新型寡糖链检测对HBV相关肝细胞癌的临床应用价值

Clinical application value of serum oligosaccharide chain detection for HBV-related hepatocellular carcinoma

目的评价血清寡糖链(serum oligosaccharide chain,G-Test)检测试剂盒辅助诊断乙型肝炎病毒(hepatitis B virus,HBV)相关肝细胞癌的临床价值。方法收集2017年2月—2018年8月就诊于南京医科大学第一附属医院(江苏省人民医院)、北京佑安医院、天津市第二人民医院的调查对象共1100例,其中正常健康人群170例,慢性乙型肝炎患者310例,乙型肝炎肝硬化患者180例,其他脏器恶性肿瘤患者80例,HBV引起的原发性肝细胞癌患者360例。用G-Test检测试剂盒检测血清中寡糖链组分的相对浓度,通过XSD-HCC模型计算并分析检测结果在临床诊断中的灵敏度、特异度、总符合率和阳性预测值、阴性预测值。采用SPSS 19.0统计软件统计分析试剂的灵敏度、特异度、总符合率和Kappa值。G-Test检测结果采用95%置信区间表示,进行受试者工作曲线分析。结果G-Test在肝细胞癌(hepatocellular carcinoma,HCC)的临床辅助诊断中具有较好的灵敏度(83.61%)、特异度(87.84%)及总符合率(86.45%),其阳性预测值为76.98%,阴性预测值为91.68%,诊断性能良好。G-Test在甲胎蛋白(alpha-fetoprotein,AFP)阴性的肝癌中检出率达到85.53%;G-Test与AFP联合使用时,可提高HCC检出灵敏度至90.17%。结论G-Test检测试剂盒的灵敏度和特异度较好,具有辅助诊断HCC的临床应用价值,G-Test在AFP阴性的肝癌患者中具有良好的临床性能,可增加AFP阴性肝癌的检出率。

Objective To evaluate the clinical value of serum oligosaccharide chain(G-Test)detection in assisting the diagnosis of hepatitis B virus(HBV)-related hepatocellular carcinoma(HCC).Methods A total of 1100 samples were collected from Jiangsu Province Hospital,Beijing Youan Hospital,and Tianjin Second People's Hospital during February 2017 and August 2018,including 170 healthy controls,310 chronic hepatitis B,180 hepatitis B-related cirrhosis,80 other solid organ malignancies,and 360 HBV-related HCC patients.The relative concentration of oligosaccharide chain components in serum was detected by the G-Test kit.The sensitivity,specificity,total coincidence rate,positive predictive value,and negative predictive value of the detection results in clinical diagnosis were calculated and analyzed by the XSD-HCC model.SPSS 19.0 software was used for statistical analysis of the sensitivity,specificity,overall concordance rate,and Kappa value of the kit.The G-Test detection results were expressed with a 95%confidence interval,and receiver operating characteristic(ROC)curve analysis was performed.Results The G-Test had good sensitivity(83.61%),specificity(87.84%),and total coincidence rate(86.45%)in the diagnosis of HCC,with a positive predictive value of 76.98%and a negative predictive value of 91.68%,demonstrating good diagnostic performance.The detection rate of the G-Test was 85.53%in alpha-fetoprotein(AFP)-negative HCC and the sensitivity of the G-Test was 90.17%in combination with AFP.Conclusions The sensitivity and specificity of G-Test is good,and it has clinical application value in assisting the diagnosis of HCC.The good clinical performance of G-Test in AFPnegative HCC can increase the detection rate of AFP-negative HCC.