Li Qihang, Tang Yida, Yu Xuefeng, Qin Guijun, Tian Limin, Cheng Lianjiang, Lu Yi, Zhao Zhigang, Liu Libin, Zhang Kai, Wang Changjun, Zhang Shuqing, Xu Yong, Song Guangyao, Zhong Fang, Fan Xiude, Wang Zhixiang, Wu Yafei, Song Yongfeng, Zhao Jiajun
Department of Endocrinology, Shandong Provincial Hospital, Shandong University; Key Laboratory of Endocrine Glucose & Lipids Metabolism and Brain Aging, Ministry of Education; Department of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong First Medical University; Shandong Clinical Research Center of Diabetes and Metabolic Diseases; and Shandong Institute of Endocrine and Metabolic Diseases, Jinan, Shandong, China (Q.L., J.Z.).
Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Beijing, China (Y.T.).
Ann Intern Med. 2025 Jul;178(7):921-929. doi: 10.7326/ANNALS-24-01559. Epub 2025 May 6.
Current clinical practice uses a one-size-fits-all approach to define reference intervals for the results of diagnostic tests about thyroid function. This approach does not recognize subgroup differences according to age, sex, or race.
To identify age-, sex-, and race-specific reference intervals for the common diagnostic tests that measure thyroid function and to examine how these new reference intervals reclassify persons into disease categories when compared with current reference intervals.
Cross-sectional analysis.
Data from the U.S. NHANES (National Health and Nutrition Examination Survey) supplemented with data from a multicenter Chinese study.
A nationally representative sample from NHANES aged 20 years or older ( = 8308) supplemented with a Chinese database of routine health checkups from 49 hospitals in 10 provinces aged 18 years or older ( = 314 302).
The thyroid function reference interval was defined as the interval of diagnostic indicator levels from the 2.5th (lower limit) to the 97.5th (upper limit) percentile by age, sex, and race subgroups.
In 8308 NHANES participants, the 97.5th percentile levels of thyroid-stimulating hormone (TSH) increased with age, whereas total triiodothyronine (TT) levels declined with age and total thyroxine (TT) levels were stable across different ages. Women had higher TT levels, and White participants had higher TSH levels. Using current reference intervals, the prevalence of subclinical hypothyroidism increased from 2.4% for ages 20 to 29 years to 5.9% for ages 70 years and older. In contrast, using age-, sex-, and race-specific reference intervals reclassified 48.5% of persons with subclinical hypothyroidism as normal, especially women and White participants, and reclassified 31.2% of persons with subclinical hyperthyroidism as normal, especially women, Black participants, and Hispanic participants. When compared with the findings from U.S. participants, many of the findings from 314 302 Chinese participants were similar.
Cross-sectional data; sample size limitations for subgroup.
These findings should help establish more accurate reference intervals for thyroid diseases and facilitate development of a consensus about how to define and manage those diseases.
National Key Research and Development Program of China and National Natural Science Foundation.
目前临床实践采用一刀切的方法来定义甲状腺功能诊断测试结果的参考区间。这种方法没有认识到根据年龄、性别或种族的亚组差异。
确定测量甲状腺功能的常见诊断测试的年龄、性别和种族特异性参考区间,并研究与当前参考区间相比,这些新的参考区间如何将人群重新分类到疾病类别中。
横断面分析。
来自美国国家健康与营养检查调查(NHANES)的数据,并补充了一项中国多中心研究的数据。
来自NHANES的20岁及以上具有全国代表性的样本(n = 8308),并补充了来自中国10个省份49家医院的18岁及以上常规健康检查数据库(n = 314302)。
甲状腺功能参考区间被定义为按年龄、性别和种族亚组划分的诊断指标水平从第2.5百分位数(下限)到第97.5百分位数(上限)的区间。
在8308名NHANES参与者中,促甲状腺激素(TSH)的第97.5百分位数水平随年龄增加,而总三碘甲状腺原氨酸(TT3)水平随年龄下降,总甲状腺素(TT4)水平在不同年龄组中保持稳定。女性的TT4水平较高,白人参与者的TSH水平较高。使用当前参考区间,亚临床甲状腺功能减退的患病率从20至29岁年龄组的2.4%增加到70岁及以上年龄组的5.9%。相比之下,使用年龄、性别和种族特异性参考区间将48.5%的亚临床甲状腺功能减退患者重新分类为正常,尤其是女性和白人参与者,并将31.2%的亚临床甲状腺功能亢进患者重新分类为正常,尤其是女性、黑人参与者和西班牙裔参与者。与美国参与者的结果相比,314302名中国参与者的许多结果相似。
横断面数据;亚组样本量有限。
这些发现应有助于为甲状腺疾病建立更准确的参考区间,并促进就如何定义和管理这些疾病达成共识。
中国国家重点研发计划和国家自然科学基金。