201299例住院患者过敏反应自动监测研究及相关药物分析  

Automatic monitoring of allergic reactions in 201 299 hospitalized patients and analysis of causative drugs

作　　者：刘思源 郭代红[1] 孔祥豪 于承暄 朱雨 LIU Si-yuan;GUO Dai-hong;KONG Xiang-hao;YU Cheng-xuan;ZHU Yu(Department of Pharmacy,Medical Security Center,Chinese People’s Liberation Army General Hospital,Beijing 100853,China;College of Pharmacy,Chongqing Medical University,Chongqing 400016,China)

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,重庆400016

出　　处：《中国临床药理学杂志》2021年第11期1436-1440,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)。

摘　　要：目的了解大样本住院人群中药源性过敏反应的发生率和致敏药物分布情况。方法依托"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2019年所有住院患者的电子病历信息,共201 299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,对过敏反应发生率、致敏药物类别、品种以及给药途径进行分析。结果在201 299例住院患者中,发生药源性过敏反应的有826例,发生率为0.41%,其中严重反应110例,发生率为5.46/万。致敏药物共有32类,225种,主要类别有抗感染药物(33.29%)、抗肿瘤药(17.55%)、免疫抑制药(9.08%)等,其中严重反应占比较高的有抗肿瘤药(22.76%)、心血管系统用药(18.52%)、中成药(15.38%),抗感染药物仅为7.64%。引起过敏反应的单品种药物主要有头孢哌酮钠舒巴坦钠、左氧氟沙星等抗感染药物,但发生率相对较低。严重反应占比较高的有多柔比星脂质体(66.67%)、奥沙利铂(33.33%),抗感染药物相对较低。结论抗感染药物引起过敏反应例数多,但以一般反应为主;抗肿瘤药例数次之,但严重反应占比高,尤其以多柔比星脂质体和奥沙利铂最为突出,临床应用时应予以重视。Objective To investigate the incidence of drug-induced allergic reactions and the distribution of causative drugs in a large sample of inpatients. Methods Based on active surveillance and assessment system of adverse drug events-Ⅱ, we retrospectively monitored the electronic medical record information of all inpatients in our hospital in 2019, a total of 201 299 cases. The data of patients with drug-induced allergic reactions were obtained and analyzed in depth after manual screening. Indicators were analyzed included the incidence of allergic reactions, the categories and varieties of causative drugs, and the route of administration. Results Among the 201 299 hospitalized patients, 826 had drug-induced allergic reactions, with an incidence of 0.41%, among which 110 had anaphylaxis, with an incidence of 5.46 per 10 000. A total of 32 categories of drugs, 225 varieties. The categories of causative drugs mainly included anti-infective drugs(33.29%), antineoplastic drugs(17.55%), immunosuppressive drugs(9.08%), etc., among which the proportion of anaphylaxis was antineoplastic drugs ( 22. 76%),cardiovascular system drugs( 18. 52%),Chinese traditional medicine( 15. 38%),and anti-infective drugs only 7. 64%. Among the single drug varieties,cefoperazone sodium sulbactan sodium and levofloxacin caused more allergic reactions,but the incidence was relatively low. Proportion of anaphylaxis were higher in doxorubicin liposomes( 66. 67%) and oxaliplatin( 33. 33%),and anti-infective drugs were relatively low. Conclusion The number of allergic reactions caused by anti-infective drugs was the largest,but the general reactions were the main ones. The number of anti-tumor drugs was second,but the proportion of severe reactions was high,especially doxorubicin liposomes and oxaliplatin,which should be paid more attention to in clinical application.

关 键 词：药源性过敏反应 严重过敏反应 致敏药物 自动监测 真实世界研究 

分 类 号：R97[医药卫生—药品]