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目的对已建立的肝癌血清标志物ELISA检测方法进行扩大规模临床样本检测,进一步评价和优化该方法。方法利用本实验室建立的肝癌血清标志物ELISA检测方法,对407份肝病患者血清和95份正常献血员血清进行检测,并对检测结果进行分析。结果324份HBV感染后的肝癌、肝硬化及肝炎患者血清样本中,2种或2种以上指标阳性比例分别为77.6%、76.1%和52.5%,肝癌患者3种或3种以上指标阳性比例较肝硬化和肝炎患者分别高39.9%和310%;在正常献血员、药物性肝炎、酒精性肝炎及其他类型的癌症患者中,87.5%～100%的患者肝癌血清标志物分子≤1种;URG7是最早出现的抗体阳性标志物分子,URG11和S15a抗体则在进展后期或已发展为肝癌的患者血清中呈优势比例出现。结论5种肝癌血清标志物分子与肝癌发生的风险呈正相关,已建立的肝癌血清标志物ELISA检测方法可用于肝癌高危人群的筛选及小肝癌的早期诊断,作为目前AFP和MRI诊断方法的有益补充。
OBJECTIVE: To develop an extended scale clinical sample test for the established ELISA method of serum marker of hepatocellular carcinoma to further evaluate and optimize the method. Methods Using the ELISA method of serum markers of liver cancer established in our laboratory, serum of 407 patients with liver disease and serum of 95 normal donors were detected and the results were analyzed. Results The positive rates of two or more of the 324 serum samples from patients with hepatocellular carcinoma, cirrhosis and hepatitis after HBV infection were 77.6%, 76.1% and 52.5%, respectively. The positive proportion of 3 or more indicators of hepatocellular carcinoma patients Patients with cirrhosis and hepatitis were 39.9% and 310% higher respectively; among the normal blood donors, drug-induced hepatitis, alcoholic hepatitis and other types of cancer patients, 87.5% to 100% of the patients had less than one serum marker molecule of liver cancer; URG7 Is the earliest antibody positive marker molecule, and URG11 and S15a antibodies appear to be predominantly in proportion to the serum of patients who have progressed or have developed liver cancer. Conclusions There is a positive correlation between the serum markers of five kinds of HCC and the risk of HCC. The established ELISA method of HCC serum markers can be used to screen the high-risk population of HCC and early diagnosis of small HCC, which is a useful supplement for the diagnosis of AFP and MRI .