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揭示慢性肾脏病患者临床试验中的性别差异。

Shedding a light on sex disparity in clinical trials in CKD patients.

作者信息

Mallamaci Francesca, Tripepi Giovanni

机构信息

Nephrology, Dialysis, and Transplantation Unit, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" of Reggio Calabria, Italy.

Institute of Clinical Physiology (IFC), National Research Council (CNR) of Reggio Calabria, Italy.

出版信息

Clin Kidney J. 2023 Jul 7;16(9):1369-1371. doi: 10.1093/ckj/sfad163. eCollection 2023 Sep.

Abstract

Clinical studies do not include an adequate proportion of female participants, and research data on drug efficacy and safety are generally collected from studies including a majority of men and extrapolated to women. This article describes the imbalance of male and female distribution in clinical studies, including patients with chronic kidney disease. The lack of sex equity in clinical research is a real 'public health problem' because not reporting sex-specific results may result in the loss of information on how a drug works according to sex. Therefore, it is essential to plan more research in the field of sex disparities in clinical studies to identify why women are underrepresented and to promote initiatives to expand women's participation in clinical studies.

摘要

临床研究中女性参与者的比例不足,关于药物疗效和安全性的研究数据通常来自以男性为主的研究,并推断应用于女性。本文描述了临床研究(包括慢性肾脏病患者)中男女分布的不平衡。临床研究中缺乏性别公平是一个切实存在的“公共卫生问题”,因为不报告性别特异性结果可能导致失去关于药物如何依性别起效的信息。因此,至关重要的是在临床研究中的性别差异领域规划更多研究,以确定女性代表性不足的原因,并推动扩大女性参与临床研究的举措。

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