山东省8566例新的药品不良反应报告分析

目的:了解山东省新的药品不良反应(ADR)发生的现状及特点,为保障患者用药安全提供参考.方法:调取2019年10月-2020年3月上报至山东省ADR监测中心自发呈报系统新的ADR报告的相关数据,对报告类型、上报机构、报告人职业和患者性别、年龄、药物类型、累及器官/系统、临床表现等情况进行统计分析.结果与结论:共筛选出新...

Analysis of 8566 New ADR Reports in Shandong Province

OBJECTIVE:To investigate the occurrence and characteristics of new adverse drug reactions(ADR)in Shandong province,so as to provide reference for the safety of drug use in the clinic.METHODS:The data of new ADR reports were collected from Spontaneous Reporting System of Shandong ADR Monitoring Center during Oct.2019 to Mar.2020.Those reports were analyzed statistically in respects of report types,reporting institution,reporters’occupation,gender and age of patients,drug type,organs/systems involved,clinical manifestations.RESULTS&CONCLUSIONS:A total of 8566 new ADR reports were screened out,accounting for 10.81%of the effective ADRs.Among them,there were 7961 new and general ADR(92.94%)and 605 new and serious ADRs(7.06%).For the new ADR,the reporting institutions were mainly medical institutions(98.42%),and the reporters’occupation were mainly doctors(78.44%).Female(4860 cases)was slightly more than male(3698 cases);most of them were 45 years old and above(70.00%),and intravenous drip(47.67%)was the main route of administration.The top five ADR suspected drugs were TCM preparations(34.50%),anti-microbials(13.75%),circulatory system drugs(11.41%),nervous system drugs(6.39%)and blood system drugs(4.81%),involving 517,91,64,53,50 types,respectively,among which Levofloxacin injection caused the most serious ADR(24 cases).The new and general ADR mainly involved gastrointestinal system,skin and its appendant;their clinical manifestations were nausea,vomiting,rash,etc.New and serious ADR mainly caused systemic damage;their clinical manifestations were anaphylactic shock,chest tightness and shivering,etc.It is suggested to strengthen the ADR monitoring of TCM preparations,anti-microbials,circulatory system drugs and other drugs,so as to ensure the safety of clinical drug use.