摘要
目的建立厂家即将上市的新一代促甲状腺素3试剂以及本地区甲状腺相关激素现用试剂的正常参考区间,为甲状腺疾病的诊治提供可靠依据。方法对431名健康体检者进行三碘甲状腺原氨酸、甲状腺素、游离三碘甲状腺原氨酸、游离甲状腺素、促甲状腺素、甲状腺过氧化物酶抗体、甲状腺球蛋白抗体水平检测。比较不同年龄、不同性别、男性不同年龄、女性不同年龄、男性45岁前后、女性45岁前后甲状腺相关激素水平。应用彩色超声显示甲状腺功能正常的469例回顾性数据对本次获得的参考区间进行验证。结果本研究所建立的甲状腺激素水平参考区间较厂家提供的参考范围偏窄。不同年龄组间甲状腺素和游离甲状腺素差异有统计学意义(P<0.05);不同性别间甲状腺素和促甲状腺素差异有统计学意义(P<0.05);男性45岁前后比较游离三碘甲状腺原氨酸差异有统计学意义(P<0.05),女性45岁前后比较甲状腺素、游离三碘甲状腺原氨酸差异有统计学意义(P<0.05)。采用回顾性数据验证获得的参考区间时,游离三碘甲状腺原氨酸未能通过?必须重新制定适合的参考区间。结论厂商提供的参考区间相对宽泛,为获得高的诊断灵敏度,实验室有必要分年龄分性别制定特定人群的参考区间并适时调整。
Objective To establish a normal reference interval for the next-generation TSH3 reagents to be marketed by the manufacturer and the current thyroid-related hormones in the region, and provide a reliable basis for the diagnosis and treatment of thyroid diseases. Methods The levels of TT3,TT4,FT3, FT4, TSH, TPOAb and TgAb were measured in 431 healthy subjects. Thyroid-related hormone levels of different ages, genders, male ages, female ages, males before and after 45 years old, and women before and after 45 years old were compared. Retrospective data of 469 patients with normal thyroid function by color ultrasound were used to verify the reference interval obtained this time. Results The thyroid hormone level reference interval established by this study was narrower than the reference range provided by the manufacturer. There were significant differences in thyroxine and free thyroxine between different age groups (P<0. 05). There were significant differences in thyroxine and thyrotropin between different sexes (P<0. 05). There was significant difference in free triiodothyronine between males before and after 45 years of age (P<0. 05). There were significant differences in thyroxine and free triiodothyronine between women before and after 45 years of age (P<0. 05). When the reference interval obtained by retrospective data validation was used, free triiodothyronine failed to pass and a suitable reference interval had to be reworked. Conclusion The reference interval provided by the manufacturer is relatively broad. In order to obtain high diagnostic sensitivity, it is necessary for the laboratory to establish a reference interval for a specific population by age, gender and adjust it in time.
作者
贺淑巍
王瑞华
曾贞贞
韩星敏
He Shuwei;Wang Ruihua;Zeng Zhenzhen;Han Xingmin(First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,Henan,China)
出处
《临床心身疾病杂志》
CAS
2019年第1期125-128,共4页
Journal of Clinical Psychosomatic Diseases
关键词
甲状腺激素
参考区间
健康成人
试剂
Thyroid hormone
reference interval
healthy adults
reagents