201299例住院患者中疑似药源性过敏反应的特征及风险分析  

Analysis of the Characteristics and Risk Factors of Suspected Drug-induced Allergic Reactions in 201299 Hospitalized Patients

作　　者：刘思源 郭代红[1] 孔祥豪 于承暄 朱雨 Liu Siyuan;Guo Daihong;Kong Xianghao;Yu Chengxuan;Zhu Yu(Department of Pharmacy,Medical Security Center,Chinese People’s Liberation Army General Hospital,Beijing 100853,China;College of Pharmacy,Chongqing Medical University)

机构地区：[1]解放军总医院医疗保障中心药剂科,北京100853 [2]重庆医科大学药学院

出　　处：《药物流行病学杂志》2021年第6期382-387,共6页Chinese Journal of Pharmacoepidemiology

基　　金：2017年军事医学创新重点项目(编号:17CXZ010)。

摘　　要：目的:了解住院患者药源性过敏反应发生的特征、救治用药和相关风险因素。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),回顾性筛查我院2019年1~12月所有住院患者的电子病历信息,共201299例,获得其中发生药源性过敏反应患者的相关数据,经人工甄别后,对患者的基本信息、临床表现、过敏反应的发生率、发生时间、严重程度、救治用药分布等数据进行深入分析。结果:药源性过敏反应发生率为0.41%,严重的全身性过敏反应发生率为5.46/万;83.64%的严重的全身性过敏反应发生于用药过程中,16.36%发生于用药后24 h内。过敏反应主要表现为皮肤症状(73.77%);而严重的全身性过敏反应中皮肤症状占比减少至33.41%,与呼吸系统症状(27.68%)、循环系统症状(16.23%)占比大致相同。110例严重的全身性过敏反应救治时,使用地塞米松63例次,肾上腺素仅8例次。既往有药物过敏史、合并心血管疾病和女性是发生严重的全身性过敏反应的风险因素。结论:药物输注过程中发生严重全身性过敏反应的可能性最大,应重点关注;临床应重点关注的高风险人群为有过敏史、合并心血管疾病和女性患者;运用信息化技术筛查病例提高了研究效率,但仍需完善报警规则。Objective:To understand the characteristics,therapeutic drug and related risk factors of drug-induced allergic reactions in a large sample of inpatients.Methods:Using active surveillance and assessment system-Ⅱof adverse drug events(ADE-ASAS-Ⅱ),the electronic medical record information of all inpatients in our hospital from January 1,2019 to December 31,2019 were retrospectively monitored,a total of 201299 cases.The data of patients with drug-induced allergic reactions were obtained and analyzed in depth after manual screening,such as basic information,clinical manifestations of patients,incidence,time of occurrence,severity of allergic reactions,distribution of treatment drugs,etc.Results:The incidence of drug-induced allergic reactions was 0.41%,and the incidence of drug-induced anaphylaxis was 5.46 per 10000.83.64%of drug-induced anaphylaxis occurred during the administration of drugs,and 16.36%occurred within 24 hours after administration.Allergic reactions were mainly manifested as skin symptoms(73.77%).But skin symptoms of anaphylaxis decreased to 33.41%,which was similar to respiratory symptoms(27.68%)and circulatory symptoms(16.23%).Dexamethasone was used 63 times and epinephrine only 8 times in 110 cases of anaphylaxis treatment.A history of drug allergy,concurrent cardiovascular disease,and female were risk factors for anaphylaxis.Conclusion:Anaphylaxis is most likely to occur during drug infusion and should be of particular concern.The high-risk patients that should be paid more attention to clinically are those with a history of drug allergy,concurrent cardiovascular disease and female patients.The use of information technology to screen cases has improved the efficiency of research,but the alarm rules still need to be improved.

关 键 词：药源性过敏反应 严重的全身性过敏反应 风险因素 自动监测 真实世界研究 

分 类 号：R595.3[医药卫生—内科学]