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目的评估重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR∶Fc)治疗类风湿关节炎的临床疗效及安全性。方法将符合诊断标准的30例类风湿关节炎患者随机分为治疗组和对照组各15例。治疗组采用rhTNFR∶Fc 50 mg皮下注射,1次/周,同时口服甲氨蝶呤片10 mg,1次/周;对照组口服甲氨蝶呤片10 mg,1次/周。两组均连续用药12周。观察治疗前后临床、实验室指标的变化及不良反应。结果患者压痛关节数、肿胀关节数,疼痛VAS评分、晨僵、患者对疾病总体状况的VAS评分、医生对疾病总体状况的VAS评分,HAQ得分、ESR和CRP水平治疗前两组间差异均无统计学意义(P均>0.05);治疗后均较基线有明显改善(P均<0.05);治疗后4、8、12周随访时,试验组上述各项评价指标均优于对照组(P均<0.05)。两组各出现4例不良反应,主要包括注射部位反应、皮疹、感染、转氨酶升高、胃肠道反应等,均经处理后缓解。结论 rhTNFR∶Fc联合甲氨蝶呤片治疗类风湿关节炎起效快,疗效好,具有较好的安全性和患者可耐受性。
Objective To evaluate the clinical efficacy and safety of recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein (rhTNFR: Fc) in the treatment of rheumatoid arthritis. Methods Thirty patients with rheumatoid arthritis who meet the diagnostic criteria were randomly divided into treatment group and control group, 15 cases each. In the treatment group, rhTNFR: Fc was injected subcutaneously 50 mg once a week, while oral methotrexate 10 mg once a week. The control group was given methotrexate 10 mg orally once a week. Both groups were treated for 12 weeks. Observed before and after treatment, laboratory changes in laboratory indicators and adverse reactions. Results The number of tender joints, number of swollen joints, pain VAS score, morning stiffness, VAS score of patient’s overall condition, VAS score of doctor’s overall condition, HAQ score, ESR and CRP were all significantly different between the two groups (All P> 0.05). After treatment, they were significantly improved compared with baseline (all P <0.05). At 4, 8 and 12 weeks after treatment, the above indexes in the experimental group were all better than those in the control group All <0.05). There were 4 adverse reactions in each group, including injection site reaction, rash, infection, elevated transaminases and gastrointestinal reactions, which were relieved after treatment. Conclusion rhTNFR: Fc combined with methotrexate tablets treatment of rheumatoid arthritis rapid onset, good effect, with good safety and patient tolerance.