寒痹外用方治疗膝骨关节炎肾虚寒湿证的疗效与安全性评价

The evaluation of clinical efficacy and safety of Hanbiwaiyong decoction (HBWYF) in treating knee osteoarthritis (KOA) belonging to kidney deficiency and cold-dampness syndrome

目的:评价寒痹外用方治疗膝骨关节炎肾虚寒湿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,2组疗程均为2周。治疗前后观察关节疼痛(患者、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92.86%,对照组总有效率85.71%,治疗组优于对照组,差异有统计学意义(P<0.01)。2组治疗后关节疼痛(患者、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<0.05),治疗组均优于对照组,差异有统计学意义(P<0.05)。治疗组有2例、对照组有1例出现轻度皮肤瘙痒,不良反应少。结论:寒痹外用方对膝骨关节炎肾虚寒湿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。

Objective：To evaluate clinical efficacy and safety of Hanbiwaiyong decoction（HBWYF）in treating knee osteoarthritis（KOA）of kidney deficiency and cold-dampness syndrome.Methods：A multicenter,prospective,randomized controlled study was carried out.Patients in the treatment group were treated with HBWYF,and in the control group were treated with Diclofenac diethylamine emulsion.The efficacy and safety indexes were evaluated at baseline and 2 weeks after the treatment.The observation indexes included Joint pain（patient＇s and doctor＇s 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（92.86%）was significantly better than that of the control guoup（85.71%）.Patients in both groups had significantly improvement after the treatment in Joint pain（patient＇s and doctor＇s evaluation）,Michel Lequesne knee osteoarthritis index of severity for knee joint osteoarthritis,WOMAC osteoarthritis index and TCM syndrome integral（P〈0.05）.The treat-ment group significantly excelled the control group in all aspects（P〈0.05）.Besides, the side effects of two groups were seldom and there was no statistical significance（P〉0.05）.Conclusion：HBWYF had the effect to relieve symptoms,improve joint function on KOA patients of kidney deficiency and cold-dampness syndrome with fewer adverse reactions.