PIVKA-Ⅱ与AFP对原发性肝癌诊断性能的验证及荟萃分析  

The Validation and Meta-analysis of PIVKA-Ⅱ and AFP in the Diagnosis of Primary Hepatocellular Carcinoma

作　　者：杨唯唯 刘铭[2] 游小芳[1] 韩厅蓄 张晨[1] 王国洪[1] 张燕[3] 王崑[2] 徐国宾[1] YANG Weiwei;LIU Ming;YOU Xiaofang;HAN Tingxu;ZHANG Chen;WANG Guohong;ZHANG Yan;WANG Kun;XU Guobin(Department of Clinical Laboratory,Key Laboratory of Carcinogenesis and Translational Research,Ministry of Education,Peking University Cancer Hospital and Institute,Beijing 100142,China;Department of Hepatopancreatobiliary Surgery Unit I,Key Laboratory of Carcinogenesis and Translational Research,Ministry of Education,Peking University Cancer Hospital and Institute,Beijing 100142,China;Department of Gastrointestinal Cancer Center,Key Laboratory of Carcinogenesis and Translational Research,Ministry of Education,Peking University Cancer Hospital and Institute,Beijing 100142,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所检验科,北京100142 [2]北京大学肿瘤医院暨北京市肿瘤防治研究所肝胆胰外一科,北京100142 [3]北京大学肿瘤医院暨北京市肿瘤防治研究所胃肠肿瘤中心一病区,恶性肿瘤发病机制及转化研究教部重点实验室,北京100142

出　　处：《标记免疫分析与临床》2020年第10期1683-1689,1705,共8页Labeled Immunoassays and Clinical Medicine

基　　金：北京市医管局临床医学发展专项(编号:ZYLX201701)。

摘　　要：目的比较异常凝血酶原(prothrombin induced by vitamin K absence or antagonist-Ⅱ,PIVKA-Ⅱ)化学发光法和酶联免疫法检测结果的一致性,并验证PIVKA-Ⅱ和AFP化学发光检测法对原发性肝癌的诊断性能。方法采用Spearman相关系数分析、偏差分析和阴阳性的符合率来评估化学发光法和酶联免疫法检测结果的一致性;观察健康人、肝炎和肝硬变以及肝癌组PIVKA-Ⅱ和AFP的水平,采用界值移动法评价PIVKA-Ⅱ和AFP诊断肝癌的特异性和灵敏度,并与荟萃分析得到的诊断性能比较。结果两种方法检测的血清PIVKA-Ⅱ水平具有良好的相关性(R2=0.925);以40 mAU/mL为诊断界值,两种方法检测PIVKA-Ⅱ阴阳性的符合率为100%。当PIVKA-Ⅱ<200 mAU/mL时,两种方法检测肝癌患者血清PIVKA-Ⅱ的绝对偏差小于10 mAU/mL,相对偏差大部分在20%以内。PIVKA-Ⅱ和AFP无相关性。当PIVKA-Ⅱ和AFP临界值分别为26.5 mAU/mL和15.5 ng/mL时,两者诊断肝癌的灵敏度分别为79.7%、56.3%,特异性分别为80.6%、78.3%。联合检查两项指标的阳性率可达86%,本结果与荟萃分析的诊断性能相似。结论酶联免疫法与电化学发光法检测PIVKA-Ⅱ水平具有良好的可比性,但仍有一定差异;AFP联合PIVKA-Ⅱ检测可提高原发性肝癌的诊断效率。Objective To compare the consistency of the results of prothrombin induced by vitamin K absence or antagonist-Ⅱ(PIVKA-Ⅱ) chemiluminescence and enzyme-linked immunosorbent assay, and to further verify the diagnostic performances of PIVKA-Ⅱ and AFP chemiluminescence on primary hepatocellular carcinoma.Methods Spearman correlation coefficient analysis, Deviation analysis and the coincidence rate of negative or positive were used to evaluate the consistency of the results of chemiluminescence and enzyme-linked immunosorbent assay. We examined the levels of PIVKA-Ⅱ and AFP in healthy people, hepatitis and cirrhosis patients, as well as the hepatocellular carcinoma group. The critical value movement method was used to evaluate the specificity and sensitivity of PIVKA-Ⅱ and AFP in the diagnosis of hepatocellular carcinoma, and the results were compared with the diagnostic performance obtained through a meta-analysis.Results The levels of PIVKA-Ⅱ of serum detected by the two methods were well correlated(R^2=0.925). PIVKA-Ⅱ was diagnosed with 40 mAU/mL as the cut-off value,and for patients with hepatocellular carcinoma, the coincidence rate of negative or positive was 100%. When PIVKA-Ⅱ <200 mAU/mL, the absolute deviation detected by the two methods was less than 10 mAU/mL, and the relative deviation was mostly within 20%. PIVKA-Ⅱ and AFP had no correlation. When the critical values of PIVKA-Ⅱ and AFP were 26.5 mAU/mL and 15.5 ng/mL respectively, the sensitivity and specificity of PIVKA-Ⅱand AFP in the diagnosis of hepatocellular carcinoma were 79.7% and 56.3%, respectively, and the specificity were 80.6% and 78.3%, respectively.The positive rate of the joint inspection of the two indicators could reach 86%. The results of this experiment were similar to those of the meta-analysis.Conclusion The detection of PIVKA-Ⅱ by enzyme-linked immunoassay and electrochemiluminescence has a good comparability but there are still some differences. AFP combined with PIVKA-Ⅱ can improve the diagnosis efficiency

关 键 词：肝癌 异常凝血酶原 甲胎蛋白 

分 类 号：R735.7[医药卫生—肿瘤]