建立中国成都妊娠期间甲状腺激素检测方法和孕期特异性参考区间。
Establishment of assay method- and trimester-specific reference intervals for thyroid hormones during pregnancy in Chengdu, China.
机构信息
Department of Clinical Laboratory, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Department of Science and Education, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
出版信息
J Clin Lab Anal. 2021 May;35(5):e23763. doi: 10.1002/jcla.23763. Epub 2021 May 4.
BACKGROUND
The reference intervals of thyroid hormone will change at different stages of pregnancy because of physiological alterations. On the other hand, the reference intervals of thyroid hormone will also change in different detection systems due to the manufacturer's methodology as well as a different race. The objective of this study was to establish the assay method- and trimester-specific reference intervals for thyroid-stimulating hormone, free thyroxine and free triiodothyronine for pregnant women in Chengdu.
METHODS
A prospective, population-based cohort study involved 23,701 reference samples of pregnant women during the three trimesters and 8646 non-pregnant women with pre-pregnancy clinical and laboratory tests. The 2.5th and 97.5th percentiles were calculated as the reference intervals for thyroid-stimulating hormone, free thyroxine and free triiodothyronine at each trimester of pregnant women according to ATA Guidelines.
RESULTS
The reference interval of thyroid-stimulating hormone in the 2.5th and 97.5th percentiles has a significant increasing trend from the first trimester, to second trimester and to third trimester, which was 0.08-3.79 mIU/L for the first trimester, and 0.12-3.95 mIU/L for the second trimester and 0.38-4.18 mIU/L for the third trimester, respectively (p < 0.001). However, the reference intervals of free thyroxine and free triiodothyronine in the 2.5th and 97.5th percentiles have significant decreasing trends from the first trimester, to second trimester and to third trimester, which were 11.87-18.83 pmol/L and 3.77-5.50 pmol/L for the first trimester, and 11.22-18.19 pmol/L and 3.60-5.41 pmol/L for the second trimester, and 10.19-17.42 pmol/L and 3.37-4.79 pmol/L for the third trimester, respectively (both p < 0.001).
CONCLUSION
It is necessary to establish assay method- and trimester-specific reference intervals for thyroid-stimulating hormone, free thyroxine, and free triiodothyronine because the reference intervals of these thyroid hormones are significantly different at different stages of pregnancy.
背景
由于生理变化，甲状腺激素的参考区间会在妊娠的不同阶段发生变化。另一方面，由于制造商的方法以及不同种族的原因，甲状腺激素的参考区间也会在不同的检测系统中发生变化。本研究的目的是为成都地区的孕妇建立检测方法和孕期特异性的促甲状腺激素、游离甲状腺素和游离三碘甲状腺原氨酸参考区间。
方法
这是一项前瞻性的基于人群的队列研究，共纳入了 23701 例妊娠早期、中期和晚期的孕妇参考样本和 8646 例未怀孕的具有孕前临床和实验室检查的妇女。根据 ATA 指南，计算了每个孕期 2.5%和 97.5%百分位的促甲状腺激素、游离甲状腺素和游离三碘甲状腺原氨酸参考区间。
结果
促甲状腺激素的参考区间在第 1 至 3 个孕期的 2.5%和 97.5%百分位呈现出显著的递增趋势，分别为 0.08-3.79 mIU/L、0.12-3.95 mIU/L 和 0.38-4.18 mIU/L（p<0.001）。然而，游离甲状腺素和游离三碘甲状腺原氨酸的参考区间在第 1 至 3 个孕期的 2.5%和 97.5%百分位呈现出显著的递减趋势，分别为 11.87-18.83 pmol/L 和 3.77-5.50 pmol/L、11.22-18.19 pmol/L 和 3.60-5.41 pmol/L，以及 10.19-17.42 pmol/L 和 3.37-4.79 pmol/L（均 p<0.001）。
结论
由于这些甲状腺激素在不同孕期的参考区间存在显著差异，因此有必要建立检测方法和孕期特异性的促甲状腺激素、游离甲状腺素和游离三碘甲状腺原氨酸参考区间。
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