930例糖肽类和噁唑烷酮类抗感染药物药品不良反应/事件报告分析

Analysis on 930 cases of ADR/ADE associated with glycopeptides and oxazolidinone antibacterials from military hospitals

目的:通过分析军队医院糖肽类和噁唑烷酮类药物药品不良反应/事件(ADR/ADE)报告,了解糖肽类和噁唑烷酮类药物ADR/ADE发生特点及规律,为临床用药提供参考。方法:采用回顾性方法,收集2009年–2015年军队ADR监测管理系统中糖肽类和噁唑烷酮类药物ADR/ADE报告930例,对患者年龄、性别、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、ADR/ADE报告类型、关联性评价及转归情况等进行描述性统计分析。结果:930例糖肽类和噁唑烷酮类药物ADR/ADE中,男女比例为1.36:1,平均年龄(48.41±24.95)岁;给药途径和药品剂型以静脉给药和注射剂型为主。930例ADR/ADE以糖肽类药物(768例,82.58%)为主,共涉及4个药物品种,万古霉素(554例,58.49%)、利奈唑胺(162例,17.42%)位居前2位。930例ADR/ADE共累及多个系统/器官,994频次,最常见的为皮肤及其附件损害(472频次,47.48%),以万古霉素(340频次,36.56%)为最;其次为血液系统损害(156频次,15.69%),以利奈唑胺(110频次,11.83%)为最。结论:930例糖肽类和噁唑烷酮类药物所致的ADR/ADE涉及不同年龄段患者,累及多个系统/器官,临床应用中应加强用药安全风险防范,及时识别并处理ADR/ADE。

Objective:To investigate the characteristics and regular patterns of adverse drug reaction reports and events(ADR/ADE associated with glycopeptides and oxazolidinone based on the analysis of glycopeptides and oxazolidinone antibacterials ADR/ADE from military hospitals,and to provide references for the clinical rational drug use.Methods:A total of930ADRs/ADEs ofglycopeptides and oxazolidinone antibacterials from2009to2015were collected from the database of PLA ADR monitoring center.The age and gender of patients,categories of suspected anti-infective drugs,route of administration,systems/organs involved,clinicalmanifestations,report type,relevance evaluation and prognosis were retrospectively analyzed.Results:Among930ADRs/ADEs,themale to female ratio was1.36:1.The average age of the patients was(48.41±24.95)years.Intravenous infusion and injection typewere the main administration route and pharmaceutical form,respectively.The ADRs/ADEs were mainly related to glycopeptidesantibacterials(768cases,82.58%).Four drugs were involved in930ADRs/ADEs,and the top2drugs in terms of frequency ofoccurrence were vancomycin(554cases,58.49%)and linezolid(162cases,17.42%).930cases of the ADR/ADE involved multiplesystems/organs(994frequencies).The most common ADRs were the skin and its appendages damage(472cases,47.48%),mostof which were associated with vancomycin(340cases,36.56%).The second was the hematological system damage(156cases,15.69%),most of which were associated with linezolid(110cases,11.83%).Conclusion:The ADR/ADE induced by glycopeptidesand oxazolidinone antibacterials involved different ages of patients and multiple systems/organs.In order to recognize and treat theADR/ADE in time,risk prevention of drug safety should be strengthened in the application of anti-infective agents.