利塞膦酸钠防治绝经后骨质疏松症

Effects of risedronate on women with postmenopausal osteoporosis

目的评价利塞膦酸钠对绝经后骨质疏松症的防治.方法 212例绝经后骨量减少及骨质疏松妇女,随机分成试验组105例和对照组107例.试验组患者每天服用利塞膦酸钠5 mg+元素钙500 mg+维生素D 200IU;对照组每天服用安慰剂+元素钙500 mg+维生素D 200IU.治疗时间1年.观察内容:骨痛、尿N肽端交联I型胶原(NTX/Cr)、血清骨钙素(BGP)、骨密度(BMD)、不良反应及椎体和椎体外新骨折.结果与用药前比较,试验组骨痛症状均有不同程度改善,骨代谢指标(NTX/Cr、BGP)均明显下降( P＜ 0.05),腰椎和髋部骨量均有显著上升( P＜ 0.05),L2～4骨密度上升6.667%,股骨颈骨密度上升3.412%,大转子骨密度上升4.131%;对照组无明显变化.各组均未见明显不良反应.结论利塞膦酸钠能有效地防治绝经后骨质疏松症.

Objective To determine the efficacy of risedronate in the prevention and treatment of postmenopausal osteoporosis. Methods 212 postmenopausal women with low bone mineral density （BMD） were randomly classified into two groups. 105 eases in group A were treated by risedronate 5 mg with calcium 0.5 g and vitamine D 200IU daily,and 107 women in group B received the same treat- mont as that in group A except that placebo was given in stead of risedronate. Duration of the study was limited to 12 months. The efficacy of the treatment was evaluated by BMD measurements at spine and hip at the 12th month of the treatment,as well as by the measurement of bone turnover marks. Results After one year treatment, BMD in the lumbar vertebrae and hip was significantly increased in group A compared to the baseline and that in group B. Bone turnover marks decreased signifieantly in group A,whieh did not in group B. Conclusion Risedronate produced greater gains in BMD,and greater reduetions in markers of bone turnover,and is an effective and well-tolerated agent for the treatment of postmenopausal osteoporosis.