1120例药品不良反应/事件的发生特点与转归分析

Characteristics and outcomes analysis of 1120 adverse drug reactions/events

目的调查我院药品不良反应/事件(ADR/ADE)发生情况,分析其发生特点和转归,为临床安全、合理用药提供参考。方法对我院2018年至2019年上报至国家不良反应监测中心的1120例药品不良反应/事件报告进行回顾性分析,探索药品不良反应/事件与年龄、性别、体重、药品种类、给药途径的相关性。结果在1120例药品不良反应/事件报告中,新的和严重的报告数共989例(88.30%),已知的药品不良反应/事件损害较严重;发生严重药品不良反应/事件的比例与性别、体重无显著相关(P>0.05),而与年龄显著相关(P<0.05),严重药品不良反应/事件患者年龄较大;给药途径以口服(624例,占55.71%)和静脉滴注(374例,占33.39%)为主,口服引起的严重药品不良反应/事件比例较高;报告数最多的药品种类是抗感染药物(298例,占26.61%),严重药品不良反应/事件占比最高的是内分泌系统用药(共143例,严重132例,占92.31%);涉及的器官/系统报告数排前三名分别是代谢及营养疾病(249例,占22.23%)、肝胆疾病(178例,占15.89%)和血管,出血及凝血疾病(170例,占15.18%);999例转归结果为痊愈或好转,63例未好转,不同处置方式对药品不良反应/事件好转率无差异(P>0.05),与未处理者存在显著差异(P<0.05);潜伏期中位数7 d,恢复期1 d。结论应加强对老年人的用药监测,特别是口服药安全问题应引起更多重视,医务人员应熟悉已知的药品不良反应/事件,以期早发现并及时处理,避免严重不良反应/事件发生。

Objective To investigate the occurrence of adverse drug reactions/events in a hospital and analyze their characteristics and outcomes,so as to provide reference for clinical safe and rational drug use.Methods A retrospective analysis was performed on 1120 ADR/ADE reports uploaded to National Center for ADR Monitoring from 2018 to 2019 in our hospital,to explore the correlation between ADR/ADE and age,gender,weight,drug type,and route of administration.Results Among the 1120 ADR/ADE reports,the number of new and serious reports was 989(88.30%),known type of ADR/ADE damage was more serious.The proportion of severe ADR/ADE was not significantly related to gender and weight(P>0.05),but was significantly related to age(P<0.05),patients with severe ADR/ADE were older;The main routes of administration were oral(624,55.71%)and intravenous drip(374,33.39%).The proportion of severe ADR/ADE caused by oral administration was relatively high;The most reported type of drug was anti-infective drugs(298,26.61%),and the drug with the highest ratio of severe ADR/ADE was endocrine system drugs(143 cases in total,132 severe cases,92.31%);The top three reported organs/systems involved were metabolic and nutritional disorders(249,22.23%),liver and biliary disorders(178,15.89%),and vascular,bleeding and clotting disorders(170,15.18%).The outcome of 999 cases was cured or improved,and 63 cases did not improve.There was no difference in the improvement rate of ADR/ADE with different treatment methods(P>0.05),which was significantly different from that of untreated patients(P<0.05);The median incubation period was 7 days,and the recovery period was 1 day.Conclusion The monitoring of medications for the elderly should be strengthened,and more attention should be paid to the safety of oral medications.Medical staff should be familiar with the known ADR/ADE in order to detect them early and deal with them in time to avoid serious adverse reactions/events.