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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 understand the characteristics and general rules of children’s adverse drug reaction (ADR) and provide a reference for clinical rational drug use. Methods: A retrospective study was conducted to collect 5,099 children’s ADRs from 2009 to 2014 in the ADRM management system. The ADR drug category, route of administration, drug dosage form, systemic / organ involvement And clinical manifestations, evaluation of the relevance and outcome of such statistical analysis. Results: Of the 5099 children with ADR, 261 new and severe ADR cases (5.11%) were reported. The ratio of males to females was 1.56: 1, with an average age of (5.12 ± 2.55) years. The incidence of ADR was the highest in children aged 1-3 years (28.85%). The route of administration and the dosage form of the drug are mainly intravenous drip and injection. The total number of drug categories involved in ADR ranked top 16 among them were anti-infectives (54.17%), proprietary Chinese medicines (8.16%), electrolytes, acid-base balance and nutritional drugs (7.79%). A total of 5099 children with ADR were involved in multiple systems / organs at 7046 frequency. The most common clinical manifestations were lesions of the skin and their appendages (3458 frequency, 49.08%), followed by gastrointestinal damage (1547 frequency, 21.96%) and systemic Damage (595 frequency, 8.44%). Conclusion: Prevention of drug abuse in children, rational use of pediatric drugs, monitoring of ADR and drug counseling should be strengthened in order to reduce or avoid the occurrence of ADR.