2016—2021年某院严重药品不良反应/事件报告的警戒性分析

Vigilance Analysis of Severe Adverse Drug Reactions/Events Reports in a Hospital from 2016 to 2021

目的:研究严重药品不良反应/事件发生特点,为临床安全用药提供参考。方法:收集院内2016年1月—2021年12月上报的所有严重药品不良反应/事件报告,对患者的基本特征、怀疑的药品种类、药物不良反应累及的系统-器官等情况进行描述性分析。结果:共纳入199例严重药品不良反应/事件,其中上报数呈逐年上升趋势,男性(67.84%)比例高于女性(32.16%),年龄17~93岁,且年龄≥60岁发生比例最高,其中43例合并有基础疾病。既往存在药品不良反应史的患者有23例(11.56%)。抗感染药物和抗肿瘤药物发生率较高,分别为59例(29.65%)和34例(17.08%)。老年人出现累及血液系统的严重不良反应比例高,有27例(31.40%),年轻人则更容易导致皮肤及其附件系统疾病,有15例(30.00%)。结论:临床中应根据患者特点进行重点监测,尤其应加强对老年人及使用抗感染药物和抗肿瘤药物患者的监测,做到安全用药的闭环管理,保障患者用药安全。

Objective:To study the characteristics of serious adverse drug reactions/events and provide references for safety drug use in clinical practice.Methods:All reports of serious adverse drug reactions/events reported in the hospital from January 2016 to December 2021 were collected.Descriptive analysis was performed on the basic characteristics of patients,the types of suspected drugs,and the systems and organs involved in adverse drug reactions.Results:A total of 199 cases of severe adverse drug reactions/events were included,among which the number reported showed an increasing trend year by year,from 14 cases in 2016 to 72 cases in 2021.There were 135 males(67.84%)and 64 females(32.16%).There were 86 patients over 60 years old(43.22%),of which 43 patients(50%)had underlying diseases.There were 23 patients(11.56%)had a history of adverse drug reactions.The incidence of anti-infective drugs and anti-tumor drugs was high,59 cases(29.65%)and 34 cases(17.09%),respectively.The elderly had a higher proportion of serious adverse reactions in the blood system 27 cases(31.40%),while the young were more likely to develop skin and adjunctive system diseases 15 cases(30%).Conclusions:In clinical practice,key monitoring should be carried out according to the characteristics of patients,especially the surveillance of the elderly and patients using anti-infective and anti-tumor drugs should be strengthened,closed-loop management should be achieved to ensure safety drug use.