固本壮骨胶囊治疗原发性骨质疏松症的临床研究

目的：评价固本壮骨胶囊的疗效和女全性。方法：我们于2002年10月至2003年7月按照国家药品食品监督管理局中药新药审批办法，通过与骨松宝颗粒剂（无糖型）多中心、随机、双盲双模拟对照的临床观察。对223例原发性骨质疏松症（肝肾不足证）患者进行了系统的临床试验研究。结果：治疗后两组都有明确疗效，两组间没有统计学差异，但试验组在改善腰膝酸软和步履艰难这二个症状方面明显优于对照组。比较骨密度的变化，各部位3个月和6个月的骨密度改变，两组无明显差异，而试验组在提高腰椎骨密度方面优于对照组。另外，治疗组在治疗过程中无明显不良反应，治疗后的各项血液生化指标和心电图均无改变。结论：固本壮骨胶囊是一种安全有效的中药新药。

A Clinical Study on Prescription Osteoporosis with Gubenzhuanggu Capsule

Objective:The therapeutic effectiveness of Gubenzhuanggu capsule on osteoporosis safety,indication matters needing attention as well,are studied.Methods:From Oct. 2002 to Jul.2003,according to the SFDA's measure approve for traditional Chinese drugs.we compare the effectiveness of Gubenzhuanggu capsule and gusongbao keli used for 223 cases with osteoporosis.Results:Two groups exist obvious therapeutic effectiveness,but no statistical difference. Gubenzhuanggu capsule group are much better than control group on back pain and walk-hardship.Compare the BMD,two groups don't exist statistical difference.BMD of L2-4, Gubenzhuanggu capsule group are better.And Gubenzhuanggu capsule group are safe in the treatment.Conclusions:Gubenzhuanggu capsule has no toixic side effect,is a kind of better drug for treating osteoporosis.