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血浆miRNA检测在极早期肝细胞癌鉴别诊断中的应用：一项多中心真实世界研究

Plasma miRNA testing in the differential diagnosis of very early-stage hepatocellular carcinoma: a multicenter real-world study

    摘要
  • 摘要:
    目的 探讨血浆7个微小RNA（miR7）检测在极早期肝细胞癌（hepatocellular carcinoma，HCC）鉴别诊断中的应用。
    方法 本研究为多中心真实世界研究。回顾性选择2019年1月至2024年12月于复旦大学附属中山医院、浙江大学医学院附属邵逸夫医院、安徽省立医院、北京大学人民医院就诊并检测血浆miR7的肝脏单发小结节（最大径≤2 cm）患者，分为极早期HCC组和非HCC组，比较2组患者的临床特征。采用受试者工作特征（receiver operating characteristic，ROC）曲线及曲线下面积（area under the curve，AUC）评价血浆miR7水平、甲胎蛋白（alpha-fetoprotein，AFP）和异常凝血酶原（des-gamma-carboxy prothrombin，DCP）在极早期HCC鉴别诊断中的价值。在AFP和DCP均阴性（AFP＜20 ng/mL、DCP＜40 mAU/mL）的患者中，分析血浆miR7检测对极早期HCC的诊断价值。
    结果  4家医院共64 528例患者接受miR7检测，最终纳入1 682例，其中1 073例被诊断为极早期HCC，609例被诊断为非HCC。HCC组患者miR7阳性率显著高于非HCC组患者（67.9% vs 24.3%，P＜0.001）。ROC曲线结果显示：在肝脏单发小结节患者中，miR7、AFP、DCP诊断极早期HCC的AUC分别为0.718、0.682和0.642，灵敏度分别为67.85%、43.71%、44.45%，特异度分别为75.70%、92.78%、83.91%。对AUC进行两两比较显示：血浆miR7检测的诊断效能显著优于AFP和DCP（P＜0.05），虽然其特异度稍低于AFP和DCP，但灵敏度显著高于AFP和DCP。在AFP和DCP均阴性的患者中，miR7对极早期HCC的诊断AUC仍为0.728，灵敏度为67.82%、特异度为77.73%。
    结论 血浆miR7检测是一种灵敏度和特异度较高的肝脏小结节鉴别诊断分子指标。在缺乏有效分子标志物（AFP及DCP阴性）的极早期HCC患者中，miR7可作为新的有效分子标志物以辅助诊断。

     

    Abstract:
    Objective To explore the application of plasma 7 microRNA (miR7) testing in the differential diagnosis of very early-stage hepatocellular carcinoma (HCC).
    Methods This study is a multicenter real-world study. Patients with single hepatic lesion (maximum diameter≤2 cm) who underwent plasma miR7 testing at Zhongshan Hospital, Fudan University, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Anhui Provincial Hospital, and Peking University People’s Hospital between January 2019 and December 2024 were retrospectively enrolled. Patients were divided into very early-stage HCC group and non-HCC group, and the clinical pathological characteristics of the two groups were compared. The value of plasma miR7 levels, alpha-fetoprotein (AFP), and des-gamma-carboxy prothrombin (DCP) in the differential diagnosis of very early-stage HCC was evaluated using receiver operating characteristic (ROC) curves and area under the curve (AUC). In patients with both negative AFP and DCP (AFP＜20 ng/mL, DCP＜40 mAU/mL), the diagnostic value of plasma miR7 for very early-stage HCC was analyzed.
    Results A total of 64 528 patients from 4 hospitals underwent miR7 testing, and 1 682 were finally included, of which 1 073 were diagnosed with very early-stage HCC and 609 were diagnosed with non-HCC. The positive rate of miR7 in HCC patients was significantly higher than that in non-HCC patients (67.9% vs 24.3%, P＜0.001). ROC curves showed that the AUCs for miR7, AFP, and DCP in distinguishing HCC patients from the non-HCC individuals were 0.718, 0.682, and 0.642, respectively. The sensitivities were 67.85%, 43.71%, and 44.45%, and the specificities were 75.70%, 92.78%, and 83.91%, respectively. The pairwise comparison of AUCs showed that the diagnostic efficacy of plasma miR7 detection was significantly better than that of AFP or DCP (P＜0.05). Although its specificity was slightly lower than AFP and DCP, the sensitivity was significantly higher. Among patients negative for both AFP and DCP, miR7 maintained an AUC of 0.728 for diagnosing very early-stage HCC, with 67.82% sensitivity and 77.73% specificity.
    Conclusions Plasma miR7 testing is a potential molecular marker with high sensitivity and specificity for the differential diagnosis of small hepatic nodules. In patients with very early-stage HCC lacking effective molecular markers (negative for both AFP and DCP), miR7 can serve as a novel and effective molecular marker to assist diagnosis.

     

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