应用中国医院药物警戒系统对左氧氟沙星导致皮肤相关不良反应的主动监测研究  

Automatic Monitoring Study of Levofloxacin-induced Skin-related ADRs Based on the China Hospital Pharmacovigilance System

作　　者：刘宏尉 杨嘉永[1] 颜志文[1] LIU Hong-wei;YANG Jia-yong;YAN Zhi-wen(Department of Pharmacy,The First Affliated Hospital of Xiamen University,Xiamen 361000,China)

机构地区：[1]厦门大学附属第一医院药剂科,福建厦门361000

出　　处：《海峡药学》2022年第9期135-138,共4页Strait Pharmaceutical Journal

摘　　要：目的应用中国医院药物警戒系统(CHPS)对左氧氟沙星导致的皮肤相关不良反应(ADR)实行主动监测,研究监测方案的设置、左氧氟沙星皮肤相关不良反应的发生情况和影响因素等。方法采用回顾性研究方法,在“药品评价系统”里建立模块条件,对我院2019年7月~2020年12月期间使用左氧氟沙星的住院患者,初步得到用药后出现皮肤及其附件损害的报警病例,经临床药师双人盲评,确定阳性病例,并分析阳性发现率、不良反应发生率、影响因素等。结果合计纳入病例4128例,报警病例85例,经人工评价,确定阳性结果20例,阳性发现率为23.53%,不良反应的发生率为0.48%。经分析,在性别、用药时长、年龄上差异上,左氧氟沙星致皮肤相关ADR无统计学意义,而在用药剂型上差异有统计学意义。结论左氧氟沙星皮肤相关ADR较为常见,利用CHPS中的“药品评价系统”创建监测模块,用于药物安全性研究时,能够高效、快速地获得目标用药患者信息,为真实世界临床用药的安全性研究提供方法思路。OBJECTIVE To implement automatic monitoring of levofloxacin-induced skin-related ADRs through the china hospital pharmacovgilance system,investigate the optimal settings of the monitoring plan,as well as the occurrence and analysis of influencing factors.METHODS A retrospective research method was adopted.Monitoring conditions were set up in the Drug Evaluation System of CHPS,and automatic monitoring was carried out on the inpatients receiving levofloxacin in our hospital from July 2019 to December 2020.Reports of skin and accessory damage after medication were initially obtained,and positive cases were confirmed after blind double-evaluation by clinical pharmacists.The positive detection rate,the incidence of ADRs and the influencing factors were analyzed.RESULTS A total of 4,128 cases were included using levofloxacin,including 85 having warning reports.20 cases were confirmed as positive after manual evaluation,with a positive rate of 23.53%,and the incidence of ADRs of 0.48%.Levofloxacin-induced skin-related ADRs were not statistically significant in gender,age,and duration of medication,the differences in dosage forms and combination of antibiotics were statistically significant.CONCLUSION Levofloxacin-induced skin-related ADRs are common.Dynamic monitoring through the Drug Evaluation System in CHPS can efficiently,quickly obtain the risk information of drug users,helping to warn medication safety and reduce clinical medication risks.

关 键 词：中国医院药物警戒系统 左氧氟沙星 主动监测 药品不良反应 皮肤损害 

分 类 号：R969.3[医药卫生—药理学]