利塞膦酸钠治疗绝经后骨质疏松症的疗效及安全性  

Effect and Safety of Oral Administration Residronate Sodiumfor Treatment of Postmenopausal Women with Osteoporosis

作　　者：张众志[1] 李裕明[1] 陈璐璐[1] 

机构地区：[1]华中科技大学同济医学院附属协和医院内分泌科,武汉430022

出　　处：《实用医学进修杂志》2006年第4期227-232,共6页Journal of Practical Training of Medicine

摘　　要：目的：探讨利寒膦酸钠治疗绝经后骨质疏松症的临床疗效，并评价其安全性。方法：54例绝经后骨质疏松症患者采取随机双盲、安慰剂平行对照方式进行12个月的药物研究，以双能量X线骨密度测量仪比较治疗前后0月，6个月，12个月腰椎及髋部骨密度（BMD）改变，检测骨代谢标志物血Ca、ALP、BGP及尿NTX在治疗前后的变化，并监测血尿常规、肝肾功能、心电图、X线等药物安全性指标，记录不良事件。结果 腰椎（L2-4）BMD增加6个月时增加3．29±1．18％，12个月时为4．51±1．64％而对照组分别为-0．62±0．24％和0．48±0．18％，股骨颈、大转子和Wards三角区骨密度骨密度改变药物组和对照组无显著差异；反映骨形成标记物ALP和BGP6个月和12个月时药物组显著降低，骨吸收标记物NTx在6月和12月较治疗前显著降低（P〈0．01）。主要不良反应为消化道反应2例（7．1％）、皮肤搔痒、皮疹2例（7．1％）和血尿1例（3．6％），均能缓解。结论：利塞膦酸钠治疗绝经后骨质疏松症有显著疗效，骨转换显著抑制，并显示该药物良好的安全性。Objective：To evaluate the effect and safety of oral administration of residronate sodium in treatment of postmenopausal women with osteoporosis. Methods：One year randomized , double blind study was done among 54 postmenopausal women with osteoporosis; The changes were compared in bone mineral density（BMD） , bone metabolism markers and adverse events after 12 months oral administration of Residronate sodium. BMD was measured by dual energy X - ray absorptionmetry （DEXA） and osteal - metabolize marker was analyzed. Results：Marked increase in BMD of the lumbar spine （3.29 ± 1. 18% , 4.51 ± 1.64% ） after 6 and 12 months treatment versus with placebo（ -0.62 ± 0.24% ,0.48 ± 0.18% ） ; Bone turnover decreased to a stable nadir over 6 and 12 months for resorption markers （ NTx, P 〈 0.05） and over 12 months for formation marker （ALP, P 〈 0.05 ;BGP,P 〈0.05） . The safety profile ofresidronate sodium was similar to that of placebo. There were no trends toward increased frequency of any adverse experience except for gastrointestinal symptoms （7. 1 % ） , rash （ 7.1% ） and hematuria（ 3.6% ） , which were usually mild , transient , and resolved with continued treatment . Conclusion： Residronate is an efficacious and safe drug in treatment of postmenopausal osteoporosis.

关 键 词：利塞膦酸钠 骨质疏松症 绝经后 骨密度 

分 类 号：R681[医药卫生—骨科学]