剪切波弹性成像新技术无创评估肝纤维化进程有效性的扩大临床验证

Expanded clinical verification of effectiveness of two-dimensional-shear wave elastography in thenoninvasive evaluation of hepatic fibrosis

目的通过大规模的临床病例验证二维剪切波弹性成像（2D－SWE）技术评估肝纤维化程度的有效性。方法选取2016年1月至2017年2月复旦大学附属中山医院预接受肝脏部分切除术患者1 079例，术前行肝实质2D－SWE弹性检测，与术后病理组织学肝纤维化分级（S0～S4）相比较。采用已公开发表的2D－SWE诊断S≥S2、S≥S3和S＝S4分别为7.2、9.2和10.4 kPa的弹性界值为依据，应用受试者工作特征（ROC）曲线法及计算曲线下面积（AUC），验证其评估不同肝纤维化程度的价值，并计算灵敏度、特异度和准确度。结果与病理诊断相比较，2D－SWE诊断S≥S2、S≥S3和S＝S4的AUC分别为0.976、0.981和0.968，敏感度分别为95.3%、92.6%和93.5%，特异度分别为87.8%、87.5%和89.3%，准确率分别为88.8%、90.0%和91.0%（P〈0.05）。结论大规模的临床验证结果显示2D－SWE是无创诊断肝纤维化程度的有效影像学手段。

Objective To evaluate the diagnostic value of two-dimensional shear wave elastography （2D-SWE） in the assessment of hepatic fibrosis in a large-scale clinical setting. Methods A total of 1 079 subjects who underwent partial hepatectomy were examined with 2D-SWE to measure liver stiffness before operation and the liver stiffness measurements were compared with histologic findings. The published cutoff values of liver stiffness examined with 2D-SWE were used as a reference, as 7.2,9.2, and 10.4 kPa for diagnosing substantial fibrosis （ S2 ）, severe fibrosis （ S3 ）, and cirrhosis （ S4 ） , respectively. The area under curve （AUC） was calculated to verify the value of 2D-SWE in the evaluation of hepatic fibrosis. Results Compared with the pathological diagnosis, the AUC of 2D-SWE in diagnosing substantial fibrosis（ S2 ） , severe fibrosis（ S3 ）, and cirrhosis （ S4 ） were 0. 976,0. 981, and 0. 968, the sensitivity were 95.3%, 92. 6%, and 93.5% ,the specificity were 87.8% , 87.5% and 89.3% , and the accuracy were 88.8% , 90.0% and 91.0% ,respectively （P 〈 0. 05 ）. Conclusion 2D-SWE is an effective imaging tool for noninvasive diagnosis of hepatic fibrosis.