基于自发呈报系统的儿童用药安全性监测研究

发布时间：2018-04-26 00:24

  本文选题：儿童用药安全 + 药品不良事件　； 参考：《天津大学》2014年博士论文

【摘要】：由于儿童脏器功能发育尚不完善,儿科药物临床试验开展困难及儿童用药信息、药物剂型剂量缺乏等原因，使儿童面临着比成人更大的用药安全问题。自发呈报系统提供了大规模药物安全警戒数据，尤其可为临床试验中涉及较少的儿童人群提供有用的药物安全性及药物相互作用等信息。 本文利用美国食品药品管理局（FDA）药品不良事件自发呈报系统数据库（2004年1月~2012年6月），采用多种数据挖掘方法对儿童用药不良事件报告进行了深入分析，重点分析了12岁以下儿童急性肾损伤事件相关的药物、药物相互作用以及和成人用药安全性的对比。本研究旨在为儿童用药提供实证性的安全性监测信息和经验，以期加强儿童用药风险效益评估和管理、进一步促进儿科临床合理用药。 首先，分析了儿童用药特点及国内外儿童药安全性监测的现状，由此指出在自发呈报系统中进行儿童用药安全性监测的重要性和必要性。其次，按照年龄分组进行分层分析，数据库中年龄分层为儿童（0-11岁），青少年（12-17岁），成年人（18-64岁），老年人（≥65岁）。12岁以下儿童年龄细分为婴幼儿（0-1岁），儿童早期（2-5岁），儿童中期（6-11岁）。结果显示，12岁以下儿童不良事件报告在性别、年龄、临床结局等方面均和成人有较大差异。第三，采用药品不良事件信号监测方法（如频率法、贝叶斯统计法）分析儿童药源性疾病-急性肾损伤相关的药物特点以及几种儿童常用药的安全性，发现非甾体抗炎药是引发儿童急性肾损伤风险较高的药物；儿童使用布洛芬、对乙酰氨基酚、头孢曲松、阿莫西林、环丙沙星等药品时，在肾脏、肝脏、牙齿、血液系统等安全性方面和成人相比均有较大差异。第四，采用药物相互作用信号监测方法（包括贝叶斯统计和logistic回归模型）分析儿童常用解热镇痛药布洛芬和对乙酰氨基酚可能存在的相互作用，，表明二药合用可显著增加儿童急性肾损伤的发生风险。最后，针对国内儿童用药安全性监测的现状和问题，提出了儿科临床用药管理及相关政策建议。
[Abstract]:Due to the incomplete development of children's viscera, the difficulties in clinical trials of pediatric drugs and the lack of drug dosage in children, children are faced with more safety problems than adults. The spontaneous reporting system provides large-scale drug safety alert data, especially useful information on drug safety and drug interactions for children who are less involved in clinical trials. In this paper, the spontaneous reporting database of adverse drug events (January 2004 to June 2012) of the Food and Drug Administration of the United States (FDAA) was used to analyze the reports of drug adverse events in children by using a variety of data mining methods. The drug, drug interaction and drug safety of acute renal injury in children under 12 years of age were analyzed. The purpose of this study was to provide practical information and experience of safety monitoring for children with drug use in order to strengthen risk and benefit assessment and management of drug use in children and to further promote rational use of drugs in pediatric clinic. Firstly, the characteristics of children's drug use and the present situation of children's drug safety monitoring at home and abroad are analyzed, and the importance and necessity of monitoring children's drug safety in spontaneous reporting system are pointed out. Secondly, the stratification analysis was carried out according to the age group. In the database, the age is divided into 0 to 11 years old for children, 12 to 17 years old for adolescents, 18 to 64 years old for adults, 0 to 1 years old for children (鈮

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