Abstract：
Volumetric absorptive microsampling (VAMS) is increasingly proposed as a clinically reliable therapeutic drug monitoring (TDM) sampling methodology. The study aimed to establish the reliability and real-life feasibility of patient self-collected capillary VAMS for TDM of antiseizure medication (ASMs), using plasma ASMs concentrations from venous blood as a reference standard. Nurses collected venous and capillary blood samples using VAMS. Afterward, persons with epilepsy (PWE) performed VAMS sampling by themselves. All samples were analyzed by UHPLC-MS/MS. We performed a cross-validation study, comparing ASMs concentrations obtained by VAMS nurses and patients\' self-collected versus plasma through Bland-Altman analysis and Passing-Bablok regression. We enrolled 301 PWE (M: F 42.5%:57.5%; mean age 44±16 years), treated with 13 ASMs, providing a total of 464 measurements. Statistical analysis comparing VAMS self-collected versus plasma ASMs concentrations showed a bias close to zero and slope and intercept values indicating a good agreement for CBZ, LCS, LEV, LTG, OXC, PB, and PHT, while a systematic difference between the two methods was found for VPA, PMP, TPM and ZNS. This is the first study showing the reliability and feasibility of the real-world application of PWE self-collected VAMS for most of the ASMs considered, giving a promising basis for at-home VAMS applications.
摘要：
越来越多地提出体积吸收微量采样（VAMS）作为临床上可靠的治疗药物监测（TDM）采样方法。该研究旨在建立患者自收集毛细血管VAMS用于抗癫痫药物（ASM）TDM的可靠性和现实可行性，使用来自静脉血的血浆ASM浓度作为参考标准。护士使用VAMS收集静脉和毛细血管血液样本。之后,癫痫患者（PWE）自行进行VAMS采样。通过UHPLC-MS/MS分析所有样品。我们进行了交叉验证研究,通过Bland-Altman分析和Passing-Bablok回归比较VAMS护士和患者自采血浆获得的ASM浓度。我们招募了301名PWE（M：F42.5％：57.5％；平均年龄44±16岁），用13个ASM治疗，提供总共464次测量。比较VAMS自收集与血浆ASM浓度的统计分析显示，偏差接近零，斜率和截距值表明CBZ具有良好的一致性。LCS,LEV,LTG,OXC,PB,PHT,虽然在VPA中发现了两种方法之间的系统性差异，PMP,TPM和ZNS。这是第一项研究，显示了PWE自收集VAMS对于大多数考虑的ASM的实际应用的可靠性和可行性，为家用VAMS应用程序提供了有希望的基础。
