2021—2022年云浮市中医院药品不良反应发生情况分析

Analysis of the Occurrence of Adverse Drug Reactions in Traditional Chinese Medicine Hospitals in Yunfu City from 2021 to 2022

目的:分析云浮市中医院2021—2022年药品不良反应(ADR)的发生规律及其影响因素,探讨防范措施,为临床安全用药提供参考。方法:收集2021年1月—2022年12月云浮市中医院成功上报至国家不良反应监测系统的425例发生ADR患者的报告,回顾性分析患者的ADR报告类型、一般情况、药品种类、给药途径、发生时间、累及系统/器官的临床表现。结果:425例患者中,ADR报告类型为一般的有377例,占比88.71%;严重的有48例,占比11.29%。男208例,占48.94%;女217例,占51.06%。患者年龄3~100岁,其中61~80岁患者占比最高(40.94%)。抗感染药物引起ADR的患者最多,共108例,占25.41%。静脉给药210例,占49.41%;口服给药133例,占31.29%;其他途径给药82例,占19.30%。ADR多发生在用药后第1天,占45.88%(195/425);用药后2~5 d发生ADR 133例,占31.29%。ADR累及皮肤及其附件最为常见,占32.49%(155/477)。发生ADR后大多数患者能好转或痊愈,占94.59%。结论:ADR的发生与患者年龄、给药途径及药物种类等多种因素相关,药品监督管理部门、生产厂家、医疗机构应加强ADR的监测及预警,确保患者用药安全。

Objective:To analyze the occurrence pattern of adverse drug reactions(ADRs)and their influencing factors in Yunfu Hospital of Traditional Chinese Medicine in 2021-2022,and to explore the preventive measures,so as to provide reference for the safe use of medicines in the clinic.Methods:The reports of 425 patients with ADRs successfully reported to the National Adverse Reaction Monitoring System in Yunfu Hospital of Traditional Chinese Medicine from January 2021 to December 2022 were col⁃lected,and the patients were retrospectively analyzed for the types of ADR reports,general conditions,types of medicines,routes of administration,time of occurrence,and clinical manifestations of the involved systems/organs.Results:among 425 patients,ADR report type was general in 377 cases(88.71%)and serious in 48 cases(11.29%).There were 208 male cases(48.94%)and 217 female cases(51.06%).The age of the patients ranged from 3 to 100 year old,with the highest percentage of patients aged 61 to 80 years(40.94%).Anti-infective drugs caused ADR in the most patients,totaling 108 cases,accounting for 25.41%.Intrave⁃nous administration was found in 210 cases(49.41%),oral administration in 133 cases(31.29%),and other routes of administra⁃tion in 82 cases(19.30%).ADRs occurred most often on the first day after administration,accounting for 45.88%(195/425);ADRs occurred 2-5 d after administration in 133 cases(31.29%).ADRs involving the skin and its adnexa were the most commonly oc⁃cured,accounting for 32.49%(155/477).Most of the patients recovered and turned better after the occurrence of ADR,accounting for 94.59%.Conclusion:The occurrence of ADR is related to various factors such as patients'age,route of administration and drug type,etc.Drug supervision and management departments,manufacturers and medical institutions should strengthen the moni⁃toring and early warning of ADR to ensure the safety of patients'medication.