中国循证医学杂志

中国循证医学杂志

真实世界研究中如何关注中西药相互作用的安全性评价

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真实世界研究有助于最大限度的反映临床事实,其方法学特点符合中医辨证论治的临床特色及当前临床中西药联用的医疗现实,有助于更高效、经济地解决中西药相互作用安全性评估问题。而在设计研究时,要特别注意数据的“关联性”与“有效性”,规范研究的数据内容与流程。可通过主动呈报方式,基于医疗系统互通、全民保险资料库的大数据研究并与精准医疗研究相结合是未来中西药联用安全性评估的重要研究方向。

Real-world study (RWS) data is extracted from real medical scenes, and it reflects the clinical facts. Besides, it adapts to characteristics of therapeutic principles of traditional Chinese medicine and the reality of the combination of Western and traditional Chinese medicine, which makes the safety assessment of herb-drug interaction more efficiently and economically. During RWS, more attention should be paid on the validity and reliability of data, especially the standardization of the process and content. The safety assessment of herb-drug interaction can combine the methods of active surveillance study, big data analysis, and base on the precision medicine in the future.

关键词: 真实世界研究; 中西药相互作用; 安全性评价; 主动呈报方式

Key words: Real-world study; Herb-drug interaction; Safety assessment; Active surveillance

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