淫羊藿总黄酮胶囊治疗原发性骨质疏松症360例的多中心临床观察

Treatment of primary osteoporosis with epimedium total flavone capsule: a multicenter clinical observation on 360 cases

目的研究淫羊藿总黄酮胶囊治疗原发性骨质疏松症的临床疗效及安全性,评价该药对骨质疏松症中医证侯及主要症状的疗效以及该药对骨量的疗效。方法收集自2007年5月3日至2008年4月12日参与研究淫羊藿总黄酮胶囊疗效各中心试验病例480例,采用随机双盲对照方法分为治疗组360例,对照组120例。治疗组给予淫羊藿总黄酮胶囊,对照组给予骨松宝胶囊治疗。观察治疗前后,两组病例骨质疏松症中医证侯及主要症状的疗效以及骨量的改变情况。结果中医总疗效分析:淫羊藿总黄酮胶囊组总有效率为90.83%;对照组总有效率75.00%。组间比较总疗效差异有统计学意义(P=0.0000)。骨密度疗效:淫羊藿总黄酮胶囊组总有效率为47.38%;对照组总有效率34.23%。组间比较疗效差异有统计学意义(P=0.0367)。两组总有效率比较差异有统计学意义(P=0.0192)。结论淫羊藿总黄酮胶囊与对照组相比能提高骨质疏松症患者的骨密度疗效,且能改善骨质疏松症中医证侯及主要症状。

Objective To study the clinical effect of epimedium total flavonoid capsule on primary osteoporosis and its safety, and to evaluate the effect of this drug on main symptom of osteoporosis and bone mass. Methods A total of 480 cases, who participated in efficacy trail of epimedium total flavone capsule in multiple centers from May 3, 2007 to April 12, 2008, were enrolled. Randomized, double blinded, and controlled method was used. All cases were divided into treatment group （n =360） and control group （n = 120）. People in treatment group were given epimedium total flavone capsule, while people in control group were given Gusongbao capsule. The effect on main symptom of osteoporosis and the changes of bone mass were compared before and after the treatment in both groups. Results The total curative effect rate of main symptom in epimedium total flavone capsule group and control group was 90. 83% and 75.00%, respectively. And the difference was significant （P = 0. 0000）. The total effective rate of bone mass in epimedium total flavone capsule group and control group was 47.38% and 34.23% , respectively. And the difference was significant （P = 0. 0367）. The total effective rate between the two groups was significantly different （P = 0. 0192）. Conclusion Compared the drug used in control group, epimedium total flavone capsule can improve the bone mineral density and ameliorate main symptom of osteoporosis in patients with osteoporosis.