Borin M T, Peters G R, Smith T C
Clinical Pharmacokinetics, Upjohn Company, Kalamazoo, Michigan 49001.
Antimicrob Agents Chemother. 1990 Oct;34(10):1944-8. doi: 10.1128/AAC.34.10.1944.
The pharmacokinetics and dose proportionality of cefmetazole were studied in 24 healthy volunteers (12 young and 12 elderly). Each volunteer received single 0.5-, 1-, and 2-g doses of cefmetazole administered intravenously over 5 min according to a three-way crossover design. Serial plasma and urine samples were collected over a 24-h period following dosing and assayed for cefmetazole by a high-performance liquid chromatography method. Results of the dose proportionality portion of the study indicated that cefmetazole pharmacokinetics are linear and proportional with dose in both age groups. Comparisons of pharmacokinetic parameters between the young and elderly groups indicated that the systemic clearance was significantly lower in elderly than in young volunteers (92.4 versus 112 ml/min). Additionally, creatinine clearance was significantly lower in elderly (74.1 ml/min) than in young (92.9 ml/min) subjects. No significant differences between age groups were observed for volume of distribution, urinary recovery, terminal half-life, nonrenal clearance, or renal clearance, although half-life was slightly prolonged in elderly volunteers relative to that in young volunteers (1.54 versus 1.34 h), and renal clearance was slightly lower in elderly than in young volunteers (83.7 versus 96.1 ml/min). Both systemic and renal clearance were significantly correlated with creatinine clearance. These results indicate that the observed age-related differences in the pharmacokinetics of cefmetazole are most likely due to differences in renal function between the two age groups. The small reduction in cefmetazole elimination in the elderly would not warrant dose adjustment in this population.
在24名健康志愿者(12名年轻人和12名老年人)中研究了头孢美唑的药代动力学和剂量比例关系。根据三交叉设计,每位志愿者接受单次静脉注射0.5g、1g和2g剂量的头孢美唑,给药时间为5分钟。给药后24小时内收集系列血浆和尿液样本,并采用高效液相色谱法测定头孢美唑含量。该研究剂量比例部分的结果表明,在两个年龄组中,头孢美唑的药代动力学呈线性且与剂量成比例。年轻人和老年人组药代动力学参数的比较表明,老年人的全身清除率显著低于年轻志愿者(分别为92.4和112ml/min)。此外,老年人的肌酐清除率(74.1ml/min)显著低于年轻人(92.9ml/min)。尽管老年志愿者的半衰期相对于年轻志愿者略有延长(分别为1.54和1.34小时),且老年志愿者的肾清除率略低于年轻志愿者(分别为83.7和96.1ml/min),但年龄组之间在分布容积、尿回收率、末端半衰期、非肾清除率或肾清除率方面未观察到显著差异。全身清除率和肾清除率均与肌酐清除率显著相关。这些结果表明,观察到的头孢美唑药代动力学的年龄相关差异很可能是由于两个年龄组之间肾功能的差异。老年人中头孢美唑消除的小幅降低并不需要对该人群进行剂量调整。