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目的研究艾拉莫德片(T-614)治疗类风湿关节炎(RA)的疗效和安全性。方法280例活动期RA患者分别采用T-614 50 mg/d(25 mg/次,每天2次)、25 mg/d(25 mg/次,每天1次)和安慰剂治疗。疗程为24周,并在2、6、12、18、24同时进行疗效及观察指标评估。结果直到用药后6周治疗组达到ACR20及ACR50的比例才显著高于安慰剂组(P<0.05),而12周、18周和24周的疗效观察显示治疗组的疗效随时间推移而逐渐增高,在24周时,25 mg组、50 mg组和安慰剂组的ACR20分别为39.1%、61.3%和24.2%.ACR50分别为23.9%、31.2%和7.4%,ACR20及ACR50治疗组优于安慰剂组,50 mg组优于25 mg组(P<0.05)。治疗组在红细胞沉降率、C反应蛋白、类风湿因子改善程度差值组间比较有统计学意义。T-614治疗组耐受性良好。结论艾拉莫德治疗RA具有良好的安全性和显著的疗效。
Objective To study the efficacy and safety of ralumure tablets (T-614) in the treatment of rheumatoid arthritis (RA). Methods 280 active RA patients were treated with T-614 50 mg / d (25 mg twice daily), 25 mg / d (25 mg once daily) and placebo. The course of treatment was 24 weeks, and in 2, 6, 12, 18, 24 at the same time the efficacy and evaluation of indicators. Results The ratio of ACR20 and ACR50 in the treatment group was significantly higher than that in the placebo group (P <0.05) 6 weeks after treatment, and the therapeutic effects at 12 weeks, 18 weeks and 24 weeks showed that the therapeutic effect of the treatment group gradually increased over time ACR20 was 39.1%, 61.3%, and 24.2% in the 25 mg, 50 mg, and placebo groups at 24 weeks, with ACR 50 of 23.9%, 31.2%, and 7.4%, respectively The dosage of 50 mg group was better than that of 25 mg group (P <0.05). The treatment group in the erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor improvement difference between the two groups was statistically significant. T-614 treatment group was well tolerated. Conclusion iguratimod on RA has good safety and significant curative effect.