我院113例新的药品不良反应报告分析

Analysis of 113 Cases of Unexpected Adverse Drug Reaction Reports in Our Hospital

目的:了解我院新的药品不良反应(ADR)的发生特点,提高ADR监测水平。方法:通过回顾性研究我院2012年发生的新的ADR报告,进行分类统计分析。结果:113例新的ADR报告中,新的严重的ADR3例(占2.65%),新的一般的ADR 110例(占97.35%);患者年龄≥60岁者51例(占45.13%),为各年龄段之首;性别无明显差异;静脉给药者89例,占78.76%;合并用药者仅2例。按药物类别分,113例新的ADR涉及12类67种药物,引发ADR药物以中药12种32例居首位,其中痰热清注射液11例,生脉注射液6例;其次为维生素营养药7种17例。累及器官或系统以皮肤及其附件31例(25.62%)为主;转归中好转93例,痊愈17例,各占82.30%和15.04%。结论:新的ADR以新的一般ADR为主,主要由静脉给药引起,年龄≥60岁者近一半,中药是引发新的ADR的主要药品。应加强老年人的用药监护,加强对中药的生产以及上市后监测,新的和严重ADR是监测重点。

OBJECTIVE： To understand the characteristics of unexpected adverse drug reactions （ADR）, and to further improve ADR monitoring. METHODS： By analyzing unexpected ADRs in 2012 retrospectively, those ADR cases were analyzed statistically. RESULTS： Among 113 cases, 3 cases were unexpected serious （2.65%） and 110 cases were unexpected general （97.35%）; 51 pa- tients aged over 60 years old took up the first place（45.13% ） ; no differences were shown about gender; 89 cases were induced by i.v. administration （78.76%）; drug combination was found in 2 cases, Drug were classified according to drug type： 113 cases of unex- pected ADR included 12 categories 67 kinds of drugs, among which there were 12 kinds of TCM in 32 cases, including 11 cases of Tanreqing injection and 6 cases of Shengmai injection; followed by 7 kinds of vitamin nutriceutical in 17 cases. Organs or systems in- volved were skin and its appendants in 31 cases （25.62%）; 93 cases were relieved （82.30%） and 17 cases were cured （15.04%）. CONCLUSIONS ： The majority of unexpected ADR are unexpected general ADR and by intravenous administration. Nearly half of ADR patients are over 60 years old, and ADR are mainly caused by TCM. It is important to strengthen surveillance of drug use in the elderly patients, manufacture, preparation and surveillance of TCM, unexpected and serious ADR monitoring.