目的 分析南阳市中心医院抗菌药物致儿童严重不良反应（ADR）发生的特点及规律，为临床安全、有效、合理用药提供参考。方法 采用回顾性调查方法对2016年1月1日—2021年5月31日南阳市中心医院上报至国家药品不良反应监测系统的72例儿童严重抗菌药物ADR报告进行统计分析。结果 72例儿童严重抗菌药物ADR报告中，男44例（61.11%），女28例（38.89%）。婴儿期（28 d～1岁）患儿严重ADR占比最高，为52.78%。静脉滴注是引发严重ADR最主要给药途径，共69例（95.83%）。引发ADR最多的抗菌药物类别是头孢菌素类，共35例（48.61%）。皮肤及其附件损害是最主要的临床表现，共73例次（68.87%）。绝大多数ADR经相应处理后痊愈或好转。结论 抗菌药物引起的严重ADR受年龄、给药途径、药品种类、用药时间等因素影响，应加强患儿抗菌药物所致严重ADR监测，保障临床用药安全、有效、合理。

Objective To analyze the characteristics and rules of serious adverse drug reaction (ADR) in children from Nanyang Central Hospital, so as to provide reference for clinical rational, safe and effective drug use induced by antibiotics. Methods In retrospective investigation, 72 cases of serious ADR reports induced by antibacterial drugs in children collected by National ADR Monitoring Center in Nanyang Central Hospital from January 2016 to May 2021 were analyzed statistically. Results Among the 72 cases of serious ADR reports, 44 cases (61.11%) were male and 28 cases (38.89%) were female. The incidence of ADR in patients aged from 28 day to 1 year were the highest (52.78%). Most of the cases were induced by intravenous injection, accounting for 69 cases (95.83%). 35 cases (48.61%) were induced by cephalosporin antibiotics. The injury of the skin and its appendages was the most common ADR, which occupied 73 cases (68.87%). Most of ADRs can be cured or improved after corresponding treatment. Conclusion The influencing factors of serious ADR induced by antibacterial drugs in children were related to many factors, such as gender, age, drug varieties, the course of medication and so on. We should strengthen the monitoring of serious ADR induced by antibacterial drugs in children so as to ensure the safe, effective and rational drug use in clinic.

R978.1

河南省医学科技攻关计划联合共建项目（LHGJ20191453）