摘要
目的评估比较2个品牌JAK抑制剂托法替布:尚杰与泰研医治中重度类风湿关节炎(RA)的疗效。方法选择该院风湿免疫科2020年1-9月经缓解病情抗风湿药物(DMARDs)治疗或配合生物制剂疗效不佳的中重度RA患者40例,分为尚杰组和泰研组,每组20例,其中尚杰组接受辉瑞制药公司生产的托法替布,泰研组接受正大天晴公司生产的托法替布,2组用法均为口服5毫克/次,2次/天,同时联用1种非甾体抗炎药(NSAIDs),和甲氨蝶呤(MTX)12.5毫克/周,连续服用12周。收集患者用药前及用药后的第4、8、12周的肿胀关节数、压痛关节数及常规实验室结果[包括红细胞沉降率(ESR)、C反应蛋白(CRP)、抗环化瓜氨酸多肽(CCP)抗体、类风湿因子(RF)],对28个关节疾病活动度进行类风湿关节炎患者病情评价(DAS28)评分,同时收集患者达到20%缓解(ACR20)、ACR50、ACR70情况。结果2组患者用药后ESR、DAS28评分、肿胀关节数、压痛关节数较用药前明显下降,差异有统计学意义(P<0.05),其抗CCP抗体及类风湿因子较用药前下降,但差异均无统计学意义(P>0.05)。2组间治疗后ACR20、ACR50、ACR70及DAS28评分、ESR、CRP、抗CCP抗体、类风湿因子(RF)、肿胀关节数、压痛关节数等指标差异均无统计学意义(P>0.05)。2组患者治疗后均未产生过敏症状,其血常规、血脂及肝肾功能指标无异常改变,亦无其他不良反应。结论尚杰与泰研医治中重度RA能有效改善部分传统抗风湿药或配合生物制剂医治疗疗效不佳的中重度RA患者病情,两者疗效无显著性差异。
Objective To evaluate and compare the efficacy of two brands of JAK inhibitors tofacitinib:Shangjie and Taiyan,in the treatment of moderate and severe rheumatoid arthritis(RA).Methods From January 2020 to September 2020,40 patients with moderate and severe RA with poor efficacy of traditional DMARDs or combined with biological agents were selected.The patients were divided into the Shangjie group and the Taiyan group,with 20 cases in each group.The Shangjie group received tofacitinib from Pfizer,while the Taiyan group received tofacitinib from CTTQ.The usage of the two groups were 5 mg/time,twice a day,combined with one NSAIDs and MTX 12.5 mg/week,for 12 weeks.The number of swollen joints,tenderness and routine laboratory results[including erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),anti-CCP antibody and rheumatoid factor(RF)]were collected before and at the fourth week,eighth week and twelfth week after medication.DAS28 score was performed for 28 joints disease activities,and ACR20,ACR50 and ACR70 were collected at the same time.Results Compared with before treatment,ESR and DAS28 score of the two groups were significantly decreased,swollen joints and tenderness were significantly less than those before treatment,the differences were statistically significant(P<0.05).The anti-CCP antibody and RF factor were significantly lower than those before treatment,but the differences were not statistically significant(P>0.05).There were no significant difference in ACR20,ACR50,ACR70 and DAS28 score,ESR,CRP,anti-CCP and ibody,RF between the two groups after treatment(P>0.05).After treatment,no allergic symptoms occurred in the two groups,and there were no abnormal changes in blood routine,blood lipid and liver and kidney function indexes,and no other adverse reactions.Conclusion Shangjie and Taiyan can effectively improve the condition of some patients with moderate and severe RA who are not effective with traditional anti rheumatic drugs or biological agents,but there is no significant difference in the ef
作者
郭霞
李俏
蒋盛芝
黄洁柔
饶慧
GUO Xia;LI Qiao;JIANG Shengzhi;HUANG Jierou;RAO Hui(Department of Rheumatology and Immunology,the First Affiliated Hospital of Hunan Normal University/Hunan Provincial People′s Hospital,Changsha,Hunan 410001,China)
出处
《重庆医学》
CAS
2022年第8期1335-1339,1343,共6页
Chongqing medicine
基金
湖南省自然科学基金科卫联合项目(2018JJ6017)。
关键词
类风湿关节炎
托法替布
尚杰
泰研
治疗结果
rheumatoid arthritis
tofacitinib
Shangjie
Taiyan
treatment outcome
