Mohmad Sallih N, Subbiah I, Ali A, Jackson N
University Malaya, Faculty of Medicine, Department of Pathology, Lembah Pantai, 59100, Kuala Lumpur, Malaysia.
Malays J Pathol. 2019 Apr;41(1):7-13.
Plasma D-dimer levels rise progressively during pregnancy, so one cannot apply normal reference ranges, or the usual cut-off value (500ng/mL), for the exclusion of venous thromboembolism (VTE), in pregnant women. This study was carried out in pregnant Malaysian women in order to build applicable reference ranges for D-dimer.
A cross-sectional study was conducted to measure D-dimer in healthy pregnant women, and a non-pregnant control group, using the quantitative HaemosIL D-dimer HS500 assay. Reference ranges were derived using CLSI 'Robust' methods, and differences between group medians were tested using the Kruskal-Wallis and Mann-Whitney U tests.
Plasma D-dimer levels were measured in 92 pregnant women (distributed across the three trimesters)and 31 control women. The medians (and reference ranges) in ng/mL were: control 265 (<799); first trimester 481 (<1070); second trimester 1073 (357-1748); 3rd trimester 1533 (771-2410). There were significant differences between the D-dimer levels of each group and each of the other groups (P<0.001).
Reference ranges for D-dimer in pregnant Malaysian women have been establised by this study. Whether these ranges can be used to determine cut-off levels for the exclusion of VTE at different stages of pregnancy is doubtful, as the levels rise continuously through pregnancy, and some very high outlying values occur in apparently normal near-term pregnancy.
孕期血浆D - 二聚体水平会逐渐升高，因此不能采用正常参考范围或通常的临界值（500ng/mL）来排除孕妇的静脉血栓栓塞（VTE）。本研究针对马来西亚孕妇开展，旨在建立适用的D - 二聚体参考范围。
采用横断面研究，通过定量HaemosIL D - 二聚体HS500检测法测量健康孕妇及非孕对照组的D - 二聚体水平。参考范围采用CLSI“稳健”方法得出，组间中位数差异采用Kruskal - Wallis检验和Mann - Whitney U检验。
对92名孕妇（分布于三个孕期）和31名对照女性进行了血浆D - 二聚体水平检测。以ng/mL计的中位数（及参考范围）为：对照组265（<799）；孕早期481（<1070）；孕中期1073（357 - 1748）；孕晚期1533（771 - 2410）。各组的D - 二聚体水平与其他各组之间均存在显著差异（P<0.001）。
本研究已建立马来西亚孕妇D - 二聚体的参考范围。由于孕期D - 二聚体水平持续升高，且在看似正常的足月妊娠中会出现一些非常高的异常值，所以这些范围能否用于确定孕期不同阶段排除VTE 的临界水平尚不确定。
