Chien S C, Chow A T, Natarajan J, Williams R R, Wong F A, Rogge M C, Nayak R K
The R.W. Johnson Pharmaceutical Research Institute, Raritan, New Jersey 08869, USA.
Antimicrob Agents Chemother. 1997 Jul;41(7):1562-5. doi: 10.1128/AAC.41.7.1562.
The influence of age and gender on the pharmacokinetics of levofloxacin in healthy subjects receiving a single oral 500-mg dose of levofloxacin was investigated in this parallel design study. Six young males (aged 18 to 40 years), six elderly males (aged > or = 65 years), six young females (aged 18 to 40 years), and six elderly females (aged > or = 65 years) were enrolled and completed the study. The study reveals that the bioavailability (rate and extent) of levofloxacin was not affected by either age or gender. In both age (young and elderly) and gender (male and female) groups of subjects, peak concentrations in plasma were reached at approximately 1.5 h after dosing; renal clearance of levofloxacin accounted for approximately 77% of total body clearance, and approximately 76% of the administered dose was recovered unchanged in urine over the 36 h of collection. The apparent differences in the calculated pharmacokinetic parameters for levofloxacin between the age groups (young versus elderly) and between the gender groups (males versus females) could be explained by differences in renal function among the subjects. A single dose of 500 mg of levofloxacin administered orally to both young and old, male and female healthy subjects was found to be safe and well tolerated. As the differences in levofloxacin kinetics between the young and the elderly or the males and the females are limited and are mainly related to the renal function of the subjects, dose adjustment based on age or gender alone is not necessary.
在这项平行设计研究中，调查了年龄和性别对接受单次口服500毫克左氧氟沙星的健康受试者中左氧氟沙星药代动力学的影响。招募了六名年轻男性（年龄18至40岁）、六名老年男性（年龄≥65岁）、六名年轻女性（年龄18至40岁）和六名老年女性（年龄≥65岁）并完成了研究。研究表明，左氧氟沙星的生物利用度（速率和程度）不受年龄或性别的影响。在受试者的年龄组（年轻和老年）和性别组（男性和女性）中，给药后约1.5小时达到血浆峰值浓度；左氧氟沙星的肾清除率约占全身清除率的77%，在36小时的收集期内，约76%的给药剂量以原形从尿液中回收。年龄组（年轻与老年）和性别组（男性与女性）之间左氧氟沙星计算的药代动力学参数的明显差异可以用受试者肾功能的差异来解释。发现对年轻和年老、男性和女性健康受试者口服单剂量500毫克左氧氟沙星是安全且耐受性良好的。由于年轻与老年或男性与女性之间左氧氟沙星动力学的差异有限且主要与受试者的肾功能有关，因此无需仅基于年龄或性别进行剂量调整。
