BACKGROUND AND AIMS Histological classifications used to diagnose/stage nonalcoholic fatty liver disease (NAFLD) are based on morphology, thus empirical, with undetermined clinical correlates and relevance. We assessed the clinical relevance of the fatty liver inhibition of progression (FLIP) algorithm and the steatosis, activity and fibrosis (SAF) scoring system. METHODS 140 consecutive patients with suspected NAFLD and a separate validation cohort of 78 patients enrolled in a therapeutic trial, all with central reading of liver biopsy, were included. FLIP and SAF defined patients with steatohepatitis (NASH), NAFL (non-NASH NAFLD) or non-NAFLD. SAF activity score assessed hepatocyte ballooning and lobular inflammation; histologically severe disease was defined as a SAF activity score of >3 and/or bridging fibrosis or cirrhosis. Clinical, biochemical and metabolic data were analyzed in relation to histology. RESULTS Patients with NASH according to the FLIP algorithm had a distinct clinical profile from those labeled NAFL, with a higher prevalence of metabolic risk factors (increased BMI, central obesity, serum glucose and HbA1c), more severe insulin resistance (fasting insulin, HOMA-IR values) and higher level of aminotransferases. Similar findings were documented for patients with severe disease vs. those without. Positive linear trends existed between NASH or severe disease and increasing BMI and HOMA-IR. There was a strong association between liver fibrosis and NASH or SAF-defined scores of activity. Patients with either significant or bridging fibrosis overwhelmingly had NASH, and bridging fibrosis most often coexisted with severe activity. CONCLUSIONS The FLIP algorithm/SAF score, although based on purely morphological grounds, are clinically relevant as they identify patients with distinct clinical and biological profiles of disease severity. Disease activity in NAFLD is associated with fibrosis severity.

中文翻译：

---

FLIP 算法和 SAF 评分在非酒精性脂肪肝患者中的临床验证

背景和目的 用于诊断/分期非酒精性脂肪性肝病 (NAFLD) 的组织学分类基于形态学，因此是经验性的，具有未确定的临床相关性和相关性。我们评估了脂肪肝进展抑制 (FLIP) 算法和脂肪变性、活性和纤维化 (SAF) 评分系统的临床相关性。方法 140 名疑似 NAFLD 的连续患者和一个由 78 名患者组成的单独验证队列参加了一项治疗试验，所有患者均进行了肝活检的中心读数。FLIP 和 SAF 定义了患有脂肪性肝炎 (NASH)、NAFL（非 NASH NAFLD）或非 NAFLD 的患者。SAF 活动评分评估肝细胞气球样变和小叶炎症；组织学上严重的疾病定义为 SAF 活动评分 >3 和/或桥接纤维化或肝硬化。临床，分析了与组织学相关的生化和代谢数据。结果 根据 FLIP 算法，NASH 患者与标记为 NAFL 的患者具有不同的临床特征，代谢危险因素（BMI 增加、向心性肥胖、血清葡萄糖和 HbA1c 增加）的患病率更高，胰岛素抵抗更严重（空腹胰岛素、HOMA- IR 值）和更高水平的氨基转移酶。对于患有严重疾病的患者与没有疾病的患者，记录了类似的发现。NASH 或严重疾病与 BMI 和 HOMA-IR 增加之间存在正线性趋势。肝纤维化与 NASH 或 SAF 定义的活动评分之间存在很强的关联。明显或桥接纤维化的患者绝大多数患有 NASH，桥接纤维化最常与严重活动共存。结论 FLIP 算法/SAF 评分虽然纯粹基于形态学基础，但具有临床相关性，因为它们可识别具有不同疾病严重程度临床和生物学特征的患者。NAFLD 的疾病活动与纤维化严重程度相关。