Department of Medicine and Rehabilitation, Policlinico di Monza, Italy; Department of Medicine and Surgery, University of Milano Bicocca, Italy.
Department of Statistics and Quantitative Methods, University of Milano Bicocca, Italy.
Diabetes Res Clin Pract. 2020 Sep;167:108358. doi: 10.1016/j.diabres.2020.108358. Epub 2020 Jul 31.
Nonalcoholic fatty liver disease (NAFLD) is prevalent in patients with type 2 diabetes mellitus (T2DM), but controversy exists on whether to screen and how to manage these patients in clinical practice. Here, we estimate the number of patients with T2DM and NAFLD in the United States that should be evaluated for advanced liver fibrosis according to proposed screening strategies.
In this cross-sectional analysis of 2940 adult patients with T2DM (projected to 15.3 million) from the 2005-2016 National Health and Nutrition Examination Survey (NHANES) we applied validated noninvasive scores of liver steatosis and fibrosis to estimate the number of referrals to hepatologists. We followed two different approaches: (1) the flow-chart from the European Association for the Study of the Liver (EASL), Diabetes (EASD) and Obesity (EASO) guidelines; (2) a strategy recently proposed in patients with T2DM aimed at excluding advanced liver fibrosis with a negative predictive value of 100%.
NAFLD (based on fatty liver index) was present in 78% of patients (projected to 11.9 million). According to the EASL-EASD-EASO guidelines 37.2-48.5% of patients (projected to 5.7-7.4 million) should be referred to experts, depending on the specific biomarker of fibrosis used. The second strategy, which is based sequentially on aspartate aminotransferase and Fibrosis-4 was able to exclude advanced fibrosis in 67.0% of patients.
Screening strategies based on noninvasive scores are able to exclude advanced liver fibrosis in 50-67% of patients with T2DM. Novel biomarkers or combination of tests may be necessary to reduce the need for liver biopsy and related bleeding episodes in the remaining 33-50%.
非酒精性脂肪性肝病(NAFLD)在 2 型糖尿病(T2DM)患者中较为常见,但在临床实践中是否需要对这些患者进行筛查以及如何管理仍存在争议。在这里,我们根据现有的筛查策略,估算了美国需要评估是否存在晚期肝纤维化的 T2DM 合并 NAFLD 患者数量。
本研究为横断面分析,纳入了 2940 名来自 2005 年至 2016 年全国健康和营养调查(NHANES)的成年 T2DM 患者(预计有 1530 万人)。我们应用了经过验证的肝脂肪变性和纤维化的非侵入性评分,来估算需要转诊给肝病专家的患者数量。我们采用了两种不同的方法:(1)欧洲肝脏研究协会(EASL)、糖尿病(EASD)和肥胖症(EASO)指南中的流程图;(2)最近在 T2DM 患者中提出的一种策略,旨在排除具有 100%阴性预测值的晚期肝纤维化。
根据脂肪肝指数(FLI),NAFLD 存在于 78%的患者中(预计有 1190 万人)。根据 EASL-EASD-EASO 指南,根据所用的特定纤维化生物标志物,有 37.2-48.5%的患者(预计有 570 万至 740 万人)需要转介给专家。第二种策略基于天门冬氨酸氨基转移酶和纤维化-4,可排除 67.0%的患者存在晚期纤维化。
基于非侵入性评分的筛查策略能够排除 50-67%的 T2DM 患者存在晚期肝纤维化。可能需要新的生物标志物或联合检测,以减少在剩余的 33-50%的患者中进行肝活检和相关出血事件的需要。