CAJ | 학술논문

药物流行病学研究在评估药物与不良事件之间的相互关系中起着重要的作用，而随着电子医疗数据库的发展，传统的药物流行病学研究方法已不能完全满足当今药物警戒工作的需求。基于对电子医疗数据库的认识及对FDA相关指南的理解，本文拟对利用电子医疗数据库进行的药物流行病学安全性研究的一般特点及FDA提出的数据采集要求进行介绍，以期对我国的药物流行病学研究及药物警戒工作提供相关的技术参考。
약물류행병학연구재평고약물여불량사건지간적상호관계중기착중요적작용，이수착전자의료수거고적발전，전통적약물류행병학연구방법이불능완전만족당금약물경계공작적수구。기우대전자의료수거고적인식급대FDA상관지남적리해，본문의대이용전자의료수거고진행적약물류행병학안전성연구적일반특점급FDA제출적수거채집요구진행개소，이기대아국적약물류행병학연구급약물경계공작제공상관적기술삼고。
Pharmacoepidemiologic studies play an important role in evaluating the interrelationship between drugs and adverse events. With the development of the electronic healthcare databases, the traditional method of pharmacoepi-demiologic study cannot completely meet the needs of the pharmacovigilance today. Based on the understanding of the electronic healthcare databases and of the FDA related guidelines, this paper proposes to introduce the general char-acteristics of pharmacoepidemiologic safety studies using electronic healthcare databases and the requirements of the data collection put forward by FDA, which aims to provide relevant technical reference to our country's pharma coepi-demiologic studies and pharmacovigilance.