【摘要】 目的　确定盐酸雷洛昔芬 (RLX)对中国绝经后妇女骨密度、骨代谢生化指标及血脂的影响。方法　将来自 3所医院的 2 0 4例绝经后妇女 [平均年龄 (6 0± 5 )岁 ,平均体重 (6 3± 9)kg]随机分组 ,进行双盲安慰剂对照的临床研究 ,受试者每天接受RLX 6 0mg(n =10 2 ,RLX组 )或安慰剂 (n =10 2 ,安慰剂组 )治疗 12个月 ,并于服药前及服药 12个月后各进行一次骨密度、骨代谢生化指标及血脂的测定。结果　与安慰剂相比 ,RLX使腰椎和髋部骨密度显著升高 ,RLX组腰椎的骨密度增加2 30 % ,而安慰剂组降低 0 0 8% ,两组比较 ,差异有极显著性 (P <0 0 0 1) ;RLX组髋部骨密度增加2 4 6 % ,安慰剂组增加 1 0 7% ,两组比较 ,差异有显著性 (P <0 0 5 )。RLX组骨代谢生化指标血清骨钙素和血清C端交联肽分别降低 2 7 6 %和 2 4 0 % ,而安慰剂组则分别降低 10 6 %和升高 15 8% ,两组比较 ,差异有极显著性 (P <0 0 0 1)。RLX组总胆固醇和低密度脂蛋白胆固醇分别降低 6 4 %和34 6 % ,而安慰剂组则分别升高 1 4 %和降低 19 1% ,两组比较 ,差异有极显著性 (P <0 0 0 1)。两组间高密度脂蛋白胆固醇和甘油三酯水平未见差异。仅有 5例因不良事件而提前退出研究 (RLX组 3例 ,安慰剂组 2例 )。结论　RLX能增加绝经后中国妇女更多还原

【Abstract】 Objective To determine the effect of raloxifene hydrochloride (RLX) on bone mineral density (BMD),biochemical markers of bone metabolism and lipid metabolism in Chinese postmenopausal women. Methods This was a multicenter,randomized,double blind placebo controlled study in China with a total of 204 postmenopausal women [mean age (60±5) years ( ±s ) and weight (63±9) kg ( ±s )] treated with either RLX 60 mg ( n =102) or placebo ( n =102) daily for 12 months. BMD,serum lipid and bone markers were determined before and after drug administration. Results Compared to 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 2.30% with RLX compared to a decrease of 0.08% with placebo ( P <0.001 ). Corresponding values for total hip BMD were 2.46% increase for RLX and 1.07% for placebo ( P <0.05) . For biochemical markers of bone metabolism,serum osteocalcin and C-telopeptide,percentage decrease were 27.6% and 24.0% in raloxifene-treated subjects. Corresponding values in placebo were 10.6% decrease and 15.8% increase (RLX compared to placebo,both P <0.001 ). For total cholesterol and low-density lipoprotein cholesterol,percentage decrease were 6.4% and 34.6% in the raloxifene-treated group. Corresponding values in placebo were 1.4% increase and 19.1% decrease (RLX compared to 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 due 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 decreased total cholesterol and low-density lipoprotein cholesterol in postmenopausal women in China.更多还原