Oxford Centre for Clinical Magnetic Resonance Research, Radcliffe Department of Medicine, University of Oxford, Oxford, UK; Translational Gastroenterology Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust and the University of Oxford, Oxford, UK.
Oxford Centre for Clinical Magnetic Resonance Research, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
J Hepatol. 2021 Oct;75(4):770-785. doi: 10.1016/j.jhep.2021.04.044. Epub 2021 May 13.
Vibration-controlled transient elastography (VCTE), point shear wave elastography (pSWE), 2-dimensional shear wave elastography (2DSWE), magnetic resonance elastography (MRE), and magnetic resonance imaging (MRI) have been proposed as non-invasive tests for patients with non-alcoholic fatty liver disease (NAFLD). This study evaluated their diagnostic accuracy for liver fibrosis and non-alcoholic steatohepatitis (NASH).
PubMED/MEDLINE, EMBASE and the Cochrane Library were searched for studies examining the diagnostic accuracy of these index tests, against histology as the reference standard, in adult patients with NAFLD. Two authors independently screened and assessed methodological quality of studies and extracted data. Summary estimates of sensitivity, specificity and area under the curve (sAUC) were calculated for fibrosis stages and NASH, using a random effects bivariate logit-normal model.
We included 82 studies (14,609 patients). Meta-analysis for diagnosing fibrosis stages was possible in 53 VCTE, 11 MRE, 12 pSWE and 4 2DSWE studies, and for diagnosing NASH in 4 MRE studies. sAUC for diagnosis of significant fibrosis were: 0.83 for VCTE, 0.91 for MRE, 0.86 for pSWE and 0.75 for 2DSWE. sAUC for diagnosis of advanced fibrosis were: 0.85 for VCTE, 0.92 for MRE, 0.89 for pSWE and 0.72 for 2DSWE. sAUC for diagnosis of cirrhosis were: 0.89 for VCTE, 0.90 for MRE, 0.90 for pSWE and 0.88 for 2DSWE. MRE had sAUC of 0.83 for diagnosis of NASH. Three (4%) studies reported intention-to-diagnose analyses and 15 (18%) studies reported diagnostic accuracy against pre-specified cut-offs.
When elastography index tests are acquired successfully, they have acceptable diagnostic accuracy for advanced fibrosis and cirrhosis. The potential clinical impact of these index tests cannot be assessed fully as intention-to-diagnose analyses and validation of pre-specified thresholds are lacking.
Non-invasive tests that measure liver stiffness or use magnetic resonance imaging (MRI) have been suggested as alternatives to liver biopsy for assessing the severity of liver scarring (fibrosis) and fatty inflammation (steatohepatitis) in patients with non-alcoholic fatty liver disease (NAFLD). In this study, we summarise the results of previously published studies on how accurately these non-invasive tests can diagnose liver fibrosis and inflammation, using liver biopsy as the reference. We found that some techniques that measure liver stiffness had a good performance for the diagnosis of severe liver scarring.
振动控制瞬时弹性成像(VCTE)、点剪切波弹性成像(pSWE)、二维剪切波弹性成像(2DSWE)、磁共振弹性成像(MRE)和磁共振成像(MRI)已被提议作为非酒精性脂肪性肝病(NAFLD)患者的非侵入性检查方法。本研究评估了它们在诊断肝纤维化和非酒精性脂肪性肝炎(NASH)方面的诊断准确性。
在 PubMed/MEDLINE、EMBASE 和 Cochrane 图书馆中搜索了评估这些指数测试诊断准确性的研究,这些研究以组织学为参考标准,针对成年 NAFLD 患者。两位作者独立筛选并评估了研究的方法学质量,并提取了数据。使用随机效应二变量逻辑正态模型,计算了纤维化分期和 NASH 的敏感性、特异性和曲线下面积(sAUC)的综合估计值。
我们纳入了 82 项研究(14609 名患者)。53 项 VCTE、11 项 MRE、12 项 pSWE 和 4 项 2DSWE 研究可进行纤维化分期的荟萃分析,4 项 MRE 研究可进行 NASH 的诊断。显著纤维化的 sAUC 为:VCTE 为 0.83,MRE 为 0.91,pSWE 为 0.86,2DSWE 为 0.75。晚期纤维化的 sAUC 为:VCTE 为 0.85,MRE 为 0.92,pSWE 为 0.89,2DSWE 为 0.72。肝硬化的 sAUC 为:VCTE 为 0.89,MRE 为 0.90,pSWE 为 0.90,2DSWE 为 0.88。MRE 对 NASH 的诊断 AUC 为 0.83。三项(4%)研究报告了意向诊断分析,15 项(18%)研究报告了针对预定义截止值的诊断准确性。
当弹性成像指数测试成功获得时,它们对晚期纤维化和肝硬化具有可接受的诊断准确性。由于缺乏意向诊断分析和对预定义阈值的验证,这些指数测试的潜在临床影响无法全面评估。
已经提出了一些测量肝硬度的非侵入性测试方法或使用磁共振成像(MRI)作为替代肝活检的方法,用于评估非酒精性脂肪性肝病(NAFLD)患者的肝瘢痕(纤维化)和脂肪炎症(脂肪性肝炎)的严重程度。在这项研究中,我们总结了先前发表的关于这些非侵入性测试在使用肝活检作为参考标准时如何准确诊断肝纤维化和炎症的研究结果。我们发现,一些测量肝硬度的技术在诊断严重肝纤维化方面表现良好。