| 儿童用药的药物警戒特征和模式探讨 |
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| 引用本文： | 刘巍,吴桂芝,侯永芳. 儿童用药的药物警戒特征和模式探讨[J]. 中国药事, 2013, 27(6): 557-560 |
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| 作者姓名： | 刘巍 吴桂芝 侯永芳 |
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| 作者单位： | 国家食品药品监督管理局药品评价中心,北京,100045 |
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| 摘 要： | 目的论述开展儿童药物警戒工作的重要性、特征以及方法,探索儿童用药药物警戒模式。方法根据欧洲药品管理局发布的儿童用药药物警戒指南,分析儿童用药的特征。结果儿童用药不良事件潜在发生率不低于成人,而且,儿童用药的不良反应特征与成人相比有差异。结论应结合我国儿童用药不良反应监测工作现状,建立科学的儿童用药不良反应监测模式。
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| 关 键 词： | 儿童用药 药物警戒 工作模式 |
Characteristics and Working Model for Pharmacovigilance of Pediatric Medication |
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| Liu Wei , Wu Guizhi , Hou Yongfang. Characteristics and Working Model for Pharmacovigilance of Pediatric Medication[J]. Chinese Pharmaceutical Affairs, 2013, 27(6): 557-560 |
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| Authors: | Liu Wei Wu Guizhi Hou Yongfang |
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| Affiliation: | (Center for Drug Reevaluation, SFDA, Beijing 100045) |
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| Abstract: | Objective To expound the importance, characteristics and practice of pharmacovigilance of medicines used in pediatric population and discuss its working model. Methods The characteristics of pediatric medication were analyzed using ＂Guideline on Conduct of Pharmacovigilance for Medicines Used by the Pediatric Population＂ released by EMEA as a reference. Results The rate of occurrence of ADRs in pediatric population is no lower than that in adults and ADR characteristics in pediatric population are different from those in adults. Conclusion China should establish the working model for pharmacovigilance of medicines used in pediatric population according to the current status of ADR monitoring system. |
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| Keywords: | pediatric medication pharmacovigilance working model |
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