2006年全国儿童严重不良反应报告分析  

Serious adverse drug reactions in children:an analysis from spontaneous reporting data in China during 2006

作　　者：王瑜歆[1] 王春婷[2] 杨月明[1] 杜晓曦[2] 金丹[1] 

机构地区：[1]辽宁省药品不良反应监测中心,沈阳110003 [2]国家药品不良反应监测中心,北京100045

出　　处：《中国新药杂志》2010年第5期453-456,448,共5页Chinese Journal of New Drugs

摘　　要：目的:以国家药品不良反应监测中心数据库中2006年儿童严重不良反应报告为研究对象,分析基本情况及相关风险因素。方法:采用病例回顾性研究方法对国家中心2006年收集到的1 088份儿童的严重药品不良反应报告进行综合分析。结果:儿童严重药品不良反应报告占全部严重药品不良反应报告(8 128份)的13.40%,不良反应涉及的药品以抗微生物药物最多,其次为中药和生物制品,不良反应累及的系统-器官以全身性损害最多,表现为过敏样反应。101份儿童死亡病例报告中涉及的药物中抗微生物药物和生物制品较多,死亡原因多为过敏性休克。结论:儿童自身的免疫系统发育特点、药动学特点、儿科常用药物的使用等相关因素可能导致儿童严重药品不良反应的发生。Objective： To indentify the general conditions and the risk factors of serious pediatric drugs adverse reaction （ADR） from the reports of National spontaneous reporting database during 2006. Methods ： Totally,1 088 pediatric serious ADR reports were collected by National Center for ADR Monitoring during 2006, and analyzed using retrospective study method. Results： Of 8 128 overall serious ADR reports, 1 088 were pediatric ADR reports （13.40%）. Most pediatric ADRs were induced by antimicrobial drugs, traditional Chinese medicines and biologic products, and the most frequently affected organ system was systemic disorder relating to anaphylactoid reactions. Of the serious pediatric ADR reports, 101 deaths occurred. Lots of deaths were associated with antimicrobial drugs and biologic products, and the causes of death were mostly anaphylactic shock. Conclusion： Pediatric drug therapy and the features of the pediatric immune systems and pharmacokinetics lead to serious pediatric ADRs.

关 键 词：儿科 药品不良反应报告 分析 

分 类 号：R95[医药卫生—药学]