CAJ | 학술논문

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）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 rhTNFR：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 rhTNFR：Fc 治疗 RA 疗效显著，不良反应发生率也不高。
목적：관찰중조인Ⅱ형종류배사인자수체항체융합단백（rhTNFR：Fc）연합갑안접령（MTX）치료류풍습관절염（rheumatoid arthritis，RA）적림상료효급안전성。방법100례활동기 RA 환자채용추첨수궤법분위량조각50례，MTX 조채용MTX 15 mg／w 치료；연합치료조채용 MTX 15 mg／w 가 rhTNFR：Fc 매차50 mg 치료。관찰용약전급용약후2、4、8、12、24주환자종창관절수、동통관절수、압통관절수、신강시간、의생화환자평개、질병활동분수평분급혈침（ESR）、초민 C 반응단백（CRP）、류풍습인자、항배과안산태항체수평。결과치료24주후，연합치료조적 ACR 개선솔명현우우대조조（P ＜0．05）；량조불량반응발생솔비교차이무통계학의의（P ＞0．05）。결론MTX 연합 rhTNFR：Fc 치료 RA 료효현저，불량반응발생솔야불고。
Objective To observe the clinical efficacy and safety of recombinant human tumor necrosis factor -αreceptorⅡ(rhTNFR):IgG-Fc fusion protein for injection combined with methotrexate (MTX)in the treatment of rheumatoid arthritis(RA).Meth-ods 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 subcuta-neous 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-re-active 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 sig -nificantly better than that in the control group (P <0.05).There was no statistical difference in the incidence of adverse reactions be -tween 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..