浙江地区汉族孕产妇D-二聚体参考区间的建立及应用

目的 建立浙江地区汉族孕产妇D-二聚体参考区间.方法 选取2009年3月至2010年8月浙江大学医学院附属妇产科医院健康孕妇669名、健康产妇578名、发生静脉血栓或DIC孕产妇8例以及健康非孕产妇对照者80名.将健康孕产妇按孕周、产后不同时间及不同分娩方式分组:(1)≤13周组120名,14～20周组120名,21～27周组145名,28～34周组147名,≥35周组137名;(2)自然分娩后第1天组163名,自然分娩后第2天组121名;(3)剖宫产后第1天组166名,剖宫产后第2天组128名.将上述各组按年龄再分为＜30岁组和≥30岁组.采集所有健康孕产妇柠檬酸钠抗凝静脉血1.8 ml,采用STA-R Evolution全自动血凝仪检测其血浆D-二聚体浓度,确定相应的参考区间.孕产妇D-二聚体浓度为偏态分布数据,采用百分位数(P95)表示参考区间的单侧上限.采用本研究建立的参考区间评估8例患静脉血栓或DIC孕产妇的D-二聚体水平,以验证建立的参考区间的有效性.结果 年龄＜30岁的孕妇组及健康对照组中,孕周≤13周、14～20周、21～27周、28～34周、≥35周的孕妇组及健康对照组血浆D-二聚体水平分别为0.25(0.17～0.37)、0.51(0.38～0.75)、0.75(0.57～1.10)、1.14(0.80～1.48)、1.60(1.14～1.89)、0.20(0.10～0.28) mg/L,差异有统计学意义(H=239.24,P＜0.05);年龄≥30岁的孕妇组及健康对照组中,上述各组的D-二聚体水平分别为0.28(0.14～0.38)、0.50(0.36～0.65)、0.83(0.59～1.41)、0.93(0.68～1.37)、1.47(1.22～1.84)、0.17(0.12～0.25)mg/L,差异有统计学意义(H=127.75,P＜0.05).年龄＜30岁的产妇组中,自然分娩后第1天、自然分娩后第 2天、剖宫产后第1天、剖宫产后第2天产妇组的血浆D-二聚体水平分别为2.45(1.51～3.77)、1.30(0.97～1.96)、2.68(1.52～3.74)、1.55(1.10～2.10) mg/L,差异有统计学意义(H=64.85,P＜0.05);年龄≥30岁的产妇组中,上述各组的血浆D-二聚体水平分别为2.20(1.33～3.54)、1.33(1.02～2.14)、2.27(1.66～3.17)、1.62(1.26～2.69) mg/L,差异有统计学意义(H=18.64,P＜0.05).孕产妇血浆D-二聚体水平在不同孕周、产后不同时间、不同分娩方式组间差异有统计学意义,应该制定不同的参考区间.孕周≤13周、14～20周、21～27周、28～34周、≥35周的孕妇血浆D-二聚体参考区间分别为≤0.64 mg/L、≤1.54 mg/L、≤2.60 mg/L、≤3.01 mg/L、≤3.19 mg/L;自然分娩后第1天、自然分娩后第2天、剖宫产后第1天、剖宫产后第2天的血浆D-二聚体参考区间分别为≤7.83 mg/L、≤3.29 mg/L、≤9.95 mg/L、≤3.80 mg/L.采用上述参考区间评估8例患静脉血栓或DIC的孕产妇的D-二聚体水平,均为阳性结果.结论 本研究初步建立并评估了浙江地区汉族孕产妇血浆D-二聚体参考区间,提高了D-二聚体检测在孕产妇人群中的应用价值.

