西安地区健康孕妇血浆D-二聚体参考区间的建立及验证  

Establishment and validation of reference interval of D-dimer in plasma of healthy pregnant women in Xi′an

作　　者：梁文娟 谢云 汪自然 董玲 韩俊锋 付欣 秦绪珍[2] Liang Wenjuan;Xie Yun;Wang Ziran;Dong Ling;Han Junfeng;Fu Xin;Qin Xuzhen(Medical Laboratory Center,Northwest Women's and Children's Hospital,Xian 710061,China;Department of Clinical Laboratory,Peking Union Hospital,Chinese Academy of Medical Sciences,Beijing100730,China)

机构地区：[1]西北妇女儿童医院医学检验中心,西安710061 [2]中国医学科学院北京协和医院检验科,北京100730

出　　处：《中华检验医学杂志》2022年第10期1083-1086,共4页Chinese Journal of Laboratory Medicine

摘　　要：目的建立西安地区健康孕妇不同孕期血浆D-二聚体生物参考区间,为临床动态监测孕期微血栓风险提供正常参考界值。方法通过调查问卷,纳入2020年12月至2022年3月在西北妇女儿童医院常规产检的健康孕妇和体检的健康非孕育龄妇女(健康非孕对照组)共1502例为研究对象,包括健康孕妇1236例和健康非孕对照组266例,年龄范围为20~45岁;孕期范围为:5~42周。分为<30岁和≥30岁两个年龄段进行比较。健康孕妇组按照孕周,分为5组:≤13周、13^(+1)~20周、20^(+1)~27周、27^(+1)~35周、≥35^(+1)周分别纳入253例、243例、241例、249例、240例。采用STA-R Evolution全自动血凝仪及其配套试剂检测血浆D-二聚体浓度,Graph Prism9.0软件统计不同孕期、不同年龄段D-二聚体的浓度水平并进行组间比较。5个孕周组再分别收集各20份样本对建立的参考区间进行验证。结果比较<30岁和≥30岁两个年龄段不同孕周血浆D-二聚体水平,差异无统计学意义;健康孕妇组的血浆D-二聚体水平明显高于同龄健康非孕妇女组(P<0.05)。随着孕周增加,孕妇的血浆D-二聚体水平明显升高,孕周≤13周、13^(+1)~20周、20^(+1)~27周、27^(+1)~35周、≥35^(+1)周的血浆D-二聚体水平分别为:0.33(0.26,0.47)μg/ml、0.41(0.30,0.51)μg/ml、0.71(0.48,0.94)μg/ml、0.91(0.70,1.27)μg/ml,1.30(0.96,1.72)μg/ml,单侧参考区间分别为≤0.89μg/ml、≤1.53μg/ml、≤2.44μg/ml、≤2.74μg/ml、≤3.82μg/ml。5个孕周组,各20份独立样本验证此研究建立的参考范围,结果可通过。结论本研究初步建立了西安地区健康孕妇不同孕周血浆D-二聚体参考区间,有助于孕期血栓疾病的辅助诊断。Objective:To provide normal reference thresholds for clinical dynamic monitoring of the risk of microthrombus during pregnancy, we aimed to establish reference intervals of D-dimer in healthy pregnant women during different periods of gestation in Xi′an.Method:From December 2020 to March 2022, a total of 1502 healthy pregnant women and healthy non-pregnant women (healthy non-pregnant control group) who received routine prenatal examination in Northwest Women and Children′s Hospital were recruited in the study by questionnaire, including 1236 healthy pregnant women and 266 healthy non-pregnant control group. Plasma D-dimer concentration was detected by STA-R Evolution automatic blood coagulation analyzer and the concentration levels of D-dimer in different pregnancies and age groups were calculated using Graph Prism 9.0 software. In addition, 20 samples were collected in each pregnancy to verify the established reference interval.Results:There was no significant difference in plasma D-dimer levels between<30 years old and ≥30 years old at different gestational weeks. Plasma D-dimer level in healthy pregnant women group was significantly higher than that in healthy non-pregnant women group of the same age (P<0.05). With the increase of gestational week, plasma D-dimer level in pregnant women increased significantly, and plasma D-dimer level at different gestational weeks ≤13 weeks, 13^(+1)-20 weeks, 20^(+1)-27 weeks, 27^(+1)-35 weeks, ≥35 ^(+1) week were 0.33 (0.26, 0.47) μg/ml, 0.41 (0.30, 0.51) μg/ml, 0.71 (0.48, 0.94) μg/ml, 0.91 (0.70, 1.27) μg/ml, 1.30 (0.96, 1.72) μg/mlrespectively. Unilateral reference interval acuities were≤0.89 μg/ml, ≤1.53 μg/ml, ≤2.44 μg/ml, ≤2.74 μg/ml, ≤3.82 μg/ml respectively. The reference range established in this study was verified by 20 independent samples from each of the 5 gestational age groups, and the results were acceptable. Conclusion:This study preliminarily established the reference interval of plasma D-dimer in healthy pregnant women at diff

关 键 词：孕妇 D-二聚体 参考区间 

分 类 号：R714[医药卫生—妇产科学]