金刚健骨片治疗原发性骨质疏松症临床研究

Clinical Study of Jingang Jiangu Tablet on Treatment of Primary Osteoporosis

目的观察金刚健骨片治疗原发性骨质疏松症(肾精亏虚证)的疗效和安全性。方法将原发性骨质疏松症患者120例随机分为金刚健骨片组(观察组)60例与骨松宝组(对照组)60例进行比较研究。观察患者治疗前后临床症状的改善、骨密度、骨代谢指标及安全性指标的变化。结果 (1)观察组临床疗效优于对照组(P<0.05);(2)两组治疗后骨密度(BMD)均有升高的趋势,但差异无统计学意义(P>0.05);骨钙素(BGP)、I型前胶原氨基端前肽(PINP)两组均较治疗前提高(P<0.05),且观察组改善优于对照组(P<0.05);血清骨源性碱性磷酸酶(BALP)两组均较治疗前降低(P<0.05),且观察组改善优于对照组(P<0.05);(3)治疗后两组腰背疼痛、腰膝酸软、下肢疼痛、步履艰难等症均较前改善(P<0.05),且观察组改善优于对照组(P<0.01);(4)在治疗过程中,观察组无严重不良反应发生。结论金刚健骨片治疗骨质疏松症安全、有效。

Objective The effect and sally of Jingang Jiangu tablet in the treatment of primary osteoporosis （syndrome of kidney essence deficiency） were observed. Methods 120 patients with primary osteoporosis patients were randomly divided into 60 cases of Jingang Jiangugroup （observation group） and 60 cases of Gusongbao （control group）. The changes before and after treatment in patients with clinical symptoms, bone mineral density, bone metabolism index and safety index were observed. Results （1） The clinical curative effect of the observation group wasbetter than the control group （P〈0.05）. （2） The bone mineral density （BMD） of both groups increased after treatment, but no statistical differences （P〉0.05）. Osteocalcin （BGP） and type I procollagen amino terminal propeptide （PINP） in two groups increased after treatment （P〈0. 05）, the improvement in observation group was better than the control group （P〈0.05）. Serum bone alkaline phosphatase （BALP） content of two groups decreased （P〈0.05）, the improvement in observation group was better than the control （P〈0.05）. （3） The clinical symptoms of pain in back and loin, soreness and weakness of waist and knees, ache of lower limb, and trudge, etc. have been improved than before（P〈0.05）, the improvement in observation group was better than the control （P〈0.01）. （4） No serious adverse reactions were observed in the observation group during treatment. Conclusion Jingang Jiangu tablet is safe and effective in treating osteoporosis.