Optimization of the vancomycin administration regimen by clinical pharmacists based on a population pharmacokinetics model: a prospective interventional study.

Haodi Lu, Lufen Duan, Yanxia Yu, Jingjing Li, Lu Shi, Sudong Xue, Qian Zhang, Qin Zhou, Chenqi Zhu, Erning Shang, Xinxin Yan, Lian Tang
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Abstract

In vancomycin treatment, the rates of correct blood sampling and initial trough concentrations within the target range are very low. Studies of interventions by clinical pharmacists based on population pharmacokinetics (PPK) models are limited. This study aimed to evaluate the intervention effect of clinical pharmacist-mediated optimization of the vancomycin administration regimen based on a PPK model. Retrospectively enrolled patients constituted the control group, and prospectively enrolled patients constituted the intervention group. The vancomycin administration regimen, trough concentration, pharmacokinetic parameters, and clinical outcomes of the two groups were compared. The control and intervention groups comprised 236 and 138 patients, respectively. Compared with those in the control group, the therapeutic drug monitoring (TDM) and correct TDM sampling time rates in the intervention group were significantly higher (76.92% vs. 43.59%; 63.9% vs. 39.0%, both p < 0.001). The rates of an initial trough concentration within 10-20 mg/L and an adjusted regimen were also significantly higher in the intervention group (55.80% vs. 30.51%, 71.95% vs. 39.18%, both p < 0.001). The rate of an area under the curve (AUC) within 400-650 mg·h/L was higher in the intervention group than in the control group (52.7% vs. 36.6%, p < 0.001). The eradication rates of Gram-positive bacteria were 91.4% in the intervention group and 81.3% in the control group (p = 0.049). Eight patients developed acute kidney injury (AKI) in the control group; however, no AKI occurred in the intervention group (p = 0.029). Intervention by clinical pharmacists can increase the rate of correct sampling time. Using the PPK model combined with Bayesian estimation, clinical pharmacists can greatly increase the trough concentration and AUCs within the target range, especially for adjusted regimens. Higher PK/PD target rates resulted in better Gram-positive bacterial eradication and reduced renal toxicity of vancomycin.

基于人群药代动力学模型的临床药师优化万古霉素给药方案的前瞻性介入研究
在万古霉素治疗中,正确的采血率和目标范围内的初始谷浓度非常低。基于群体药代动力学(PPK)模型的临床药师干预研究有限。本研究旨在基于PPK模型评价临床药师介导的万古霉素给药方案优化的干预效果。回顾性入组患者为对照组,前瞻性入组患者为干预组。比较两组患者万古霉素给药方案、谷浓度、药动学参数及临床疗效。对照组和干预组分别有236例和138例患者。与对照组相比,干预组治疗药物监测(TDM)和正确TDM采样时间率显著高于对照组(76.92% vs. 43.59%;63.9% vs. 39.0%, p均为0.001)。干预组的初始谷浓度在10-20 mg/L以内和调整方案的比率也显著高于干预组(55.80% vs. 30.51%, 71.95% vs. 39.18%, p均为0.001)。干预组血药浓度在400 ~ 650 mg·h/L范围内的曲线下面积(AUC)率高于对照组(52.7%比36.6%,p < 0.001)。干预组革兰氏阳性菌根除率为91.4%,对照组为81.3% (p = 0.049)。对照组8例发生急性肾损伤(AKI);干预组无AKI发生(p = 0.029)。临床药师的干预可提高采样正确率。使用PPK模型与贝叶斯估计相结合,临床药师可以在目标范围内大幅提高谷浓度和auc,特别是对调整后的方案。较高的PK/PD靶率导致更好的革兰氏阳性细菌根除和降低万古霉素的肾毒性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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