金乌骨通胶囊治疗膝关节骨性关节炎对照研究

Clinical study of Jinwugutong capsule in the treatment of knee osteoarthritis

目的 探讨金乌骨通胶囊治疗膝关节骨性关节炎患者的临床疗效和安全性.方法 将76例膝关节骨性关节炎患者按随机数字表法分为观察组与对照组,每组38例,观察组口服金乌骨通胶囊治疗,对照组口服双氯芬酸钠缓释片治疗,观察1个月.治疗后依据中药新药的临床研究指导原则评定临床疗效,治疗过程中随时记录不良反应发生情况.结果 治疗后观察组总有效率（94.7%）显著高于对照组（68.4%）（P〈0.01）,不良反应发生率（5.3%）显著低于对照组（34.2%）（P〈0.01）.结论 金乌骨通胶囊治疗膝关节骨性关节炎患者疗效显著,安全性高,值得在临床推广应用.

Objective To investigate the clinic effect and safety of Jinwugutong capsule in the treatment of knee osteoarthritis. Methods 76 patients with knee osteoarthritis were selected and randomly divided into observation group and control group, 38 patients in observation group and were given oral Jinwugutong capsules for treatment, 38 patients in control group and were given Diclofenac Sodium Sustained Release Tablets, they were observed for 1 month. Clinic effect after treatment was evaluated by Chinese herbal medicine clinical research guide, adverse reaction condition was recorded all times during therapeutic process. Results After treatment, total efficiency of observation group （94.7%） was obviously higher than control group （68.4%） （P〈0.01）, adverse reaction rate of observation group （5.3%） was obviously lower than control group （34.2%） （P〈0.01）. Conclusion Jinwugutong capsule in treatment of knee osteoarthritis has significant effect, it has higher safety and is worthy of wide application.