雷洛昔芬对绝经后妇女骨密度、骨代谢生化指标和血脂影响的随机对照研究

被引:11
作者
郑淑蓉
吴宜勇
张忠兰
杨欣
惠英
张颖
陈淑玲
邓文慧
刘慧
Abie Ekangaki
Jodie Stocks
Kristine Harper
刘建立
不详
机构
[1] 北京大学第一医院妇产科
[2] 卫生部北京医院妇产科
[3] 解放军总医院妇产科
[4] 美国礼来公司
关键词
绝经后期; 雷洛昔芬; 骨密度; 脂类;
D O I
暂无
中图分类号
R969 [临床药理学];
学科分类号
100602 ; 100706 ;
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
引用
收藏
页码:37 / 40
页数:4
相关论文
共 14 条
[1]  
Effects of raloxifene hydrochloride on the endometrium of postmenopausal women. Boss SM,Huster WJ,Neild JA,et al. American Journal of Obstetrics and Gynecology . 1997
[2]  
Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. Delmas PD,Bjarnason NH,Mitlak BH,et al. The New England Journal of Medicine . 1997
[3]  
In search of optimal long-term female hormone replacement: the potential of selective estrogen receptor modulators. Mitlak BH,Cohen FJ. Hormone Research . 1997
[4]  
Hormone replacement therapy for osteoporosis: clinical and pathological aspects. Compston JE. Reproductive Medicine Review . 1994
[5]  
Management of abnormal bleeding in women receiving hormone replacement therapy. Spencer CP,Cooper AJ,Whitehead MI. British Medical Journal . 1997
[6]  
Long-term effects of raloxifene on bone mineral density, bone turnover, and serum lipid levels in early postmenopausal women: three-year data from 2 double-blind,randomized, placebo-controlled trials. Johnston CC,Bjarnasona NH,Cohen FJ,et al. Archives of Internal Medicine . 2000
[7]  
Raloxifene and cardiovascular events in osteoporotic postmenopausal women: four-year results from the MORE (Multiple Outcomes of Raloxifene Evaluation)randomized trial. Barrett-Connor E,Grady D,Sashegyi A,et al. The Journal of The American Medical Association . 2002
[8]  
Patient-specific decisions about hormone replacement therapy in postmenopausal women. Col NF,Eckman MH,Karss RH,et al. The Journal of The American Medical Association . 1997
[9]  
The effect of raloxifene on risk of breast cancer in postmenopausal women.Results from the MORE randomized trial. Cummings SR,Eckert S,Krueger KA,et al. The Journal of The American Medical Association . 1999
[10]  
Treatment of established postmenopausal osteoporosis with raloxifene: a randomized trial. Lufkin EG,Whitaker MD,Nickelsen T,et al. Journal of Bone and Mineral Research . 1998