Clinical Research Center, Helen Hayes Hospital, Route 9W, West Haverstraw, NY 10993, USA.
Osteoporos Int. 2011 Feb;22(2):447-51. doi: 10.1007/s00198-010-1440-x. Epub 2010 Nov 11.
Hormone therapy classically consists of an estrogen with an added progestin; however, concerns have been raised about the potential negative effects of progestin. The recent realization that estrogen agonist-antagonists or selective estrogen receptor modulators might be paired with estrogens instead of a progestin has led to the development of a novel form of menopausal therapy called tissue selective estrogen complex (TSEC). A TSEC is the pairing of a selective estrogen receptor modulator (SERM) with estrogen(s). The TSEC containing conjugated estrogens (CE) and the SERM, bazedoxifene (BZA), has reached clinical development. This short review outlines the effects of this particular TSEC, which maintains or increases bone mass in women at high risk for osteoporosis, and has clinical qualities of a promising new menopausal therapy. Randomized, double-blind, placebo-controlled phase 3 trials in postmenopausal women showed that, in addition to bone preservation, BZA/CE was shown to relieve hot flushes and treat vulvar-vaginal atrophy and its symptoms, with a good safety and tolerability profile.
激素疗法经典地由雌激素与孕激素组成；然而，人们对孕激素的潜在负面影响提出了担忧。最近意识到，雌激素激动剂-拮抗剂或选择性雌激素受体调节剂可能与雌激素而不是孕激素配对，这导致了一种新的更年期治疗方法的发展，称为组织选择性雌激素复合物（TSEC）。TSEC 是选择性雌激素受体调节剂（SERM）与雌激素的配对。含有结合雌激素（CE）和 SERM 巴多昔芬（BZA）的 TSEC 已进入临床开发。这篇简短的综述概述了这种特殊 TSEC 的作用，它可以维持或增加有骨质疏松高风险的女性的骨量，并且具有一种有前途的新更年期治疗方法的临床特性。在绝经后妇女中进行的随机、双盲、安慰剂对照的 3 期试验表明，除了骨保护外，BZA/CE 还显示出缓解热潮红并治疗外阴阴道萎缩及其症状的作用，具有良好的安全性和耐受性。
