FibroScan对慢性乙型肝炎患者中重度肝纤维化的诊断价值

Clinical value of FibroScan in diagnosis of moderate-to-severe liver fibrosis in patients with chronic hepatitis B

目的评估瞬时弹性超声成像（FibroScan）在慢性乙型肝炎（CHB）患者中重度肝纤维化的临床应用价值。方法选取2012年-2015年在上海市公共卫生临床中心进行FibroScan和血清实验室检查,并经肝活组织检查病理确诊的患者245例,分为轻度肝纤维化组（S1~S2,n=189）和中重度肝纤维化组（S3~S4,n=56）。测定患者的FibroScan、APRI、透明质酸（HA）、AST、ALT水平。符合正态分布的计量资料组间比较采用t检验;非正态分布的计量资料组间比较采用Mann-Whitney U秩和检验。采用Logistic分析进行风险预测。采用受试者工作特征曲线（ROC曲线）,95%可信区间（95%CI）及ROC曲线下面积（AUC）表示FibroScan诊断中重度肝纤维化的准确度。选取敏感度和特异度之和的最大值所对应的FibroScan值表示肝纤维化不同分期的最佳截断值。结果 2组患者的年龄,ALT、AST、HA水平,以及APRI、FibroScan值比较差异均有统计学意义（P值均〈0.05）;单因素分析显示,肝纤维化严重程度与FibroScan测定值、HA和APRI水平相关（比值比分别为2.56、1.03、31.73,P值均〈0.001）;多因素分析显示,FibroScan是唯一中重度肝纤维化的相关参数（比值比=2.25,P〈0.001）。FibroScan、HA和APRI诊断中重度肝纤维化的AUC分别为0.985、0.842、0.868,95%CI分别为0.969~1.000、0.774~0.911、0.813~0.922,临界值分别为11.65、104.4、0.69;FibroScan、HA和APRI诊断中重度肝纤维化的灵敏度分别为98.9%、96.3%、96.3%;特异度分别为85.7%、55.4%、48.2%;阳性预测值分别为95.9%、87.9%、86.3%;阴性预测值分别为96.0%、81.6%和79.4%。结论 FibroScan诊断中重度肝纤维化有较高的临床应用价值,对及时发现肝纤维化并准确判定纤维化程度具有重要作用。

Objective To investigate the clinical value of transient elastography（ FibroScan） in the diagnosis of moderate- to- severe liver fibrosis in patients with chronic hepatitis B（ CHB）. Methods A total of 245 patients with pathologically confirmed CHB by liver biopsy who underwent FibroScan and serological examinations in Shanghai Public Health Clinical Center from 2012 to 2015 were enrolled and divided into mild liver fibrosis group（ S1- S2,189 patients） and moderate- to- severe liver fibrosis group（ S3- S3,56 patients）. The FibroScan value,aspartate aminotransferase- to- platelet ratio index（ APRI） [（ aspartate aminotransferase/upper limit of normal × 100）/platelet count],and levels of hyaluronic acid（ HA）,aspartate aminotransferase（ AST）,and alanine aminotransferase（ ALT） were measured. The t- test was used for comparison of normally distributed continuous data between groups,and the Mann- Whitney U rank sum test was used for comparison of non- normally distributed continuous data between groups. A logistic regression analysis was used for risk prediction. The receiver operating characteristic（ ROC） curve,95% confidence interval（ 95% CI）,and area under the ROC curve（ AUC） were used to investigate the accuracy of FibroScan in the diagnosis of moderate- to- severe liver fibrosis. The FibroScan value corresponding to the maximum of the sum of sensitivity and specificity was the optimal cut- off value for liver fibrosis. Results There were significant differences in age,the levels of ALT,AST,and HA,APRI,and FibroScan value between the two groups（ all P〈0. 05）. The univariate analysis showed that the severity of liver fibrosis was associated with the measured FibroScan value,HA level,and APRI（ OR = 2. 56,1. 03,and31. 73,all P〈0. 001）,and the multivariate analysis showed that only FibroScan value was associated with moderate- to- severe liver fibrosis（ OR = 2. 25,P〈0. 001）. The AUCs of FibroScan,HA,and APRI in the diagnosis of moderate- to- severe liver fibrosis were 0. 985（ 95% CI： 0. 969- 1. 000）,0. 842（ 95% CI： 0. 774- 0. 911）,and 0. 868（ 95% CI： 0. 813- 0. 922）,respectively,at cut- off values of11. 65,104. 4,and 0. 69,respectively. In the diagnosis of moderate- to- severe liver fibrosis,FibroScan,HA,and APRI had sensitivities of98. 9%,96. 3%,and 96. 3%,specificities of 85. 7%,55. 4%,and 48. 2%,positive predictive values of 95. 9%,87. 9%,and 86. 3%,and negative predictive values of 96. 0%,81. 6%,and 79. 4%. Conclusion FibroScan has a high clinical value in the diagnosis of moderate- to- severe liver fibrosis and plays an important role in early identification of liver fibrosis and accurate evaluation of fibrosis degree.