重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎有效性和安全性研究

The Efficacy and Safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ for Treatment of Rheumatoid Arthritis

目的研究重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(益赛普,Ecep)对活动性类风湿关节炎(RA)患者的有效性及安全性。方法 68例活动性RA患者随机分为两组,试验组患者给予25mg益赛普(Ecep)皮下注射,每周2次;对照组患者给予1.0柳氮磺吡啶(SASP)口服,每日2次,10mg甲氨喋呤(MTX)口服,每周1次。试验疗程24周。结果治疗2,4,8,12,24周后,Ecep组ACR50有效率均高于SASP+MTX组。组间比较差异有统计学意义(P<0.05);两组药物之间总的不良反应发生率差异无统计学意义(P>0.05)。结论益赛普(Ecep)用于治疗活动性RA具有良好的有效性及安全性。

Objective To study the efficacy and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ（Etanercept） on the activity of rheumatoid arthritis （ RA ）. Methods Sixty-eight patients with active RA were randomly divided into two groups. Experimental group ： 25mg Ecep was given twice times perweek by subcutaneous injection;The control group：1. 0 sulfasalazine（ SASP） for twice a day and 10mg methotrexate（ MTX） for once a week was given by oral administration. The course of treatment persisted 24 weeks. Results Two, four, eight, twelve and twenty- four weeks after treatment, the ACR50 effective rate in Ecep group was higher than that of SASP ＋ MTX group. The difference between the two groups was significant （ P 〈 0.05 ） ; The difference between the two groups in incidence of adverse reactions was not significant （ P 〉 0.05 ）. Conclusion Etanercept has good efficacy and safety for the treatment of active RA.