Clinic for Nuclear Medicine and Competence Center for Thyroid Diseases, Imaging Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.
Laboratory for Endocrinology and Tumour Markers, Department of Laboratory Medicine, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.
Clin Chem Lab Med. 2019 Dec 18;58(1):130-137. doi: 10.1515/cclm-2019-0654.
Background Differentiated thyroid carcinoma (DTC) has an excellent prognosis and the role of high-sensitive thyroglobulin measured during levothyroxine (ON-T4 hs-Tg) testing to discriminate patients with structural from not-evidence of disease (SED and NED, respectively) has been investigated. We conducted a systematic review and meta-analysis evaluating the performance of ON-T4 hs-Tg in two clinical scenarios considering its negative predictive value (NPV) as primary outcome: (1) diagnostic performance of Tg when undetectable value and NED status are simultaneously demonstrated; (2) prognostic performance of undetectable Tg in predicting NED in the subsequent follow-up. Methods This systematic review and meta-analysis were registered on PROSPERO (CRD42019125092). PubMed, Scopus, CENTRAL and Web of Science were searched until February 12, 2019. Original articles reporting data on SED/NED in patients with detectable/undetectable ON-T4 hs-Tg were selected. Summary operating points were estimated using a random-effects model. Results Out of 1413 retrieved papers, 10 studies evaluating 1796 patients were included. Participants were outpatients diagnosed with DTC, treated with near-total (NTx) or total thyroidectomy (TTx) with or without radioactive iodine (RAI). The NPV of ON-T4 hs-Tg for diagnostic and prognostic performance was 99.4% (95% CI 98.9-99.9; I2 = 13%) and 99.4% (95% CI 98.8-100; I2 = 0%), respectively. Conclusions Our findings show that ON-T4 hs-Tg is an excellent diagnostic tool and prognostic factor to rule-out SED. A high level of evidence is provided to decrease the intensity and frequency of follow-up in those DTC patients having undetectable high-sensitive Tg.
分化型甲状腺癌（DTC）预后良好，已经研究了在左旋甲状腺素（ON-T4 hs-Tg）检测期间测量高敏甲状腺球蛋白（Tg）以区分有结构性疾病（SED）和无疾病证据（SED 和 NED）的患者的作用。我们进行了一项系统评价和荟萃分析，评估了 ON-T4 hs-Tg 在两种临床情况下的表现，主要结果为其阴性预测值（NPV）：（1）当同时证明 Tg 值不可检测和 NED 状态时的 Tg 诊断性能；（2）在后续随访中不可检测的 Tg 预测 NED 的预后性能。方法：本系统评价和荟萃分析已在 PROSPERO（CRD42019125092）上注册。检索了 PubMed、Scopus、CENTRAL 和 Web of Science，检索时间截至 2019 年 2 月 12 日。选择了报告可检测/不可检测 ON-T4 hs-Tg 患者中 SED/NED 数据的原始文章。使用随机效应模型估计汇总操作点。结果：在 1413 篇检索到的论文中，有 10 项研究纳入了 1796 例患者。参与者为门诊诊断为 DTC 的患者，接受了近全甲状腺切除术（NTx）或全甲状腺切除术（TTx），伴有或不伴有放射性碘（RAI）治疗。ON-T4 hs-Tg 的 NPV 用于诊断和预后性能分别为 99.4%（95%CI 98.9-99.9；I2=13%）和 99.4%（95%CI 98.8-100；I2=0%）。结论：我们的研究结果表明，ON-T4 hs-Tg 是一种极好的诊断工具和预后因素，可以排除 SED。为减少具有不可检测高敏 Tg 的 DTC 患者的随访强度和频率提供了高证据水平。
