Universitätspoliklinik für Osteoporose, Inselspital Bern, 3010 Bern, Switzerland.
Eur Spine J. 2012 Dec;21(12):2407-17. doi: 10.1007/s00586-012-2404-y. Epub 2012 Jun 28.
BACKGROUND/AIM: Raloxifene is the first selective estrogen receptor modulator that has been approved for the treatment and prevention of osteoporosis in postmenopausal women in Europe and in the US. Although raloxifene reduces the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer, it is approved in that indication in the US but not in the EU. The aim was to characterize the clinical profiles of postmenopausal women expected to benefit most from therapy with raloxifene based on published scientific evidence to date.
Key individual patient characteristics relevant to the prescription of raloxifene in daily practice were defined by a board of Swiss experts in the fields of menopause and metabolic bone diseases and linked to published scientific evidence. Consensus was reached about translating these insights into daily practice.
Through estrogen agonistic effects on bone, raloxifene reduces biochemical markers of bone turnover to premenopausal levels, increases bone mineral density (BMD) at the lumbar spine, proximal femur, and total body, and reduces vertebral fracture risk in women with osteopenia or osteoporosis with and without prevalent vertebral fracture. Through estrogen antagonistic effects on breast tissue, raloxifene reduces the risk of invasive estrogen-receptor positive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. Finally, raloxifene increases the incidence of hot flushes, the risk of venous thromboembolic events, and the risk of fatal stroke in postmenopausal women at increased risk for coronary heart disease. Postmenopausal women in whom the use of raloxifene is considered can be categorized in a 2 × 2 matrix reflecting their bone status (osteopenic or osteoporotic based on their BMD T-score by dual energy X-ray absorptiometry) and their breast cancer risk (low or high based on the modified Gail model). Women at high risk of breast cancer should be considered for treatment with raloxifene.
Postmenopausal women between 50 and 70 years of age without climacteric symptoms with either osteopenia or osteoporosis should be evaluated with regard to their breast cancer risk and considered for treatment with raloxifene within the framework of its contraindications and precautions.
背景/目的：雷洛昔芬是首个被批准用于治疗和预防欧洲和美国绝经后妇女骨质疏松症的选择性雌激素受体调节剂。虽然雷洛昔芬降低了骨质疏松症和高侵袭性乳腺癌风险的绝经后妇女的侵袭性乳腺癌风险，但它在美国被批准用于该适应症，而在欧盟则未被批准。目的是根据迄今为止已发表的科学证据，描述最有可能从雷洛昔芬治疗中获益的绝经后妇女的临床特征。
瑞士绝经和代谢性骨病领域的专家小组定义了与日常实践中雷洛昔芬处方相关的关键个体患者特征，并将其与已发表的科学证据联系起来。专家小组就将这些见解转化为日常实践达成了共识。
通过对骨骼的雌激素激动作用，雷洛昔芬将骨转换的生化标志物降低至绝经前水平，增加腰椎、近端股骨和全身的骨密度，并降低伴有或不伴有先前椎体骨折的绝经后妇女的椎体骨折风险。通过对乳腺组织的雌激素拮抗作用，雷洛昔芬降低了骨质疏松症和高侵袭性乳腺癌风险的绝经后妇女的侵袭性雌激素受体阳性乳腺癌风险。最后，雷洛昔芬增加了绝经后妇女的热潮红发生率、静脉血栓栓塞事件风险和致命性中风风险，而这些妇女患冠心病的风险增加。考虑使用雷洛昔芬的绝经后妇女可以分为 2×2 矩阵，反映她们的骨骼状况（基于双能 X 射线吸收法的骨密度 T 评分，骨量减少或骨质疏松症）和乳腺癌风险（基于改良 Gail 模型，低风险或高风险）。应考虑高乳腺癌风险的妇女接受雷洛昔芬治疗。
50 至 70 岁无更年期症状且骨量减少或骨质疏松症的绝经后妇女应评估其乳腺癌风险，并考虑在其禁忌症和注意事项的框架内接受雷洛昔芬治疗。
