2019年至2021年四川省南充市医疗机构新的及严重药品不良反应分析  

Analysis of New and Serious Adverse Drug Reactions in Medical Institutions in Nanchong,Sichuan from 2019 to 2021

作　　者：李锐 唐志勇 刘福[1] 杨明[1] LI Rui;TANG Zhiyong;LIU Fu;YANG Ming(The Affiliated Hospital of North Sichuan Medical College,Nanchong,Sichuan,China 637000;Nanchong Central Hospital·The Second Affiliated Clinical Medical College of North Sichuan Medical College,Nanchong,Sichuan,China 637007;Nanchong Jialing District People′s Hospital·Nanchong Central Hospital Jialing Branch,Nanchong,Sichuan,China 637900)

机构地区：[1]川北医学院附属医院,四川南充637000 [2]四川省南充市中心医院·川北医学院第二临床医学院,四川南充637007 [3]四川省南充市嘉陵区人民医院·四川省南充市中心医院嘉陵院区,四川南充637900

出　　处：《中国药业》2023年第14期26-29,共4页China Pharmaceuticals

基　　金：四川省南充市社会科学研究“十四五”规划项目[NC23B014];四川省南充市应用技术研究与开发项目[20YFZJ0014];北京康盟慈善基金会医学科研发展基金项目[B21010CS]。

摘　　要：目的减少新的及严重的药品不良反应(ADR)发生,确保患者用药安全。方法通过国家药品不良反应监测系统获取2019年至2021年四川省南充市医疗机构新的及严重的ADR数据,根据患者的性别、年龄、药品种类、给药途径、ADR的类型、累及器官/系统等指标进行统计分析。按《常见不良反应事件评价标准(CTCAE 4.0)》等评价标准判定ADR;根据国家药品不良反应监测中心ADR关联性评价标准进行关联性评价。结果共上报新的及严重ADR 5928例,患者中男2659例,女3269例。老年(年龄≥65岁)患者发生ADR较多(2526例、42.61%)。关联性评价为“可能”(3307例、55.79%)最多。类型以新的一般ADR较多(3501例、59.06%),严重ADR和新的严重ADR分别为1771例(29.88%)和656例(11.07%);抗感染药物ADR占比较高(1283例、21.64%),以β-内酰胺类药物为主(765例、12.90%),其次为中药制剂(918例、15.49%);主要累及皮肤及其附件(1856例、27.72%),其次为消化系统(1421例、21.22%);发生ADR的给药途径为静脉给药(3890例、65.62%),口服给药(1767例、29.81%),体外给药(182例、3.07%)等。结论医护人员应重视新的及严重ADR监测工作,提高对ADR的甄别和处理能力,尤其是加强对老年患者的用药监护,减少ADR的发生,确保患者用药安全。Objective To reduce the occurrence of new and serious adverse drug reactions(ADRs),and to ensure the medication safety of patients.Methods The new and serious ADRs of medical institutions in Nanchong,Sichuan from 2019 to 2021 in the National Adverse Drug Reaction Monitoring System were collected and analyzed based on the patients'gender,age,drug variety,administration route,ADR type,involved organs/systems and other indicators.The ADRs were evaluated according to the Common Terminology Criteria Adverse Events(CTCAE 4.0)and other evaluation standards.The ADR correlation evaluation standard recommended by the National Center for ADR Monitoring,China was used for the correlation evaluation.Results A total of 5928 cases of new and serious ADR were reported,including 2659 males and 3269 females.Elderly patients(≥65 years)had the highest incidence of ADR(2526 cases,42.61%).The ADRs with a correlation evaluation of"possible"were the most(3307 cases,55.79%).For the ADR type,the cases with new and general ADRs were the most(3501 cases,59.06%),and there were 1771 cases of serious ADR(29.88%)and 656 cases of new and serious ADR(11.07%).The proportion of ADRs induced by anti-infective drugs was the highest(1283 cases,21.64%),mainlyβ-lactam drugs(765 cases,12.90%);followed by the traditional Chinese medicine preparations(918 cases,15.49%).ADRs mainly involved the skin and its accessories(1856 cases,27.72%),followed by the digestive system(1421 cases,21.22%).The administration routes inducing ADRs were intravenous administration(3890 cases,65.62%),oral administration(1767 cases,29.81%),in vitro administration(182 cases,3.07%)and so on.Conclusion Medical staff should pay attention to new and serious ADR monitoring,improve the abilities to identify and respond to ADRs,strengthen the medication monitoring for patients(especially the elderly),reduce the occurrence of ADRs and ensure the medication safety of patients.

关 键 词：新的药品不良反应 严重药品不良反应 药品不良反应监测 用药安全 医疗机构 

分 类 号：R969.3[医药卫生—药理学]