两种免疫试剂检测妊娠期甲状腺功能结果的比较
량충면역시제검측임신기갑상선공능결과적비교
Comparison of thyroid function tests results determined by two kinds of immunoassay in uncomplicated pregnant women
  • 万方数据
    中华围产医学杂志 중화위산의학잡지
    CHINESE JOURNAL OF PERINATAL MEDICINE
    2012年 7期 404-410 ,共7页

    罗军%韩密%宋梦帆%许诗珺%范建霞

    라군%한밀%송몽범%허시군%범건하

    妊娠%促甲状腺素%甲状腺原氨酸类%试剂盒,诊断%参考值 妊娠%促甲狀腺素%甲狀腺原氨痠類%試劑盒,診斷%參攷值
    임신%촉갑상선소%갑상선원안산류%시제합,진단%삼고치
    Pregnancy%Thyrotropin%Thyronines%Reagent kits,diagnostic%Reference values
    目的 比较2种临床常用的自动化化学发光免疫检测试剂对不同孕周的正常孕妇甲状腺功能指标的检测结果和参考范围的差异.方法 采集2011年2月17日至6月9日就诊于上海交通大学医学院附属国际和平妇幼保健院的正常孕妇血清样本共693例,按孕周不同分妊娠9～13、16～20、24～28、32～34和37～40周共5组.同期采用2种检测试剂—— 雅培试剂(Abbott Architect I2000)和罗氏试剂(Roche Cobas Elecsys 600)进行血清促甲状腺激素(thyroid stimulating hormone,TSH)、游离甲状腺素(free thyroxine,FT4)和游离三碘甲状腺原氨酸(free triiodothyronine,FT3)的检测.根据美国临床生化研究院建议的甲状腺功能检测指标参考范围的制定方法,将测定结果的第2.5～97.5百分位数作为各项指标的参考范围.采用单因素方差分析、多重比较法和Spearman相关分析进行统计学分析.结果 妊娠期间,2种检测试剂测定的TSH值有线性相关性且变化趋势一致(r=0.833～0.973,P均=0.000),均在妊娠9～13周显著低于同一试剂其他妊娠时点,而在妊娠37～40周显著高于同一试剂其他妊娠时点(F雅培=18.830,F罗 氏=21.012,P均=0.000)；同一样本罗氏试剂测得的各妊娠时点的TSH水平及参考范围均显著高于雅培试剂(|t|=3.002、4.948、6.353、4.636、4.391,P均＜0.01).2种检测试剂测定的妊娠9～13周血清FT4水平均显著高于同一试剂其他妊娠时点(F雅培=17.230,F罗氏=14.439,P均=0.000)；罗氏试剂测定的妊娠9～13周血清FT4水平显著高于雅培试剂(|t|=4.964,P=0.000),而妊娠24～28周和37～40周FT4水平显著低于雅培试剂(|t|=4.183,P=0.000;|t|=2.417,P=0.016).2种检测试剂测定的妊娠9～13周和16～20周血清FT3水平均显著高于同一试剂其他妊娠时点(F雅培=46.142,F罗氏 =68.149,P均=0.000)；罗氏试剂测得的各妊娠时点的FT3水平及参考范围均显著高于雅培试剂(|t|=31.762、26.411、28.877、22.710、22.736,P均=0.000).2种试剂均仅在妊娠9～13周时,血清TSH与FT4、FT3之间呈现显著相关性(雅培试剂:r=-0.319和 -0.361,P均=0.000;罗氏试剂:r=-0.352和-0.329,P均=0.000).结论 血清TSH最能准确反映甲状腺功能,美国甲状腺学会推荐的经验性妊娠期TSH参考范围上限不宜在国内直接采纳,不同检测试剂应建立各自的妊娠期甲状腺功能参考范围.
    목적 비교2충림상상용적자동화화학발광면역검측시제대불동잉주적정상잉부갑상선공능지표적검측결과화삼고범위적차이.방법 채집2011년2월17일지6월9일취진우상해교통대학의학원부속국제화평부유보건원적정상잉부혈청양본공693례,안잉주불동분임신9～13、16～20、24～28、32～34화37～40주공5조.동기채용2충검측시제—— 아배시제(Abbott Architect I2000)화라씨시제(Roche Cobas Elecsys 600)진행혈청촉갑상선격소(thyroid stimulating hormone,TSH)、유리갑상선소(free thyroxine,FT4)화유리삼전갑상선원안산(free triiodothyronine,FT3)적검측.근거미국림상생화연구원건의적갑상선공능검측지표삼고범위적제정방법,장측정결과적제2.5～97.5백분위수작위각항지표적삼고범위.채용단인소방차분석、다중비교법화Spearman상관분석진행통계학분석.결과 임신기간,2충검측시제측정적TSH치유선성상관성차변화추세일치(r=0.833～0.973,P균=0.000),균재임신9～13주현저저우동일시제기타임신시점,이재임신37～40주현저고우동일시제기타임신시점(F아배=18.830,F라 씨=21.012,P균=0.000)；동일양본라씨시제측득적각임신시점적TSH수평급삼고범위균현저고우아배시제(|t|=3.002、4.948、6.353、4.636、4.391,P균＜0.01).2충검측시제측정적임신9～13주혈청FT4수평균현저고우동일시제기타임신시점(F아배=17.230,F라씨=14.439,P균=0.000)；라씨시제측정적임신9～13주혈청FT4수평현저고우아배시제(|t|=4.964,P=0.000),이임신24～28주화37～40주FT4수평현저저우아배시제(|t|=4.183,P=0.000;|t|=2.417,P=0.016).2충검측시제측정적임신9～13주화16～20주혈청FT3수평균현저고우동일시제기타임신시점(F아배=46.142,F라씨 =68.149,P균=0.000)；라씨시제측득적각임신시점적FT3수평급삼고범위균현저고우아배시제(|t|=31.762、26.411、28.877、22.710、22.736,P균=0.000).2충시제균부재임신9～13주시,혈청TSH여FT4、FT3지간정현현저상관성(아배시제:r=-0.319화 -0.361,P균=0.000;라씨시제:r=-0.352화-0.329,P균=0.000).결론 혈청TSH최능준학반영갑상선공능,미국갑상선학회추천적경험성임신기TSH삼고범위상한불의재국내직접채납,불동검측시제응건립각자적임신기갑상선공능삼고범위.
