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目的比较应用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(益赛普,TNFR:Fc)联合甲氨蝶呤(MTX)与TNFR:Fc联合来氟米特(LEF)治疗早期类风湿关节炎的安全性和有效性。方法将58例早期类风湿关节炎患者随机分为2组。A组28例,给予MTX 10 mg/次,1周1次,口服;TNFR:Fc 25 mg/次,1周2次,皮下注射。B组LEF 20 mg/次,每天1次,口服;TNFR:Fc 25 mg/次,1周2次,皮下注射。2组随访24周,观察治疗前后临床及实验室指标的变化,了解不良反应,并评定疗效。结果治疗4周后,B组ACR20有效率为54%,A组为27%,组间比较差异有统计学意义(P<0.05)。治疗12、24周后,B组与A组的ACR20有效率组间比较差异亦有统计学意义(P<0.05)。治疗第12、24周时B组与A组的ACR50、ACR70组间比较差异无统计学意义(P>0.05),2组不良反应差异无统计学意义(P>0.05),而肝毒性的发生率B组明显低于A组(P<0.05)。结论 TNFR:Fc+LEF治疗早期类风湿关节炎起效快,疗效优于TNFR:Fc+MTX,具有良好的安全性和耐受性。LEF可作为替代MTX有益的药物选择。
Objective To compare the effects of recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein (Isphaset, TNFR: Fc) combined with methotrexate (MTX) and TNFR: Fc with leflunomide (LEF) in the treatment of early rheumatoid arthritis Inflammation of the safety and effectiveness. Methods 58 cases of early rheumatoid arthritis were randomly divided into two groups. A group of 28 patients, given MTX 10 mg / time, once a week, oral; TNFR: Fc 25 mg / time, twice a week, subcutaneous injection. Group B, LEF 20 mg / time, once daily, oral; TNFR: Fc 25 mg / time, twice a week for subcutaneous injection. The two groups were followed up for 24 weeks. The changes of clinical and laboratory indexes before and after treatment were observed, the adverse reactions were observed, and the curative effect was evaluated. Results After 4 weeks of treatment, the effective rate of ACR20 in group B was 54% and that in group A was 27%. The difference between the two groups was statistically significant (P <0.05). After 12 and 24 weeks of treatment, the effective rate of ACR20 in group B and group A was also significantly different (P <0.05). There were no significant differences in ACR50 and ACR70 between the two groups at the 12th and 24th week (P> 0.05), but there was no significant difference between the two groups (P> 0.05), while the incidence of hepatotoxicity Rate of B group was significantly lower than that of A group (P <0.05). Conclusion TNFR: Fc + LEF treatment of early rheumatoid arthritis rapid onset, the effect is better than TNFR: Fc + MTX, with good safety and tolerability. LEF can be used as an alternative medicine to MTX.