Individual case safety reports in children in commonly used drug groups - signal detection.

Gertrud Brunlöf, Carina Tukukino, Susanna M Wallerstedt
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引用次数: 27

Abstract

Background: Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children.

Methods: Number and type of individual case safety reports in the 30 groups of drugs (5th level ATC-code) most sold (number of defined daily doses) in outpatient treatment to children (<15 years old) during 2005 were obtained. Descriptive analyses of the adverse drug reactions reported in children were performed.

Results: The number of individual case safety reports per million defined daily doses in children varied in the groups of drug between 0 and 24. The largest number was found in the drug group R03DC, the leukotriene receptor antagonist montelukast; the majority of the children being <5 years old and experiencing psychiatric adverse drug reactions.

Conclusion: The number of individual case safety reports per million defined daily doses varies in different groups of drugs. A possible signal for montelukast and psychiatric adverse drug reactions was found, which should be further explored.

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儿童常用药物组的个案安全报告-信号检测。
背景:由于儿科药物安全性研究较少,对儿童药物治疗风险的认识有限。需要增加这方面的知识,以便在用药物治疗儿科患者时进行适当的风险-效益分析。本研究的目的是调查儿童常用药物组与儿童个案安全报告的类型和频率。方法:对儿童门诊销售最多的30组药物(第5级atc代码)(限定日剂量)的个案安全报告数量和类型进行分析。结果:儿童每百万限定日剂量的个案安全报告数量在0 ~ 24个药物组之间存在差异。白三烯受体拮抗剂孟鲁司特R03DC组数量最多;结论:在不同的药物组中,每百万限定日剂量的个案安全报告数有所不同。发现了孟鲁司特与精神科药物不良反应的可能信号,有待进一步探讨。
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