PIVKA-II在肝细胞癌和慢性肝病中的临床应用：中国多中心研究

StephenW

PIVKA-II在肝细胞癌和慢性肝病中的临床应用：中国多中心研究
君吉1、刘丽娟2、蒋飞飞3、薛文1、张宇2、李胜从2、金丽楼3、英王3、刘宁3、秋艳国3、嘉永美3、高春芳1
隶属关系
隶属关系

    1
    上海第二军医大学东方肝胆外科医院检验科。
    2
    【作者单位】： 福建医科大学孟超肝胆医院检验科;
    3
    首都医科大学附属北京佑安医院临床检验中心，北京，中国。

    PMID：34590755 DOI：10.1002/jcla.24013

抽象的

背景：由于缺乏特异性症状和低存活率，迫切需要有效的肝细胞癌（HCC）诊断生物标志物。本研究的目的是评估由维生素 K 缺失或拮抗剂-II (PIVKA-II) 诱导的蛋白质的诊断性能，并确定 HBV 感染相关 HCC 的最佳截止值。

方法：我们在中国进行了一项横断面、多中心研究，以确定 CHB 和 HBV 相关肝硬化背景下 HCC 患者的临界值。受试者工作特征曲线（ROC）和曲线下面积（AUC）用于评估PIVKA-II的诊断性能。

结果：本研究招募了 784 名受试者，证明 PIVKA-II 在诊断慢性肝病 HCC 的敏感性为 84.08%，特异性为 90.43%。在将 HCC 与慢性乙型肝炎 (CHB) 患者区分开来时，PIVKA-II 在 37.5 mAU/mL 的临界值下产生的 AUC 为 0.9737（敏感性 91.78% 和特异性 96.30%）。 PIVKA-II 在 45 mAU/mL 的临界值下产生的 AUC 为 0.9419（敏感性 77.46% 和特异性 95.12%），用于区分 HCC 和 HBV 相关肝硬化患者。此外，使用 PIVKA-II 的 40 mAU/mL 截止值作为 HCC 标志物，只有 4.81% (15/312) 在慢性肝炎和 12.80% (37/289) 肝硬化患者中呈阳性，揭示了令人满意的特异性PIVKA-II 在不同病因的慢性肝病中的作用。

结论：我们的数据表明 PIVKA-II 具有令人满意的诊断效率，可用作 HCC 高危人群的筛查或监测生物标志物。

关键词：维生素K缺失或拮抗剂-II诱导的蛋白质；慢性肝病；诊断评估；肝细胞癌;多中心研究。

© 2021 作者。由 Wiley Periodicals LLC 出版的《临床实验室分析杂志》。

StephenW

The clinical application of PIVKA-II in hepatocellular carcinoma and chronic liver diseases: A multi-center study in China
Jun Ji  1 , Lijuan Liu  2 , Feifei Jiang  3 , Xue Wen  1 , Yu Zhang  2 , Shengcong Li  2 , Jinli Lou  3 , Ying Wang  3 , Ning Liu  3 , Qiuyan Guo  3 , Yongmei Jia  3 , Chunfang Gao  1
Affiliations
Affiliations

    1
    Department of Laboratory Medicine, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China.
    2
    Department of Laboratory Medicine, Mengchao hepatobiliary Hospital of Fujian Medical University, Fujian, China.
    3
    Center for Clinical Laboratory, Beijing Youan Hospital, Capital Medical University, Beijing, China.

    PMID: 34590755 DOI: 10.1002/jcla.24013

Abstract

Background: Due to the absence of specific symptoms and low survival rate, efficient biomarkers for hepatocellular carcinoma (HCC) diagnosis are urgently required. The purpose of this study was to evaluate the diagnostic performance of protein induced by vitamin K absence or antagonist-II (PIVKA-II) and to determine the optimal cutoff values for HBV infection-related HCC.

Methods: We conducted a cross-sectional, multi-center study in China to ascertain the cutoff value for HCC patients in the context of CHB- and HBV-related cirrhosis. The receiver operating characteristic curve (ROC) and the area under the curve (AUC) were used to evaluate the diagnostic performance of PIVKA-II.

Results: This study enrolled 784 subjects and demonstrated that PIVKA-II had a sensitivity of 84.08% and a specificity of 90.43% in diagnosis HCC from chronic liver diseases. PIVKA-II at a cutoff of 37.5 mAU/mL yielded an AUC of 0.9737 (sensitivity 91.78% and specificity 96.30%) in discriminating HCC from chronic hepatitis B (CHB) patients. PIVKA-II at a cutoff of 45 mAU/mL yielded an AUC of 0.9419 (sensitivity 77.46% and specificity 95.12%) in discriminating HCC- from HBV-related cirrhosis patients. Furthermore, using a cutoff value of 40 mAU/mL for PIVKA-II as an HCC marker, only 4.81% (15/312) was positive in chronic hepatitis and 12.80% (37/289) in cirrhosis patients, revealing the satisfactory specificity of PIVKA-II in chronic liver disease of different etiologies.

Conclusion: Our data indicated that PIVKA-II had satisfactory diagnostic efficiencies and could be used as a screening or surveillance biomarker in HCC high-risk population.

Keywords: Protein induced by vitamin K absence or antagonist-II; chronic liver diseases; diagnostic evaluation; hepatocellular carcinoma; multi-center study.

© 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.

StephenW

https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/jcla.24013