Department of Clinical Laboratory, Maternal and Children Health Care Hospital (Huzhong Hospital) of Huadu, Guangzhou, Guangdong, China.
Department of Clinical Laboratory, Chancheng Centre Hospital, Foshan, Guangdong, China.
Indian J Cancer. 2022 Apr-Jun;59(2):223-229. doi: 10.4103/ijc.IJC_752_19.
Pancreatic cancer (PC) has poor early diagnosis rates due to its insidious onset. Since human epididymis protein 4 (HE4) is highly expressed in patients with PC, we assessed whether serum HE4 could be a marker for the detection 3 of PC.
: Between May 2017 and October 2018, 127 patients with PC were recruited for the study along with 108 healthy controls who underwent health examinations. Serum HE4 concentrations were determined together with levels of carcinoembryonic antigen (CEA) and carbohydrate antigens (CA) 242 (CA242), CA19-9, CA15-3, and CA72-4 by electrochemiluminescence immunoassay (ECLIA) or chemiluminescence immunoassay (CLIA). Correlations between these biomarkers were assessed.
: Serum levels of all six biomarkers were higher in patients with PC than in controls (P < 0.05). No correlation was observed between the serum levels of HE4 and the five other tumor markers, although there were strongly significant positive correlations between CA19-9 and CA15-3, and between CA242 and CA72-4. The lack of correlation indicates that HE4 has independent value in the diagnosis of PC. The combined assessment of serum HE4 levels and the other tumor markers improved the sensitivity of diagnosis. In particular, HE4 combined with CA19-9 performed significantly better than HE4 alone, or CA19-9 combined with the other markers. The HE4/CA19-9 combination resulted in 94.49% sensitivity and 99.07% specificity (95% confidence interval: 96.9-100).
: HE4 is a biomarker associated with PC with a high specificity , either used alone, or evaluated with other biomarkers together improving the detection of PC. This study may provide a new clinical diagnostic approach for PC detection.
胰腺癌（PC）由于其隐匿性发病，早期诊断率较低。由于人附睾蛋白 4（HE4）在 PC 患者中高度表达，我们评估了血清 HE4 是否可作为 PC 检测的标志物。
2017 年 5 月至 2018 年 10 月，共招募了 127 例 PC 患者和 108 例接受健康检查的健康对照者。通过电化学发光免疫分析（ECLIA）或化学发光免疫分析（CLIA）测定血清 HE4 浓度以及癌胚抗原（CEA）和糖类抗原（CA）242（CA242）、CA19-9、CA15-3 和 CA72-4 的水平。评估这些生物标志物之间的相关性。
与对照组相比，PC 患者的六种生物标志物血清水平均升高（P<0.05）。尽管 CA19-9 和 CA15-3 之间以及 CA242 和 CA72-4 之间存在强烈的正相关，但 HE4 血清水平与其他五种肿瘤标志物之间无相关性。缺乏相关性表明 HE4 在 PC 的诊断中有独立的价值。血清 HE4 水平和其他肿瘤标志物的联合评估提高了诊断的敏感性。特别是，HE4 联合 CA19-9 的表现明显优于 HE4 单独使用，或 CA19-9 联合其他标志物。HE4/CA19-9 联合检测的敏感性为 94.49%，特异性为 99.07%（95%置信区间：96.9-100）。
HE4 是与 PC 相关的生物标志物，具有较高的特异性，无论是单独使用还是与其他标志物一起评估，均可提高 PC 的检测率。本研究可能为 PC 检测提供一种新的临床诊断方法。
