Sex and racial differences in pharmacological response: Where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics
Sex and racial differences in pharmacological response: Where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics
复制标题
DOI：
10.1089/jwh.2005.14.19
复制
发表时间：
2005-01-01
影响因子：
3.5
通讯作者：
Anderson, GD
中科院分区：
文献类型：
--
作者：
Anderson, GD
美国食品和药物管理局（FDA）在1995年至2000年期间审查了300种新药申请。在包括性别分析的163种药物中，有11种药物显示男性和女性之间的药代动力学差异>40%，这在产品标签上列出，但没有基于性别提出剂量建议。女性已被证明是临床相关药物不良反应的风险因素。根据女性不同的药代动力学简单地给药是否会降低不良事件的发生率？答案尚不清楚。已确定性别依赖性药效学效应。药代动力学与药效学的作用尚不清楚，药物遗传学对两者的影响也不清楚。这篇综述强调了每个领域的一些具体例子，在这些领域中，药代动力学和药效学的性别差异是重要的，并为额外的研究提供了建议。
The Food and Drug Administration (FDA) reviewed 300 new drug applications between 1995 and 2000. Of the 163 that included a sex analysis, 11 drugs showed a >40% difference in pharmacokinetics between males and females, which was listed on the product label, yet no dosing recommendations were made based on sex. Female sex has been shown to be a risk factor for clinically relevant adverse drug reactions. Would simply dosing females based on their different pharmacokinetics decrease the incidence of adverse events? The answer is not known. Sex-dependent pharmacodynamic effects have been identified. The role of pharmacokinetics vs. pharmacodynamics is unclear, as is the impact of pharmacogenetics on both. This review highlights a few specific examples in each area in which sex differences in pharmacokinetics and pharmacodynamics are important and provides recommendations for additional needed research.