应用阿仑膦酸钠治疗绝经后骨质疏松失效改用雷洛昔芬的疗效观察  

Efficacy of raloxifene in postmenopausal women with osteoporosis after 3 to 5 years treatment failure of alendronate

作　　者：陈琳[1] 游利[1] 陈瑾瑜[1] 潘凌[1] 彭永德[1] 

机构地区：[1]上海交通大学附属第一人民医院内分泌代谢科,上海200080

出　　处：《中华骨质疏松和骨矿盐疾病杂志》2015年第2期132-137,共6页Chinese Journal Of Osteoporosis And Bone Mineral Research

摘　　要：目的观察绝经后骨质疏松症患者应用阿仑膦酸钠治疗3~5年失效后改用雷洛昔芬的疗效。方法选取2005年10月至2013年10月在上海市第一人民医院骨质疏松门诊就诊的11 538例患者中符合条件的绝经后骨质疏松症患者240例作为受试者并分为2组：A组（155例）仅用雷洛昔芬治疗;B组（85例）阿仑膦酸钠治疗3~5年失效后改为雷洛昔芬治疗。所有患者均同时加用活性维生素D及钙剂。采用回顾性分析,记录受试者一般资料,用药时间,治疗前后骨密度（BMD）、骨转换指标（BTM）、是否有新发骨折等临床资料。结果 A组治疗12个月后,腰椎、股骨颈、全髋骨密度较治疗前均明显升高（t=10.778,P〈0.000 1;t=3.587,P〈0.000 1;t=7.998,P〈0.000 1）。腰椎、股骨颈及全髋骨密度较治疗前分别上升3.3%、1.5%及1.4%（均P〈0.05）。骨钙素（BGP）下降28.8%（t=6.392,P〈0.000 1）,Ⅰ型胶原羧基端肽（β-CTX）下降44.5%（t=13.078,P〈0.000 1）。B组应用雷洛昔芬治疗12个月后,腰椎、股骨颈、全髋骨密度较治疗前有上升趋势,但差异无统计学意义（t=1.093,P=0.277;t=1.896,P=0.061;t=1.045,P=0.299）。BGP及β-CTX治疗后年变化率较治疗前差异无统计学意义（t=1.608,P=0.112;t=1.621,P=0.109）。改用雷诺昔芬1年后,腰椎、股骨颈及全髋骨密度年变化率分别较换药前1年（即阿仑膦酸钠治疗最后1年）骨密度年变化率显著升高（t=3.729,P〈0.0001;t=2.191,P=0.031;t=2.929,P〈0.01）。A组腰椎、股骨颈及全髋骨密度年变化率均显著高于B组（t=5.756,P〈0.000 1;t=0.713,P〈0.000 1;t=0.736,P〈0.000 1）。结论雷洛昔芬能显著增加初次用药的绝经后骨质疏松症患者骨密度,降低骨转换;应用阿仑膦酸钠治疗3~5年后失效者改用雷洛昔芬可显著减慢骨丢失率。Objective To observe the efficacy of sequential therapy of raloxifene in postmenopausal women with osteoporosis after 3 to 5 years treatment of alendronate. Methods 240 eligible cases of postmenopansal women with oste- oporosis from il 538 patients selected according to the inclusion criteria in Shanghai first people＇s hospital between Octo- ber 2005 and October 2013 were collected. Subjects were divided into two groups （ A and B）. A group （ 155 cases） ： All patients newly initiated treatment with raloxifene. B group （85 cases） ： Patients with 3 to 5 years failure of alendronate treatment previously were switch to raloxifene. All patients received supplemental calcium and active vitamin D. A retro- spective statistical analysis was performed for basic clinical characteristics, duration of treatment, BTM, BMD and fracture data. Results BMD at lumbar spine, femoral neck and hip in the A group were significantly higher after raloxifene treatment for 12 months than that before treatment （t = 10. 778, P 〈0. 000 1 ; t =3. 587, P 〈0. 000 1 ; t =7. 998, P 〈0. 000 1 ）. The percent changes in BMD at the lumbar spine and femoral neck were 3.3% and 1.5% and 1.4 % （P 〈 0. 05）. There was a significant difference in the percent decrease in BGP and [3-CTX at 12 months （t =6. 392, P 〈0. 000 1 ; t = 13. 078, P 〈0. 000 1 ）. B group switched to raloxifene after 3 -5 years of alendronate treatment. BMD at lumbar spine, femoral neck and hip in the sequential therapy group were trend to be higher than that before treatment, but the difference was not statistically significant （ t = 1. 0931 P = 0. 277 ; t = 1. 896, P = 0. 061 ; t = 1. 045, P = 0. 299 ）. No statistically significant difference of annual change rate of BGP and 13-CTX was found after raloxifene treatment than before. However, the percentage changes in the BMD at lumbar spine and femoral neck were significantly higher after raloxifene treatment for 12 months than that before treatment （t=3.729, P〈0.000 1; t=2.191, P=O. 031;

关 键 词：绝经后骨质疏松症 雷洛昔芬 阿仑膦酸钠 骨密度 骨转换指标 

分 类 号：R681[医药卫生—骨科学]