| 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 |
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| 引用本文： | 朱田田,叶小飞,郭晓晶,张天一,汪晶,史文涛,贺佳.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[J].中国药物警戒,2014(7):413-415. |
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| 作者姓名： | 朱田田 叶小飞 郭晓晶 张天一 汪晶 史文涛 贺佳 |
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| 作者单位： | 第二军医大学卫生统计学教研室,上海200433 |
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| 基金项目： | 上海市公共卫生重点学科（12GWZX0602）;国家自然科学基金（No.81072388,No.81202285,No.81373105）;上海市自然科学基金（12ZR1453700）;上海市领军人才计划（022）. |
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| 摘 要： | 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。
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| 关 键 词： | 药物流行病学安全性研究 电子医疗数据库 药物警戒 |
Characteristics and Requirements of Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Databases |
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| ZHU Tian-tian,YE Xiao-fei,GUO Xiao-jing,ZHANG Tian-yi,WANG Jing,SHI Wen-tao,HE Jia.Characteristics and Requirements of Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Databases[J].Chinese JOurnal of Pharmacovigilance,2014(7):413-415. |
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| Authors: | ZHU Tian-tian YE Xiao-fei GUO Xiao-jing ZHANG Tian-yi WANG Jing SHI Wen-tao HE Jia |
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| Institution: | (Department of Health Statistics, Second Military Medical University, Shanghai 200433, China) |
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| Abstract: | 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. |
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| Keywords: | pharmacoepidemiologic safety studies electronic healthcare databases pharmacovigilance |
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