四妙消痹汤治疗类风湿关节炎活动期临床研究

Clinical Study on Active Rheumatoid Arthritis Treated with Simiao Xiaobi Decoction

目的观察四妙消痹汤治疗类风湿关节炎(rheumatold arthritis,RA)活动期湿热毒痹证的临床疗效及安全性。方法将120例患者随机分为治疗组(四妙消痹汤组,60例)和对照组(甲氨蝶呤组,60例),疗程均为12周。评价治疗前后中、西医疗效,中、西医症状体征,中医证候积分及DAS28积分,理化指标变化,远期疗效及平均起效时间,其中西医疗效评价参照欧洲风湿病防治联合会(EULAR)判定标准,对药物疗效进行意向性分析(ITT)和符合方案数据分析(PP),同时观察记录不良反应。结果研究纳入患者120例(ITT集),完成观察患者103例(PP集)。PP分析显示:治疗组(52例)中、西医疗效均优于对照组(51例,分别是92.3%vs70.6%及86.5%vs62.7%,P<0.05)。在改善患者症状、体征,降低中医证候积分、DAS28积分以及远期疗效方面,治疗组较对照组有一定优势。治疗组起效时间(周)5.31±0.36短于对照组(8.28±0.45,P<0.05),而不良反应发生率(6.7%)低于对照组(43.3%,P<0.05)。结论四妙消痹汤可综合改善类风湿关节炎活动期湿热毒痹证患者的关节及全身病变,且起效早,不良反应较少。

Objective To observe the clinical efficacy and safety of Simiao Xiaobi Decoction （SXD） in treating active rheumatoid arthritis （RA） of humid pyretic toxic Bi-Zheng （HPTB） syndrome type. Methods One hundred and twenty RA patients were randomly assigned to 2 groups, 60 in the treatment group receiving SXD, and 60 in the control group receiving methotrexate, all were treated for 12 weeks. Clinical efficacy in patients was evaluated, referring to the criteria recommended by European League Against Rheumatoism （ EULAR）, in terms of effective rate, main symptoms, signs, scoring on symptom/sign by Chinese medicine scale and DAS28, physical and chemical indices, long-term outcome of patients and the average therapeutic effect initiating time. Meantime, the adverse reaction was recorded. Results The study was completed in 103 patients, 52 in the treated group and 51 in the control group. According to a per-protocol analysis, the effective rate was better in the treatment group than in the control group with marked difference in terms of Chinese and Western medicine respectively （92.3% vs 70.6% and 86.5% vs 62.7%, P 〈0.05）. Superiorities in the treatment group were also seen in the improvements of main symptoms and signs, symptom/sign scores, DAS28 scores, and long-term outcome. Moreover, the average therapeutic effect initiating time was shorter （5.31 ±0.36 weeks vs 8.28 ± 0.45 weeks）, while the incidence of adverse reaction was less in the treatment group than in the control group （6.7% vs 43.3%, P 〈 0. 05）. Conclusion SXD can improve the joint symptoms and general condition of RA patients of HPTB type with shorter initiating time and less adverse reaction.