正常孕妇中期产前筛查指标中位数数据库的建立  

Establishment of median for the antepartum screening biomarkers in normal pregnant women

作　　者：唐少华[1] 毛义建[1] 潘胜勇[1] 谢丙乐[1] 杨雪梅[1] 沈旭娜 许向阳[2] 叶雪平[2] 

机构地区：[1]温州市产前诊断中心实验室温州市第二人民医院中心实验室,325000 [2]温州市产前诊断中心实验室温州市第二人民医院妇产科,325000

出　　处：《中华检验医学杂志》2009年第3期309-314,共6页Chinese Journal of Laboratory Medicine

基　　金：浙江省卫生厅资助项目（20028050）

摘　　要：目的评价我国常用的3种国外产前筛查风险计算软件内嵌AFP、游离β-人绒毛膜促性腺激素（free-B-HCG）指标中位数数据库的差异，选择合适的产前筛查指标中位数计算模型，建立温州地区正常孕妇群产前筛查AFP、free-β-HCG指标中位数数据库。方法应用时间分辨荧光检测技术检测20054名正常孕妇群AFP、free-β-HCG含量，应用双因素方差分析比较本组数据与目前常用2T-risk（2T）、Lifeeycle-2．2（LC2．2）和Lifeeycle-3．0（LC3．0）3种风险软件中数据的差异，分析本组数据与国内沈阳、宁波区域数据是否存在差异，应用模型校正拟合度、模型拟合对数分布均数和标准差等指标，评价3个软件中配给的非线性回归模型的稳定性，选择适合本组数据的回归模型，建立温州地区孕妇群筛查指标中位数数据库。结果本组数据AFP、free-β-HCG测定值比2T软件内嵌中位浓度分别高10％和16％；比LC-2．2分别高15％和20％；比LC-3．0分别高6％和17％，差异有统计学意义（FAFP=161．757，P〈0．01；0．8IHcG=58．261，P〈0．01）。本组温州地区数据AFP、free-β-HCG浓度比我国沈阳地区高2％和低3％、比宁波高1％和2％，温州、沈阳、宁波3个区域数据之间AFP指标差异无统计学意义（FAFP=0．174，P=0．840），free-β-HCG指标3个地区间差异有统计学意义（Ffree HCc：13．303，P〈0．01）。2T、LC-2．2、LC-3．0风险软件中用于中位值计算的二次方程回归模型、指数二次函数回归模型、指数四次函数回归模型差别不大，以指数四次函数回归模型为佳。结论我国温州、沈阳、宁波3个区域筛查指标的数据与国外2TC、LC-2．2、LC-3．03个版本软件内嵌数据均存在显著差异，人种的不同和回归模型参数不同是造成差异的原因，我国需建立自己的模型参数和中位数数据库。我国温州、沈阳、宁波3个区域之间大样本的数�Objective To evaluate the differences of α-fetoprotein（ AFP）, freeβ-human chorionic gonadotropin （HCG） indexes in 3 foreign median databases for antepartum risk screening, and establish the median databases of normal pregnant women in Wenzhou for antepartum screening of AFP, free-13-HCG indexes through the suitable median computational models. Methods The levels of AFP and free 13-HCG of 20054 normal pregnant women in Wenzhou were detected by time-resolved fluorometry. The data in this paper were compared with the data of 2T-risk （2T）, Lifecycle-2. 2 （ LC2. 2 ） and Lifecycle -3.0 （ LC3.0 ） by double-factor ANOVA. The differences between the data in the paper and the data from Shenyang and Ningbo were analyzed. The median database of Wenzhou pregnant women was established by the suitable regression model, with the stability of nonlinear regression models of the 3 software assessed by model correcting fitting, distribution mean of model fitting logarithmic and standard deviation. Results The levels of AFP and freeβ- hCG reported here were 10% and 16% higher than the data of 2T-risk, 15% and 20% higher than that of LC 2. 2, 6% and 17% higher than that of LC 3.0 respectively. The differences were statistically significant. （ FAFP = 161. 757, P 〈 0. 01 ; Ffree-β-HCC = 58. 261, P 〈 0. 01 ）. The levels of AFP and free 13- hCG in Wenzhou were 2% higher and 3% lower than that of Shenyang, 1% and 2% higher than that of Ningbo. There was no statistical difference of AFP levels among Wenzhou , Shenyang and Ningbo（ FAFP = 0. 174, P = 0. 840 ） while the differences of free-β-hCG were statistically significant （Ffree-β-HCG = 13. 303, P 〈 0. 01 ）. The differences of quadratic equation regression model, exponent quadratic function regression model and exponent quadru-function regression model of 2T, LC-2. 2 and LC-3.0 were not remarkable. The exponent quadru-function regression model was the best. Conclusions There are significant differences between the data from Wenzhou, Shenyang and

关 键 词：产前筛查 甲胎蛋白类 绒毛膜促性腺激素 β亚单位 人 参考值 

分 类 号：R686[医药卫生—骨科学]