【作者】 王建明； 韩乐军； 张军力； 王倩； 孙继华； 鄢泽然； 张英泽； 徐愿； 金笛儿； 罗静； 吕素飞； 何春晓； 陈鹏凯； 阎小萍； 陶庆文；

【Author】 WANG Jian-ming;HAN Le-jun;SUN Ji-hua;WANG Qian;ZHANG Jun-li;YAN Ze-ran;ZHANG Ying-ze;XU Yuan;JING Di-er;LUO Jing;LU Su-fei;HE Chun-xiao;CHEN Peng-kai;YAN Xiao-ping;TAO Qing-wen;TCM Rheumatology of China-Japan Freindship Hospital;Beijing dongcheng district gymnasium road community health service center;Beijing Dongcheng District community health service center outside Yongding;Graduate school of Beijing university of traditional Chinese medicine;

【机构】 中日医院； 北京市东城区体育馆路社区卫生服务中心； 北京市东城区永定门外社区卫生服务中心； 北京中医药大学研究生院；

【摘要】 目的:评价寒痹外用方治疗膝骨关节炎肾虚湿热证的临床疗效和安全性。方法:采取多中心、前瞻性、随机对照试验方法,治疗组予外用方离子导入治疗,对照组予给予双氯芬酸二乙胺乳剂外用治疗,两组疗程均为2周。治疗前后观察关节疼痛(患者评价)、关节疼痛(医生评价)、Michel Lequesne膝OA严重指数、WOMAC骨关节炎指数、中医证候积分、安全性指标等,评估其疗效及安全性。结果:治疗组总有效率95.24%,对照组总有效率90.48%,治疗组疗效优于对照组,差异有统计学意义(P<0.01)。治疗组治疗后关节疼痛(患者评价)、关节疼痛(医生评价)、Michel Lequesne膝OA严重指数、WOMAC骨关节炎指数、中医证候积分等方面均有明显改善,差异有统计学意义(P<0.01)。对照组治疗后关节疼痛(患者评价)、关节疼痛(医生评价)、WOMAC骨关节炎指数等方面均有明显改善,差异有统计学意义(P<0.01),在Michel Lequesne膝0A严重指数、中医证候积分等方面均有明显改善,差异有统计学意义(P<0.05)。治疗组均优于对照组,差异有统计学意义(P<0.05)。治疗组有1例出现轻度皮肤瘙痒,不良反应少,对照组未出现不良反应,差异无统计学意义(P>0.05)。结论:热痹外用方对膝骨关节炎肾虚湿热证患者具有缓解症状、改善关节功能活动、体征的作用,且不良反应少,是治疗膝骨关节炎肾虚湿热证的有效外治中药。更多还原

【Abstract】 Objective:To evaluate clinical efficacy and safety of Rebiwaiyong decoction(RBWYF) in treating knee osteoarthritis(KOA) of kidney deficiency and hot-dampness syndrome.Methods:A multicenter,prospective,randomized controlled study was carried out,the treatment group treated with RBWYF for 2 weeks,the control group treated with Diclofenac diethylamine emulsion for 2 weeks.The efficacy and safety index were evaluated at baseline and 2 weeks after the treatment,the observation indexes included Joint pain(patient evaluation),Joint pain(doctor evaluation),Michel Lequesne knee osteoarthritis index of severity for knee joint osteoarthritis,WOMAC osteoarthritis index,and TCM syndrome integral.Results:The effective rate of treatment group(95.24%)significantly better than the control guoup(90.48%).The treatment groups had significantly improvement after the treatment in Joint pain(patient evaluation),Joint pain(doctor evaluation),Michel Lequesne knee osteoarthritis index of severity for knee joint osteoarthritis,WOMAC osteoarthritis index,and TCM syndrome integral(P <0.01).The control groups had significantly improvement after the treatment in Joint pain(patient evaluation),Joint pain(doctor evaluation),WOMAC osteoarthritis index(P <0.01).The control groups had significantly improvement after the treatment in Michel Lequesne knee osteoarthritis index of severity for knee joint osteoarthritis and TCM syndrome integral(P <0.05).The treatment group significantly excelled the control group in all aspects(P <0.05).Besides,the side effects of two groups were seldom,there was no statistical significance(P >0.05).Conclusion:RBWYF had the effect to relieve symptoms,improve joint function.And there was fewer adverse reactions,it was an effective herb for the treatment of KOA belonging to kidney deficiency and hot dampness syndrome.更多还原