阿仑膦酸钠普通片和肠溶片对绝经后女性骨质疏松骨代谢作用的比较

目的:比较阿仑膦酸钠(ALN)普通片和肠溶片对绝经期后女性骨质疏松骨代谢的作用。方法:计划入组240例绝经后女性患者,1∶1随机分成两组,分别以ALN普通片和肠溶片联合钙剂治疗6个月,用DEXA测定治疗前后的腰椎总骨密度值,用酶联免疫吸附法测定治疗前后的血清骨钙素(OC)和血清Ⅰ型胶原C端肽(CTX-Ⅰ)的浓度,考察治疗前后骨密度值的变化率和骨代谢标志物OC和血清CTX-Ⅰ的水平变化,评价两制剂的治疗效果是否有差异。结果:ALN普通片组和肠溶片组骨密度的变化率分别增长(4.03±8.21)%和(4.90±7.41)%,OC分别下降(3.42±7.20)和(4.33±5.54)ng.mL-1,血清CTX-Ⅰ分别下降(0.24±0.33)和(0.26±0.28)ng.mL-1。结论:两种制剂对绝经期后女性骨质疏松均有较好效果,同期比较两种制剂对绝经期后女性骨质疏松骨密度变化率的增长作用及对骨代谢标志物OC和血清CTX-Ⅰ的降低作用均无统计学差异。

Comparison of bone metabolism in Chinese women with postmenopausal osteoporosis after alendronate sodium compressed tablets and alendronate enteric-coated tablets treatment

Objective:To compare the effects of alendronate compressed tablets and alendronate enteric-coated tablets on bone metabolism in Chinese women with postmenopausal osteoporosis.Methods:In a randomized trial,240 women with postmenopausal osteoporosis were enrolled,and divided into 2 groups.The patients in compressed tablets group(n=99) were treated with alendronate sodium compressed tablets combined with calcium for 6 months.The patients in enteric-coated tablets group(n=102) were treated with alendronate sodium enteric-coated tablets combined with calcium for 6 months.Chang rate of total bone mineral density in lumbar spine 6 months later after alendronate treatment was assessed by DEXA.The serum levels of OC and CTX were measured and analyzed before and 6 months after treatment to evaluate the difference between the 2 alendronate preparations.Results:In compressed tablets group,the change rate of total bone mineral density in lumbar spine 6 months after alendronate treatment was(4.03±8.21)%,and serum levels of OC and CTX significantly reduced(3.42±7.20) and(0.24±0.33) ng·mL-1,respectively.In enteric-coated tablets group,the change rate of total bone mineral density in lumbar spine 6 months after alendronate treatment was(4.90±7.41)%,and serum levels of OC and CTX significantly reduced(4.33±5.54) and(0.26±0.28) ng·mL-1,respectively.Conclusions: The two alendronate preparations can significantly improve the bone metabolism in Chinese women with postmenopausal osteoporosis.No differences were observed in values of the 3 indicators including change rate of total bone mineral density in lumbar spine,serum levels of OC and CTX between the two groups.