独步汤联合常规西药治疗高度活动类风湿关节炎肝肾不足证临床研究

Clinical Study on Dubu Decoction Combined with Conventional Western Medicine for Treatment of Highly Active Rheumatoid Arthritis with Liver and Kidney Deficiency Syndrome

目的探讨独步汤联合常规西药治疗高度活动类风湿关节炎(RA)肝肾不足证的临床疗效和安全性。方法采用随机数字表法将高度活动RA肝肾不足证患者分为试验组和对照组各55例。对照组予甲氨蝶呤片(10 mg/次,1次/周)、艾拉莫德片(25 mg/次,2次/d)、叶酸片(10 mg/次,1次/周),口服;试验组在对照组基础上加用独步汤,1袋/次,2次/d,口服。2组均连续治疗12周。观察2组临床疗效,比较2组治疗前后中医症状积分、关节肿胀数、关节压痛数、晨僵时间、视觉模拟评分法(VAS)评分、28个关节的疾病活动度(DAS28)评分、红细胞沉降率(ESR)、超敏C反应蛋白(hs-CRP)、白细胞介素-6(IL-6),监测止痛药服用情况和不良反应。结果试验组总有效率为96.15%(50/52),对照组为78.85%(41/52),试验组高于对照组(P<0.05)。与本组治疗前比较,2组治疗后中医症状积分、关节肿胀数、关节压痛数、晨僵时间、VAS评分、DAS28评分及ESR、hs-CRP、IL-6水平均显著下降(P<0.05)。2组治疗后比较,试验组中医症状积分、关节肿胀数、关节压痛数、晨僵时间、VAS评分、DAS28评分及ESR、hs-CRP、IL-6水平均低于对照组(P<0.05)。试验组止痛药服药频次比率和不良反应率均低于对照组(P<0.05)。结论独步汤联合常规西药治疗高度活动RA肝肾不足证的临床疗效和安全性优于常规西药,可更加有效地改善患者临床症状和体征,减轻炎症反应,降低止痛药服药频次比率和不良反应率。

Objective To explore the efficacy and safety of Dubu Decoction combined with conventional Western medicine in treating highly active rheumatoid arthritis(RA)with liver and kidney deficiency syndrome.Methods The patients with highly active RA with liver and kidney deficiency syndrome were divided into the experimental group and the control group by random number table method,with 55 cases in each group.The control group was given methotrexate tablets(10 mg/time,once/week),iguratimod tablets(25 mg/time,twice/day),folic acid tablets(10 mg/time,once/week),orally;the experimental group was given Dubu Decoction,1 bag/time,twice/day,orally,on the basis of the control group.Both groups were treated continuously for 12 weeks.Clinical efficacy of both groups was observed.TCM symptom score,joint swelling number,joint tenderness number,morning stiffness time,visual analogue scale(VAS)score,disease activity score of 28 joints(DAS28),erythrocyte sedimentation rate(ESR),high-sensitivity C-reactive protein(hs-CRP),interleukin-6(IL-6),analgesic use and adverse reaction rate were compared between the two groups before and after treatment.Results The total clinical effective rate of the experimental group was 96.15%(50/52)and that of the control group was 78.85%(41/52).The clinical curative effect of the experimental group was significantly higher than that of the control group.Compared with before treatment,the TCM symptom score,joint swelling,joint tenderness,morning stiffness time,VAS score,DAS28 score,ESR,hs-CRP and IL-6 of the two groups decreased significantly after treatment(P<0.05).After treatment,the TCM syndrome score,joint swelling,joint tenderness,morning stiffness time,VAS score,DAS28 score,ESR,hs-CRP,and IL-6 of experimental group were lower than of the control group(P<0.05).The frequency of taking analgesic and the adverse reaction rate of the experimental group were much lower than the control group(P<0.05).Conclusion The clinical efficacy and safety of Dubu Decoction combined with conventional Western medicine in the treatment of highly active RA with liver and kidney deficiency syndrome is better than that of conventional Western medicine,which can effectively improve the clinical symptoms and signs of patients,reduce the inflammatory reaction,reduce the frequency of taking analgesic and the rate of adverse reactions.