摘要
目的:分析我院2009例药品不良反应(ADR)报告的发生特点,提取并发现风险信号,为优化药品安全性监测模式,促进临床合理用药提供参考。方法:以《WHO不良反应术语集》、《药品不良反应报告和监测管理办法》、《药品不良反应因果关系评价表》等为标准,采用回顾性调查研究方法,对2009例有效ADR报告中患者年龄、给药途径、严重ADR涉及药物种类、ADR累及器官/系统、监测上报人员类型等数据进行分类汇总和统计分析。结果:2009例有效ADR报告中,60岁以上患者ADR的发生比例为34.15%,14岁及以下患者ADR的发生比例为7.22%;静脉滴注给药途径ADR的发生例数最高,肌肉注射给药途径ADR的发生例数最低。ADR涉及药物品种主要为心血管系统药物、抗微生物药物和抗肿瘤药物;ADR临床表现以全身性损害最为常见,其次分别是皮肤及其附件损害和中枢及外周神经系统损害;ADR报表上报人员以医师为主,占比为87.11%,药师上报例数最低,占比为0.99%;严重ADR主要涉及抗肿瘤药物、诊断用药(造影剂)和抗微生物药物。结论:在ADR日常监测过程中,抗感染药物、心血管药物及抗肿瘤药物是ADR监测重点药物类别,60岁以上和14岁及以下的患者是ADR监测重点人群,静脉滴注给药途径是ADR监测重点给药途径,皮肤及其附件病变是提示ADR发生的重要信号。临床ADR监测应重点关注上述影响因素,结合患者具体情况,实施个体化给药,进一步提高临床合理用药水平,确保患者用药安全。
OBJECTIVE To analyze 2009 cases of adverse drug reactions（ADRs）in our hospital and to screen and find out risk signals in order to optimize the model of drug safety monitoring and to improve the rational drug use in clinical practice.METHODS WHO Adverse Reaction Terminology,Regulations of Drug Adverse Reaction Report and Monitor and Naranjo algorithm were used as the criteria for retrospective analysis of the age,administration,medication type for severe adverse drug reaction,organ involvement,types of reporter.RESULTS ADRs occurred in 34.15% in patients older than 60 years and7.22%in patients younger than 14 years.Intravenous dripping induced the most ADRs while intramuscular injection induced the least.The major drugs involved in ADRs were cardiovascular drugs,antimicrobial agents and antitumor drugs.The most common features of ADRs was systematic lesion,followed by skin and appendage and PNS and CNS lesion.The main reporters were doctors accounting for 87.11% while pharmacists were the least only accounting for 0.99%.The severe adverse drug reactions involved antitumor agents,diagnostic agents and antimicrobial agents.CONCLUSION The major drugs to be monitored are antimicrobial agents,cardiovascular drugs and antitumor agents,and major patients to be monitored are those older than60 years or younger than14 years.Intravenous drip is the important administration route to be monitored for ADRs,while skin and appendage lesions are important signals to suggest ADRs.All the factors mentioned should be monitored closely to further improve rational use of drugs in clinical practice and ensure medication safety by combining the actual conditions of patients and implement individualized medication.
作者
熊代琴
李桂荣
阳莹
李东锋
XIONG Dai-qing LI Gui-rong YANG Yin LI Dong-feng(Department of Pharmacy, First Affiliated Hospi- tal of Xinjiang Medical University, Xinjiang Urumqi 830011, China Xinjiang Medical University, Xinjiang Urumqi 830011, China)
出处
《中国医院药学杂志》
CAS
北大核心
2017年第17期1753-1759,共7页
Chinese Journal of Hospital Pharmacy
基金
新疆医科大学人文社会科学基金项目(药物警戒信号对医院安全用药警示作用的研究
项目编号2014XYDSK46)
关键词
药品不良反应
回顾分析
风险信号
监测
用药安全
adverse drug reaction
retrospective analysis
risk signals
monitor
medication safety
