宝鸡地区854例严重药品不良反应/事件回顾分析

Retrospective analysis of 854 cases of serious adverse drug reactions/event in Baoji area

目的分析宝鸡地区854例严重药品不良反应/事件(ADR/ADE)的发生规律和特点,旨在提高药品安全监测和预警水平,为临床安全用药提供参考。方法从国家药品不良反应监测系统库宝鸡市药品不良反应监测中心调取并筛选2014—2018年上报的严重ADR/ADE数据,将患者年龄、性别、怀疑药品信息、ADR/ADE发生过程描述等信息进行统计分析。结果854份严重ADR/ADE报告中,≥65岁的患者有261例,其中合并用药患者占50.96%。抗感染药物、中成药及中药注射剂和主要作用于中枢神经系统的药物的发生率较高,分别是291例(30.16%)、146例(15.13%)和140例(14.51%)。全身性损害发生频次最高,为455频次(32.99%),其次为皮肤及其附件损害215频次(15.59%)。静脉给药是主要的给药方式,包括静脉滴注、静脉注射及泵内注射三种给药途径,共计737例(76.38%)。新的严重ADR/ADE有264例(30.91%)。结论本研究中严重ADR/ADE的发生与患者年龄、药品种类、给药途径有关。医疗机构、生产经营企业应加强严重ADR/ADE的监测,保障患者用药安全。

Objective To analyze the occurrence regularity and characteristics of 854 cases of severe adverse drug reactions/events (ADR/ADE) in Baoji area in order to improve the level of drug safety monitoring and early warning, and provide reference for clinical safe drug use. Methods The serious ADR/ADE data reported from 2014 to 2018 were collected and screened from the National Adverse Drug Reaction Monitoring System Database Baoji Adverse Drug Reaction Monitoring Center. The age, gender, suspected drug information, ADR/ADE occurrence process description and other information were analyzed statistically. Results Among 854 reports of serious ADR/ADE, 261 cases were over 65 years old, of which 50.96% were combined with drugs. The incidences of anti-infective drugs, traditional Chinese medicine and traditional Chinese medicine injections and drugs mainly acting on the central nervous system were higher, which were 291 cases (30.16%), 146 cases (15.13%) and 140 cases (14.51%) respectively. The highest frequency of systemic damage was 455 (32.99%), followed by 215 (15.59%) of skin and appendages disorders damage. Intravenous administration was the main way of administration, including intravenous drip, intravenous injection and pump injection, with a total of 737 cases (76.38%). New serious ADR/ADE were 264 cases (30.91%). Conclusion The occurrence of serious ADR/ADE in this study is related to patients' age, drug type and route of administration. Medical institutions and production and operation enterprises should strengthen the monitoring of serious ADR/ADE to ensure the safety of drug use of patients.