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目的评估肝癌特异性γ-谷氨酰转肽酶Ⅱ(GGT-Ⅱ)对原发性肝癌(PHC)的诊断价值。方法从3个临床试验中心收集PHC 595例(PHC组),对照组为肝炎后肝硬化或慢性肝炎246例及正常人群166例。采用GGT-Ⅱ检测试剂盒检测GGT-Ⅱ,化学发光法检测甲胎蛋白(AFP)。分析两者对PHC的诊断价值。结果 595例PHC患者中,387例AFP>400μg/L,500例GGT-Ⅱ阳性。GGT-Ⅱ诊断PHC的灵敏度为84.03%,特异度为91.26%,误诊率为8.74%,漏诊率为15.97%,正确率为86.99%,Youden指数为75.30%。而AFP诊断PHC的灵敏度为65.04%,特异度为88.83%,误诊率11.17%,漏诊率34.96%,正确率74.78%,Youden指数为53.85%。GGT-Ⅱ与AFP诊断PHC一致性指标:Kappa=0.2687,95%可信区间(CI)为(0.1929,0.3446)。结论与AFP检测比较,GGT-Ⅱ诊断PHC敏感性好,特异性高,准确度高,误诊和漏诊率较低。
Objective To evaluate the value of GGT-Ⅱ in the diagnosis of primary hepatocellular carcinoma (PHC). Methods 595 cases of PHC (PHC group) were collected from 3 clinical trial centers. The control group included 246 cases of posthepatitic cirrhosis or chronic hepatitis and 166 cases of normal population. GGT-Ⅱ was detected by GGT-Ⅱ kit and AFP was detected by chemiluminescence. Analysis of both the diagnostic value of PHC. Results Among the 595 PHC patients, 387 were AFP> 400 μg / L and 500 were GGT-Ⅱ positive. The sensitivity and specificity of GGT-Ⅱ in diagnosing PHC were 84.03%, 91.26%, 8.74%, 15.97%, 86.99% respectively, and Youden index was 75.30%. The sensitivity, specificity and accuracy of AFP in diagnosing PHC were 65.04%, 88.83%, 11.17%, 34.96%, 74.78% respectively, and Youden index was 53.85%. GGT-Ⅱ and AFP diagnosis of PHC consistency indicators: Kappa = 0.2687, 95% confidence interval (CI) (0.1929,0.3446). Conclusion Compared with AFP test, GGT-Ⅱ has good sensitivity, specificity and accuracy in diagnosis of PHC. Misdiagnosis and missed diagnosis rate of PHC are lower.