血清甲状腺球蛋白Ⅱ的检测及其对甲状腺疾病临床处理的影响

Clinical evaluation of thyroglobulin Ⅱ assay and its impact on clinical management of thyroid diseases

目的 比较新一代高灵敏血清Tg（TgⅡ）与其原代血清Tg（Tg Ⅰ）的检测结果差异,并分析其对甲状腺疾病临床处理的影响.方法 收集上海交通大学附属第六人民医院249例甲状腺疾病患者（其中良性甲状腺疾病30例,DTC 219例;男64例,女185例,平均年龄43.0岁）的血清标本,于-40℃存储,解冻后同时进行血清TgⅡ与TgⅠ检测.血清TgⅠ的检测范围为0.10～1 000.00 μg/L,TgⅡ为0.04～500.00μg/L.分析血清TgⅡ与TgⅠ的结果差异及其对甲状腺疾病临床处理的影响.采用IBM SPSS 19.0软件对数据进行Wilcoxon符号秩检验和Spearman秩相关分析.结果 血清TgⅡ与TgⅠ检测值高度一致（rs=0.979,P＜0.05）,但绝大多数患者（246例）的TgⅡ检测值低于TgⅠ,二者的M（Q1～Q3）分别为2.31（0.06～ 13.17）μg/L和3.63（0.41 ～ 16.84） μg/L（z=-13.25,P＜0.001）.30例甲状腺良性疾病患者TgⅡ为5.61（1.07～26.39） μg/L,TgⅠ为6.31（2.07～33.93） μg/L（z=-4.78,P＜0.05）;108例未接受过131Ⅰ治疗的DTC患者TgⅡ为2.18（0.07～7.47） μg/L,Tg Ⅰ为3.50（0.39～10.18） μg/L（z=-9.02,P＜0.001）;TgⅡ分别低于TgⅠ约11.09％和37.71％,但这种改变对临床诊疗无影响.TSH在低值、TgAb在参考范围内且经131Ⅰ清除残留甲状腺组织（简称清甲）治疗的DTC患者共71例,其中3例患者Tg Ⅰ＞1.0 μg/L,但TgⅡ＜1.0μg/L,12例患者Tg Ⅰ ＞0.1 μg/L,而TgⅡ＜0.04 μg/L.结论 血清TgⅡ与 TgⅠ检测值高度相关,但TgⅡ检测值低于TgⅠ.TgⅡ对甲状腺良性疾病和DTC的临床诊断无明显影响,但TgⅡ的低值可部分改变对DTC患者清甲治疗后的病情判断.

Objective To compare the consistence and difference between the assay results of the second generation of Tg （Tg Ⅱ） and the first generation of Tg （Tg Ⅰ） immunoassay,as well as to evaluate the impact of Tg Ⅱ on the clinical management of thyroid diseases.Methods Serum samples of 249 patients （30 with benign thyroid disorders and 219 with DTC;64 males and 185 females,average age 43.0 years）were collected and assayed by Tg Ⅱ and TgⅠ kits simultaneously.The measuring ranges of TgⅠ and TgⅡ were 0.10-1 000.00 μg/L and 0.04-500.00 μg/L,respectively.Data were analyzed by the Wilcoxon rank sum test and Spearman correlation analysis using IBM SPSS 19.0.Results The assay results of TgⅡ and TgⅠ strongly correlated （rs =0.979,P〈0.05）.However,the median value of TgⅡ （2.31 （0.06-13.17） μg/L） was lower than that of TgⅠ（3.63（0.41-16.84） μg/L）（z=-13.25,P〈0.001）.The difference between Tg Ⅱ and Tg Ⅰ got bigger when TgⅠ value decreased more.TgⅡ values were 11.09% lower than TgⅠ （5.61（1.07-26.39） μg/L） vs 6.31（2.07-33.93） μg/L;z=-4.78,P〈0.05） in 30 patients with benign thyroid disorders and 37.71% lower （2.18（0.07-7.47） μ.g/L） vs 3.50（0.39-10.18） μg/L;z=-9.02,P〈0.001） in 108 DTC patients without 131 Ⅰ treatment.But the above changes had no influence on clinical diagnosis and treatment.In the 71 DTC patients post 131Ⅰ treatment with low TSH and normal TgAb,there were 3 cases with TgⅠ〉1.0 μg/L but TgⅡ〈1.0μg/L,and 12 cases with TgⅠ〉0.1 μg/L but TgⅡ〈0.04 μg/L.Conclusions Serum TgⅡand Tg Ⅰ assay results are strongly correlated,though Tg Ⅱ value is slightly lower than Tg Ⅰ value.This difference may have no significant influence on the clinical diagnosis of thyroid diseases.However,TgⅡ may be better to evaluate the curative effect in some DTC patients post 131Ⅰ therapy.