阿仑膦酸钠肠溶片预防和治疗绝经后妇女骨质疏松症的疗效及安全性分析  

Alendronate Sodium Enteric-coated Tablets in Prevention and Treatment of Osteoporosis in Postmenopausal Women

作　　者：李锦军[1] 宋艳霞[1] 王志义[1] 

机构地区：[1]首都医科大学附属北京友谊医院骨科,北京市100050

出　　处：《中国全科医学》2008年第20期1829-1831,共3页Chinese General Practice

摘　　要：目的评价阿仑膦酸钠肠溶片治疗绝经后妇女骨质疏松症的临床疗效及安全性。方法选择我院收治的绝经后骨质疏松症妇女84例,随机分为3组,每组28例,A组给予阿仑膦酸钠肠溶片10 mg/d,B组给予阿仑膦酸钠片10 mg/d,C组给予阿仑膦酸钠肠溶片70 mg/周。3组患者在此基础上加服钙尔奇D600,疗程均为6个月。观察3组患者治疗前后骨密度、血骨钙素(BGP)、C端交联多肽(CTX)水平及新骨折发生情况,同时观察不良反应。结果3组患者疗效(骨密度改善情况)间差异无统计学意义(P=0.43);治疗后3组患者的BGP、CTX水平间差异均无统计学意义(P>0.05);3组患者消化系统不良反应发生率间差异无统计学意义(P>0.05)。治疗期间3组均无新骨折发生,无严重不良事件发生。结论阿仑膦酸钠肠溶片治疗绝经后妇女骨质疏松症临床疗效与阿仑膦酸钠片无差异,消化系统不良反应发生率间亦无差异。Objective To assess the clinical efficacy and safety of alendronate sodium enteric-coated tablets in treatment of ostroporosis in postmenopausal women.Methods A Six-month randomized,double-blind,three-simulation,masculine drug study was done on 84 postmenopausal women with osteoporosis.The patients were divided by 1:1:1 into three groups,28 in each.Group A were treated with enteric-coated tablets of alendronate sodium 10mg/d,group B with conventional tablets of alendronate sodium 10mg/d,group C with enteric-coated tablets of alendronate sodium 70mg/week.On this basis,all patients were given additional calcium D600 daily at the same time.The treatments lasted 6 months.Then bone mineral density(BMD),serum bone gla protein(BGP) and C-terminal cross-linking polypeptide(CTX) were measured to evaluate its efficacies and side effects,and the liver and kidney function were observed by autonomic analysis to assess its safety.Results After six-month treatment,BMD of the lumbar spines increased,and serum BGP and CTX decreased in all groups,but there was no significant difference between them(P>0.05).No more fractures occurred,and no serious side-effects were noted during treatment.Conclusion Enteric-coated tablets of alendronate sodium have the same clinical effects as its conventional tablets in treatment of osteoporosis in Chinese postmenopausal women.There is no difference in incidence rates of side-effects between them,which may mean that too few cases were included in this study.It needs a further research.

关 键 词：阿仑膦酸钠肠溶片 骨质疏松 绝经后 骨密度 

分 类 号：R[医药卫生]