Hofmann Wolf Peter, Buggisch Peter, Schubert Lisa, Dikopoulos Nektarios, Schwenzer Jeannette, Muche Marion, Felten Gisela, Heyne Renate, Ingiliz Patrick, Schmidt Anna, Stein Kerstin, Wedemeyer Heiner, Berg Thomas, Wiegand Johannes, Lammert Frank, Zeuzem Stefan, Schattenberg Jörn M
Gastroenterologie am Bayerischen Platz, Berlin, Germany.
Association of Gastroenterologists in Private Practice (Berufsverband Niedergelassener Gastroenterologen Deutschlands), Ulm, Germany.
JHEP Rep. 2020 Aug 4;2(6):100168. doi: 10.1016/j.jhepr.2020.100168. eCollection 2020 Dec.
BACKGROUND & AIMS: NAFLD is a growing health concern. The aim of the Fatty Liver Assessment in Germany (FLAG) study was to assess disease burden and provide data on the standard of care from secondary care.
The FLAG study is an observational real-world study in patients with NAFLD enrolled at 13 centres across Germany. Severity of disease was assessed by non-invasive surrogate scores and data recorded at baseline and 12 months.
In this study, 507 patients (mean age 53 years; 47% women) were enrolled. According to fibrosis-4 index, 64%, 26%, and 10% of the patients had no significant fibrosis, indeterminate stage, and advanced fibrosis, respectively. Patients with advanced fibrosis were older, had higher waist circumferences, and higher aspartate aminotransferase and gamma-glutamyltransferase as well as ferritin levels. The prevalence of obesity, arterial hypertension, and type 2 diabetes increased with fibrosis stages. Standard of care included physical exercise >2 times per week in 17% (no significant fibrosis), 19% (indeterminate), and 6% (advanced fibrosis) of patients. Medication with either vitamin E, silymarin, or ursodeoxycholic acid was reported in 5%. Approximately 25% of the patients received nutritional counselling. According to the FibroScan-AST score, 17% of patients presented with progressive non-alcoholic steatohepatitis (n = 107). On follow-up at year 1 (n = 117), weight loss occurred in 47% of patients, of whom 17% lost more than 5% of body weight. In the weight loss group, alanine aminotransferase activities were reduced by 20%.
This is the first report on NAFLD from a secondary-care real-world cohort in Germany. Every 10th patient presented with advanced fibrosis at baseline. Management consisted of best supportive care and lifestyle recommendations. The data highlight the urgent need for systematic health agenda in NAFLD patients.
FLAG is a real-world cohort study that examined the liver disease burden in secondary and tertiary care. Herein, 10% of patients referred to secondary care for NAFLD exhibited advanced liver disease, whilst 64% had no significant liver scarring. These findings underline the urgent need to define patient referral pathways for suspected liver disease.
非酒精性脂肪性肝病（NAFLD）日益引发人们对健康的关注。德国脂肪肝评估（FLAG）研究的目的是评估疾病负担，并提供二级医疗保健的护理标准数据。
FLAG研究是一项针对德国13个中心招募的NAFLD患者的观察性现实世界研究。通过非侵入性替代评分评估疾病严重程度，并记录基线和12个月时的数据。
本研究共纳入507例患者（平均年龄53岁；47%为女性）。根据纤维化-4指数，分别有64%、26%和10%的患者无显著纤维化、处于不确定阶段和有晚期纤维化。晚期纤维化患者年龄更大，腰围、天冬氨酸转氨酶、γ-谷氨酰转移酶以及铁蛋白水平更高。肥胖、动脉高血压和2型糖尿病的患病率随纤维化阶段增加。护理标准包括17%（无显著纤维化）、19%（不确定阶段）和6%（晚期纤维化）的患者每周进行超过2次体育锻炼。5%的患者报告使用了维生素E、水飞蓟宾或熊去氧胆酸进行药物治疗。约25%的患者接受了营养咨询。根据FibroScan-AST评分，17%的患者出现进行性非酒精性脂肪性肝炎（n = 107）。在第1年随访时（n = 117），47%的患者体重减轻，其中17%的患者体重减轻超过5%。在体重减轻组中，丙氨酸转氨酶活性降低了20%。
这是德国二级医疗保健现实世界队列中关于NAFLD的首份报告。每10名患者中就有1名在基线时出现晚期纤维化。治疗包括最佳支持性护理和生活方式建议。这些数据凸显了为NAFLD患者制定系统健康议程的迫切需求。
FLAG是一项现实世界队列研究，研究了二级和三级医疗保健中的肝脏疾病负担。在此研究中，因NAFLD转诊至二级医疗保健的患者中有10%表现出晚期肝病，而64%没有明显的肝瘢痕形成。这些发现强调了迫切需要确定疑似肝病患者的转诊途径。
