基于电子医疗数据库的药物流行病学安全性研究的特点及要求

Characteristics and Requirements of Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Databases

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。

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 pharmacoepidemiologic 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 characteristics 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＆#39;s pharma coepidemiologic studies and pharmacovigilance.