佛山市妊娠期特异血清甲状腺指标参考值的建立及评价

Establishment and evaluation of trimester-specific reference intervals for thyroid tests during pregnancy in Foshan

目的建立广东省佛山市妊娠期特异血清甲状腺指标参考值范围,并对妊娠期甲状腺疾病患病率进行评价。方法回顾性分析2017年6月~2018年6月在佛山市产检孕妇的血清甲状腺指标,包括促甲状腺激素(TSH)、游离甲状腺素(FT4)、甲状腺过氧化物酶抗体(TPOAb)、甲状腺球蛋白抗体(TgAb)。根据美国临床生化研究院标准,筛选出样本量1386例,建立妊娠三期特异参考值范围。结果妊娠特异TSH和FT4参考值范围分别为0.03~3.86mU/L、11.81~21.86pmol/L(孕早期);0.13~4.50mU/L、11.75~20.99pmol/L(孕中期);0.38~4.73mU/L、10.84~18.48pmol/L(孕晚期)。采用上述妊娠期特异甲状腺指标参考值范围,计算甲减、亚临床甲减、甲亢、亚临床甲亢的患病率分别为0%、0.93%、0.93%、1.55%(孕早期);0%、1.29%、1.29%、3.23%(孕中期);0%、2.11%、0.55%、2.39%(孕晚期)。与试剂盒参考值范围比较,只有妊娠早期甲亢及三期亚临床甲亢患病率有统计学差异。结论佛山市妊娠期特异血清甲状腺指标参考值范围的建立,为本地区妊娠甲状腺疾病的诊断提供了临床依据。试剂盒的甲状腺指标参考值范围可用于佛山市临床甲减、亚临床甲减的诊断,但不适合应用于佛山市甲亢、亚临床甲亢的诊断。

Objective To establish the trimester-specific reference intervals of thyroid tests during pregnancy in Foshan, Guangdong, then to evaluate the prevalence of gestational thyroid diseases. Methods The medical records of pregnant women with took prenatal care in Foshan from Jun 2017 to Jun 2018 were retrospectively analyzed. The thyriod tests included TSH, FT4, TPOAb, TgAb. All pregnant women were screened according to the National Academy of Clinical Biochemistry (NACB) recommendations. A total of 1386 samples at different stages of gestation were selected for setting reference intervals, which were 2.5th-97.5th. Results The TSH and FT4 trimester-specific reference intervals were 0.03-3.86 mU/L, 11.81-21.86 pmol/L(1st trimester);0.13-4.50 mU/L, 11.75-20.99 pmol/L(2nd trimester);and 0.38-4.73 mU/L, 10.84-18.48 pmol/L(3rd trimester), respectively. The prevalence of clinical hypothyroidism, subclinical hypothyroidism, hyperthyroidism, subclinical hyperthyroidism were 0%, 0.93%, 0.93%, and 1.55%(1st trimester);0%, 1.29%, 1.29%, 3.23%(2nd trimester);0%, 2.11%, 0.55%, 2.39%(3rd trimester), respectively. There were significant differences between trimester-specific thyroid function reference intervals and the reference range of the kit on the prevalence of hyperthyroidism during 1st trimester and subclinical hyperthyroidism during 1st-3rd trimester. Conclusion The establishment of trimester-specific thyroid function reference intervals of Foshan city provides a clinical basis for the diagnosis of gestational thyroid diseases. The thyroid tests reference range of the kit can be used for the diagnosis of clinical hypothyroidism and subclinical hypothyroidism, while it is not suitable for the diagnosis of hyperthyroidism and subclinical hyperthyroidism in foshan city.