重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白靶向治疗类风湿关节炎的临床疗效观察

Clinical Study on the Efficacy and Safety of Etanercept in the Treatment of Active Rheumatoid Arthritis

目的观察重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(益赛普)联合甲氨蝶呤(MTX)治疗类风湿关节炎的临床疗效观察及安全性。方法类风湿关节炎患者60例,随机分为两组。实验组30例,给予每周两次益赛普25mg注射,联合甲氨蝶呤(MTX)治疗12周;对照组30例,单用MTX治疗12周。结果实验组有效率96.7%,对照组有效率66.7%,实验组与对照组比较差异有统计学意义(P<0.05)。实验组在改善临床症状指标方面明显优于对照组(P<0.05),两组不良反应发生率比较无显著统计学意义。结论益赛普联合MTX治疗与单用MTX相比可明显改善类风湿关节炎临床症状和实验室指标,起效迅速,疗效显著,且不良反应无明显增加。

Objective To study the efficacy safety of etanercept combined with methotrexate （MTX）therapy for patients with active rheumatoid arthritis. Methods The sixty patients with RA were randomly assigned to twice groups.Thirty were randomized to thetreatment group and other thirty were randomized to the control group. The treatment group received etanercept injection 25mg twice weekly while MTX was administered orally by 12 week. The control subjects received MTX 10mg orally once weekly by 12 week. Results At twelfth week,the response achieved 96.7% in the etanercept ＋MTX group and 66.7% in the control group. The results showed that all efficacy endpoints in the etanercept＋MTX group were better than those of the control subjects （P〈0.05）. But there was no significant difference in the total adverse effects between the two groups. Conclusion The etanercept group has shown a rapid efficacy onset and a significantly better therapeutic effect compared to that of the MTX group. The adverse effect does not increase apparently.