| Background Liver cancer is still the leading malignant tumor in the world in terms of cancer incidence and mortality.AFP has always been the main serological indicator for liver cancer screening and diagnosis in my country.However,some patients are negative or have low concentrations of AFP and are difficult to be early diagnosis.Objective A case-control study was conducted to explore the employment of serum PIVKA-Ⅱcombined with AFP within the medical science designation of HCC.Methods Using the desired inclusion and exclusion criteria,270 eligible patients attending the Sinopharm Gezhouba Central Hospital,the Central People’s Hospital,and also the Municipal Cancer Hospital in Yichang,Hubei Province,between July 2018 and March2021 were elite for this study.Among these 270 patients were ninety patients with primary liver cancer(PLC),sixty patients with cirrhosis liver disease(LC),sixty patients with chronic hepatitis B(CHB),and sixty healthy people(HP),as well as sixty patients with hepatoma(HCC)and thirty patients with intrahepatic cholangiocarcinoma(ICC)among the patients with cancer of the liver.Collected 5ml of fasting venous blood and detected the serum PIVKA-Ⅱand AFP concentrations by chemiluminescence above those subjects.Above those five groups,the serum PIVKA-Ⅱand AFP levels and positive rates was compared.According to the AFP concentration,PLC is divided into AFP-negative liver cancer(AFP<8.1ng/ml),AFP low-concentration liver cancer(8.1≤AFP<200 ng/ml)and AFP high-concentration liver cancer(AFP≥200 ng/ml).he serum PIVKA-Ⅱconcentration in patients with primary liver cancer was compared with different AFP levels,tumor diameters and whether they were combined with liver cirrhosis.Used receiver operating characteristic curve(ROC curve)to assess the supplement diagnosis of AFP low-level liver cancer by serum PIVKA-Ⅱand estimate the diagnosis ability of primary hepatocellular carcinoma by serum PIVKA-Ⅱand AFP alone and in combination.Determine the cut-off value of serum PIVKA-Ⅱand AFP for the diagnosis of primary hepatocellular carcinoma according to the corresponding variable value when the Youden index(sensitivity+specificity-1)is maximum,and calculate the cut-off value for the detection of serum PIVKA alone and in combination-Ⅱ.Specificity,sensitivity,negative prophetical worth(-PV),positive predictive price(+PV)and total coincidence rate of the serum markers in the diagnosis of HCC.Results(1)It was 33.00(21.00,76.00)m AU/ml in 55 cases of AFP-negative liver cancer what median concentration of serum PIVKA-Ⅱwas,the median concentration in 22 cases of AFP low-concentration liver cancer was 719.50(32.5,1161.75)m AU/ml,and the median concentration in 13 cases of AFP high-concentration liver cancer was 1135.00(155,1692.5)m AU/ml.The statistical analysis of the three groups showed that compared with AFP-negative liver cancer,the serum PIVKA-Ⅱlevel was relatively higher in AFP low-concentration and high-concentration liver cancer(P<0.01),but the serum PIVKA-Ⅱlevel was relatively higher in AFP low-concentration and high-concentration liver cancer which was no statistically significant difference in high-concentration liver cancer(P>0.05).The median concentrations of PIVKA-Ⅱin liver cancers with a diameter of less than 3 cm were 48.00(27.75,207.50)m AU/ml and the cancer with a diameter of 3 to 5 cm was 1144.50(65.00,1748.75)m AU/ml.(P<0.05).the median concentration of AFP in liver cancers with a diameter of less than 3 cm was 4.00(2.18,29.35)ng/ml and 6.50(2.31,80.62)ng/ml in a diameter of 3 to 5 cm,respectively(P>0.05).It shows that the level of serum PIVKA-Ⅱwas related to the tumor diameter which that the size was bigger and the level was higher.Serum foetoprotein concentration is higher in liver disease with liver disease than in patients while not liver disease(PIVKA-Ⅱ:650.00 m AU/ml,48.00 m AU/ml,P>0.05;AFP were 9.00 ng/ml and 3.30 ng/ml,P<0.05),but the concentration of serum PIVKA-Ⅱin liver cancer with cirrhosis and without cirrhosis has little difference(Z=-0.886,P=0.376).