Department of Obstetrics and Gynecology, Wake Forest School of Medicine, Winston-Salem, NC, USA.
Reprod Sci. 2013 Oct;20(10):1130-6. doi: 10.1177/1933719113497290. Epub 2013 Aug 13.
Vulvar and vaginal atrophy (VVA) is a chronic, progressive medical condition prevalent among postmenopausal women, which produces symptoms such as dyspareunia, vaginal dryness, and vaginal irritation. Currently, the only prescription options are systemic and vaginal estrogen therapies that may be limited by concerns about long-term safety and breast cancer risk. Ospemifene is a tissue-selective estrogen agonist/antagonist (a selective estrogen receptor modulator) recently approved by the US Food and Drug Administration for treatment of dyspareunia, a symptom of VVA, due to menopause. Ospemifene, the first nonestrogen oral treatment for this indication, may provide an alternative to treatment with estrogen. Animal models with ospemifene suggest an inhibitory effect on growth of malignant breast tissue, but animal data cannot necessarily be extrapolated to humans. Clinical trials, including 3 long-term studies assessing the overall safety of ospemifene, support that ospemifene is generally well tolerated, with beneficial effects on the vagina, neutral effects on the breast, and minimal effects on the endometrium.
外阴和阴道萎缩（VVA）是一种常见于绝经后妇女的慢性、进行性医学病症，会产生性交困难、阴道干燥和阴道刺激等症状。目前，唯一的处方选择是全身和阴道雌激素治疗，但可能会因对长期安全性和乳腺癌风险的担忧而受到限制。奥昔孕酚是一种组织选择性雌激素激动剂/拮抗剂（一种选择性雌激素受体调节剂），最近被美国食品和药物管理局批准用于治疗因绝经引起的 VVA 相关性交困难症状。奥昔孕酚是治疗该适应症的第一种非雌激素口服药物，可能为雌激素治疗提供替代方案。奥昔孕酚的动物模型表明其对恶性乳腺组织的生长具有抑制作用，但动物数据不一定可以外推至人类。包括 3 项长期研究在内的临床试验评估了奥昔孕酚的总体安全性，支持奥昔孕酚通常具有良好的耐受性，对阴道有有益作用，对乳房无影响，对子宫内膜的影响最小。
