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Improving clinical outcomes through attention to sex and hormones in research
Nature Reviews Endocrinology ( IF 31.0 ) Pub Date : 2021-07-27 , DOI: 10.1038/s41574-021-00531-z
Michelle M Mielke 1, 2, 3 , Virginia M Miller 2, 4, 5, 6
Affiliation  

Biological sex, fluctuations in sex steroid hormones throughout life and gender as a social construct all influence every aspect of health and disease. Yet, for decades, most basic and clinical studies have included only male individuals. As modern health care moves towards personalized medicine, it is clear that considering sex and hormonal status in basic and clinical studies will bring precision to the development of novel therapeutics and treatment paradigms. To this end, funding, regulatory and policy agencies now require inclusion of female animals and women in basic and clinical studies. However, inclusion of female animals and women often does not mean that information regarding potential hormonal interactions with pharmacological treatments or clinical outcomes is available. All sex steroid hormones can interact with receptors for drug targets, metabolism and transport. Genetic variation in receptors or in enzymatic function might contribute to sex differences in therapeutic efficacy and adverse drug reactions. Outcomes from clinical trials are often not reported by sex, and, if the data are available, they are not translated into clinical practice guidelines. This Review will provide a historical perspective for the current state of research related to hormone trials and provide concrete strategies that, if implemented, will improve the health of all people.



中文翻译:


通过在研究中关注性和激素来改善临床结果



生物性别、一生中性类固醇激素的波动以及性别作为一种社会结构都会影响健康和疾病的各个方面。然而,几十年来,大多数基础和临床研究只包括男性个体。随着现代医疗保健向个性化医疗迈进,很明显,在基础和临床研究中考虑性别和激素状态将为新型疗法和治疗范例的开发带来精确性。为此,资助、监管和政策机构现在要求将雌性动物和妇女纳入基础和临床研究。然而,纳入雌性动物和女性通常并不意味着可以获得有关潜在激素与药物治疗或临床结果相互作用的信息。所有性类固醇激素都可以与药物靶标、代谢和运输的受体相互作用。受体或酶功能的遗传变异可能导致治疗效果和药物不良反应的性别差异。临床试验的结果通常不按性别报告,即使有数据,也不会转化为临床实践指南。本综述将为与激素试验相关的研究现状提供历史视角,并提供具体策略,如果实施这些策略,将改善所有人的健康。

更新日期:2021-07-27
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