A risk prediction model for fetal hypospadias by testing maternal serum AFP and free beta-HCG

A risk prediction model for fetal hypospadias by testing maternal serum AFP and free beta-HCG
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DOI:
10.1016/j.clinbiochem.2019.05.015
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发表时间:
2019-07-01
影响因子:
2.8
通讯作者:
Mei, Jin
Mei, Jin
中科院分区:
医学3区
文献类型:
--
作者:
Chen, Yiming;Huang, Jianxia;Mei, Jin

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目的:探讨妊娠中期孕妇血清甲胎蛋白(AFP)、游离人绒毛膜促性腺激素β亚基(游离β-HCG)与胎儿尿道下裂的相关性,并建立风险预测模型。方法:采用多中心病例对照研究。我们将胎儿分为两组(69 名患有胎儿尿道下裂的胎儿和 62 名未患有胎儿尿道下裂的胎儿)。采用时间分辨免疫荧光法测定血清 AFP 和游离 β-HCG 水平。根据受试者工作特征(ROC)曲线确定最佳切值和曲线下面积(AUC),评估AFP和游离β-HCG的诊断价值。结果:研究组AFP水平为中位数(MOM)的1.14倍,高于对照组(0.96 MOM);差异显着(Z = 2.831,P = .005)。同样,研究组的游离 β-HCG 水平为 1.30 MOM,也显着高于对照组(0.84 MOM;Z = 3.131,P = .004)。我们分别使用 AFP 和游离 β-HCG 水平来预测尿道下裂胎儿,AUC 分别为 0.644(95% 置信区间 (CI):0.5500.737,P = .005)和 0.659(95% CI:0.5650.752,P = .002)。根据ROC曲线,AFP和游离β-HCG的最佳截止值分别为0.945 MOM和1.275 MOM。将 AFP 水平与游离 β-HCG 水平结合,AUC 为 0.700(95% CI:0.610-0.789,P < .001),敏感性为 0.551,特异性为 0.855。 结论:妊娠中期早期母体血清 AFP 和游离 β-HCG 水平联合筛查胎儿尿道下裂具有较高的敏感性和特异性,可用作新标记。
Objective: We aimed to determine the correlation between serum alpha-fetoprotein (AFP), the free human chorionic gonadotropin beta subunit (free beta-HCG) in pregnant women during the mid-trimester, and fetal hypospadias, and tried to establish a risk prediction model.Methods: A multi-center case-control study was conducted. We divided the fetuses into two groups (69 with fetal hypospadias and 62 without fetal hypospadias). Time-resolved immunofluorescence was used to determine the serum levels of AFP and free beta-HCG. The best cut-value and area under curve (AUC) were determined based on the Receiver operating characteristics (ROC) curve, and the diagnostic value of AFP and free beta-HCG was evaluated.Results: The level of AFP in the study group was 1.14 multiple of Median(MOM), which was higher than in the control group (0.96 MOM); the difference was significant (Z = 2.831, P = .005). Similarly, the free beta-HCG level was 1.30 MOM in the study group, and was also significantly higher than in the control group (0.84 MOM; Z = 3.131, P = .004). We used the AFP and free beta-HCG levels separately to predict fetuses with hypospadias, and the AUCs were 0.644 (95% Confidence interval (CI): 0.5500.737, P = .005) and 0.659 (95% CI: 0.5650.752, P = .002), respectively. According to the ROC curve, the best cut-off values for AFP and free beta-HCG were 0.945 MOM and 1.275 MOM, respectively. When we combined the AFP level with the free beta-HCG level, the AUC was 0.700 (95% CI: 0.610-0.789, P < .001), with a sensitivity of 0.551 and a specificity of 0.855.Conclusion: Combined screening for fetal hypospadias with maternal serum AFP and free beta-HCG levels during the early second trimester has high sensitivity and specificity, which can be used as a new marker.