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目的通过比较孕妇血清甲胎蛋白(AFP)、绒毛膜促性腺激素β亚单位(β-hCG)两联和AFP、β-hCG、游离雌三醇(uE3)三联两种筛查风险计算模型的检出率、假阳性率和Cut-Off值,探讨uE3在唐氏综合征(DS)产前筛查中的效果。方法收集上海4家保健机构提供的2001~2004年筛查数据,对孕14+~20+周的14642例孕妇的血清学指标和随访结果进行统计分析,应用统计学方法拟合年龄风险与各指标的似然比风险计算模型。分别应用两联筛查风险计算模型、uE3与年龄风险计算模型和三联筛查风险模型进行计算,在3%~8%假阳性率时比较各模型的检出率、阳性预测值和Cut-Off值。在85%检出率的基础上比较各模型的假阳性率、Cut-Off值和阴性预测值。结果①14642例孕妇随访确认为DS的有15例,发病率约1/1000;②比较DS组(1.0787ng/ml)和正常组(1.7125ng/ml)的血清uE3水平,两者存在统计学差异(t=2.96,P<0.01);③比较各模型预测风险检出效果,在5%假阳性率时年龄和uE3组合检出率为46.7%,两联筛查模型为60%,三联模型则为93.3%,两联和三联检出率比较差异有统计学意义(x2=4.658,P<0.05);④在85%的检出率时uE3和年龄因素模型的假阳性率为16.40%,两联模型为7.18%,三联模型则为4.9%,后二者假阳性率存在统计学差异(x2=66.79,P<0.01)。结论uE3在唐氏综合征多指标联合产前筛查中能提高筛查的检出率,减少假阳性率。
OBJECTIVE: To compare the risk factors of pregnant women with AFP, β-hCG, AFP, β-hCG and uE3 Detection rate, false positive rate and Cut-Off value, to investigate the effect of uE3 on Down’s syndrome (DS) prenatal screening. Methods The data of screening from 2001 to 2004 provided by four health institutions in Shanghai were collected and the serological parameters and follow-up results of 14 642 pregnant women with gestational 14 + to 20 + weeks were statistically analyzed. The statistical methods were used to fit the relationship between age risk and each Indicator Likelihood Ratio Risk Computation Model. The detection rates, the positive predictive value and the Cut-Off of each model were compared at the 3% -8% false positive rate by using the calculation model of dual-screen risk, uE3 and age-risk calculation model and triple-screen risk model respectively. value. On the basis of the detection rate of 85%, the false positive rate, Cut-Off value and negative predictive value of each model were compared. Results ①14642 pregnant women were followed up for 15 cases of DS, the incidence rate was about 1/1000. ②Comparison of serum uE3 levels in DS group (1.0787ng / ml) and normal group (1.7125ng / ml) (t = 2.96, P <0.01). ③The risk prediction results of each model were compared. At the 5% false positive rate, the detection rate of age and uE3 combination was 46.7%, and the two-way screening model was 60% (X2 = 4.658, P <0.05); ④ The false-positive rate of uE3 and age-related factors was 16.40% at the detection rate of 85% The combined model was 7.18%, while the triple model was 4.9%. The false positive rate of the latter two was statistically different (x2 = 66.79, P <0.01). Conclusion uE3 can improve the detection rate of screening and reduce the false positive rate in combined multi-index prenatal screening of Down’s syndrome.