无锡地区孕中期孕妇血清AFP、freeβ-HCG、uE3中位数标化及其应用

摘要

Objective To detect the median equation of maternal serum markers including free β-human chorionic gonadotrophin (free β-hCG),alpha-fetoprotein (AFP),and unconjugated estriol (uE3)in the second trimester of single-birth pregnant women in Wuxi and to establish the regional parameters for triple screening model based on revised gestation age and weight.We also evaluated the efficacy of this method in risk assessment of trisomy 21 syndrome (DS),trisomy 18 syndrome (ES)and neural tube defect (NTD).Methods The levels of AFP,free β-hCG and μE3 were detected in 8 783 single-birth pregnant women (15-20 +6 gestational weeks)in Wuxi.The median of serum AFP,free β-hCG and uE3 levels were analyzed by Life Cycle 4.0 software.And then we got the new median after adjusting the standard of gestational age and body mass.ES and NTD risk assessment was performed by using the standardized median,and the application efficien-cy of the median of the serum indexes before and after the standardization was compared by taking the results of the amniotic fluid karyotype analysis and the postnatal outcome as the standard.Results The median of free β-hCG in the second tri-mester of normal pregnant women in Wuxi was significantly higher as compared with the un-standardized median from Cau-casia women(all P <0.01).After revising gestational age and weight,the false positive rate (4.59%)for DS in standard-ized median equation was higher than that in the software built-in (3.97%).The screening efficiency for DS,ES and NTD in standardized median equation was improved as compared with that in the software built-in.Meanwhile,the total detection rate (10 /12)for DS,ES and NTD in standardized median equation was higher than that in the software built-in (8 /12). Compared with the values of mMoMin serum markers of the software built-in,the values of mMoMin the standardized ones were higher in AFP,but lower in free β-hCG and μE3 (all P <0.01).Conclusions The median of AFP,free β-HCG and uE3 based on standardized gestation age and weight is established,which is different from the LifeCycle 4.0 median. The standardized median equations may help to improve the screening efficiency.%目的：对无锡地区孕中期单胎孕妇血清甲胎蛋白（AFP）、游离β人绒毛膜促性腺激素（free β-HCG）、游离雌三醇（uE3）水平的中位数进行孕周、体质量标化，并分析其在21三体综合征（DS）、18三体综合征（ES）及神经管缺陷（NTD）风险评估中的应用效能。方法对无锡地区8783名孕中期（孕15～20＋6周）单胎孕妇进行血清AFP、free β-HCG、uE3检测。应用 Life Cycle4．0软件分析得到血清 AFP、free β-HCG、uE3水平的中位数，先后进行孕周、体质量标化调整，得到新的中位数。应用标化后的中位数进行 DS、ES 及 NTD 风险评估，以羊水核型分析结果和出生后结局为标准，比较标化前后血清学指标中位数的应用效能。结果无锡地区孕妇血清 free β-HCG 中位数较高，与未标化中位数（软件内置，来自高加索人群）相比，P 均＜0．01。标化中位数对 DS、ES 的筛查效率较未标化中位敉提高；运用标化中位数对 DS、ES、NTD 的总体检出率为10／12，高于未标化中位数的8／12。与未标化血清学指标中位数倍数值的中位数（mMoM）相比，标化血清 AFP 的 mMoM升高，free β-HCG、uE3的 mMoM降低（P 均＜0．01）。结论经过孕周、体质量标化调整后，建立了无锡地区孕妇血清 AFP、free β-HCG、uE3水平中位数，与Life Cycle4．0软件内置中位数存在差异。参考标化后的 AFP、free β-HCG、uE3水平中位数判定筛查结果，有助于提高筛查效率。