循环生物标志物对非酒精性脂肪肝炎的诊断性能
Arun J Sanyal1, Sudha S Shankar2, Katherine P Yates3
1Virginia Commonwealth University School of Medicine, Richmond, VA, USA. arun.sanyal@vcuhealth.org.
Nature medicine
|September 7, 2023
概括
新的血液测试显示出诊断高风险非酒精性脂肪肝炎 (NASH) 和其纤维化严重程度的前景. 这些经过验证的生物标志物可以帮助早期检测和治疗肝病.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 生物标志物发现发现
- 诊断发展 诊断发展
背景情况:
- 非酒精性脂肪肝炎 (NASH) 缺乏对风险患者的批准诊断生物标志物,这一群体有增加的肝病风险.
- 目前用于诊断非酒精性脂肪性肝病 (NAFLD) 纤维化严重程度的诊断方法可能具有侵入性或缺乏精度.
- 该FNIH-NIMBLE项目旨在促进新型NASH生物标志物的监管批准.
研究的目的:
- 评估五个基于血液的生物标志物面板的诊断性能,以确定NAFLD患者风险NASH和纤维化阶段.
- 评估这些面板是否符合预先规定的性能指标,包括接收器操作特征曲线 (AUROC) 下的面积和优于现有的测试.
- 确定可靠的非侵入性生物标志物,用于临床治疗NAFLD和NASH.
主要方法:
- 使用了一个具有NAFLD全谱的观察队列 (NASH CRN DB2,n=1,073).
- 五个基于血液的面板 (NIS4,OWLiver,ELF测试,PROC3,FibroMeter VCTE) 被评估用于诊断有风险的NASH和纤维化阶段.
- 通过AUROC (≥0.7) 测量性能,并与氨酸转移酶和FIB-4测试进行比较.
主要成果:
- NIS4小组在诊断有风险的NASH时获得了0.81的AUROC.
- 在ELF测试,PROC3和纤维仪VCTE中,临床显著纤维化 (≥2阶段),晚期纤维化 (≥3阶段) 或肝硬化 (4阶段) 的AUROC ≥0.8被证明.
- 在所有纤维化终点上,ELF和FibroMeter VCTE的表现优于FIB-4测试.
结论:
- 一些基于血液的生物标志物面板显示了在NAFLD中具有风险的NASH和纤维化严重程度的显著诊断性能.
- 这些发现代表了对这些非侵入性生物标志物的监管资格的关键一步.
- 经过验证的生物标志物可以改善早期检测,风险分层和NAFLD和NASH患者的管理.
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