MRI and MRE for non-invasive quantitative assessment of hepatic steatosis and fibrosis in NAFLD and NASH: Clinical trials to clinical practice.
MRI and MRE for non-invasive quantitative assessment of hepatic steatosis and fibrosis in NAFLD and NASH: Clinical trials to clinical practice.
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DOI：
10.1016/j.jhep.2016.06.005
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发表时间：
2016-11
影响因子：
25.7
通讯作者：
Loomba R
中科院分区：
文献类型：
--
作者：
Dulai PS;Sirlin CB;Loomba R
非酒精性脂肪性肝病（NAFLD）是慢性肝病最常见的病因之一，其在全球的患病率正在上升。非酒精性脂肪性肝炎（NASH）的发生与疾病相关的发病率和死亡率大幅增加有关。因此，围绕药物研发出现了大量创新，以努力抵消这种疾病的自然进展和长期风险。目前，NAFLD在临床试验和临床实践中的疾病评估是通过肝活检进行的。然而，基于肝活检的评估仍然不准确，且并非没有成本或风险。这对将治疗性干预措施推向市场的可行性和成本具有重大影响。因此，需要可靠且高度准确的替代终点，可用于2期和3期临床试验，以降低试验规模要求和成本，同时提高在临床实践中的可行性和实施的便利性。磁共振技术现已取得重大进展，磁共振成像（MRI）和磁共振弹性成像（MRE）已被证明是检测肝脂肪变性和纤维化的高度准确的诊断工具。在这篇综述文章中，我们将总结关于在NAFLD患者中使用MRI和MRE的现有证据，以及这些替代生物标志物在NASH和肝纤维化临床试验快速发展的领域中所起的不断变化的作用。此外，我们将强调这些工具如何能够容易地应用于常规临床实践，在临床实践中，NAFLD日益加重的负担将需要通过强化监测算法来应对。
Nonalcoholic fatty liver disease (NAFLD) represents one of the most common causes of chronic liver disease, and its prevalence is rising worldwide. The occurrence of nonalcoholic steatohepatitis (NASH) is associated with a substantial increase in disease related morbidity and mortality. Accordingly, there has been a surge of innovation surrounding drug development in an effort to off-set the natural progression and long-term risks of this disease. Disease assessment within clinical trials and clinical practice for NAFLD is currently done with liver biopsies. Liver biopsy-based assessments, however, remain imprecise and are not without cost or risk. This carries significant implications for the feasibility and costs of bringing therapeutic interventions to market. A need therefore arises for reliable and highly accurate surrogate end-points that can be used in phase 2 and 3 clinical trials to reduce trial size requirements and costs, while improving feasibility and ease of implementation in clinical practice. Significant advances have now been made in magnetic resonance technology, and magnetic resonance imaging (MRI) and elastrography (MRE) have been demonstrated to be highly accurate diagnostic tools for the detection of hepatic steatosis and fibrosis. In this review article, we will summarize the currently available evidence regarding the use of MRI and MRE among NAFLD patients, and the evolving role these surrogate biomarkers will play in the rapidly advancing arena of clinical trials in NASH and hepatic fibrosis. Furthermore, we will highlight how these tools can be readily applied to routine clinical practice, where the growing burden of NAFLD will need to be met with enhanced monitoring algorithms.
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影响因子：
4.4
作者：
Bonekamp, Susanne;Tang, An;Mashhood, Arian;Wolfson, Tanya;Changchien, Christopher;Middleton, Michael S.;Clark, Lisa;Gamst, Anthony;Loomba, Rohit;Sirlin, Claude B.
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作者：
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通讯作者：
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影响因子：
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作者：
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通讯作者：
Neubauer, Stefan