标准MedDRA查询浅析及启示

Analysis and Implications of Standardised MedDRA Queries

2003年,MedDRA维护与支持服务组织(MSSO)建立了标准MedDRA查询(SMQ)。标准MedDRA查询是若干MedDRA术语的集合及在其基础上建立的查询策略,建立目的是协助识别和查询可能相关的病例。我国药品不良反应病例报告目前超过300万,以此数据为基础评估药品安全性风险时,查询策略的准确性和全面性是科学评估的基础。本文分析SMQ产生背景,研究SMQ的详细设计,并以此为启示,探讨建立不良反应术语标准查询。

In 2003,Medical Dictionary for Regulatory Activities（MedDRA） Maintenance and Support Services Organization（MSSO） established Standardised MedDRA Queries（SMQ）,which is a collection of a number of MedDRA terms and the query strategy based on them.The purpose for SMQ is to help identify and retrieve potentially relevant cases.Adverse drug reactions in China have currently more than 3 million case reports.And when we carry out the risk assessment for drug safety based on this data,the accuracy and completeness of the query strategy is the basis of scientific assessments.This article is to analyze the background and detailed design of SMQ,and to explore the establishment of standardised query of adverse reaction terms.