196例药品不良反应报告

Reports on 196 Cases of Adverse Drug Reaction

目的:了解太仓市中医医院(以下简称"我院")药品不良反应(adverse drug reaction,ADR)发生的特点,发现ADR监测过程中的不足,探讨改进措施。方法:对我院2015年1月—2016年11月上报的196例ADR报告进行整理分析。结果:2016年1—11月,我院上报的ADR明显多于2015年;主要为临床医师上报,ADR多发生于住院患者。196例ADR报告中,女性略多于男性;患者年龄3个月~87岁,<10岁及>60岁者较为多见;静脉给药引发ADR病例数最多,其次为口服给药;共涉及药物13类69种,抗感染药致ADR病例数最多,其次为中药制剂。抗感染药引发126例ADR,共涉及10类药物20个品种,病例数排序居前3位的分别为头孢菌素类、青霉素类和氟喹诺酮类;排序居前3位的药品为左氧氟沙星、哌拉西林他唑巴坦及五水头孢唑林。ADR主要累及皮肤及其附件,其次为消化系统和循环系统。结论:开展ADR监测是医院药事管理的重要内容之一,通过医药护多方合作可提高ADR上报率及临床合理用药水平。

OBJECTIVE： To investigate the characteristics of adverse drug reaction（ ADR） in Taicang Hospital of Traditional Chinese Medicine（ hereinafter referred to as ＂our hospital ＂）,and to find out the limitation during the monitoring process,so as to probe into the improvement strategy. METHODS： Analysis was conducted on 196 cases of ADR reports reported from Jan. 2015 to Nov. 2016. RESULTS： From Jan. to Nov. 2016,the number of ADR reports was significantly higher than that in 2015; the ADR were mainly reported by clinicians, and concentrated in inpatients. Of the 196 ADR reports,females were more than males; and the ADR cases were aged from 3 months to 87 years old,mainly concentrated in under 10 years of age and over 60 years of age. The number of ADR cases induced by intravenous administration took the lead,followed by oral administration. Totally 10 kinds and 69 categories were involved,and the number of ADR cases induced by anti-infectious agent took the lead,followed by Chinese herba preparation. The number of ADR induced by anti-infectious agent was 126,and totally 10 kinds and 20 categories were involved,the top 3 categories ranked by number of cases were respectively cephalosporins,penicillins and fluoroquinolones; and the top 3 drugs ranked by number of cases were respectively levofloxacin, piperacillintazobactam and cefazolin sodium pentahydrate for injection. ADR mainly involved skin and accessories,followed by digestive and circulatory systems. CONCLUSIONS： Development of ADR monitoring is an essential part of hospital pharmacy management,report rate of ADR can be increased and rational clinical drug use level can be improved through cooperation among clinicians,pharmacists and nurses.