艾拉莫德治疗类风湿关节炎多中心随机双盲安慰剂对照研究

Treatment of rheumatoid arthritis with T-614:a multicenter,randomized,double blind,placebo-controlled trial

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 T-614 in treating rheumatoid arthritis （RA）. Methods Two hundred and eighty patients with active RA were randomly allocated to 3 groups： T-614 50 mg each day, 25 mg each day or placebo. Clinical and laboratory parameters were analyzed at baseline, 2, 4, 6, 12, 18 and 24 weeks. Results The ACR response rate was significantly higher in the T-614 treatment group compared with the placebo group during the first 6 weeks. After 24 weeks, 25 mg/d, 50 mg/d dosage group and the placebo group showed 39.1%, 61.3% and 24.2% in ACR20, 23.9%, 31.2% and 7.4% in ACR50 respectively. A time-response in ACR response after 24 weeks was observed, with clear superiority of the 25 mg/d and 50 mg/d dosage groups compared to the placebo, and 50 mg/d dosage group compared to 25 mg/d dosage group （P〈0.05）. ESR, CRP and RF were different significantly in the treatment groups after 24 weeks. Conclusion T-614 is ef- fective in the treatment of rheumatoid arthritis and is well tolerated.