Dahlqvist R, Borgå O, Rane A, Walsh Z, Sjöqvist F
Br J Clin Pharmacol. 1979 Dec;8(6):547-52. doi: 10.1111/j.1365-2125.1979.tb01042.x.
1 Plasma protein binding of phenytoin and of valproic acid were measured in ten epileptic patients on this drug combination. Ten other epileptics not on valproic acid served as controls. All patients had normal kidney function. 2 The measured free fraction of phenytoin among the patients on valproic acid ranged from 12.5 to 23.2% and after recalculation to a plasma albumin level of 45 g/l from 12.5 to 20.0 (median 15.4%). This differed significantly (P = 0.002, Mann- Whitney U-test) from the control patients where the normalized values ranged from 9.9 to 13.9% with a median value of 11.8%. 3 The measured free fractions of phenytoin and of valproic acid showed a significant correlation which, however, was due to the quantitative relation between the degree of binding of both these drugs and the concentration of plasma albumin. There was no discernable relation in this material between the free concentration of valproic acid and the free fraction of phenytoin. 4 It is concluded that patients on combined treatment with phenytoin and valproic acid have an unpredictably raised free fraction of phenytoin. This drug interaction therefore can complicate the important plasma level monitoring of phenytoin in epileptic patients unless the free concentration of this drug can be analysed or estimated.
对10例联合使用苯妥英钠和丙戊酸的癫痫患者测定了这两种药物的血浆蛋白结合率。另外10例未使用丙戊酸的癫痫患者作为对照。所有患者肾功能均正常。
使用丙戊酸的患者中,苯妥英钠的游离分数测定值在12.5%至23.2%之间,重新计算至血浆白蛋白水平为45 g/l后,游离分数在12.5%至20.0%之间(中位数为15.4%)。这与对照患者有显著差异(P = 0.002,曼-惠特尼U检验),对照患者的标准化值在9.9%至13.9%之间,中位数为11.8%。
苯妥英钠和丙戊酸的游离分数测定值显示出显著相关性,然而,这是由于这两种药物的结合程度与血浆白蛋白浓度之间的定量关系所致。在该研究材料中,丙戊酸的游离浓度与苯妥英钠的游离分数之间没有明显关系。
得出结论,联合使用苯妥英钠和丙戊酸治疗的患者,其苯妥英钠的游离分数会不可预测地升高。因此,这种药物相互作用会使癫痫患者苯妥英钠重要的血药浓度监测变得复杂,除非能够分析或估算该药物的游离浓度。