Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany.
Institute of Medical Biometry and Informatics, Heidelberg, Germany.
Obes Facts. 2021;14(5):490-500. doi: 10.1159/000517383. Epub 2021 Aug 20.
Nonalcoholic fatty liver disease covers a broad spectrum. Simple steatosis has usually a benign course while nonalcoholic steatohepatitis (NASH) can progress into hepatocellular carcinoma, and cirrhosis. Therefore, differentiating patients with benign steatosis and NASH is crucial. Liver biopsy, the usual gold standard for NASH diagnosis, cannot be used as a screening method due to its associated risks. This is especially problematic for obese patients with a prevalence of nonalcoholic fatty liver disease (NAFLD) in >80% of patients. The aim of this study was therefore to develop and validate a noninvasive NASH screening test in a cohort of high-risk, morbidly obese patients.
This prospective study examined diagnostic accuracy in accordance with STARD guidelines. 112 liver biopsies were consecutively assigned to either a training or validation cohort. Using the Bedossa histological scoring system, the cohorts were subdivided into NASH versus NAFLD/No NAFLD. Predictors of NASH were evaluated with receiver operating characteristic (ROC) curves. A model was then constructed using a backward stepwise logistic regression and evaluated in an independent validation cohort.
53.5% of the patients had NASH and 4 patients had cirrhosis. Mean body mass index (BMI) was 49.8 ± 7.5 kg/m2. Backward stepwise logistic regression identified 4 parameters associated with the presence of NASH: alanin-aminotransferase, albumin, BMI, and triglycerides. The noninvasive NASH detection score (NI-NASH-DS) had an ROC of 0.851 and 0.727 in the training and validation cohorts, respectively. Sensitivity and specificity were 77.1% and 88% in the training cohort and 88% and 48% in the validation cohort which was much better than the established noninvasive scores.
DISCUSSION/CONCLUSION: The NI-NASH-DS is easy-to-use, inexpensive, and noninvasive and can reliably detect NASH in patients with morbid obesity. Due to its simplicity, it can be used frequently and repeatedly.
非酒精性脂肪性肝病涵盖广泛的范围。单纯性脂肪变性通常具有良性过程,而非酒精性脂肪性肝炎(NASH)则可能进展为肝细胞癌和肝硬化。因此,区分良性脂肪变性和 NASH 患者至关重要。肝活检是 NASH 诊断的常用金标准,但由于其相关风险,不能用作筛查方法。对于肥胖患者来说,这尤其成问题,因为 >80%的患者患有非酒精性脂肪性肝病(NAFLD)。因此,本研究旨在为高危肥胖患者队列开发和验证一种非侵入性 NASH 筛查试验。
这项前瞻性研究按照 STARD 指南检查了诊断准确性。连续将 112 例肝活检分配到训练或验证队列中。使用 Bedossa 组织学评分系统,将队列分为 NASH 与 NAFLD/无 NAFLD。使用接收者操作特征(ROC)曲线评估 NASH 的预测因素。然后使用向后逐步逻辑回归构建模型,并在独立验证队列中进行评估。
53.5%的患者患有 NASH,4 例患者患有肝硬化。平均体重指数(BMI)为 49.8 ± 7.5 kg/m2。向后逐步逻辑回归确定了与 NASH 存在相关的 4 个参数:丙氨酸转氨酶、白蛋白、BMI 和甘油三酯。非侵入性 NASH 检测评分(NI-NASH-DS)在训练和验证队列中的 ROC 分别为 0.851 和 0.727。在训练队列中,敏感性和特异性分别为 77.1%和 88%,在验证队列中,敏感性和特异性分别为 88%和 48%,明显优于已建立的非侵入性评分。
讨论/结论:NI-NASH-DS 使用方便、价格低廉、非侵入性,可可靠地检测肥胖患者的 NASH。由于其简单性,它可以频繁且重复使用。