摘要
目的综合评估Elecsys血清异常凝血酶原(PIVKA-Ⅱ)检测试剂在中国人群中辅助诊断肝细胞癌(HCC)的临床价值。方法研究采用多中心病例-对照设计,连续收集首次确诊且未经治疗的HCC患者样本、良性肝病患者样本和干扰性样本进行Elecsys PIVKA-Ⅱ与甲胎蛋白(AFP)检测,并对受试者的多项临床信息进行汇总分析。计算特定阳性截断值下PIVKA-Ⅱ(21.29 ng/ml)和AFP(400 ng/ml)用于HCC诊断的效能。采用Kruskal-Wallis检验或受试者操作特征曲线进行统计学分析。结果最终在5家中心共纳入448例受试者,其中包括185例HCC病例。以良性肝病组为对照组时,PIVKA-Ⅱ的诊断灵敏度和准确率均高于AFP:84.86%对比30.81%和89.01%对比63.66%,而特异度略低。敏感性分析显示在该特定阳性截断值下,PIVKA-Ⅱ的临床性能在AFP阴性受试者亚组、不同病因亚组及多个巴塞罗那癌症分期的HCC患者亚组(含早期HCC)中的灵敏度均>80%。同时,PIVKA-Ⅱ的受试者操作特征曲线下面积亦略高于AFP(0.9200对比0.8809)。结论Elecsys PIVKA-Ⅱ在中国人群中的临床性能良好且稳定,有潜力改善临床AFP阴性HCC诊断和早期HCC监测中的漏诊现状以进一步提升中国人群HCC精准辅助诊断效率。
ObjectiveTo comprehensively evaluate the clinical value of Elecsys serum abnormal prothrombin(PIVKA-Ⅱ)test reagent for auxiliary diagnosis of hepatocellular carcinoma(HCC)in the Chinese population.MethodsA multicenter case-control design was used in the study.Samples from patients with first-time confirmed,diagnosed,and untreated HCC,benign liver disease and interfering controls were collected continuously.Elecsys PIVKA-II and alpha-fetoprotein(AFP)were tested for analysis.Various clinical details of the subjects were collected and analyzed.The efficacy of PIVKA-II(21.29 ng/ml)and AFP(400 ng/ml)for HCC diagnosis was calculated at specific positive cut-off values.Statistical analysis was performed using the Kruskal-Wallis test or receiver operating characteristic curve.ResultsA total of 448 subjects were eventually enrolled from five centers,including 185 HCC cases.PIVKA-II had a higher diagnostic sensitivity and accuracy than AFP(84.86%vs.30.81%and 89.01%vs.63.66%)when the benign liver disease group was used as the control group,while the specificity was slightly lower.A sensitive analysis showed that PIVKA-II had a sensitivity of>80%at this specific positive cut-off value in the subgroup of AFP-negative subjects,patients with different etiologies,and HCC patients with multiple Barcelona Clinic liver cancer stages(including early-stage HCC).At the same time,the PIVKA-II subject had a slightly higher area under the receiver operating characteristic curve than the AFP(0.9200 vs.0.8809).ConclusionThe clinical efficacy of Elecsys PIVKA-Ⅱis good and stable in the Chinese population.Additionally,it has the clinical potential to improve the current missed diagnosis status of AFP-negative HCC and HCC monitoring at an early stage,as well as the effectiveness of accuracy promotion for HCC auxiliary diagnosis in China.
作者
梁携儿
程黎明
许颂霄
张钧
陈红松
濮存莹
樊蓉
侯金林
Liang Xieer;Cheng Liming;Xu Songxiao;Zhang Jun;Chen Hongsong;Pu Cunying;Fan Rong;Hou Jinlin(Hepatology Unit and Department of Infectious Diseases,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China;Department of Laboratory Medicine,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Department of Clinical Laboratory,Zhejiang Cancer Hospital,Hangzhou 310006,China;Department of Clinical Laboratory,Sir Run Run Shaw Hospital,Zhejiang University,School of Medicine,Hangzhou 310016,China;Peking University People's Hospital,Peking University Hepatology Institute,Beijing 100044,China;Roche Diagnostics(Shanghai)Limited,Medical and Scientific Affairs,Shanghai 200126,China)
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2024年第7期650-656,共7页
Chinese Journal of Hepatology
基金
国家重点研发计划(2022YFC2304800,2022YFC2303600)。
关键词
肝细胞癌
甲胎蛋白
血清异常凝血酶原
早期原发性肝癌
截断值
诊断
Hepatocellular carcinoma
Alpha-fetal protein
Elecsys PIVKA-Ⅱ
Early-stage Primary hepatocellular carcinoma
Cut-off value
Diagnosis
