99例抗感染药物严重药品不良反应/事件分析

Analysis of 99 Serious Adverse Drug Reaction/Event Associated with Anti-Infective Agents

目的:分析某院抗感染药物严重药品不良反应/事件(ADR/ADE)的特点及规律,为临床合理应用提供参考。方法:收集2010~2022年某院上报至国家药品不良反应监测系统的99例抗感染药物严重ADR/ADE报告,并进行统计分析。结果:99例抗感染药物严重ADR/ADE中,男性患者与女性患者之比为1.7∶1;60岁及以上人群发生率最高,占21.2%;12例既往有药物过敏史;给药途径主要是静脉滴注(53.5%);共涉及13大类37种抗感染药物,其中例次数最多的是抗结核药(60.2%);具体品种例次数最多的是吡嗪酰胺和利福平(均为15.1%);累及系统/器官主要是皮肤及皮肤附件疾病(19.1%)。结论:在使用抗感染药物治疗时,除临床最为关注的抗感染疗效外,潜在的药品安全问题同样不容忽视,尤其是严重ADR/ADE。应制定有效措施,以降低抗感染药物ADR/ADE的发生。

Objective:To analyze the characteristics and rules of serious adverse drug reaction/event(ADR/ADE)associated with anti-infective agents,and provide references for the promotion of rational clinical use of these medications.Methods:99 serious ADR/ADE reports associated with anti-infection agents reported by a hospital to the National Adverse Drug Reaction Monitoring Center between 2010 and 2022 were selected and analyzed statistically.Results:In the 99 serious ADR/ADE,the male-to-female patient ratio was 1.7:1.Patients aged over 60 experienced the highest incidences(21.2%).12 patients had a previous history of drug allergy.The primary route of administration was intravenous infusion(53.5%).The study involved 13 major categories and 37 types of anti-infective agents,with the highest frequency of reports associated with anti-tuberculosis drugs(60.2%).Notably,pyrazinamide and rifampin rank highest for ADR/ADE incidence(15.1%).The system organ class involved was mainly skin and appendages disorders(19.1%).Conclusion:For clinical application of anti-infective agents,besides anti-infective efficacy,we should also be alert to the potential drug safety issues,especially serious adverse drug reactions ADR/ADE.Effective measures should be formulated to lower the incidence of ADR/ADE to anti-infective agents.