ICH二级指导原则M1适用性研究-国家药品不良反应术语集映射实践

Study on Applicability of ICH Guideline M1 Mapping Practice of National Adverse Drug Reaction Terminology

目的对“国家药品不良反应术语集”向MedDRA进行映射转换。方法基于“国家药品不良反应术语集”、“MedDRA 21.0版本”、“UMC-Bridge”等,采用“一词三码”的技术路线进行映射和匹配,对找到编码相同的术语基本确认映射关系,对找到编码不同术语或仅找到一个编码的术语进行人工审核,对未找到编码的术语进行外请专家人工编码。结果6717个术语中有2733个基本确认映射关系,3175个术语进行人工审核,809个进行外请专家人工编码。结论采用本技术路线,可以实现“国家药品不良反应术语集”向MedDRA的映射转换。为促进MedDRA在我国的应用,助力药品不良反应直报制度的落实,建议与MSSO建立协调机制以提高中文版本准确性,建立中国药品不良反应术语集(C-ART)和药品不良反应术语填写指南等。

Objective To map and transform the "National Adverse Drug Reaction Terminology" to MedDRA. Methods Based on "National Adverse Drug Reaction Terminology""MedDRA version 21.0""UMC-Bridge" and so on, using"one term three codes" technological route to map and match the "national adverse drug reaction terminology" to MedDRA. If the codes found by different routes were the same, then mapping relationship was almost determined. If the codes found by different routes were different or only one code was found, then mapping relationship need to be reviewed artificially. If no code was found, the term needed to be coded by external experts. Results Of the 6 717 terms, 2 733 terms were basically determined, 3 175 terms need to be manually reviewed, and 809 terms needed to be manually coded by external experts. Conclusion The mapping and transformation of "National Adverse Drug Reaction Terminology" to MedDRA can be realized by adopting this technological route. In order to promote the application of MedDRA in China and facilitate the implementation of the direct reporting system, it is suggested to establish a coordination mechanism with MSSO to improve the accuracy of the Chinese version, establish the Chinese glossary of adverse drug reactions (C-ART) and guide for the filling of adverse drug reaction terms, etc.