重组人Ⅱ型肿瘤坏死因子受体-体融合蛋白联合甲氨蝶呤对改善病情抗风湿药治疗无效活动性类风湿关节炎的疗效

目的观察重组人Ⅱ型肿瘤坏死因子受体．抗体融合蛋白（rhTNFR：Fc，益赛普）联合甲氨蝶呤（methotrexate，MTX）对改善病情抗风湿药（disease—modifying antirheumatic drug，DMARD）无效类风湿关节炎（rheumatoid arthritis，RA）患者的疗效。方法DMARD治疗效果不佳的活动性RA患者64例，根据患者性别、年龄、病程及疾病活动程度将患者随机分为具有可比性的两组。试验组32例，予每周2次皮下注射rhTNFR：Fc 25mg／次．同时口服MTX 15mg／周；对照组32例，13服泼尼松5～10mg／d，同时口服MTX1 5mg／周。疗程12周。疗效评价采用美国风湿病学会（ACR）疗效评定标准。结果治疗第4、8和12周，试验组ACR20有效率（45．2％、54．8％和64．5％）均显著高于对照组（16．1％、19．4％和22．6％）（P〈0．05）。治疗第8和12周试验组ACR50有效率亦显著高于对照组（P〈0．05）。结论相对于应用小剂量激素联合甲氨蝶呤，rhTNFR：Fc联合甲氨蝶呤治疗DMARD无效的RA效果更佳。

Efficacy of Combination Therapy with rhTNFR：Fc Plus Methotrexate in the Patients with Disease-modifying Antirheumatic Drug-resistant Rheumatoid Arthritis

Objective To observe the efficacy of combining recombinant human tumour necrosis factor-Fc （rhTNFR：Fc, etanercept） and methotrexate （MTX） in patients with disease-modifying antirheumatic drug （DMARD）-resistant rheumatoid arthritis. Methods Sixty-four active RA patients with DMARD-resistant were enrolled in this study. According to patients＇ gender, age, duration and extent of disease activity, they were randomly divided into two groups. Thirty-two patients were treated with twice-weekly subcutaneous etanercept （25 mg） puls weekly oral MTX （15 mg）; the other thirty-two patients were treated with daily oral prednisone （5-10 mg） puls weekly oral MTX （15 mg）. Course of treatment was 12 weeks. Clinical response was assessed using American College of Rheumatology （ACR） criteria. Results Compared with patients receiving prednisone and MTX, patients received etanercept and MTX had a more significant improvement at ACR20 at 4th, 8th and 12th weeks （P 〈 0.05）, and a more significant improvement at ACR50 at 8th and 12th weeks （P 〈 0.05）. Conclusion traditional combination of MTX and low dose prednisone, etanercept combining MTX is Compared to more effective in patients with DMARD-resistant rheumatoid arthritis.