汕头市新生儿先天性甲状腺功能减低症TSH筛查切值的研究

目的探讨建立汕头地区诊断新生儿先天性甲状腺功能减低症(CH)促甲状腺素(TSH)切值的方法。方法时间分辨荧光法检测2013年1月至2015年12月汕头地区90 798例新生儿足跟血的TSH水平。百分位数法及ROC曲线确立TSH筛查切值。结果 90 798例新生儿TSH筛查频数呈现偏态分布,TSH平均水平为(2.38±2.12)mU/L;范围0.0~324.2mU/L;P_(90)为3.46mU/L;P_(95)为4.63mU/L;P_(99)为8.88 mU/L;汕头地区CH发病率为1/2 974;P_(99)百分位法TSH诊断切值8.88mU/L,ROC曲线法诊断切值8.49mU/L,召回率经χ~2检验分析,P_(99)百分位法与ROC曲线差异无统计学意义(χ~2=0.965,P=0.326),P_(99)百分位法与试剂盒差异有统计学意义(χ~2=10.861,P=0.001);ROC曲线与试剂盒差异有统计学意义(χ~2=5.450,P=0.020);P_(99)百分位法、ROC曲线法灵敏度均为100.0%,P_(99)百分位法Youden指数为0.969、特异度为96.9%,稍占优。结论 P_(99)百分位法确立的TSH筛查切值更适合临床新生儿疾病的筛查工作。

Study on the value of TSH screening for neonatal congenital hypothyroidism in Shantou

Objective To explore the method of establishing the value of TSH in the diagnosis of neonatal congenital hypothyroidism in Shantou area.Methods Time resolved fluorescence was conducted to detect the level of heel blood thyrotropin(TSH)in 90 798 neonatal from January 2013 to December 2015 in Shantou area.Percentile method and ROC curve were used to establish the value of TSH screening.Results The frequency of TSH screening in 90 798 cases of neonatal showed normal distribution.The average content of TSH was(2.38-t-2.12)mU/L,ranging 0.0-324.2 mU/L;P90 for 3.46 mU/L;P95 for 4.63 mU/L and P99 for 8.88 mU/L.CH incidence rate in Shantou was 1/2 974;the P99 percentile method TSH diagnostic cut-off value was 8.88 mU/L,and the ROC curve diagnostic cut-off value was 8.49 mU/L.Besides,the recall rate analyzed by chi square test showed no significant difference between the P99 percentile method and ROC curves (χa =0.965,P =0.326).While,a significant difference were found between P99 percentile method and kit(χ2 =10.861,P=0.001),ROC curve and kit(χ2 =5.450,P =0.020).The sensitivity of P99 percentile method and ROC curve method was 100.0 ％.The Youden index of P99 percentile method was 96.9 ％.Conclusion The P99 percentile method is more suitable for clinical neonatal diseases of TSH screening.