兰州地区孕期特异性甲状腺功能参考值范围的序贯方法研究

Sequential method studyon reference range of specific thyroid function during pregnancy

目的探索建立兰州地区不同孕期妇女甲状腺功能的参考值范围。方法采用前瞻性研究方法,对2018年6月至2019年11月在甘肃省妇幼保健院进行常规孕期检查的单胎妊娠妇女进行尿碘检测、甲状腺功能检测、问卷调查及妊娠结局追踪,最终确立416例作为研究对象。采用电化学免疫分析法检测研究对象在孕早、中、晚三期的甲状腺功能指标:血清促甲状腺激素(TSH)、游离甲状腺素(FT4),参考值范围采用中位数(M)和百分位数(P2.5~P97.5)表示。根据新建立的甲状腺功能参考值范围,对比2011版、2017版美国甲状腺协会(ATA)指南推荐的参考值范围,并使用新建立的甲状腺功能参考值范围对该地区1779例孕妇的甲状腺功能进行评估。结果孕早、中、晚期妇女甲状腺功能参考值范围:TSH分别为2.27(0.41~4.28)mIU/L、2.63(0.99~4.50)mIU/L、3.16(1.52~4.91)mIU/L;FT4分别为14.56(9.90~18.60)pmol/L、13.80(9.41~17.90)pmol/L、12.69(9.20~16.60)pmol/L。血清TSH值随孕期增加而上升,不同孕期血清TSH值比较差异有统计学意义(F=88.590,P<0.05);血清FT4值随孕期增加而下降,不同孕期血清FT4值比较差异有统计学意义(F=111.430,P<0.05)。根据新建立的甲状腺功能参考值范围对孕妇甲状腺功能评估显示,孕妇亚临床甲状腺功能减低、甲状腺功能减低的检出率分别为6.91%、1.24%,低于ATA指南推荐参考值范围的检出率(χ^2值分别为687.362,8.092,均P<0.05)。结论初步建立了该地区不同孕期妇女特异性甲状腺功能指标的参考值范围,与ATA指南提供的甲状腺功能参考值范围存在差异。今后还需进一步研究验证新参考值范围的可信度。

Objective To establish the reference value range of thyroid function for women in different periods of pregnancy in this region.Methods In this prospective study,urine iodine test,thyroid function test,questionnaire survey and pregnancy outcome tracking were performed on single pregnant women who underwent routine pregnancy examination in Gansu Provincial Maternity and Child-care Health Hospital from June 2018 to November 2019,and 416 cases were finally identified as study subjects.The electrochemical immunoassay method was used to detect the thyroid function indicators of the study objects in the early,middle and late trimester:serum thyroid stimulating hormone(TSH)and free thyroxine(FT4),reference ranges were expressed by median(M)and percentage(P2.5~P97.5).The newly established reference range was compared with the reference range recommended by the version 2011 and the version 2017 of American Thyroid Association(ATA)guidelines and use the newly established thyroid function reference value range to evaluate the thyroid function of 1779 pregnant women in the region.Results The range of reference values for thyroid function in early,middle and late pregnancy were shown as below.TSH was 2.27(0.41~4.28)mIU/L,2.63(0.99~4.50)mIU/L and 3.16(1.52~4.91)mIU/L,respectively.FT4 was 14.56(9.90~18.60)pmol/L,13.80(9.41~17.90)pmol/L and 12.69(9.20~16.60)pmol/L,respectively.The serum TSH value increased with the increase of pregnancy,and the difference between different pregnancy periods was statistically significant(F=88.590,P<0.05).The serum FT4 value decreased with the increase of pregnancy,and the difference between different pregnancy periods was statistically significant(F=111.430,P<0.05).Assessment of thyroid function in pregnant women using newly established reference ranges showed that the detection rates of subclinical hypothyroidism and hypothyroidism in pregnant women were 6.91%and 1.24%,respectively,which were lower than the detection rates by the ATA guidelines recommended reference range(χ~2=687.362 and 8.092,respectively,both P<0.05).Conclusion The reference ranges of specific thyroid function indicators for women during different pregnancies in this region were preliminarily established,which was different from the reference range provided by ATA guidelines.Further studies are needed to verify the credibility of the new reference range.