【Abstract】：Objective To evaluate the clinical value of serum protein induced by vitamin K absence or antagonist-Ⅱ(PIVKA-Ⅱ) and alpha-fetoprotein (AFP), alone or in combination, in the diagnosis of hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). Methods A total of 450 patients with HBV infection, who underwent serological tests in the Department of Infectious Diseases, The Affiliated Hospital of Xuzhou Medical University, from February 2016 to June 2017, were enrolled in our hospital, including 200 patients with HBV-related HCC (80 surgically treated cases), 143 patients with hepatitis B cirrhosis, 65 patients with severe chronic hepatitis B (CHB), and 42 CHB patients with liver failure. The serum levels of PIVKA-Ⅱ and AFP were compared between the four groups. An analysis of variance was used to compare normally distributed continuous data between multiple groups; the Kruskal-Wallis H test was used to compare non-normally distributed continuous data between multiple groups, and the Mann-Whitney U test was used for further comparison between two groups. The chi-square test was used for comparison of categorical data between groups. A binary stepwise logistic regression was used to obtain a new variable as a combination of PIVKA-Ⅱ and AFP. The receiver operating characteristic (ROC) curve was used to calculate the area under the ROC curve (AUC) of AFP and PIVKA-Ⅱ, alone or in combination, in the diagnosis of HBV-related HCC, and the DeLong test was used for comparison of AUC between these variables. Results The HBV-related HCC patients had significantly higher PIVKA-Ⅱ and AFP levels than other groups (Z=-9.432, -6.369, -2.158, -13.202, -9.609, and -7.584, all P＜0.05). The PIVKA-Ⅱ levels of the patients with severe CHB and CHB patients with liver failure were significantly higher than that of the patients with hepatitis B cirrhosis (Z=-2.977 and -2.308, both P＜0.05). The HBV-related HCC patients showed significant reductions in AFP and PIVKA-Ⅱ levels within 5-7 days after surgical treatment (Z=-96.892 and -76.997, both P＜0.05). In the diagnosis of HBV-related HCC, PIVKA-Ⅱ had 84.0% sensitivity and 86.4% specificity, and AFP had 81.5% sensitivity and 50.4% specificity. The AUCs of AFP, PIVKA-Ⅱ, and a combination of AFP and PIVKA-Ⅱ in the diagnosis of HBV-related HCC were 0.757, 0.905, and 0.912, respectively; there were significant differences in AUC between PIVKA-Ⅱ and AFP (Z=6.048, P＜0.001) and between AFP and a combination of AFP and PIVKA-Ⅱ (Z=7.814, P＜0.001). A combination of AFP and PIVKA-Ⅱ had the highest diagnostic efficiency for HBV-related HCC. Conclusion Serum PIVKA-II has a better diagnostic value for HBV-related HCC than AFP, and a combination of the two can increase the detection rate of HCC and reduce the rate of misdiagnosis.
【Key words】：carcinoma, hepatocellular; PIVKA-Ⅱ; diagnosis