CAJ | 학술논문

目的：分析药品不良反应报告质量评估工作的现状。方法对目前国内药品不良反应个案报告表质量和药品不良反应数据库整体质量评估工作的历史和现状进行回顾和总结。结果对每份个案报告表质量的评估能发现报告表填写、评价审核中存在的细节问题，而药品不良反应数据库整体质量评估则能发现监测工作在方法、导向以及趋势等方面相对宏观的问题。二者互为补充，对推动监测工作健康发展具有积极作用。结论药品不良反应报告质量提高工作是药品不良反应监测工作的重要内容，亟待建立针对药品不良反应个案报告表和药品不良反应数据库建立科学、可操作的评估体系和方法。
목적：분석약품불량반응보고질량평고공작적현상。방법대목전국내약품불량반응개안보고표질량화약품불량반응수거고정체질량평고공작적역사화현상진행회고화총결。결과대매빈개안보고표질량적평고능발현보고표전사、평개심핵중존재적세절문제，이약품불량반응수거고정체질량평고칙능발현감측공작재방법、도향이급추세등방면상대굉관적문제。이자호위보충，대추동감측공작건강발전구유적겁작용。결론약품불량반응보고질량제고공작시약품불량반응감측공작적중요내용，극대건립침대약품불량반응개안보고표화약품불량반응수거고건립과학、가조작적평고체계화방법。
s:Objective To review the progress of the evaluation for the quality of the adverse drug reactions (ADR) in China. Methods Progress of the evaluation for the quality of the ICSRS and the ADR database in China were reviewed and summarized. Results By the evaluation for the quality of the ICSRS, the detail problems such as spelling could be found. By the evaluation for the quality of the ADR database, the macroscopic problems such as the method and the trend could be found. They complement each other and play a positive role for the healthy development of ADR monitor-ing. Conclusion The quality of ADR report is an important content of the ADR monitoring, so it is very necessary to establish scientific and operable evaluation system and methods.