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目的:建立潍坊地区正常孕妇产前筛查唐氏综合征血清学标志物甲胎蛋白(AFP)、游离人绒毛膜促性腺激素(F-β-hCG)的中位数据库。方法:应用时间分辨荧光检测技术,对13 827例15~20周的孕妇血清进行AFP、F-β-hCG含量的测定,排除各种异常病例,将剩余的13 399例正常孕妇进行统计学分析,2T-risk进行风险评估。结果:建立了潍坊地区正常孕妇15~20周产前筛查血清学标志物AFP、F-β-hCG的中位数据库,实验数据分别与软件内嵌值及温州地区相应数据比较:AFP中位浓度与软件内嵌相应数据比较差异无统计学意义(PAFP>0.05),与温州地区比较差异有统计学意义(PAFP<0.05);F-β-hCG中位浓度与软件内嵌数据比较差异有统计学意义(PhCG<0.05);与温州地区比较差异无统计学意义(PhCG>0.05)。利用本地区的中位数据库将13 399例孕妇重新进行风险评估,唐氏综合征检出率和假阴性率不变的前提下,潍坊地区的产前筛查的阳性率及假阳性率降低了。结论:各地区应尽快建立自己的中位数值数据库。
Objective: To establish a median database of prenatal screening of AFP and F-β-hCG in normal pregnant women in Weifang. Methods: The serum levels of AFP and F-β-hCG in 13 827 pregnant women aged 15 to 20 weeks were determined by time-resolved fluorescence detection. All kinds of abnormal cases were excluded. The remaining 13 399 normal pregnant women were analyzed statistically , 2T-risk for risk assessment. Results: A median database of antenatal screening serological markers AFP and F-β-hCG was established in normal pregnant women aged 15-20 weeks in Weifang. The experimental data were compared with the software embedded values and the corresponding data in Wenzhou: AFP median (PAFP> 0.05). There was significant difference between the concentration and software (PAFP <0.05). There was significant difference between F-β-hCG median concentration and software embedded data Statistical significance (PhCG <0.05); Compared with Wenzhou, there was no significant difference (PhCG> 0.05). With 13 399 pregnant women re-evaluated for risk using the median database in the region, the positive rate and false-positive rate of prenatal screening in Weifang decreased with the detection rate of Down’s syndrome and the false negative rate unchanged . Conclusion: All regions should set up their own median database as soon as possible.