利塞膦酸钠片防治绝经后骨质疏松症的有效性和安全性

目的评价利塞膦酸钠(抗绝经后妇女骨质疏松症)防治绝经后骨质疏松症的疗效和安全性。方法223名绝经后妇女随机分为试验组和对照组,分别给予利塞膦酸钠每日5 mg或安慰剂,同时2组均每日加碳酸钙D3咀嚼片1片,随访12个月。结果与安慰剂相比,利塞膦酸钠使腰椎骨密度(BMD)显著升高,治疗后试验组血清骨钙素(BGP)和尿-型胶原交联氨基端肽(NTx)值分别降低31.8%和56.3%,与治疗前比较差异有非常显著性(P<0.01),而对照组无变化,2组比较差异有非常显著性(P<0.01)。用药后12个月,试验组总有效率和显效率均高于对照组(P<0.05)。结论利塞膦酸钠每日5 mg可以防止绝经后的骨丢失,降低骨转换,改善骨密度,是治疗绝经后妇女骨质疏松症的有效和安全的药物。

Efficacy and safety of risedronate in the prevention and treatment of postmenopausal osteoporosis

Objective To evaluate the efficacy and safety of risedronate in the prevention and treatment of postmenopausal osteoporosis.Methods A total of 223 women were randomly divided into test(risedronate 5 mg once daily)group and control(placebo)group,in addition,all women received supplemental calcium and vitmine D for 12 months.Re- suits The bone mineral density(BMD)at spine and proximal femur in- creased in test group compared with the control.Serum bone Gla protein (BGP)and uriary cross-linked N-telopepitide of type 1 collagen (NTx)decreased 31.8 % and 56.3 % at the end of the study,compared with those at the beginning.However,this was not found in control group.Furthermore,significant differences were found in BGP and NTx between the two groups.The test group obtained higher efficacy than that in the control.Conclusion This study confirms that risedronate at dose of 5 mg once daily exerts positive effects on the skeleton,increasing BMD and decreasing biochemical markers of bone turnover in postmenopausal women.