MedDRA及其在不良事件分析中的应用

发布时间：2018-09-06 13:38

【摘要】：临床试验的安全性评价很大程度上依赖于对不良事件的深入细致分析。然而,实践中因受试者地域、语言、民族、文化等不同,存在着对同样的不良事件表达上的各异,给不良事件资料的汇总归类、数据管理和统计分析带来困难。为了确保不良事件原意表达的本质归属,必须解决不良事件术语标准化的问题。国际医学用语词典(Med DRA)可为临床试验不良事件报告标准化提供有力支持,已在国际上得到广泛推荐和应用。本文对Med DRA的发展情况、适用范围、层次结构、编码术语选择、标准查询策略等进行介绍,在此基础上,进一步阐明Med DRA在临床试验不良事件编码中的应用流程,并基于Med DRA编码对不良事件统计分析的相关事项进行框架性探讨。
[Abstract]:The safety evaluation of clinical trials depends largely on a thorough and detailed analysis of adverse events. However, in practice, due to the different regions, languages, nationalities and cultures of the subjects, there are different expressions of the same adverse events, which brings difficulties to the collection and classification of the adverse events data, data management and statistical analysis. In order to ensure the essential attribution of the expression of adverse events, we must solve the problem of standardization of adverse event terminology. The International Dictionary of Medical terms (Med DRA), which can support the standardization of adverse event reporting in clinical trials, has been widely recommended and applied in the world. This paper introduces the development of Med DRA, its application scope, hierarchy, coding terminology selection, standard query strategy and so on. On this basis, the application process of Med DRA in adverse event coding in clinical trials is further expounded. And based on Med DRA coding, the related items of adverse event statistical analysis are discussed.
【作者单位】：南京军区南京总医院医务部;
【分类号】：R95

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