郑　新，严健聪，刘　福，朱玉清，王缉义，卢安妮(玉林市妇幼保健院药剂科，广西 玉林　537000)



266例儿童药品不良反应报告分析

郑新*，严健聪，刘福，朱玉清，王缉义，卢安妮(玉林市妇幼保健院药剂科，广西 玉林537000)

DOI10.14009/j.issn.1672-2124.2016.01.031

摘要目的：了解广西壮族自治区玉林市妇幼保健院(以下简称“我院”)儿童药品不良反应(adverse drug reaction，ADR)发生的基本情况、相关因素及特点，为促进该地区ADR监测及儿童安全用药提供参考。方法：对2012—2014年我院筛选出的266例儿童ADR报告，进行性别及年龄、给药途径、给药时间、药物类别、所累及器官和(或)系统和临床表现、转归、ADR报告情况进行统计分析。结果：266例ADR 报告中，0～3岁发生较多，共188例(占70.68%)；由静脉滴注引起的有246例(占92.48%)；用药过程中0～30 min出现较多，有219例(占82.33%)；中成药注射剂117例(占43.98%)和抗菌药物105例(占39.47%)所致ADR最常见；累及皮肤及其附件损害的有209例(占73.33%)；报告情况中严重的5例(占1.88%)，其中1例(占0.38%)为新的严重的ADR；其余为一般的，其中7例(2.68%)为新的一般的ADR。结论：医院管理及临床治疗应更重视儿童ADR的发生，促进临床合理用药、安全用药。

关键词药品不良反应； 儿童； 安全用药

Analysis of 266 Children of Adverse Drug Reaction Reports

ZHENG Xin, YAN Jiancong, LIU Fu, ZHU Yuqing, WANG Jiyi, LU Anni(Dept.of Pharmacy, Yulin Maternal and Child Health Care Hospital, Guangxi Yulin 537000, China)

ABSTRACTOBJECTIVE：To investigate the basic situations, related factors and characteristics of adverse drug reaction (ADR) in children from Yulin Maternal and Child Health Care Hospital(hereinafter referred to as “our hospital”), and to provide reference for the promotion of ADR monitoring and medication safety in children. METHODS: 266 ADR cases collected during 2012-2014 in our hospital were statistically analyzed in terms of gender and age, administration routes, drug categories, ADR involved organs and (or) systems and clinical manifestations, prognosis and ADR reports situation. RESULTS: Of the 266 cases, patients at 0～3 years old took the lead, totally 188 cases(70.68%); 246 cases (92.48%) were induced by intravenous drip; and cases during 0-30 min of the administration process were common, totally 219 cases (82.33%). 117 cases (43.98%) were induced by Chinese patent medicine injections and 105 cases (39.47%) were induced by antibacterial agents, both of which were the commonest ADR. Skin and its appendages impairment were 209 cases(73.33%). Of the reports situation, 5 cases were severe (1.88%), one case was new severe; others were common, and 7 cases (2.68%) were new common.

KEYWORDSAdverse drug reaction; Children; Safe drug use

儿童是特殊的生理群体，药物在其体内动力学差别很大，而耐受能力却较弱。儿童药物不良反应(adverse drug reaction，ADR)的发生对儿童的用药安全构成威胁，在我国约高于成人两倍[1]。ADR监测工作的全面开展有利于及时有效地控制药品风险，减少药源性反应的发生，保障公众用药安全[2]，对儿童安全用药指导意义更加重大。

1资料与方法

1.1资料来源

266例发生ADR的儿童均来自广西壮族自治区玉林市妇幼保健院(以下简称“我院”)2012—2014年的合格报告。……