重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白对类风湿关节炎病人实验室指标的影响的初步观察

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,商品名“益赛普”)对类风湿关节炎病人实验室指标的影响。方法:采用随机、双盲双模拟、阳性药物对照的方法,将40例活动性类风湿关节炎病人随机分为试验组和对照组。治疗组20例,受试者每周口服1次空白模拟甲氨喋呤(MTX)(7.5mg/次起,8周内逐步加到15mg/次),同时每周2次皮下注射rhTNFR:Fc(25mg/次);对照组20例,受试者每周1次口服MTX(7.5mg/次起,8周内逐步加到15mg/次,同时每周2次皮下注射空白模拟rhTNFR:Fc(25mg/次)。连续用药24周。观察药物对血常规、肝肾功能和类风湿关节炎炎症活动指标的影响。结果:治疗组出现1例白细胞下降,1周内复查恢复正常,未发现药物对红细胞系统、血小板系统和肝肾功能有不良影响。治疗后两组病人的ESR均有明显下降,但益赛普于用药2周即可显著降低ESR,起效速度快于对照组。两组病人CRP、RF滴度均有显著下降,两组差别无统计学意义。结论:益赛普与MTX均可有效降低RA炎症或病情活动的指标。益赛普有良好的实验室指标安全性。

The Influence of Recombinant Human TUmor Necrosis Factor Receptor-Fc Fusion Protein on Laboratory Examination Parameters of Patients with Rheumatoid Arthritis

Objective: To observe the influence of recombinant human tumor necrosis factor receptor-Fc fusion protein on laboratory examination parameters of patients with rheumatoid arthritis.Methods: A randomized,double-blind,and active-comparator-controlled,parallel-group study were conducted in 40 patients.They were randomly divided to receive twice-weekly subcutaneous injection of rhTNFR:Fc(25mg) plus placebo of methotrate(MTX)(rhTNFR:Fc group,n=20),or placebo of subcutaneous rhTNFR:Fc(25mg) plus MTX(mean,15mg/week)(MTX group,n=20) for 24 weeks.Blood routine,liver function,erythrocyte sedimentation rate(ESR),C-reactive protein,and rheumatoid factor were monitored.Results:Leukopenia was observed in one patient in rhTNFR:Fc group,but it was normal after a week.No adverse effect on blood red cell,thrombocyte,liver and kidney function was observed.The level of ESR decreased in two groups significantly after 24 weeks.However,the level of ESR decreased in two weeks in rhTNFR:Fc group,that was faster than that in MTX group(P<0.05).The level of CRP and RF reduced significantly in both of groups,but the difference in two groups didn't show statistical significance.Conclusions: rhTNFR:Fc can reduce inflammatory or disease activity index in RA patients,and is a safety drug in laboratory test.