密骨胶囊治疗原发性骨质疏松症(肝肾不足证)的临床研究

目的:评价密骨胶囊治疗原发性骨质疏松症(肝肾不足证)的临床疗效及安全性。方法:采用随机双盲对照的临床试验方法,将48例原发性骨质疏松症(肝肾不足证)患者,随机分为密骨胶囊治疗组及阳性药物(仙灵骨葆)对照组。两组疗程为六个月,运用双能X线骨密度仪(DEXA)检测治疗前后腰椎及髋部骨密度变化;观察患者治疗前后临床症状变化及血钙、磷、碱性磷酸酶变化。结果:主症方面:统计学处理,两组相比较无显著性差异,说明两组疗效相当,密骨胶囊对原发性骨质疏松症有治疗作用。次症方面:组间比较试验药(密骨胶囊)与对照药(仙灵骨葆)相比差异无统计学意义,两组疗效相当;从组内比较来看,治疗六个月后,经统计学处理,绝大多数疗效指标P<0.05,差异有统计学意义。说明试验药(密骨胶囊)治疗后较治疗前有良好的治疗作用,且在治疗Ward三角骨密度测量值及测量值占峰值百分比方面,中医证候总分的改善方面明显优于对照组。结论:密骨胶囊在目前的口服剂量疗程范围内,治疗骨质疏松疗效确切,安全,无毒副作用,是一种治疗骨质疏松症安全、有良好疗效的中药新药。

The Clinical Research of MiGu Capsule's Therapeutic Effectiveness on Primary Osteoporosis

Objective:To appraise the clinical curative effect and the security of treating primary osteoporosis(syndrome of deficiency of both liver and kidney) with MiGu capsules.Methods:Adopting pairs of blind clinical test method that contrast at random,48 primary OP patients(syndrome of deficiency of both liver and kidney) were divided into the MiGu group(treated with MiGu capsules) and the control group(treated with XianLingGuBao) at random.The period of treatment of both groups was six months,observing the change in bone mineral density(BMD) of lumbar vertebrae and hip by dual energy X-ray absorptiometry(DEXA) and the change of patient's clinical symptom,blood calcium,phosphorus and alkaline phosphatase before and after treat the ment.Results:In main symptom aspects: there was no statistical difference between the two groups(P>0.05),suggesting that MiGu capsules has the advantage value as the same as XianlingGuBao in treating OP.In minor symptom aspects: There was no significant difference between the MiGu group and the control group(P>0.05) either;but after six months' treatment,most of the criteria in the MiGu group were significantly different from those before the treatment,thus there was statistical difference(P<0.05).It indicates that MiGu capsule is an effective new medicine in treating OP,moreover the measuring value and the peak value of BMD at Ward's triangle site in the MiGu group were better than those in the control group.The total points of improvement in the syndrome of TCM were obviously superior to the control group.Conclusions: MiGu capsule is a safe and effective new medicine of TCM in treating OP,with any toxical and side effect.