{
  "abstract": "目的构建本地区妊娠期特异性液相色谱-串联质谱法（Liquid chromatography-tandem mass spectrometry，LC-MS/MS）检测游离甲状腺素（Free thyroxine，FT4）的参考区间，评估LC-MS/MS与化学发光免疫分析法（Chemiluminescence immunoassay，CLIA）的方法学差异，构建CLIA误判风险模型。方法收集150例正常妊娠人群3个孕期（早、中、晚孕期）的血清用LC-MS/MS进行FT4的检测，构建本地区妊娠期特异性FT4的参考区间（P2.5~P97.5）。匹配131例同时具备LC-MS/MS与CLIA结果的样本，通过组内相关系数（ICC）、Passing-Bablok回归和Bland-Altman法评估方法学一致性与偏倚。构建CLIA结果误判风险热力图，最后前瞻性纳入10例CLIA初诊亚临床甲状腺功能减退孕妇，应用LC-MS/MS复测FT4，旨在验证CLIA诊断并动态监测治疗反应。结果（1）LC-MS/MS测定的FT4随孕期进展显著下降（P<0.001），早、中、晚孕期参考区间分别为（7.41～17.45）pmol/L、（5.63～11.53）pmol/L、（5.21～10.75） pmol/L；（2）CLIA-FT4的中位数（13.80 pmol/L）显著高于 LC-MS/MS（8.81 pmol/L，P<0.001），两种方法的总体 ICC=0.829，但在低 FT4 浓度区（LC-MS/MS<7.41 pmol/L，n=31例），两种方法的相关性骤降（ICC=0.361），且CLIA存在4.57 pmol/L 恒定正偏倚（回归方程：CLIA=4.57+1.04×LC-MS/MS）；（3）建立临床可转化的误判风险模型：当 LC-MS/MS-FT4 处于临界低值（6.96~7.41 pmol/L）时，CLIA 假阴性风险>95%；10 例 CLIA 初诊 SCH 孕妇中，1 例（10%）经 LC-MS/MS 确认为真性低 FT4，且该患者治疗后 LC-MS/MS-FT4 上升斜率（3.4 pmol/周）显著高于 CLIA（2.5 pmol/周）。结论CLIA在妊娠期尤其是低FT4浓度范围内，存在显著的系统性高估和检测波动性，可能导致低FT4漏诊。建议在CLIA检测结果临界或诊断存疑时，采用LC-MS/MS进行复核，以提高妊娠期甲状腺功能评估的准确性。",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": null,
  "arxiv": null,
  "author_total": 5,
  "authors": [
    {
      "name": "王链链"
    },
    {
      "name": "唐慧荣"
    },
    {
      "name": "王娅"
    },
    {
      "name": "王媛"
    },
    {
      "name": "李洁"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/e1871sr3vkjje.bib",
  "cited_by": 0,
  "doi": null,
  "fulltext_url": "http://zszd.publish.founderss.cn/thesisDetails#10.3969/j.issn.1007-4287.2026.10.003",
  "id": "e1871sr3vkjje",
  "issns": [
    "1007-4287"
  ],
  "landing_url": "http://zszd.publish.founderss.cn/thesisDetails#10.3969/j.issn.1007-4287.2026.10.003",
  "language": "zh",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "lcc",
      "RB1-214"
    ]
  ],
  "openalex": null,
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-24",
  "publisher": "Editorial Office of Chinese Journal of Laboratory Diagnosis",
  "ris": "https://research.draconitic.com/paper/e1871sr3vkjje.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T13:44:48Z",
      "native_id": "e05fb598dca045e88692b2224c3a7efb",
      "source": "doaj",
      "url": "http://zszd.publish.founderss.cn/thesisDetails#10.3969/j.issn.1007-4287.2026.10.003"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "lcc:RB1-214",
      "subfield": "general"
    }
  ],
  "title": "液相色谱-串联质谱法在妊娠期甲状腺功能检测中的价值评估",
  "title_text": "液相色谱-串联质谱法在妊娠期甲状腺功能检测中的价值评估",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T13:44:48Z",
  "url": "https://research.draconitic.com/paper/e1871sr3vkjje",
  "venue": "Zhongguo shiyan zhenduanxue",
  "versions": []
}