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目的:探讨高危分化型甲状腺癌(DTC)患者手术及n 131I治疗后疗效分类,并分析影响治疗疗效的相关因素。n 方法:回顾性分析2015年1月到2018年1月就诊于郑州大学第一附属医院的256例高危DTC患者[男70例,女186例;年龄(47.6±12.9)岁]。依据2015年美国甲状腺协会(ATA)指南以及患者术后半年刺激状态下所测数据将患者分为最佳治疗反应(ER)组、疗效不确定(IDR)组、血清学反应欠佳(BIR)组和影像学反应欠佳(SIR)组,BIR和SIR进一步合并为不完全反应(IR)组。采用n χ2检验、Fisher确切概率法和Kruskal-Wallis秩和检验比较4个疗效组各临床参数的差异;采用受试者工作特征(ROC)曲线评估n 131I治疗前刺激性甲状腺球蛋白(psTg)、肿瘤最大径对ER、IR的预测价值。采用多因素logistics回归分析患者ER、IR的独立影响因素。对有B-Raf原癌基因丝/苏氨酸蛋白激酶(BRAF)n V006E突变检测结果的亚组单独行疗效的n χ2检验。n 结果:ER、IDR、BIR和SIR组的患者比例分别为48.05%(123/256)、20.31%(52/256)、19.53%(50/256)、12.11%(31/256)。4个疗效组患者的性别(n χ2=11.495,n P=0.008)、肿瘤最大径(n H=21.368, n P<0.001)、N分期(n χ2=42.012, n P<0.001)、远处转移(n P<0.001)、psTg水平(n H=142.829, n P<0.001)差异有统计学意义。通过ROC曲线获得的预测ER和IR的psTg界值为5.38 μg/L和15.85 μg/L,灵敏度分别为79.7%(98/123)和88.9%(72/81),特异性分别为84.2%(112/133)和91.4%(160/175);预测ER和IR的肿瘤最大径的界值为1.45 cm和1.95 cm,灵敏度分别为63.4%(78/123)和53.1%(43/81),特异性分别为66.2%(88/133)和74.3%(130/175)。女性[比值比(n OR)=2.305,95% n CI:1.041~5.104]、N0期(n OR=2.365,95% n CI:1.104~5.066)、psTg<5.38 μg/L(n OR=17.271,95% n CI:8.561~34.841)、肿瘤最大径4.0 cm(n OR=47.060,95% n CI:2.449~904.360)是IR的独立预测因素。SIR组中远处转移亚组的BRAFn V006E突变率显著低于其余3组疗效组(n χ2值:20.852~40.905,均n P<0.008)。n 结论:高危DTC患者初始治疗半年后,48.05%的患者可以达到ER而重新归为低危。女性、N0分期、psTg<5.38 μg/L、肿瘤最大径4.0 cm的患者初始治疗后疗效较差。“,”Objective:To explore the classification of the therapeutic effect of patients with high-risk differentiated thyroid carcinoma (DTC) after surgery and n 131I treatment, and to analyze the relevant factors that affect the therapeutic effect.n Methods:From January 2015 to January 2018, 256 high-risk DTC patients (70 males, 186 females; age (47.6±12.9) years) in the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed. According to the 2015 American Thyroid Association(ATA)guidelines for therapeutic effect classification standards and the data measured during 6 months postoperative stimulation state, patients were divided into excellent response (ER) group, inderterminate response (IDR) group, biochemical incomplete response (BIR) group and structurally incomplete response (SIR) group, and the latter two groups were further combined into incomplete response (IR) group. n χ2 test, Fisher exact test and Kruskal-Wallis rank sum test were used to compare the clinical characteristics among the four groups. The receiver operating characteristic (ROC) curve of the relationship with ER and IR was established. Multivariate logistic regression was used to analyze the independent influencing factors of ER and IR. The subgroups with B-Raf proto-oncogene, serine/threonine kinase (BRAF)n V006E results were individually tested with n χ2 test of therapeutic efficacy.n Results:There were 48.05%(123/256), 20.31%(52/256), 19.53%(50/256) and 12.11%(31/256) of DTC patients in ER, IDR, BIR and SIR groups respectively. The differences in gender (n χ2=11.495, n P=0.008), tumor size (n H=21.368, n P<0.001), N stage (n χ2=42.012, n P<0.001), distant metastasis (n P<0.001) and pre-ablation stimulated thyroglobulin (psTg) level (n H=142.829, n P<0.001) were statistically significant among the 4 groups. The cut-off values of psTg for predicting ER and IR were 5.38 μg/L and 15.85 μg/L with the sensitivities of 79.7%(98/123) and 88.9%(72/81), with the specificities of 84.2%(112/133) and 91.4%(160/175) respectively. The cut-off values of tumor size for predicting ER and IR were 1.45 cm and 1.95 cm with the sensitivities of 63.4%(78/123) and 53.1%(43/81), with the specificities of 66.2%(88/133) and 74.3%(130/175) respectively. Multivariate regression analysis showed that female (odds ratio (n OR)=2.305, 95% n CI: 1.041-5.104), N0 stage (n OR=2.365, 95% n CI: 1.104-5.066), psTg<5.38 μg/L (n OR=17.271, 95% n CI: 8.561-34.841) and tumor size 4.0 cm( n OR=47.060, 95% n CI: 2.449-904.360) were independent predictors of IR. The BRAFn V006E mutation rate of patients in the distant metastasis subgroup of the SIR group was significantly lower than that in ER, IDR, and BIR groups (n χ2 values: 20.852-40.905, all n P<0.008).n Conclusions:About 48.05% of high-risk patients can achieve ER half a year after the initial treatment and be classified as low-risk again. Female, patients with N0 stage, psTg<5.38 μg/L and tumor size 4.0 cm have poor therapeutic effect after initial treatment.