托法替布治疗类风湿关节炎的疗效与安全性研究

Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis

目的探讨托法替布治疗类风湿关节炎(rheumatoid arthritis,RA)的疗效和安全性。方法选取2018年1月至6月于上海交通大学医学院附属仁济医院门诊接受托法替布治疗的RA患者65例纳入研究,记录患者人口学资料、临床特征、实验室指标和治疗相关不良反应,评估随访时患者红细胞沉降率计算的28个关节疾病活动评分(disease activity score in 28 jointserythrocyte sedimentation rate,DAS28-ESR)和临床疾病活动指数(clinical disease activity index,CDAI)。结果共45例患者完成随访,治疗后4周、12周、24周,患者DAS28-ESR均显著低于治疗前(均P<0.05)。治疗期间发生不良反应3例(6.67%),包括感染2例,头痛1例。治疗后24周,使用生物制剂失败组患者DAS28-ESR为3.18±0.98,未使用生物制剂组患者DAS28-ESR为3.12±0.73,两组患者DAS28-ESR比较差异无统计学意义(P=0.117)。结论托法替布治疗RA安全有效,既往生物制剂治疗失败并不影响托法替布对RA的治疗效果。

Objective To explore the efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis(RA).Method Sixty-five RA patients who received tofacitinib treatment in Renji Hospital,Shanghai Jiaotong University School of Medicine from January to June 2018 were selected for the study.Patients'demographic data,clinical features,laboratory indexes and treatmentrelated adverse reaction,diseases activity score in 28 joints-erythrocyte sedimentation rate(DAS28-ESR)and clinical disease activity index(CDAI)were recorded.Result A total of 45 patients were followed up.4 weeks,12 weeks and 24 weeks after treatment,the DAS28-ESR of the patients was significantly lower than that before treatment(all P<0.05).Three cases(6.67%)of adverse events occurred during treatment,including 2 cases of infection and 1 case of headache.Twenty-four weeks after treatment,the DAS28-ESR of patients in failure group using biologics was 3.18±0.98,and that of patients in non-use group was 3.12±0.73.There was no statistically significant difference in DAS28-ESR between the two groups(P=0.117).Conclusion Tofacitinib is safe and effective in the treatment of RA patients.The failure of previous biologic therapy does not affect the therapeutic effect of tofacitinib on RA.