随着中西医结合模式的推广，中西药联用的合理性与安全性话题引起医药界乃至社会各界的广泛关注。面对中西药联用的临床获益-风险证据不足、科学内涵尚不明确的现状，探索基于临床实践的中西药相互作用（Chinese and western medicine interactions，CWI）研究路径，有助于回答中西药联用的合理性与安全性。据此提出以临床获益-风险为导向的CWI发现和评价的研究策略：（1）构建以临床获益-风险信号为主、以物质体内暴露信号为辅的CWI发现路径；（2）探索以代谢酶、转运体等药动学靶标及功效靶标为突破点的相互作用评价路径；（3）形成以临床价值为导向的CWI发现及评价的证据体系。旨在优化并推广合理的中西药联用方案，揭示中西药联用有效性与安全性的科学内涵，助力提高中西医结合临床水平。

With the promotion of the integrated Chinese and western medicine model, the topic of the rationality and safety of the combination of Chinese and western medicine have been drawing broad attention from the pharmaceutical industry and even various sectors of society. We are facing the current situation of the combination of Chinese and western medicine, such as insufficient clinical benefit-risk evidence and unclear scientific connotations. Exploration of a research pathway for the interaction between Chinese and western medicine (CWI) based on clinical practice can help understand the rationality and safety of the combination of Chinese and western medicine. The authors propose strategies to discover and evaluate the CWI dominated by clinical benefit-risk signals. Firstly, establishing the discovery pathways for CWI primarily based on clinical benefit-risk signals and supplemented by in vivo exposure signals of substances. Secondly, exploring the evaluation pathways for CWI with breakthroughs in pharmacokinetic targets, such as metabolic enzymes and transporters, as well as efficacy targets. Thirdly, forming a clinical value-oriented evidence system for discovering and evaluating the CWI. The purpose is to optimize and promote a reasonable combination scheme of Chinese and western medicine, and reveal the scientific connotation of the effectiveness and safety of integrative medicine. It will help improve the clinical significance of integrated Chinese and western medicine.

R285

国家重大新药创制计划项目（2018ZX09734-002）；国家自然科学基金资助项目（8237250）；国家中医药管理局青年岐黄学者支持项目；天津市教委科研计划项目（2021ZD017，2021ZD030，2021KJ159）