(2)The area under the ROC curve for the diagnosis of low-level AFP liver cancer by serum PIVKA-Ⅱwas 0.793(Z=9.147,P<0.001).It shows that serum PIVKA-Ⅱhas a moderate level of diagnostic ability for low-level AFP liver cancer.(3)The median humour PIVKA-II concentration within the primary malignant hepatoma cluster was 205.00 m AU/ml,that was considerably over than that within the ICC cluster(30.5m AU/ml),the CHB cluster(21.00 m AU/ml),the LC cluster(20.50 m AU/ml)and also the HP cluster(20.50 m AU/ml)(Z=-4.036,-6.768,-7.211,-7.477,P<0.05).Comparison of humour PIVKA-II concentrations with healthy controls discovered no vital variations between the LC cluster and also the CHB cluster(Z=-1.918,-0.717,P>0.05).Meanwhile,the comparison of AFP concentrations in every cluster yielded a median serum AFP concentration of eight.90ng/ml within the HCC cluster,that was above that within the ICC cluster(2.40 ng/ml),the CHB cluster(3.97 ng/ml),the LC hepatitis cluster(3.70 ng/ml)and also the management healthy cluster(2.32 ng/ml),the variations between all teams compared were statistically vital(Z=-3.642,-1.992,-2.706,-5.512,P<0.05).When compared with healthy controls,AFP levels were higher in PLC,CHB and LC(P>0.05),however there was no statistically vital distinction between ICC and healthy controls(Z=-1.439,P=0.150).(4)The positive rate of each markers during this part of the comparison of the four teams,patients with PIVKA-II expression on top of the cut-off worth accounted for seventieth of all HCC teams,and therefore the positive altogether different teams was below within the HCC cluster,wherever patients with ICC(30%),LC(13.3%)and CHB(6.7%),all differed from the HCC cluster in positive rates with statistically vital(х~2=13.032,39.634,50.905,P<0.05).By conniving the positive rate of AFP was conjointly found to be the best in HCC patients,with a positive rate of 30.3%,once more all beyond in different management teams,wherever the positive rates in patients with ICC(6.7%),CHB(31.7%)and LC(23.3%),differed from the HCC cluster(х~2=18.529,5.763,11.422,P<0.05).AFP positivism rate was considerably higher within the LC and CHB teams than within the ICC cluster(х~2=6.988,3.801,P<0.05).The positive rates of PIVKA-II and AFP within the HCC cluster were additional compared.it absolutely was found that 25 cases were positive for each,accounting for 41.7%of all HCC,14 cases were negative for each,accounting for 23.3%of all,17 cases were positive for PIVKA-II and negative for AFP,accounting for 28.3%of all cases,and therefore the remaining 4 cases were positive for AFP however negative for PIVKA-II,accounting for6.7%.Byх~2 test,the speed of PIVKA-II quality within the primary carcinoma cluster was more than that of AFP quality(х~2=7.020,P=0.008).(5)Performed on the PIVKA-II and AFP levels of all subjects by Spearman rank correlation analysis,and r_s=0.247(p<0.05)which means the the levels of serum PIVKA-II and AFP hasn’t relationship.(6)The area underneath the curve of PIVKA-II was 0.848(95%CI:0.792～0.894),and therefore the best cut-off price of PIVKA-II for the identification of HCC was 42.50 m AU/ml at a index of 0.573,with a sensitivity of 0.7 and a specificity of 0.792.the curve for AFP is0.647(95%CI:0.578～0.711),and therefore the best cut-off price for AFP was 20.8 ng/ml once the index wais 0.330,with a sensitivity of 55.0%and a specificity of 88.0%.the area was 0.890(95%CI:0.840～0.929).If the two liquid were combined for identification we found that the sensitivity and specificity of the check were somewhat improved,reaching 72.5%and91.7%,severally.Conclusion(1)The level of serum PIVKA-Ⅱis likely to associate with tumor size;(2)Serum PIVKA-Ⅱhas auxiliary diagnostic value for liver cancer with low AFP level;(3)Serum PIVKA-Ⅱand AFP has good specificity in primary liver cancer,especially in HCC;(4)Serum PIVKA-Ⅱand AFP have no obvious correlation;(5)Serum PIVKA-II has higher sensitivity than AFP,however less specificity than AFP.Combining the two will improve each the sensitivity and specificity of the assay,and has higher diagnostic effectiveness. |
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