Abstract：
Since steroids are crucial for diagnosing endocrine disorders, the lack of research on factors that affect hormone levels makes interpreting the results difficult. Our study aims to assess the stability of the pre-analytical procedure and the impact of hormonal physiological fluctuations using real-world data. The datasets were created using 12,418 records from individuals whose steroid hormone measurements were taken in our laboratory between September 2019 and March 2024. 22 steroid hormones in plasma by a well-validated liquid chromatography tandem mass spectrometry method were measured. After normalization transformation, outlier removal, and z-score normalization, generalized additive models were constructed to evaluate preanalytic stability and age, sex, and sample time-dependent hormonal fluctuations. Most hormones exhibit significant variability with age, particularly steroid hormone precursors, sex hormones, and certain corticosteroids such as aldosterone. 18-hydroxycortisol, 18-oxocortisol. Sex hormones varied between males and females. Levels of certain hormones, including cortisol, cortisone, 11-deoxycortisol, 18-hydroxycortisol, 18-oxocortisol, corticosterone, aldosterone, estrone, testosterone, dihydrotestosterone, dehydroepiandrosterone sulfate, 11-ketotestosterone, and 11-hydroxytestosterone, fluctuated with sampling time. Moreover, levels of pregnenolone and progesterone decreased within 1 hour of sampling, with pregnenolone becoming unstable with storage time at 4 degrees after centrifugation, while other hormone levels remained relatively stable for a short period of time without or after centrifugation of the sample. This is the first instance real-world data has been used to assess the pre-analytic stability of plasma hormones and to evaluate the impact of physiological factors on steroid hormones.
摘要：
由于类固醇对诊断内分泌失调至关重要,缺乏对影响激素水平的因素的研究使得解释结果变得困难。我们的研究旨在评估分析前程序的稳定性以及使用现实世界数据的荷尔蒙生理波动的影响。该数据集是使用来自个体的12,418条记录创建的，这些个体的类固醇激素测量是在2019年9月至2024年3月期间在我们的实验室进行的。我们使用经过充分验证的液相色谱和串联质谱技术常规测量了血浆中的22种类固醇激素。归一化转换后，离群值去除,和z分数归一化，构建了广义相加模型来评估预分析稳定性和年龄，性别,和样本时间依赖的荷尔蒙波动。大多数激素随着年龄的增长表现出显著的变异性，特别是类固醇激素前体，性激素,和某些皮质类固醇如醛固酮。18-羟基皮质醇,18-氧皮质醇,性激素在男性和女性之间有所不同。某些激素水平,包括皮质醇,可的松,11-脱氧皮质醇，18-羟基皮质醇,18-氧皮质醇,皮质酮,醛固酮,estrone,睾丸激素，双氢睾酮,硫酸脱氢表雄酮，11-酮雌酮,和11-羟基睾酮，随采样时间波动。此外，孕烯醇酮和孕酮水平在取样后1小时内下降，孕烯醇酮在离心后4度的储存时间变得不稳定，而其他激素水平在不离心或离心样品后的短时间内保持相对稳定。这是首次使用真实世界数据来评估血浆激素的分析前稳定性并评估生理因素对类固醇激素的影响。
