强骨活力片治疗原发性骨质疏松症临床分析

Clinical Observation on Qianggu Huoli Pills in the Treatment of Primary Osteoporosis

目的:初步评价强骨活力片治疗原发性骨质疏松症(肾虚血瘀证)的疗效及安全性。方法:按照多中心,随机,双盲,安慰剂平行对照的原则进行分组,符合方案集患者共227例,两组均给钙尔奇D做基础治疗药物,同时治疗组(A组)110例,给予强骨活力片口服治疗,1074mg,bid,疗程24周;对照组(B组)117例,给予安慰剂口服治疗,疗程24周。治疗前后作腰背四肢骨痛积分;结果:治疗前后腰背四肢骨痛积分差值及中医证候积分差值的两组比较,治疗组明显优于对照组(P<0.05);两组骨密度变化率的均值比较无明显差异(P>0.05);与药物可能相关不良事件发生率小于6%。结论:强骨活力片治疗原发性骨质疏松症效果明显,且安全性高,值得临床推广。

Objective：To evaluate the efficacy and safety of Qianggu Huoli Pills （QHP） in treating primary osteoporosis （PO）. Methods：The present study was designed as a multieenter, randomized, double--blinded and placebo--paralleled trial. Two hundred and twenty--seven patients of PO were divided into treatment group （110 cases） and control group （117 cases）, who received QHP and placebo respectively at the same dose （1074mg, bid） for 24 weeks. Meanwhile, all patients received Caltrate D as the basic treatment. The pain quantitative scores in lumbar, back and limbs as well as Chinese symptomatic quantitative scores were recorded before and after treatment. The bone mineral density （BMD） of the lumbar vertebrae 2 to 5, femoral neck and femoral trochanter were detected by double energy X-ray. Also, serum calcium, phosphorus, alkaline phosphatase, blood routine, urine routine, stool routine, liver function, renal function, electrocardiogram and vital sign were monitored. Moreover, the adverse events were recorded. Results： The quantitative scores for clinical symptoms and bone pain were decreased significantly in treatment group compared with control group （P〈0.05） ; There were no statistical differences in BMD changes between the two groups （P〉0.05）. The incidence rate of adverse reaction was less than 6%. Conclusion： QHP is effective and safe for primary osteoporosis, which deserves wide clinical application.