盐酸雷洛昔芬防治绝经后骨质疏松症随机双盲对照研究

A double blind,randomized,placebo-controlled study for raloxifene hydrochloride in prevention and treatment of menopausal osteoporosis

目的:评价雷洛昔芬(RLX)对绝经后妇女骨密度及骨代谢生化标志、脂代谢的影响及使用12个月的安全性观察。方法:采用随机、双盲安慰剂对照研究,68例绝经后妇女分为试验(n=34)及安慰剂组(n=34),每日分别服用RLX 60mg或安慰剂,疗程12个月。结果:RLX组用药后腰椎及髋部骨密度均显著增加,腰椎骨密度升高2.30％,髋部骨密度升高2.07％,与安慰剂组比较骨密度变化的百分数差异有显著性(P<0.01)。2组血清骨钙素、C端交联肽、总胆固醇、低密度脂蛋白胆固醇水平均下降,其变化百分率2组比较差异均有显著性(P<0.01)。结论:RLX能增加绝经后妇女骨密度,降低骨转换率及血清总胆固醇、低密度脂蛋白胆固醇水平。

Objective:To evaluate the efficacy and safety of raloxifene hydrochloride (RLX) onbone mineral density (BMD) ,biochemical markers of bone metabolism and lipid metabolism in post-menopausal women. Methods: 68 postmenopausal women were equally randomized to receive either RLX (60mg,oral,daily) or placebo daily for 12 months. Results:RLX women presented significantly higher lumbar spine BMD and hip BMD. Bone density increased after 1 year of therapy, totaling a 2.30% gain for the spine and 2.07 % gain for the hip, compared with placebo women (P < 0.01). The osteocalcin,c-telopeptide,total cholesterol and lower density lipoprotein cholesterol (LDL-C) in RXL women exhibited lower values than in the placebo women (P < 0.01). Conclusion: RXL showed a good correlation with the yearly outcome for BMD, metabolism of bone turnover, serum cholesterol and LDL-C in postmenopausal women.