抚顺地区妇女妊娠期特异性甲状腺功能参考区间的建立与评价

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目的建立辽宁省抚顺地区妇女妊娠期特异性甲状腺功能检测指标的参考区间,比较与非妊娠妇女参考区间的差异,评估依据非妊娠人群参考区间造成的妊娠甲状腺疾病误诊、漏诊率,探讨妊娠期甲状腺疾病的正确诊断。方法选取662例妊娠期女性,按照美国临床生化研究院的标准(National Academy of Clinical Biochemistry,NACB)筛选出妊娠早期、中期、晚期妇女各120例,采用DXI 800全自动化学发光免疫分析系统及配套试剂测定TSH、FT3、FT4水平,经数据分析建立甲状腺功能参考区间,并比较其与非妊娠妇女参考区间的差异,计算662例妊娠期女性按非妊娠人群参考区间判定的误诊率。结果妊娠早期参考区间:TSH(0.08~5.21)m IU/L,FT3(2.51~4.67)pmol/L,FT4(7.17~15.24)pmol/L;妊娠中期TSH(0.46~3.64)m IU/L,FT3(2.18~4.13)pmol/L,FT4(6.20~10.71)pmol/L;妊娠晚期:TSH(0.32~4.33)m IU/L,FT3(2.05~3.36)pmol/L,FT4(6.25~12.20)pmol/L。使用非妊娠人群参考区间判定,妊娠早期将有13.2%TSH、6.6%FT3和3.9%FT4被误诊;妊娠中期误诊率分别为3.6%、10.6%和27.0%;妊娠晚期误诊率分别为4.2%、50.0%和22.0%。结论应用非妊娠正常人群的参考区间判定妊娠妇女甲状腺功能,将会导致部分妊娠妇女被误诊,采用各实验室的设备与方法建立应用本地区妇女妊娠期甲状腺功能特异性参考区间会降低妊娠妇女甲状腺功能异常的误诊率。 Objective To establish a reference interval for pregnancy-specific thyroid function test in women in Fushun, Liaoning Province, and to compare the difference with the reference interval of non-pregnant women to assess the misdiagnosis and misdiagnosis rate of pregnancy-induced thyroid disease caused by non-pregnant population reference interval Correct diagnosis of the disease. Methods A total of 662 pregnant women were enrolled in this study. 120 women in early, middle and late pregnancy were selected according to the National Academy of Clinical Biochemistry (NACB) standard. DXI 800 automated chemiluminescence immunoassay system and matched The levels of TSH, FT3 and FT4 were determined by data analysis. Thyroid function reference interval was established by data analysis. The difference of reference interval with non-pregnant women was also calculated. The misdiagnosis rate of 662 pregnant women in non-pregnant reference interval was calculated. Results The first trimester pregnancy reference interval was TSH (0.46 ~ 3.64) mIU / L, FT3 (2.51 ~ 4.67) pmol / L and FT4 FT3 (2.18 ~ 4.13) pmol / L and FT4 (6.20 ~ 10.71) pmol / L in the second trimester of pregnancy; TSH 0.32 ~ 4.33 mU / L, FT3 2.03 ~ 3.36 pmol / pmol / L. Using non-pregnant population reference interval determination, early pregnancy will have 13.2% TSH, 6.6% FT3 and 3.9% FT4 were misdiagnosed; mid-pregnancy misdiagnosis rates were 3.6%, 10.6% and 27.0%; late pregnancy misdiagnosis rates were 4.2% 50.0% and 22.0%. Conclusion The determination of thyroid function in pregnant women using the reference interval of non-pregnant normal population will lead to the misdiagnosis of some pregnant women. Using the laboratory equipment and methods to establish the thyroid function-specific reference interval during pregnancy in women in the region will reduce the thyroid Misdiagnosis rate of abnormal function.
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