中国临床医学2025，Vol.32Issue(3)：350-354,5.DOI:10.12025/j.issn.1008-6358.2025.20250735
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
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.关键词
肝细胞癌/血浆miRNA/鉴别诊断/真实世界研究/分子标志物Key words
hepatocellular carcinoma/plasma miRNA/differential diagnosis/real-world study/molecular marker分类
医药卫生引用本文复制引用
胡捷,史颖弘,邱双健,孙惠川,高强,樊嘉,周俭,许颖,黄傲,於雷,王征,王晓颖,杨欣荣,丁振斌,叶青海..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[J].中国临床医学,2025,32(3):350-354,5.基金项目
上海市生物医药科技支撑专项(22S11901100),"四大慢病"防治研究国家科技重大专项(2024ZD0525402).Supported by Shanghai Biomedical Technology Support Special Project(22S11901100)and Four Major Chronic Diseases National Science and Technology Major Project(2024ZD0525402). （22S11901100）
