不同检测方法之间用于估算霉酚酸暴露量的有限采样策略的外部验证：PETINIA 和 HPLC 方法

IF 1.9 4区医学 Q2 SURGERY

Clinical Transplantation Pub Date : 2024-09-26 DOI:10.1111/ctr.15471

Kosuke Doki, Keigo Yoshida, Joichi Usui, Kazuhiro Takahashi, Tatsuya Oda, Kunihiro Yamagata, Masato Homma

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引用次数: 0

摘要

导言：在临床实践中，用于估算免疫抑制剂霉酚酸（MPA）血浆浓度-时间曲线下面积（AUC0-12）的有限采样策略（LSS）被用于治疗药物监测（TDM）。我们的研究深入探讨了 MPA AUC0-12 LSS 的适用性，该 LSS 最初是利用颗粒增强比浊抑制免疫测定（PETINIA）测量方法开发的，现在则适用于通过紫外检测高效液相色谱法（HPLC-UV）获得的测量结果。方法我们在 32 例接受霉酚酸酯治疗的成人肾移植患者中开发了一种基于 PETINIA 测量的 LSS，用于估算 MPA AUC0-12。通过 PETINIA 和 HPLC-UV 测量，在另外 14 名成人肾移植患者（验证集）中对该策略进行了验证。预测性能采用平均绝对误差 (MAE)、均方根误差 (RMSE) 和 "良好猜测 "进行评估，"良好猜测 "的定义是预测的 AUC 在观察到的 AUC ± 15% 范围内。结果三个时间点方程（0、2 和 6 h）是估算 MPA AUC0-12 的最佳方法，在临床环境中兼顾了预测性能和实用性。在验证集中，PETINIA 测量（0.978）和 HPLC-UV 测量（0.958）的观察 AUC0-12 与预测 AUC0-12 的判定系数一致。在 PETINIA 测量（分别为 6.4%、8.1% 和 85.7%）和 HPLC-UV 测量（分别为 7.6%、9.4% 和 85.7%）中观察到了相似的 MAE、RMSE 和 "好猜测 "结果。结论我们的研究结果支持将最初使用 PETINIA 测量方法开发的 MPA AUC0-12 LSS 应用于通过 HPLC-UV 获得的测量方法。

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External Validation of a Limited Sampling Strategy for the Estimation of Mycophenolic Acid Exposure Between Different Assay Methods: PETINIA and HPLC Methods

Introduction

A limited sampling strategy (LSS) for estimating the area under the plasma concentration–time curve (AUC_0–12) of the immunosuppressant mycophenolic acid (MPA) is used for therapeutic drug monitoring (TDM) in clinical practice. Our study delves into the applicability of the MPA AUC_0–12 LSS, originally developed using particle-enhanced turbidimetric inhibition immunoassay (PETINIA) measurements, to those obtained via high-performance liquid chromatography with ultraviolet detection (HPLC–UV).

Methods

We developed an LSS for estimating MPA AUC_0–12 based on PETINIA measurements in 32 adult kidney transplant patients who were receiving mycophenolate mofetil. Validation of this strategy was conducted in an additional 14 adult kidney transplant patients (validation sets) through measurements obtained by both PETINIA and HPLC–UV. Predictive performance was assessed using mean absolute error (MAE), root mean squared error (RMSE), and “good guess” defined as predicted AUC within observed AUC ± 15%.

Results

The three time point equation (0, 2, and 6 h) emerged as optimal for estimating MPA AUC_0–12, balancing predictive performance and usefulness in clinical settings. In validation sets, the coefficient of determination for observed versus predicted AUC_0–12 was consistent between PETINIA (0.978) and HPLC–UV (0.958) measurements. Comparable MAE, RMSE, and “good guess” outcomes were observed for PETINIA (6.4%, 8.1%, and 85.7%, respectively) and HPLC–UV (7.6%, 9.4%, and 85.7%, respectively) measurements.

Conclusion

Our findings support the application of the MPA AUC_0–12 LSS, originally developed using PETINIA measurements, to those obtained via HPLC–UV.

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来源期刊

Clinical Transplantation 医学-外科

CiteScore

3.70

自引率

4.80%

发文量

286

审稿时长

2 months

期刊介绍： Clinical Transplantation: The Journal of Clinical and Translational Research aims to serve as a channel of rapid communication for all those involved in the care of patients who require, or have had, organ or tissue transplants, including: kidney, intestine, liver, pancreas, islets, heart, heart valves, lung, bone marrow, cornea, skin, bone, and cartilage, viable or stored. Published monthly, Clinical Transplantation’s scope is focused on the complete spectrum of present transplant therapies, as well as also those that are experimental or may become possible in future. Topics include: Immunology and immunosuppression; Patient preparation; Social, ethical, and psychological issues; Complications, short- and long-term results; Artificial organs; Donation and preservation of organ and tissue; Translational studies; Advances in tissue typing; Updates on transplant pathology;. Clinical and translational studies are particularly welcome, as well as focused reviews. Full-length papers and short communications are invited. Clinical reviews are encouraged, as well as seminal papers in basic science which might lead to immediate clinical application. Prominence is regularly given to the results of cooperative surveys conducted by the organ and tissue transplant registries. Clinical Transplantation: The Journal of Clinical and Translational Research is essential reading for clinicians and researchers in the diverse field of transplantation: surgeons; clinical immunologists; cryobiologists; hematologists; gastroenterologists; hepatologists; pulmonologists; nephrologists; cardiologists; and endocrinologists. It will also be of interest to sociologists, psychologists, research workers, and to all health professionals whose combined efforts will improve the prognosis of transplant recipients.