930例糖肽类和唑烷酮类抗感染药物药品不良反应/事件报告分析

摘要

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 of 930 ADRs/ADEs of glycopeptides and oxazolidinone antibacterials from 2009 to 2015 were 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, clinical manifestations, report type, relevance evaluation and prognosis were retrospectively analyzed.Results: Among 930 ADRs/ADEs, the male to female ratio was 1.36 : 1. The average age of the patients was (48.41 ± 24.95) years. Intravenous infusion and injection type were the main administration route and pharmaceutical form, respectively. The ADRs/ADEs were mainly related to glycopeptides antibacterials (768 cases, 82.58%). Four drugs were involved in 930 ADRs/ADEs, and the top 2 drugs in terms of frequency of occurrence were vancomycin (554 cases, 58.49%) and linezolid (162 cases, 17.42%). 930 cases of the ADR/ADE involved multiple systems/organs (994 frequencies). The most common ADRs were the skin and its appendages damage (472 cases, 47.48%), most of which were associated with vancomycin (340 cases, 36.56%). The second was the hematological system damage (156 cases, 15.69%), most of which were associated with linezolid (110 cases, 11.83%).Conclusion: The ADR/ADE induced by glycopeptides and oxazolidinone antibacterials involved different ages of patients and multiple systems/organs. In order to recognize and treat the ADR/ADE in time, risk prevention of drug safety should be strengthened in the application of anti-infective agents.%目的：通过分析军队医院糖肽类和唑烷酮类药物药品不良反应/事件（ADR/ADE）报告，了解糖肽类和唑烷酮类药物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。