Gennari Luigi, Merlotti Daniela, De Paola Vincenzo, Nuti Ranuccio
Department of Internal Medicine, Endocrine-Metabolic Sciences and Biochemistry, University of Siena, Policlinico Le Scotte 53100-Siena, Italy.
Core Evid. 2010 Jun 15;4:113-29. doi: 10.2147/ce.s6001.
Osteoporosis is a skeletal disorder characterized by compromised bone strength and increased risk of fracture. It is a common disorder in elderly subjects and represents a major public health problem, affecting up to 40% postmenopausal women and 15% of men. Among the several therapeutical interventions, hormone replacement therapy (HRT) was traditionally seen as the gold standard for preventing osteoporotic fractures in postmenopausal women, as well as for the management of menopausal symptoms. However HRT, especially if administered long-term, may lead to an increased risk of breast and, when unopposed by progestins, endometrial cancers. Alternative therapies include bisphosphonates and raloxifene, a selective estrogen receptor modulator (SERM). While the former have been associated with suboptimal adherence, the latter was considerably less potent than estrogen and its effect in the prevention of nonvertebral fractures remain uncertain.
The purpose of this article is to review the clinical trials of lasofoxifene, a new SERM for the treatment of postmenopausal osteoporosis. The medical literature was reviewed for appropriate articles containing the terms "lasofoxifene" and SERMs".
There are three (phase II or phase III) clinical trials that clearly demonstrate efficacy and safety of this new SERM in the suppression of bone loss and the prevention of vertebral and nonvertebral fractures. Moreover, lasofoxifene treatment also reduced breast cancer risk and the occurrence of vaginal atrophy.
With its increased potency and efficacy on the prevention of nonvertebral fractures lasofoxifene may be an alternative and cost-effective therapy for osteoporosis in postmenopausal women.
骨质疏松症是一种以骨强度受损和骨折风险增加为特征的骨骼疾病。它在老年人群中很常见,是一个重大的公共卫生问题,影响高达40%的绝经后女性和15%的男性。在几种治疗干预措施中,激素替代疗法(HRT)传统上被视为预防绝经后女性骨质疏松性骨折以及管理绝经症状的金标准。然而,HRT,尤其是长期使用时,可能会增加患乳腺癌的风险,并且在没有孕激素对抗时,会增加子宫内膜癌的风险。替代疗法包括双膦酸盐和雷洛昔芬,一种选择性雌激素受体调节剂(SERM)。虽然前者与依从性欠佳有关,但后者的效力远低于雌激素,其预防非椎体骨折的效果仍不确定。
本文的目的是综述来索昔芬(一种用于治疗绝经后骨质疏松症的新型SERM)的临床试验。检索医学文献以查找包含“来索昔芬”和“SERMs”的相关文章。
有三项(II期或III期)临床试验清楚地证明了这种新型SERM在抑制骨质流失以及预防椎体和非椎体骨折方面的有效性和安全性。此外,来索昔芬治疗还降低了乳腺癌风险和阴道萎缩的发生率。
来索昔芬在预防非椎体骨折方面效力和效果增强,可能是绝经后女性骨质疏松症的一种替代且具有成本效益的治疗方法。