目的 初步临床观察葛藤异黄酮提取物分散片治疗绝经后骨质疏松的疗效,药效学研究主要考察其治疗骨质疏松的分子机制.方法 采用随机对照方法,连续口服6个月,临床试验初步考察受试品治疗骨质疏松症的临床作用,药效学研究采用去卵巢大鼠,连续给药6个月考察药物对大鼠血清指标的影响.结果 临床试验观察分散片明显改善骨质疏松症患者椎体(L2-L4)和股骨颈骨密度.总有效率达82.22%.药效学实验观察可见分散片可明显改善大鼠血清碱性磷酸酶水平,提高血清雌二醇含量,降低骨钙素含量.结论 葛藤异黄酮提取物分散片具有明确的治疗骨质疏松症的作用.%Objective To observe the preliminary clinical effect of dispersible tablets of kudzu isoflavone extract on postmenopausal osteoporosis, and to investigate the molecular mechanism of the treatment of osteoporosis with pharmacology. Methods The randomized control method was used. All patients received a 6-month consecutive oral administration. The clinical test was adopted to preliminarily investigate the clinical effect of the samples on osteoporosis. The ovariectomized rats were used in pharmacodynamical study. Changes in rat serum indicators were observed after a 6-month consecutive oral administration. Results In clinical observation, the dispersible tablets could improve BMD of the L2 - L4 and the femoral neck of patients with osteoporosis obviously. The total effective rate was 82. 22% . In pharmacodynamical study, the dispersible tablets could increase the level of rat serum alkaline phosphatase obviously, improve the concentration of serum estradiol ( E2 ), and decrease the concentration of osteocalcin. Conclusion Dispersible tablets of kudzu isoflavone extract have obvious effect on treating osteoporosis.
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