168例药品不良反应/事件报告分析

Analysis of 168 Adverse Drug Reaction/Event Reports

目的了解药品不良反应/事件发生的特点及一般规律,为临床安全、合理用药提供参考;评价药品不良反应/事件报告表填写质量。方法对我院2007年1月～2009年6月收集到的168例药品不良反应/事件报告进行回顾性分析。结果168例药品不良反应/事件涉及104种药品,其中抗感染药物居首位(占45.2%),其次是中药制剂(占25.6%);给药途径以静脉滴注所占比例最大(占61.9%);临床表现以皮肤及其附件损害最常见(38.6%);严重不良反应/事件有4例;绝大多数药品不良反应/事件出现在用药61分钟至24小时内(112例);对症治疗52例,未进行特殊处理的60例。我院药品不良反应/事件报告总数偏少,报告表填写质量较差。结论应加强药品不良反应监测和报告,确保临床安全、有效、合理用药。抗感染药、中药制剂的应用及静脉用药的给药方式是药品不良反应/事件发生的主要因素,应加强其使用的监督管理。

Objective To investigate the features and general pattern of the adverse drug reaction/event（ADR/ADE）,and provide references of clinical rational and safty use of drug and evaluate the quality of ADR/ADE reports.Methods A total of 168 ADR/ADE cases collected in our hospital from Jan.2007 to June 2009 were analyzed retrospectively.Results A total of 104 drugs were involved in the 168 ADR/ADE,mainly anti-infective drugs（45.2%）,followed by Traditional Chinese Medicines（25.6%）.The main route of administration was by intravenous drip（61.9%）.The ADR/ ADE were chiefly characterized by the lesions of skin and appendages（46.4%）.There were four severe cases and most of ADR/ADE occurred within 24 hours after medication（112 cases）;52 cases were given symptomatic treatment and 60 cases were left untreated.The number of ADR/ADE reports was less than expected and the quality of ADR/ ADE reports was poor.Conclusion ADR monitoring and reporting should be strengthened to ensure safe,effective and rational drug use in the clinic.The ADR/ADE occurred in our hospital were mainly induced by the use of antiinfectives and Chinese materia medica preparation administered by intravenous drip.Measures should be taken to tighten control on rational drug use.