利塞膦酸钠治疗绝经后骨质疏松症骨转换标志物的变化

目的:通过利塞膦酸钠(RIS)治疗绝经后骨质疏松症,观察其对骨转换标志物的影响。方法:采用多中心、随机、双盲、安慰剂对照试验方法,RIS组118例,口服RIS5mg/d,安慰剂组119例,口服安慰剂1片/d。所有受试者均加凯思立D(含元素钙500mg和维生素D200IU)1片/d,治疗12个月。于治疗前、治疗后6个月和12个月测定血浆骨钙素(BGP)和空腹尿Ⅰ型胶原交联N端肽(NTX)。结果:RIS组血BGP治疗后6个月和12个月均下降(P<0.01),安慰剂组治疗后血BGP无明显变化(P>0.05),2组间治疗后比较差异有统计学意义(P<0.01)。RIS组尿NTX治疗后6个月和12个月均下降(P<0.01),安慰剂组尿NTX治疗后6个月无明显变化(P>0.05),12个月下降(P<0.05)。2组间治疗后比较差异有统计学意义(P<0.01)。结论:RIS能抑制骨吸收,降低骨转换。

Effects of Risedronate Sodium on Bone Turnover Markers in Women with Postmenopausal Osteoporosis

Objective : To observe the effects of Risedronate(RIS) on bone turnover markers in women with postmenopausal osteoporosis. Methods: A multicenter,randomized,double-blind and placebo controlled clinical trial was used in the study. Two hundreds and thirty-seven women with postmenopausal osteoporosis were divided into two groups,which were RIS group (n = 118) and placebo group(n = 119). Both groups of cases were treated with RIS 5 mg and placebo daily respectively for 12 months. Meanwhile,all of women in both groups were treated with calcium 0.5 g-vitamin D 200 IU daily for 12 months. Serum BGP and urine NTX were determined before,6 months after the treatment and at the end of study. Results: Serum BGP and urine NTX were significantly decreased in RIS group(P < 0.01) while placebo group had no obvious changes except that urine NTX decreased significantly after 6 and 12-month treatments(P < 0.05). There were statistical significance of serum BGP and urine NTX between two groups after the treatment. Conclusion: RIS can inhibit bone resorption and decrease bone turnover.