二维剪切波弹性成像评估慢性肝病患者肝纤维化：一项前瞻性队列研究。

Two-dimensional shear wave elastography for assessing liver fibrosis in patients with chronic liver disease: a prospective cohort study.

机构信息

Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.

Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea.

出版信息

Korean J Intern Med. 2022 Mar;37(2):285-293. doi: 10.3904/kjim.2020.635. Epub 2021 Dec 7.

BACKGROUND/AIMS: The objective of this study was to determine whether the newly developed two-dimensional shear wave elastography (2D-SWE, RS85, Samsung-shearwave imaging) was more valid and reliable than transient elastography (TE) for predicting the stage of liver fibrosis.

METHODS

The study prospectively enrolled a total of 116 patients with chronic liver disease who underwent 2D-SWE, TE, laboratory testing, and liver biopsy on the same day from two tertiary care hospitals. One patient with unreliable measurement was excluded. The measurement of 2D-SWE was considered acceptable when a homogenous color pattern in a region of interest of at least 10 mm was detected at 10 different sites. Diagnostic performance was calculated using area under the receiver operating characteristic curve (AUROC).

RESULTS

Liver fibrosis stages included F0 (18%), F1 (19%), F2 (24%), F3 (22%), and F4 (17%). Interclass correlation coefficient for inter-observer agreement in 2D-SWE was 0.994 (95% confidence interval [CI], 0.988 to 0.997). Overall, the results of 2D-SWE and stages of histological fibrosis were significantly correlated (r = 0.601, p < 0.001). For The 2D-SWE showed good diagnostic ability (AUROC, 0.851; 95% CI, 0.773 to 0.911) comparable to TE (AUROC, 0.859; 95% CI, 0.781 to 0.916) for the diagnosis of significant fibrosis (≥ F2), and the cut-off value was 5.8 kPa. AUROC and optimal cut-off of 2D-SWE for the diagnosis of liver cirrhosis were 0.889 (95% CI, 0.817 to 0.940) and 9.6 kPa, respectively. TE showed similar diagnostic performance in distinguishing cirrhosis (AUROC, 0.938; 95% CI, 0.877 to 0.974; p = 0.08).

CONCLUSION

2D-SWE is comparable to TE in diagnosing significant fibrosis and liver cirrhosis with high reliability.

背景/目的：本研究旨在确定新开发的二维剪切波弹性成像（2D-SWE，RS85，Samsung-shearwave imaging）是否比瞬时弹性成像（TE）更有效和可靠，以预测肝纤维化的分期。

方法

本研究前瞻性纳入了 2 家三级医疗机构的 116 例慢性肝病患者，这些患者于同一天接受了 2D-SWE、TE、实验室检测和肝活检。排除了一位测量不可靠的患者。当在至少 10 个不同部位的感兴趣区域中检测到均匀的彩色图案时，认为 2D-SWE 的测量是可接受的。使用受试者工作特征曲线下的面积（AUROC）计算诊断性能。

结果

肝纤维化分期包括 F0（18%）、F1（19%）、F2（24%）、F3（22%）和 F4（17%）。2D-SWE 的观察者间一致性的组内相关系数为 0.994（95%置信区间 [CI]，0.988 至 0.997）。总体而言，2D-SWE 与组织纤维化分期结果具有显著相关性（r = 0.601，p < 0.001）。2D-SWE 显示出良好的诊断能力（AUROC，0.851；95%CI，0.773 至 0.911），与 TE（AUROC，0.859；95%CI，0.781 至 0.916）相当，可用于诊断显著纤维化（≥F2），其截断值为 5.8kPa。2D-SWE 诊断肝硬化的 AUROC 和最佳截断值分别为 0.889（95%CI，0.817 至 0.940）和 9.6kPa。TE 在鉴别肝硬化方面表现出相似的诊断性能（AUROC，0.938；95%CI，0.877 至 0.974；p = 0.08）。