Clinic and Polyclinic of Oncology, Gastroenterology, Hepatology, Pneumology and Infectious Diseases, University Hospital Leipzig, Leipzig, Germany.
Clinical Trial Center Leipzig, University of Leipzig, Leipzig, Germany.
Scand J Gastroenterol. 2020 Jun;55(6):706-711. doi: 10.1080/00365521.2020.1766554. Epub 2020 Jun 1.
Licensed therapies for nonalcoholic fatty liver disease (NAFLD) do not yet exist, but clinical trials are testing treatment options. Inclusion criteria often require liver biopsy showing fibrosis (F2/3) or cirrhosis (F4) and nonalcoholic steatohepatitis (NASH). However, histological criteria pose a serious obstacle for recruitment. Characterize the relevance of liver biopsies in the selection of patients with NAFLD. Patients between 2013 and 2018 with the ICD-10 code K76.0 were analyzed. Fibrosis was defined by the NASH clinical research network (CRN) fibrosis staging system, NASH by a NAFLD activity score (NAS) ≥4. Predictive factors were determined by logistic regression. Liver biopsy was performed in 87/638 (13.6%) patients (49% female, age 52.5 ± 14.0, BMI 30.4 ± 5.9 kg/m). Fibrosis stage F0/F1/F2/F3/F4 was observed in = 7/47/7/17/9, an NAS ≥4 in = 27. Fibrosis stage F2/F3 and F4 along with NAS ≥4 was found in 1.7% and 0.5% of cases. Liver stiffness measurement, LSM (OR 2.3 per doubling of value; CI 1.3-4.4, = .005) and FIB-4 (OR 2.3 per doubling of value; CI 1.2-4.4, = .012) were significant predictors for fibrosis ≥ F2. Predictive factors for NASH were not identified. The biopsy rate in NAFLD patients is low and fibrosis ≥ F2 along with NAS ≥4 only present in a few cases. Transient elastography and FIB-4 are useful to select patients at risk for fibrosis for liver biopsy.
非酒精性脂肪性肝病 (NAFLD) 的许可疗法尚未问世，但临床试验正在测试治疗选择。纳入标准通常需要肝脏活检显示纤维化 (F2/3) 或肝硬化 (F4) 和非酒精性脂肪性肝炎 (NASH)。然而，组织学标准为招募带来了严重障碍。描述肝脏活检在选择 NAFLD 患者中的相关性。分析了 2013 年至 2018 年间具有 ICD-10 编码 K76.0 的患者。纤维化由 NASH 临床研究网络 (CRN) 纤维化分期系统定义，NASH 由 NAFLD 活动评分 (NAS) ≥4 定义。通过逻辑回归确定预测因素。在 638 名患者中有 87 名 (13.6%) 进行了肝活检 (49%为女性，年龄 52.5 ± 14.0，BMI 30.4 ± 5.9 kg/m)。观察到纤维化分期 F0/F1/F2/F3/F4 分别为 7/47/7/17/9，NAS ≥4 为 27。F2/F3 和 F4 纤维化分期以及 NAS ≥4 在 1.7%和 0.5%的病例中发现。肝硬度测量值 LSM (每增加一倍值的比值比为 2.3；95%CI 1.3-4.4， = .005) 和 FIB-4 (每增加一倍值的比值比为 2.3；95%CI 1.2-4.4， = .012) 是纤维化 ≥ F2 的显著预测因子。NASH 的预测因素未被确定。NAFLD 患者的活检率较低，纤维化 ≥ F2 加上 NAS ≥4 仅在少数情况下出现。瞬时弹性成像和 FIB-4 可用于选择有肝纤维化风险的患者进行肝活检。
