59403例新生儿促甲状腺激素筛查结果分析与切值探讨

Analysis on screening results of thyroid stimulating hormone of 59,403 newborns and discussion of cut-off value

目的通过新生儿促甲状腺激素筛查结果的分析,明确莆田市新生儿先天性甲状腺功能减低症(CH)的发病情况并建立筛查切值,避免出现漏诊和资源浪费的情况,以此来提高筛查效率。方法选择2020年7月—2023年9月莆田市出生的新生儿为研究对象,采用时间分辨荧光免疫法检测新生儿滤纸干血斑中的促甲状腺激素(TSH)浓度。按照季节分组,分别运用百分位数法和ROC曲线法进行数据分析,以确定最佳的筛查切值。结果确诊患儿73例,其中CH37例、高TSH血症36例,CH发病率为1︰1605,高TSH血症发病率1︰1650。春冬季TSH的P99浓度值为11.95μU/ml,ROC曲线法得出其最优切值为9.37μU/ml;夏秋季TSH的P99浓度值为10.51μU/ml,ROC曲线法得出其最优切值为10.09μU/ml。结论莆田市地区2020—2023年CH发病率为1︰1605,高于国内平均发病率;TSH的浓度会随季节和温度而变化,春冬两季使用切值9.37μU/ml,而夏秋两季则使用切值10.09μU/ml,更适合莆田地区新生儿人群,TSH筛查的特异度和敏感度最高。

Objective To analyze the screening results of thyroid-stimulating hormone from newborns,to clarify the incidence of congenital hypothyroidism(CH)in newborns in Putian City and establish screening cut-off values,avoid missed diagnosis and waste of resources,so as to improve the screening efficiency.Methods Neonates born from July 2020 to September 2023 in Putian City were enrolled as study subjects.Thyroid-stimulating hormone(TSH)concentration in dried blood spots of newborns'filter paper was detected by time-resolved fluorescence immunoassay.The test data were grouped according to season and statistically analyzed using the percentile and ROC curve methods,respectively,to determine the optimal screening cut-off value.Results Seventy-three children were diagnosed,including 37 cases of CH and 36 cases of high TSH blood syndrome,with an incidence of CH of 1:1605 and an incidence of high TSH blood syndrome of 1:1650.The P99 concentration of TSH in spring and winter was 11.95μU/ml,and the optimal cut-off value was 9.37μU/ml by the ROC curve method.The P99 concentration of TSH in summer and autumn was 10.51μU/ml,and the optimal cut-off value was 10.09μU/ml by the ROC curve method.Conclusions The incidence of CH in Putian City during 2020-2023 is 1:1605,which is higher than the national average.The concentration of TSH varies with seasons and temperatures,using a cut-off value of 9.37μU/mL in spring and winter,and a cut-off value of 10.09μU/mL in summer and autumn,which is more suitable for the neonatal population in Putian area,and TSH screening has the highest specificity and sensitivity.