Padrini R, Piovan D, Javarnaro A, Cucchini F, Ferrari M
Department of Pharmacology, University of Padua, Italy.
Clin Pharmacokinet. 1993 Nov;25(5):408-14. doi: 10.2165/00003088-199325050-00006.
The pharmacokinetics of ajmaline were studied in 10 patients with suspected paroxysmal atrioventricular block who received a 1 mg/kg intravenous dose over 2 minutes for diagnostic purposes (ajmaline test). Plasma concentration decay followed a triexponential time course with a final half-life much longer (7.3 +/- 3.6 hours) than that previously found by other investigators (about 15 minutes). Mean total plasma clearance and renal clearance were 9.76 ml/min/kg and 0.028 ml/min/kg, respectively. Although most of the dose was eliminated through the extrarenal route (only 3.5% of the intravenous dose was recovered in urine), no fluorescent metabolites could be detected either in plasma or urine. The steady-state volume of distribution averaged 6.17 L/kg, and plasma protein binding ranged between 29 and 46%. Three patients developed a transient atrioventricular block after ajmaline administration. In the remainder, the drug prolonged atrio-His bundle (AH interval), His bundle-ventricular (HV interval) and intraventricular (QRS interval) conduction times. Corrected ventricular repolarisation time (QTc interval) showed less marked changes, which were biphasic at times. The mean maximum ajmaline-induced increase in HV interval was 98%, in QRS was 58%, in AH was 30%, and in QTc was 17%. In most cases the time course of electrocardiographic changes lagged behind that of plasma concentrations, suggesting a delayed equilibrium of plasma concentrations with the site of action (hysteresis). Despite that, the pharmacokinetic-pharmacodynamic model, which accounted for hysteresis, failed to fit the experimental data adequately.(ABSTRACT TRUNCATED AT 250 WORDS)
对10例疑似阵发性房室传导阻滞的患者进行了阿义马林的药代动力学研究,这些患者为诊断目的接受了2分钟内静脉注射1mg/kg剂量的阿义马林(阿义马林试验)。血浆浓度衰减呈三指数时间过程,其终末半衰期(7.3±3.6小时)比其他研究者先前发现的(约15分钟)长得多。平均总血浆清除率和肾清除率分别为9.76ml/min/kg和0.028ml/min/kg。尽管大部分剂量通过肾外途径消除(静脉注射剂量仅3.5%在尿液中回收),但在血浆或尿液中均未检测到荧光代谢物。稳态分布容积平均为6.17L/kg,血浆蛋白结合率在29%至46%之间。3例患者在阿义马林给药后出现短暂性房室传导阻滞。其余患者中,该药物延长了心房-希氏束(AH间期)、希氏束-心室(HV间期)和室内(QRS间期)传导时间。校正后的心室复极时间(QTc间期)变化不太明显,有时呈双相性。阿义马林引起的HV间期平均最大增加为98%,QRS为58%,AH为30%,QTc为17%。在大多数情况下,心电图变化的时间过程滞后于血浆浓度,提示血浆浓度与作用部位达到平衡存在延迟(滞后现象)。尽管如此,考虑到滞后现象的药代动力学-药效学模型仍不能充分拟合实验数据。(摘要截短至250字)