摘要
目的依靠骨代谢生化指标的测定,对健康的绝经后妇女进行两种不同剂量(20和40 mg)苯卓昔芬(Bazedoxifene Ace-tate,BZA)药效、安全性和耐受性,及对脂代谢影响的评价。方法采取多中心、双盲、随机、安慰剂对照,将实验对象228例随机分为3组,20和40 mg BZA组分别为60和63例,安慰剂组105例,除服用BZA或安慰剂之外,每位实验对象均同时给以每日600 mg的碳酸钙(钙尔奇-D),持续3个月。观察用药前后尿CTx(U-CTx)、血清骨钙素(S-OC)、CTx(S-CTx)、骨特异性碱性磷酸酶(S-BSAP)及尿NTx(U-NTx)的变化。同时观察低密度脂蛋白(LDL)、高密度脂蛋白(HDL)、总胆固醇、甘油三脂和LDL/HDL的比值改变。在实验开始和结束时分别行阴道B超测定子宫内膜的双层厚度、两侧卵巢体积的大小和卵巢囊肿是否存在,并在整个过程中记录药物副反应的发生情况。结果BZA治疗组与安慰剂组比较,用药前后U-CTx变化有显著性差异(BZA20 mg组,P<0.001;BZA40 mg组,P=0.016),BZA 20和40 mg组,用药后较用药前U-CTx分别明显下降了42%和37%,二者与用药前U-CTx中位值比较均有统计学意义(P<0.001)。S-CTx,U-NTx,S-OC在BZA组用药前后的降低显著高于安慰剂组。3组HDL用药后均有升高[安慰剂组(12.26±2.01)%,BZA 20 mg(12.31±2.61)%,BZA 40 mg(16.57±2.49)%]。子宫内膜的厚度及卵巢体积的大小在3组用药前后均无明显变化。结论BZA可以使正常的绝经后妇女骨转换降低至绝经前的水平,正常的绝经后妇女应用BZA是安全的,耐受性好。
OBJECTIVE To assess the effect, safety and tolerance of Bazedoxifine Acetate of two dosage in the healthy menopausal women by the levels of bone markers. METHODS It was a muhicenter, double blind, randomized and placebo controlled study. Total 228 subjects were randomized into three groups. 60 and 63 subjects were designed into the groups of 20 and 40 mg respectively. The placebo group had 105 subjects. Except taking BZA or placebo, each subject was provided with Calcium Carbonate 600 mg（ Caltrate-D） simultaneously. The treatment period was 3 months. The changes of Urine CTx （U-CTx） , osteocalcin （ S-OC ）, CTx （ S- CTx）, S-BSAP and Urine NTx （U-NTx） before treatment and after treatment were observed. Also the changes of low-density lipoprotein （LDL） , high-density lipoprotein （HDL） , total cholesterol, triglycerides and LDL/HDL were observed. A transvaginal ultrasound was conducted to measure the thickness of endometrium and volumes of both ovaries, and to see if cysts existed at the beginning and end of trial. Adverse event was observed and recorded during the study. RESULTS Compared BZA groups with placebo group, U-CTx showed significant changes between before and after treatment （ BZA 20 mg group P 〈 0. 001 ; BZA 40 mg group P = 0. 016）. In BZA 20 mg group and BZA 40 mg group, the U-CTx decreased by 42% and 37% after treatment compared with that before treatment. The median in two groups had statistic significance after treatment compared with that before treatment （ P 〈 0.001 ）. The S-CTx, U-NTx, S-OC in BZA group showed significant decrease compared with that in placebo group. The HDL increased in three groups after treatment. [ Placebo（ 12. 26 ± 2. 01 ） % ; BZA 20 mg（ 12. 31±2. 61 ） % ; BZA 40 mg（ 16. 57 ± 2. 49） % ]. The bulk of ovaries and thickness of endometrium showed no changes in three groups before and after the treatment. CONCLUSION BZA can decrease the bone turnover in menopausal women to the level of before menopausal. It is safety and has good tolerance.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2007年第12期949-952,共4页
Chinese Pharmaceutical Journal
关键词
苯卓昔芬
骨指标
绝经
bazedoxifene
bone markers
postmenopausal
