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目的 观察阿伦膦酸钠对妇女原发性骨质疏松症的有效性和安全性。方法 2 5例原发性骨质疏松症妇女每日口服阿伦膦酸钠 10mg和元素钙 5 0 0mg(碳酸钙 )疗程 12月。通过双能X线吸收仪 (DEXA)、定量CT(QCT)、胫骨超声速率 (SOS)及生化指标观察治疗中及治疗后的骨量及骨转换的变化。结果 DEXA骨密度L2～ 4于治疗 3个月、6个月和 12个月时均较治疗前有显著升高 (P <0 0 1) ,升高率分别为 3 3 %、4 4%和 7 2 %。股骨近端骨密度也有升高 ;经QCT检查的腰椎 (L1～ 4 )骨密度于治疗 12个月时显著增加 (8 1% ,P <0 0 1) ;胫骨超声速率于治疗的 6个月、9个月和 12个月时较治疗前分别增加 1 4% (P <0 0 5 )、1 8% (P <0 0 1)和 1 4% (P <0 0 5 )。同时治疗中伴有骨转换指标的降低。未发现与药物有关的不良反应。结论 阿伦膦酸钠 10mg/d对绝经后妇女骨质疏松症有效和安全
Objective To observe the efficacy and safety of alendronate in women with primary osteoporosis. Methods Twenty-five women with primary osteoporosis were randomized to oral alendronate 10 mg and elemental calcium 500 mg (calcium carbonate) for 12 months. The changes of bone mass and bone turnover during and after treatment were observed by dual energy X-ray absorptiometry (DEXA), quantitative computed tomography (QCT), tibia sonicated rate (SOS) and biochemical parameters. Results The bone mineral density (DEXA) L2 ~ 4 was significantly increased at 3, 6 and 12 months after treatment (P <0.01), the rates of increase were 33% and 44% 7 2%. The BMD of the proximal femur also increased. The BMD of lumbar vertebrae (L1 ~ 4) after QCT examination increased significantly at 12 months (81%, P <0.01) (P <0.05), 18% (P <0.01) and 14% (P <0 05), respectively, before treatment at 9 months and 12 months. At the same time with the reduction of bone turnover indicators. No drug-related adverse events were found. Conclusion alendronate 10mg / d is effective and safe for postmenopausal women with osteoporosis