正常孕中期孕妇血清学产前筛查指标中位数数据库存的建立

Establishment of Median Database for the Antepartum Screening Biomarkers in Mid-pregnancy Period of Normal Pregnant Women

目的研究杭州地区3年正常孕中期孕妇血清标志物AFP和游离β-人绒毛膜促性腺激素(freeβ-HCG)的中位数,分析人种、区域性、实验室误差对中位数差异的影响,探讨中位数建立的标准化流程,实现质量控制下的数据库建立。方法应用时间分辨免疫荧光法测定83375份标本的浓度值,Lifecycle3.0软件计算3年的中位数,运用SSPS 17.0统计软件的Mann-whitney U检验方法两两比较3年中位数之间的差异。采用杭州地区的中位数和软件内嵌高加索人中位数计算筛查风险率进行人种差异比较。结果 AFP的中位数2008年与2009年两组比2010年的偏高2.8%,差异有统计学意义(P<0.01);2008年与2009年之间差异无统计学意义(P=0.841)。freeβ-HCG的中位数2009年与2010年两组比2008年偏低3.5%,差异有统计学意义(P<0.01);2009年与2010年之间差异无统计学意义(P=0.852)。杭州地区AFP、freeβ-HCG的中位数比软件内嵌高加索人中位数分别偏高5.5%和10.4%。结论杭州地区AFP和freeβ-HCG的中位数与软件内嵌高加索人种的中位数比较提示有人种差异。运用地区中位数计算筛查率比运用内嵌中位数可降低假阳性率。需要建立有一定的区域代表性的产前筛查指标的中位数数据库。

Objective To study the last three years＇ median for the serum biomarkers of alpha fetal protein （AFP） and free - β - human chorionic gonadotropin （HCG） in mid -pregnancy period of normal pregnant women in Hangzhou, analyze the effect of race, region and laboratory error on median, and discuss the standard of the establishment of median, in order to establish the data base met the quality control. Methods The levels of AFP and free β- HCG of 83375 normal pregnant women in mid - pregnancy period from 2008 to 2010 in Hangzhou were detected by time- resolved fluorometry, and the medians were calculated by Lifecycle3. O. Then the comparisons of the medians in these three years were performed by SPSS 17.0 using Mann - whitney U test. The racial difference was compared by the screening risk rate come from the data of Hangzhou and Lifecycle3.0 embedded Caucasian. Result The medians of AFP in 2008 and 2009 were 2.8% which was higher than 2010, with statistical significance （P 〈 0.01 ） , and there was no difference between 2008 and 2009 （P = 0. 841 ）. The medians of free -β - HCG in 2009 and 2010 were 3.5% which was lower than 2008, with statistical significance （P 〈0.01 ） , and there was no difference between 2009 and 2010（P =0. 852）. The median of AFP in Hangzhou were 5.5% which was higher than the data of Lifecycle3.0 embedded Caucasian, and the median of free - β - HCG was 10.4%. Conclusion The median of AFP and free - β - HCG in Hangzhou had racial difference from the embedded Caucasian. The median for screening biomarkers may have regional difference. It is important to establish a consistent and standard screening process. Calculating the median conventionally and periodically is an effective way to make the process better. It is suggested that establishment of median database for the antepartum screening biomarkers of regional representation in normal pregnant women is necessary.