复方杜仲健骨颗粒治疗膝关节骨性关节炎Ⅱ期临床试验总结  

II Period Clinical Trial of Compound Du Zhong Jian Gu Grain Treating Knee Osteoarthritis

作　　者：葛继荣[1] 王和鸣[1] 杨连梓[1] 殷海波[2] 冯兴华[2] 姜泉[2] 朱立国[3] 张军[3] 李金学[3] 郭振江[4] 罗涛[4] 黄明华[4] 

机构地区：[1]福建省中医药研究院,福州350003 [2]中国中医研究院广安门医院 [3]中国中医研究院骨伤科研究所 [4]北京中医医院

出　　处：《中国中医骨伤科杂志》2002年第5期19-23,共5页Chinese Journal of Traditional Medical Traumatology & Orthopedics

基　　金：国家药监局新药临床研究基金资助

摘　　要：目的 :评价复方杜仲健骨颗粒治疗膝关节骨性关节炎的临床疗效和安全性。方法 :采用多中心、双盲双模拟随机对照方法 ,将膝关节骨性关节炎患者 2 0 0例分为复方杜仲健骨颗粒组 (试验组 ) 1 0 0例 ,壮骨关节丸组 (对照组 ) 1 0 0例 ,对比分析两组的临床疗效。结果 :1试验组总有效率为 92 % ,对照组总有效率为82 % ,试验组疗效优于对照组 (P<0 .0 1 )。 2两组治疗单项症状均有效。 3试验组治疗中医证候有效 ,且优于对照组。 4试验组在治疗过程中未见明显不良反应。结论 :复方杜仲健骨颗粒是一种治疗膝关节骨性关节炎安全有效的药物。Objective:To evaluate the effectiveness and safety of Compound Du Zhong Jian Gu grain treating knee osteoarthritis.Methods:During the multicentre,double blind and double dummy clinical trial,two hundred patients of knee oseteoarthritis were randomly divided into two groups: one group(100 cases) received Compound Du Zhong Jian Gu grain (treatment group) and the other(100 cases) Zhuang Gu joint pill(control group),to analyse two group's effectiveness.Results:① The effect rate getting 92% in the treatment group,while 82% in the control.Obviously the treatment group was superior to the control at the clinical effectiveness(P<0.01).② Two groups could improve the symotom of osteoarthritis.③ The treatment group was better than the control in ameliorating Chinese medicine symptom.④ No severe side effect was found in the treatment group.Conclusion:Compound Du Zhong Jian Gu grain is an effective and safe Chinese traditional medicine in the therapy of knee osteoarthritis.

关 键 词：复方杜仲健骨颗粒 治疗 膝关节 骨性关节炎 临床试验 

分 类 号：R274.943[医药卫生—中西医结合] R285.6[医药卫生—中医骨伤科学]