唑来膦酸治疗原发性骨质疏松的临床实验研究

The Clinical Trial of Zoledronic Acid in the Treatment of Primary Osteoporosis

目的探讨唑来膦酸对绝经后妇女原发性骨质疏松症的治疗效果。方法将124例原发性骨质疏松患者,随机分为治疗组(唑来膦酸)和对照组(钙剂和Vit D),观察骨代谢生化指标、骨密度变化、疼痛改善评价评分、患者经治疗后腰腿痛改善情况。结果 (1)治疗组血钙水平上升、血磷、碱性磷酸酶水平下降;(2)治疗组与对照组的25羟维生素D均较治疗前有所改善,治疗组水平增加更为显著;(3)治疗组与对照组的腰椎(L1-4)和股骨近端骨密度明显增加;(4)治疗组病情改善起始时间为2.5 w,而对照组病情改善起始时间为4 w,治疗组腰腿痛缓解总体有效率为85.4%,对照组为54.8%。结论唑来膦酸治疗原发性骨质疏松可以改善钙、磷代谢,提高25羟维生素D水平和骨密度,缩短病情改善起始时间,显著改善患者的腰腿痛情况,效率高,疗效好。

Objective To investigate the therapeutic effect of zoledronic acid on postmenopausal women with primary osteoporosis. Methods 124 patients with primary osteoporosis were randomly divided into experimental group（treated with zoledronic acid）and control group（treated with calcium and Vit D）. The biochemical indexes of bone metabolism,bone density change,pain improvement evaluation score and the improvement of lumbago and leg pain after treatment were observed. Results（1） Blood calcium level of experimental group increased,while their blood phosphorus and alkaline phosphatase level decreased.（2） The levels of 25-hydroxy-vitamin D of experimental group and control group were both improved compared with those before treatment,and the level of experimental group increased more significantly.（3） The bone mineral density of the lumbar spine（L1-4） and proximal femur of the experimental group and the control group increased significantly.（4） The improvement of the experimental group occurred in 2. 5 w,while the beginning of improvement of the control group appeared in 4 w. The total effective rate of lumbar pain relief was 85. 4% in the experimental group and 54. 8% in the control group. Conclusion Applying zoledronic acid to the treatment of primary osteoporosis can improve the metabolism of calcium and phosphorus,increase the level of 25-hydroxy-vitamin D and bone density,shorten the period before the beginning of improvement and improve the patients＇ lumbago and leg pain,which is with high efficiency and good curative effects.