Department of Ophthalmology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
Eye (Lond). 2013 Aug;27(8):964-71. doi: 10.1038/eye.2013.120. Epub 2013 Jun 7.
To investigate if TSH-receptor antibody (TRAb) levels measured in early Graves' orbitopathy (GO) stages are predictive of clinical disease course beyond 1 year after initial GO diagnosis and to compare performance of two newly developed TRAb assays (third-generation thyrotropin-binding inhibitor immunoglobulin (TBII) assay vs Mc4-thyroid-stimulating immunoglobulin (TSI) bioassay) in predicting disease course.
Newly diagnosed, untreated GO patients whose duration of ocular symptoms was less than 6 months were included. One year after initial diagnosis, all patients were classified as presenting either a mild (Group 1) or severe course (Group 2) according to their clinical manifestations. The measurements of two TRAb assays at initial GO diagnosis were used for analysis.
Data from 112 patients were available for analysis. Seventy-three patients (65.2%) were designated as Group 1, and 39 patients (34.8%) as Group 2. Patients with higher initial TRAb levels demonstrated a higher risk of severe disease course upon multiple regression analysis (P<0.01). The cutoff values for the prediction of severe course of the third-generation TBII and Mc4-TSI assays were 10.67 IU/l and 555.10%, respectively, with assay specificities of 84.9 and 89.0%. The TBII assay predictive power (area under the curve (AUC)=0.817; 95% confidence interval (CI) =0.732-0.902) was equivalent to the TSI bioassay (AUC=0.868, 95% CI=0.803-0.934) (P=0.203).
The predictive power of the third-generation TBII assay and Mc4-TSI bioassay are similarly strong. Measurement of TRAb using either third-generation TBII or Mc4-TSI in early GO periods would provide important prognostic information on future GO course.
研究促甲状腺激素受体抗体（TRAb）在 Graves 眼病（GO）早期阶段的水平是否可预测初始 GO 诊断后 1 年以上的临床疾病进程，并比较两种新开发的 TRAb 检测方法（第三代促甲状腺激素结合抑制免疫球蛋白（TBII）检测法和 Mc4-甲状腺刺激免疫球蛋白（TSI）生物检测法）在预测疾病进程方面的性能。
纳入了新诊断的、未经治疗的 GO 患者，其眼部症状持续时间少于 6 个月。在初始诊断 1 年后，根据临床表现，所有患者被分为轻度（第 1 组）或重度病程（第 2 组）。使用初始 GO 诊断时的两种 TRAb 检测方法进行分析。
112 例患者的数据可用于分析。73 例患者（65.2%）被指定为第 1 组，39 例患者（34.8%）为第 2 组。多因素回归分析显示，初始 TRAb 水平较高的患者发生重度疾病的风险更高（P<0.01）。第三代 TBII 和 Mc4-TSI 检测法预测重度病程的截断值分别为 10.67 IU/L 和 555.10%，检测特异性分别为 84.9%和 89.0%。TBII 检测法的预测效能（曲线下面积（AUC）=0.817；95%置信区间（CI）=0.732-0.902）与 TSI 生物检测法相当（AUC=0.868，95% CI=0.803-0.934）（P=0.203）。
第三代 TBII 检测法和 Mc4-TSI 生物检测法的预测能力同样较强。在早期 GO 期间使用第三代 TBII 或 Mc4-TSI 测量 TRAb 可提供关于未来 GO 病程的重要预后信息。
