苯卓昔芬对健康绝经后妇女骨代谢及血脂的影响

Effect of bazedoxifene on biochemical markers of bone metabolism and serum lipids in healthy Chinese postmenopausal women

目的:评价苯卓昔芬对健康绝经后妇女骨代谢指标及血脂的影响。方法:采用双盲、随机、安慰剂对照研究,将45例健康的绝经后妇女随机分3组:苯卓昔芬(BZ)20mg组12例、BZ40mg组13例、安慰剂组(PL)20例,各组均每日服用苯卓昔芬及钙尔奇各1片,连服3月。服药前后测定骨代谢生化指标及血脂水平。结果:骨代谢指标变化:BZ40mg组的血、尿C端交联多肽(s-CTx,u-CTx)、尿N端交联多肽(u-NTx)及血清骨钙素(BGP)水平均较基础值明显下降(P<0.001),与PL组比较均出现统计学显著性差异(P<0.05);BZ20mg组的u-CTx,s-CTx,u-NTx下降显著(P<0.05),与PL组比较仅s-CTx出现统计学差异(P<0.05)。血脂变化:各组用药后HDL-C水平均上升(P<0.01),BZ组与PL组比较无统计学差异(P>0.05)。BZ40mg组LDL-C水平下降5.45%(P<0.05),20mg组下降1.74%,PL组上升0.77%,与PL组比较BZ40mg组出现统计学差异(P<0.05)。BZ20mg或40mg对总胆固醇及甘油三脂未产生显著影响。BZ组无严重不良事件发生。结论:苯卓昔芬可以降低骨代谢指标、升高HDL-C、降低LDL-C水平,对健康绝经后妇女具有良好的安全性及耐受性。

Objective ： To determine the effect of bazedoxifene acetate （20 and 40 mg） on serum biochemical markers of bone metabolism and lipids in healthy Chinese postmenopausal women. Methods： In a randomized, double-blind, placebo-control trial, a total of 45 healthy postmenopausal women were treated with bazedoxifene at either 20 mg（n = 12） or 40 mg（n = 13）, or with plaeebo（n =20） daily for 3 months. In addition, all the women took elemental calcium, 600 mg daily for 3 months. Serum lipids and bone biochemical markers were determined before and after drug administration. Results： Bazedoxifene at 40 mg significantly decreased the biochemical markers of bone metabolism （ P 〈 0.05 ）, including urine N-telopetide （ u-NTx）, C-telopetide （ u-CTx）, serum C-telopetide （s-CTx） and osteocalcin, as compared to placebo group. Bazedoxifene at 20 mg decreased u-CTx, u-NTx and s-CTx, but only significantly decreased s-CTx as compared to placebo（P 〈 0.05）. At 3 months, both 20 and 40 mg bazedoxifene significantly increased the high-density lipoprotein cholesterol（P 〈 0.01 ） from the baseline values, but did not differ from the values of placebo group（P 〉0.05）. Bazedoxifene decreased the low-density lipoprotein cholesterol by 5.45% （P 〈0.05） at 40 mg, and by 1.74% （P 〉0.05） at 20 mg. No differences were found in total cholesterol or triglyceride levels between the bazedoxifene （20 and 40 mg） and placebo groups（P 〉 0.05）. No severe side effects were found in each group. Conclusion： Bazedoxifene at 20 and 40 mg·d^-1 for 3 months can decrease biochemical markers of bone metabolism, and has a benefitial effect on serum lipid profile in healthy Chinese postmenopausal women.