Objective: To examine the value of serum protein induced by vitamin K absence or antagonist-Ⅱ (PIVKA-Ⅱ) detection in the early diagnosis and surveillance of hepatocellular carcinoma (HCC). Methods: The clinical data of 215 patients with HCC admitted to Department of Hepatobiliary-Pancreatic Surgery of China-Japan Union Hospital of Jilin University from October 2017 to May 2018 were analyzed retrospectively. There were 172 males and 43 females, aged of (59.0±9.3) years old (range 34 to 86 years old). In addition, there were 85 non HCC patients were enrolled in the control group, 42 males and 43 females, aged (54.2±11.3) years old (range 22 to 80 years old). The blood sample of 3 ml was drawn from the elbow vein at 6∶00 am on the next day of admission, and then was kept in low temperature away from light, and sent for PIVKA-Ⅱ detection on the same day. The positive value of AFP was ≥20 μg/L and PIVKA-Ⅱ was ≥32 AU/L. The data were analyzed statistically by χ(2) test, t test or rank sum test. The correlation between AFP, PIVKA-Ⅱ and tumor maximum diameter was analyzed by linear regression. Results: The sensitivity of PIVKA-Ⅱ detection only for the diagnosis of HCC in all stages was significantly higher than AFP or equivalent to AFP, the overall sensitivity of PIVKA-Ⅱ and AFP was 85.1% and 52.1%, respectively. But the specificity of PIVKA-Ⅱ was lower than that of AFP, they were 78.8% and 96.5%, respectively. In particularly, in the earlier stage of HCC (Ⅰa) , the sensitivity of PIVAK-Ⅱ to HCC was 64.5%, while the AFP was only 26.3%. Combined detection of PIVKA-Ⅱ and AFP significantly improved the diagnostic rate of HCC to 88.4%, and the specificity to 76.5%. Moreover, there was a positive correlation between PIVKA-Ⅱ level and the maximum tumor diameter (r(2)=0.587, P<0.05), but there was no correlation between the AFP level and the maximum tumor diameter (r(2)=0.296, P>0.05). The positive rate of PIVKA-Ⅱ in the diagnosis of HCC with vascular invasion was also significantly higher than that of AFP (P<0.01) . Conclusions: PIVKA-Ⅱ can be used as a serological marker for HCC screening and diagnosis. In particular, PIVKA-Ⅱ detection was significantly sensitive than AFP in the earlier stage of HCC. Combined detection of PIVKA-Ⅱ and AFP can effectively improve the diagnostic rate of HCC in all stages. The significant elevation of PIVKA-Ⅱ is also helpful to determine the tumor aggressiveness, vascular invasion and prognosis of HCC patients.
目的： 探讨血清异常凝血酶原（PIVKA-Ⅱ）检测在肝细胞肝癌（HCC）早期诊断和监测中的价值。 方法： 回顾性分析2017年10月至2018年5月吉林大学中日联谊医院肝胆胰外科收治的215例HCC患者的临床资料。男性172例，女性43例，年龄（59.0±9.3）岁（范围：34~86岁）。另纳入同期收治的85例非HCC患者作为对照组，男性42例，女性43例，年龄（54.2±11.3）岁（范围：22~80岁）。患者入院后第2天清晨6时，采用真空采血管，空腹采肘静脉血约3 ml，避光低温保存，当日送检。取甲胎蛋白（AFP）≥20 μg/L为阳性，PIVKA-Ⅱ≥32 AU/L为阳性。数据的比较采用χ(2)检验、t检验或秩和检验。采用线性回归分析AFP和PIVKA-Ⅱ与肿瘤最大径的相关性。 结果： PIVKA-Ⅱ单独检测在HCC各期的灵敏度均高于或等于AFP，PIVKA-Ⅱ和AFP单独诊断HCC的总体灵敏度分别为85.1%和52.1%，但PIVKA-Ⅱ的特异度不及AFP高，分别为78.8%和96.5%。在HCC的早期（Ⅰa期），PIVKA-Ⅱ单独检测的灵敏度为64.5%，而AFP的灵敏度仅为26.3%。两者联合检测可提高HCC诊断的灵敏度至88.4%，特异度至76.5%。PIVKA-Ⅱ值与肿瘤最大径呈正相关（r(2)=0.587，P<0.05），而AFP水平与肿瘤最大径无相关性（r(2)=0.296，P>0.05），PIVKA-Ⅱ诊断伴有血管侵犯的HCC患者的阳性率亦高于AFP（P<0.01）。 结论： PIVKA-Ⅱ可作为HCC筛查和诊断的血清学标志物，在早期肝癌诊断的阳性率显著高于AFP。PIVKA-Ⅱ和AFP联合检测可有效提高HCC各期检出率。PIVKA-Ⅱ的大幅度增高有助于协助判断HCC的侵袭性、是否存在血管侵犯及预后等。.
Keywords: Alpha fetal protein; Diagnosis; Liver neoplasm; Protein induced by vitamin K absence or antagonist-Ⅱ; Sensitivity; Specificity.