重组人Ⅱ型肿瘤坏死因子受体-Fc融合蛋白联合甲氨蝶呤治疗中重度类风湿关节炎的疗效与安全性

Efficacy and safety of recombinant human typeⅡtumor necrosis factor receptor-Fc fusion protein combined with methotrexate in the treatment of moderate to severe rheumatoid arthritis

目的:观察国产重组人Ⅱ型肿瘤坏死因子受体-Fc融合蛋白(TNFRⅡ-Fc)与甲氨蝶呤(MTX)联合治疗中重度类风湿关节炎的疗效与安全性。方法:46例病人随机分为MTX组和TNFRⅡ-Fc联合MTX组,疗程24周。疗效评价采用美国风湿病学会(ACR)疗效评定标准。结果:治疗2周后,联合治疗组的ACR20改善率和ACR50改善率均显著高于MTX组(P<0.05,P<0.01)。治疗24周后,联合治疗组的ACR50改善率约为MTX组的2倍;ACR70改善率约为MTX组的3.5倍。与基线值相比,MTX组在治疗12周后DAS28明显下降,而联合治疗组在治疗2周后DAS28即有所下降。在治疗2～24周期间,联合治疗组的DAS28较基线值下降的幅度均显著大于MTX组。MTX组和联合用药组不良事件总的发生率分别为17.4%和30.4%,差异无显著意义。其中最常见的不良事件为恶心和上腹不适。结论:TNFRⅡ-Fc联合MTX较单用MTX能更有效控制类风湿关节炎的病情活动,且不良反应无明显增加。

Objective： To evaluate the efficacy and safety of recombinant human type Ⅱ tumor necrosis factor receptor-Fc fusion protein （TNFR Ⅱ-Fe） combined with methotrexate （MTX） in the treatment of moderate to severe rheumatoid arthritis. Methods：Forty-six patients were randomized into two groups, and treated with either TNFR Ⅱ Fc combined with MTX （the combined group） or MTX monotherapy（the MTX group）, all with a treatment course of 24 weeks. Clinical assessments were performed by using the American College of Rheumatology （ACR） Improvement Criteria. Results： After 2 weeks of treatment, the percentages of the patients meeting ACR20 and ACR50 Improvement Criteria were significantly higher in the combined group than those in the MTX group, At 24 weeks, the percentages of the patients meeting ACR50 and ACR 70 Improvement Criteria in the combined group were nearly twice and 3.5 times of those in the MTX group, respectively. Significant decrease in DAS28 occurred after 2 and 12 weeks of treatment in the combined group and in the MAX group, respectively. During 2 24 weeks of treatment,the decrease in DAS28 from the baseline for the combined group was obviously more than that for the MTX group. There was no significant difference in the adverse events between the MTX group and the combined group （17.4 %vs 30.4%）. Conclusion：TNFR JI-Fc combined with MTX seems to produce better efficacy on the control of disease activity of rheumatoid arthritis than MTX monotherapy,and there was no significant increase in adverse drug reactions.