唑来膦酸钠治疗老年严重骨质疏松症的临床试验

目的探讨唑来膦酸钠治疗老年严重骨质疏松症的临床效果。方法临床收集老年严重骨质疏松症患者120例，随机分为治疗组（60例，平均67．6岁），给予钙尔奇＋阿法D3＋唑来膦酸钠；对照组（60例，平均66．4岁），给予钙尔奇＋阿法D3。对两组患者治疗前与治疗2周以后疼痛程度进行评判；测定治疗前和治疗12个月后两组患者髋部及腰椎骨密度；检测治疗前后血钙、磷、碱性磷酸酶（AKP）水平；治疗过程中观察药物不良反应情况。结果排除治疗中3例脱落患者后，治疗组（57例）骨痛缓解快，骨密度改善程度也明显优于对照组（53例）（P〈0．05）。治疗组AKP较治疗前明显下降【（95．2±11．2）VS（147．3±16．1）IU／L；P〈0．05]。两组血钙、血磷及对照组AKP治疗前后无明显改变（P〉0．05）。结论唑来膦酸钠能显著缓解严重骨质疏松症患者骨痛，提高骨密度。

Zoledronic acid for treatment of severe osteoporosis in the elderly: a clinical trial

Objective To discuss the curative effect of zoledronic acid on severe osteoporosis in the elderly. Methods Totally 120 patients were randomly divided into treatment group（n=60, mean age： 67.6 years） receiving Caltrate D and Alpha D3 plus zoledronic acid treatment for 24 weeks, and the control group（n=60, mean age： 66.4 years） receiving Caltrate D and Alpha D3treatment only. Bone pain of patients in two groups before and two weeks after treatment was assessed and bone mineral density（BMD） of hip and lumbar vertebrae was examined before and 12 months after treatment. In addition, calcium, phosphorus and alkaline phosphatase（AKP） in plasma were also assessed and adverse events were observed. Results After excluding the 3 drop-out cases, bone pain was alleviated faster in treatment group（n=57） than in control group（n=53）, and improvement of BMD in treatment group was also significantly better than that in control group（P 〈 0.05）. AKP was decreased significantly in treatment group（95.2 ±11.2） vs （147.3 ±16.1）IU/L; P 〈 0.05], while kept no change in control group after treatment. There were no significant differences in the levels of plasma calcium and phosphorus in both groups between pre- and post- treatment（P 〉 0.05）. Conclusion Zoledronic acid can significantly relieve pain and other symptoms, and improve BMD in patients with severe osteoporosis.