阿仑膦酸钠治疗绝经后妇女骨质疏松症的临床研究

Clincal Study of Alendronate Sodium in the Treatment for Postmenopausal Osteoporosis

目的:评价阿仑膦酸钠治疗绝经后妇女骨质疏松症的疗效及安全性。方法:选择120个病例,试验组和对照组按1∶1比例分配,每组各60例:试验组为阿仑膦酸钠加钙尔奇D600;对照组为安慰剂加钙尔奇D600。所有入组的患者进入12个月的双盲期治疗。结果:12个月时试验组和对照组的腰椎总骨密度变化率分别为-9.64%和-13.15%,两组比较差异有统计学意义(P<0.05)。用药12个月后,试验组血骨钙素下降5.07ng/ml,对照组下降2.41ng/ml,两组比较差异有统计学意义(P<0.05);用药12个月后,试验组血C端交联多肽下降0.12ng/ml,对照组下降0.01ng/ml,两组比较差异有统计学意义(P<0.05)。治疗期间,两组胸椎和腰椎侧位X线检查均无新的椎体骨折发生,未发生其他部位确切骨折,未发生严重不良事件。结论:阿仑膦酸钠能明显抑制骨吸收作用,减少腰椎骨量的丢失,且不良反应较少,是绝经后妇女一种理想的预防和治疗骨质疏松症的药物。

Objective： To evaluate the clinical therapeutic effect and safety of alendronate sodium（ALN） in the treatment for postrnenopausal osteoporosis. Methods： 120 postmenopausal women with osteoporosis were enrolled, who were randomly divided into 2 groups according to 1 ： 1 ratio. The experimental group was given ALN and Caltrate D600, the control group was given placebo and Caltrate D6（X）. All of the patients were received double blind treatment for 12 months. Results：At the 12th month, the change rate of total bone mineral density in lumbar spine was -9.64% and - 13.15% respectively in experimental group and control group. 12 months later, the serum osteocal- cin in experimental group was decreased 5.07 ng/ml, and in control group was decreased 2.41 ng/ml（ P〈 0.05）, C - terminal crosslinkJng polypeptide in experimental group decreased 0.12 ng/ml,and in control group decreased 0.01 ng/ml（ P 〈 0.05）. There was no new spine bone fracture in lateral projection of lumba＇r vertebrate and thoracic vertebrae in two group, while there was no bone fracture in other site. No serious adverse effects were observed during the trial. Conclusions：Alendronate sodium can obviously inhibit bone resorption, reduce the loss of bone mass in lumbar spine. It has less adverse effects. It is a desirable prophylactic and treatment drug of osteoporosis in postmenopausal women.