中国健康孕妇凝血生物标志物（TAT、PIC、TM、tPAI-C）的三个月特定参考区间及其临床相关性
Trimester-specific reference intervals for coagulation biomarkers (TAT, PIC, TM, tPAI-C) and their clinical associations in healthy Chinese pregnant women.
摘要(中文译文)
妊娠期女性处于高凝状态，易发生血栓栓塞性疾病，生物标志物可用于产前保健中血栓栓塞的管理。本研究旨在探讨四种凝血生物标志物——凝血酶-抗凝血酶复合物（TAT）、纤溶酶-α2-纤溶酶抑制剂复合物（PIC）、组织型纤溶酶原激活剂/纤溶酶原激活剂抑制剂-1复合物（tPAI-C）及可溶性血栓调节蛋白（TM）——在妊娠期间的变化及其相关因素，并建立其在孕妇中的参考区间。我们纳入2024年11月至2025年6月在复旦大学附属妇产科医院接受产前保健的329名健康孕妇。采用自动化荧光免疫分析法测定这些凝血生物标志物的水平，发现TAT、TM和tPAI-C在三个孕期均升高，而PIC降低。依据CLSI EP28-A3c指南建立了孕期特异性参考区间。多元线性回归显示，孕周是全部四种生物标志物的显著影响因素，而当前BMI对TAT呈负向影响，舒张压对tPAI-C呈正向影响。未发现年龄、孕次和产次与这些生物标志物存在显著关联。本研究证实了妊娠期间进行性高凝状态，并利用荧光免疫分析平台建立了TAT、PIC、TM和tPAI-C的孕期特异性参考区间。与BMI和血压相关的新发现值得进一步研究。这些生物标志物及其参考区间可能有助于在产前保健中区分生理性变化与病理性凝血-纤溶紊乱。
Abstract
During pregnancy, women are in hypercoagulable status, predisposing them to thromboembolic disorders and biomarkers can be used for management of thromboembolism during prenatal care. This study aimed to explore changes and association factors of four coagulation biomarkers - thrombin-antithrombin complex (TAT), plasmin-α2-plasmin inhibitor complex (PIC), tissue plasminogen activator/plasminogen activator inhibitor-1 complex (tPAI-C), and soluble thrombomodulin (TM), during pregnancy and establish their reference intervals in pregnant women. We enrolled 329 healthy pregnant women undergoing prenatal care in Obstetrics and Gynecology Hospital of Fudan University from November 2024 to June 2025. We quantified the levels of these coagulation biomarkers using automated fluorescence immunoassays, and found TAT, TM and tPAI-C increased across three trimesters while PIC decreased. Trimester-specific reference intervals were established following the CLSI EP28-A3c guideline. Multiple linear regression showed that gestational week was a significant influencing factor for all the four biomarkers, while current BMI influenced TAT negatively and diastolic blood pressure influenced tPAI-C positively. No significant association of age, gravidity and parity with these biomarkers was found. This study confirms the progressive hypercoagulable state during pregnancy and established the trimester specific reference intervals of TAT, PIC, TM and tPAI-C using a fluorescence immunoassay platform. The novel finding of associations with BMI and blood pressure warrants further investigation. These biomarkers and their reference intervals may assist in distinguishing between physiological changes and pathological coagulation-fibrinolysis disorders in prenatal care.
如何引用
AMA
Fei Ji, Beibei Qian, Jiaying Tao, Ying Zhang, Peimin Mao. Trimester-specific reference intervals for coagulation biomarkers (TAT, PIC, TM, tPAI-C) and their clinical associations in healthy Chinese pregnant women.. Scientific reports. 2026; doi:10.1038/s41598-026-61568-6.
APA
Fei Ji, Beibei Qian, Jiaying Tao, Ying Zhang, Peimin Mao (2026). Trimester-specific reference intervals for coagulation biomarkers (TAT, PIC, TM, tPAI-C) and their clinical associations in healthy Chinese pregnant women.. Scientific reports. https://doi.org/10.1038/s41598-026-61568-6
GB/T 7714
Fei Ji, Beibei Qian, Jiaying Tao, Ying Zhang, Peimin Mao. Trimester-specific reference intervals for coagulation biomarkers (TAT, PIC, TM, tPAI-C) and their clinical associations in healthy Chinese pregnant women.[J]. Scientific reports, 2026 doi:10.1038/s41598-026-61568-6.
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