334例儿童药品不良反应及其超说明书用药使用分析

Analysis of 334 cases of adverse drug reactions in children and their off-label use of drug

目的:对我院儿童药品不良反应(ADR)发生特点及其超说明书用药使用情况进行分析,旨为临床合理用药提供参考。方法:采用回顾性分析的方法,收集我院2011年1月–2017年12月年上报的所有18岁以下的ADR报告,利用Excel表格分别对患儿的性别、年龄、疾病诊断、药品种类、ADR累及系统/器官及临床表现等方面进行统计分析。结果:334例ADR中,男性192例(57.49%),女性142例(42.51%),超说明书使用人数189人,涉及药品77种。其中超说明书使用药品达32种(41.56%);引发ADR的药物中以抗感染药物最多,共涉及23个品种(29.87%);引发ADR的超说明书用药类型中,未提及儿童用药信息涉及药品26种(53.06%);ADR累及系统以皮肤及皮肤附件损害比例最高,共计181例(54.19%);ADR涉及的药品排在前10位的以抗感染药物为主。结论:超说明书用药导致儿童ADR发生率远高于成人,应加强对儿童ADR的监测和用药监护工作。

Objective: To analyze the characteristics of adverse drug reaction (ADR) in children in our hospital and their off-label use of drugs, and provide references for clinical rational drug use. Methods: A retrospective analysis method was used to collect all ADR reports in the patients whose ages were under the age of 18 from January 2011 to December 2017 in our hospital. Using Excel spreadsheets, the gender, age, disease diagnosis, drug type, systems/organs involved and clinical manifestation of ADRs were analyzed statistically. Results: In 334 ADR cases, there were 192 male patients (57.49%) and 142 female patients (42.51%), and the ADR cases involved 77 kinds of drugs. The number of patients who took drugs with off-label use was 189. Among them, 32 kinds of drugs (41.56%) were used ultra-instruction. The number of anti-infective drugs caused ADR was most when compared with other types of drugs, and there were 23 varieties (29.87%) anti-infectives involved. Among the types of off -label use of drug, there were 26 kinds of drugs (53.06%) which indications did not mention children's drug information. The highest proportion was skin and skin appendages damage in ADR involvement system, there were a total of 181 cases (54.19%);most of drugs were anti-infective drugs in terms of the top 10 drugs involved ADR. Conclusion: The presence of off-label use of drugs in children may be one cause of the higher incidence of ADR than adults. The ADR and medication monitoring in children should be strengthened.