Qin X, Tang G, Gao R, Guo Z, Liu Z, Yu S, Chen M, Tao Z, Li S, Liu M, Wang L, Hou L, Xia L, Cheng X, Han J, Qiu L
Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, China.
Department of Cardiology, Beijing Hospital of the Ministry of Health, Beijing, China.
Int J Lab Hematol. 2017 Aug;39(4):392-401. doi: 10.1111/ijlh.12639. Epub 2017 Mar 20.
The aim of this study was to investigate the reference interval of protein-induced vitamin K absence or antagonist-II (PIVKA-II) in China population and to evaluate its medical decision level for hepatocellular carcinoma (HCC) diagnosis.
To determine the reference range for Chinese individuals, a total of 855 healthy subjects in five typical regions of China were enrolled in this study to obtain a 95% reference interval. In a case-control study which recruited the subjects diagnosed with HCC, metastatic liver cancer, bile duct cancer, hepatitis, cirrhosis, other benign liver diseases and the subjects administrated anticoagulant, receiver operating characteristic analysis was used to determine PIVKA-II cutoff value for a medical decision.
The concentration of PIVKA-II had no relationship with age or gender and that region was a significant factor associated with the level of PIVKA-II. The 95% reference interval determined in this study for PIVKA-II in Chinese healthy individuals was 28 mAU/mL, and the cutoff value which to distinguish patients with HCC from disease control groups is 36.5 mAU/mL.
In clinical applications, it is recommended that each laboratory chooses their own reference interval based on the regional population study or cutoff value for disease diagnosis.
本研究旨在调查中国人群中蛋白质诱导的维生素K缺乏或拮抗剂-II（PIVKA-II）的参考区间，并评估其在肝细胞癌（HCC）诊断中的医学决策水平。
为确定中国个体的参考范围，本研究纳入了中国五个典型地区的855名健康受试者，以获得95%的参考区间。在一项病例对照研究中，招募了被诊断为HCC、转移性肝癌、胆管癌、肝炎、肝硬化、其他良性肝病的受试者以及接受抗凝治疗的受试者，采用受试者操作特征分析来确定用于医学决策的PIVKA-II临界值。
PIVKA-II的浓度与年龄或性别无关，地区是与PIVKA-II水平相关的一个重要因素。本研究确定的中国健康个体PIVKA-II的95%参考区间为28 mAU/mL，区分HCC患者与疾病对照组的临界值为36.5 mAU/mL。
在临床应用中，建议每个实验室根据地区人群研究或疾病诊断的临界值选择自己的参考区间。
