补肾健骨胶囊治疗肝肾不足型骨质疏松症的临床研究

A Clinical Observation of Bushen Jiangu Capsule for Primary Osteoprosis with

目的：评价补肾健骨胶囊治疗原发性肝肾不足型骨质疏松症的疗效和安全性。方法：分别采用双盲双模拟随机对照、单盲随机对照和开放治疗的方法进行。结果：①试验组临床总有效率为８９．５％，显效率为４７．６％，开放组总有效率为 ９１．ｌ％， 显效率为 ４７．８％。骨松宝对照组总有效率为 ８０．８％，显效率为 ２２，５％，两组比较有显著性差异，试验组疗效优于对照组。②试验组与开放组中医证候积分治疗前后比较均有非常显著性差异，试验组与对照组组间积分下降值比较有非常显著性差异，试验组疗效优于对照组；试验组在改善某些部位骨密度方面优于对照组；未发现明显的不良反应。结论：补肾健骨胶囊在目前的口服剂量、疗程范围内，是一种治疗原发性骨质疏松症安全、有效的药物。

Objective:To study the therapeutic effect and safety of Bushen Jiangu Capsule (BJC)for primary osteoporosis (PO)with kidney-yin and liver-yin deficiency syndrome.Methods:Double -blind double -mimic randomized control trial, single - blind randomized control trial and open treatment were adopted. Three hundred and thirty cases of PO were allocated to BJC treatment group (Group A), BJC open treatment group (Group B) and Gusongbao control group (Group C). Results: The total effective rate and the remarkably effective rate were 89.5%and 47.6%in Group A, 91. 1 %and 47. 8%in Group B and 80. 8%and 22. 5%in Group C respectively. The differences of the above indexes between Group A and Group C were significant. The differences of symptom score between Group A and Group B were significant. The improvement of symptoms and femur bone mineral density in Group A were superior to Group B. No obvious adverse actions were found. Con clusion: BJC in the test dose is an effective and safe drug for PO.