Abstract：

Objective To establish D-dimer normal reference range in pregnant and postpartum women in Zhejiang Han population.Methods Plasma samples were collected from 669 healthy pregnant women, 578 healthy postpartum women, 8 venous thrombosis or DIC patients and 80 healthy non-pregnant women in Women′s Hospital, School of Medicine, Zhejiang University from March 2009 to August 2010.According to different gestational week, postpartum days and delivery pattern, the healthy pregnant and postpartum women were stratified into 3 groups: (1) ≤13 weeks (n=120), 14-20 weeks (n=120), 21-27 weeks (n=145), 28-34 weeks (n=147), ≥35 weeks (n=137);(2) The first day after vaginal delivery (n=163), the second day after vaginal delivery (n=121);(3) The first day after cesarean sections (n=166), the second day after cesarean sections (n=128). These groups were further stratified based on age: ＜30 years old and ≥30 years old.All blood samples were drawn in citrate sodium anticoagulated blood.D-dimer concentration was determined by STA-R Evolution coagulation analyzer.Since D-dimer concentration showed non-normal distribution, the normal values (one-tailed) were established by using (P95) percentile method.The results of 8 patients were used to validate the established normal values.Results In the group of ＜30 years old, the D-dimer valuesM(P25-P75)]in group of ≤13 weeks, 14-20 weeks, 21-27 weeks, 28-34 weeks, ≥35 weeks and healthy non-pregnant women were 0.25(0.17-0.37), 0.51(0.38-0.75), 0.75(0.57-1.10), 1.14(0.80-1.48), 1.60(1.14-1.89) and 0.20(0.10-0.28) mg/L, respectively, which showed statistical difference(H=239.24, P＜0.05).In the group of ≥30 years old, the D-dimer values of the above different groups were 0.28(0.14-0.38), 0.50(0.36-0.65), 0.83(0.59-1.41), 0.93(0.68-1.37), 1.47(1.22-1.84) and 0.17(0.12-0.25) mg/L, respectively, which also showed statistical difference(H=127.75, P＜0.05).In the group of ＜30 years old, the D-dimer values were 2.45(1.51-3.77), 1.30(0.97-1.96), 2.68(1.52-3.74) and 1.55(1.10-2.10) on the first and second day after vaginal delivery and cesarean section, respectively, which showed statistical difference (H=64.85,P＜0.05).In the group of ≥30 years old, the corresponding values were 2.20(1.33-3.54), 1.33(1.02-2.14), 2.27(1.66-3.17) and 1.62(1.26-2.69), respectively, which also showed statistical difference(H=18.64, P＜0.05).D-dimer normal values were established based on different gestational week, postpartum days and delivery pattern.The normal values of ≤13 weeks, 14-20 weeks, 21-27 weeks, 28-34 weeks and ≥35 weeks were ≤0.64 mg/L, ≤1.54 mg/L, ≤2.60 mg/L, ≤3.01 mg/L and ≤3.19 mg/L, respectively. The normal values of 1st day after vaginal delivery, 2nd day after vaginal delivery,1st day after cesarean sections and 2nd day after cesarean sections were ≤7.83 mg/L, ≤3.29 mg/L, ≤9.95 mg/L and ≤3.80 mg/L.All 8 patients showed positive results with the above normal values.Conclusion D-dimer normal values in pregnant and postpartum women in Zhejiang Han population are established, which can improve the application values of D-dimer in the pregnant and postpartum population.

Establishment and application of D-dimer reference range in pregnant and postpartum women in Zhejiang Han population

Objective To establish D-dimer normal reference range in pregnant and postpartum women in Zhejiang Han population.Methods Plasma samples were collected from 669 healthy pregnant women, 578 healthy postpartum women, 8 venous thrombosis or DIC patients and 80 healthy non-pregnant women in Women′s Hospital, School of Medicine, Zhejiang University from March 2009 to August 2010.According to different gestational week, postpartum days and delivery pattern, the healthy pregnant and postpartum women were stratified into 3 groups: (1) ≤13 weeks (n=120), 14-20 weeks (n=120), 21-27 weeks (n=145), 28-34 weeks (n=147), ≥35 weeks (n=137);(2) The first day after vaginal delivery (n=163), the second day after vaginal delivery (n=121);(3) The first day after cesarean sections (n=166), the second day after cesarean sections (n=128). These groups were further stratified based on age: ＜30 years old and ≥30 years old.All blood samples were drawn in citrate sodium anticoagulated blood.D-dimer concentration was determined by STA-R Evolution coagulation analyzer.Since D-dimer concentration showed non-normal distribution, the normal values (one-tailed) were established by using (P95) percentile method.The results of 8 patients were used to validate the established normal values.Results In the group of ＜30 years old, the D-dimer valuesM(P25-P75)]in group of ≤13 weeks, 14-20 weeks, 21-27 weeks, 28-34 weeks, ≥35 weeks and healthy non-pregnant women were 0.25(0.17-0.37), 0.51(0.38-0.75), 0.75(0.57-1.10), 1.14(0.80-1.48), 1.60(1.14-1.89) and 0.20(0.10-0.28) mg/L, respectively, which showed statistical difference(H=239.24, P＜0.05).In the group of ≥30 years old, the D-dimer values of the above different groups were 0.28(0.14-0.38), 0.50(0.36-0.65), 0.83(0.59-1.41), 0.93(0.68-1.37), 1.47(1.22-1.84) and 0.17(0.12-0.25) mg/L, respectively, which also showed statistical difference(H=127.75, P＜0.05).In the group of ＜30 years old, the D-dimer values were 2.45(1.51-3.77), 1.30(0.97-1.96), 2.68(1.52-3.74) and 1.55(1.10-2.10) on the first and second day after vaginal delivery and cesarean section, respectively, which showed statistical difference (H=64.85,P＜0.05).In the group of ≥30 years old, the corresponding values were 2.20(1.33-3.54), 1.33(1.02-2.14), 2.27(1.66-3.17) and 1.62(1.26-2.69), respectively, which also showed statistical difference(H=18.64, P＜0.05).D-dimer normal values were established based on different gestational week, postpartum days and delivery pattern.The normal values of ≤13 weeks, 14-20 weeks, 21-27 weeks, 28-34 weeks and ≥35 weeks were ≤0.64 mg/L, ≤1.54 mg/L, ≤2.60 mg/L, ≤3.01 mg/L and ≤3.19 mg/L, respectively. The normal values of 1st day after vaginal delivery, 2nd day after vaginal delivery,1st day after cesarean sections and 2nd day after cesarean sections were ≤7.83 mg/L, ≤3.29 mg/L, ≤9.95 mg/L and ≤3.80 mg/L.All 8 patients showed positive results with the above normal values.Conclusion D-dimer normal values in pregnant and postpartum women in Zhejiang Han population are established, which can improve the application values of D-dimer in the pregnant and postpartum population.