托法替布与益赛普分别联合甲氨蝶呤治疗难治性类风湿关节炎的疗效及安全性分析  

Efficacy and safety analysis of tofacitinib and yisaipu combined with methotrexate in the treatment of refractory rheumatoid arthritis

作　　者：罗寰[1] 张霞 冯娅娆 赵悦 任占芬[1] 杨金良[1] 郑学军[1] LUO Huan;ZHANG Xia;FENG Yarao;ZHAO Yue;REN Zhanfen;YANG Jinliang;ZHENG Xuejun(Department of Rheumatology,the First Affiliated Hospital of Hebei North University,Zhangjiakou 075000,China)

机构地区：[1]河北北方学院附属第一医院风湿免疫科,075000

出　　处：《天津医药》2022年第8期883-887,共5页Tianjin Medical Journal

基　　金：河北省卫健委科研基金项目(20211727)。

摘　　要：目的探究托法替布与肿瘤坏死因子(TNF)-α受体拮抗剂益赛普分别联合甲氨蝶呤治疗难治性类风湿关节炎(RRA)疗效及安全性。方法采用随机数字表法将60例RRA患者分为A组、B组和C组,每组20例。A组采用枸橼酸托法替布(5 mg)联合甲氨蝶呤(10 mg)治疗,B组单用益赛普(25 mg)治疗,C组采用益赛普(25 mg)联合甲氨蝶呤(10 mg)治疗。比较各组临床疗效、临床症状、病情活动指标、炎性因子及不良反应情况。结果治疗后,A组临床有效率明显高于B组(P<0.05),但A组与C组、B组与C组临床疗效指标的比较差异无统计学意义(P>0.05)。治疗后3组患者关节压痛数、关节肿胀数、血沉(ESR)、类风湿因子(RF)、C-反应蛋白(CRP)、血清白细胞介素(IL)-6、IL-1β及IL-17水平均治疗前降低,其中A组关节压痛数、关节肿胀数、晨僵时间、ESR、RF、CRP、IL-6、IL-1β及IL-17水平均低于B组、C组,C组晨僵时间、ESR、RF、CRP、IL-6、IL-1β及IL-17水平低于B组(P<0.05)。治疗期间3组的不良反应发生率差异无统计学意义(P=1.000)。结论托法替布联合甲氨蝶呤治疗RRA疗效显著,在临床症状改善、病情活动指标控制及炎性因子水平抑制方面优于单用益赛普和益赛普联合甲氨蝶呤,且安全性良好。Objective To explore the effect and safety of tofacitinib and tumor necrosis factor-αreceptor antagonist(yisaipu)combined with methotrexate in the treatment of refractory rheumatoid arthritis(RRA).Methods According to random number table method,60 patients with RRA were divided into the group A,the group B and the group C,20 cases in each group.The group A was treated with citrate tofacitinib(5 mg)and methotrexate(10 mg),the group B was treated with yisaipu(25 mg),and the group C was treated with yisaipu(25 mg)and methotrexate(10 mg).The clinical curative effects,clinical symptoms,disease activity indexes,inflammatory factors and adverse reactions were compared between different groups.Results After treatment,the clinical effective rate was significantly higher in the group A than that in the group B(P<0.05).However,there were no significant differences in indexes of clinical curative effect between the group A and the group C,and between the group B and the group C(P>0.05).After treatment,joint tenderness,joint swelling,levels of erythrocyte sedimentation rate(ESR),rheumatoid factor(RF),C-reactive protein(CRP),serum interleukin(IL)-6,IL-1βand IL-17 were significantly decreased compared with before treatment in the three groups(P>0.05).The number of joint tenderness and joint swelling,morning stiffness time,levels of ESR,RF,CRP,IL-6,IL-1βand IL-17 were lower in the group A than those in the group B and the group C.The morning stiffness time,levels of ESR,RF,CRP,IL-6,IL-1βand IL 17 were lower in the group C than those in the group B(P<0.05).There was no significant difference in the incidence of adverse reactions during treatment between the three groups(P>0.05).Conclusion Tofacitinib combined with methotrexate has significant efficacy in the treatment of RRA,which is superior to yisaipu alone or yisaipu combined with methotrexate in clinical symptom improvement,disease activity index control and inflammatory factor level inhibition,with good safety.

关 键 词：关节炎 类风湿 甲氨蝶呤 受体 肿瘤坏死因子 Ⅱ型 托法替布 疗效 安全性 

分 类 号：R593.22[医药卫生—内科学]