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基于真实世界数据的中国妊娠期甲状腺激素模型的建立及参考区间。

Establishment of Early Pregnancy Related Thyroid Hormone Models and Reference Intervals for Pregnant Women in China Based on Real World Data.

机构信息

Department of Clinical Laboratory, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, P. R. China.

Department of Obstetrics and Gynecology, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, P. R. China.

出版信息

Horm Metab Res. 2021 Apr;53(4):272-279. doi: 10.1055/a-1402-0290. Epub 2021 Apr 14.

DOI:10.1055/a-1402-0290
PMID:33853119
Abstract

Thyroid hormone reference intervals are crucial for diagnosing and monitoring thyroid dysfunction during early pregnancy, and the dynamic change trend of thyroid hormones during pregnancy can assist clinicians to assess the thyroid function of pregnant women. This study aims to establish early pregnancy related thyroid hormones models and reference intervals for pregnant women. We established two derived databases: derived database* and derived database#. Reference individuals in database* were used to establish gestational age-specific reference intervals for thyroid hormones and early pregnancy related thyroid hormones models for pregnant women. Individuals in database# were apparently healthy non-pregnant women. The thyroid hormones levels of individuals in database# were compared with that of individuals in database* using nonparametric methods and the comparative confidence interval method. The differences in thyroid stimulating hormone and free thyroxine between early pregnant and non-pregnant women were statistically significant (p<0.0001). The reference intervals of thyroid stimulating hormone, free thyroxine and free triiodothyronine for early pregnant women were 0.052-3.393 μIU/ml, 1.01-1.54 ng/dl, and 2.51-3.66 pg/ml, respectively. Results concerning thyroid stimulating hormone and free thyroxine reference intervals of early pregnancy are comparable with those from other studies using the same detection platform. Early pregnancy related thyroid hormones models showed various change patterns with gestational age for thyroid hormones. Early pregnancy related thyroid hormones models and reference intervals for pregnant women were established, so as to provide accurate and reliable reference basis for the diagnosing and monitoring of maternal thyroid disfunction in early pregnancy.

摘要

甲状腺激素参考区间对于诊断和监测妊娠早期甲状腺功能障碍至关重要,而甲状腺激素在妊娠期间的动态变化趋势可以帮助临床医生评估孕妇的甲状腺功能。本研究旨在建立妊娠早期相关的甲状腺激素模型和孕妇的参考区间。我们建立了两个衍生数据库:衍生数据库和衍生数据库#。数据库中的参考个体用于建立特定于胎龄的甲状腺激素参考区间和孕妇的妊娠早期相关甲状腺激素模型。数据库#中的个体为明显健康的非孕妇。数据库#中的个体的甲状腺激素水平与数据库*中的个体进行比较,采用非参数方法和比较置信区间方法。妊娠早期妇女的促甲状腺激素和游离甲状腺素与非妊娠妇女之间存在显著差异(p<0.0001)。妊娠早期妇女的促甲状腺激素、游离甲状腺素和游离三碘甲状腺原氨酸的参考区间分别为 0.052-3.393 μIU/ml、1.01-1.54 ng/dl 和 2.51-3.66 pg/ml。关于妊娠早期促甲状腺激素和游离甲状腺素参考区间的结果与使用相同检测平台的其他研究相似。妊娠早期相关的甲状腺激素模型显示甲状腺激素随胎龄的变化呈现出不同的模式。建立了妊娠早期相关的甲状腺激素模型和孕妇的参考区间,为妊娠早期母体甲状腺功能障碍的诊断和监测提供了准确可靠的参考依据。

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