严重药品不良反应148例报告分析

Analysis of 148 cases of serious adverse drug reactions

目的统计分析我县严重药品不良反应(ADR)发生的特点及规律,为临床合理用药提供依据。方法采用回顾性方法,收集我县ADR报告信息系统2012-2017年上报的148例严重ADR报告资料,按照患者性别、年龄、怀疑药品种类、给药途径、不良反应累及的系统/器官及临床表现等数据进行描述性统计分析。结果在148例严重ADR中,男女比例为0.97∶1;以50岁以上年龄患者的发生率最高(78例,52.70%),其次是9岁以下的儿童(26例,17.57%);引发严重ADR的药物品种主要是抗菌药物(52例,35.14%)、中药制剂(46例,31.08%);静脉给药方式严重ADR发生率明显高于口服给药发生率(66.89%vs 29.73%);临床主要表现为全身性反应(53例,25.24%),其次为皮肤及其附件损害(42例,20.00%)。结论严重ADR对患者造成的伤害涉及全身各系统、器官,临床应加强ADR监测工作,促进合理用药,降低药品不良反应的发生。

Objective To investigate the characteristics and clinical manifestations of serious adverse drug reaction(ADR) related to provide reference for clinical rational drug use.Methods With the retrospective method,a total of 148 serious ADR case reports were collected from my county ADR report system from 2012 to 2017.The gender and age of patients,categories of suspected drug,route of administration,organs or systems involved in ADR and clinical manifestations were analyzed.Results Among the 148 ADR cases,male and female cases ratio was 0.97:1,had the highest incidence in patients aged more than 50 years(78 cases,52.70%),followed by children under the age of 9(26 cases,17.57%);main type of serious ADR-inducing drugs was antimicrobial drugs(52 cases,35.14%),followed by the Chinese native medicine preparation(46 cases,31.08%);The incidence of serious ADR induced by intravenous administration was significantly higher than that of oral administration(66.89% vs 29.73%);main clinical manifestation were systemic damage(53 cases,25.24%),skin and its accessories damage(42 cases,20.00%).Conclusion The serious ADR may involve various organs and systems,drug monitoring should be strengthened in order to promote clinical rational drug use and avoid or reduce the occurrence of serious ADR.