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槲皮素对中国汉族男性志愿者头孢丙烯药代动力学的影响。

Effects of quercetin on pharmacokinetics of cefprozil in Chinese-Han male volunteers.

作者信息

Jia Fei-Fei, Tan Zhi-Rong, McLeod Howard L, Chen Yao, Ou-Yang Dong-Sheng, Zhou Hong-Hao

机构信息

a Department of Clinical Pharmacology , Xiangya Hospital, Central South University , Changsha , China .

b Department of Cancer Epidemiology , DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center , Tampa , FL , USA , and.

出版信息

Xenobiotica. 2016 Oct;46(10):896-900. doi: 10.3109/00498254.2015.1132792. Epub 2016 Feb 29.

Abstract
  1. The primary objective of this study was to evaluate the effects of quercetin on the pharmacokinetics of cefprozil. The secondary objective was to evaluate the safety of the combined use of cefprozil and quercetin. 2. An open-label, two-period, crossover phase I trial among 24 Han Chinese male subjects was conducted. Participants were given 500 mg of quercetin orally once daily for 15 d followed by single dose of cefprozil (500 mg) on day 15. Serum concentrations of cefprozil were then measured in all participants on day 15. A 15-d washout period was then assigned after which a 500 mg dose of cefprozil was administered and measured in the serum on day 36. 3. All subjects completed the trial, and no serious adverse events were reported. We measured mean serum concentrations of cefprozil in the presence and absence of quercetin in all participants. The maximum serum concentration of cefprozil in the presence of quercetin was 8.18 ug/ml (95% CI: 7.55-8.81) versus a maximum cefprozil concentration of 8.35 ug/ml (95% CI: 7.51-9.19) in the absence of quercetin. We conclude that the concurrent use of quercetin has no substantial effect on serum concentrations of orally administered cefprozil. 4. Co-administration of quercetin showed no statistically significant effects on the pharmacokinetics of cefprozil in healthy Chinese subjects.
摘要
  1. 本研究的主要目的是评估槲皮素对头孢丙烯药代动力学的影响。次要目的是评估头孢丙烯与槲皮素联合使用的安全性。2. 在24名汉族男性受试者中进行了一项开放标签、两期、交叉的I期试验。参与者每天口服500毫克槲皮素,持续15天,然后在第15天给予单剂量的头孢丙烯(500毫克)。然后在第15天测量所有参与者血清中头孢丙烯的浓度。之后安排15天的洗脱期,之后在第36天给予500毫克剂量的头孢丙烯并测量血清中的浓度。3. 所有受试者均完成试验,未报告严重不良事件。我们测量了所有参与者在有和没有槲皮素存在情况下头孢丙烯的平均血清浓度。在有槲皮素存在时,头孢丙烯的最大血清浓度为8.18微克/毫升(95%置信区间:7.55 - 8.81),而在没有槲皮素时,头孢丙烯的最大浓度为8.35微克/毫升(95%置信区间:7.51 - 9.19)。我们得出结论,槲皮素的同时使用对口服头孢丙烯的血清浓度没有实质性影响。4. 在健康中国受试者中,槲皮素的联合给药对头孢丙烯的药代动力学没有统计学上的显著影响。

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