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Gender Differences in the Oral Pharmacokinetics of Fluconazole

机译：氟康唑口服药代动力学中的性别差异

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Background and objective: Fluconazole is a triazole derivative widely used for the treatment of mycoses. It has been established that several factors are able to modify its pharmacokinetics, including the bodyweight of the patient; however, there is controversy about the influence of gender on the pharmacokinetics of fluconazole. In order to clarify this controversy we decided to evaluate the pharmacokinetics of fluconazole in males and females. Methods: Fifty-nine subjects (26 males and 33 females) were enrolled in this study. Volunteers received an oral dose of fluconazole l00mg under fasting conditions and blood samples were collected at selected times over a period of 96 hours. Plasma was obtained and analysed by a high-performance liquid chroma-tography method. Results: The plasma fluconazole concentrations obtained in women were higher than those obtained in men. This was reflected in differences in most pharmaco-kinetic parameters. However, when parameters were normalised according to the bodyweight of subjects, differences were reduced, indicating that this factor plays a role in the differences observed. Notwithstanding, differences in other parameters, such as normalised maximum plasma concentration, time to reach maximum plasma concentration, volume of distribution and half-life, remained. Conclusion: Fluconazole pharmacokinetics are influenced by both bodyweight and gender, most likely because of differences in total body water between males and females. Although the clinical impact on efficacy and safety of the pharmaco-kinetic differences observed in this study was not established, it is desirable that fluconazole dosage regimens take into account both the gender and the bodyweight of the patient.
机译：背景与目的：氟康唑是广泛用于治疗真菌病的三唑衍生物。已经确定，多种因素能够改变其药代动力学，包括患者的体重。然而，性别对氟康唑药代动力学的影响存在争议。为了澄清这一争议，我们决定评估氟康唑在男性和女性中的药代动力学。方法：59例受试者（男26例，女33例）入选本研究。志愿者在禁食条件下接受了氟康唑的口服剂量100mg，并在96小时内的选定时间收集了血液样本。获得血浆并通过高效液相色谱法进行分析。结果：女性血浆氟康唑的浓度高于男性。这反映在大多数药代动力学参数的差异上。但是，当根据受试者的体重对参数进行归一化时，差异会减小，表明该因素在观察到的差异中起作用。尽管如此，其他参数的差异仍然存在，例如标准化的最大血浆浓度，达到最大血浆浓度的时间，分布体积和半衰期。结论：氟康唑的药代动力学受体重和性别的影响，最可能的原因是男性和女性体内总水分的差异。尽管尚未确定对本研究中观察到的药代动力学差异的功效和安全性有临床影响，但希望氟康唑剂量方案同时考虑患者的性别和体重。

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