重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白治疗难治性类风湿关节炎临床疗效观察.docVIP

重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白治疗难治性类风湿关节炎临床疗效观察 　　[摘要] 目的：探讨重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc)治疗难治性类风湿关节炎的临床疗效。方法：50例难治性类风湿关节炎（refractory or resistant rheumatoid arthritis，RRA）随机分为治疗组25例和对照组25例。治疗组:益赛普25 mg，皮下注射，每周2次，疗程6个月；对照组：安慰剂25 mg，皮下注射，每周2次，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：治疗组ACR20、ACR50、ACR70有效率均高于对照组(P0.05)，治疗组24周ACR20、ACR50、ACR70的有效率高于治疗组4周(P0.05)；治疗组发生不良事件6例(24.0%)高于对照组3例(12.0%)。结沦：rhTNFR:Fc治疗难治性类风湿关节炎有较好的疗效。 　　[关键词] 肿瘤坏死因子类；重组融合蛋白质类；关节炎；类风湿；难治；疗效 　　[中图分类号] R593.22[文献标识码]C [文章编号]1673-7210（2008）08（b）-073-02 　　 　　The curative effect of refractory or resistant rheumatoid arthritis(RRA) with recombinant human tumor necrosis factor(rhTNFR:Fc) protein 　　CHEN Mei-ling, TAN Zhi-ming, ZOU Shi-yong, HUANG Zhi-yong 　　(Huizhou Center Peoples Hospital,Huizhou516001，China) 　　[Abstract] Objective:To study curative effect of refractory or resistant rheumatoid arthritis(RRA) with a recombinant human tumor necrosis factor (rhTNFR:Fc) protein. Methods:50 cases of RRA were randomly divided into 25 cases of treatment group and 25 cases of the control group. The treatment group: 25 mg，subcutaneous injection,the second week,for 6 months; control group: placebo 25 mg，subcutaneous injection,the second week，the course of 24 weeks. Evaluation by the United States Institute of Rheumatology (ACR) criteria to be in effect. Results:The treatment group ACR20,ACR50,ACR70 efficiency were higher than the controls(P0.05),the treatment group 24 weeks ACR20,ACR50,ACR70 efficient than the four-week treatment group(P0.05); treatment group incidence of adverse events 6(24.0%)higher than three cases(12.0%). Conclusion:rhTNFR:Fc treatment of RRA have a better effect. 　　[Key words] Tumor necrosis factors; Recombinant fusion proteins; Arthritis; Rheumatoid; Refractory or resistant; Curative effect 　　 　　重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc)是一种采用重组DNA技术生产的重组融合蛋白[1]。它可以特异性结合肿瘤坏死因子（TNF），阻断其与细胞表面TNF受体相互作用，降低其活性[2]。早期应用可阻止关节破坏，降低致残率。“益赛普”是由上海中信国健药业有限公司自主开发研制的rhTNFR:Fc。为研究该药治疗难治性类风湿关节炎（refractory or resistant rheum