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一种用于血浆样本中万古霉素测定的简单且经过验证的高效液相色谱法:伊朗南部开展治疗药物监测中心的必要性。

A simple and validated HPLC method for vancomycin assay in plasma samples: the necessity of TDM center development in Southern Iran.

作者信息

Ghasemiyeh Parisa, Vazin Afsaneh, Zand Farid, Azadi Amir, Karimzadeh Iman, Mohammadi-Samani Soliman

机构信息

Department of Clinical Pharmacy, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, I.R. Iran.

Department of Pharmaceutics, Faculty of Pharmacy, Shiraz University of Medical Sciences, Shiraz, I.R. Iran.

出版信息

Res Pharm Sci. 2020 Nov 27;15(6):529-540. doi: 10.4103/1735-5362.301337. eCollection 2020 Dec.

Abstract

BACKGROUND AND PURPOSE

Vancomycin is a glycopeptide antibiotic which is the drug of choice against methicillin-resistant . It has a narrow therapeutic index, and thus therapeutic drug monitoring (TDM), and clinical pharmacokinetic assessment are necessary in order to prevent adverse drug reactions such as nephrotoxicity. In this study, we aimed to develop a simple and validated HPLC method for vancomycin assay in order to establish a TDM center for patients admitted to the ICU of Nemazee Hospital in southern Iran.

EXPERIMENTAL APPROACH

In this study, a brief review of different parameters and variables which could affect the sensitivity, selectivity of the validated HPLC method for vancomycin determination were considered. According to the previous studies a simple, fast, and the relatively low-cost method was established for vancomycin determination in plasma samples.

FINDINGS/RESULTS: The developed HPLC assay indicated a calibration curve with R-square of > 0.999, acceptable selectivity, the accuracy of 90-105%, CV% of less than 15%, the limit of quantification of 1 μg/mL, and limit of detection of 300 ng/mL. Vancomycin trough level, the area under the curve, renal clearance, the volume of distribution, and elimination constant were measured in patients using this validated method.

CONCLUSION AND IMPLICATIONS

Validated method for assay of vancomycin plasma levels was used to quantify vancomycin levels of four patients who were admitted to the ICU of Nemazee Hospital. According to the results, two of these patients showed lower levels than recommended therapeutic purposes while one of them showed a toxic level. According to the results, the TDM assessment of vancomycin is strongly recommended for patients who are hospitalized in ICU.

摘要

背景与目的

万古霉素是一种糖肽类抗生素,是治疗耐甲氧西林菌的首选药物。它的治疗指数较窄,因此需要进行治疗药物监测(TDM)和临床药代动力学评估,以预防诸如肾毒性等药物不良反应。在本研究中,我们旨在开发一种简单且经过验证的高效液相色谱(HPLC)法来测定万古霉素,以便为伊朗南部内马齐医院重症监护病房(ICU)收治的患者建立一个TDM中心。

实验方法

在本研究中,我们考虑了对已验证的用于测定万古霉素的HPLC法的灵敏度、选择性可能产生影响的不同参数和变量的简要综述。根据先前的研究,建立了一种简单、快速且成本相对较低的方法来测定血浆样本中的万古霉素。

研究结果

所开发的HPLC测定法显示校准曲线的决定系数R²>0.999,选择性可接受,准确度为90 - 105%,变异系数(CV%)小于15%,定量限为1μg/mL,检测限为300ng/mL。使用这种经过验证的方法对患者的万古霉素谷浓度、曲线下面积、肾清除率、分布容积和消除常数进行了测定。

结论与意义

已验证的用于测定万古霉素血浆水平的方法被用于对内马齐医院ICU收治的4例患者的万古霉素水平进行定量。根据结果,其中2例患者的水平低于推荐的治疗目标,而其中1例显示出中毒水平。根据结果,强烈建议对入住ICU的患者进行万古霉素的TDM评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1512/8020853/ee995eeee11f/RPS-15-529-g009.jpg

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