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首页> 外文期刊>Pediatric critical care medicine: a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies >Pharmacokinetics of levosimendan in pediatric patients evaluated for cardiac surgery.
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Pharmacokinetics of levosimendan in pediatric patients evaluated for cardiac surgery.

机译：左西孟旦在儿科患者心脏手术中的药代动力学。

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OBJECTIVE: The objective of the study was to evaluate the pharmacokinetics, hemodynamic effects, and safety of levosimendan in children with congenital heart disease. DESIGN: Open, one group, single-dose study. SETTING: Cardiac catheter laboratory in a pediatric cardiology department of a university hospital. Patients and Treatments: Thirteen children between the ages of 3 months and 7 yrs coming for preoperative cardiac catheterization were enrolled into this study. All children received 12 microg/kg levosimendan as an intravenous infusion given over 10 mins during the catheterization. Measurements: Concentrations of levosimendan and its metabolites were determined at specified time points before and after infusion (0-4 hrs). Invasive hemodynamics was evaluated up to 25 mins after the start of the infusion and echocardiography up to 2 hrs after the start of the infusion. MAIN RESULTS: The mean maximum concentration of levosimendan was 59 +/- 23 ng/mL in children older than 6 months of age. Levosimendan was rapidly distributed, with a mean half-life of 0.24 +/- 0.07 hrs. Mean terminal elimination half-life was 1.6 +/- 0.80 hrs. Total plasma clearance for the 10-min infusion was 3.6 +/- 1.3 mL/min/kg. Terminal elimination half-life in children aged 3-6 months was slower than in older children, i.e., 2.3 hrs vs. 1.6 hrs. Values of other pharmacokinetic variables were on the same level between the two age groups. The changes in hemodynamic variables were not statistically significant. There were no serious adverse events or unexpected adverse drug reactions during the study. CONCLUSIONS: The pharmacokinetic profile of levosimendan in children with congenital heart disease is similar to that in adult patients with congestive heart failure. The minimal hemodynamic efficacy after the 12 microg/kg levosimendan bolus was probably due to a small dose relative to body surface area.
机译：目的：本研究的目的是评估左西孟旦在先天性心脏病儿童中的药代动力学，血液动力学效应和安全性。设计：开放，一组，单剂量研究。地点：大学医院小儿心脏病科的心导管实验室。患者和治疗：13例年龄在3个月至7岁之间的术前进行心脏导管插入术的儿童入选了这项研究。在导管插入过程中，所有孩子在10分钟内接受了12 microg / kg左西孟旦静脉滴注。测量：在输注前后（0-4小时）的指定时间点测定左西孟旦及其代谢产物的浓度。在开始输注后25分钟内评估侵袭性血流动力学，在开始输注后2小时内评估超声心动图。主要结果：6个月以上儿童左西孟旦的平均最大浓度为59 +/- 23 ng / mL。左西孟旦迅速分布，平均半衰期为0.24 +/- 0.07小时。平均末端消除半衰期为1.6 +/- 0.80小时。 10分钟输注的总血浆清除率为3.6 +/- 1.3 mL / min / kg。 3-6个月大的儿童的终末消除半衰期比大一点的儿童慢，即2.3小时和1.6小时。在两个年龄组之间，其他药代动力学变量的值处于相同水平。血液动力学变量的变化无统计学意义。在研究期间没有严重的不良事件或意外的不良药物反应。结论：左西孟旦在先天性心脏病儿童中的药代动力学特征与成人充血性心力衰竭患者相似。左西孟旦12微克/千克推注后的最小血流动力学功效可能是由于相对于体表面积的小剂量。

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