3301例利妥昔单抗用药人群相关超敏反应的自动监测与影响因素研究  

Study on automatic monitoring of rituximab-related hypersensitivity reactions in 3301 patients and analysis of influencing factors

作　　者：刘思源 郭代红[1] 姚翀 王伟兰[1] 朱曼[1] LIU Si-yuan;GUO Dai-hong;YAO Chong;WANG Wei-lan;ZHU Man(Department of Pharmacy,Medical Security Center,Chinese People’s Liberation Army General Hospital,Beijing 100853,China)

机构地区：[1]解放军总医院医疗保障中心药剂科,北京100853

出　　处：《中国临床药理学杂志》2021年第15期2072-2076,共5页The Chinese Journal of Clinical Pharmacology

基　　金：中央军委后勤保障部军事医学创新工程重点基金资助项目(17CXZ010);中国研究型医院学会委托项目。

摘　　要：目的了解利妥昔单抗临床应用情况和相关超敏反应发生特征,并分析其影响因素。方法借助“临床药物不良事件主动监测与智能评估警示系统-Ⅱ(ADE-ASAS-Ⅱ)”,回顾性监测我院2009-2019年所有利妥昔单抗用药人群,获得利妥昔单抗临床应用情况、相关超敏反应发生特征,并用倾向性评分方法平衡混杂因素,进一步探究相关影响因素。结果在3301例(14007例次)用药人群中,适应症主要包括B细胞非霍奇金淋巴瘤(57.26%)、视神经脊髓炎(14.00%)、肾病综合征(10.45%);超敏反应总发生率为3.00%,80.81%发生在首次用药。多因素Logistics回归结果显示,过敏史[比值比(OR)=2.431,95%CI=1.1025.362,P<0.05]和用药前淋巴细胞计数(OR=1.421,95%CI=1.0711.887,P<0.05)是发生超敏反应的风险因素。预防给药(OR=0.329,95%CI=0.1470.738,P<0.01)是保护因素。结论利妥昔单抗相关超敏反应属常见,绝大多数发生于首次用药。需要重点关注的人群有既往有药物过敏史或者淋巴细胞计数高的患者;用药前预防给予地塞米松、异丙嗪可以减少超敏反应发生。Objective To understand the clinical application of rituximab and the characteristics of rituximab-related hypersensitivity reactions,and to explore the influencing factors.Methods With the aid of the active surveillance and assessment system of adverse drug events-Ⅱ(ADE-ASAS-Ⅱ),the present study retrospectively monitored patients using rituximab among inpatients in our hospital from 2009 to 2019 to obtain the clinical application of rituximab,characteristics of associated hypersensitivity reactions.Propensity score matching was used to reduce the interference of confounding factors to further explore the relevant influencing factors.Results Among 3301 patients(14007 cases)using rituximab,the indications mainly included B-cell non-Hodgkin’s lymphoma(57.26%),neuromyelitis optica(14.00%),and nephrotic syndrome(10.45%).The overall incidence of hypersensitivity was 3.00%,80.81%of which occurred in the first administration.Multivariate logistic regression results showed that allergy history[odds ratio(OR)=2.431,95%CI=1.102-5.362,P<0.05]and lymphocyte count before medication(OR=1.421,95%CI=1.071-1.887,P<0.05)were risk factors,and prophylactic administration(OR=0.329,95%CI=0.147-0.738,P<0.01)was a protective factor.Conclusion Rituximab-related hypersensitivity reactions are common,most of which occurred during or after the first administration.Patients with a history of drug allergy or a high lymphocyte count are the ones who need attention.Pre-medication prophylaxis of dexamethasone and promethazine may reduce the incidence of hypersensitivity reactions.

关 键 词：利妥昔单抗 超敏反应 主动监测 药物警戒 倾向性评分 

分 类 号：R979.1[医药卫生—药品]