PIVKA-II 联合甲胎蛋白对儿童肝肿瘤的诊断价值：一项多中心、前瞻性观察研究。
PIVKA-II combined with alpha-fetoprotein for the diagnostic value of hepatic tumors in children: a multicenter, prospective observational study.
机构信息
Department of Pediatric General Surgery, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Dongfang Road No. 1678, Pudong New District, Shanghai, 200127, China.
Department of Laboratory Medicine, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.
出版信息
Hepatol Int. 2024 Aug;18(4):1326-1335. doi: 10.1007/s12072-024-10668-4. Epub 2024 Apr 16.
BACKGROUND
To investigate whether protein induced by vitamin K antagonist-II (PIVKA-II) combined with alpha-fetoprotein (AFP) can improve the diagnostic and differential diagnostic accuracy of childhood hepatic tumors.
METHODS
A multi-center prospective observational study was performed at nine regional institutions around China. Children with hepatic mass (Group T) were divided into hepatoblastoma group (Group T) and hemangioendothelioma group (Group T), children with extrahepatic abdominal mass (Group C). Peripheral blood was collected from each patient prior to surgery or chemotherapy. The area under the curve (AUROC) was used to evaluate the diagnostic efficiency of PIVKA-II and the combined tumor markers with AFP.
RESULTS
The mean levels of PIVKA-II and AFP were both significantly higher in Group T than Group C (p = 0.001, p < 0.001), in Group T than Group T (p = 0.018, p = 0.013) and in advanced HB than non-advanced HB (p = 0.001, p = 0.021). For the diagnosis of childhood hepatic tumors, AUROC of PIVKA-II (cut-off value 32.6 mAU/mL) and AFP (cut-off value 120 ng/mL) was 0.867 and 0.857. The differential diagnostic value of PIVKA-II and AFP in hepatoblastoma from hemangioendothelioma was further assessed, AUROC of PIVKA-II (cut-off value 47.1mAU/mL) and AFP (cut-off value 560 ng/mL) was 0.876 and 0.743. The combined markers showed higher AUROC (0.891, 0.895 respectively) than PIVKA-II or AFP alone.
CONCLUSIONS
The serum level of PIVKA-II was significantly higher in children with hepatic tumors, especially those with malignant tumors. The combination of PIVKA-II with AFP further increased the diagnostic performance.
TRIAL REGISTRATION
Clinical Trials, NCT03645655. Registered 20 August 2018, https://www.
CLINICALTRIALS
gov/ct2/show/NCT03645655 .
背景
为了探讨维生素 K 拮抗剂-II（PIVKA-II）诱导蛋白联合甲胎蛋白（AFP）是否能提高儿童肝肿瘤的诊断和鉴别诊断准确性。
方法
在中国 9 个地区中心进行了一项多中心前瞻性观察性研究。有肝脏肿块的儿童（T 组）分为肝母细胞瘤组（T 组）和血管内皮细胞瘤组（T 组），有肝外腹部肿块的儿童（C 组）。每位患者在手术或化疗前采集外周血。采用曲线下面积（AUROC）评估 PIVKA-II 和联合 AFP 的肿瘤标志物的诊断效率。
结果
T 组的 PIVKA-II 和 AFP 水平均显著高于 C 组（p=0.001，p<0.001），T 组也显著高于 T 组（p=0.018，p=0.013），晚期 HB 也显著高于非晚期 HB（p=0.001，p=0.021）。对于儿童肝肿瘤的诊断，PIVKA-II（截断值 32.6 mAU/mL）和 AFP（截断值 120ng/mL）的 AUROC 分别为 0.867 和 0.857。进一步评估 PIVKA-II 和 AFP 在肝母细胞瘤与血管内皮细胞瘤中的鉴别诊断价值，PIVKA-II（截断值 47.1 mAU/mL）和 AFP（截断值 560ng/mL）的 AUROC 分别为 0.876 和 0.743。联合标志物的 AUROC 高于 PIVKA-II 或 AFP 单独检测（分别为 0.891、0.895）。
结论
儿童肝肿瘤，尤其是恶性肿瘤患儿血清 PIVKA-II 水平明显升高。PIVKA-II 联合 AFP 进一步提高了诊断效能。
试验注册
临床试验，NCT03645655。于 2018 年 8 月 20 日注册，https://www.clinicaltrials.gov/ct2/show/NCT03645655。
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