摘要目的研究注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（益赛普）和甲氨蝶呤治疗类风湿关节炎(RA)的临床疗效和不良反应。方法将46例活动性RA患者采用随机分层抽样法分为益赛普组和甲氨蝶呤组，益赛普组22例，皮下注射益赛普12.5 mg，每周2次；甲氨蝶呤组24例，口服甲氨蝶呤5～ 10mg，每周1次。24周为1个观察周期，观察并比较两组的美国风湿病学会评价标准20％、50％、70％改善(ACR20、ACR50、ACR70)情况及药物的不良反应。结果治疗后24周益赛普组ACR50、ACR70分别为54.5％(12/22)、31.8％(7/22)，甲氨蝶呤组分别为16.7％(4/24)、4.2％（1/24），两组比较差异有统计学意义(P＜0.05)。益赛普组总有效率为86.4％ (19/22)，甲氨蝶呤组为20.8％(5/24)，两组比较差异有统计学意义(P＜0.05)。益赛普组不良反应发生率为22.7％(5/22)，甲氨蝶呤组为50.0％(12/24)，两组比较差异有统计学意义(P＜0.05)，益赛普组胃肠道反应少。结论益赛普治疗RA起效快，疗效可靠，不良反应少，耐受性好。

abstractsObjective To evaluate and compare the efficacy and adverse effects of recombinant human tumor necrosis factor receptor Ⅱ : IgG Fc protein for injection (etanercept) and methotrexate ( MTX )regimens for rheumatoid arthritis (RA). Methods Forty-six patients were randomly divided into two groups by stratified sampling method:etanercept group,22 patients were treated with 12.5 mg of etanercept,twice times per week by subcutaneous injection;and MTX group,24 patients were treated with 5-10 mg of MTX,once per week by oral administration. The course of treatment lasted 24 weeks in both groups, so as to observe their ACR20, ACR50, ACR70 and adverse effects of the drugs. Results After treated for 24 weeks,ACR50,ACR70 respectively achieved 54.5％ (12/22),31.8％ (7/22) in etanercept group,which were significantly higher than those in MTX group [16.7％(4/24),4.2％( 1/24)]. The total efficacy was 86.4％ (19/22) in etanercept group, 20.8％ (5/24) in MTX group, the difference between the two groups was significant (P ＜ 0.05 ). The incidence of adverse effects was not significant between the two groups [22.7％(5/22) vs. 50.0％ (12/24)](P ＞ 0.05). Conclusion Etanercept has a good efficacy and safety for the treatment of active RA.