上海地区儿童甲状腺功能检测指标参考区间的建立

doi:10.3969/j.issn.1673-8640.2016.12.008

摘要/Abstract

摘要：

目的建立上海地区儿童甲状腺功能检测指标——促甲状腺激素（TSH）、游离三碘甲状腺原氨酸（FT₃）和游离甲状腺素（FT₄）的参考区间。方法选取2014年8月至2015年7月于上海地区9家医院就诊的4 d~17岁健康儿童720名,按年龄分为6组,每组120名。血液收集后离心,血清-20 ℃冷冻保存,使用贝克曼库尔特UniCel DxI 800免疫分析系统进行测定。依据美国临床实验室标准化协会（CLSI）C28-A3文件及国际临床化学和检验医学联合会（IFCC）的相关要求制定参考区间的合理方法和可靠依据,以非参数法确定TSH、FT₃和 FT₄的95%参考区间（百分位数范围为2.5%~97.5%,可信区间为90%）。结果各组按年龄段划分参考区间为：A组（4 d~<1个月）,TSH 0.53~18.91 μIU/mL,FT₃ 2.42~5.67 pmol/L,FT₄ 11.85~33.81 pmol/L;B组（1~<12个月）,TSH 0.75~5.75 μIU/mL,FT₃ 4.21~8.16 pmol/L,FT₄ 9.40~19.54 pmol/L;C组（1~<5岁）,TSH 0.63~6.20 μIU/mL,FT₃ 3.54~6.90 pmol/L,FT₄ 9.32~18.40 pmol/L;D组（5~<10岁）,TSH 0.58~5.39 μIU/mL,FT₃ 3.97~7.83 pmol/L,FT₄ 10.65~19.23 pmol/L;E组（10~<14岁）,TSH 0.39~5.36 μIU/mL,FT₃ 4.27~8.55 pmol/L,FT₄ 9.80~19.64 pmol/L。F组（14~17岁）,TSH 0.48~5.06 μIU/mL,FT₃ 3.14~6.15 pmol/L,FT₄ 9.57~18.27 pmol/L。A组新生儿与相邻的B组参考区间分布比较,差异有统计学意义（Z>3）;各组内不同性别间TSH、FT₃、FT₄水平比较,差异无统计学意义（P>0.05）。结论建立了上海地区4 d~17岁健康儿童按年龄分组TSH、FT₃和 FT₄的参考区间。利用以上参考区间能够解释儿童甲状腺功能的检测结果,有助于诊断、治疗和监测甲状腺功能减低症、甲状腺功能亢进症、甲状腺炎、甲状腺肿及甲状腺肿瘤等疾病。

关键词: 促甲状腺激素, 游离三碘甲状腺原氨酸, 游离甲状腺素, 参考区间, 儿童

Abstract:

