无锡地区孕早期产前筛查指标中位数的建立及临床意义  

Establishment of median value for screening serum-markers in first-trimester prenatal screening and investigation of its clinical significance in Wuxi

作　　者：石皓[1] 吴晓[1] 王峻峰[1] 肖建平[1] 杨灿峰[1] 赵丽[1] 杨岚[1] 

机构地区：[1]南京医科大学附属无锡妇幼保健院产前诊断中心,江苏无锡214002

出　　处：《中国现代医学杂志》2017年第11期112-116,共5页China Journal of Modern Medicine

基　　金：无锡市医管中心面上项目(No:YGZXM1510);无锡市科技发展基金项目(No:CSE31N1511);江苏省妇幼保健重点资助项目(No:F201315)

摘　　要：目的建立无锡地区孕早期筛查血清学指标游离β-人绒毛膜促性腺激素(freeβ-HCG),妊娠相关蛋白A(PAPP-A)在不同孕周的中位数值,探讨孕早期筛查指标中位数方程的本地化调整对筛查效率的影响。方法采用时间分辨免疫荧光(TRFIA)技术和Life Cycle 4.0软件对无锡地区5 294例孕9~13(^(+6))周单胎孕妇进行血清游离β-HCG、PAPP-A浓度测定并计算筛查风险,应用统计软件分析两项血清学指标的中位数,建立本地区孕妇各孕周的游离β-HCG、PAPP-A中位数的回归方程,再经体重校正得到新的中位数,对产筛数据重新作风险评估,结合产前诊断核型分析结果及随访的孕妇妊娠结局,比较中位数校正前后的筛查效果。结果与软件内嵌值比较,本地孕妇孕早期血清学指标经孕周及体重校准后的中位数值普遍偏高(游离β-HCG:P>0.05;PPAPP-A:P<0.05)。采用本地与内嵌软件两组中位数分别计算筛查风险,两者对21三体的检出率分别为85.7%和71.4%;假阳性率分别为4.59%和4.74%。结论中位数参数存在种族与地域差异,建立本地区孕早期人群产前筛查血清标志物中位数方程并进行体重校正非常重要,校正后的本地化中位数能提高产前筛查的筛查效率。Objective To establish the median equation of serum free β-human chorionic gonadotropin （free β-HCG）, pregnancy-associated plasma protein A （PAPP-A） in the first trimester in Wuxi, and to evaluate the influence of the local adjustment of the median equation on the screening efficiency. Methods A total of 5,294 gravidas [9 to 13 （＋6） gestational weeks] underwent a screening test of double serum markers including free β-HCG, PAPP-A by automatic time-resolved fluorescence immunoassay analyzer （TRFIA）. The risks of Downs syndrome, Edward syndrome were evaluated by Life Cycle 4.0 software. The median values of free β- hCG, PAPP-A were analyzed with statistical software, and the median regression equation of free β-hCG and PAPP-A in suited local pregnant women with different gestational weeks was established. Then the risks of the screening data were re-evaluated. Combined with prenatal diagnosis of chromosomal karyotype results and pregnancy outcomes and pregnant women followed up, the screening efficiency between the two median equa-tions was compared. Results Compared with gaucasian markers of built-in software, the median level for serum β-HCG and PAPP-A were higher on average respectively after revised gestations] age and weight （free β-HCG： P〉0.05, PPAPP-A： P〈 0.05）. The detection rates for trisomy 21 were 85.4% in local median equation and 71.4% in the software built-in one. The faulse positive rates for trisomy 21 were 4.59% in local median equation and 4.74%% in the software built-in one. Conclusions There are significant differences on the race and region when using the LifeCycle 4.0 median equations. It is very important to establish the local median equation based on revised gestation age and weight in the first trimester for prenatal serum screening test. Adjusted local median can help to improve the screening efficiency of prenatal screening.

关 键 词：产前筛查 孕早期 中位数 游离β-人绒毛膜促性腺激素 妊娠相关蛋白A 体重 

分 类 号：R714.53[医药卫生—妇产科学]