复方杜仲健骨颗粒改善膝关节骨性关节炎患者膝关节功能400例分析

背景根据国家药品监督管理局批文精神,进行复方杜仲健骨颗粒(伯司庄)治疗膝关节骨性关节炎临床试验.目的评价复方杜仲健骨颗粒改善膝骨关节炎患者膝关节功能及治疗的安全性.设计以壮骨关节丸为对照药,双盲双模拟随机方法.单位福建省中医药研究院、中国中医研究院广安门医院、中国中医研究院骨伤科研究所和北京中医医院.对象自1999-09/12,进行Ⅱ期临床试验,观察膝关节骨性关节炎患者200例,其中复方杜仲健骨颗粒组100例,壮骨关节丸组100例;自1999-12/2000-03,进行Ⅲ期临床试验,观察膝关节骨性关节炎患者400例,其中复方杜仲健骨颗粒组300例,壮骨关节丸组100例.所有患者均经X射线检查确诊;中医证见肝肾不足,筋脉瘀滞证;患者均知情同意.方法复方杜仲健骨颗粒组复方杜仲健骨颗粒(1包/次,3次/d)+壮骨关节丸模拟剂;壮骨关节丸组复方杜仲健骨颗粒模拟剂+壮骨关节丸(1包/次,2次/d).双盲双模拟随机对照,治疗1个月,观察临床疗效.主要观察指标患者经治疗后的关节功能、临床疗效、中医证侯积分和不良反应.结果参选的600例患者全部完成数据采集,无脱落者.①复方杜仲健骨颗粒组总有效率明显优于壮骨关节丸组(92%,82%).②与壮骨关节丸组比较,复方杜仲健骨颗粒组关节功能明显优于壮骨关节丸组.③复方杜仲健骨颗粒在改善中医证侯方面优于壮骨关节丸组(积分下降值分别为7.03±3.38,5.43±3.16).④试验过程中未见明显不良反应.结论复方杜仲健骨颗粒能有效改善膝骨关节症状,应用安全、有效.

Analysis of fufang duzhong jiangu keli in improvement of knee joint function in 400 cases of knee osteoarthritis

BACKGROUND:According to the thrust of document issued by State Drug Administration, the clinical experiment was carried onfufang duzhongjiangu keli (compound) (Bo Si Zhuang) in treatment of knee joint osteoarthritis.OBJECTIVE: To evaluate the improvement of the compound in treatment of knee joint osteoarthritis and its safety.DESIGN: Zhuanggu guanjie wan (bolus) was taken as controlled drug and double blind, double-simulation randomized method was designed.SETTING: Fujian Institute of Chinese Medicine, Guananmen Hospital of China Academy of Traditional Chinese Medicine, Institute of Orthopedics and Traumatology of China Academy of Traditional Chinese Medicine and Beijing Hospital of Chinese Medicine.PARTICIPANTS: Clinical experiment Ⅱ was performed since December 19, 1999, in which, 200 cases of knee joint osteoarthritis were observed and divided into compound group (100 cases) and bolus group (100 cases).From December 1999 to March 2000, clinical experiment Ⅲ was performed to observe 400 cases of knee joint osteoarthritis, in which, 300cases were divided in compound group and 100 cases in bolus group. All of cases were diagnosed by X-ray test and differentiated in Chinese medicine as insufficiency of liver and kidney and stasis of tendons and vessels. All of patients were in the known of experiment.METHODS: In compound group, fufang duzhong zhuanggu keli (1bag/time, 3 times/day) + simulated dosage of zhuanggu guanjie wan were administrated. In bolus group, fufang duzhong zhuanggu keli simulated dosage + zhuanggu guanjie wan (1bag/time, twice/day) were administrated.Double blind and double-simulation randomized control experiment was given in one-month treatment to observe clinical therapeutic effects.MAIN OUTCOME MEASURES: Evaluation on clinical indexes of joint function ,clinical therapeutic effect, syndrome score in Chinese medicine and adverse reaction.RESULTS: Totally 600 cases employed had all accomplished datum collections, no dropped-off case. ① The total effective rate of compound group was superior remarkably to bolus group (92.%, 82%). ② The result of joint function in compound group was superior remarkably to that of bolus group. ③ Concerning to improvement of syndromes in Chinese medicine, the result in compound group was superior to that of bolus group (the decreased integrals were 7.03±3.38 and 5.43±3.16 respectively). ④No obvious harmful effect presented during experiment.CONCLUSION: Fufang duzhong jiangu keli improves the symptoms of osteoarthritis of knee safely and effectively.