重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白联合甲氨蝶呤治疗类风湿关节炎50例临床观察

The clinical observation of 50 patients with rheumatoid arthritis treated with a recombinant human tumor necrosis factor-α receptorⅡ: IgG-Fc fusion protein combined with methotrexate

目的观察重组人Ⅱ型肿瘤坏死因子受体抗体融合蛋白(rh TNFR:Fc)联合甲氨蝶呤(MTX)治疗类风湿关节炎(rheumatoid arthritis,RA)的临床疗效及安全性。方法 100例活动期RA患者采用抽签随机法分为两组各50例,MTX组采用MTX 15 mg/w治疗;联合治疗组采用MTX 15 mg/w加rh TNFR:Fc每次50 mg治疗。观察用药前及用药后2、4、8、12、24周患者肿胀关节数、疼痛关节数、压痛关节数、晨僵时间、医生和患者评价、疾病活动分数评分及血沉(ESR)、超敏C反应蛋白(CRP)、类风湿因子、抗环瓜氨酸太抗体水平。结果治疗24周后,联合治疗组的ACR改善率明显优于对照组(P<0.05);两组不良反应发生率比较差异无统计学意义(P>0.05)。结论 MTX联合rh TNFR:Fc治疗RA疗效显著,不良反应发生率也不高。

Objective To observe the clinical efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ（rhTNFR） ： IgG-Fc fusion protein for injection combined with methotrexate（MTX） in the treatment of rheumatoid arthritis（RA）. Methods One hundred patients with active rheumatoid arthritis were randomly divided into MTX and combined therapy groups,50 in each group. The MTX group was treated with MTX 15 mg/w while the combined therapy group was treated with MTX 15 mg/w plus subcutaneous injection of rhTNFR： Fc fusion protein 50 mg/w. The number of swollen joints, painful joints, tender joint count, duration of morn- ing stiffness ,doctor and patient evaluation ,disease activity score（DAS28） ,erythrocyte sedimentation rate（ ESR）, ultra-sensitivity C-reactive protein（ CRP）, rheumatoid factors （RF）and anti-cyclic citrullinated peptide antibody level were observed before and after 2,4,8, 12 and 24 weeks of treatment. Results After 24 weeks of treatment, the improvement of ACR in the combined therapy group was significantly better than that in the control group（P 〈 0. 05）.3 There was no statistical difference in the incidence of adverse reactions between the two groups. Conclusion It is effective of MTX combined with rhTNFR：Fc in the treatment of RA while adverse reactions rate is not high..