机构地区:[1]四川省妇幼保健院医学遗传与产前诊断科,成都610045
出 处:《中华医学遗传学杂志》2024年第12期1432-1440,共9页Chinese Journal of Medical Genetics
摘 要:目的回顾性分析孕中期血清学产前筛查的结果,探索假阳性率(FPR)的相关因素。方法以2013年1月至2022年12月四川省妇幼保健院检测的632825份孕中期血清学筛查样本中选择随访结局为假阳性的样本作为病例组,用倾向性评分匹配法(PSM)1:1匹配真阴性样本作为对照组。采用单因素及多因素Logistic回归模型分析FPR的影响因素。本研究已通过四川省妇幼保健院医学伦理委员会的审查(批准号:20240607-270)。结果PSM后病例组及对照组各匹配30598例。单因素分析显示采样季节、超声与末次月经孕周差、月度甲胎蛋白(AFP)中位数倍数的中位数(mMoM)、月度游离人绒毛膜促性腺激素(freeβ-hCG)的mMoM值在2组数据之间的差异有统计学意义(P<0.05)。多因素Logistic回归分析发现,冬季(OR=0.938;95%CI:0.893~0.985)、月度AFP mMoM≥1.11(OR=0.846;95%CI:0.761~0.941)、月度freeβ-hCG mMoM≤0.89(OR=0.827;95%CI:0.737~0.929)为FPR增加的保护因素,而春季(OR=1.124;95%CI:1.072~1.179)、夏季(OR=1.121;95%CI:1.062~1.183)、超声与末次月经孕周差为8~14天(OR=1.319;95%CI:1.241~1.402)、>14天(OR=1.689;95%CI:1.542~1.850)、月度AFP mMoM等于0.90~0.94(OR=1.088;95%CI:1.046~1.131)、月度freeβ-hCG mMoM等于1.05~1.10(OR=1.046;95%CI:1.000~1.094)、≥1.11(OR=1.062;95%CI:1.002~1.126)为FPR增加的风险因素。结论采样季节、超声与末次月经孕周差、生化标志物的月度mMoM值是血清学产前筛查FPR的相关因素,筛查实验室可通过这些因素寻找FPR异常的原因并进行相应的调整。ObjectiveTo retrospectively analyze the results of second-trimester serological prenatal screening and explore the factors which may influence the false-positive rate(FPR).MethodsFrom January 2013 to December 2022,false-positive samples with follow-up outcomes from 632,825 second-trimester serological prenatal screening samples tested at Sichuan Provincial Maternity and Child Health Care Hospital were selected as the study group,while true-negative samples were 1:1 matched as the control group by propensity-score matching(PSM).Univariate and Multivariate Logistic Regression Models were used to analyze the influencing factors.The study has approved by the Medical Ethics Committee of the Sichuan Provincial Maternity and Child Health Care Hospital(Ethic No.20240607-270).ResultsThe study and control groups were each matched with 305,998 cases.Univariate analysis showed that sampling season,the difference between ultrasound and gestational weeks calculated by last menstrual period(LMP),monthly median multiple of the median(mMoM)of alpha-fetoprotein(AFP),and monthly mMoM of freeβ-human chorionic gonadotropin(freeβ-hCG)were significantly different between the two groups(P<0.05).Multivariate Logistic Regression analysis showed that winter(OR=0.938;95%CI:0.893~0.985),monthly AFP mMoM≥1.11(OR=0.846;95%CI:0.761~0.941),monthly freeβ-hCG mMoM≤0.89(OR=0.827;95%CI:0.737~0.929)are protective factors for FPR increase,whilst spring(OR=1.124;95%CI:1.072~1.179),summer(OR=1.121;95%CI:1.062~1.183),the difference between ultrasound and gestational weeks calculated by LMP of 8~14 days(OR=1.319;95%CI:1.241~1.402),>14 days(OR=1.689;95%CI:1.542~1.850),monthly AFP mMoM of 0.90~0.94(OR=1.088;95%CI:1.046~1.131),and monthly freeβ-hCG mMoM of 1.05~1.10(OR=1.046;95%CI:1.000~1.094),≥1.11(OR=1.062;95%CI:1.002~1.126)are risk factors for FPR increase.ConclusionSampling season,difference between ultrasound and gestational weeks by LMP,monthly AFP mMoM,and monthly freeβ-hCG mMoM are risk factors for FPR during serological prenatal screening
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