摘要
为了解阿伦膦酸盐对骨密度的影响及其安全性和耐受性,对20名绝经后骨质疏松的妇女中进行阿伦膦酸盐(alendronate)10mg/天和安慰剂的随机、双盲、前瞻性研究,为期一年。结果显示,1年后阿伦膦酸盐组与安慰剂组相比,骨密度平均增长率:椎骨分别为4.87%与-0.23%;股骨颈分别为6.89%与-1.84%,(P<0.05)。副反应仅为轻微胃肠道反应。结论:阿伦膦酸盐能有效增加骨密度,且药物安全。
Objectives: To observe the safety,efficacy and tolerability of alendronate 10 mg/day for 12 months to postmenopausal women with osteoporosis. Design: A randomized double blind prospective study was performed on postmenopausal women with osteoporosis. Subjects: 20 women with low bone mass(L 2-4 <0.980 g/m 2),were recruited. Methods: Participants were randomly assigned to oral alendronate 10 mg or placebo once daily for 12 months.All patients and investigators remained blind to treatment assignment until completion of the study.BMD were measured pretreatment and during treatment 3,6 and 12 months.Adverse effects were observed. Results: At 12 months,the mean BMD increase in the Alendronate groups were greater than in the placebo groups(4.87% vs -0.23%, P <0.05) at the lumber spine,and (6.89% vs -1.84%, P < 0.05 )at the femoral neck.The adverse effects of upper gastrointestinal tract in both groups were also similar and mild. Conclusion: Alendronate is a safe,effective and well tolerable therapy for postmenopausal osteoporosis.
出处
《生殖医学杂志》
CAS
1999年第1期11-14,共4页
Journal of Reproductive Medicine
关键词
阿伦膦酸盐
骨质疏松
骨密度
绝经后
Alendronate Osteoporosis Bone mineral density Postmenopause