不同用药方案阿仑磷酸钠治疗老年性骨质疏松症的临床疗效分析

目的探讨阿仑膦酸钠的不同给药方案防治老年性骨质疏松症的临床疗效与安全性。方法采用随机平行对照实验,连续入选600例老年性骨质疏松症患者,按给药间隔分成两组。A组为常规间隔,每周1次口服阿仑膦酸钠70 mg;B组为长间隔,每两周口服阿仑膦酸钠70 mg。两组均联用钙尔奇D600每日1片。测定两组治疗前、治疗26、52 w的骨密度值,检测治疗前、治疗13、52 w的血清钙、磷、碱性磷酸酶水平及尿钙/肌酐比值;观察不良反应与新生骨折的发生情况。结果与治疗前相比,治疗26、52 w两组骨密度均明显增加,差异有统计学意义(P0.05);而两组骨密度变化率比较无显著差异(P0.05)。与治疗前相比,治疗13、52 w两组血清碱性磷酸酶水平、尿钙/肌酐比值均明显减少,差异有显著统计学意义(P0.01);血钙、血磷水平无明显变化。A、B两组治疗52w总有效率分别为85.31%和84.89%,差异无统计学意义(P0.05);不良反应发生率分别为9.09%和3.60%,差异有显著统计学意义(P0.01)。两组均无新生骨折发生。结论阿仑膦酸钠防治老年性骨质疏松症安全有效。与常规间隔用药相比,延长用药间隔的临床疗效相似、不良反应发生率较低,更为便捷经济。因此,阿仑膦酸钠间断、小剂量的用药方案在临床值得推荐。

Efficacy analysis of different therapeutic regimens of alendronate in the treatment of senile osteoporosis

Objective To investigate the clinical efficacy and safety of different therapeutic regimens of alendronate in the treatment and prevention of senile osteoporosis. Methods A random parallel controlled study was performed. Six hundred consecutive senile patients with osteoporosis were included. All the patients were divided into 2 groups according to the interval of drug administration. Patients in Group A had regular interval, taking an oral medication of 70mg alendronate once a week, while patients in Group B had long interval, taking an oral medication of 70mg alendronate once 2 weeks. Patients in both groups also took 600mg Caltrate D per day simultaneously. Bone mineral density (BMD) in both groups was detected before the treatment and at the 26th week and the 52nd week after the treatment, respectively. The serum levels of serum calcium, phosphorus, ALP, and urinary calcium/creatine were also detected before the treatment and at the 13th week and 52nd week after the treatment. The adverse events and the occurrence of new fractures were also observed. Results Compared with that before the treatment, BMD at the 26th week and the 52nd week after the treatment increased significantly (P<0.05), while the changing rate of BMD in both groups showed no significant difference (P>0.05). Compared with that before the treatment, the serum levels of ALP and urinary calcium/creatine decreased significantly (P<0.01), while the serum levels of calcium and phosphorus showed no significant changes. The effective rate after 52-week treatment in Group A and Group B was 85.31% and 84.89%, respectively, and no significant difference was observed (P>0.05). The rate of adverse events was 9.09% and 3.60%, respectively, and the difference was significant (P<0.01). No new fractures were observed in both groups. Conclusion The application of alendronate in the treatment and prevention of senile osteoporosis is safe and effective. Compared with that with regular interval, the clinical efficacy of medication with longer interval is similar, but the rate of adverse events is lower, and the treatment is much more convenient and economical. Therefore, the intermittent, lose-dosage therapeutic regimen of alendronate should be recommended in clinical practice.