陕西省商洛地区孕早期妇女甲状腺功能参考范围的初步建立和应用研究

Preliminary Study on Thyroid Function Reference Ranges of Pregnant Women During Early Pregnancy in Shangluo

目的调查商洛地区健康妇女孕早期甲状腺功能各指标的水平,探究方法学特异性的参考范围,并对比该调查获得的参考范围和成人参考范围在检出孕早期甲状腺功能异常的差异。方法选取2018年7月~2019年3月在商洛市中心医院产科例行产检的386例健康的孕早期单胎孕妇作为实验组,另选取146例同期体检的非妊娠的健康女性作为对照组,采用国际推荐的电化学发光法测定受试者血清中TSH,FT4,FT3,TT3,TT4,TPOAb及TG水平。结果孕早期甲状腺功能各指标中位数及95%参考范围:TSH为1.90(0.05~4.09)u IU/ml,FT4为16.99(13.43~22.64)pmol/L,FT3为4.55(3.47~5.71)pmol/L,TT4为133.70(86.62~194.06)nmol/L,TT3为2.38(1.58~3.48)nmol/L,TPOAb为10.03(0~21.89)IU/ml, TG为8.37(0.32~28.09)ng/ml。与对照组相比,TSH, TT3, TT4, TPOAb及TG[2.35(0.86~4.16)u IU/ml, 1.81(1.31~2.40)nmol/L,104.75(76.33~142.64)nmol/L, 11.02(0~30.30)IU/ml和6.86(0.29~31.79)ng/ml]差异均有统计学意义(U=7 917.5~23 950,均P<0.05),FT4, FT3[4.50(3.38~5.61)pmol/L,17.20(13.37~22.21)pmol/L]差异无统计学意义(U=26 688~27 337.5,P>0.05)。使用本研究建立的参考范围和正常成人的参考范围,对458例孕早期产检的孕妇进行筛查,甲状腺功能异常检出率[n(%)]分别为:甲状腺功能亢进症9(1.97%)&14(3.06%),亚临床甲状腺功能亢进症3(0.66%)&15(3.28%),甲状腺功能减退症4(0.87%)&1(0.22%),亚临床甲状腺功能减退症40(8.73%)&44(9.61%),低甲状腺素血症13(2.84%)&3(0.66%)。结论商洛市健康女性孕早期甲状腺功能各指标参考范围不同于非妊娠女性,建立该地区孕早期特异性的参考范围具有重要的临床意义。

Objective To investigate the thyroid function level of healthy women in early pregnancy in Shangluo, explore the method-specific reference range, and compare the difference between the reference range obtained by the survey and the reference range of adults for detecting thyroid dysfunction in early pregnancy.Methods A total of 386 healthy pregnant women with single birth who underwent routine antenatal examination in obstetrics in Shangluo Central Hospital from July 2018 to March 2019 were selected as the experimental group.146 healthy non-pregnant women who underwent physical examinations at the same time were selected as the control group, and the levels of serum TSH,FT4, FT3,TT3, TT4, TPOAb and TG were measured by electrochemiluminescence,this method recommended by internationally. Results Median and 95% reference range of thyroid function in early pregnancy:TSH was 1.90(0.05~4.09) uIU/ml, FT4 was 16.99(13.43~22.64)pmol/L,FT3 was 4.55(3.47~5.71) pmol/L,TT4 was 133.70(86.62~194.06)nmol/L,TT3 was 2.38(1.58~3.48)nmol/L,TPOAb was 10.03(0~21.89)IU/ml, and TG was 8.37(0.32~28.09) ng/ml, respectively. Compared with the control group,TSH,TT3,TT4,TPOAb and TG [2.35(0.86~4.16)uIU/ml,1.81(1.31~2.40)nmol/L,104.75(76.33~142.64)nmol/L,11.02(0~30.30)IU/ml and 6.86(0.29~31.79)ng/ml], the difference was statistically significant(U=7 915.5~23 950, all P<0.05),while FT4 and FT3 were 4.50(3.38~5.61)pmol/L,17.20(13.37~22.21 pmol/L), the difference was not statisticall significant(26 688~27 337.5, all P>0.05).458 pregnant women undergoing prenatal examination in early pregnancy were diagnosed by using the reference range established in this study and the reference range of normal adults.The number of cases with abnormal thyroid function and the detection rate were as follows:hyperthyrea 9(1.97%) & 14(3.06%),subclinical hyperthyroidism 3(0.66%) & 15(3.28%),hypothyrea 4(0.87%) & 1(0.22%), subclinical hypothyroidism 40(8.73%) & 44(9.61%) and hypothyroxinemia 13(2.84%) & 3(0.66%).Conclusion The reference range of thyroid function indexes of healthy women in Shangluo City in early pregnancy was different from that of non-pregnant women.It is of great clinical significance to establish a specific reference range for early pregnancy in this region.