【摘要】 目的:通过规范的临床研究,系统观察类风湿Ⅰ号丸联合免疫抑制剂甲氨蝶呤(MTX)、来氟米特(LEF)、雷公藤多苷片(TWP)对高度活动类风湿关节炎脾气亏虚、湿热阻络证的治疗,评估临床疗效。方法:将138例高度活动类风湿关节炎,中医辨证为脾气亏虚、湿热阻络证患者随机分为两组,两组均口服同剂量、同疗程MTX、LEF、TWP,治疗组加服类风湿Ⅰ号丸,观察两组治疗后各项疗效评价指标的改善情况,并记录不良反应。结果:治疗24周后两组均有明显疗效,但治疗组左右手握力、关节疼痛数、关节肿胀数、受试者疼痛VAS评分、研究者疾病总体状况VAS评分及RF优于对照组(P<0.05);治疗组晨僵时间,ESR、CRP、CCP,ACR50、ACR70及DAS28有效率明显优于对照组(P<0.01)。结论:类风湿Ⅰ号丸联合MTX、LEF、TWP对高度活动类风湿关节炎有显著疗效,可迅速缓解症状,改善炎症指标。更多还原

【Abstract】 Objective: To systematically evaluate and compare the therapeutic efficacy of RheumatoidⅠcombined with MTX,LEF and TWP in treating highly active rheumatoid inflammation( phlegm resistance of spleen insufficiency,damp-heat stagnation in meridian syndrome of Bi disease) by standard clinical research so as to evaluate the clinical effect. Methods: All of the 138 highly active rheumatoid patients were randomly divided into different groups. All patients took the same dose and course MTX,LEF and TWP while the treating group combined with RheumatoidⅠ. Signs and symptoms and chemical examination result and adverse effect were observed after treatment. Results: After 24 weeks treatment, both groups got obvious curative effect. The grip strength,the numbers of pain and swell joint,patients VAS score with pain,research VAS score and RF in the treatment group were much better than those in the control group( P < 0. 05). The treatment group was superior to the control group in terms of duration of morning stiffness,ESR,CRP,CCP and the improvement of ACR20,ACR50 and DAS28 efficacy judgment( P < 0. 01). Conclusion: RheumatoidⅠcombined with MTX,LEF and TWP can significantly improve the clinical symptoms and laboratory of patients with highly active rheumatoid arthritis.更多还原