中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2009年
3期
309-314
,共6页
唐少华%毛义建%潘胜勇%谢丙乐%杨雪梅%沈旭娜%许向阳%叶雪平
唐少華%毛義建%潘勝勇%謝丙樂%楊雪梅%瀋旭娜%許嚮暘%葉雪平
당소화%모의건%반성용%사병악%양설매%침욱나%허향양%협설평
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
產前篩查%甲胎蛋白類%絨毛膜促性腺激素,β亞單位,人%參攷值
산전사사%갑태단백류%융모막촉성선격소,β아단위,인%삼고치
Prenatal screening%Alpha-Fetoprotein%Chorionic gonadotropin,beta-subunit,human%Reference values
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-β-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莲型,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20 054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)、Lifecycle-2.2(LC2.2)和Lifecycle-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莘异,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;Ffree-β-HCG=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-β-HCG=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、指数四次函数叫门模型差别不大,以指数四次函数回门模型为佳.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-3.0 3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小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据AFP指标差异无显著性,free-β-HCG指标稳定性较差,3个区域之间有些差异,温州、宁波数据较接近.提示我国小样本的实验室在相同实验条件情况下,可参考国内大样本数据建立自己实验室参数.3个软件内公认的回归计算模型稳定性差别不大,本组数据以指数四次函数回归模型为佳,可适用于同本组数据分布相似的我国其他筛查中心筛查指标中位数数据库的建立.
目的 評價我國常用的3種國外產前篩查風險計算軟件內嵌AFP、遊離β-人絨毛膜促性腺激素(free-β-HCG)指標中位數數據庫的差異,選擇閤適的產前篩查指標中位數計算模蓮型,建立溫州地區正常孕婦群產前篩查AFP、free-β-HCG指標中位數數據庫.方法 應用時間分辨熒光檢測技術檢測20 054名正常孕婦群AFP、free-β-HCG含量,應用雙因素方差分析比較本組數據與目前常用2T-risk(2T)、Lifecycle-2.2(LC2.2)和Lifecycle-3.0(LC3.0)3種風險軟件中數據的差異,分析本組數據與國內瀋暘、寧波區域數據是否存在莘異,應用模型校正擬閤度、模型擬閤對數分佈均數和標準差等指標,評價3箇軟件中配給的非線性迴歸模型的穩定性,選擇適閤本組數據的迴歸模型,建立溫州地區孕婦群篩查指標中位數數據庫.結果 本組數據AFP、free-β-HCG測定值比2T軟件內嵌中位濃度分彆高10%和16%;比LC-2.2分彆高15%和20%;比LC-3.0分彆高6%和17%,差異有統計學意義(FAFP=161.757,P<0.01;Ffree-β-HCG=58.261,P<0.01).本組溫州地區數據AFP、free-β-HCG濃度比我國瀋暘地區高2%和低3%、比寧波高1%和2%,溫州、瀋暘、寧波3箇區域數據之間AFP指標差異無統計學意義(FAFP=0.174,P=0.840),free-β-HCG指標3箇地區間差異有統計學意義(Ffree-β-HCG=13.303,P<0.01).2T、LC-2.2、LC-3.0風險軟件中用于中位值計算的二次方程迴歸模型、指數二次函數迴歸模型、指數四次函數叫門模型差彆不大,以指數四次函數迴門模型為佳.結論 我國溫州、瀋暘、寧波3箇區域篩查指標的數據與國外2TC、LC-2.2、LC-3.0 3箇版本軟件內嵌數據均存在顯著差異,人種的不同和迴歸模型參數小同是造成差異的原因,我國需建立自己的模型參數和中位數數據庫.我國溫州、瀋暘、寧波3箇區域之間大樣本的數據AFP指標差異無顯著性,free-β-HCG指標穩定性較差,3箇區域之間有些差異,溫州、寧波數據較接近.提示我國小樣本的實驗室在相同實驗條件情況下,可參攷國內大樣本數據建立自己實驗室參數.3箇軟件內公認的迴歸計算模型穩定性差彆不大,本組數據以指數四次函數迴歸模型為佳,可適用于同本組數據分佈相似的我國其他篩查中心篩查指標中位數數據庫的建立.
목적 평개아국상용적3충국외산전사사풍험계산연건내감AFP、유리β-인융모막촉성선격소(free-β-HCG)지표중위수수거고적차이,선택합괄적산전사사지표중위수계산모련형,건립온주지구정상잉부군산전사사AFP、free-β-HCG지표중위수수거고.방법 응용시간분변형광검측기술검측20 054명정상잉부군AFP、free-β-HCG함량,응용쌍인소방차분석비교본조수거여목전상용2T-risk(2T)、Lifecycle-2.2(LC2.2)화Lifecycle-3.0(LC3.0)3충풍험연건중수거적차이,분석본조수거여국내침양、저파구역수거시부존재신이,응용모형교정의합도、모형의합대수분포균수화표준차등지표,평개3개연건중배급적비선성회귀모형적은정성,선택괄합본조수거적회귀모형,건립온주지구잉부군사사지표중위수수거고.결과 본조수거AFP、free-β-HCG측정치비2T연건내감중위농도분별고10%화16%;비LC-2.2분별고15%화20%;비LC-3.0분별고6%화17%,차이유통계학의의(FAFP=161.757,P<0.01;Ffree-β-HCG=58.261,P<0.01).본조온주지구수거AFP、free-β-HCG농도비아국침양지구고2%화저3%、비저파고1%화2%,온주、침양、저파3개구역수거지간AFP지표차이무통계학의의(FAFP=0.174,P=0.840),free-β-HCG지표3개지구간차이유통계학의의(Ffree-β-HCG=13.303,P<0.01).2T、LC-2.2、LC-3.0풍험연건중용우중위치계산적이차방정회귀모형、지수이차함수회귀모형、지수사차함수규문모형차별불대,이지수사차함수회문모형위가.결론 아국온주、침양、저파3개구역사사지표적수거여국외2TC、LC-2.2、LC-3.0 3개판본연건내감수거균존재현저차이,인충적불동화회귀모형삼수소동시조성차이적원인,아국수건립자기적모형삼수화중위수수거고.아국온주、침양、저파3개구역지간대양본적수거AFP지표차이무현저성,free-β-HCG지표은정성교차,3개구역지간유사차이,온주、저파수거교접근.제시아국소양본적실험실재상동실험조건정황하,가삼고국내대양본수거건립자기실험실삼수.3개연건내공인적회귀계산모형은정성차별불대,본조수거이지수사차함수회귀모형위가,가괄용우동본조수거분포상사적아국기타사사중심사사지표중위수수거고적건립.
Objective To evaluate the differences of α-fetoprotein (AFP), ffeeβ-human chorionic gnnadotropin (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-β-HCG indexes through the suitable median computational models. Methods The levels of AFP and free β-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-HCG = 58. 261, P < 0.01 ). The levels of AFP and free β- 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( F<,free-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 Ningbo and the data of T-2 risk, LC-2. 2, LC -3.0. The discrepancy is due to the ethnic and different parameters of regression models. So the model parameters and the median databases are urgently required in China. The differences of large sample size of AFP from Wenzhow, Shengyang and Ningbo are not significant, while the differences of free-β- hCG from Wenzhow, Shengyang and Ningbo is remained because of its instability. The levels from Wenzhow and Ningbo are near. It is suggested that the laboratories with small sample size can establish their own laboratory parameters using the reference obtained from large sample size under the same experimental conditions. There are no significant differences of stability among regression computational models in the 3 software. The exponent quadru-function regression model can be used to establish the median databases for the screening with the similar data distribution in the paper.
