基于真实世界临床数据的 PIVKA-II 在肝细胞癌检测中的有效性。
Effectiveness of PIVKA-II in the detection of hepatocellular carcinoma based on real-world clinical data.
机构信息
Department of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, 400038, China.
Chongqing Key Laboratory of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, 400038, China.
出版信息
BMC Cancer. 2017 Sep 1;17(1):608. doi: 10.1186/s12885-017-3609-6.
BACKGROUND
Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II) is an efficient biomarker specific for hepatocellular carcinoma (HCC). Some researchers have proved that levels of PIVKA-II reflect HCC oncogenesis and progression. However, the effectiveness of PIVKA-II based on real-world clnical data has barely been studied.
METHODS
A total of 14,861 samples were tested in Southwest Hospital in over 2 years' time. Among them, 4073 samples were PIVKA-II positive. Finally, a total of 2070 patients with at least two image examinations were enrolled in this study. Levels of AFP and PIVKA-II were measured by chemiluminescence enzyme immunoassay (CLEIA) and chemiluminescent microparticle Immunoassay (CMIA), respectively.
RESULTS
A total of 1016 patients with HCC were detected by PIVKA-II in a real-world application. In all these cases, 88.7% cases primarily occurred and patients with advanced HCC covered 61.3%. Levels of PIVKA-II were significantly higher in advanced group (4650.0 mAU/ml, 667.0-33,438.0 mAU/ml) than early-stage group (104.5 mAU/ml, 61.0-348.8 mAU/ml; P < 0.001). Levels of PIVKA-II elevated significantly in recurrence and residual group than recovery group (P < 0.001). A total of 1054 PIVKA-II positive patients were non-HCC cases. Among them, cirrhosis took the largest part (46.3%), followed by hepatitis (20.6%) and benign nodules (15.3%). High-levels of PIVKA-II in at-risk patients is an indicator of HCC development in two-year time.
CONCLUSIONS
Our data showed that PIVKA-II effectively increases the detection rate of HCC was a valid complement to AFP and image examination in HCC surveillance.
背景
维生素 K 缺乏或拮抗剂 II 诱导蛋白（PIVKA-II）是一种针对肝细胞癌（HCC）的有效特异性生物标志物。一些研究人员已经证明，PIVKA-II 的水平反映了 HCC 的发生和进展。然而，基于真实世界临床数据的 PIVKA-II 的有效性几乎没有被研究过。
方法
在西南医院的两年多时间里，共检测了 14861 个样本。其中，4073 个样本为 PIVKA-II 阳性。最后，共纳入 2070 例至少有两次影像学检查的患者进行本研究。AFP 和 PIVKA-II 的水平分别采用化学发光酶免疫分析（CLEIA）和化学发光微粒子免疫分析（CMIA）进行检测。
结果
在真实世界应用中，通过 PIVKA-II 共检测到 1016 例 HCC 患者。在所有这些病例中，88.7%的病例最初发生，61.3%的病例为晚期 HCC。晚期组（4650.0 mAU/ml，667.0-33438.0 mAU/ml）的 PIVKA-II 水平明显高于早期组（104.5 mAU/ml，61.0-348.8 mAU/ml；P<0.001）。复发和残留组的 PIVKA-II 水平明显高于恢复组（P<0.001）。共 1054 例 PIVKA-II 阳性患者为非 HCC 病例。其中，肝硬化占比最大（46.3%），其次为肝炎（20.6%）和良性结节（15.3%）。高危患者高水平的 PIVKA-II 是 HCC 在两年内发展的一个指标。
结论
我们的数据表明，PIVKA-II 可有效提高 HCC 的检出率，是 HCC 监测中 AFP 和影像学检查的有效补充。
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