965例儿童药品不良反应报告分析

目的对西安市儿童药品不良反应(ADR)进行回顾性分析,以促进儿童安全、合理用药。方法对2015年国家ADR监测系统中西安市儿童ADR报告进行统计分析。从ADR涉及的给药途径、药品种类、累及器官、主要临床表现、关联性评价和转归情况等方面进行分析。结果在965例儿童ADR中,男性多于女性(1.3∶1.0);3岁以下患儿最多(37.3%);由注射给药途径导致的ADR有674例(69.8%);由抗微生物药引起的ADR有568例(58.9%);不良反应主要累及皮肤系统(492例)和消化系统(312例)。结论必须加强在儿童用药过程中的监测和观察,尤其是在注射给药和使用抗微生物药物时,应警惕ADR的发生。

Analysis of 965 adverse drug reaction reports occurred in children

Objective:A retrospective analysis of adverse drug reactions (ADR) in children in Xi′an was carried out to promote the safety and rational use of drugs in children.Methods The ADR reports of children received by Xi′an Adverse Drug Reaction Monitoring Center in 2015 were analyzed.The administration routes, the organs,the main clinical manifestations and the outcome involved in ADRs were analyzed.Results Among the 965 ADRs,the gender ratio was 1.3∶1.0,more male than female.The proportion of children under 3 years old was the highest,37.3%.674 cases (69.8%) were caused by injection,and 568 cases (58.9%) were caused by antimicrobial agents.Most of the ADRs involved in the skin system (492 cases) and the digestive system (312 cases).Conclusion We should pay more attention to the drug monitoring and observation in children to prevent the occurrence of ADRs,especially to the injection and antimicrobial drugs.