重组人肿瘤坏死因子受体-抗体融合蛋白治疗类风湿关节炎65例的疗效与安全性观察

Efficacy and safety of recombinant human tumor necrosis factor receptor-antibody fusion protein in rheumatoid arthritis:Observation on 65 cases

目的研究注射用重组人肿瘤坏死因子受体-抗体融合蛋白依那西普(Etanercept,ETA)治疗类风湿关节炎(rheumatoid arthritis,RA)的疗效及安全性。方法 65例患者以抽签方式随机分为试验组(31例)和对照组(34例)。试验组每周1次口服空白模拟甲氨蝶呤10 mg或来氟米特片20 mg/d,同时每周2次皮下注射ETA 25 mg;对照组每周1次口服甲氨蝶呤10 mg或来氟米特片20mg/d,同时每周2次皮下注射空白模拟ETA 25 mg,疗程3月。疗效评价采用美国风湿病学会(ACR)疗效评定标准。结果试验组治疗后的类风湿因子滴度(RF)、血沉(ESR)、c反应蛋白(CRP)水平及DAS28评分明显低于对照组(P<0.05),达到ACR50及ACR70的患者试验组均明显高于对照组(P=0.02,P<0.001)。两组不良反应发生率差异无统计学意义。结论 ETA用于治疗RA具有良好的安全性和显著的疗效。

To study the efficacy and safety of recombinant human tumor necrosis factor-antibody fusion protein in patients with rheumatoid arthritis. Sixty-five patients were assigned to the experimental group and the control group.Patients in the experimental group were treated with analog Methotrexate 10 mg po once a week or Leflunomide 20 mg q.d,and underwent subcutaneous injection of Etanercept（ETA） 25 mg twice a week for 3 months.The control group was discharged on Methotrexate 10 mg po once a week or Leflunomide 20 mg q.d,,and underwent subcutaneous injection of analog ETA 25 mg twice a week for 3 months.The American College of Rheumatology（ACR）criteria was used for clinical assessment. Compared with the control group,the level of RF,ESR and CRP,and the score of DAS28 in the experimental group were significantly lower（P 0.05）.Patients with ACR over 50 and those with ACR 70 were significant more than those in the control group（P =0.02,P 0.001）.There was no significant difference between the two groups in adverse effects. ETA has significant efficacy and safety in patients with rheumatoid arthritis.