化学发光微粒子免疫法测定维生素K缺乏诱导蛋白成人参考区间的建立

doi:10.3969/j.issn.1673-8640.2019.12.003

摘要/Abstract

摘要：

目的建立绵阳地区化学发光微粒子免疫法（CMIA）测定血清维生素K缺乏诱导蛋白（PIVKA-Ⅱ）的成人参考区间,并探讨病毒性肝炎、肝硬化和肝细胞肝癌（HCC）患者血清PIVKA-Ⅱ水平的变化。方法采用化学发光微粒子免疫法测定674名表观健康者、147例病毒性肝炎患者、90例肝硬化患者及98例HCC患者血清PIVKA-Ⅱ水平。采用x±1.96s方式建立PIVKA-Ⅱ的参考区间。采用受试者工作特征（ROC）曲线评估PIVKA-Ⅱ诊断肝炎、肝硬化及HCC的效能。结果 674名表观健康者血清PIVKA-Ⅱ测定值呈近似正态分布（z=1.428,P=0.034）,男、女性之间血清PIVKA-Ⅱ水平差异无统计学意义（P>0.05）,按年龄分组（18~30岁组、31~44岁组、45~59岁组、60~69岁组、≥70岁组）后各年龄组之间血清PIVKA-Ⅱ水平差异均无统计学意义（P>0.05）。合并数据后采用x±1.96s方式建立的参考区间为8.75~36.72 U/L。与正常对照组比较,病毒性肝炎组、肝硬化组和HCC组血清PIVKA-Ⅱ水平均明显升高（P<0.001）。HCC组血清PIVKA-Ⅱ水平明显高于病毒性肝炎组、肝硬化组（P<0.001）,而病毒性肝炎组与肝硬化组之间差异无统计学意义（P>0.05）。ROC曲线分析结果显示,血清PIVKA-Ⅱ诊断病毒性肝炎、肝硬化和HCC的曲线下面积分别为0.656、0.663、0.900,最佳临界值分别为27.27、29.86和40.36 U/L,敏感性分别为49.7%、52.2%和80.6%,特异性分别为75.7%、80.8%和94.5%。结论初步建立了绵阳地区CMIA检测血清PIVKA-Ⅱ的成人参考区间。PIVKA-Ⅱ在病毒性肝炎和肝硬化等非肝癌患者中也有不同程度的升高,因此不宜单独作为HCC标志物使用。

关键词: 维生素K缺乏诱导蛋白, 参考区间, 化学发光微粒子免疫法, 肝细胞肝癌

Abstract:

Objective To establish the reference interval of adult protein-induced vitamin K absence/antagonist Ⅱ（PIVKA-Ⅱ） in Mianyang by chemiluminescent microparticle immunoassay（CMIA）,and to investigate the change of PIVKA-Ⅱ levels in patients with viral hepatitis,cirrhosis and hepatocellular carcinoma（HCC）. Methods Serum PIVKA-Ⅱ levels were determined by CMIA in 674 healthy subjects,147 viral hepatitis patients,90 cirrhosis patients and 98 HCC patients. The reference interval of PIVKA-Ⅱwas established by x±1.96s. The diagnostic efficiency of PIVKA-Ⅱto viral hepatitis,cirrhosis and HCC was evaluated by receiver operating characteristic（ROC） curve. Results The results of serum PIVKA-Ⅱ determination of 674 healthy subjects showed approximate normal distribution（z=1.428,P=0.034）,and there was no statistical significance between males and females（P>0.05）. The subjects were classified according to ages（18-30-year-old,31-44-year-old,45-59-year-old,60-69-year-old and ≥70-year-old groups）,and there was no statistical significance in these groups（P>0.05）. The data were merged,and the reference interval established by x±1.96s was 8.75-36.72 U/L. Compared to healthy control group,serum PIVKA-Ⅱ levels in viral hepatitis group,cirrhosis group and HCC group increased（P<0.001）. Serum PIVKA-Ⅱ levels in HCC group were higher than those in viral hepatitis group and cirrhosis group（P<0.001）,and there was no statistical significance between viral hepatitis group and cirrhosis group（P>0.05）. By ROC curve analysis,the areas under curve（AUC） of serum PIVKA-Ⅱ for viral hepatitis,cirrhosis and HCC were 0.656,0.663 and 0.900,and the optimal cut-off values were 27.27,29.86 and 40.36 U/L,the sensitivities were 49.7%,52.2% and 80.6%,and the specificities were 75.7%,80.8% and 94.5%,respectively. Conclusions The reference interval of serum adult PIVKA-Ⅱ by CMIA in Mianyang has preliminarily been established. PIVKA-Ⅱ increases in various degrees in patients with non-liver cancer,such as viral hepatitis and cirrhosis,and it should not be used alone as a marker of HCC.

Key words: Protein-induced vitamin K absence/antagonist Ⅱ, Reference interval, Chemiluminescent microparticle immunoassay, Hepatocellular carcinoma

中图分类号:

R446.1

唐洁, 杨渝伟, 王堃, 喻晶. 化学发光微粒子免疫法测定维生素K缺乏诱导蛋白成人参考区间的建立[J]. 检验医学, 2019, 34(12): 1072-1076.

TANG Jie, YANG Yuwei, WANG Kun, YU Jing. Establishment the reference interval of adult protein-induced vitamin K absence/antagonist Ⅱ by chemiluminescent microparticle immunoassay[J]. Laboratory Medicine, 2019, 34(12): 1072-1076.

图/表 4

参考文献 10

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组别	例数	PIVKA-Ⅱ（U/L）
18~30岁组	15	24.10±7.92
31~44岁组	179	22.99±7.17
45~59岁组	310	23.13±6.92
60~69岁组	128	21.61±7.34
≥70岁组	42	21.75±7.61
F值		1.409
P值		0.229

组别	例数	PIVKA-Ⅱ（U/L）
18~30岁组	15	24.10±7.92
31~44岁组	179	22.99±7.17
45~59岁组	310	23.13±6.92
60~69岁组	128	21.61±7.34
≥70岁组	42	21.75±7.61
F值		1.409
P值		0.229

组别	例数	PIVKA-Ⅱ（U/L）
HCC组	98	1 091.38（13.29~283 389.09）
肝硬化组	90	30.09（9.05~324.08）
病毒性肝炎组	147	27.02（8.46~77.14）
正常对照组	674	22.24（6.03~44.82）
F值		282.667
P值		<0.001

组别	例数	PIVKA-Ⅱ（U/L）
HCC组	98	1 091.38（13.29~283 389.09）
肝硬化组	90	30.09（9.05~324.08）
病毒性肝炎组	147	27.02（8.46~77.14）
正常对照组	674	22.24（6.03~44.82）
F值		282.667
P值		<0.001

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