盐酸雷洛昔芬对绝经后女性骨密度、骨代谢及血脂的影响：一项在北京开展的随机临床试验

Effects of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in postmenopausal women: a randomized clinical trial in Beijing.

作者信息

Zheng Shurong, Wu Yiyong, Zhang Zhonglan, Yang Xin, Hui Ying, Zhang Ying, Chen Shuling, Deng Wenhui, Liu Hui, Ekangaki Abie, Stocks Jodie, Harper Kristine, Liu Jianli

机构信息

Department of Obstetrics and Gynaecology, Peking University First Hospital, Beijing 100034, China.

出版信息

Chin Med J (Engl). 2003 Aug;116(8):1127-33.

PMID:12935394

Abstract

OBJECTIVE

To determine the effects of raloxifene hydrochloride (RLX) on bone mineral density (BMD), bone metabolism markers and serum lipids in healthy postmenopausal women in Beijing.

METHODS

A multicenter, randomized, double-blind, placebo-controlled study was conducted in a total of 204 healthy postmenopausal women (age 59.5 +/- 5.0 years and weight 62.8 +/- 8.7 kg) treated with either RLX 60 mg (n = 102) or placebo (n = 102) daily for 12 months. BMD, serum lipids, and bone markers were measured before and after drug administration.

RESULTS

Compared with placebo, RLX produced a significant increase in both total lumbar spine and total hip BMD. For the lumbar spine, percentage increase in total BMD was 2.3% with RLX compared with a decrease of 0.1% with placebo (P < 0.001). Corresponding values for total hip BMD were a 2.5% increase for RLX and a 1.1% increase for placebo (P = 0.011). For biochemical markers of bone metabolism, serum osteocalcin and C-telopeptide, percentage decreases were 27.65% and 24.02% in RLX-treated subjects. Corresponding values in placebo were a 10.64% decrease and a 15.75% increase (RLX compared with placebo, both P < 0.001). For total cholesterol and low-density lipoprotein cholesterol levels, percentage decreases were 6.44% and 34.58% in the RLX-treated group. Corresponding values in placebo-treated patients were a 1.44% increase and a 19.07% decrease (RLX compared with placebo, both P < 0.001). No differences were found for high-density lipoprotein cholesterol or triglyceride levels between the two groups. Only 5 subjects discontinued early owing to an adverse event (3 in the RLX group and 2 in the placebo group).

CONCLUSIONS

This study confirms that RLX exerts positive effects on the skeleton, increasing BMD and decreasing biochemical markers of bone metabolism, and has a positive effect on the overall serum lipid profile in postmenopausal women in China.

摘要

目的

确定盐酸雷洛昔芬（RLX）对北京健康绝经后女性骨密度（BMD）、骨代谢标志物和血脂的影响。

方法

对总共204名健康绝经后女性（年龄59.5±5.0岁，体重62.8±8.7kg）进行了一项多中心、随机、双盲、安慰剂对照研究，她们被分为两组，一组每天服用60mg RLX（n = 102），另一组每天服用安慰剂（n = 102），持续12个月。在给药前后测量骨密度、血脂和骨标志物。

结果

与安慰剂相比，RLX使腰椎和全髋部骨密度均显著增加。对于腰椎，RLX组总骨密度增加了2.3%，而安慰剂组下降了0.1%（P < 0.001）。全髋部骨密度的相应数值为，RLX组增加了2.5%，安慰剂组增加了1.1%（P = 0.011）。对于骨代谢的生化标志物，血清骨钙素和C-末端肽，RLX治疗组的百分比下降分别为27.65%和24.02%。安慰剂组的相应数值分别为下降10.64%和上升15.75%（RLX与安慰剂相比，P均< 0.001）。对于总胆固醇和低密度脂蛋白胆固醇水平，RLX治疗组的百分比下降分别为6.44%和34.58%。安慰剂治疗患者的相应数值分别为上升1.44%和下降19.07%（RLX与安慰剂相比，P均< 0.001）。两组之间的高密度脂蛋白胆固醇或甘油三酯水平没有差异。只有5名受试者因不良事件提前停药（RLX组3名，安慰剂组2名）。