椒桐汤外洗治疗肝肾亏虚兼风寒湿痹型膝骨关节炎临床研究

Clinical Study on the Treatment of Knee Osteoarthritis of Liver and Kidney Deficiency with Wind-Cold-Damp Bi Type by External Wash with Jiaotong Decoction(椒桐汤)

目的:观察椒桐汤外洗治疗肝肾亏虚兼风寒湿痹型膝骨关节炎(KOA)的临床疗效、安全性。方法:选择68例KOA肝肾亏虚兼风寒湿痹型患者,按随机数字表法分为观察组和对照组各34例。对照组患者给予仙灵骨葆胶囊、盐酸氨基葡萄糖胶囊治疗;观察组在对照组基础上增加椒桐汤外洗,均治疗4周。在治疗前、治疗2周、治疗4周以及治疗后3个月,观察骨关节炎指数(WOMAC)、疼痛视觉模拟评分(VAS)量表、膝关节中医证候评分变化,以及治疗期间不良反应发生率、4周治疗后的总有效率。结果:两组患者治疗后3个时间点WOMAC总评分和疼痛、僵直、关节功能评分,VAS评分、膝关节中医证候积分均较本组治疗前降低,且在治疗2周、4周后,观察组上述评分改善较对照组更低(P<0.05);观察组有效29例,无效4例,总有效率87.88%;对照组有效21例,无效12例,总有效率63.64%(P<0.05);安全性方面,观察组6例出现不良反应,总不良反应率18.18%,对照组有4例出现不良反应,总不良反应率12.12%(P>0.05)。结论:椒桐汤外洗短期内可有效改善肝肾亏虚兼风寒湿痹型KOA疼痛、僵直、关节功能及中医证候,且无明显不良反应。

Objective:To clarify the clinical efficacy and safety of Jiaotong Decoction(椒桐汤)in the treatment of knee osteoarthritis(KOA)of liver and kidney deficiency with wind-cold-damp bi type.Methods:Sixty eight patients with KOA of liver and kidney deficiency with wind-cold-damp bi type were selected from the outpatient and inpatient departments of our hospital,and were randomly divided into the experimental group and the control group,34 patients in each group.The control group was treated with Xianling Gubao capsules and glucosamine hydrochloride capsules;the experimental group was further treated with external wash with Jiaotong Decoction.Both groups were treated for 4 weeks.Before treatment,2 weeks of treatment,4 weeks of treatment,and 3 months after treatment,the changes in Western Ontario and McMaster Universities Arthritis Index(WOMAC),visual analogue scale(VAS)score,traditional Chinese medicine(TCM)syndrome score of knee joint,and incidence of adverse reactions during the treatment,and total effective rate after 4 weeks of treatment were observed.Results:At the three time points after treatment,the total WOMAC score,pain,stiffness and joint function,VAS score,TCM syndrome score of knee joints were all lower than before treatment,and after 2 and 4 weeks of treatment,the improvement of the above scores was lower in the experimental group than in the control group(P<0.05).In the experimental group,the treatment was effective in 29 patients while ineffective in 4 patients,with an effective rate of 87.80%;in the control group,the treatment was effective in 21 patients and ineffective in 12 patients with an effective rate of 63.60%(P=0.042<0.05).In terms of safety,in the experimental group adverse reactions occurred in 6 patients with a total adverse reaction rate of 15.15%,and in the control group occurred in 4 patients with a total adverse reaction rate of 12.12%(P>0.05).Conclusions:External wash with Jiaotong Decoction can effectively relieve the pain,stiffness,improve joint function and TCM symptoms of KOA of liver and kidney deficiency with wind-cold-damp bi type in a short period of time without obvious adverse reactions.