依那西普治疗活动性类风湿关节炎的安全性和有效性  

Efficiency and safety of etanercept in patients with rheumatoid arthritis:an open-label controlled trial

作　　者：艾脉兴[1] 马丽[1] 赵孟君[1] 王丽英[1] 林冰[1] 王国春[1] 吴东海[1] 

机构地区：[1]卫生部中日友好医院风湿免疫科,北京100029

出　　处：《中国新药杂志》2007年第15期1208-1211,共4页Chinese Journal of New Drugs

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(依那西普,etanercept,rhTNF:Fc)对活动性类风湿关节炎(RA)患者的疗效及安全性。方法:本研究为标签开放研究。30例活动期RA患者随机分为试验组和对照组,每组15例。试验组在每周口服甲氨蝶呤(MTX)10～15 mg基础上联合应用依那西普,每周皮下注射2次,每次25 mg。对照组口服相同剂量的MTX。疗程均12周。疗效采用美国风湿病学会(ACR)核心标准评定。结果:治疗6周后,试验组和对照组的ACR20比例分别为42.8%和21.4%(P<0.001),ACR50缓解比例为14.3%和0%(P<0.001)。治疗12周后,试验组和对照组的ACR20比例分别为71.4%和50.0%(P=0.003),ACR50缓解比例为42.9%和0%(P<0.001)。试验组主要不良反应是注射部位局部反应。结论:MTX联用依那西普比单用MTX治疗RA起效快、疗效肯定、安全性好。Objective： To determine the effect of recombinant human tumor necrosis factor receptor-Fc fusion protein（ rhTNFR ： Fc, etanercept） treatment in active rheumatoid arthritis （RA）. Methods ： Thirty patients with active RA were enrolled. 15 patients were treated with methotrexate （ 10 ～ 15 mg, once a week）as monotherapy. Other 15 patients were treated with methotrexate（ 10 ～15 mg, once a week） and etanercept（25 mg, twice a week）as combined therapy. The percentage of patients achieving a 20 percent ACR criteria for improvement was recorded at 2-week and 12-week. The adverse events were monitored throughout the trial. Results： As compared with patients who received methotrexate, patients who received the 25-mg dose of etanercept had a more rapid rate of improvement, with significantly more patients having 20 percent improvement （ACR core set）in disease activity during the first 6 weeks （ACR20, MTX 21.4% vs etanercept plus MTX 42.8% ,P 〈 0. 001. ACR50, MTX 0% vs etanercept plus MTX 14.3% , P 〈0. 001 ） and 12 weeks （ ACR20, MTX 50.0% vs etanercept plus MTX 71.4% , P = 0. 003. ACRS0, MTX 0% vs etanercept plus MTX 42.9% , P 〈 0. 001 ）. The adverse events associated with etanercept were mild injection-site reactions. Conclusion： Compared with oral methotrexate, subcutaneous etanercept can safely provide rapid, significant, and sustained benefit in patients with active rheumatoid arthritis.

关 键 词：类风湿关节炎 Ⅱ型肿瘤坏死因子受体 甲氨蝶呤 依那西普 

分 类 号：R593.22[医药卫生—内科学] R969.4[医药卫生—临床医学]