摘要
目的评估利塞膦酸钠对绝经后骨质疏松症的疗效与安全性。方法48例绝经后骨质疏松症患者采用随机、双盲、安慰剂对照进行12个月的研究,随机分为:治疗组(24例):每日服用利塞膦酸钠片5mg+凯思立D1片;对照组(24例):每日服用与利塞膦酸钠外观一样的安慰剂+凯思立D1片。用双能量X线骨密度测量仪比较治疗前后腰椎及髋部骨密度(BMD)改变,同时检测骨代谢生化指标血BGP、ALP及尿NTX在治疗前后的变化。结果治疗组服药后6个月和12个月腰椎BMD明显增加,与治疗前相比差异有显著性(P<0.05);而对照组治疗后6个月及12个月腰椎BMD稍增加,但与治疗前比较差异无显著性(P>0.05);治疗组股骨颈BMD治疗后12个月明显增加,与治疗前比较差异有显著性(P<0.05)。治疗组反映骨形成标记物BGP和ALP治疗后6个月与12个月均明显降低,与治疗前比较差异有显著性(P<0.01);治疗组反映骨吸收标记物NTX治疗后6个月及12个月较治疗前明显降低(P<0.01);而对照组BGP、ALP及NTX下降不明显,两组治疗后BGP、ALP及NTX同期比较差异有显著性(P<0.01)。主要不良反应为消化道反应1例,低钙血症1例。结论利塞膦酸钠能够增加绝经后骨质疏松症患者骨密度,显著降低骨转换率,抑制骨吸收,不良反应少,具有很好的安全性。
[Objective] To eveluate the effect and safety of risedronate sodium(RID)on postmenopausal women with osteoporosis.[Methods] One year randomized,double blind place-bo controlled study was conducted among 48 postmenopausal women with osteoporosis.The bone mineral density(BMD),bone metabolism markers and adverse events were compared before and after given RID or placebo.Twenty-four patients with postmenopausal osteoporosis were treated with RID.The control group(24 cases)were treated with placebo.Both two groups were given calcium carbonate(0.5g)and victamine D3(200IU)everyday.BMD was measured by dual energy X-ray absorptionmetry(DEXA)and osteal mentabolize markers were analyzed.[Results] Remarkable increase in BMD of the lumbar spine was found after 6 and 12 months treatment(P 〈0.05).BMD of the femoral neck increase after 12 months treatment(P 〈0.05).The resorption markers of bone NTX turnover decreased to a stable nadir over 6 and 12 month than the control group(P 〈0.01).The formation marker of bone decreased significantly in the treatment group than the control group(P 〈0.01).The main side effect was gastrointestinal symptoms 1 case,hypocalcemia 1 case.[Conclusion] Risedronate produced greater gains in BMD,and greater reductions in markers of bone turnover.It is an effective and safe medicine for the treatment of postmenopausal Osteoporosis.
出处
《中国现代医学杂志》
CAS
CSCD
北大核心
2007年第14期1729-1732,共4页
China Journal of Modern Medicine
关键词
利塞膦酸钠
骨密度
骨代谢
绝经后骨质疏松症
risedronate sodium
bone density
bone metabolism
postmenopausal osteoporosis