机构地区:[1]Hepatobiliary Division,Department of Internal Medicine,Kaohsiung Medical University Hospital,Kaohsiung Medical University,Kaohsiung [2]PhD Program in Translational Medicine,College of Medicine,Kaohsiung Medical University,and Academia Sinica,Kaohsiung [3]Faculty of Internal Medicine,School of Medicine and Hepatitis Research Center,College of Medicine,Kaohsiung Medical University,Kaohsiung [4]Clinical Algorithms&Biomarker Statistics,Roche Diagnostics GmbH,Penzberg,Germany [5]Department of Internal Medicine,Kaohsiung Municipal Siaogang Hospital,Kaohsiung Medical University,Kaohsiung [6]Department of Internal Medicine,Kaohsiung Municipal Ta-Tung Hospital,Kaohsiung Medical University,Kaohsiung [7]Clinical Development&Medical Affairs,Roche Diagnostics International AG,Rotkreuz,Switzerland [8]School of Medicine and Doctoral Program of Clinical and Experimental Medicine,College of Medicine and Center of Excellence for Metabolic Associated Fatty Liver Disease,National Sun Yat-sen University,Kaohsiung
出 处:《Journal of Clinical and Translational Hepatology》2024年第11期907-916,共10页临床与转化肝病杂志(英文版)
基 金:funded by Roche Diagnostics GmbH and partly supported by the“Center of Excellence for Metabolic Associated Fatty Liver Disease,National Sun Yat-sen University,Kaohsiung”,under The Featured Areas Research Center Program within the framework of the Higher Education Sprout Project by the Ministry of Education in Taiwan.
摘 要:Background and Aims:Early detection of hepatocellular carcinoma(HCC)is crucial for improving survival in patients with chronic hepatitis.The GALAD algorithm combines gen-der(biological sex),age,α-fetoprotein(AFP),Lens culinaris agglutinin-reactive fraction of AFP(AFP-L3),and protein in-duced by vitamin K absence or antagonist-II(PIVKA-II)for HCC detection.Similarly,the GAAD algorithm incorporates gender(biological sex),age,AFP,and PIVKA-II.This study aimed to assess the clinical utility of AFP-L3 in the GALAD algorithm and its potential synergies with ultrasound.We compared the clinical performance of GALAD with GAAD;AFP;AFP-L3;and PIVKA-II,with or without ultrasound,in Taiwan residents adults.Methods:A total of 439 serum samples were analyzed using a Cobas®e 601 analyzer(healthy con-trols,n=200;chronic liver disease controls,n=177;HCC cases,n=62).Performance was assessed through receiver operating characteristic curve analyses to calculate the area under the curve.Results:The area under the curve for dif-ferentiating early-stage HCC from patients with chronic liver disease was optimal for PIVKA-II(84.9%),GAAD(79.8%),and GALAD(79.4%),with slightly improved performance for detecting all-stage HCC.Clinical performance was unaffected by disease stage or etiology.Sensitivity for early-stage HCC was highest for GAAD(57.6%)and GALAD(57.6%).Sen-sitivity for each strategy was further enhanced when com-bined with ultrasound,regardless of disease stage or etiology(P<0.01).Conclusions:These findings indicate that the role of AFP-L3 in the GALAD algorithm is minimal,supporting the use of GAAD for HCC detection.A combination of GAAD,GALAD,or PIVKA-II with ultrasound may improve diagnostic efficiency compared with recommended strategies.
关 键 词:Algorithm Biomarkers CIRRHOSIS Diagnosis DETECTION GAAD GALAD Hepatocellular carcinoma Liver cancer SURVEILLANCE Ultrasound
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