基于多因素非条件Logistic回归分析探讨无创产前检测技术筛查失败的影响因素

Exploration of factors for failure of non-invasive prenatal testing based on Logistic regression analysis

目的探讨无创产前检测(NIPT)技术筛查失败影响因素的多因素非条件Logistic回归分析。方法选取2019年7月至2020年6月就诊于大连市妇女儿童医疗中心的3410例孕妇为研究对象。采取回顾性分析方法,按照首次NIPT筛查结果,将其分为首次成功组(n=3350)与首次失败组(n=60)。采集2组孕妇年龄、体重、身体质量指数(BMI)、取样孕龄、妊娠类型(单胎/双胎)、是否经产、肝素治疗史、受孕方式[自然受孕/辅助生殖技术助孕(ART)]等临床资料。2组孕妇临床资料比较采用独立样本t检验和χ2检验,多因素非条件Logistic回归分析探讨影响NIPT筛查失败因素,运用ROC曲线分析评价诊断及预测效果。结果本研究共纳入3410例孕妇,首次成功组3350例,首次失败组60例,NIPT首次失败率为1.76%(60/3410)。2组孕妇在年龄、体重、BMI和受孕方式(自然受孕/ART)差异无统计学意义(P>0.05)。与首次成功组相比,首次失败组的取样孕龄、经产妇比例较低,双胎妊娠和肝素治疗比例较高(P<0.05)。多因素非条件Logistic回归分析显示,取样孕龄(OR=0.931,95%CI:0.845~1.026,P<0.001)和肝素使用史(OR=8.771,95%CI:2.708~28.409,P<0.001)是孕妇首次NIPT失败的独立影响因素。取样孕龄单因素非条件Logistic回归分析显示,NIPT筛查失败的回归方程为Logit(P)=-9.867+0.319×取样孕龄,ROC曲线下面积为0.742,约登指数为0.427,截断值为16.36周。结论取样孕龄和使用肝素治疗是NIPT首次筛查失败的独立影响因素。基于Logistic回归分析及ROC曲线评估取样孕龄对首次NIPT筛查失败的预测价值,建立回归方程,确定最佳取样孕龄为16.36周,可为NIPT筛查时机提供一定参考依据。

Objective To explore the factors for the failure of non-invasive prenatal testing(NIPT)through multifactorial unconditional Logistic regression analysis.Methods A total of 3410 pregnant women who had visited Dalian Women and Children Medical Group from July 2019 to June 2020 were selected as the study subjects and divided into first success NIPT group(n=3350)and first failed group(n=60).Clinical data including age,weight,body mass index(BMI),gestational week,type of pregnancy(singleton/twin),history of delivery,heparin treatment,and conception method[natural conception/assisted reproductive technology(ART)]were collected.Independent sample t-test and Chi-square test were carried out for comparing the two groups,and multi-factorial unconditional Logistic regression analysis was carried out to explore the factors for the failure of NIPT,and receiver operating characteristic curve(ROC)analysis was used to evaluate the diagnosis and predictive effects.Results Among the 3410 pregnant women,3350 were assigned to the first success NIPT group,and 60 were assigned to the first failed group,and the first-time failure rate was 1.76%(60/3410).No significant difference was found in age,weight,BMI and method of conception between the two groups(P>0.05).Compared with first success group,first failed group had lower sampling gestational weeks,lower proportion of women with previous history of delivery,and higher proportion of twin pregnancies and heparin treatment(P<0.05).Multi-factorial unconditional Logistic regression analysis indicated that sampling gestational week(OR=0.931,95%CI:0.845~1.026,P<0.001)and history of heparin use(OR=8.771,95%CI:2.708~28.409,P<0.001)are independent factors for first failed NIPT.One-way unconditional Logistic regression analysis for sampling gestational weeks indicated that the regression equation for NIPT screening failure was Logit(P)=-9.867+0.319×sampling gestational week,with the area under the ROC curve being 0.742,a Jordan index of 0.427,and a cutoff value of 16.36 weeks.Conclusion Gestational week and heparin treatment are independent factors for the first failed NIPT.A regression equation has been established and determined the optimal sampling gestational week to be 16.36 weeks,which may provide a reference for the timing of NIPT screening.