瞬时弹性成像技术与多参数模型评估慢性肝病肝纤维化程度的临床研究

Clinical study on FibroTouch and multi-parameter model for diagnosis of hepatic fibrosis in patients with chronic liver disease

目的评估肝脏瞬时弹性成像技术FibroTouch的应用价值，为肝纤维化的准确诊断提供安全、可靠的检测方法。方法选择2014年1月至2015年2月就诊于河北医科大学第三医院并经肝活体组织检查确诊的慢性肝病患者190例，应用FibroTouch检测肝脏硬度（kSM）；测定ALT、AST和TBil；检测血小板（PLT）计数，并计算AST／PLT比值（APRI）和FIB-4指数。以肝组织病理学结果为依据，分析LSM、APRI及FIB-4与肝纤维化程度的相关性。应用SPSS16．0统计学软件进行统计学分析，采用受试者工作特征曲线（ROC）分析三者诊断慢性肝病肝纤维化的准确性，Spearman相关分析影响肝脏硬度（LSM）值的相关因素。结果190例慢性肝病患者LSM值中位数为10．8kPa；APRI中位数为0．71；FIB-4指数中位数为1．31。LSM值与肝纤维化程度呈正相关（r=0．804，P=0．000），LSM诊断肝组织病理学纤维化分期S≥2、S≥3及S=4的ROC曲线下面积分别为：0．894、0．938和0．961，明显高于APRI（0．678、0．698及0．658）和FIB-4（0．765、0．785及0．775）诊断的相应ROC曲线下面积。Spearman相关分析显示：LSM与年龄、ALT≥2倍正常值上限、AST、TBil及肝组织炎症分级呈正相关，相关系数，分别为0．309、0．558、0．504、0．492及0．532（P〈0．05），与PLT呈负相关r=-0．444（P〈0．05）。结论FibroTouch是一种简便、可靠的慢性肝病肝纤维化诊断方法，其灵敏度及特异度均优于APRI及FIB-4。

Objective To explore the clinical application and related factors of FibroTouch in the diagnosis of liver fibrosis in patients with chronic liver disease through comparison of the specificity and sensitivity of FibroTouch and multi-parameter models, and to identify whether FibroTouch is a more accurate and safe method in diagnosis of liver fibrosis and evaluation of the therapeutic effect. Methods A total of 190 patients with chronic liver disease were performed liver biopsy and underwent liver stiffness measurement （LSM） using FibroTouch in department of Traditional and Western Medical Hepatology, Third Hospital of Hebei Medical University from January 2014 to February 2015. Serum alanine aminotransferase （ALT）, aspartate aminotransferase （AST） and total bilirubin （TBIL） were tested by enzymic method with automatic biochemistry analyzer. Blood platelet counts were detected by automatic blood cell analyzer. AST-to-PLT ratio index （APRI） and fibrosis index based on the 4 factor （FIB-4） were calculated. The diagnostic values of FibroTouch, APRI and FIB-4 for liver fibrosis degree were calculated and compared by receiver operating characteristic （ROC） curves. The related factors of LSM were analyzed by Spearman analysis. Results There was significant correlation between LSM and histological fibrosis （r= 0.804, P = 0.000）. The area under ROC curve of LSM for S≥ 2, S ≥3 and S = 4 was 0.894, 0.938 and 0.961, respectively, which was significantly higher than APRI （0.678, 0.698 and 0.658） and FIB-4 （0.765, 0：785 and 0.775）. On Spearman analysis, LSM was positively correlated with age, ALT, AST, TBIL （≥2×ULN） and the grade of liver inflammation （r = 0.309, 0.558, 0.504, 0.492 and 0.532, respectively） but negatively with PLT （1- = -0.444）, （allP 〈 0.05）. Conclusions LSM is a convenient and reliable approach for diagnosis of liver fibrosis in patients with chronic liver disease. The sensitivity and specificity of Fibrotouch in diagnosis of hepatic fibrosis is superior to APRI and FIB-4, and age, high level ofALT, AST and TBIL （ ≥ 2×ULN） were independent predictors of LSM inaccuracy.