Objective To establish the reference intervals of thyroid stimulating hormone（TSH）,free triiodothyronine（FT₃） and free thyroxine（FT₄） for children in Shanghai.Methods A total of 720 healthy children of 4 d to 17 years old from 9 hospitals in Shanghai were enrolled from August 2014 to July 2015. These children were classified into 6 groups according to ages and 120 cases were in each group. After centrifugation,serum specimens were frozen at -20 ℃. The levels of TSH,FT₃ and FT₄were determined by Beckman Coulter DxI 800 automated immunoassay system. The reference intervals of TSH,FT₃ and FT₄ were established according to the Clinical and Laboratory Standards Institute（CLSI） C28-A3 and the International Federation of Clinical Chemistry and Laboratory Medicine（IFCC） guidelines. Nonparametric methods were used to establish the 2.5th and 97.5th percentiles for reference intervals and 90% confidence interval. Results The ages of Group A-F were 4 d -<1 month,1-<12 months,1-<5 years,5-<10 years,10-<14 years and 14-17 years,respectively. The reference intervals of Group A were TSH 0.53-18.91 μIU/mL,FT₃ 2.42-5.67 pmol/L and FT₄ 11.85-33.81 pmol/L. The reference intervals of Group B were TSH 0.75-5.75 μIU/mL,FT₃ 4.21-8.16 pmol/L and FT₄ 9.40-19.54 pmol/L. The reference intervals of Group C were TSH 0.63-6.20 μIU/mL,FT₃ 3.54-6.90 pmol/L and FT₄ 9.32-18.40 pmol/L. The reference intervals of Group D were TSH 0.58-5.39 μIU/mL,FT₃ 3.97-7.83 pmol/L and FT₄ 10.65-19.23 pmol/L. The reference intervals of Group E were TSH 0.39-5.36 μIU/mL,FT₃ 4.27-8.55 pmol/L and FT₄ 9.80-19.64 pmol/L. The reference intervals of Group F were TSH 0.48-5.06 μIU/mL,FT₃ 3.14-6.15 pmol/L and FT₄ 9.57-18.27 pmol/L. There was statistical significance for reference interval distribution between Group A and B（Z>3）. The TSH,FT₃ and FT₄ reference intervals for sex in all age groups showed no statistical significance（P>0.05）. Conclusions The reference intervals of TSH,FT₃ and FT₄ are established for healthy children of 4 d to 17 years old in Shanghai. The reference intervals above can explain the results of thyroid function,which can improve the diagnosis,treatment and monitoring of hypothyroidism,hyperthyroidism,thyroiditis,goiter and thyroid neoplasm for children.

Key words: Thyroid stimulating hormone, Free triiodothyronine, Free thyroxine, Reference intervals, Children

中图分类号:

R446.62

李怀远, 蒋黎敏, 钱悦平, 傅启华, 李冬. 上海地区儿童甲状腺功能检测指标参考区间的建立[J]. 检验医学, 2016, 31(12): 1045-1049.

LI Huaiyuan, JIANG Limin, QIAN Yueping, FU Qihua, LI Dong. Establishment of the reference intervals of thyroid function for children in Shanghai[J]. Laboratory Medicine, 2016, 31(12): 1045-1049.

图/表 6

参考文献 11

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项目	低值血清			高值血清
项目	x	s	CV（%）	x	s	CV（%）
TSH （μIU/mL）	0.63	0.03	4.76	7.14	0.29	4.06
FT₄（pmol/L）	9.74	0.34	3.49	26.93	0.75	2.78
FT₃（pmol/L）	3.86	0.12	3.11	10.45	0.43	4.11

项目	低值血清			高值血清
项目	x	s	CV（%）	x	s	CV（%）
TSH （μIU/mL）	0.63	0.03	4.76	7.14	0.29	4.06
FT₄（pmol/L）	9.74	0.34	3.49	26.93	0.75	2.78
FT₃（pmol/L）	3.86	0.12	3.11	10.45	0.43	4.11

项目	低值血清			高值血清
项目	x	s	CV（%）	x	s	CV（%）
TSH （μIU/mL）	1.15	0.04	3.48	11.78	0.34	2.89
FT₄（pmol/L）	8.85	0.36	4.07	35.67	1.21	3.39
FT₃（pmol/L）	2.82	0.11	3.90	22.82	0.68	2.98

项目	低值血清			高值血清
项目	x	s	CV（%）	x	s	CV（%）
TSH （μIU/mL）	1.15	0.04	3.48	11.78	0.34	2.89
FT₄（pmol/L）	8.85	0.36	4.07	35.67	1.21	3.39
FT₃（pmol/L）	2.82	0.11	3.90	22.82	0.68	2.98

组别	年龄范围	例数	FT₃（pmol/L）			Z值
组别	年龄范围	例数	P₅₀	P_2.5	P_97.5	Z值
A组	4 d~<1月	120	4.36	2.42	5.67
B组	1~<12月	120	6.36	4.21	8.16	Z_A、B=19.96
C组	1~<5岁	120	5.38	3.54	6.90	Z_B、C=9.66
D组	5~<9岁	120	5.77	3.97	7.83	Z_C、D=3.74
E组	9~<14岁	120	6.19	4.27	8.55	Z_D、E=3.43
F组	14~17岁	120	4.86	3.14	6.15	Z_E、F=12.03