Waters Ansley, Laitner Melissa H
Virginia Department of Health, Office of Epidemiology, Division of Clinical Epidemiology The George Washington University Washington, D.C. USA.
Director of Public Policy & Government Affairs The Society for Women's Health Research Washington, D.C. USA.
Alzheimers Dement (N Y). 2021 Feb 14;7(1):e12111. doi: 10.1002/trc2.12111. eCollection 2021.
For decades, researchers have largely ignored sex as a biological variable (SABV) within preclinical studies. Recent literature indicates scientists are increasingly including male and female subjects in studies, but fewer studies assess for sex differences in study outcome. This is particularly concerning within the field of Alzheimer's disease (AD), as disease burden is higher among women and evidence suggests sex differences exist in etiology and disease course.
We conducted an informal review of preclinical AD research studies.
Results confirmed that only about one-third of ≈150 recent studies included both male and female mice, and <15 of nearly 150 studies examined SABV as an outcome of interest.
Previous research supports the idea that better integration of SABV could open new doors in treatment research. We provide examples of best practices and discuss the need for Alzheimer's researchers to account for SABV within preclinical studies.
几十年来,研究人员在很大程度上忽视了临床前研究中的性别作为一种生物学变量(SABV)。最近的文献表明,科学家们在研究中越来越多地纳入男性和女性受试者,但评估研究结果中性别差异的研究较少。这在阿尔茨海默病(AD)领域尤其令人担忧,因为女性的疾病负担更高,而且有证据表明病因和病程存在性别差异。
我们对临床前AD研究进行了非正式综述。
结果证实,在约150项近期研究中,只有约三分之一纳入了雄性和雌性小鼠,在近150项研究中,不到15项将SABV作为感兴趣的结果进行研究。
先前的研究支持这样一种观点,即更好地整合SABV可以为治疗研究打开新的大门。我们提供了最佳实践的例子,并讨论了阿尔茨海默病研究人员在临床前研究中考虑SABV的必要性。