泸州地区健康妊娠女性促甲状腺激素一致性参考区间的建立及验证  

Establishment and validation of thyroid stimulating hormone consistency reference interval among healthy pregnant women in Luzhou area

作　　者：贺江[1] 刘育欣[1] 代娟 杨清明[1] 郭永灿 何丽[3] 陈坚[4] 董念[5] 彭胡 邱厚兵 HE Jiang;LIU Yuxin;DAI Juan;YANG Qingming;GUO Yongcan;HE Li;CHEN Jian;DONG Nian;PENG Hu;QIU Houbin(Department of Clinical Laboratory,Luzhou Municipal Hospital of Traditional Chinese Medicine,Luzhou,Sichuan 646000,China;Department of Clinical Laboratory,Affiliated Hospital of Traditional Chinese Medicine,Southwest Medical University,Luzhou,Sichuan 646000,China;Department of Clinical Laboratory,Hejiang County People's Hospital,Luzhou,Sichuan 646200,China;Department of Clinical Laboratory,Xuyong County People's Hospital,Luzhou,Sichuan 646400,China;Department of Clinical Laboratory,Gulin County People's Hospital,Luzhou,Sichuan 646500;Department of Medical Affairs,Luzhou Municipal Hospital of Traditional Chinese Medicine,Luzhou,Sichuan 646000,China)

机构地区：[1]四川省泸州市中医医院检验科,四川泸州646000 [2]西南医科大学附属中医医院检验科,四川泸州646000 [3]四川省泸州市合江县人民医院检验科,四川泸州646200 [4]四川省泸州市叙永县人民医院检验科,四川泸州646400 [5]四川省泸州市古蔺县人民医院检验科,四川泸州646500 [6]四川省泸州市中医医院医务部,四川泸州646000

出　　处：《国际检验医学杂志》2022年第18期2238-2243,2248,共7页International Journal of Laboratory Medicine

基　　金：四川省卫生和计划生育委员会科研课题(16PJ172);四川省泸州市卫生局科研课题(201430);西南医科大学-泸州市中医医院联合专项科研课题(201608)。

摘　　要：目的 建立适用于泸州地区临床实验室健康妊娠女性各孕期促甲状腺激素(TSH)一致性参考区间,并验证其适用性。方法 选择代表泸州地理区域的5个临床实验室,采用多中心研究的方法,选取2019年1月至2020年12月进行孕期检查的健康妊娠女性2 728例(各实验室各孕期人数不低于120例),按孕周不同将其分为孕早期组(≤12周,819例)、孕中期组(>12~27周,1 057例)和孕晚期组(>27周,852例)3个试验组;同时选取646例同期进行健康体检的非妊娠健康育龄女性作为对照组。检测所有人群的TSH水平(A-1、A-2、B、C、D 5个检测系统)并进行统计分析,建立各孕期的参考区间。结果 不同检测系统检测孕早、中、晚期组及对照组TSH水平比较,差异有统计学意义(P<0.05),两两比较,检测系统B和D检测孕早、中、晚期组及对照组的TSH水平差异有统计学意义(P<0.005),检测系统D与A-1、A-2、B、C检测孕中期组的TSH水平比较,差异有统计学意义(P<0.005),其余各组比较,差异无统计学意义(P>0.005)。根据检测系统不同的检测原理分为化学发光组与电化学发光组,两组TSH水平在孕早、中、晚期者及对照者间比较,差异有统计学意义(P<0.05)。将泸州地区健康妊娠女性TSH参考区间按检测原理和孕期分为2个亚组。化学发光组TSH参考区间:孕早期0.13~3.84 mIU/L、孕中期0.28~4.23 mIU/L、孕晚期0.44~4.55 mIU/L;电化学发光组TSH参考区间:孕早期0.20~4.81 mIU/L、孕中期0.30~4.49 mIU/L、孕晚期0.48~5.25 mIU/L。新建立的TSH参考区间经5个实验室验证,均符合要求。结论 泸州地区健康妊娠女性孕早、中、晚期TSH参考区间与非妊娠女性有明显差异,相同检测原理的不同检测系统可以建立统一的参考区间,便于临床检测结果的互认,不同检测原理的检测系统间TSH结果差异有统计学意义,不能使用相同的参考区间。Objective To establish the consistency reference interval of thyroid stimulating hormone(TSH) for healthy pregnant women suitable for the clinical laboratories in Luzhou area, and to verify its applicability.Methods Five clinical laboratories representing the geographical area of Luzhou were selected, and 2 728 healthy pregnant women(the number of women with different pregnant stages in each laboratory should not be less than 120 cases) undergoing the pregnancy tests from January 2019 to December 2020 were selected by the method of multi-center study.They were divided into the three experimental groups according to different gestational weeks: early pregnancy group(≤12 weeks, 819 cases),middle pregnancy group(>12-27 weeks, 1 057 cases) and late pregnancy group(>27 weeks, 852 cases).At the same time, 646 non-pregnant healthy women of childbearing age undergoing the physical examination during the corresponding period were selected as the control group.The TSH levels(5 detection systems of A-1,A-2,B,C,D) of all subjects were detected and statistically analyzed.Then the reference interval of each pregnant stage was established.Results The TSH levels detected by different detection systems had statistical differences among the early pregnancy group, middle pregnancy group, late pregnancy group and control group(P<0.05).In the pairwise comparison, the TSH level detected by the detection system B and D had a statistically significant difference among the early, middle and late pregnancy groups and control group(P<0.005),the TSH level in the middle pregnancy group had statistical difference among the detection system D,A-1,A-2,B and C(P<0.005),the difference among the other groups had no statistical significance(P>0.005).The subjects were divided into the chemiluminescence group and electrochemiluminescence group according to the different detection principle in the detection system.There was significant difference in TSH level between the early, middle and late pregnant women and the control women in the two groups(P

关 键 词：妊娠女性 促甲状腺激素 多中心 参考区间 

分 类 号：R446.6[医药卫生—诊断学]