补肾清化治尪汤联合甲氨喋呤治疗类风湿关节炎湿热伤肾证的疗效

The evaluation of clinical efficacy and safety of Bushenqinghuazhiwang decoction combined with methotrexate in the treatment of rheumatoid arthritis belonging to dampness-heat injury kidney syndrome

目的:评价补肾清化治尪汤联合甲氨喋呤(MTX)治疗类风湿关节炎(RA)湿热伤肾证的临床疗效和安全性。方法:采用前瞻性、随机对照研究,治疗组(100例)予补肾清化治尪汤联合MTX(10mg/周),对照组(100例)予MTX(10mg/周),2组疗程均为24周。观察治疗前后临床症状体征、病情评估、健康状况评估(HAQ)、疾病活动指数(DAS28)、血沉(ESR)、C反应蛋白(CRP)、安全性指标、中医证候积分等改变。结果:治疗组总有效率(81.7%)显著高于对照组(65.8%)(P<0.01)。2组治疗后在症状体征、ESR、CRP、患者对疾病评估(VAS)、医生对疾病评估(VAS)、HAQ、DAS28、中医证候积分等方面均有显著改善(均P<0.01)。治疗组在减少压痛关节数、肿胀关节数、降低ESR、CRP、改善患者对疾病评估(VAS)、医生对疾病评估(VAS)、DAS28、中医证候积分等方面均优于显著对照组(均P<0.05),不良反应显著少于对照组(P<0.05)。结论:补肾清化治尪汤与MTX联合用药治疗RA湿热伤肾证可缓解症状、改善关节功能活动、体征及降低ESR、CRP,减少MTX的不良反应。

Objective：To evaluate clinical efficacy and safety of Bushenqinghuazhiwang decoction（BSQHZWT）combined with methotrexate（MTX）in the treatment of rheumatoid arthritis（RA）belonging to dampness-heat injury kidney syndrome.Methods：A prospective,randomly controlled study was carried out.Treatment group treated with BSQHZWT combined with MTX（10 mg/week）for 24 weeks,control group with MTX（10 mg/week）.The efficacy and safety indexes were evaluated at baseline and 24 weeks after the treatment,including clinical signs and symptoms,condition assessment,disease activity index 28（DAS28）,laboratory parameters of erythrocyte sedimentation rate（ESR）and C-reactive protein（CRP）,safety index and TCM syndrome integral.Results：The effective rate of treatment group（81.7%）was significantly higher than that of the control group（65.8%）.Two groups had significant improvement after the treatment（all P 〈0.01）.The treatment group significantly excelled the control group in improving tender joints,swollen joints,the global disease assessment of patients and doctors（VAS）,ESR,CRP,DAS28 and TCM syndrome integral（all P 〈0.05）.Besides,the side effects of the treatment group were significantly lower than those of the control group（P〈0.05）.Conclusion：BSQHZWT combined with MTX had the effect to relieve symptoms,improve joint function,reduce ESR and CRP,and reduce the side effect in the treatment of RA belonging to dampness-heat injury kidney syndrome.