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目的通过较大样本的人群血清学筛查,建立各孕周AFP、F-β-HCG的中位数,并探讨高危人群范围。方法对8341例孕14-21+6周孕妇,采用时间分辨荧光免疫系统进行血清标志物检测,通过特殊软件进行风险计算,得出高危孕妇,并对其进行产前诊断。并利用非线性加权回归模型计算并建立各孕周的AFP、F-β-HCG的中位数。结果筛查出唐氏综合征高危485例,筛查阳性率5.81%(485/8341),确诊唐氏患儿8例,假阴性病例1例。建立的各孕周AFP、F-β-HCG的中位数与原始筛查软件内嵌参考值比铰均有显著性差异。经修正后的中位数重新分析,9例唐氏患儿全部检出。结论建立适合各地区人群的唐氏综合征血清学筛查AFP、F-β-HCG的中位数值,对提高了筛查效率很有必要。
Objective To establish the median of AFP and F-β-HCG in each gestational age through serological screening of large sample population and to explore the range of high-risk population. Methods Totally 8341 pregnant women with gestational age 14-21 + 6 weeks were enrolled in the study. Serum markers were detected by time-resolved fluorescence immune system. Risk was calculated by special software to obtain high-risk pregnant women, and their prenatal diagnosis was obtained. The median of AFP and F-β-HCG in each gestational week was calculated and established by using nonlinear weighted regression model. Results A total of 485 cases of Down syndrome were screened at high risk. The positive rate of screening was 5.81% (485/8341). There were 8 cases of Down’s syndrome diagnosed and 1 case of false-negative cases. Median AFP and F-β-HCG in each gestational week established were significantly different from the hinges embedded in the original screening software. The revised median re-analysis, 9 cases of Down’s children were all detected. Conclusion It is necessary to establish a median serum AFP and F-β-HCG serological screening for Down Syndrome in different regions of the population, which is necessary to improve the screening efficiency.