利塞膦酸钠胶囊防治绝经后骨质疏松症的随机、双盲、安慰剂平行对照、多中心临床研究  

A randomized double-blind placebo-control clinical study of risedronate sodium in prevention or treatment for postmenopausal osteoporosis

作　　者：周日[1] 袁志[1] 刘建[1] 施宇翔[2] 王养维[3] 王长江[4] 王国新[5] 蔡辉[6] 郭郡浩[6] 黄立新[7] 沈忆新[8] 

机构地区：[1]第四军医大学西京医院骨科,西安710031 [2]第四军医大学西京医院麻醉科,西安710031 [3]陕西省人民医院内分泌科 [4]安徽医科大学第一附属医院内分泌科 [5]南京医科大学第一附属医院康复医学科 [6]南京军区南京总医院中西医结合科 [7]苏州大学附属第一医院骨科 [8]苏州大学附属第二医院

出　　处：《中国骨质疏松杂志》2010年第3期173-176,160,共5页Chinese Journal of Osteoporosis

摘　　要：目的评价利塞膦酸钠胶囊防治绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)的疗效及安全性。方法240名受试者随机等分入利塞膦酸钠组(A组)和安慰剂组(B组)。A组给予利塞膦酸钠胶囊+碳酸钙D3咀嚼片,B组给予安慰剂+碳酸钙D3咀嚼片,整个试验疗程为12个月。在治疗前、用药后6月末及12月末随访,通过对腰椎2～4骨密度(bone mineral density,BMD)、髋部BMD的测量及骨代谢生化指标:血骨钙素(osteocalcin,OCN)和尿Ⅰ型胶原氨基末端肽/肌酐(urine cross-linked N-telopeptide of collagen typeⅠ/creatine,NTX/Cr)的检测,对有效性进行评估;在治疗前、3月末、6月末和12月末随访,通过对一般体征、心电图、血常规、尿常规、肝功能、肾功能的观察对安全性进行评估。结果治疗结束后,腰椎2～4BMD变化率A组增高8.28%±13.79%,B组增高4.09%±14.60%,组间有统计学差异(P<0.05);髋部BMD变化率A组增高8.49%±15.58%,B组增高6.84%±18.34%,组间无统计学差异(P>0.05)。血OCNA组下降2.94±4.73ng/ml,B组下降0.53±3.90ng/ml,组间比较有统计学差异(P<0.01);尿NTX/CrA组下降9.38±65.93nMBCE/mMCR,B组升高3.59±59.86nMBCE/mMCR,组间比较有统计学差异(P<0.05)。治疗期间,A组发生新骨折8例,发生率7.84%;B组6例,发生率5.76%,组间差别无统计学意义(P>0.05)。试验过程中未发生与药物有关的严重不良事件。结论利塞膦酸钠胶囊能够有效提高绝经后骨质疏松症妇女的骨密度,抑制骨吸收,降低骨转换,不良反应少,用于防治PMOP安全有效。Objective To evaluate the efficacy and safety of risedronate sodium in prevention or treatment of postmenopausal osteoporosis（PMOP）. Methods 240 postmenopausal women with low bone mineral density （BMD） were randomly classified into two groups. 120 cases in group A were treated by risedronate sodium 5 mg with calcium 0. 5 g and vitamin D 200 IU daily, and 120 women in group B received the same treatment as that in group A except that placebo was given instead of risedronate sodium. Duration of the study was limited to 12 months. The efficacy of the treatment was evaluated by BMD measurements at spine and hip at the 12^th month of the treatment, as well as by the measurement of bone turnover marks. Results After 1 year treatment, BMD in the lumbar vertebrae and hip was significantly increased in group A compared to the baseline and that in group B. Bone turnover marks decreased significantly in group A, which did not in group B. Conclusion Risedronate sodium is effective and safe in the treatment of postmenopausal osteoporosis without severe side effect.

关 键 词：利塞膦酸钠 骨质疏松 骨密度 

分 类 号：R589.9[医药卫生—内分泌]