The assay of saliva samples provides a valuable alternative to the use of blood samples for therapeutic drug monitoring (TDM), at least for certain categories of patients. To determine the feasibility of using saliva sampling for the TDM of rufinamide, we compared rufinamide concentrations in paired samples of saliva and plasma collected from 26 patients with epilepsy at steady state. Within‐patient relationships between plasma rufinamide concentrations and dose, and the influence of comedication were also investigated. Assay results in the two tested fluids showed a good correlation (r2 = .78, P < .0001), but concentrations in saliva were moderately lower than those in plasma (mean saliva to plasma ratio = 0.7 ± 0.2). In eight patients evaluated at three different dose levels, plasma rufinamide concentrations increased linearly with increasing dose. Patients receiving valproic acid comedication had higher dose‐normalized plasma rufinamide levels than patients comedicated with drugs devoid of strong enzyme‐inducing or enzyme‐inhibiting activity. Overall, these findings indicate that use of saliva represents a feasible option for the application of TDM in patients treated with rufinamide. Because rufinamide concentrations are lower in saliva than in plasma, a correction factor is needed if measurements made in saliva are used as a surrogate for plasma concentrations.

中文翻译：

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癫痫患者唾液与血浆卢非酰胺浓度的关系

唾液样品的测定为使用血液样品进行治疗药物监测 (TDM) 提供了一种有价值的替代方案，至少对于某些类别的患者而言。为了确定使用唾液采样进行卢非酰胺 TDM 的可行性，我们比较了从 26 名处于稳态的癫痫患者收集的唾液和血浆配对样本中的卢非酰胺浓度。还研究了血浆卢非酰胺浓度和剂量之间的患者内部关系，以及药物治疗的影响。两种测试液体的测定结果显示出良好的相关性（r2 = .78，P < .0001），但唾液中的浓度略低于血浆中的浓度（平均唾液与血浆比率 = 0.7 ± 0.2）。在以三种不同剂量水平评估的八名患者中，血浆卢非酰胺浓度随剂量增加呈线性增加。与服用缺乏强酶诱导或酶抑制活性的药物的患者相比，服用丙戊酸药物的患者具有更高的剂量标准化血浆卢非酰胺水平。总体而言，这些发现表明，唾液的使用代表了在接受卢非酰胺治疗的患者中应用 TDM 的可行选择。由于唾液中卢非酰胺的浓度低于血浆中的浓度，如果使用唾液中的测量值作为血浆浓度的替代物，则需要一个校正因子。这些发现表明，唾液的使用代表了在接受卢非酰胺治疗的患者中应用 TDM 的可行选择。由于唾液中卢非酰胺的浓度低于血浆中的浓度，如果使用唾液中的测量值作为血浆浓度的替代物，则需要一个校正因子。这些发现表明，唾液的使用代表了在接受卢非酰胺治疗的患者中应用 TDM 的可行选择。由于唾液中卢非酰胺的浓度低于血浆中的浓度，如果使用唾液中的测量值作为血浆浓度的替代物，则需要一个校正因子。