健骨颗粒治疗原发性骨质疏松症(肝肾不足证)Ⅲ期临床研究

Clinical Study(phase III) on the Effecs of Jiangu Granula in Primary Osteoporosis

目的:在Ⅱ期临床试验基础上,进一步评价健骨颗粒治疗原发性骨质疏松症(肝肾不足证)的临床疗效和安全性。方法:96例原发性骨质疏松症(肝肾不足证)患者,采用随机双盲、阳性药物对照的临床试验设计方法。结果:两组治疗后腰椎骨密度值均上升,治疗组股骨颈骨密度值明显高于对照组,两组比较有显著性差异(P<0.05)。骨质疏松症疗效:治疗组有效率为80.4%,对照组为80.0%,两组比较无明显差异(P>0.05);结论:健骨颗粒在口服剂量内能明显改善临床症状,升高骨密度值,用药安全,对于骨质疏松症有较好的治疗效果。

Objective： To observe the efficacy and safety of JianGu Granula in the treatment of the primary osteoporosis （traditional chinese medicine＇ syndrome of insufficient of liver and kidney） based on Clinical Study（ phase 11 ）. Methods： The randomized, double-blind and compared with masc-medicine methods were adopted, 96 primary osteoporosis （TCM＇ syndrome of insufficient of liver and kidney） patients were divided into the experiment group （72 patiants treated with JianGu Granula two bags once, twice a day） and the control group （24 patiants treated with GuSongbao Granula two bags once, twice a day）. The duration of treatment of both groups was six months. Results： Results showed that the bone mineral density （BMD） of lumbar vertebra increased in both two groups after treatment, but the BMD of neck of femur in experiment group increased higher than that of control group, there was significant difference between two groups（P〈0.05）. In curative effect of osteoporosis aspects： the effective rate was 80.4% in experient group, and 80.0% in control group, indicating no statistical difference in comparison（ P〉0. 05）. In curative effect of traditional chinese medicine＇ symptom aspects： the effective rate was 97.8% in experient group, and 100% in control group, indicating no statistical difference in comparison （ P〉0. 05）. There were no cases with toxic-side effects in experient group, and the rate of that was 6.25% in control group（P〈0.05）. Conclusions.. The clinical effects of treatment with JianGu Granula in OP were confirmed. In range of oral-administrative dosage and indication, JianGu Granula is the safe and effective drug for primary osteoporosis.