阿仑膦酸钠治疗绝经后骨质疏松症  

Effect of oral administration alendronate sodium for treatment of postmenopausal women with osteoporosis

作　　者：何耀华[1] 邱贵兴[1] 秦明伟[2] 金今[1] 余卫[2] 陈风领[3] 林守清[3] 

机构地区：[1]北京协和医院骨科,北京100730 [2]北京协和医院放射科,北京100730 [3]北京协和医院妇科内分泌组,北京100730

出　　处：《临床骨科杂志》2002年第3期185-188,共4页Journal of Clinical Orthopaedics

摘　　要：目的　探讨阿仑膦酸钠治疗绝经后骨质疏松症的临床疗效 ,评价其安全性。方法　 5 5例绝经后骨质疏松症患者作为期 1年的随机双盲、安慰剂平行对照研究 ;113例绝经后骨质疏松症患者作为期半年的开放前瞻性研究。用药半年比较治疗前后骨密度和药物的副作用。用双能量X线骨密度测量仪测定骨密度。结果　用药组治疗 1年时 ,腰椎骨密度、股骨颈骨密度分别平均增加 4 7%±3 0 %、1 4 %± 3 7% ,安慰剂组增加 0 1%± 4 1%、- 1 3%± 5 8% ,差异有显著性 (P <0 0 5 )。用药组骨转换指标Ca/Cr、Hop/Cr在 3个月时降低到最低点 ;ALP在 6个月时降低到最低点 (P <0 0 1)。在开放组中 ,腰椎骨密度、股骨颈骨密度平均分别增加 4 5 %± 4 3% (P <0 0 1)、1 5 %±5 2 % (P <0 0 1) ,用药前后差异有显著性。主要副作用为消化道反应 (13 3% )、其次为皮疹和头昏 ,均为轻度、一过性 ,继续用药后自然缓解。结论　阿仑膦酸钠治疗绝经后骨质疏松症有效并且安全。Objective To assess efficacy and safety of oral administration of alendronate sodium in treatment of postmenopausal women with osteoporosis. Methods One year randomized, double blind study was done among 50 postmenopausal women with osteoporosis; The changes were compared in bone mineral density(BMD)and adverse experience before and after 6 months of administration of alendronate sodium among another 113 postmenopausal women with osteoporosis. BMD was measured by dual energy X ray absorptionmetry (DEXA). Results Marked increase in BMD of the lumbar spine (4 7%± 3 0%), femoral neck (1 4%±3 7%)(each P< 0 05) after one year treatment versus 0 1%±4 1% and -1 3%±5 8% with placebo. Bone turnover decreased to a stable nadir over 3 months for resorption markers(Ca/Cr, urine HOP, P < 0 01) and over 6 months for formation marker (alkaline phosphatase, P <0 01) Through treatment for 6 months in other 113 postmenopausal women, BMD of the lumbar spine and femoral neck were increased significantly by 4 5%± 4 3%, (P < 0 01) and 1 5%±5 2%, (P <0 01). The safety profile of alendronate sodium was similar to that of placebo. There were no trends toward increased frequency of any adverse experience except for gastrointestinal symptoms (13 3%), vertigo (11 5%) and rash (11 5%), which were usually mild, transient, and resolved with continued treatment. Conclusion Alendronate is an efficacious and safe drug in treatment of postmenopausal osteoporosis.

关 键 词：治疗 阿仑膦酸钠 骨质疏松 骨密度 绝经后妇女 

分 类 号：R681[医药卫生—骨科学] R711.75[医药卫生—外科学]