481例喹诺酮类药品不良反应病例报告分析  

Analysis of 481 Reports of Adverse Drug Reactions Induced by Quinolone Drugs

作　　者：林鑫 李晋 任慧玲[1] LIN Xin;LI Jin;REN Huiling(Institute of Medical Information,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100020,China;School of Aerospace Engineering,Tsinghua University,Beijing 100084,China)

机构地区：[1]北京协和医学院/中国医学科学院医学信息研究所,北京100020 [2]清华大学航天航空学院,北京100084

出　　处：《中国药物警戒》2019年第10期617-624,共8页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金项目（NSFC91846106）：基于自然语言处理的内分泌常用药物不良反应监测数据库的构建;中国医学科学院医学与健康科技创新工程项目（2017-I2M-3-014）：中文临床医学术语系统构建研究

摘　　要：目的分析我国喹诺酮类药品不良反应(adverse drug reaction,ADR)的发生情况。方法基于国家人口与健康科学数据共享平台收集481例记录有喹诺酮类药品致ADR的病例报告,将报告中的各个字段进行规范,并利用Jieba分词模块和WHO药品不良反应术语集对ADR症状进行提取与规范。采用回顾性分析的方法,对病例报告中患者的性别、年龄、给药途径、ADR累及系统-器官等进行分析。结果在所有病例报告中,男性患者略多于女性且20~59岁比例较高;静脉滴注引起的ADR最多且多发于给药10 min内;多数报告中记录的ADR较轻微,严重ADR中最为常见的是危及生命,左氧氟沙星引起的严重ADR最多;这些病例报告共涉及184个ADR,主要表现为瘙痒、胸痛、心悸等;主要累及系统-器官为皮肤及其附件,临床表现为瘙痒、皮疹等。结论本研究通过对病例报告进行ADR症状的提取与术语规范,可有效对喹诺酮类药品所致ADR进行分析,提供了ADR回顾性分析的新途径。同时医护人员应密切关注喹诺酮类药品在临床中可能出现的不良反应,确保临床用药安全合理。Objective To analyze the occurrence of adverse drug reactions(ADRs) induced by quinolone drugs in China. Methods Based on the National Science Data Sharing Platform for Population and Health, 481 case reports of quinolone drugs-induced ADRs were collected. The fields in each case report were standardized, and the ADR symptoms were extracted and standardized by using Jieba word segmentation module and WHO adverse reaction terminology. In addition, gender, age, routes of administration and organs/systems involved in ADRs were retrospectively analyzed. Results In these reports, male patients slightly outnumbered female ones and the proportion of patients aged 20 to 59 was higher. ADRs induced by intravenous drip were the most common and tended to occur within 10 minutes of administration. The ADRs recorded in most of these case reports were relatively mild. The most common serious ADRs were life-threatening, and levofloxacin caused most of the serious adverse reactions. Quinolone drugs were involved in a total of 184 adverse drug reactions, the dominating ones of which were chest pain and palpitation. The main organ system involved was the skin and its appendages, with such clinical manifestations as pruritus and rash. Conclusion This study has effectively analyzed ADRs caused by quinolone drugs by extracting the adverse reaction symptoms from case reports and standardizing the terms, providing a novel approach to retrospective analysis of adverse reactions. Health care workers should pay close attention to adverse reactions that may occur along with the use of quinolone drugs to ensure safe and rational clinical use.

关 键 词：喹诺酮类 药品不良反应 病例报告 合理用药 

分 类 号：R994.11[医药卫生—毒理学]