目的 研究年龄和性别因素对健康人体单次口服500mg左氧氟沙星药代动力学的影响.方法 选择6名青年(18～40岁)男性、6名老年(65岁以上)男性、6名青年(18～40岁)女性和6名老年(65岁以上)女性参与本试验,均给予500mg左氧氟沙星单次口服,观察不同年龄组和不同性别组药代动力学参数.结果 年龄和性别对左氧氟沙星的生物利用度都没有影响.各组血浆中的药物浓度在服药大约1.5h时达到峰值.肾清除率大约占人体总清除率的77%,在36h采集的尿中,给药的76%以原形存在.不同年龄和性别组的左氧氟沙星的药代动力学参数因为受试者个体肾功能的差别而显著不同.结论 对于所有青年、老年,男性、女性受试者,单次口服500mg左氧氟沙星是安全的,并且耐受性良好.由于在所有青年、老年,男性、女性受试者中,左氧氟沙星的药动学差别有限并且主要由于受试者肾功能差别引起,所以基于年龄和性别的差异来调整给药量是没有必要的.%Objective It is to study the effective factors of age and gender on pharmacokinetics in healthy people given 500 mg levofloxacin one time by oral use. Methods 6 young males( 18 - 40 years old ), 6 old males ( ＞ 65 years old ), 6 young females( 18 - 40 years old ), 6 old females ( ＞ 65 years old ) were chosen to perform on this experiment. All the subjects were given levofloxacin one time by oral use. Indexes of pharmacokinetics in different groups of age and gender were observed. Results Both age and gender had no effect on bioavailability of levofloxacin. The plasma contents of levofloxacin reach their peak value in approximate 1. 5 h after taking drugs in every group. The proportion of kidney clearing rate to body total clearing rate was 77％ . 76％ drugs taken were existed as their prototype in the urine collected in 36 h. There were significant differences in pharmacokinetics indexes of levofloxacin among groups of different age and gender because that individual subjects had different kidney function. Conclusion Taking 500 mg levofloxacin one time by oral use is safe with a good tolerance in all the young and old, male and female subjects. It is not necessary to improve the dosage of levofloxacin based on age and gender, because there is little significant difference in the pharmacokinetics of the drug which mainly was caused by subject' s kidney function.
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