080/14740338.2018.1424831. Epub 2018 Jan 15.
In the case of primary male hypogonadism (HG), only testosterone (T) replacement therapy (TRT) is possible whereas when the problem is secondary to a pituitary or hypothalamus alteration both T production and fertility can be, theoretically, restored. We here systematically reviewed and discussed the advantages and limits of medications formally approved for the treatment of HG.
Data derived from available meta-analyses of placebo controlled randomized trials (RCTs) were considered and analyzed. Gonadotropins are well-toleratedand their use is mainly limited by higher costs and a more cumbersome treatment schedule than TRT. Available RCTs on TRT suggest that cardiovascular (CV) and venous thromboembolism risk is not a major issue and that prostate safety is guaranteed. The risk of increased hematocrit is mainly limited to the use of short terminjectable preparations.
In the last few years the concept of 'organic' irreversible HG and 'functional' or age- and comorbidity-related HG has been introduced. This definition is not evidence-based. The majority of RCTs enrolled patients with 'functional' HG. Considering the significant improvement in body composition, glucose metabolism and sexual activity, TRT should not be limited to 'organic' HG, but also offered for 'functional'.
对于原发性男性性腺功能减退（HG），仅可进行睾酮（T）替代疗法（TRT），而当问题继发于垂体或下丘脑改变时，理论上T的产生和生育能力均可恢复。我们在此系统回顾并讨论了正式批准用于治疗HG的药物的优点和局限性。
考虑并分析了来自安慰剂对照随机试验（RCT）的现有荟萃分析的数据。促性腺激素耐受性良好，其使用主要受成本较高以及治疗方案比TRT更繁琐的限制。关于TRT的现有RCT表明，心血管（CV）和静脉血栓栓塞风险不是主要问题，并且前列腺安全性有保障。血细胞比容升高的风险主要限于短期注射制剂的使用。
在过去几年中，引入了“器质性”不可逆HG和“功能性”或与年龄及合并症相关的HG的概念。这一定义并非基于证据。大多数RCT纳入了“功能性”HG患者。考虑到身体成分、糖代谢和性功能的显著改善，TRT不应仅限于“器质性”HG，也应提供给“功能性”HG患者。
