艾拉莫德治疗活动性类风湿关节炎的临床研究

Clinical study of iguratimod in the treatment of active rheumatoid arthritis

目的研究艾拉莫德治疗活动性类风湿关节炎的临床疗效与安全性。方法选取90例活动性类风湿关节炎患者，按随机数字表法分为A组、B组和c组，每组30例。A组患者给予艾拉莫德25mg口服，2次／d；甲氨蝶呤10mg口服，1次倜。B组患者给予艾拉莫德25mg口服，2次／d。C组患者给予甲氨蝶呤15mg口服，1次／周。根据美国风湿病学会标准判定肿胀及触痛关节数改善达20％、50％和70％（ACR20、ACR50、ACR70）情况，并观察不良反应。结果A组和B组治疗后ACR20、ACR50和ACR70均高于C组[76．67％（23／30）和60．00％（18／30）比40．00％（12／30）、50．00％（15／30）和33.33％（10／30）比20．00％（6／30）、23．33％（7／30）和13．33％（4／30）比6．67％（2／30）]，而且A组高于B组，差异均有统计学意义（P〈0．05）。A组和B组不良反应发生率明显低于c组[16．67％（5／30）和13．33％（4／30）比30．00％（9／30）]，差异有统计学意义（P〈0．05）；A组和B组不良反应发生率比较差异无统计学意义（P，0．05）。结论单药应用艾拉莫德治疗活动性类风湿关节炎疗效优于甲氨蝶呤，且不良反应少；两者联合应用效果更显著，而且可减少甲氨蝶呤剂量，减少不良反应发生率，值得临床推广应用。

Objective To study the clinical efficacy and safety of iguratimod in the treatment of active rheumatoid arthritis. Methods Ninety patients with rheumatoid arthritis were randomly divided into three groups, with 30 cases in each group. Group A： oral administration of iguratimod, 25 mg two times a day, and oral administration of methotrexate, 10 mg once a week. Group B： oral administration of iguratimod, 25 mg two times a ady. Group C： oral administration of methotrexate, 15 mg once a week. According to the American College of Rheumatology criteria for judging 20%, 50% and 70% （ACR20, ACR 50 and ACR 70） improvement of swollen and tender joint was judged according to the American College Of Rheumatology criteria, and the adverse reactions were observed. Results After the treatment in group A and group B ACR20, ACR50 and ACR70 were higher than those in group C [76.67% （23/30） and 60.00% （18/30） than 40.00% （12/30）, 50.00% （15/30） and 33.33% （10/30） than 20.00% （6/30）, 23.33% （7/30） and 13.33% （4/30） than 6.67% （2/30）], and in group A was higher than that in group B. The differences were statistically significant （P 〈 0.05）. The adverse reaction rate in group A and group B was significantly lower than that in group C ：16.67% （5/30） and 13.33% （4/30） than 30.00% （9/30）, and the difference was statistically significant （P 〈 0.05）; the adverse reaction occurred rate in group A and group B, had no significant difference （P 〉 0.05）. Conclusions Monotherapy with iguratimod in the treatment of active rheumatoid arthritis is superior to methotrexate, and has fewer side effects. The combined application of the two drugs is more effective, and can reduce the dose of methotrexate and reduce the incidence of side effects, which is worthy of clinical application.