艾拉莫德联合甲氨蝶呤治疗活动性类风湿关节炎的临床研究

Clinical effect of iguratimod combined with methotrexate in the treatment of rheumatoid arthritis

目的研究艾拉莫德(Iguratimod,T-614)联合甲氨蝶呤(MTX)治疗活动性类风湿关节炎(RA)的疗效及安全性。方法将符合纳入研究标准的60例RA患者,按照随机数字表随机分成实验组和对照组,每组30例。对照组给予MTX口服,15 mg/次,1次/周。实验组在对照组治疗的基础上加用T-614口服,25 mg/次,饭后服用,早晚各一次,两组患者疗程均为12周。观察两组患者治疗前后关节肿胀、疼痛改善情况,红细胞沉降率(ESR)、C反应蛋白(CRP)、类风湿因子(RF)、抗环瓜氨酸肽(CCP)抗体等指标的变化以及不良反应的发生情况,根据上述指标计算并比较两组患者的ACR20、ACR50、ACR70的比率。结果两组患者治疗12周后的临床症状、体征和实验室指标均有明显好转,实验组、对照组患者ACR20有效率分别为83.33%和50.00%,ACR50有效率分别为66.67%和36.67%,ACR70有效率分别为53.33%和26.67%,实验组患者临床疗效均优于对照组,两组比较差异具有统计学意义(P<0.01或P<0.05)。两组患者均无严重不良反应发生,不良反应发生率比较差异无统计学意义(P>0.05)。结论 T-614联合MTX治疗活动性RA疗效明显优于单用MTX,安全性较好,值得推广应用。

Objective To explore the clinical effect and safety of iguratimod （T-614） combined with methotrexate （MTX） in the treatment of rheumatoid arthritis（RA）. Methods 60 patients with RA were randomly divided into experimental group and control group according to random number table,30 cases in each. Control group was treated with oral MTX, 15 mg per time, once a week, while experimental group was treated with iguratimod on the based of control group, the treatment of iguratimod was 25mg per time after meals , b. i. d. The treatment course of both groups were 12 weeks. The joint swelling, pain relief, the changes of the erythrocyte sedimentation rate （ ESR）, C-reactive protein （ CRP）, the rheumatoid factor （ RF）, anti-cyclic citrullinated peptide （CCP） antibodies as well as other indicators and the occurrence of the adverse reaction of the two groups were observed before and after treatment. The ratio of ACR20, ACR50, ACR70 between the two groups were calculated and compared based on the above index. Results After 12 weeks of treatment, the clinical symptoms, signs and laboratory parameters were significantly improved in the two groups. The effective rate of ACR20, ACR50, ACR70 in experimental group were 83.33%, 66.67% ,53.33% and 50.00%, 36.67% ,26.67% in control group,respectively. The clinical efficacy of the experimental group was better than that in the control group and the difference was statistically significant （P 〈 0.01 or P 〈 0.05）. Both of the two groups had no serious adverse events, and the incidence of adverse reactions between two groups was no significant difference （P 〉 0.05）. Conclusions T-614 combined with MTX show a good clinical efficacy and security in the treatment of RA, which is better than MTX treatment alone and should be widely applied.