数字孪生融入中西药联用个体化临床安全性评价思路

Individualized clinical safety evaluation of traditional Chinese and Western medicine combination in a context of Digital Twin:A conceptual approach

国务院办公厅印发《关于加快中医药特色发展的若干政策措施》,强调推动中西医相互补充、协调发展,逐步建立中西医多学科诊疗体系[1].在中西医结合、中西药并用的大背景下,中西药联用的未知风险也在增加.1中西药联用临床安全性评价研究薄弱中医药疗效逐渐被广泛认可,但如何客观评价其临床安全性已成为制约发展的关键问题之一.以中药注射剂为例,国家药品不良反应监测年度报告统计发现,联合用药占总体报告前20的中药注射剂不良反应发生率的43.4%,占严重不良反应发生率的56.5%[2].一项中药注射剂安全性集中监测研究结果显示,出现不良反应(adverse drug reactions,ADRs)的患者中,94.4%存在联合用药情况[3].在医保纳入的中药注射剂说明书中。

Clinical safety evaluation of traditional Chinese medicine(TCM)combined with Western medicine has become one of the key issues hindering the development of TCM itself.It is generally acknowledged as being a complicated and hazard-prone area.Medical practice has entered the era of 5P medicine,which emphasizes predictive,preventive,personalized,participatory and precision approaches.Personalized diagnosis and treatment are gradually becoming mainstream in clinical practice.Physicians make medication choices and safety assessments based on personalized symptoms and physical signs.Each patient has their personalized symptoms and signs.Individualized factors can affect the characteristics of adverse drug reactions(ADRs)through internal mechanisms.However,most of the existing research on the safety of TCM-Western medicine combination concentrates on mechanisms or risk factors.There is a lack of the correlation research between individualized information and ADRs.This makes it difficult to predict the occurrence of individual ADRs.There are discrepancies between research findings and clinical diagnostic patterns.As a result,the guidance provided for ensuring individual safety is of limited significance.Data is a new type of production factor.Developing and utilizing the data have become significant propositions.The concept of“Digital Twin”can be traced back to the realms of manufacturing and engineering.Specifically,digital twin refers to the creation of a virtual representation of a physical object,system,or process using digital technologies.It is conducive to exploring and solving complex individualized safety problems in the TCM-Western medicine combination.This research draws on the experience from the concept of evidence-based medicine and introduces multidisciplinary and interdisciplinary technologies,such as digital twin,and artificial intelligence.To be specific,multidisciplinary research methods will be applied,such as the feature-target association method,multidimensional information collection in comprehensive inspection diagnosis technologies,and so on.The feature-target association method can summarize existing clinical and experimental evidences,providing foundational evidence of“clinical and experimental”for individualized patient characteristics.The concept can be delineated into three steps:Collecting individualized safety information for TCM-Western medicine combination,constructing individualized digital twin model,and validating clinical individualized safety information.The digital twin-based evaluation and prediction method will be established to ensure the safety of TCM-Western medicine combination.However,there are many factors that need to be noted,such as the complexity of humanity,variability of data,and so on.There is still a long time before digital twin technology is fully integrated into the clinical individualized safety evaluation.