Donovitz Gary S
Morehouse School of Medicine, Department of Obstetrics and Gynecology, Atlanta, GA 30310, USA.
BioTE Medical, LLC, 1875 West Walnut Hill Lane, Suite 100, Irving, TX 75038, USA.
J Pers Med. 2022 Jul 22;12(8):1194. doi: 10.3390/jpm12081194.
Hormone replacement therapy continues to be a controversial topic in medicine, with certain narratives regarding safety concerns that are not scientifically established in peer-reviewed literature. These negative narratives, specifically undermining the use of testosterone in women, have caused women to remain without any Food and Drug Administration (FDA)-approved testosterone therapies, while more than 30 FDA-approved testosterone therapies are available for men in the United States. This has resulted in millions of women suffering in silence with very common symptoms of perimenopause and menopause that could easily be addressed with the use of testosterone. There is growing evidence to support the use of physiologic doses of testosterone for sexual function, osteoporosis prevention, brain protection, and breast protection. The safety of testosterone use in women has been evaluated for the past 80 years. A recent publication on the complications of subcutaneous hormone-pellet therapy, looking at a large cohort of patients over 7 years, demonstrated long-term safety. In addition, there have been two large long-term peer-reviewed studies showing a significant reduction in the incidence of invasive breast cancer in women on testosterone therapy. Perhaps it is time for the FDA to consider approving products that would benefit testosterone-deficient women.
激素替代疗法在医学上仍然是一个有争议的话题,关于安全问题的某些说法在同行评审文献中并未得到科学证实。这些负面说法,特别是对女性使用睾酮的诋毁,导致女性仍然没有任何获得美国食品药品监督管理局(FDA)批准的睾酮疗法,而在美国有30多种FDA批准的睾酮疗法可供男性使用。这使得数百万女性默默忍受围绝经期和绝经的常见症状,而这些症状使用睾酮很容易得到缓解。越来越多的证据支持使用生理剂量的睾酮来改善性功能、预防骨质疏松、保护大脑和乳房。在过去80年里,一直在评估女性使用睾酮的安全性。最近一篇关于皮下激素植入疗法并发症的出版物,对一大群患者进行了7年的观察,证明了其长期安全性。此外,有两项大型长期同行评审研究表明,接受睾酮治疗的女性浸润性乳腺癌发病率显著降低。也许FDA是时候考虑批准能使睾酮缺乏的女性受益的产品了。