基础医学与临床 ›› 2007, Vol. 27 ›› Issue (2): 174-177.

• 研究论文 • 上一篇    下一篇

阿仑磷酸钠对绝经后骨质疏松症的疗效与耐受性研究

孟迅吾 李梅   

  1. 北京协和医院内分泌科 北京协和医院内分泌科
  • 收稿日期:2006-02-16 修回日期:2006-06-30 出版日期:2007-02-25 发布日期:2007-02-25
  • 通讯作者: 李梅

efficacy and tolerability of alendronate daily in Chinese postmenopausal osteoporotic women

  

  • Received:2006-02-16 Revised:2006-06-30 Online:2007-02-25 Published:2007-02-25

摘要: 目的 评价阿仑膦酸钠对改善中国绝经后骨质疏松症患者骨密度和骨转换指标的疗效与耐受性。方法 对274例绝经后骨质疏松症妇女进行前瞻性、多中心、自身前后对照研究。患者年龄49~82(平均65.0±6.3)岁,绝经年限3~34(平均15.3±6.8)年。予日服阿仑膦酸钠10mg及元素钙500mg,疗程6个月,观察腰椎及髋部骨密度、身高、骨转换生化指标~尿I型胶原氨基末端肽/肌酐(NTX/Cr)、血钙、磷、碱性磷酸酶浓度、肝肾功能及不良反应,以判断药物的疗效和耐受性。用双能X线骨密度仪测量骨密度,用酶联免疫吸附法测量尿NTX/Cr,用自动分析仪检测生化指标。结果 阿仑膦酸钠治疗6个月后,患者腰椎2-4、股骨颈、Ward's三角及大转子骨密度显著增加,增幅分别达4.1%、2.5%、3.3%及2.4%(均P<0.001)。治疗后血碱性磷酸酶及尿NTX/Cr浓度快速、显著下降,降幅达31.6%和26.7%(P<0.001)。患者身高无明显改变,仅1例外伤后足趾骨新发骨折,钙磷水平、血尿常规及肝肾功能在正常范围内波动,12例(4.4%)出现与治疗有关的腹胀、返酸、腹痛等轻度胃肠道反应。结论 阿仑膦酸钠是治疗中国绝经后骨质疏松症安全而有效的药物。

Abstract: Objective: To observe the efficacy and tolerability of a daily alendronate in improving bone mineral density (BMD) and bone turnover markers in Chinese osteoporotic women. Subjects and methods:274 Chinese osteoporotic women, 49-82 years old with more than 3 years of menopause period were included. 10mg Alendronate and 500mg calcium were prescribed daily. The bone mineral density (BMD, by Lunar DPX-L,Norland XR-36 or Hologic QDR-2000), urine NTX/Cr(by Elisa, kit of Osteomark, USA), serum calcium, phosphate and alkaline phosphatase levels(by autonomic analysis) were measured to evaluate the efficacy. The side effects, liver and kidney function (by autonomic analysis) were observed to assess the tolerability. Results: BMD at Lumbar 2-4, Neck, Wards and Trochanter sites were increased significantly by 4.1%, 2.5%, 3.3% and 2.4% respectively(P<0.001). Urine NTX/Cr and alkaline phosphatase levels decreased by 31.6% and 26.7%(P<0.001 vs baseline). It indicated that Alendronate effectively inhibited bone turnover. Body height of patients had no change. Except one case with foot phalange fracture caused by a trauma, no new fracture occurred during treatment. Blood and urine routine test, liver and kidney function were all in normal ranges. Mild upper gastrointestinal side effects were found in 4.4% cases possibly related to Alendronate. Conclusion: Alendronate was effective and well tolerated in Chinese postmenopausal osteoporotic women.