2009–2014年军队医院5099例儿童药品不良反应报告分析  

Analysis on 5099 ADR reports occurred in children in military hospitals from 2009 to 2014

作　　者：谢婷婷[1] 郭代红[1] 赵粟裕 马亮[1] 赵靓[1] 徐元杰[1] 朱曼[1] 赵鹏芝[1] 郭俊荣[1] 

机构地区：[1]解放军总医院药品保障中心,北京100853 [2]重庆医科大学药学院,重庆401331

出　　处：《中国药物应用与监测》2015年第6期360-364,共5页Chinese Journal of Drug Application and Monitoring

基　　金：2014年全军后勤科研重点项目:军队药品风险监测防控技术与支撑平台的研究(BWS14R039)

摘　　要：目的：了解儿童药品不良反应（ADR）发生的特点及一般规律,为临床合理用药提供参考。方法：采用回顾性方法,收集2009–2014年军队药品不良反应监测管理系统中儿童药品不良反应报告5099例,对患者性别、年龄、引起ADR药品种类、给药途径、药品剂型,累及系统/器官及临床表现、关联性评价及转归等情况进行统计分析。结果：5099例儿童ADR报告中,新的和严重的ADR 261例（5.11%）。男女比例为1.56：1,平均年龄为（5.12±2.55）岁,1~3岁儿童ADR发生率最高（28.85%）。给药途径和药品剂型以静脉滴注和注射剂型为主。共涉及药物类别16种,其中引起ADR排名前三位的药物类别分别为抗感染药物（54.17%）、中成药（8.16%）、电解质、酸碱平衡及营养药物（7.79%）。5099例儿童ADR共累及多个系统/器官,7046频次,最常见的临床表现为皮肤及其附件损害（3458频次,49.08%）,其次为胃肠系统损害（1547频次,21.96%）及全身性损害（595频次,8.44%）。结论：应加强对于儿童用药风险防范工作,合理使用儿科药物,重视ADR的监测及药物咨询等工作,以减少或避免ADR的发生。Objective： To investigate the characteristics and general pattern of adverse drug reaction（ADR） occurred in children, and provide reference for clinical rational drug use. Methods： With the retrospective method, a total of 5099 ADR reports occurred in children were collected from 2009 to 2014 in the database of PLA ADR monitoring center. The data in respect of age and gender of patients, categories of drugs, route of administration, dosage form, systems and organs involved in ADR and clinical manifestations, relevance evaluation and prognosis were analyzed statistically. Results： Among 5099 ADR reports, new and severe ADR reports were 261 cases（5.11%）, the male to female ratio was 1.56 ： 1, the average age of the patients was（5.12 ± 2.55） years, the incidence of ADR was the highest in the childeren of 1 – 3 years old（28.85%）. Intravenous infusion and injection type were the main administration route and dosage form, respectively. The ADRs were related to 16 kinds of drug categories. The top 3 drug categories involved in ADRs were anti-infection drugs（54.17%）, Chinese patent medicine（8.16%）, electrolyte and acid-base balance and nutrition drugs（7.79%）, respectively. These children’s ADRs involved multiple systems and organs（7046 frequencies）, the most common clinical manifestation was skin and its accessories damage（3458 frequencies, 49.08%）, followed by gastrointestinal system damage（1547 frequencies, 21.96%） and systemic damage（595 frequencies, 8.44%）. Conclusion： We should strengthen the risk prevention work on children’s drugs and the rational use of drugs in pediatrics. ADR monitoring and drug consulting work need to be paid more attention to, in order to reduce or avoid the occurrence of ADR.

关 键 词：儿童 药品不良反应 报告 分析 

分 类 号：R95[医药卫生—药学]