比较三种新型生物制剂治疗中重度活动性类风湿关节炎的疗效与安全性.pdfVIP

中国药物应用与监测 2014 年6 月第11卷第3 期 Chinese Journal of Drug Application and Monitoring, Vol.11, No.3, June 2014 比较三种新型生物制剂治疗中重度活动性类风湿关节炎的疗效与安全性 赵　征，朱　剑，张江林，张亚美，黄　烽，邓小虎（解放军总医院风湿科，北京 100853 ） [摘要]　目的：观察利妥昔单抗、托珠单抗及阿达木单抗联合慢作用抗风湿药物（DMARDs ）治疗中重度活动性类风湿关节 炎24 周后的疗效和安全性。方法：共入组87 例DAS28 3.2 的活动性类风湿关节炎患者，给予利妥昔单抗或托珠单抗或阿 达木单抗同时联合DMARDs ，或仅用DMARDs 药物治疗，主要疗效指标为达到ACR20 的患者比例，次要疗效指标为达到 ACR50 、ACR70 的比例及DAS28-CRP 的改善情况。结果：在24 周时，利妥昔单抗、托珠单抗及阿达木单抗达到ACR20 的 比例分别为66.67% 、94.44% 和73.08% ，而单用DMARDs 组则为53.57% ，同时各治疗组患者DAS28-CRP 亦较基线及仅用 DMARDs 组显著下降，且托珠单抗及阿达木单抗组优于利妥昔单抗组。最常见的不良事件为上呼吸道感染，其次是淋巴细 胞下降及肝功能异常。结论：利妥昔单抗、托珠单抗及阿达木单抗对类风湿关节炎均具有显著的疗效和良好的安全性，阿达 木单抗及托珠单抗的疗效优于利妥昔单抗。 [关键词]　生物制剂；类风湿关节炎；疗效；安全性；药品不良反应 [ 中图分类号]　R971+.1 ；R969.4　　 [ 文献标识码]　A　 [ 文章编号]　1672 – 8157(2014)03 – 0134 – 05 Efficacy and safety of three new biologics in the treatment of moderate to severe rheumatoid arthritis ZHAO Zheng, ZHU Jian, ZHANG Jiang-lin, ZHANG Ya-mei, HUANG Feng, DENG Xiao-hu(Department of Rheumatology, PLA General Hospital, Beijing 100853, China) [ABSTRACT]　Objective: To observe the efficacy and safety of rituximab, tocilizumab and adalimumab combined with disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA). Methods: A total of 87 RA patients with a 28-joint Disease Activity Score (DAS28) 3.2 were randomly given rituximab, tocilizumab, adalimumab combined with DMARDs respectively or DMARDs alone for 24 weeks. The primary end point was the proportion of patients achieving American College of Rheumatology criteria for 20% improvement (ACR20). The secondary end points included the proportion of patients achieving ACR50, ACR70, improvement of DAS28, C-reactive protein (CRP) and Health Assessment Questionnaire (HAQ). Safety th was assessed by adverse event documentation. Results: At the end of the 24 week, 82 patients completed the treatment. The prop