长春新碱的个体化治疗循证药学研究：从治疗药物监测到模型引导的精准用药

Evidence-based Pharmaceutical Research of Individualized Vincristine Treatment: From Therapeutic Drug Monitoring to Model-Informed Precision Dosing

关键词:  长春新碱  个体化治疗  药物监测  模型引导的精准用药

Key words:  vincristine, individualized  treatment, therapeutic  drug monitoring, model-informed  precision dosing

摘要:

目的 探讨治疗药物监测（therapeutic drug monitoring，TDM）和模型引导的精准用药（model-informed precision dosing，MIPD）在长春新碱个体化治疗中的循证药学研究情况。方法 在中国知网和PubMed数据库上以“长春新碱”、“治疗药物监测”、“模型引导的精准用药”、“生理药动学模型”、“药动学/药效学模型”、“群体药动学模型”、“人工智能”、“vincristine”、“therapeutic drug monitoring”、“model-informed precision dosing”、“physiologically based pharmacokinetic model”、“pharmacokinetic/pharmacodynamic model”、“population pharmacokinetics model”、“artificial intelligence”为关键词进行文献检索，检索时间自建库至2025年6月，纳入相关临床研究。制定支持临床实施长春新碱个体化治疗的技术问题框架。围绕长春新碱临床应用过程中实施TDM及MIPD的最新进展系统梳理各类循证药学证据，分析总结回答框架问题。结果 当前证据表明，长春新碱的治疗窗狭窄，药物暴露存在显著的个体间变异。TDM和MIPD有助于长春新碱的个体化治疗，但指导长春新碱个体化剂量调整的模型还有待进一步开发。结论 目前评估长春新碱TDM和MIPD研究仍然十分有限，但其在个体化用药方面的潜力已逐渐凸显，迫切需要更多的研究证明在临床实践中实施 TDM和MIPD的合理性。

Abstract:

OBJECTIVE To investigate the evidence-based pharmaceutical research on Therapeutic Drug Monitoring (TDM) and Model-Informed Precision Dosing (MIPD) in the individualized treatment of vincristine. METHODS Literature searches were performed in the CNKI database using Chinese keywords and in the PubMed database using English keywords for the following terms: "vincristine" "therapeutic drug monitoring" "model-informed precision dosing" "physiologically based pharmacokinetic model" "pharmacokinetic/pharmacodynamic model" "population pharmacokinetics model" and "artificial intelligence". The search covered the period from the inception of each database to June 2025. Relevant clinical studies were included. A technical framework was developed to address issues supporting the clinical implementation of individualized vincristine therapy. The latest advancements in TDM and MIPD for vincristine were systematically reviewed, and evidence-based pharmaceutical data were analyzed to address the framework questions. RESULTS Current evidence indicates that vincristine has a narrow therapeutic window and exhibits significant interindividual variability in drug exposure. TDM and MIPD show potential in optimizing individualized vincristine therapy; however, models guiding dose adjustment require further development. CONCLUSION While current research on TDM and MIPD for vincristine remains limited, their potential for individualized therapy is increasingly evident. Further studies are urgently needed to justify the implementation of TDM and MIPD in clinical practice.