注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合甲氨蝶呤治疗活动性类风湿关节炎的效果及安全性研究  

Efficacy and safety of recombinant human tumor necrosis factor receptorⅡ-immunoglobulin G-Fc fusion protein for injection combined with methotrexate for injection in the treatment of active rheumatoid arthritis

作　　者：周雪梅 卢祥云 梁宏达[1] 王晓庆 ZHOU Xuemei;LU Xiangyun;LIANG Hongda;WANG Xiaoqing(Department of Rheumatology and Immunology,the Afiliated Hospital of Qingdao University,Qingdao 266000,Shandong Province,China;Department of Rheumatology and Immunology,Gaomi People's Hospital,Weifang 261599,Shandong Province,China)

机构地区：[1]青岛大学附属医院风湿免疫科,山东青岛266000 [2]高密市人民医院风湿免疫科,山东潍坊261599

出　　处：《世界临床药物》2023年第3期258-262,共5页World Clinical Drug

基　　金：潍坊市科技发展计划项目(2019YX106)。

摘　　要：目的评价并比较注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(recombinant human tumor necrosis factor receptorⅡ-immunoglobulin G-Fc fusion protein for injection,rhTNFR-Fc)联合甲氨蝶呤(methotrexate,MTX)与单用MTX治疗活动性类风湿关节炎(rheumatoid arthritis,RA)的效果与安全性。方法选取2021年7月1日至2022年7月1日于高密市人民医院风湿免疫科就诊的活动性RA患者72例,根据就诊顺序编号,按随机数字表法分为联合组和单药组,每组36例。两组均予MTX口服,联合组加用安佰诺,均治疗24周。比较治疗前后关节症状、炎症指标、疗效及不良反应发生情况。结果治疗后,两组C反应蛋白(2.50 mg/L vs 6.35 mg/L)、红细胞沉降率(20.50 mm/h vs 27.50 mm/h)水平下降,差异均具有统计学意义(P<0.05)。两组美国风湿病学会(American College of Rheumatology,ACR)疗效评价标准20(88.89%vs 66.67%)、ACR50(75.00%vs 50.00%)及ACR70应答率(63.89%vs 38.89%)、28个关节疾病活动度评分(2.32分vs 2.74分)差异具有统计学意义(P<0.05)。结论rhTNFR-Fc联合MTX可降低RA患者的炎症指标,效果较佳且不会增加不良反应发生率,具有较高的安全性与临床应用价值,值得进一步推广。Objective To evaluate and compare efficacy and safety of recombinant human tumor necrosis factor receptorⅡ-immunoglobulin G-Fc fusion protein for injection(rhTNFR-Fc)combined with methotrexate(MTX)and MTX alone in the treatment of active rheumatoid arthritis(RA).Methods A total of 72 patients with active RA who visited department of rheumatology and immunology,Gaomi people's hospital from July 1,2021 to July 1,2022 were selected and divided into combination group and control group according to the order of treatment and random number table method,with 36 cases in each group.Both groups were given MTX orally and the combination group was given rhTNFR-Fc,all patients were treated for 24 weeks.Joint symptoms,inflammatory indicators,efficacy and adverse reactions were compared before and after treatment.Results After treatment,the levels of C-reactive protein(2.50 mg/L vs 6.35 mg/L)and erythrocyte sedimentation rate(20.50 mm/h vs 27.50 mm/h)decreased in the two groups,and the differences were statistically significant(P<0.05).There were significant differences in response rates of American College of Rheumatology(ACR)20(88.89%vs 66.67%),ACR50(75.00%vs 50.00%)and ACR70(63.89%vs 38.89%)and disease activity score 28(2.32 scores vs 2.74 scores)(P<0.05).Conclusion RhTNFR-Fc combined with MTX can reduce inflammatory indexes in RA patients with better effect and does not increase the incidence of adverse reactions.It has high safety and clinical application value,and is worthy of further promotion.

关 键 词：注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 甲氨蝶呤 类风湿关节炎 疗效 安全性 

分 类 号：R593.22[医药卫生—内科学]