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中国药物性过敏反应:基于北京药品不良反应监测数据库的10年回顾性分析

Drug-induced anaphylaxis in China: a 10 year retrospective analysis of the Beijing Pharmacovigilance Database.

作者信息

Zhao Ying, Sun Shusen, Li Xiaotong, Ma Xiang, Tang Huilin, Sun Lulu, Zhai Suodi, Wang Tiansheng

机构信息

Department of Pharmacy, Peking University Third Hospital, Beijing, China.

Department of Pharmacy, Beijing Shijitan Hospital, Beijing, China.

出版信息

Int J Clin Pharm. 2018 Oct;40(5):1349-1358. doi: 10.1007/s11096-017-0535-2. Epub 2017 Oct 31.

Abstract

Background Few studies on the causes of drug-induced anaphylaxis (DIA) in the hospital setting are available. Objective We aimed to use the Beijing Pharmacovigilance Database (BPD) to identify the causes of DIA in Beijing, China. Setting Anaphylactic case reports from the BPD provided by the Beijing Center for Adverse Drug Reaction Monitoring. Method DIA cases collected by the BPD from January 2004 to December 2014 were adjudicated. Cases were analyzed for demographics, causative drugs and route of administration, and clinical signs and outcomes. Main outcome measure Drugs implicated in DIAs were identified and the signs and symptoms of the DIA cases were analyzed. Results A total of 1189 DIA cases were analyzed. The mean age was 47.6 years, and 732 (61.6%) were aged from 18 to 59 years. A total of 627 patients (52.7%) were females. There was a predominance of cardiovascular (83.8%) followed by respiratory (55.4%), central nervous (50.1%), mucocutaneous (47.4%), and gastrointestinal symptoms (31.3%). A total of 249 different drugs were involved. DIAs were mainly caused by antibiotics (39.3%), traditional Chinese medicines (TCM) (11.9%), radiocontrast agents (11.9%), and antineoplastic agents (10.3%). Cephalosporins accounted for majority (34.5%) of antibiotic-induced anaphylaxis, followed by fluoroquinolones (29.6%), beta-lactam/beta-lactamase inhibitors (15.4%) and penicillins (7.9%). Blood products and biological agents (3.1%), and plasma substitutes (2.1%) were also important contributors to DIAs. Conclusion A variety of drug classes were implicated in DIAs. Patients should be closely monitored for signs and symptoms of anaphylaxis when medications are administered especially with antibiotics, TCM, radiocontrast and antineoplastic agents.

摘要

背景

关于医院环境中药物性过敏反应(DIA)病因的研究较少。目的:我们旨在利用北京药品不良反应监测中心的北京药物警戒数据库(BPD)来确定中国北京地区药物性过敏反应的病因。设置:由北京药品不良反应监测中心提供的BPD中的过敏反应病例报告。方法:对BPD在2004年1月至2014年12月期间收集的药物性过敏反应病例进行判定。分析病例的人口统计学特征、致病药物及给药途径、临床症状和结局。主要结局指标:确定与药物性过敏反应相关的药物,并分析药物性过敏反应病例的体征和症状。结果:共分析了1189例药物性过敏反应病例。平均年龄为47.6岁,732例(61.6%)年龄在18至59岁之间。共有627例患者(52.7%)为女性。主要症状以心血管系统症状(83.8%)为主,其次为呼吸系统症状(55.4%)、中枢神经系统症状(50.1%)、皮肤黏膜症状(47.4%)和胃肠道症状(31.3%)。共涉及249种不同药物。药物性过敏反应主要由抗生素(39.3%)、中药(11.9%)、造影剂(11.9%)和抗肿瘤药物(10.3%)引起。头孢菌素占抗生素所致过敏反应的大多数(34.5%),其次为氟喹诺酮类(29.6%)、β-内酰胺/β-内酰胺酶抑制剂(15.4%)和青霉素类(7.9%)。血液制品和生物制剂(3.1%)以及血浆代用品(2.1%)也是药物性过敏反应的重要原因。结论:多种药物类别与药物性过敏反应有关。给药时,尤其是使用抗生素、中药、造影剂和抗肿瘤药物时,应密切监测患者的过敏反应体征和症状。

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