广州地区健康孕妇血浆D-二聚体参考范围的建立

Establishment of D-dimer reference intervals for healthy pregnant women

目的建立广州地区健康孕妇血浆D-二聚体的参考范围。方法选择454例健康孕妇作为研究组,按孕周分为早孕组、中孕组、晚孕组。选择127例健康育龄非孕妇女作为对照组。将2组按年龄分为<30岁组和≥30岁组。选取1例妊娠期发生下肢静脉血栓的患者作为疾病组。使用Sysmex CA 7000全自动血凝分析仪(免疫比浊法)检测各组血浆D-二聚体浓度,以百分位数(≤P95)表示血浆D-二聚体的参考区间的单侧上限。结果健康孕妇血浆D-二聚体的95%参考范围:早孕组:≤1.06 mg/L FEU;中孕组:≤1.91 mg/L FEU;晚孕组:≤3.6 mg/L FEU;孕妇血浆D-二聚体浓度水平随孕周增加而逐渐升高;孕妇不同年龄间血浆D-二聚体差异无统计学意义(P>0.05)。结论初步建立广州地区健康孕妇血浆D-二聚体参考范围,与试剂厂家提供的参考范围有较大差异,有必要建立本地区健康孕产妇的正常参考值范围。

Objective To establish the D-dimer reference intervals for pregnant women in Guangzhou area. Methods 454 healthy pregnant women were collected as the research group and divided into three groups according to the gestational week,the early pregnant group,the middle pregnant group and the late pregnant group. 127 healthy non-pregnant women were collected as the control group. These groups were further stratified based on ages,the 30 years old and the ≥30 years old. One patient with lower limb venous thrombosis in pregnancy was collected as disease group. Sysmex CA-7000 fully automatic blood coagulation analyze was applied to determine the concentration of plasma D-dimer,and the percentile（ ≤P95） was used to express the unilateral upper limit of plasma reference in interval D-dimer. Results The 95% reference intervals was as the following with the early pregnant group ≤1. 06 mg / L FEU,the middle pregnant group ≤1. 91 mg / L FEU and the late pregnant group ≤3. 6 mg / L FEU. D-dimer level increased progressively with the pregnancy time. The difference of plasma D-dimer levels during different pregnant period was statistically significant. Conclusion A preliminary definition of D-dimer reference intervals for healthy pregnant women was established in Guangzhou area. There are great differences with the reference intervals provided by reagent manufacture. It is very essential to establish the reference intervals for healthy pregnant women in the area.