基于蒙特卡洛模拟评价新生儿万古霉素给药方案

目的:基于药代动力学(PK)原理制定新生儿万古霉素的给药方案，并通过回顾性病例研究对方案进行评价。方法:收集我院2019年1月-2022年4月万古霉素的药敏数据及2018年11月-2021年12月新生儿的万古霉素治疗数据。通过已有群体药代动力学(PPK)模型及蒙特卡洛模拟制定万古霉素日剂量推荐表，并参照推荐表比较是否符合推荐剂量组间谷浓度和临床疗效的差异。结果:共收集177例患儿数据，制定万古霉素的推荐日剂量为25～225 mg,与不符合推荐剂量组相比符合推荐剂量组显示出更高的谷浓度(P<0.05)和更高的临床有效率(P<0.05),但两组患儿谷浓度达标率比较差异无统计学意义(P>0.05)。结论:不同亚组新生儿万古霉素推荐日剂量差异较大。基于PPK原理制定的给药方案与谷浓度达标率无显著相关，但显示出更高的谷浓度和临床有效率，该方案可为临床治疗决策提供一定的参考。

Evaluation on Administration Regimen of Vancomycin in Neonates Based on Monte Carlo Simulation

Objective: To formulate administration regimen of vancomycin in neonates based on pharmacokinetics (PK), and to evaluate the regimen by retrospective case studies. Methods: Drug sensitivity data of vancomycin in our hospital from Jan. 2019 to Apr. 2022 and vancomycin treatment data of neonates from Nov. 2018 to Dec. 2021 were collected. A vancomycin daily dose recommendation table was developed by the existing population pharmacokinetics (PPK) model and Monte Carlo simulation. Differences in valley concentration and clinical efficacy between groups meeting the recommended dose were compared with reference to the recommendation table. Results: Data were collected from 177 neonates, and the recommended daily dose of vancomycin was formulated as 25 to 225 mg. The group conforming to the recommended dose showed higher valley concentration (P<0. 05) and higher clinical effective rate (P< 0. 05) compared with the group not conforming to the recommended dose, yet there was no statistical difference in the attainment of valley concentration between two groups (P>0. 05). Conclusion: The recommended daily dose of vancomycin was different in different subgroups. The administration regimen based on PPK has no significant correlation with the compliance rate of valley concentration, yet shows higher valley concentration and clinical effective rate, which could provide a certain reference for clinical treatment decision.