心力衰竭试验中性别差异原因的评估

Holly Morgan, A. Sinha, M. McEntegart, S. Hardman, D. Perera
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引用次数: 7

摘要

目的心血管疾病是导致妇女死亡和发病的主要原因之一。尽管如此,即使在当代研究中,女性患者在试验中的代表性也很低。本研究旨在探讨心力衰竭(HF)试验中性别差异背后的原因。方法确定2000年至2020年期间发表在7份高影响力临床期刊(影响因子>20)上的HF试验。试验包括300多名男女参与者。大型HF登记处以及人口统计数据也使用相同的标准进行了确定。结果我们确定了146项HF试验,其中248项 共620例。女性患者的中位比例为25.8%,在纳入缺血性心肌病患者(17.9%)、严重收缩功能障碍患者(左心室射血分数<35%)(21.4%)和侵入性手术患者(21.1%)的试验中,女性患者的比例最低,以及包括老年参与者的试验(40.5%)。在所有LVEF类别中,女性试验参与者的患病率和人群患病率之间存在显著差异(25.8%vs 49.0%,p<0.01)。结论HF试验中发现了显著的性别差异,在评估LVEF严重降低和缺血性病因的患者的试验中最为明显。这可能是由于入学偏见和生物变异之间的复杂相互作用。此外,这两个方面的程度可以根据试验类型而变化。展望未来,我们应该鼓励所有HF试验评估其招募日志,并提出任何报告的性别差异的原因。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the causes of sex disparity in heart failure trials
Objectives Cardiovascular disease is one of the leading causes of mortality and morbidity in women. Despite this, even in contemporary research, female patients are poorly represented in trials. This study aimed to explore reasons behind the sex disparity in heart failure (HF) trials. Methods HF trials published in seven high-impact clinical journals (impact factor >20), between 2000 and 2020, were identified. Trials with over 300 participants of both sexes were included. Large HF registries, as well as population statistics, were also identified using the same criteria. Results We identified 146 HF trials, which included 248 620 patients in total. The median proportion of female patients was 25.8%, with the lowest proportions seen in trials enrolling patients with ischaemic cardiomyopathy (17.9%), severe systolic dysfunction (left ventricular ejection fraction (LVEF) <35%) (21.4%) and those involving an invasive procedure (21.1%). The highest proportion of women was seen in trials assessing HF with preserved LVEF (51.6%), as well as trials including older participants (40.5%). Significant differences were seen between prevalence of female trial participants and population prevalence in all LVEF categories (25.8% vs 49.0%, p<0.01). Conclusions A significant sex disparity was identified in HF trials, most visible in trials assessing patients with severely reduced LVEF and ischaemic aetiology. This is likely due to a complex interplay between enrolment bias and biological variation. Furthermore, the degree of both these aspects may vary according to trial type. Going forward, we should encourage all HF trials to appraise their recruitment log and suggest reasons for any reported sex disparity.
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