双醋瑞因联合甲氨喋呤治疗类风湿关节炎的临床与-第三军医大学学报.DOCVIP

双醋瑞因联合甲氨喋呤治疗类风湿关节炎的临床研究 尉世同，孙永华，邹巧菲，张鲁阳，卢世涛，宗世华 （264001 山东 烟台，山东省烟台市烟台山医院风湿科） [作者简介] 尉世同，电话：补充座机号码？E-mail：Weishitong_17@ [摘要] 目的 评价双醋瑞因（Diacerein）联合甲氨喋呤（MTX）及单用甲氨蝶呤治疗类风湿关节炎的疗效、细胞因子变化及安全性。 方法 符合纳入及排除标准的类风湿关节炎120例随机数字表法分为单用甲氨喋呤（10 mg/周）组、双醋瑞因联合甲氨喋呤治疗组（Diacerein 50 mg/bid＋MTX 10 mg/周）（问题1：每天2次每次50 mg，还是每天2次共50 mg？用中文，不用bid）。总疗程52周，在2、6、26、52周进行疗效、细胞因子变化及安全性评价，以ACR20作为主要疗效指标，ACR50作为次要疗效指标。结果 在第2、6、26、52周双醋瑞因联合甲氨喋呤组达ACR20改善的患者比例高于甲氨喋呤治疗组，52周时双醋瑞因联合甲氨喋呤组疼痛、PGA、HAQ、ESR、CRP、IL-1、IL-6、TNF-ａ的改善和变化高于单用甲氨喋呤组（P0.01， P 0.05）;甲氨蝶呤;类风湿关节炎;细胞因子 Clinical and experimental study of diacerein combined with the MTX for treatment of aheumatoid arthritis WEI Shitong, SUN Yonghua, ZOU Qiaofei, ZHANG Luyang, LU Shitao,ZONG shihua （Department of Rheumatology, Yantaishan Hospital of Yantai,Shandong，264001,China） [Abstract] Objective Toevaluate the clinical effieacy and cytokines and safety of diacerein combined with the methotrexate(MTX), MTX in patients with active rheumatoid arthritis(RA). Methods 120patients were randonly assigned to receive MTX(10mg/w) or diacerein plus MTX(diacerein 50mg/bid＋MTX10mg/w).The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria(achieving an ACR response) at week 52.The secondary end points were responses of the ACR50. the clinical effieacy and cytokines and safety were analyzed at baseline,2,6,26,52 weeks respectively. Results The ACR response rate was significantly higher in the diacerein plus MTX group compared with MTX group 2,6,26,52. The change was significantly higher in the diacerein plus MTX group compared with MTX group from PGA、HAQ、ESR、CRP、IL-1、IL-6、TNF-ａAt week 52. Conclusion The diacerein plus MTX effectively reduces the sigus and symptoms of RA and is generrally well tolerated by patients without significant increase in the rate of adverse events with monotherapy. [Key words] diacerein；methotrexate(MTX)；rheumatoid arthritis（RA）；cytokine 类风湿关节炎（rheuma