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464例儿童药品不良反应/事件特点及其超说明书用药情况分析
李洪燕,刘恩梅,谢晓虹
0
(重庆医科大学附属儿童医院,重庆 400014)
摘要:
目的:回顾性分析我院2014年主动上报的464例药品不良反应的特点及相应的药品发生超说明书用药情况,为预防药品不良反应和合理用药提供参考。方法:描述性分析464例药品不良反应的特点,统计发生药品不良反应相应的药品超说明书构成比、超说明书类型。结果:发生不良反应情况以儿童组(2~11岁)患儿构成比最高,男女构成比为1.83︰1。发生不良反患儿主要疾病类型以呼吸道感染疾病多见,且临床表现以皮肤及其附件较常见。发生不良反应相应的药品按患儿例数及使用药品例数计超说明书用药发生率分别为49.1%、52.0%。超说明书类型以无儿童用药信息最常见(59.9%)。结论:我院药品不良反应中超说明书用药发生率较高;抗菌药物导致的不良反应可能更多的是剂量相关性不良反应。
关键词:  药品不良反应  超说明书用药  儿童
DOI:doi:10.13407/j.cnki.jpp.1672-108X.2017.02.010
基金项目:
The Characteristics and the Analysis of Off-Label Drug Use of 464 Cases of Children Adverse Drug Reactions or Events
Li Hongyan, Liu Enmei, Xie Xiaohong
(Children's Hospital of Chongqing Medical University, Chongqing 400014, China)
Abstract:
Objective: To retrospective analyze the characteristics of 464 cases adverse drug reactions and the off-label drug use in our hospital in 2014, prevent adverse drug reaction and provide the reference of rational drug use. Methods: Descriptive analyzed the characteristics of 464 cases adverse drug reactions and counted constituent ratio and the category of the off-label drug use. Results: The highest constituent ratio of adverse reactions was the children group. The constituent ratio of boys and girls was 1.83∶1. Respiratory infection and the symptoms of skin and its appendages were common. Respectively, according to the number of drugs and children, the constituent ratio of the off鄄label drug use was 49.1%, 52.0%. The main category of the off-label drug use was no pediatric information. Conclusion: The constituent ratio of the off-label drug use is high in adverse reactions. Adverse reactions of antimicrobial drugs may be dose-related.
Key words:  adverse drug reactions  off-label drug use  children

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