Kuromatsu R, Tanaka M, Shimauchi Y, Shimada M, Tanikawa K, Watanabe K, Yokoo T
Second Department of Internal Medicine, Kurume University School of Medicine, Japan.
J Gastroenterol. 1997 Aug;32(4):507-12. doi: 10.1007/BF02934091.
As a tumor marker for hepatocellular carcinoma (HCC), serum protein induced by vitamin K absence or antagonist-II (PIVKA-II) has high specificity, yet its sensitivity is relatively low, marking it less suitable to serve as an adjunct in the diagnosis of small HCC. Recently, the ED036 kit (Eisai, Tokyo, Japan), whose detection limit is approximately ten times superior to that of a conventional kit (Eitest MONOP II, Eisai) has been developed. In this study, serum PIVKA-II levels in serum samples from 83 patients with benign chronic liver diseases (CLD) and 129 patients with HCC were measured with those two kits. With the ED036 kit, the cut-off value was set at 40 mAU/ml. For PIVKA-II measured with the ED036 kit, sensitivity was 45.0%, specificity 92.8%, and accuracy 63.7%, when we discriminated patients with HCC from those with CLD without HCC. While maintaining a high specificity, of 92.8%, the ED036 kit showed a significantly higher sensitivity than the conventional kit (45.0% versus 27.9%; P < 0.0001). With patients who had HCC consisting of a single nodule 30 mm or less in diameter, the positivity rate for serum PIVKA-II with the ED036 kit was significantly greater than the rate with the conventional kit (21.4% versus 9.5%; P < 0.005). Thus, the ED036 kit was thought to be more useful than the conventional kit as a tumor marker for small HCC.
作为肝细胞癌（HCC）的肿瘤标志物，维生素K缺乏或拮抗剂-II诱导的血清蛋白（PIVKA-II）具有高特异性，但其敏感性相对较低，这使得它不太适合作为小肝癌诊断的辅助手段。最近，已开发出ED036试剂盒（日本东京卫材株式会社），其检测限约为传统试剂盒（Eitest MONOP II，卫材）的十倍。在本研究中，用这两种试剂盒测量了83例良性慢性肝病（CLD）患者和129例HCC患者血清样本中的血清PIVKA-II水平。使用ED036试剂盒时，临界值设定为40 mAU/ml。在用ED036试剂盒测量PIVKA-II时，当我们区分HCC患者和无HCC的CLD患者时，敏感性为45.0%，特异性为92.8%，准确性为63.7%。在保持92.8%的高特异性的同时，ED036试剂盒显示出比传统试剂盒显著更高的敏感性（45.0%对27.9%；P < 0.0001）。对于直径30 mm或更小的单个结节性HCC患者，ED036试剂盒检测血清PIVKA-II的阳性率显著高于传统试剂盒（21.4%对9.5%；P < 0.005）。因此，ED036试剂盒被认为作为小肝癌的肿瘤标志物比传统试剂盒更有用。
