Can Fam Physician. 2000 Aug;46:1592-6, 1599-603.
Raloxifene is marketed in France for prevention of nontraumatic vertebral fracture in postmenopausal women. In animal pharmacology studies, it was found to both agonize and antagonize estrogen. The assessment file is methodologically sound but fails to answer many practical questions. A placebo-controlled trial showed that raloxifene reduced the risk of vertebral collapse after 2 years of treatment, in both primary and secondary prevention, but demonstrated no effect on nonvertebral fractures. In this trial, raloxifene also reduced the risk of breast cancer. Two trials versus combined hormone replacement therapy (HRT) showed HRT had a more favourable effect on surrogate end points reflecting the risk of fracture and cardiovascular risk (changes in bone mineral density and lipid profile). Compared with combined HRT, raloxifene reduced the incidence of menorrhagia and mastodynia, but did not relieve symptoms linked to menopause. Results of animal studies call for close clinical monitoring to detect a possible increase in the incidence of ovarian cancer.
雷洛昔芬在法国被用于预防绝经后女性的非创伤性椎体骨折。在动物药理学研究中，发现它兼具雌激素激动剂和拮抗剂的作用。评估文件在方法上是合理的，但未能回答许多实际问题。一项安慰剂对照试验表明，雷洛昔芬在治疗2年后可降低原发性和继发性预防中椎体塌陷的风险，但对非椎体骨折无作用。在该试验中，雷洛昔芬还降低了乳腺癌风险。两项与联合激素替代疗法（HRT）对比的试验表明，HRT对反映骨折风险和心血管风险的替代终点（骨矿物质密度和血脂谱变化）有更有利的影响。与联合HRT相比，雷洛昔芬降低了月经过多和乳房疼痛的发生率，但未缓解与绝经相关的症状。动物研究结果要求进行密切临床监测，以检测卵巢癌发病率可能的增加。
