两种不同方法检测的血清HBsAg水平预测慢性乙型肝炎患者肝组织病理学变化的效能评价*

目的 探讨两种方法检测血清HBsAg水平预测慢性乙型肝炎患者肝组织病理学改变的效能及其一致性。方法 在132例HBeAg阳性和115例HBeAg阴性的慢性乙型肝炎患者,行肝活检,分别采用Maccura IS1200和Architect I2000全自动化学发光免疫分析法检测血清HBsAg（HBsAg- IS1200和HBsAg-I2000）。结果 在HBeAg阳性或阴性患者,HBsAg- IS1200与HBsAg- I2000均呈显著正相关（r=0.937,P<0.0001和r=0.964,P<0.0001）,并且有紧密的线性关系（F=935.970,P<0.0001和F=1496.884,P<0.0001）;根据ROC曲线分析,在HBeAg阳性患者,HBsAg-IS1200和HBsAg-I2000对肝组织病理学分级≥G2、≥G3和分期≥S2、≥S3、≥S4均有显著的预测意义（P<0.005）;在HBeAg阴性患者,HBsAg-IS1200和HBsAg-I2000对病理学分级≥G2、≥G3和分期≥S2、≥S3、≥S4均无显著的预测意义（P>0.05）;无论HBeAg阳性或阴性患者,HBsAg-IS1200与HBsAg-I2000预测病理学分级≥G2、≥G3和分期≥S2、≥S3、≥S4的ROC曲线下面积之间的差异均无统计学意义（P>0.05）;在HBeAg阳性患者,HBsAg-IS1200与HBsAg-I2000预测肝组织病理学分级≥G2、≥G3和分期≥S2、≥S3和≥S4的结果均具有高度或极高的一致性（Kappa=0.7243、Kappa=0.6967和Kappa=0.8438、Kappa=0.8308、Kappa=0.7097）。结论 HBsAg-IS1200与HBsAg-I2000定量预测慢性乙型肝炎患者肝组织不同病理学改变的效能保持高度的一致。

Efficacy of serum HBsAg levels by two quantitative methods in predicting liver histopathological grading and staging in patients with chronic hepatitis B

Objective To investigate the efficacy of serum HBsAg by two quantitative methods in predicting liver histopathological grading and staging in patients with chronic hepatitis B. Methods 132 HBeAg-positive and 115 HBeAg-negative patients with chronic hepatitis B,who had underwent liver biopsy,were enrolled in the present study. Liver histopathological diagnosis was made with reference to the Scheuer scoring system and serum HBsAg levels were detected by Maccura IS1200 （HBsAg-IS1200） and by Architect I2000 （HBsAg-I2000）. Results In both HBeAg-positive and HBeAg-negative patients,HBsAg-IS1200 was significantly positively correlated with HBsAg-I2000（r=0.937,P<0.0001 and r=0.964,P<0.0001）,and had a close linear correlation with HBsAg-I2000（F=935.970,P<0.0001 and F=1496.884,P<0.0001）;according to ROC curve analyses,both HBsAg-IS1200 and HBsAg-I2000 had significant predictive values for pathologic grade ≥G2,≥G3 and stage ≥2,≥S3,≥S4（P<0.005） in HBeAg-positive patients,and both HBsAg-IS1200 and HBsAg-I2000 had no significant predictive values for pathologic grade ≥G2,≥G3 and stage ≥2,≥S3,≥S4（P>0.05） in HBeAg-negative patients; there were no significant differences in all the areas under ROC curves between HBsAg-IS1200 and HBsAg-I2000 in predicting pathological grade ≥G2,≥G3 and stage ≥2,≥S3,≥S4（P>0.05） in both HBeAg-positive and HBeAg-negative patients, with reference to the optimal cut-off value based on the maximum Youden indexes,the results between HBsAg-IS1200 and HBsAg-I2000 in predicting the liver pathological grade ≥G2,≥G3 and stage ≥S2,≥S3,≥S4 had high or very high consistency （Kappa=0.7243,Kappa=0.6967 and Kappa=0.8438,Kappa=0.8308,Kappa=0.7097） in HBeAg-positive patients. Conclusion HBsAg-IS1200 is highly consistent with HBsAg-I2000 in predicting liver histopathological grading and staging in patients with chronic hepatitis B.