利塞膦酸钠不同给药方式治疗男性骨质疏松症疗效分析

Efficacy and tolerability of risedronate under different administration ways in the treatment of male osteoporosis

目的 观察利塞膦酸钠不同给药方式在男性骨质疏松症治疗中的疗效和耐受性。方法 共纳入72例男性骨质疏松症患者,其中38例为口服利塞膦酸钠每日5 mg;34例为每周35 mg口服,随访1年。分别测定两组患者治疗前后L1-L4椎体骨密度值和骨转化指标,并观察两组骨质疏松性骨折的发生率及服药后的不良反应。结果 口服利塞膦酸钠治疗后,患者L1-L4椎体和股骨颈的骨密度值较治疗前上升显著,每日口服组和每周口服组间比较无统计学差异（P〉0.05）;两组间的骨转化指标和骨折发生率亦无统计学差异。结论 观察口服利塞膦酸钠治疗后1年,每周口服35 mg与每日口服5 mg比较,均能有效地提高骨质量。

Objective To evaluate the efficacy and tolerability of risedronate under different administration ways in the treatment of male osteoporosis（MOP）. Methods Seventy-two elderly osteoporosis men were divided into daily group（n =38） orweekly group（n =34） that received oral risedronate 5 mg daily or 35 mg once a week, respectively, for one year. The subject＇s bone mineral density（BMD） and bone turnover markers were determined. The incidence of osteoporotic fracture and side effects after drug treatment in both groups were also observed. Results The mean percent changes from baseline in the BMD values of the lumbar vertebra 1-4 and femoral neck significantly increased both in daily group and in the weekly group. There were no statistically significant differences between the two treatment groups in terms of mean percent changes in BMD at the lumbar spine and femoral neck at any time point（P〉 0.05）. The changes of bone turnover markers（NTx / Cr and BALP）, outcomes and safety assessment were also similar in these two groups in one year fellowup. Conclusion The weekly 35 mg and daily 5 mg risedronate dosing administration showed similar efficacy in improving BMDs and biochemical markers of bone turnover in osteoporosis men during one year of follow-up. Treatment with weekly 35 mg risedronate provides an alternative for osteoporosis men who prefer once-a-week oral dosing.