    Objective To compare thyroid function test (TFT) results and reference range of normal pregnant women in different gestational stages between two kinds of automation chemiluminescence immunoassay kit commonly used.Methods Serum of 693 normal pregnant women attended antenatal clinics in the International Peace Maternity & Child Health Hospital Affiliated to the Medical School of Shanghai Jiaotong University from Feb.17th to June 9th,2011 was collected,and were divided into five groups according to their gestational age,9-13,16-20,24-28,32-34 and 37-40 weeks.Thyroid stimulating hormone (TSH),free thyroxine (FT4) and free triiodothyronine (FT3) levels were determined by 2 kinds of detection reagents:Abbott Architect I2000 and Roche Cobas Eleesys 600.According to National Academy of Clinical Biochemistry (NACB),the reference range of the TFT indexes was calculated.The results were analyzed by one-way ANOVA,t-test and Spearman relation analysis.Results During pregnancy,TSH level at different stage of pregnancy detected by the two reagents showed linear correlation and the changing pattern was also consistent (r =0.833-0.973,P =0.000).In 9-13 gestational weeks group,TSH level were significantly lower than that of other groups; and in 37-40 gestational week group,it was higher than that of other groups (FAbbott =18.830,FRoche =21.012,all P=0.000).And TSH levels and its reference range determined by Roche detection reagent in each group were higher than those by Abbott detection reagent (|t| =3.002,4.948,6.353,4.636 and 4.391,P＜0.01,respectively).In 9-13 gestational weekgroup,FT4 level was higher than that of other groups (F A b bott =17.230,FRoche =14.439,P=0.000).In 9-13 week group,FT4 level determined by Roche reagent was higher than that detected by Abbott reagent (|t| =4.964,P=0.000).While in 24-28 and 37-40 weeks group,they were lower (|t| =4.183,P=0.000; |t| =2.417,P=0.016).In 9-13 and 16-20 gestational weeks group,FT:3 levels,determined by both Abbott and Roche reagents,were higher than those of other groups (FAbbott =46.142,FRoche=68.149,P=0.000).The FT3 level in each group detected by Roche reagent were higher than that detected by Abbott reagent (|t| =31.762,26.411,28.877,22.710 and 22.736,P=0.000).Only in 9-13 weeks group,the TSH level was related to FT4 and FT3 level determined byboth reagents (Abbott:r=-0.319 and -0.361,P=0.000; Roche:r=-0.352 and -0.329,P=0.000).Conclusions TSH serum level is the most accurate indicator of thyroid function.The upper limit of the empirical TSH reference range during pregnancy recommended by America Thyroid Association might not be appropriate for Chinese.Different reference range for pregnant women should be established according to different reagents applied.
    원문보기 원문다운로드 사이트로이동
저자의 최근 논문