电子患者档案嵌入模型信息精确剂量与医生剂量相比,在脏移植中使用塔克罗利
Dirk R J Kuypers1,2, Pieter Annaert3, Borefore Jallah1
1Department of Nephrology and Renal Transplantation, University Hospitals, Leuven, Belgium.
Clinical pharmacology and therapeutics
|October 11, 2025
概括
在移植患者中,TACROLIMUS的模型知情精确剂量 (MIPD) 改善了药物度目标. 这种自动化系统与基于医生的剂量相比,表现优越.
科学领域:
- 腎病學和免疫學 腎病學和免疫學
- 药理动力学和药理动力学
- 临床药学和药理学 临床药学和药理学
背景情况:
- 塔克罗利斯是移植中的关键免疫抑制剂,需要仔细监测治疗药物.
- 达到目标的塔克罗利斯度对于移植的生存和最小化毒性至关重要.
- 目前基于医生的剂量策略往往导致药物暴露不足于最佳水平.
研究的目的:
- 评估一个完全自动化的模型知情精确剂量 (MIPD) 应用程序的疗效,用于新腎全移植接受者的塔克罗利斯.
- 为了比较MIPD的性能与标准的基于医生的剂量,以达到目标塔克罗利斯度.
主要方法:
- 一项前性随机对照临床验证研究,涉及293名移植接受者.
- 实现一个完全自动化的MIPD应用程序,集成到电子患者档案中.
- 在MIPD和医生剂量组之间,对Tacrolimus剂前最低度和目标范围内的样本分数进行比较.
主要成果:
- 在MIPD组中,更多的患者在第8天达到3个目标塔克罗利斯度的初级终点 (52.2%对35.7%).
- 目标范围内的样本的平均分数在MIPD手臂 (0.38对0.28) 中显著更高.
- MIPD治疗导致从目标度窗口的平均距离显著降低.
结论:
- 一个完全自动化的MIPD应用对脏移植接受者的tacrolimus在实现目标药物暴露方面表现出卓越的性能.
- 医生对MIPD剂量建议的推翻是最小的 (<1%),表明对系统的信任.
- 自动化MIPD显示了作为一种有价值的决策支持工具的承诺,以改善移植的临床结果.
相关概念视频
01:25Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant
208
In patients with renal disease, dosage adjustments are necessary to maintain therapeutic plasma drug concentrations and prevent toxicity or subtherapeutic exposure. Renal impairment alters drug pharmacokinetics, especially in conditions like uremia, where changes such as prolonged elimination half-life and altered apparent volume of distribution can significantly affect drug disposition. These changes require careful modification of the dosing regimen to achieve the desired clinical...
208
01:28Drug Dosing in Renal Diseases: Estimation of Glomerular Filtration Rate Based on Serum Creatinine Concentration
189
Glomerular filtration rate (GFR) can be estimated from serum creatinine using the modification of diet in renal disease (MDRD) formula or the chronic kidney disease–epidemiology collaboration (CKD–EPI) equation. Both methods are widely used in clinical practice to assess kidney function and guide treatment decisions.The MDRD equation does not require weight or height measurements and is normalized to the body surface area of 1.73 m², considered the average adult surface area.
189
01:01Dosage Regimens: Partial Pharmacokinetic Parameters
150
It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
150
01:24Dosage Regimen: Individualization
166
Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
166
01:15Determination of Multiple Dosing Parameters: Steady-State, Minimum and Maximum Concentrations
235
Gentamicin, an aminoglycoside antibiotic, is commonly administered via intermittent intravenous infusion to treat severe infections. An intermittent one-hour infusion of gentamicin, administered at eight-hour intervals, allows for precise control of plasma drug concentrations, minimizing toxicity while ensuring therapeutic efficacy. Pharmacokinetic principles govern the dynamics of plasma concentrations and can be mathematically described using specific equations.The plasma drug concentration...
235
01:25Drug Dosing in Renal Diseases: Measurement of Serum Creatinine Concentration and Clearance
183
In healthy individuals, serum creatinine levels remain stable due to a balance between its constant production—primarily from muscle metabolism—and renal excretion. Creatinine is freely filtered by the glomeruli, making it a valuable marker for estimating renal function. When the glomerular filtration rate (GFR) decreases, the kidneys can only eliminate less creatinine, causing serum levels to rise.Serum creatinine concentration is widely used to estimate creatinine clearance...
183