妊娠期甲状腺功能指标参考区间的建立

doi:10.3969/j.issn.1673-8640.2016.08.004

摘要/Abstract

摘要：

目的建立广东省人民医院孕早期和孕中期甲状腺功能指标参考区间。方法参照美国国家临床生化学院（NACB）指南排除标准并结合广东省人民医院产科临床筛选出279名正常单胎孕妇（孕早期147 名和孕中期132名）,用化学发光免疫法测定血清游离三碘甲状腺原氨酸（FT₃）、游离甲状腺素（FT₄）和促甲状腺激素（TSH）,对其结果进行统计分析,建立相应的参考区间,并按中华人民共和国卫生行业标准WS/T402进行验证。结果以中位数（M）及双侧限值（P_2.5和P_97.5）表示参考区间：（1）FT₃：3.48~5.20 pmol/L（孕早期）、3.26~5.46 pmol/L（孕中期）;（2）FT₄：8.05~14.86 pmol/L（孕早期）、7.09~12.12 pmol/L（孕中期）;（3）TSH：0.10~2.98 mIU/L（孕早期）、0.05~2.48 mIU/L（孕中期）,均验证通过。除FT₄孕早期外,各孕期的FT₃、FT₄和TSH检测结果与非妊娠对照组的结果相比差异均有统计学意义（P<0.05）。结论各实验室需要建立本实验室妊娠期甲状腺功能指标参考区间,才能准确评估和判断妊娠期妇女的甲状腺功能状态。

关键词: 甲状腺激素, 妊娠, 参考区间

Abstract:

Objective To establish the reference ranges of thyroid function determination for pregnant women during the 1st and 2nd trimesters in Guangdong General Hospital. Methods A total of 279 pregnant women with singleton pregnancy,including 147 women during the 1st trimester pregnancy and 132 women during the 2nd trimester pregnancy,were screened according to the National Academy of Clinical Biochemistry （NACB） recommendations and clinical criteria. The levels of free triiodothyronine（FT₃）,free thyroxine（FT₄） and thyroid stimulating hormone（TSH） were determined by chemiluminescence immunoassay. The trimester-specific reference ranges were established,according to the national health industry standard WS/T402 . Results The reference ranges of FT₃ calculated by median（M） and two-sided limits（P_2.5 and P_97.5） were 3.48-5.20 pmol/L at the 1st trimester and 3.26-5.46 pmol/L at the 2nd trimester,the reference ranges of FT₄ were 8.05-14.86 pmol/L and 7.09-12.12 pmol/L,and the reference ranges of TSH were 0.10-2.98 mIU/L and 0.05-2.48 mIU/L,respectively. The validation of these reference ranges was passed. Compared with non-pregnant control women,FT₃,FT₄ and TSH of pregnant women during the 1st and 2nd trimesters had statistical significance,except FT₄ during the 1st trimester（P<0.05）. Conclusions For the judgement and diagnosis for pregnant women's thyroid function,it is necessary for hospitals to establish the reference ranges for thyroid function determination.

Key words: Thyroid hormone, Pregnancy, Reference range

中图分类号:

R446.1

梁敏文, 郑有为, 陈任燊, 李靖华, 李正康. 妊娠期甲状腺功能指标参考区间的建立[J]. 检验医学, 2016, 31(8): 652-655.

LIANG Minwen, ZHENG Youwei, CHEN Renshen, LI Jinghua, LI Zhengkang. Establishment of the reference ranges of thyroid function determination for pregnant women[J]. Laboratory Medicine, 2016, 31(8): 652-655.

图/表 4

参考文献 15

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组别	例数	FT3 （pmol/L）	FT4 （pmol/L）	TSH （mIU/L）
对照组	159	4.63±0.43	11.52±1.29	1.87±0.88
孕早期	147	4.28±0.44^*	11.18±1.65	1.15±0.72^*
孕中期	132	4.19±0.53^*	9.34±1.26^*	1.28±0.63^*

组别	例数	FT3 （pmol/L）	FT4 （pmol/L）	TSH （mIU/L）
对照组	159	4.63±0.43	11.52±1.29	1.87±0.88
孕早期	147	4.28±0.44^*	11.18±1.65	1.15±0.72^*
孕中期	132	4.19±0.53^*	9.34±1.26^*	1.28±0.63^*

编号	孕早期			孕中期
编号	FT₃	FT₄	TSH	FT₃	FT₄	TSH
1	4.80	11.85	0.625	4.46	9.76	1.798
2	3.81	10.95	0.821	4.23	9.06	1.451
3	4.53	10.57	1.396	4.76	10.23	1.650
4	4.49	12.37	1.004	3.54	9.32	1.760
5	4.24	10.38	2.163	3.84	9.59	1.536
6	4.39	12.43	1.391	3.99	9.65	0.857
7	5.18	11.81	0.330	4.39	9.40	2.719^*
8	4.48	9.55	0.620	4.34	9.58	2.410
9	4.02	10.76	1.366	4.79	8.95	0.770
10	4.04	10.95	1.768	3.87	10.89	1.240
11	4.77	10.34	0.901	4.61	9.37	0.707
12	4.51	11.61	0.131	3.98	10.64	2.501^*
13	4.29	9.98	0.576	3.87	10.86	1.660
14	4.03	9.84	0.734	3.47	9.82	0.630
15	4.36	8.64	2.037	3.86	9.44	0.853
16	3.90	10.05	0.656	4.54	9.77	2.120
17	4.27	9.99	0.820	4.52	7.55	1.660
18	4.35	9.76	1.377	3.82	7.56	2.390
19	4.64	8.98	0.523	3.64	7.68	1.549
20	3.85	8.15	0.218	4.22	9.29	0.469
R	1.37	4.28	2.030	1.32	3.34	2.250
D_大/R	0.277	0.014	0.062	0.023	0.009	0.097
D_小/R	0.029	0.114	0.043	0.053	0.003	0.072

编号	孕早期			孕中期
编号	FT₃	FT₄	TSH	FT₃	FT₄	TSH
1	4.80	11.85	0.625	4.46	9.76	1.798
2	3.81	10.95	0.821	4.23	9.06	1.451
3	4.53	10.57	1.396	4.76	10.23	1.650
4	4.49	12.37	1.004	3.54	9.32	1.760
5	4.24	10.38	2.163	3.84	9.59	1.536
6	4.39	12.43	1.391	3.99	9.65	0.857
7	5.18	11.81	0.330	4.39	9.40	2.719^*
8	4.48	9.55	0.620	4.34	9.58	2.410
9	4.02	10.76	1.366	4.79	8.95	0.770
10	4.04	10.95	1.768	3.87	10.89	1.240
11	4.77	10.34	0.901	4.61	9.37	0.707
12	4.51	11.61	0.131	3.98	10.64	2.501^*
13	4.29	9.98	0.576	3.87	10.86	1.660
14	4.03	9.84	0.734	3.47	9.82	0.630
15	4.36	8.64	2.037	3.86	9.44	0.853
16	3.90	10.05	0.656	4.54	9.77	2.120
17	4.27	9.99	0.820	4.52	7.55	1.660
18	4.35	9.76	1.377	3.82	7.56	2.390
19	4.64	8.98	0.523	3.64	7.68	1.549
20	3.85	8.15	0.218	4.22	9.29	0.469
R	1.37	4.28	2.030	1.32	3.34	2.250
D_大/R	0.277	0.014	0.062	0.023	0.009	0.097
D_小/R	0.029	0.114	0.043	0.053	0.003	0.072