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[目的]探讨益赛普联合甲氨蝶呤治疗中重度活动性类风湿关节炎(RA)患者的疗效及安全性.[方法]84例中重度RA患者,随机分为试验组(益赛普+甲氨蝶呤)和对照组(激素+甲氨蝶呤),各42例;比较连续治疗24周后两组患者的临床疗效及不良反应.[结果]治疗24周后,两组血沉(ESR)、C反应蛋白(CRP)、类风湿因子(RF)、疾病活动性评分(DAS28)及腕关节(WJ)、第2及第3掌指关节(MCP2、3,)、第2及第3近端指间关节(PIP2、3)、膝关节(Kne)的滑膜厚度均较治疗前降低(P<00.5),且试验组较对照组降低更为显著(P<00.5);试验组按美国风湿病学会(ACR)疗效标准,ACR20、ACR50、ACR70疗效分别为833.3%(35/42)、619.0%(26/42)、428.6%(18/42),对照组分别为761.9%(32/42)、476.2%(20/42)、214.3%(9/42),试验组的ACR70疗效率高于对照组(P<00.5);试验组的不良反应发生率为261.9%,高于对照组190.5%(P<00.5).[结论]益赛普联合甲氨蝶呤治疗中重度活动性RA患者的临床效果较好,但不良发应发生率较高.“,”[Objective] To study the clinical efficacy and safety of etanercept combined with methotrexate in the treatment of pa-tients with moderate to severe rheumatoid arthritis (RA) .[Methods]Eighty-four cases of severe RA patients were randomly divided into experimental group (etanercept + methotrexate) and control group (hormone + methotrexate) ,42 cases in each group .The clini-cal efficacy and side effects of the two groups were compared after 24 weeks of continuous treatment [.Results]After 24 weeks of treat-ment ,the synovial membrane thicknesss of erythrocyte sedimentation rate (ESR) ,C reactive protein (CRP) ,rheumatoid factor (RF) , disease activity score (DAS28) and wrist ,the second and third metacarpophalangeal joints (MCP2 ,3) ,the second and third proximal interphalangeal joints (PIP2 ,3) and the knee of the two groups were lower than those before treatment ( P <00.5) ,and the experi-mental group was more significant than the control group ( P <00.5);The efficacy of ACR20 ,ACR50 and ACR70 in the experimental group were 833.3% (35/42) ,619.0% (26/42) ,and 428.6% (18/42) ,and that of the control group were 761.9% (32/42) ,476.2%(20/42) ,214.3% (9/42);the efficiency of ACR70 in the experimental group was higher than that of the control group ( P <00.5);The incidence of adverse reactions in the experimental group was 261.9% ,which was higher than that in the control group (190.5% ) ( P <00.5)[.Conclusion]Etanercept combined with methotrexate has better clinical outcome in treatment of severe active RA ,but the incidence of adverse is higher .