托珠单抗在类风湿关节炎临床实践中的用药模式:一项多中心 非干预性研究  

Patterns of tocilizumab use in clinical practice of rheumatoid arthritis:a multi-center,non-interventional study in China

作　　者：武丽君[1] 董凌莉 李涯松[3] 肖长虹 史晓飞[5] 张岩 李芹[7] 赵毅[8] 周彬[9] 方勇飞[10] 戴冽[11] 叶志中[12] 周毅[13] 尉世同[14] 刘剑平[15] 李娟[16] 石桂秀 孙凌云 邹耀红[19] 李敬扬 李鸿斌[21] 刘湘源[22] 张奉春[23] Wu Lijun;Dong Lingli;Li Yasong;Xiao Changhong;Shi Xiaofei;Zhang Yan;Li Qin;Zhao Yi;Zhou Bin;Fang Yongfei;Dai Lie;Ye Zhizhong;Zhou Yi;Wei Shitong;Liu Jianping;Li Juan;Shi Guixiu;Sun Lingyun;Zou Yaohong;Li Jingyang;Li Hongbin;Liu Xiangyuan;Zhang Fengchun(Department of Rheumatology and Immunology,People's Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830001,China;Department of Rheumatology and Immunology,Tongji Hospital,Huazhong University of Scienceand Technology,Wuhan 400030,China;Department of Rheumatology and Immunology,Zhejiang Provincial People's Hospital,Hangzhou 310014,China;Department of Rheumatology,Integrative Medicine Hospital of Southern Medical University,Guangzhou 510315,China;Department of Rheumatology and Immunology,First Affiliated Hospital of Henan University of Science and Technology,Luoyang 471003,China;Department of Rheumatology and Immunology,Second Affiliated Hospital of Fourth Military Medical Univer-sity,Xi'an 710038,China;Department of Rheumatology and Immunology,the First People's Hospital of Yun-nan Province,Kunming 650224,China;Department of Rheumatology and Immunology,West China Hospital,Sichuan University,Chengdu 610041,China;Department of Rheumatology and Immunology,Sichuan Provin-cial People's Hospital,Chengdu 610072,China;Department of Traditional Chinese Medicine and Rheumatology and Immunology,Southwest Hospital,Chongqing 400038,China;Department of Rheumatology and Immunology,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510235,China;Department of Rheumatology and Immunology,Shenzhen Futian Hospital,Guangdong 518033,China;Department of Rheumatology,the First Affiliated Hospital of Jinan University,Guangzhou 510632,China;Department of Rheumatology,Yantaishan Hospital,Shangdong 264000,China;Department of Rheumatology and Hemato-logy,the Affiliated Hospital of North Sichuan Medical College,Nanchong 637000,China;Department of Rheumatology,Nanfang Hospital of Southern Medical University,Guangzhou 510515,China;Department of Rheumatology and Immunology,the First A

机构地区：[1]新疆维吾尔自治区人民医院风湿免疫科,乌鲁木齐830001 [2]华中科技大学附属同济医院风湿免疫科,武汉400030 [3]浙江省人民医院风湿免疫科,杭州310014 [4]南方医科大学中西医结合医院风湿病科,广州510315 [5]河南科技大学第一附属医院风湿免疫科,洛阳471003 [6]第四军医大学第二附属医院风湿免疫科,西安710038 [7]云南省第一人民医院风湿免疫科,昆明650224 [8]四川大学华西医院风湿免疫科,成都610041 [9]四川省人民医院风湿免疫科,成都610072 [10]第三军医大学西南医院中医与风湿免疫科,重庆400038 [11]中山大学附属孙逸仙纪念医院风湿免疫科,广州510235 [12]广东省深圳市福田区人民医院风湿免疫科,518033 [13]暨南大学第一附属医院风湿科,广州510632 [14]山东省烟台市烟台山医院风湿内科,264000 [15]川北医学院附属医院风湿血液内科,南充637000 [16]南方医科大学南方医院风湿病科,广州510515 [17]厦门大学第一附属医院风湿免疫科,361003 [18]南京鼓楼医院风湿免疫科,210008 [19]江苏省无锡市人民医院风湿免疫科,214002 [20]湖南省株洲市中心医院风湿免疫科,412007 [21]内蒙古医科大学附属医院风湿免疫科,呼和浩特010050 [22]北京大学第三附属医院风湿免疫科,100191 [23]北京协和医院风湿免疫科,100032

出　　处：《中华风湿病学杂志》2020年第4期234-239,共6页Chinese Journal of Rheumatology

摘　　要：目的:观察我国RA患者在临床实践中的托珠单抗使用模式、临床疗效及安全性。方法:共招募407例来自全国23个中心的接受托珠单抗治疗的RA患者,随访6个月,观察并收集托珠单抗的使用模式,有效性,以及不良事件、严重不良事件的发生率等。采用SAS 9.4软件进行统计学描述。结果:396例患者纳入分析,其中330例(83.3%)接受托珠单抗联合传统合成改善病情抗风湿药(csDMARD)治疗,托珠单抗单药治疗比例为16.7%(66/396)。基线时,224例(56.6%)患者和38例(9.6%)患者分别在csDMARDs和其他生物制剂改善病情抗风湿药(bDMARDs)失败后开始注射托珠单抗。随访6个月期间,托珠单抗平均用药频率为(3.7±1.6)次,平均托珠单抗剂量为(7.4±1.2)mg/kg体质量,平均给药间隔时间为(40±13)d。6个月时,102例(25.8%)的患者继续接受托珠单抗治疗。6个月时观察到疾病活动度、关节症状、患者报告结局等均显著改善。90例(22.7%)的患者发生过至少1次治疗后出现的不良事件,8例患者发生过至少1次严重不良事件。结论:RA患者使用托珠单抗治疗6个月时有效性、耐受性及安全性良好。患者使用托珠单抗的持续性需改善。Objective To study the patterns of tocilizumab(TCZ)use,its efficacy and safety in patients with rheumatoid arthritis(RA)in routine clinical practice.Methods A total of 407 patients with RA were enrolled from 23 centers and treated with TCZ within 8 weeks prior to the enrollment visit,and were followed for 6-month.The patterns of TCZ treatment at 6 months,the effectiveness and safety outcomes were recorded.Statistical analysis was performed using SAS version 9.4.Results A total of 396 patients were included for analysis,in which 330(83.3%)patients received TCZ combined with conventional synthetic disease-modifying antirheumatic drugs(csDMARDs),and 16.7%(66/396)received TCZ monotherapy.At baseline,TCZ was initiated in 56.6%(224/396)and 9.6%(38/396)of patients after failure of DMARDs and other biological agents(bDMARDs)respectively.During the 6-month follow-up period,the mean frequency of TCZ administration was(3.7±1.6),the mean TCZ dosage was(7.4±1.2)mg/kg,and the mean interval between doses was(40±13)days.120(25.8%)patients were on TCZ treatment at the end of the study.Improvements in disease activity,systemic symptoms and patient report outcomes were observed at the end of the study.22.7%(90/396)patients experienced at least one treatment related adverse event,and 8 patients experienced at least one serious adverse event.Conclusion This study demonstrates that TCZ treatment is effective in patients with RA when being treated for 6 months with an acceptable safety profile.The duration of TCZ treatment needs to be extended.

关 键 词：关节炎 类风湿 抗风湿药 生物制剂 托珠单抗 非干预性研究 

分 类 号：R593.22[医药卫生—内科学]