血清异常凝血酶原用于辅助诊断肝细胞癌临床价值的评估:一项基于中国人群的多中心病例对照研究
Assessment of the clinical value with the application of serum abnormal prothrombin for auxiliary diagnosis of hepatocellular carcinoma:a multicenter Chinese population-based case-control study
梁携儿 1程黎明 2许颂霄 3张钧 4陈红松 5濮存莹 6樊蓉 1侯金林1
作者信息
- 1. 南方医科大学南方医院感染内科暨肝病中心,广州 510515
- 2. 华中科技大学同济医学院附属同济医院检验科,武汉 430030
- 3. 浙江省肿瘤医院检验科,杭州 310006
- 4. 浙江大学医学院附属邵逸夫医院检验科,杭州 310016
- 5. 北京大学人民医院北京大学肝病研究所,北京 100044
- 6. 罗氏诊断产品(上海)有限公司医学科学事务部,上海 200126
- 折叠
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一对照设计,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(0.920 0对比0.880 9).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.
Abstract
Objective To 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.Methods A 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.Results A 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(0.920 0 vs.0.880 9).Conclusion The clinical efficacy of Elecsys PIVKA-Ⅱ is 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.
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Key words
Hepatocellular carcinoma/Alpha-fetal protein/Elecsys PIVKA-Ⅱ/Early-stage Primary hepatocellular carcinoma/Cut-off value/Diagnosis引用本文复制引用
基金项目
国家重点研发计划(2022YFC2304800)
国家重点研发计划(2022YFC2303600)
出版年
2024
NETL
NSTL
万方数据