187例儿童严重药品不良反应/事件相关因素分析

Analysis on Relevant Factors of 187 Cases of Children's Severe Adverse Drug Reactions / Events

目的：分析儿童严重药品不良反应/事件（ADR/ADE）发生的相关因素,以减少其发生率及危害程度。方法：以2010年1月至2014年6月广西省百色市药品不良反应监测中心收集的187例儿童严重ADR/ADE报告为对象,采用回顾性研究方法进行统计分析。结果：本组资料中,0~3岁患儿比例最高（43.32%）;静脉给药是引发严重ADR/ADE的主要给药途径（86.64%）;抗菌药物引发的严重ADR/ADE最多（41.71%）,其次为中药注射剂（23.00%）;儿童严重ADR/ADE可能与不合理用药相关;非儿童专用药品可能更易导致严重ADR/ADE的发生。结论：应针对性地加强儿童严重ADR/ADE监测工作,避免或减少严重ADR/ADE给儿童造成的伤害。

Objective： To investigate the relevant factors of children＇ s severe adverse drug reactions/events （ ADR/ADE ）, and reduce its incidence and the extent of injure. Methods： A total of 187 children＇ s severe ADR/ADE reports from January 2010 to June 2014 were collected in Baise Adverse Drug Reaction Monitoring Center and statistically analyzed retrospectively. Results： Of the 187 ADR/ ADE cases, their peak age were from 0 to 3 years old （43.32%）, and intravenous administration was the main way to cause severe ADR/ADE （86.64%）. Furthermore 41.71% were induced by antibiotics versus, 23.00% by traditional Chinese herbal injections. Children＇s severe ADR/ADE cases may be related to irrational drug use and deficiency of children＇s special drugs. Conclusion： The monitoring and management of Children＇ s severe ADR/ADE should be strengthened to reduce the occurrence and harmful.