甲氨蝶呤联合艾拉莫德治疗活动期类风湿关节炎的疗效和安全性

Efficacy and Safety of Methotrexate Combined Iguratimod in Treatment of Active Rheumatoid Arthritis

目的观察甲氨蝶呤(MTX)联合艾拉莫德治疗活动期类风湿关节炎(RA)的疗效和安全性。方法选取符合美国风湿病学会(ACR)和欧洲抗风湿联盟(EULAR)2010年联合推出的RA诊断标准的活动期RA患者60例,按随机数字表法分为研究组和对照组,每组30例。研究组采用MTX+艾拉莫德治疗,对照组单用MTX治疗。记录治疗前及治疗24周后2组关节压痛计数、关节肿胀计数、疼痛指数(VAS评分)、患者对病情的总体评估(VAS评分)、医生对病情的总体评估(VAS评分)、RA疾病活动性评分(DAS28)、健康评估问卷(HAQ)、简明疾病活动指数(SDAI)及血常规、尿常规、肝肾功能、血沉(ESR)、C反应蛋白(CRP),并评估2组ACR缓解率和安全性。结果治疗24周后,研究组ACR50、DAS28、ESR、CRP、HAQ、SDAI、关节肿胀计数、关节压痛计数、疼痛指数、患者对病情总体评估、医生对病情总体评估均优于对照组(P<0.05);研究组不良事件与对照组相比未见明显增多(P>0.05)。结论 MTX联合艾拉莫德治疗活动期RA较单用甲氨蝶呤临床疗效好,且不良事件小,安全性好。

Objective To observe the efficacy and safety of methotrexate（MTX）combined with iguratimod in the treatment of active rheumatoid arthritis（RA）.Methods Sixty RA patients were enrolled according to the 2010 American College of Rheumatology（ACR）and the European League Against Rheumatism（EULAR）classification criteria,and were randomly treated with MTX alone（control group,n=30）or in combination with iguratimod（combined group,n=30）.The counts of joint tenderness and swelling,VAS scores for pain index and patients＇ and physicians＇ global assessment,disease activity score of RA（DAS28）,questionnaires for health assessment（HAQ）,simplified disease activity index（SDAI）,routine blood parameters,routine urine parameters,hepatic and renal function,erythrocyte sedimentation rate（ESR）,and C-reactive protein（CRP）levels were recorded before and after treatment for 24 weeks.In addition,the ACR remission rate and safety were evaluated in both groups.Results Compared with control group,the ACR50,DAS28,ESR,CRP,HAQ、SDAI、counts of joint tenderness and swelling、pain index、patients＇ and physicians＇ global assessment,and other improved in combined group（P〈0.05）.No significant differences in adverse reactions were found between the two groups（P〈0.05）.Conclusion Combined treatment with MTX and iguratimod is superior to MTX alone for treating active RA with less adverse reactions and higher safety.