【摘要】：臨床試驗的安全性評價很大程度上依賴于對不良事件的深入細致分析。然而,實踐中因受試者地域、語言、民族、文化等不同,存在著對同樣的不良事件表達上的各異,給不良事件資料的匯總歸類、數(shù)據(jù)管理和統(tǒng)計分析帶來困難。為了確保不良事件原意表達的本質(zhì)歸屬,必須解決不良事件術(shù)語標準化的問題。國際醫(yī)學用語詞典(Med DRA)可為臨床試驗不良事件報告標準化提供有力支持,已在國際上得到廣泛推薦和應用。本文對Med DRA的發(fā)展情況、適用范圍、層次結(jié)構(gòu)、編碼術(shù)語選擇、標準查詢策略等進行介紹,在此基礎(chǔ)上,進一步闡明Med DRA在臨床試驗不良事件編碼中的應用流程,并基于Med DRA編碼對不良事件統(tǒng)計分析的相關(guān)事項進行框架性探討。
[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.
【作者單位】： 南京軍區(qū)南京總醫(yī)院醫(yī)務部;
【分類號】：R95

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