利塞膦酸钠对绝经后骨质疏松症的疗效与安全性研究

Study of the effect and safety of risedronate sodium for treatment of postmenopausal women with osteoporosis

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.