Center for Liver Diseases, Inova Fairfax Hospital, 3300 Gallows Road, Falls Church, VA 22042, USA.
Obes Surg. 2011 Apr;21(4):431-9. doi: 10.1007/s11695-010-0204-1.
Patients with biopsy-proven NASH and especially those with fibrosis are at risk for progressive liver disease, emphasizing the clinical importance of developing non-invasive biomarkers for NASH and NASH-related fibrosis.
This study examines the performance of a new biomarker panel for NASH and NASH-related fibrosis with a combination of clinical and laboratory variables.
Enrolled patients had biopsy-proven NAFLD. Clinical data, laboratory data, and serum samples were collected at the time of biopsy. Fasting serum was assayed for adiponectin, resistin, glucose, M30, M65, Tissue inhibitor of metalloproteinases-1 (Timp-1), ProCollagen 3 N-terminal peptide (PIIINP), and hyaluronic acid (HA). Regression models predictive of NASH, NASH-related fibrosis, and NASH-related advanced fibrosis were designed and cross-validated.
Of the 79 enrolled NAFLD patients, 40 had biopsy-proven NASH and 39 had non-NASH NAFLD. Clinical and laboratory data were from this cohort were used to develop a NAFLD Diagnostic Panel that includes three models (models for NASH, NASH-related fibrosis, and NASH-related advanced fibrosis). The model for predicting NASH includes diabetes, gender, BMI, triglycerides, M30 (apoptosis), and M65-M30 (necrosis) [AUC: 0.81, 95% CI, 0.70-0.89, 300 p value <9E 301 (-06)]. The NASH-related fibrosis prediction model includes the same predictors [AUC: 0.80, 95% CI 0.68-0.88, 307 p value <0.00014]. Finally, the NASH-related advanced fibrosis model includes type 2 diabetes, serum triglycerides, Timp-1, and AST [AUC: 0.81, 95% CI, 0.70-0.89; p value, 0.000062].
This NAFLD Diagnostic Panel based on a clinical and laboratory data has good performance characteristics and is easy to use. This biomarker panel could become useful in the management of patients with NAFLD.
患有经活检证实的 NASH 且尤其是有纤维化的患者存在进行性肝病的风险，这突出强调了开发用于 NASH 和 NASH 相关纤维化的非侵入性生物标志物的临床重要性。
本研究通过结合临床和实验室变量，检查一种新的 NASH 和 NASH 相关纤维化生物标志物组合的性能。
纳入的患者均患有经活检证实的非酒精性脂肪性肝病。在活检时收集临床数据、实验室数据和血清样本。空腹血清用于测定脂联素、抵抗素、血糖、M30、M65、金属蛋白酶组织抑制剂-1（Timp-1）、前胶原 3 N 端肽（PIIINP）和透明质酸（HA）。设计并交叉验证了预测 NASH、NASH 相关纤维化和 NASH 相关晚期纤维化的回归模型。
在纳入的 79 例非酒精性脂肪性肝病患者中，40 例有活检证实的 NASH，39 例有非 NASH 非酒精性脂肪性肝病。本研究使用该队列的临床和实验室数据开发了一种非酒精性脂肪性肝病诊断性面板，该面板包含三个模型（用于预测 NASH、NASH 相关纤维化和 NASH 相关晚期纤维化的模型）。用于预测 NASH 的模型包括糖尿病、性别、BMI、甘油三酯、M30（凋亡）和 M65-M30（坏死）[AUC：0.81，95%CI，0.70-0.89，300 p 值 <9E 301（-06）]。NASH 相关纤维化预测模型包括相同的预测因子[AUC：0.80，95%CI 0.68-0.88，307 p 值 <0.00014]。最后，NASH 相关晚期纤维化模型包括 2 型糖尿病、血清甘油三酯、Timp-1 和 AST[AUC：0.81，95%CI，0.70-0.89；p 值，0.000062]。
该基于临床和实验室数据的非酒精性脂肪性肝病诊断性面板具有良好的性能特征且易于使用。该生物标志物组合可能在非酒精性脂肪性肝病患者的管理中发挥作用。
