万古霉素个体化给药决策支持系统的研制

Development of decision system for individualization of vancomycin dosage

万古霉素是目前治疗耐甲氧西林的金葡球菌感染的一线用药。因其药动学存在较大的个体差异,给药方案需要个体化。本研究通过系统检索,收集中国人群的万古霉素群体药动学特征参数,结合R语言rjags包的最大后验贝叶斯算法,研制了万古霉素的个体化给药决策辅助系统"Smart Dose"。该系统可针对普通成人以及新生儿、老年人、神经外科患者等特殊人群,制定个体化的万古霉素给药方案。系统功能包括制定初始方案、根据治疗药物监测结果调整方案,以及自定义用药方案等。系统算法可靠,与金标准NONMEM软件相比无显著差异。同时,Smart Dose为基于Web的应用系统,适用面广,为万古霉素的个体化用药提供了有力的工具。

Vancomycin has been widely prescribed as the first-line antibiotic in the treatment of methicillin-resistant Staphylococcus aureus and other serious Gram-positive infections. Due to its large pharmacokinetic（PK） variability and narrow therapeutic range, it requires optimization of dosage to achieve target exposure. In this study, Smart Dose, a decision support system for individualization of vancomycin dosage is developed using the maximum a posterior Bayesian estimation（MAPB） by the open-source language R combined with the population PK characteristics of vancomycin in Chinese patients. It provides initial design and adjustment of dose regimens based on the therapeutic drug monitoring（TDM） results, as well as a user-defined module to facilitate optimal vancomycin therapy. Smart Dose has a high computational reliability, which is validated by NONMEM, the golden standard PK software. Meanwhile, Smart Dose is established as a web-based application and its operational flexibility makes it an efficient tool for vancomycin dose optimization in routine clinical settings.