Dried Blood Spot Analysis for Therapeutic Drug Monitoring of Pazopanib
Dried Blood Spot Analysis for Therapeutic Drug Monitoring of Pazopanib
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DOI：
10.1002/jcph.558
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发表时间：
2015-12-01
影响因子：
2.9
通讯作者：
van Erp, Nielka P.
中科院分区：
文献类型：
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作者：
de Wit, Djoeke;den Hartigh, Jan;van Erp, Nielka P.
干血斑（DBS）采样可能是帕唑帕尼静脉采样的一种更患者友好和灵活的替代方法。本研究确定了帕唑帕尼DBS与血浆浓度之间的一致性，以促进帕唑帕尼DBS采样在临床实践中的实施。在12名患者中采集了成对DBS和血浆样本。帕唑帕尼血浆浓度使用公式从DBS浓度计算：血浆浓度= DBS浓度/（1 -红细胞压积）。使用Passing-Bablok和Bland-Altman分析确定计算的和测量的血浆浓度之间的一致性。我们预先确定了Bland-Altman分析的临床可接受限度为25%。Passing-Bablok分析显示计算浓度和测量浓度之间存在较小的常数（截距估计值，-8.53 [95%CI，-12.22至-4.41]）和轻微成比例（斜率估计值，1.15 [95%CI，1.04-1.24]）偏倚。如Bland-Altman分析所示，该偏倚无临床意义;计算浓度与测量浓度的平均比值为0.94（95%CI，0.65-1.23）。临床可接受限度完全在95%一致性限度内。更具体地说，92.6%的数据点在预定义的验收限度内。帕唑帕尼血浆浓度可以从DBS浓度准确计算。尽管需要验证患者自己制备的DBS卡，但这些结果表明DBS采样可用于在临床实践中监测帕唑帕尼治疗。
Dried blood spot (DBS) sampling is potentially a more patient-friendly and flexible alternative to venous sampling of pazopanib. This study determined the agreement between pazopanib DBS and plasma concentrations to facilitate implementation of pazopanib DBS sampling into clinical practice. Paired DBS and plasma samples were collected in 12 patients. Pazopanib plasma concentrations were calculated from DBS concentrations using the formula: plasma concentration = DBSconcentration/(1 - hematocrit). Passing-Bablok and Bland-Altman analyses were used to determine the agreement between calculated and measured plasma concentrations. We predefined a clinical acceptance limit of 25% for the Bland-Altman analysis. Passing-Bablok analysis showed a small constant (intercept estimate, -8.53 [95%CI, -12.22 to -4.41]) and slightly proportional (slope estimate, 1.15 [95%CI, 1.04-1.24]) bias between calculated and measured concentrations. This bias was clinically nonrelevant, as shown by Bland-Altman analysis; the mean ratio of calculated to measured concentrations was 0.94 (95%CI, 0.65-1.23). The clinical acceptance limits were well within these 95% limits of agreement. More specifically, 92.6% of the data points were within the predefined acceptance limits. Pazopanib plasma concentrations can be accurately calculated from DBS concentrations. Although validation of DBS cards prepared by patients themselves is required, these results show that DBS sampling can be used to monitor pazopanib therapy in clinical practice.