一种 TSHR-LH/CGR 嵌合体，可测量功能型甲状腺刺激自身抗体（TSAb），可预测 Graves 病患者接受抗甲状腺药物（ATD）治疗后的缓解或复发。

A TSHR-LH/CGR chimera that measures functional thyroid-stimulating autoantibodies (TSAb) can predict remission or recurrence in Graves' patients undergoing antithyroid drug (ATD) treatment.

机构信息

Unit of Endocrinology, Department of Medicine and Sciences of Aging, University "G. D'Annunzio" and Aging Research Center, "Gabriele D'Annunzio" University Foundation, 66013 Chieti-Pescara, Italy.

出版信息

J Clin Endocrinol Metab. 2012 Jul;97(7):E1080-7. doi: 10.1210/jc.2011-2897. Epub 2012 Apr 6.

DOI:10.1210/jc.2011-2897

PMID:22492869

Abstract

CONTEXT

A functional thyroid-stimulating autoantibodies (TSAb) assay using a thyroid-stimulating hormone receptor chimera (Mc4) appears to be clinically more useful than the commonly used assay, a binding assay that measures all the antibodies binding to the thyroid-stimulating hormone receptor without functional discrimination, in diagnosing patient with Graves' disease (GD).

OBJECTIVE

The objective of the study was to investigate whether an Mc4 assay can predict relapse/remission of hyperthyroidism after antithyroid drug (ATD) treatment in patients with GD.

DESIGN

An Mc4 assay was used to prospectively track TSAb activity in GD patients treated with ATD over a 5-yr period.

SETTING AND PATIENTS

GD patients from the Chieti University participated in this study.

INTERVENTIONS

Interventions included the assessment of patients' sera using the Mc4 assay, the Mc4-derivative assay (Thyretain), and a human monoclonal thyroid-stimulating hormone receptor antibody, M22 assay.

MAIN OUTCOME MEASURES

The Mc4 assay, a sensitive index of remission and recurrence, was used in this study.

RESULTS

The TSAb levels significantly decreased only in the remitting group as evidenced by Mc4 assay values at the end of ATD (0.96 ± 1.47, 10.9 ± 26.6. and 24.7 ± 37.5 arbitrary units for the remitting, relapsing, and unsuspended therapy groups, respectively). Additional prognostic help was obtained by thyroid volume measurements at the end of treatment. Although not statistically significant, the Mc4 assay has a trend toward improved positive predictive value (95.4 vs. 84.2 or 87.5%), specificity (96.4 vs. 86.4 and 90.9%), and accuracy (87.3 vs. 83.3 and 80.9%) comparing the Mc4, Thyretain, and M22 assays, respectively. Thyretain has a trend toward improved negative predictive value (82.6 vs. 81.8 and 76.9%) and sensitivity (80 vs. 77.8 and 70%) comparing Thyretain, Mc4, and M22 assays, respectively.

CONCLUSION

The Mc4 assay is a clinically useful index of remission and relapse in patients with GD. Larger studies are required to confirm these findings.

摘要

背景

使用促甲状腺激素受体嵌合体（Mc4）的甲状腺刺激自身抗体（TSAb）功能测定似乎比常用的测定方法（结合测定法）更具临床意义，后者测量所有与促甲状腺激素受体结合的抗体，而没有功能区分，用于诊断格雷夫斯病（GD）患者。

目的

本研究的目的是探讨 Mc4 测定法是否可以预测 GD 患者接受抗甲状腺药物（ATD）治疗后甲状腺功能亢进的复发/缓解。

设计

使用 Mc4 测定法在 5 年内前瞻性跟踪 GD 患者接受 ATD 治疗后的 TSAb 活性。

地点和患者

来自切塞纳大学的 GD 患者参加了这项研究。

干预措施

包括使用 Mc4 测定法、Mc4 衍生物测定法（Thyretain）和人单克隆促甲状腺激素受体抗体 M22 测定法评估患者的血清。

主要观察指标

Mc4 测定法是一种敏感的缓解和复发指标，用于本研究。

结果

仅在缓解组中，TSAb 水平显著降低，证据是 Mc4 测定法在 ATD 结束时的值：缓解组、复发组和未停药组分别为 0.96±1.47、10.9±26.6 和 24.7±37.5 个任意单位。治疗结束时的甲状腺体积测量提供了额外的预后帮助。尽管没有统计学意义，但 Mc4 测定法在阳性预测值（95.4%比 84.2%或 87.5%）、特异性（96.4%比 86.4%和 90.9%）和准确性（87.3%比 83.3%和 80.9%）方面有改善趋势，与 Mc4、Thyretain 和 M22 测定法相比。Thyretain 在阴性预测值（82.6%比 81.8%和 76.9%）和敏感性（80%比 77.8%和 70%）方面有改善趋势，与 Thyretain、Mc4 和 M22 测定法相比。