艾拉莫德或来氟米特联合甲氨蝶呤治疗活动性类风湿关节炎的疗效和安全性比较:一项多中心 随机 双盲 双模拟对照的临床研究

目的旨在评价艾拉莫德联合甲氨蝶呤治疗活动性RA的疗效与安全性.方法本研究是一项多中心、随机、双盲、双模拟、对照临床试验.研究纳入中重度活动期RA患者,按照1∶1比例随机分配到艾拉莫德联合甲氨蝶呤治疗组(A组)与来氟米特联合甲氨蝶呤治疗组(B组).分别在用药后12、24、52周对2组的疗效和安全性进行评价.主要疗效终点为治疗后52周ACR20达标率.分别采用Pearson χ^2检验及两因素方差分析比较2组52周时ACR20达标率以及DAS28改善幅度,采用Pearson χ^2检验或Fisher确切概率检验比较2组治疗后ACR50和ACR70达标率之间差异.2组中计量资料采用独立样本t检验或非参数检验进行比较.结果共有240例符合入排标准的患者纳入研究.基线2组人口统计学资料与疾病活动性比较差异无统计学意义.A组和B组治疗后52周ACR20达标率分别为84.1%与81.0%(χ^2=0.35,P=0.56).2组在用药后12、24、52周ACR50/70达标率、DAS28、简明疾病活动指数以及同基线比DAS28下降绝对值比较差异均无统计学意义.A组不良事件更少(60.0%和79.0%,P<0.01).A组较B组出现AST/ALT升高和白细胞降低者更少,且更少使用护肝药物(P<0.05).结论艾拉莫德联合甲氨蝶呤是一种安全、有效的治疗活动性RA的方案,其疗效与来氟米特联合甲氨蝶呤相当,但安全性更好.

The efficacy and safety of iguratimod or leflunomide combined with methotrexate in treating active rheumatoid arthritis(TRANMOD):a multicenter,randomized,double-blinded,double dummy and controlled clinical trial

Objective The aim of this study was to compare the efficacy and safety of iguratimod(IGU)or leflnomide(LEF)in combination with methotrexate(MTX)in patients with active rheumatoid arthritis(RA).Methods This was a multicenter,randomized,double-blinded,double dummy and controlled clinical trial.Patients with moderate or high active RA were randomized in a 1∶1 ratio to receive IGU+MTX(Group A)or LEF+MTX(Group B)treatment.The efficacy and safety were assessed at week 12,24 and 52,respectively.The primary endpoint was the American Colleague of Rheumatology 20(ACR20)response rates at the 52th week.Pearson chi square test and two-way Analysis of Variance(ANOVA)were used to compare the improve-ment of ACR20 and DAS28 at 52 weeks.Pearson chi square test or Fisher exact probability test were used to compare the ACR 20 and ACR70 rate between the two groups after treatment.The measurement data of the two groups were compared by independent sample t-test or nonparametric test.Results A total of 240 RA patients were enrolled in the present study.As a result,84.1%and 81.0%of patients achieved ACR20 criteria at the 52th week in Group A and Group B,respectively(χ2=0.35,P=0.56).And the ACR50/70 response rates,disease activity score 28(DAS28),simplified disease activity index(SDAI)and the absolute decrease of DAS28 from baseline were not statistically different between the two groups at week 12,24 and 52.The rates of adverse events were lower in Group A than those in Group B(60.0%vs 79.0%,P<0.01).The elevations of glutamic pyruvic transaminase/glutamic oxalacetic transaminase levels,concomitant use of hepatinica and white blood cell decrease were more common in Group B(P<0.05).Conclusion IGU in combination with MTX is an efficacious and safe treatment regimen,which is comparable in efficacy in control active RA but superior in safety to LEF combined with MTX.