宝鸡地区甲状腺功能五项指标生物参考区间的调查

Investigation on Biology Reference Intervals for Five Parameters of Thyroid Gland Function in Baoj i Area

目的：调查宝鸡地区甲状腺功能五项指标（TSH，T3，T4，FT3和 FT4）的生物参考区间，为准确筛查及诊断甲状腺疾病提供依据。方法参照美国临床实验室标准化委员会（NCCLS）C28-A2文件中涉及到的有关参考区间定义，调查，验证的描述，采用罗氏Cobas E601电化学发光免疫分析仪及其配套试剂、标准品、质控品，对4820名健康人群的甲状腺功能五项指标进行检测，检测结果按性别差异进行统计学分析处理，确定各项指标的参考区间。并与第三版全国临床检验操作规程作比较。结果该地区甲状腺功能五项指标95％正常参考区间分别为男性：TSH 0.20～4.28 mIU／L，T31.22～2.46 nmol／L，T464.64～149.00 nmol／L，FT33.00～6.04 pmol／L和 FT411.93～22.21 pmol／L；女性：TSH 0.20～4.52 mIU／L，T31.24～2.44 nmol／L，T467.60～142.40 nmol／L，FT32.96～5.76 pmol／L和 FT411.86～21.54 pmol／L。男性TSH，FT3，FT4水平与女性相比较，差异具有统计学意义（t值分别为3.962，7.570，5.132，P 值分别为0.042，0.026，0.033）。男性T3，T4水平与女性相比较，差异无统计学意义（t值分别为0.000，1.151，P 值分别为1.000，0.120）。该地区结果与第三版全国临床检验操作规程相比较，男性 T3，T4，FT3和 FT4差异有统计学显著性意义（t值分别为9.755，4.349，114.7，79.82；P值分别为0.000，0.003，0.000，0.000），女性 TSH，T3，FT3和 FT4差异亦有统计学显著性意义（t值分别为5.304，9.548，128.9，72.99；P值分别为0.002，0.000，0.000，0.000）。结论该地区罗氏 Cobas E601电化学发光免疫分析仪甲状腺功能五项指标生物参考区间的调查为临床诊疗工作提供了更准确的参考数据。

Objective To investigate the biology reference intervals for five parameters of thyroid gland function（TSH,T3, T4,FT3 and FT4）in Baoji area,in order to provide evidence for effective filtration and diagnosis.Methods Refer to the files recommended by （NCCLS）C28-A2 about the description of definition,establishment and confirmation,five parameters of thyroid gland function were measured in 4 820 healthy persons by using Roche E601 electrochemical immunoassay analyzer and its assemble reagent,calibration materials and quality control,the statistical method was applied to the data processing by different gender,to establish the biology reference intervals of each parameters.And compared with National Guide to Clinical Laboratory Procedures（Third Edition）.Results The range of 95% normal reference intervals of TSH,T3,T4,FT3 and FT4 in male were 0.20～4.28 mIU/L,1.22～2.46 nmol/L,64.64～149.00 nmol/L,3.00～6.04 pmol/L,11.93～22.21 pmol/L respectively,and in female were 0.20～4.52 mIU/L,1.24～2.44 nmol/L,67.60～142.40 nmol/L,2.96～5.76 pmol/L and 11.86～21.54 pmol/L,respectively.Compared the level of TSH,FT3,FT4 between male and female, differences were statistical significance（t=3.962,7.570,5.132;P=0.042,0.026,0.033）.Compared the level of T3,T4 be-tween male and female,there was no statistical significance （t=0.000,1.151;P=1.000,0.120）.The study compared with National Guide to Clinical Laboratory Procedures （Third Edition）,the results of T3,T4,FT3 and FT4 in male were statisti-cal significance （t=9.755,4.349,114.7,79.82;P=0.000,0.003,0.000,0.000）,the results of TSH,T3,FT3 and FT4 in female were statistical significance （t=5.304,9.548,128.9,72.99;P=0.002,0.000,0.000,0.000）.Conclusion The in-vestigation of biology reference intervals for five parameters of thyroid gland function in Baoji area can provide more precise-ly reference data for clinical diagnosis and treatment.