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二维剪切波弹性成像的可靠性标准:788 例患者 4277 次测量的分析。

Reliability Criteria of Two-Dimensional Shear Wave Elastography: Analysis of 4277 Measurements in 788 Patients.

机构信息

Département de Radiologie, Centre Hospitalier Universitaire d'Angers, Angers, France; Laboratoire HIFIH, UPRES EA3859, SFR 4208, Université d'Angers, Angers, France.

Département de Radiologie, Centre Hospitalier Universitaire d'Angers, Angers, France.

出版信息

Clin Gastroenterol Hepatol. 2022 Feb;20(2):400-408.e10. doi: 10.1016/j.cgh.2020.12.013. Epub 2020 Dec 16.

DOI:10.1016/j.cgh.2020.12.013
PMID:33340779
Abstract

BACKGROUND & AIMS: Two-dimensional shear wave elastography (2D-SWE) is an accurate method for the non-invasive evaluation of liver fibrosis. We aimed to determine the reliability criteria and the number of necessary reliable measurements for 2D-SWE.

METHODS

788 patients with chronic liver disease underwent liver biopsy and 2D-SWE examination in three centers. The 4277 2D-SWE measurements performed were 2:1 randomly divided into derivation (n = 2851) and validation (n = 1426) sets. Reliability criteria for a 2D-SWE measurement were defined in the derivation set from the intrinsic characteristics given by the device (mean liver stiffness, standard deviation, diameter of the region of interest), with further evaluation in the validation set.

RESULTS

In the whole population of 4277 measurements, AUROC for bridging fibrosis was 0.825 ± 0.006 and AUROC for cirrhosis was 0.880 ± 0.006. Mean stiffness and coefficient of variation (CV) were independent predictors of bridging fibrosis or cirrhosis. From these two parameters, new criteria were derived to define a reliable 2D-SWE measurement: stiffness <8.8 kPa, or stiffness between 8.8-11.9 kPa with CV <0.25, or stiffness ≥12.0 kPa with CV <0.10. In the validation set, AUROC for bridging fibrosis was 0.830 ± 0.013 in reliable measurements vs 0.667 ± 0.031 in unreliable measurements (P < .001). AUROC for cirrhosis was 0.918±0.014 vs 0.714 ± 0.027, respectively (P < .001). The best diagnostic accuracy for a 2D-SWE examination was achieved from three reliable measurements.

CONCLUSIONS

Reliability of a 2D-SWE measurement relies on the coefficient of variation and the liver stiffness level. A 2D-SWE examination should include three reliable measurements according to our new criteria.

摘要

背景与目的

二维剪切波弹性成像(2D-SWE)是一种用于无创评估肝纤维化的准确方法。本研究旨在确定 2D-SWE 的可靠性标准和所需的可靠测量次数。

方法

在三个中心,788 例慢性肝病患者接受了肝活检和 2D-SWE 检查。在这 788 例患者中,共进行了 4277 次 2D-SWE 测量,其中 2:1 随机分为推导(n = 2851)和验证(n = 1426)组。在推导组中,根据设备给出的固有特性(平均肝硬度、标准偏差、感兴趣区域的直径)定义了 2D-SWE 测量的可靠性标准,并在验证组中进一步评估。

结果

在整个 4277 次测量的人群中,桥接纤维化的 AUROC 为 0.825 ± 0.006,肝硬化的 AUROC 为 0.880 ± 0.006。平均硬度和变异系数(CV)是桥接纤维化或肝硬化的独立预测因素。从这两个参数中,得出了新的标准来定义可靠的 2D-SWE 测量:硬度<8.8 kPa,或硬度在 8.8-11.9 kPa 之间,CV<0.25,或硬度≥12.0 kPa,CV<0.10。在验证组中,可靠测量的桥接纤维化 AUROC 为 0.830 ± 0.013,不可靠测量的 AUROC 为 0.667 ± 0.031(P<0.001)。肝硬化的 AUROC 分别为 0.918±0.014 和 0.714 ± 0.027(P<0.001)。2D-SWE 检查的最佳诊断准确性来自三个可靠的测量。

结论

2D-SWE 测量的可靠性取决于变异系数和肝硬度水平。根据我们的新标准,2D-SWE 检查应包括三个可靠的测量。

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