1085例各种甲状腺疾病患者及正常人的血清促甲状腺受体抗体含量分析

Clinical study of serum TRAb in 1085 cases of patients with thyroid disease and normal adults

目的 制备富含甲状腺刺激阻断性抗体（TSBAb）抗原决定簇的重组TrxTSHRc蛋白为抗原,建立人血清酶联免疫吸附（ELISA）技术,检测正常人血清促甲状腺素受体抗体（TRAb）,计算阳性切限值并应用于临床甲状腺疾病特别是桥本甲状腺炎（HT）的检测分析.方法以重组TrxTSHRc蛋白为抗原,通过不同的抗原包被量、不同的血清稀释度优化,建立间接ELISA检测方法（TRAb-C ELISA以检测TSBAb为主）.以此方法检测1 085例各种甲状腺疾病患者及部分正常人群血清TRAb.结果本法检测正常人A405值（（-x）±s）为0.319±0.107,阳性切限值（（-x）±2 s）为0.533,正常人组阳性率3.30%（9/272）;HT患者阳性率66.01%（336/509）,其中伴甲状腺功能减退者阳性率77.78%（252/324）、伴甲状腺功能亢进者52.94%（63/119）、甲状腺功能正常者31.82%（21/66）;初发Graves病患者阳性率41.86%（44/105）;治疗1年Graves病患者阳性率17.86%（5/28）;单纯性甲状腺肿患者阳性率6.98%（3/43）;亚急性甲状腺炎患者阳性率11.1%（5/45）;非毒性结节性甲状腺肿患者阳性率8.70%（6/69）;甲状腺腺瘤患者阳性率3.2%（1/31）.结论TRAb-C ELISA以检测TSBAb为主,此法对自身免疫性甲状腺疾病,尤其是HT的诊断、疗效观察及预后有重要意义.

Objective Using recombinant TrxTSHRc protein which contains TSBAb antigen epitope as antigen, an enzyme linked immunosorbent assay （ELISA） was established. The cut-off of positive values of TSH receptor antibody （TRAb） was established. Methods Using recombinant TrxTSHRc protein as antigen, the optimum condition was determined, and the indirect ELISA for detecting TRAb （TRAb-C） in the serum of normal control subjects and thyroid disease patients was established. A total of 1 085 patients and healthy controls were tested for this antibody. Results TRAb-C ELISA mainly detected TSBAb. The A405（（-x）±s） value in healthy group was 0. 319±0. 107 with a cut-off value （（-x）±2 s）of 0. 533. The positive rate in thyroid disease patients showed significant deviation, with 66. 01 % in patients with Hashimoto＇s thyroiditis, 41.68% in newly-diagnosed Graves＇disease, 6.98% in simple goiter, 11.1% in subacute thyroiditis, 8.7% in nontoxic thyroid nodular goiter, and 3.2% in thyroid adenoma. Conclusion The TRAb-C ELISA mainly detects TSBAb, which is very valuable for autoimmune thyroid disease, especially for the diagnosis, prognosis and therapy evaluation in Hashimoto＇ s thyroiditis.