磁共振质子密度脂肪分数——一种具有潜力的非酒精性脂肪性肝炎临床试验替代终点

Magnetic resonance imaging-proton density fat fraction:A potential surrogate endpoint for nonalcoholic steatohepatitis clinical trials

磁共振质子密度脂肪分数(MRI-PDFF)是一种运用磁共振技术对整个肝脏中的脂肪进行客观定量无创评估的成像方法。主要分析了MRI-PDFF值与“金指标”——非酒精性脂肪性肝炎(NASH)肝组织学评价之间的相关性,探讨其作为NASH临床试验无创性评价指标的优劣。研究表明,MRI-PDFF作为一种新兴的无创技术,适用于定量肝脂肪含量,评价肝脂肪变性程度,但不能替代肝活检作为NASH诊断的工具。同时,药物干预后MRI-PDFF的相对下降不仅与脂肪沉积改善高度相关,而且与炎症和气球样变的改善具有相关性,可以一定程度预测肝组织学的整体改善情况。MRI-PDFF被认为具有作为NASH临床试验替代终点的潜力。

Magnetic resonance imaging-proton density fat fraction(MRI-PDFF)is an imaging method that uses magnetic resonance technology to perform objective,quantitative,and noninvasive assessment of fat in the whole liver.This article mainly analyzes the correlation between MRI-PDFF value and the“gold index”nonalcoholic steatohepatitis(NASH)liver histological evaluation and explores its advantages and disadvantages as a noninvasive evaluation index for NASH clinical trials.Current studies have shown that MRI-PDFF,as an emerging noninvasive technique,is suitable for quantifying liver fat content and evaluating the degree of hepatic steatosis,but it cannot replace liver biopsy as a tool for the diagnosis of NASH.Meanwhile,the relative reduction in MRI-PDFF after drug intervention is not only highly correlated with the improvement of fat deposition,but also correlated with the improvement of inflammation and ballooning degeneration,and MRI-PDFF can predict the overall improvement of liver histology to a certain extent.Therefore,MRI-PDFF is considered a potential surrogate endpoint for NASH clinical trials.