本文選題：兒童用藥安全 + 藥品不良事件　； 參考：《天津大學(xué)》2014年博士論文

【摘要】：由于兒童臟器功能發(fā)育尚不完善,兒科藥物臨床試驗(yàn)開展困難及兒童用藥信息、藥物劑型劑量缺乏等原因，使兒童面臨著比成人更大的用藥安全問(wèn)題。自發(fā)呈報(bào)系統(tǒng)提供了大規(guī)模藥物安全警戒數(shù)據(jù)，尤其可為臨床試驗(yàn)中涉及較少的兒童人群提供有用的藥物安全性及藥物相互作用等信息。 本文利用美國(guó)食品藥品管理局（FDA）藥品不良事件自發(fā)呈報(bào)系統(tǒng)數(shù)據(jù)庫(kù)（2004年1月~2012年6月），采用多種數(shù)據(jù)挖掘方法對(duì)兒童用藥不良事件報(bào)告進(jìn)行了深入分析，重點(diǎn)分析了12歲以下兒童急性腎損傷事件相關(guān)的藥物、藥物相互作用以及和成人用藥安全性的對(duì)比。本研究旨在為兒童用藥提供實(shí)證性的安全性監(jiān)測(cè)信息和經(jīng)驗(yàn)，以期加強(qiáng)兒童用藥風(fēng)險(xiǎn)效益評(píng)估和管理、進(jìn)一步促進(jìn)兒科臨床合理用藥。 首先，分析了兒童用藥特點(diǎn)及國(guó)內(nèi)外兒童藥安全性監(jiān)測(cè)的現(xiàn)狀，由此指出在自發(fā)呈報(bào)系統(tǒng)中進(jìn)行兒童用藥安全性監(jiān)測(cè)的重要性和必要性。其次，按照年齡分組進(jìn)行分層分析，數(shù)據(jù)庫(kù)中年齡分層為兒童（0-11歲），青少年（12-17歲），成年人（18-64歲），老年人（≥65歲）。12歲以下兒童年齡細(xì)分為嬰幼兒（0-1歲），兒童早期（2-5歲），兒童中期（6-11歲）。結(jié)果顯示，12歲以下兒童不良事件報(bào)告在性別、年齡、臨床結(jié)局等方面均和成人有較大差異。第三，采用藥品不良事件信號(hào)監(jiān)測(cè)方法（如頻率法、貝葉斯統(tǒng)計(jì)法）分析兒童藥源性疾病-急性腎損傷相關(guān)的藥物特點(diǎn)以及幾種兒童常用藥的安全性，發(fā)現(xiàn)非甾體抗炎藥是引發(fā)兒童急性腎損傷風(fēng)險(xiǎn)較高的藥物；兒童使用布洛芬、對(duì)乙酰氨基酚、頭孢曲松、阿莫西林、環(huán)丙沙星等藥品時(shí)，在腎臟、肝臟、牙齒、血液系統(tǒng)等安全性方面和成人相比均有較大差異。第四，采用藥物相互作用信號(hào)監(jiān)測(cè)方法（包括貝葉斯統(tǒng)計(jì)和logistic回歸模型）分析兒童常用解熱鎮(zhèn)痛藥布洛芬和對(duì)乙酰氨基酚可能存在的相互作用，，表明二藥合用可顯著增加兒童急性腎損傷的發(fā)生風(fēng)險(xiǎn)。最后，針對(duì)國(guó)內(nèi)兒童用藥安全性監(jiān)測(cè)的現(xiàn)狀和問(wèn)題，提出了兒科臨床用藥管理及相關(guān)政策建議。
[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

本文編號(hào)：1803656