惠州地区妊娠早中期甲状腺功能参考值的建立及与推荐值的比较  

Establishment of reference intervals of thyroid hormones for first and second trimester pregnant women in Huizhou and comparison with current guidelines

作　　者：李郭奕 潘文静 张娣 李墅怡 吴怡 张素娟 袁雪蓉 严伟玲 张育超 刘兆敏 LI Guo⁃yi;PAN Wen⁃jing;ZHANG Di;LI Shu⁃yi;WU Yi;ZHANG Su⁃juan;YUAN Xue⁃rong;YAN Wei⁃ling;ZHANG Yu⁃chao;LIU Zhao⁃min(Department of Nutrition,School of Public Health,Sun Yat⁃sen University,Guangzhou,Guangdong 510000;Huizhou First Maternal and Children′s Hospital,Huizhou,Guangdong 516000,China)

机构地区：[1]中山大学公共卫生学院营养系,广东广州510000 [2]惠州市第一妇幼保健院,广东惠州516000

出　　处：《热带医学杂志》2020年第5期615-619,共5页Journal of Tropical Medicine

基　　金：中山大学百人计划科研启动基金(51000-18841203)。

摘　　要：目的建立惠州地区妊娠早中期甲状腺功能的参考值范围,并与指南或试剂盒提供的参考值对比。方法根据美国临床生化研究院(NACB)的标准,于2019年1-10月期间在惠州市第一妇幼保健院纳入602例符合条件的妊娠妇女,建立惠州地区妊娠期特异的血清甲状腺指标参考值范围。分别采用本研究建立的、2017美国甲状腺协会(ATA)推荐、Roche试剂盒提供和2019中国指南推荐的参考值作为诊断标准,对同期3581名孕早中期单胎妊娠妇女进行亚临床甲状腺功能减退症(SCH)的筛查,比较不同标准诊断的SCH患病率差异,比较不同标准诊断的漏诊和误诊率。结果惠州地区游离甲状腺素(FT4)和促甲状腺激素(TSH)参考值范围为:妊娠早期FT4:12.59~23.05 pmol/L,TSH:0.01~3.76 mIU/L;妊娠中期FT4:12.01~20.04 pmol/L,TSH:0.02~4.11 mIU/L。本研究建立的标准诊断的SCH患病率与其他三个标准诊断的亚甲减患病率差异均有统计学意义(P<0.000);采用2017 ATA、Roche试剂盒和2019中国指南推荐的参考值在妊娠早期分别造成0.64%、1.14%和1.55%的孕妇被漏诊,妊娠中期分别造成0.36%的孕妇被误诊为SCH,0.65%和0.65%的孕妇被漏诊。结论2017 ATA、Roche试剂盒或2019年中国指南推荐的诊断标准会扩大惠州地区妊娠早中期妇女SCH的误诊率或漏诊率,应采用本地区特异的血清甲状腺激素参考值作为妊娠早中期妇女的参考值范围。Objective To establish the reference intervals of thyroid function in Huizhou for women during their first and second trimester pregnancy and compare the new reference with other diagnosis criteria.Methods 602 women who were conformed to the requirement of National Academy of Clinical Biochemistry(NACB)for determination of thyroid hormones were included to establish trimester⁃specific reference intervals of thyroid function in the Huizhou First Maternal and Children′s Hospital from January to October 2019.Subclinical hypothyroidism(SCH)prevalence as well as the over and mis⁃diagnosis rates were compared by different diagnosis criteria including new reference in Huizhou,2017 Guidelines of American Thyroid Association(ATA),2019 Guidelines of Chinese Society of Endocrinology and Perinatal Medicine(2019 CSEPM)and Roche reference of the reagent kits for thyroid hormones(Roche reference)among 3581 women of pregnancy.Results Our new established criteria in Huizhou indicated that,thyroid stimulating hormone(TSH)reference ranges were 0.01⁃3.76 mIU/L and 0.02⁃4.11 mIU/L,and the free thyroxine(FT4)reference ranges were 12.59⁃23.05 pmol/L and 12.01⁃20.04 pmol/L,for the first and second trimester,respectively.There was statistically significant difference in the prevalence rates of SCH in both the first and second trimester among the four criteria(P<0.000).With the new criteria in Huizhou as standard reference,the mis⁃diagnosis rates of SCH in the first trimester were 0.64%for 2017 ATA,1.14%for Roche reference and 1.55%for 2019 CSEPM,respectively.For the second trimester,about 0.36%pregnant women would be over diagnosed by 2017 ATA,and 0.65%by Roche reference and 0.65%by 2019 CSEPM would be mis⁃diagnosed.Conclusion The SCH diagnostic criteria recommended by the 2017 ATA,the Roche reference,or the 2019 CSEPM were not applicable in Huizhou district,which would significantly increase the over⁃diagnosis and mis⁃diagnosis rates of SCH.A district and population specific reference ranges for thyroid hormones wo

关 键 词：妊娠 SCH TSH FT4 

分 类 号：R714.256[医药卫生—妇产科学]