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孕中期母体血清三联筛查标志物异常对不良妊娠结局的预测价值

[Predictive value of abnormal second-trimester maternal serum triple screening markers for adverse pregnancy outcomes].

作者信息

Hu Zhuming, Liu Xiangyin, Li Linlin, Jia Chunshu, Li Dejun, Liu Ruizhi

机构信息

Reproductive Medicine Center, First Hospital of Jilin University, Changchun 130021, China.

Reproductive Medicine Center, First Hospital of Jilin University, Changchun 130021, China. Email:

出版信息

Zhonghua Fu Chan Ke Za Zhi. 2014 Oct;49(10):749-53.

PMID:25537246
Abstract

OBJECTIVE

To investigate the predictive value of abnormal multiples of the median (MoM) of second trimester maternal serum triple screening (STMSTS) markers for adverse pregnancy outcomes.

METHODS

16 000 singleton pregnancies at 15⁺⁰ to 20⁺⁵ weeks' gestation who underwent STMSTS between July 2010 and January 2013 in the First Hospital of Jilin University were recruited. Maternal serum AFP, free β-hCG (F-β-hCG) and unconjugated estriol (uE3) levels were measured using time- resolved fluoroimmunoassay, and then converted to MoM. LifeCycle 3.2 software was used to calculate risk, and a risk value greater than 1 in 270 or 1 in 350 was considered as high risk for trisomy 21 syndrome (Down syndrome, DS) and trisomy 18 syndrome (Edwards syndrome, ES), respectively. MoM of AFP more than 2.5 was considered high risk for open neural tube defect (ONTD). Amniocentesis and karyotyping, ultrasound screening were advised for high risk women. AFP, F-β-hCG higher than 2.0 MoM or uE3 lower than 0.5 MoM was considered as abnormal, respectively. The MoM of STMSTS marker between women with adverse pregnancy outcome and with normal outcome was compared.

RESULTS

(1) The median MoM of AFP, F-β-hCG and uE3 was 0.91 MoM, 0.94 MoM and 1.05 MoM, respectively. Of the 16 000 pregnant women, there was no statistical difference in the median MoM of triple screening marker at different weeks of gestation (P > 0.05). The positive rate of DS, ES and ONTD in women ≤35 years old (n = 14 972) was 4.03% (603/14 972), 0.36% (54/14 972) and 0.29% (44/14 972) respectively. And in women>35 years old (n = 1 028), the positive rate was 24.51% (252/1 028), 1.95% (20/1 028) and 0.78% (8/1 028), respectively. There was a statistically significant difference of positive rate between the two groups (P < 0.05). (2) 9 cases of DS, 1 case of ES and 1 case of ONTD were found in the high risk group, and 2 cases of DS in the low risk group. The detection rate of DS, ES and ONTD was 9/11, 1/1 and 1/1 respectively; and the positive predictive value was 1.05% (9/855), 1.35% (1/74) and 1.92% (1/52), respectively. (3)The incidence of adverse outcome (group 1) was 1.49 % ( 239/16 000). 7 760 pregnant women in this study were healthy during pregnancy, so were their fetuses (group 2). There were significant differences in the age at delivery, body weight and markers' MoM of STMSTS between the two groups (P < 0.01). (4) In group 1, the rate of abnormal MoM of AFP or F-β-hCG was 7.95% (19/239) and 23.85% (57/239), and the abnormal rate of MoM of uE3 was 4.18% (10/239). The rate of two abnormal MoM of markers was 5.02% (12/239); the rate that all three MoM were abnormal was 0.84% (2/239). However, in group 2, the rate of two abnormal MoM of markers was 0.14 % ( 11/7 760); and the rate that all three MoM were abnormal was 0. There was a significant difference of abnormal MoM of maternal serum marker between the two groups (P < 0.01).

CONCLUSIONS

There is a relationship between abnormal marker of STMSTS and adverse outcomes. STMSTS show a high value in the detection of DS, ES and ONTD.

摘要

目的

探讨孕中期母血清三联筛查(STMSTS)指标的中位数倍数(MoM)异常对不良妊娠结局的预测价值。

方法

选取2010年7月至2013年1月在吉林大学第一医院接受STMSTS检查的16000例单胎妊娠孕妇,孕周为15⁺⁰至20⁺⁵周。采用时间分辨荧光免疫分析法测定母血清甲胎蛋白(AFP)、游离β-人绒毛膜促性腺激素(F-β-hCG)和未结合雌三醇(uE3)水平,然后换算为MoM。使用LifeCycle 3.2软件计算风险,风险值大于1/270或1/350分别被视为21三体综合征(唐氏综合征,DS)和18三体综合征(爱德华兹综合征,ES)的高风险。AFP的MoM大于2.5被视为开放性神经管缺陷(ONTD)的高风险。建议高风险孕妇进行羊水穿刺和染色体核型分析以及超声筛查。AFP、F-β-hCG高于2.0 MoM或uE3低于0.5 MoM分别被视为异常。比较不良妊娠结局孕妇和正常结局孕妇的STMSTS指标MoM。

结果

(1)AFP、F-β-hCG和uE3的MoM中位数分别为0.91 MoM、0.94 MoM和1.05 MoM。在16000例孕妇中,不同孕周三联筛查指标的MoM中位数差异无统计学意义(P>0.05)。年龄≤35岁的孕妇(n = 14972)中,DS、ES和ONTD的阳性率分别为4.03%(603/14972)、0.36%(54/14972)和0.29%(44/14972)。年龄>35岁的孕妇(n = 1028)中,阳性率分别为24.51%(252/1028)、1.95%(20/1028)和0.78%(8/1028)。两组阳性率差异有统计学意义(P<0.05)。(2)高风险组发现9例DS、1例ES和1例ONTD,低风险组发现2例DS。DS、ES和ONTD的检出率分别为9/11、1/1和1/1;阳性预测值分别为1.05%(9/855)、1.35%(1/74)和1.92%(1/52)。(3)不良结局发生率(第1组)为1.49%(239/16000)。本研究中有7760例孕妇孕期及胎儿均健康(第2组)。两组间分娩年龄、体重和STMSTS指标的MoM差异有统计学意义(P<0.01)。(4)第1组中,AFP或F-β-hCG的MoM异常率分别为7.95%(19/239)和23.85%(57/239),uE3的MoM异常率为4.18%(10/239)。两项指标MoM异常率为5.02%(12/239);三项MoM均异常率为0.84%(2/239)。然而,第2组中两项指标MoM异常率为0.14%(11/7760);三项MoM均异常率为0。两组孕妇母血清标志物MoM异常差异有统计学意义(P<0.01)。

结论

STMSTS指标异常与不良结局之间存在关联。STMSTS在DS、ES和ONTD的检测中具有较高价值。

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