托珠单抗治疗中至重度类风湿关节炎患者用药现状和依从性的单中心观察研究  

Current application and drug adherence to tocilizumab in patients with moderate to severe rheumatoid arthritis： a real-life single center study

作　　者：叶丛 朱盈姿 余毅恺[1] 沈桂芬 李守新 胡绍先 董凌莉[1] 

机构地区：[1]华中科技大学同济医学院附属同济医院风湿免疫科,武汉430030

出　　处：《中华风湿病学杂志》2017年第10期690-693,共4页Chinese Journal of Rheumatology

基　　金：国家自然科学基金（81501415）;湖北省武汉市应用基础研究计划（2017060201010184）

摘　　要：目的了解托珠单抗治疗中至重度RA患者的用药现状、依从性和不良反应。方法本研究是一项为期24周、针对托珠单抗治疗中至重度RA患者的单中心观察性研究。用药依从性计算方法为用药期间的实际剂量/标准剂量×100%。疗效评估指标包括医生对疾病的总体评估（PGA）、患者对疾病的总体评估（PtGA）、DAS28评分等。安全性评估主要依据不良反应（AE）。结果入组60例患者，平均剂量依从性为（67±27）%。PGA、PtGA、患者疼痛视觉模拟评分（VAS评分）、疼痛和肿胀关节数均随疗程逐渐下降。第12周时，DAS28〈2.6和EULAR治疗应答良好的患者比例分别为25%（6/24）、29%（7/24）。不良反应共18例次，其中严重不良反应2例，且均与托珠单抗无关。结论托珠单抗治疗我国中-重度RA患者安全性较高，但患者用药依从性仍有待提高。Objective To evaluate the safety and drug adherence of tocilizumab （TCZ） in patients with moderate to severe rheumatoid arthritis （RA） in routine clinical practice.MethodsThis 24 week single center observational study recruited patients with moderate to severe RA. Therapy adherence rate was calculated by actual dosing/expected dosing×100%. Efficacy end points included physician global assessment of disease activity （PGA）, patient global assessment of disease activity （PtGA）, 28-joint disease activity score （DAS28） and so on. Safety was evaluated by recorded adverse events （AEs）.ResultsSixty patients were enrolled with a mean （SD） treatment adherence of （67±27）%. PGA, PtGA, pain assessment （VAS）, TJC and SJC all decreased during this study. At the 12th week, 25%（6/24） and 29%（7/24） of the patients achieved DAS28 remission and EULAR good response, respectively. Eighteen AEs were recorded, of which only 2 were severe AEs （SAEs） and neither was related to TCZ.ConclusionTCZ is a highly safe treatment for decreasing disease activity in patients with moderate to severe RA in China. However, drug adherence still need to be improved.

关 键 词：关节炎 类风湿 托珠单抗 依从性 安全性 

分 类 号：R593.22[医药卫生—内科学]