基于血清AFP、AFP-L3、PIVKA-Ⅱ肝癌预测模型的构建与比较

肝脏 ›› 2026, Vol. 31 ›› Issue (2): 228-233.

基于血清AFP、AFP-L3、PIVKA-Ⅱ肝癌预测模型的构建与比较

李波, 王海玉, 蒋文, 郁金红, 张永臣

210003 南京南京中医药大学附属南京医院(南京市第二医院)检验科(李波,郁金红,张永臣),肿瘤科(王海玉,蒋文)

收稿日期:2025-02-06 出版日期:2026-02-28 发布日期:2026-04-17
通讯作者: 张永臣,Email:zhangyongchen@126.com
基金资助:
南京市卫生科技发展专项基金(YKK21124)

Construction and comparison of hepatocellular carcinoma prediction models based on serum AFP, AFP-L3 and PIVKA-Ⅱ

LI Bo, WANG Hai-yu, JIANG Wen, YU Jin-hong, ZHANG Yong-chen

1. Department of Laboratory Medicine, the Second Hospital of Nanjing, Nanjing Hospital Affiliated to Nanjing University of Chinese Medicine, Nanjing 210003, China;
2. Department of Oncology, the Second Hospital of Nanjing, Nanjing Hospital Affiliated to Nanjing University of Chinese Medicine, Nanjing 210003, China

Received:2025-02-06 Online:2026-02-28 Published:2026-04-17
Contact: ZHANG Yong-chen,Email:zhangyongchen@126.com

摘要/Abstract

摘要： 目的构建基于血清AFP、AFP-L3、PIVKA-Ⅱ肝细胞癌(HCC)的预测模型,并和以往已发表预测模型的价值进行比较,探究其在临床的应用价值。方法收集2023年1月至5月南京市第二医院收治的106例肝癌患者和60例肝硬化患者作为训练集,收集2024年5月至7月本院收治的40例肝癌患者和46例肝硬化患者作为验证集,通过logistic逐步向后回归分析建立肝癌发病的风险预测模型,并在验证集上对模型的效果进行验证。通过受试者工作特征(ROC)的曲线下面积(AUC)和已报道的2个肝癌预测模型进行比较,从而评价各肝癌预测模型的诊断价值。结果肝细胞癌组患者AFP[596.85 (60.71,16 338.00) (ng/mL)]、AFP-L3[58.07 (7.05,2 730.50) (ng/mL)]和PIVKA-Ⅱ[1 934.50 (59.42,19 036.25)(ng/mL)]水平显著高于肝硬化组,差异具有统计学意义(P<0.01)。通过多因素logistic回归分析发现,AFP[OR(95%CI):1.030(1.008~1.052),P=0.007]、AFP-L3[OR(95%CI):0.971(0.950~0.992),P=0.007]、PIVKA-Ⅱ[OR(95%CI):1.002(1.000~1.004),P=0.031]可作为肝癌诊断的预测指标。基于上述变量构建模型,其在训练集和验证集的AUC为0.979(95%CI:0.943~0.995),灵敏度和特异度分别为94.30%和91.70%;在验证集ROC曲线的AUC为0.939(95%CI:0.866~0.979),灵敏度和特异度分别为100.00%和76.10%,与ASAP模型和GALAD模型相比,自建模型具有良好的诊断效能。结论本研究构建的自建模型能够预测高危险因素患者罹患肝癌的风险,为肝癌的早期诊断提供重要的临床依据。

关键词: 甲胎蛋白, 甲胎蛋白异质体, 异常凝血酶原, 肝细胞癌, 预测模型

Abstract: Objective To construct a prediction model for hepatocellular carcinoma (HCC) based on serum alpha fetoprotein (AFP), alpha fetoprotein isoform (AFP-L3), and protein induced by vitamin K absence or antagonist-Ⅱ (PIVKA-Ⅱ), and to compare its value with previously published predictive models, exploring its clinical application significance. Methods A total of 106 patients with HCC and 60 patients with liver cirrhosis were collected from the Second Hospital of Nanjing between January and May 2023 as the training set. An additional 40 cases of HCC and 46 cases of liver cirrhosis were collected from May to July 2024 as the validation set. A risk prediction model for HCC was established using stepwise backward logistic regression, and its efficacy was validated in the validation set. The diagnostic value of the model was evaluated by comparing the area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, and accuracy with two previously reported HCC predictive models. Results The levels of AFP [596.85 (60.71, 16 338.00)(ng/mL)], AFP-L3 [58.07 (7.05,2730.50)(ng/mL)]and PIVKA-Ⅱ [1 934.50 (59.42, 19 036.25)(ng/mL)] in HCC group were significantly higher than those in cirrhosis group, and the differences were statistically significant (P<0.01). Through multivariate logistic regression analysis, AFP [OR(95%CI): 1.030(1.008~1.052), P=0.007], AFP-L3 [OR(95%CI): 0.971(0.950~0.992), P=0.007] and PIVKA-Ⅱ [OR(95%CI): 1.002(1.000~1.004), P=0.031] were identified as predictive variables for HCC diagnosis. A model was constructed based on these variables. The AUC for the ROC curve in the training set was 0.979 (95%CI: 0.943~0.995), with sensitivity and specificity of 94.30% and 91.70%, respectively. In the validation set, the AUC was 0.939 (95%CI: 0.866~0.979), with sensitivity and specificity of 100% and 76.10%, respectively. Our constructed model demonstrated good diagnostic performance compared to the ASAP and GALAD models. Conclusion The developed predictive model effectively assesses the risk of HCC in high-risk patients, providing important clinical evidence for early diagnosis of hepatocellular carcinoma.

Key words: Alpha fetoprotein, Alpha fetoprotein isoform, PIVKA-Ⅱ, Hepatocellular carcinoma, Predictive model

李波, 王海玉, 蒋文, 郁金红, 张永臣. 基于血清AFP、AFP-L3、PIVKA-Ⅱ肝癌预测模型的构建与比较[J]. 肝脏, 2026, 31(2): 228-233.

LI Bo, WANG Hai-yu, JIANG Wen, YU Jin-hong, ZHANG Yong-chen. Construction and comparison of hepatocellular carcinoma prediction models based on serum AFP, AFP-L3 and PIVKA-Ⅱ[J]. Chinese Hepatolgy, 2026, 31(2): 228-233.

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