To discuss the clinical value of Protein induced by Vitamin K Antagonist-Ⅱ (PIVKA-Ⅱ) and alpha-Fetoproteins (AFP) in diagnosing hepatocellular carcinoma (HCC) and monitoring the treatment effects.

Patients were recruited by the Affiliated Hospital of Qingdao University, from August 2013 to March 2014. Serum levels of PIVKA-Ⅱ and AFP were measured by both chemiluminescence assay (CLIA) and electrochemiluminescence assay (ECLA) in patients with HCC (n=148), intrahepatic cholangiocellular carcinoma (n=37), gastric cancer and colorectal cancer (n=44), cirrhosis (n=63), chronic hepatitis B (n=38) and healthy subjects (n=57).To analyze the areas under the receiver operating characteristic curves (ROC-AUC) and to compare the sensitivity and specificity of single PIVKA-Ⅱ or AFP assay, and the combined detection.To analyze the correlation of PIVKA-Ⅱ and both tumor size and TNM staging, so do AFP, respectively.To compare the serum level changes of the two indicators in HCC patients before and after treatment.

The serum levels of both PIVKA-Ⅱ and AFP in HCC group were higher than that in intrahepatic cholangiocellular carcinoma, gastric cancer and colorectal cancer, cirrhosis, chronic hepatitis B and healthy subjects groups (PIVKA-Ⅱ：U=866.50, 424.00, 958.00, 292.00 and 448.00 ; AFP：U=713.00, 440.50, 1 182.00, 614.00 and 399.00, P<0.001) . The ROC-AUCs of the single PIVKA-Ⅱ or AFP assay and the combined detection in HCC group were not statistically different (P>0.05) . The sensitivity of PIVKA-Ⅱ（87.16%） was higher than that of AFP（68.92%，χ²=4.73，P<0.05）in diagnosing HCC; the sensitivity of the combined detection of PIVKA-Ⅱ and AFP（93.24%）was higher than that of PIVKA-Ⅱ itself （87.16%，adjusted χ²=64.70，P<0.01）; while the specificities among them did not show statistical significance (P>0.05).Tested by Spearman rank correlation, the serum levels of PIVKA-Ⅱ and AFP were both positively related to tumor size (r=0.716, 0.475 respectively, P<0.001).The serum levels of PIVKA-Ⅱ and AFP in HCC patients increased gradually correlated with tumor size (H=72.70, 37.02 respectively, P<0.001) and the positive rates of PIVKA-Ⅱ and AFP were gradually improved ( χ²=26.74, 21.62 respectively, P<0.01), too.Based on the International TNM Staging System, the serum levels of PIVKA-Ⅱ and AFP (H=46.63, 21.38 respectively, P<0.001) and the positive rates of PIVKA-Ⅱ and AFP (PIVKA-Ⅱ： χ² = 20.40，P<0.01；AFP： χ² = 8.33，P<0.05) in HCC patients fromⅠ-Ⅳ stages were increased as TNM stages elevated.The serum levels of PIVKA-Ⅱ and AFP in HCC patients were both dropped sharply compared with preoperative levels (Z=－4.59, －4.22 respectively, P<0.001) and also both dropped in each of theⅠ-Ⅳ TNM stages (PIVKA-Ⅱ:Z=-2.85、-2.98、-2.70 respectively, P<0.05; AFP:Z= -2.48、-3.82、-2.50 respectively, P<0.05) compared with serum levels before treatment.

PIVKA-Ⅱ and AFP both have high clinical application values in diagnosing HCC and monitoring treatment effects.The sensitivity of PIVKA-Ⅱ in diagnosing HCC is significantly higher than AFP, and the sensitivity can be elevated by the combined detection in diagnosing HCC without reducing the specificity.（Chin J Lab Med，2014,37：928-932）

Carcinoma, hepatocellular; Protein precursors; Prothrombin; Biological markers; Alpha-Fetoproteins