托法替布联合甲氨蝶呤对难治性类风湿性关节炎患者疾病活动度、类风湿因子水平及晨僵时间的影响

Effect of tofacitinib combined with methotrexate on disease activity,rheumatoid factor level and morning stiffness time in patients with refractory rheumatoid arthritis

目的探讨托法替布联合甲氨蝶呤对难治性类风湿性关节炎(RA)患者疾病活动度、类风湿因子(RF)水平及晨僵时间的影响。方法选取2019年6月至2020年6月河北北方学院附属第一医院诊治的120例难治性RA患者作为研究对象,采用随机数字表法将其分为益赛普组、益赛普+甲氨蝶呤组、托法替布+甲氨蝶呤组,每组40例。益赛普组给予单一益赛普治疗,益赛普+甲氨蝶呤组给予益赛普联合甲氨蝶呤治疗,托法替布+甲氨蝶呤组给予托法替布联合甲氨蝶呤治疗。比较3组治疗12、24、48周的临床疗效、疾病活动度、RF水平、晨僵时间及不良反应发生率。结果3组临床总有效率比较,益赛普+甲氨蝶呤组和托法替布+甲氨蝶呤组高于益赛普组(均P<0.05),且托法替布+甲氨蝶呤组高于益赛普+甲氨蝶呤组(P<0.05)。与益赛普组治疗后比较,益赛普+甲氨蝶呤组、托法替布+甲氨蝶呤组治疗后临床症状及疾病活动性评分(DAS28)改善更明显(均P<0.05),且托法替布+甲氨蝶呤组比益赛普+甲氨蝶呤组改善更显著(P<0.05)。与益赛普组治疗后比较,益赛普+甲氨蝶呤组、托法替布+甲氨蝶呤组治疗后血沉(ESR)、RF及C-反应蛋白(CRP)水平更低(均P<0.05),且托法替布+甲氨蝶呤组ESR、RF、CRP水平低于益赛普+甲氨蝶呤组(均P<0.05)。3组患者总不良反应发生率比较(7.50%vs 12.50%vs 12.50%),差异无统计学意义(P>0.05)。结论托法替布联合甲氨蝶呤可有效改善难治性RA患者疾病活动度、类风湿因子水平及晨僵时间,安全性较高,值得临床应用推广。

Objective To investigate the effect of tofacitinib combined with methotrexate on disease activity,rheumatoid factor(RF)level and morning stiffness time in patients with refractory rheumatoid arthritis(RA).Methods A total of 120 patients with refractory RA diagnosed and treated in the First Affiliated Hospital of Hebei North University from June 2019 to June 2020 were selected as the study subjects,and they were randomly divided into three groups by random number table method:etanercept group,etanercept+methotrexate group,and tofacitinib+methotrexate group,with 40 patients in each group.The etanercept group was given etanercept treatment,the etanercept+methotrexate group was given etanercept combined with methotrexate treatment,and the tofacitinib+methotrexate group was given tofacitinib combined with methotrexate treatment.The clinical efficacy(12 W,24 W and 48 W of treatment),disease activity,RF level,morning stiffness time and incidence of adverse reactions were compared among the three groups.Results Comparison of the total clinical effective rate of the three groups:the total clinical effective rate of the etanercept+methotrexate group and the tofacitinib+methotrexate group was higher than that of the etanercept group(both P<0.05),and the tofacitinib+methotrexate group was higher than that of the etanercept+methotrexate group(P<0.05).After treatment,the clinical symptoms and disease activity scores(DAS28)in the etanercept+methotrexate and tofacitinib+methotrexate groups were significantly improved compared with the etanercept group(all P<0.05),and the improvements in the tofacitinib+methotrexate group were more significant than those in the etanercept+methotrexate group(P<0.05).After treatment,the erythrocyte sedimentation rate(ESR),RF and C-reactive protein(CRP)levels were lower in the etanercept+methotrexate and tofacitinib+methotrexate groups than those in the etanercept groups(all P<0.05),and the ESR,RF and CRP levels in the tofacitinib+methotrexate groups were lower than those in the etanercept+methotrexate group(all P<0.05).There was no significant difference in the incidence of total adverse reactions among 3 groups(7.50%vs 12.50%vs 12.50%)(P>0.05).Conclusions Tofacitinib combined with methotrexate can effectively improve the disease activity,RF level and morning stiffness time in patients with refractory RA,with high safety,which is worthy of clinical application and promotion.