军队医院310例喹诺酮类药物严重药品不良反应/事件报告分析  

Analysis on 310 cases of serious adverse drug reaction and event associated with quinolones in military hospitals

作　　者：黄翠丽[1] 郭代红[1] 朱曼[1] 苏畅[1,2] 吴旭[1,2] 赵粟裕 马亮[1] 赵鹏芝 赵靓[1] 

机构地区：[1]解放军总医院临床药学中心,北京100853 [2]重庆医科大学药学院,重庆401331

出　　处：《中国药物应用与监测》2018年第1期28-31,共4页Chinese Journal of Drug Application and Monitoring

基　　金：2014年全军后勤科研重点项目:军队药品风险监测防控技术与支撑平台的研究(BWS14R039)

摘　　要：目的:了解喹诺酮类药物严重药品不良反应/事件(ADR/ADE)的发生规律及特点,为临床用药提供参考。方法:采用回顾性方法,收集2009–2015年军队ADR监测管理系统中喹诺酮类药物严重ADR/ADE报告,共计310例,对患者性别、年龄、引起ADR药品种类、给药途径、药品剂型,累及系统/器官及临床表现、关联性评价及转归情况等进行描述性统计分析。结果:310例严重ADR/ADE中,男女比例为1.21:1,平均年龄为(57.64±22.27)岁,给药途径以静脉滴注为主,共涉及11个品种,位居前3位的分别为左氧氟沙星122例(39.35%)、莫西沙星116例(37.42%)、加替沙星13例(4.19%)。310例严重ADR/ADE中最多见为全身性损害93例次(24.28%),其次为皮肤及其附件损害51例次(13.32%),神经紊乱42例次(10.97%)位居第3位;严重ADR表现中位居前3位的分别是过敏性休克(40例次,10.44%)、过敏样反应(30例次,7.83%)和肝功能异常(27例次,7.05%)。结论:喹诺酮类药物所致的严重ADR/ADE涉及多个药物品种,累及多个系统/器官,应用时除关注抗感染疗效外,还应密切监测患者的肝功能、过敏反应及神经系统症状,及时处置用药安全问题。Objective： To investigate the regularities and characteristics of serious adverse drug reaction and event （ADR/ADE） related to quinolones, and provide references for the rational drug use in clinic. Methods： A total of 310 serious ADR/ADE of quinolones were collected from the database of PLA ADR monitoring center from 2009 to 2015, retrospectively. The age and gender of patients, categories of suspected quinolones, route of administration, dosage form, systems/organs involved and clinical manifestations, relevance evaluation and prognosis were analyzed with descriptive statistical method. Results： Among 310 serious ADR/ADE reports, the male to female ratio was 1.21 ： 1, the average age of the patients was （57.64 ± 22.27） years, the main route of administration was intravenous injection, and the ADR/ADE were related to 11 kinds of quinolones. Among suspected drugs, levofoxacin （122 cases, 39.35%）, moxifoxacin （116 cases, 37.42%） and gatifoxacin （13 cases, 4.19%） were the top three. In 310 cases of serious ADR/ADE, the most common damage was systemic damage （93 cases, 24.28%）, followed by the skin and its appendages damage （51 cases, 13.32%） and neuropsychiatric disorder （42 cases, 10.97%）. Allergic shock （40 cases, 10.44%） ranked the frst place in the appearance of ADR/ADE, followed by anaphylactoid reaction （30 cases, 7.83%） and abnormal liver function （27 cases, 7.05%）. Conclusion： Quinolones associated serious ADR/ADE involved various categories and multiple systems and organs. Besides the effcacy of anti-infection, we should focus on the liver function, allergic reaction and nervous system symptoms, so as to handle safety issues in time.

关 键 词：喹诺酮类药物 严重药品不良反应 药品不良事件 

分 类 号：R969.3[医药卫生—药理学]