8503例喹诺酮类药物致ADR/ADE的帕累托图分析

Analysis of 8 503 Cases of Quinolones Adverse Drug Reactions by Pareto Diagram

目的:分析喹诺酮类药物所致药品不良反应/事件(ADR/ADE)的发生特点及规律,为临床安全用药提供参考。方法:采用帕累托分析法对北京市ADR监测中心2012年1月至2017年12月接收的喹诺酮类药物药品不良反应/事件报告进行整理,按照患者性别、年龄、用药情况、不良反应累及系统-器官及临床表现、类型及转归情况等数据进行描述性统计分析。结果:8 503例喹诺酮类药物所致ADR/ADE中,男女比例为1∶1.43,21～30岁(17.48%),51～60岁(16.62%),31～40岁(15.82%),71～80岁(13.30%),61～70岁(13.08%) 5个年龄段报告占比大; ADR/ADE涉及喹诺酮类药物中10个品种,其中左氧氟沙星最多(68.01%),其次为莫西沙星(28.38%);引起ADR/ADE的给药途径以静脉滴注为主; ADR/ADE共累及多个系统/器官,皮肤及其附件损害(43.55%)、胃肠疾病(13.18%)、神经系统疾病(11.53%)和用药部位疾病(9.69%)相关的ADR/ADE例数较多;严重ADR/ADE报告206例,其中死亡13例;未合并用药7 205例(84.73%),合并用药1 298例(15.27%)。结论:喹诺酮类药物ADR/ADE发生率与患者年龄、给药途径、合并用药有一定关系。此外,在关注老年人用药安全的同时,也要加强青年人用药的安全及风险意识。

Objective:To analyze the characteristics and regularity of adverse drug reactions/events(ADR/ADEs)caused by quinolones in Beijing,and to provide reference for clinical safe drug use.Methods:ADR/ADE reports of quinolones from January 2012 to December 2017 in Beijing ADR/ADE monitoring center were analyzed by Pareto analysis.The data were analyzed according to sex,age,drug use,adverse drug reactions involving system/organs and clinical manifestations,ADR/ADE report types and prognosis.Results:Among 8 503 quinolone-induced ADR/ADE cases,the male-female ratio was 1∶1.43,21-30 years old(17.48%),51-60 years old(16.62%),31-40 years old(15.82%),71-80 years old(13.30%)and 61-70 years old(13.08%)had the largest proportion of ADR/ADE reports.Among the 10 quinolones reported by ADR/ADE,levofloxacin was the most common(68.01%)and moxifloxacin was the second(28.38%).The main route of administration of ADR/ADE was venous route.8 503 Cases of quinolone-related ADR/ADE involving multiple systems/organs,skin and its accessories damage(43.55%),gastrointestinal system damage(13.18%),nervous system damage(11.53%)and drug site damage(9.69%)related ADR/ADE cases were more.Serious ADR/ADE reported 206 cases,of which 13 cases died.Among 8 503 ADR/ADE reports,7 205(84.73%)were not combined with other drugs,while 1 298(15.27%)were combined with other drugs.Conclusion:The incidence of ADR/ADE of quinolones is related to patients′age,route of administration and combination of drugs.In addition,while paying attention to the safety of drug use in the elderly,we should also strengthen the risk awareness of drug use safety in young people.