University of Virginia, Charlottesville, VA, USA.
Menopause. 2010 May-Jun;17(3):642-53. doi: 10.1097/gme.0b013e3181c4f1d6.
Selective estrogen receptor modulators (SERMs) have the ability to provide mixed functional estrogen receptor (ER) agonist or antagonist activity, depending on the target tissue. Tamoxifen, the first SERM available for clinical use, is regarded as a highly effective agent for the prevention and treatment of breast cancer. However, tamoxifen exhibits ER agonist activity in the uterus and is associated with an increased risk of endometrial hyperplasia and malignancy. Endometrial safety has been an important consideration in the clinical development of SERMs, with improved benefit-risk profiles. Raloxifene, which is currently approved for the prevention and treatment of postmenopausal osteoporosis and for the prevention of breast cancer, seems to have neutral effects on the uterus. Promising results have been observed with the targeted development of newer and more tissue-specific SERMs, many of which are under investigation for postmenopausal osteoporosis. Of the newer SERMs in development, lasofoxifene has been shown to reduce fracture risk and decrease the incidence of breast cancer but has been associated with an increased incidence of vaginal bleeding, endometrial thickening, and endometrial polyps. Lasofoxifene and ospemifene have shown beneficial effects on the vaginal epithelium. Phase 3 clinical data have shown that bazedoxifene is effective in preventing and treating postmenopausal osteoporosis, without adverse effects on the endometrium or breast. Arzoxifene has been evaluated in phase 3 trials for postmenopausal osteoporosis and has been studied for the treatment of uterine malignancies but is no longer in clinical development. Further investigation of newer SERMs is warranted to more clearly define the endometrial safety of these agents.
选择性雌激素受体调节剂 (SERMs) 具有提供混合功能雌激素受体 (ER) 激动剂或拮抗剂活性的能力,具体取决于靶组织。他莫昔芬是临床应用的第一种 SERM,被认为是预防和治疗乳腺癌的有效药物。然而,他莫昔芬在子宫中表现出 ER 激动剂活性,并且与子宫内膜增生和恶性肿瘤的风险增加相关。子宫内膜安全性一直是 SERMs 临床开发中的一个重要考虑因素,具有改善的获益风险特征。雷洛昔芬目前被批准用于预防和治疗绝经后骨质疏松症以及预防乳腺癌,似乎对子宫没有影响。针对新的和更具组织特异性的 SERMs 的靶向开发取得了有希望的结果,其中许多正在研究用于绝经后骨质疏松症。在开发中的新型 SERMs 中,拉索昔芬已被证明可降低骨折风险和减少乳腺癌的发生,但与阴道出血、子宫内膜增厚和子宫内膜息肉的发生率增加相关。拉索昔芬和奥昔布芬对阴道上皮有有益的影响。III 期临床数据表明,巴泽多昔芬可有效预防和治疗绝经后骨质疏松症,对子宫内膜或乳房无不良影响。阿佐昔芬已在 III 期试验中评估用于绝经后骨质疏松症的治疗,并已研究用于治疗子宫恶性肿瘤,但不再处于临床开发阶段。需要进一步研究新型 SERMs,以更清楚地定义这些药物的子宫内膜安全性。