血清异常凝血酶原和甲胎蛋白联合检测对原发性肝癌的临床价值
혈청이상응혈매원화갑태단백연합검측대원발성간암적림상개치
The clinical value of serum PIVKA-Ⅱ and AFP detection for hepatocellular carcinoma
  • 万方数据
    中华检验医学杂志 중화검험의학잡지
    CHINESE JOURNAL OF LABORATORY MEDICINE
    2014年 12期 928-932 ,共5页

    席强%孙桂荣%丛培珊%刘明军%宗金宝

    석강%손계영%총배산%류명군%종금보

    癌,肝细胞%蛋白质前体%凝血酶原%生物学标记%甲胎蛋白类 癌,肝細胞%蛋白質前體%凝血酶原%生物學標記%甲胎蛋白類
    암,간세포%단백질전체%응혈매원%생물학표기%갑태단백류
    Carcinoma,hepatocellular%Protein precursors%Prothrombin%Biological markers%Alpha-Fetoproteins
    目的 探讨血清异常凝血酶原(PIVKA-Ⅱ)和甲胎蛋白(AFP)在原发性肝癌(HCC)诊断和疗效监测中的价值.方法 病例对照研究.用化学发光法和电化学发光法检测2013年8月至2014年3月期间青岛大学附属医院148例肝细胞癌、37例肝内胆管细胞癌、44例胃、结直肠癌、63例肝硬化、38例慢性乙型肝炎、57例体检健康者血清PIVKA-Ⅱ和AFP水平,分别分析两者单独及联合检测诊断HCC的受试者工作曲线下面积(ROC-AUC)、敏感度和特异性;分析血清PIVKA-Ⅱ和AFP水平与肿瘤直径大小及TNM分期的相关性;比较HCC患者治疗前后两指标血清水平的变化.结果 肝细胞癌组血清PIVKA-Ⅱ和AFP水平均高于肝内胆管细胞癌组、胃结直肠癌组、肝硬化组、慢性乙型肝炎组和健康对照组(PIVKA-Ⅱ:U值分别为866.50、424.00、958.00、292.00和448.00;AFP:U值分别为713.00、440.50、1 182.00、614.00和399.00,P均＜0.001).两指标单独检测和联合检测对HCC组患者的ROC-AUC均差异无统计学意义(P＞0.05).PIVKA-Ⅱ诊断HCC的敏感度(87.16％)高于AFP(68.92％,x2=4.73,P＜0.05),PIVKA-Ⅱ和AFP联合检测诊断HCC的敏感度(93.24％)高于PIVKA-Ⅱ单项检测(87.16％,校正x2 =64.70,P＜0.01),但特异度之间比较差异均无统计学意义(P＞0.05).Spearman秩相关分析显示,血清PIVKA-Ⅱ和AFP水平与肿瘤大小均呈正相关(相关系数分别为0.716和0.475,P均＜0.001).随肿瘤直径增大,HCC患者PIVKA-Ⅱ和AFP水平逐渐升高(H值分别为72.70、37.02,P均＜0.001);阳性率也逐渐提高(x2值分别为26.74、21.62,P均＜0.01).按国际肿瘤TNM分期,Ⅰ～Ⅳ期血清PIVKA-Ⅱ和AFP水平(H值分别为46.63、21.38,P均＜ 0.001)与阳性率(PIVKA-Ⅱx2=20.40,P＜0.01;AFP:x2 =8.33,P＜0.05)也随TNM肿瘤分期的增高而升高.HCC患者治疗后血清PIVKA-Ⅱ和AFP水平均低于治疗前(Z值分别为-4.59、-4.22,P均＜0.001),不同TNM分期患者治疗后PIVKA-Ⅱ(Z值分别为-2.85、-2.98、-2.70,P均＜0.05)和AFP水平均分别低于同期治疗前水平(Z值分别为-2.48、-3.82、-2.50,P均＜0.05).结论 血清PIVKA-Ⅱ和AFP对HCC诊断和疗效监测均具有较高的临床应用价值,PIVKA-Ⅱ诊断HCC的敏感度明显高于AFP,两者联合检测可提高单独检测的敏感度,而不降低其特异度.
    목적 탐토혈청이상응혈매원(PIVKA-Ⅱ)화갑태단백(AFP)재원발성간암(HCC)진단화료효감측중적개치.방법 병례대조연구.용화학발광법화전화학발광법검측2013년8월지2014년3월기간청도대학부속의원148례간세포암、37례간내담관세포암、44례위、결직장암、63례간경화、38례만성을형간염、57례체검건강자혈청PIVKA-Ⅱ화AFP수평,분별분석량자단독급연합검측진단HCC적수시자공작곡선하면적(ROC-AUC)、민감도화특이성;분석혈청PIVKA-Ⅱ화AFP수평여종류직경대소급TNM분기적상관성;비교HCC환자치료전후량지표혈청수평적변화.결과 간세포암조혈청PIVKA-Ⅱ화AFP수평균고우간내담관세포암조、위결직장암조、간경화조、만성을형간염조화건강대조조(PIVKA-Ⅱ:U치분별위866.50、424.00、958.00、292.00화448.00;AFP:U치분별위713.00、440.50、1 182.00、614.00화399.00,P균＜0.001).량지표단독검측화연합검측대HCC조환자적ROC-AUC균차이무통계학의의(P＞0.05).PIVKA-Ⅱ진단HCC적민감도(87.16％)고우AFP(68.92％,x2=4.73,P＜0.05),PIVKA-Ⅱ화AFP연합검측진단HCC적민감도(93.24％)고우PIVKA-Ⅱ단항검측(87.16％,교정x2 =64.70,P＜0.01),단특이도지간비교차이균무통계학의의(P＞0.05).Spearman질상관분석현시,혈청PIVKA-Ⅱ화AFP수평여종류대소균정정상관(상관계수분별위0.716화0.475,P균＜0.001).수종류직경증대,HCC환자PIVKA-Ⅱ화AFP수평축점승고(H치분별위72.70、37.02,P균＜0.001);양성솔야축점제고(x2치분별위26.74、21.62,P균＜0.01).안국제종류TNM분기,Ⅰ～Ⅳ기혈청PIVKA-Ⅱ화AFP수평(H치분별위46.63、21.38,P균＜ 0.001)여양성솔(PIVKA-Ⅱx2=20.40,P＜0.01;AFP:x2 =8.33,P＜0.05)야수TNM종류분기적증고이승고.HCC환자치료후혈청PIVKA-Ⅱ화AFP수평균저우치료전(Z치분별위-4.59、-4.22,P균＜0.001),불동TNM분기환자치료후PIVKA-Ⅱ(Z치분별위-2.85、-2.98、-2.70,P균＜0.05)화AFP수평균분별저우동기치료전수평(Z치분별위-2.48、-3.82、-2.50,P균＜0.05).결론 혈청PIVKA-Ⅱ화AFP대HCC진단화료효감측균구유교고적림상응용개치,PIVKA-Ⅱ진단HCC적민감도명현고우AFP,량자연합검측가제고단독검측적민감도,이불강저기특이도.
    Objective 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.Methods 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.Results 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％,x2 =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 x2 =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 (x2 =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:x2 =20.40,P ＜0.01 ;AFP:x2 =8.33,P ＜0.05) in HCC patients from Ⅰ-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 the Ⅰ-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.Conclusion 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.
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