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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.1447

摘要内容如下：

重要性

代谢功能障碍相关性脂肪变性肝病（MASLD）是目前世界范围内最常见的慢性肝病。发展非侵入性检测对评估疾病的严重程度和预后具有重要意义。

目的

研究基于振动控制瞬时弹性成像（VCTE）评分的基线水平和动态变化的预后意义，该评分用于诊断MASLD患者的晚期纤维化（AGILE 3+）和肝硬化（AGILE 4）。

设计、设置和参与者

该队列研究纳入了2004年2月至2023年1月在美国、欧洲和亚洲的16个三级转诊中心接受VCTE检查的MASLD患者的自然史队列数据，其中14个中心的数据是前瞻性收集的。入选患者为年龄至少18岁的成人，通过组织学方法（≥5%的肝细胞脂肪变性）或影像学检查（超声检查、计算机断层扫描或磁共振成像，或通过VCTE控制衰减参数≥248dB/m）诊断为肝脂肪变性。

主要成果和措施

主要转归是肝脏相关事件（LRE），定义为肝细胞癌或肝脏失代偿（腹水、静脉曲张出血、肝性脑病或肝肾综合征）、肝移植和肝脏相关死亡。将Agile评分与组织学和其他8种非侵入性检查进行比较。

结果

共有16603名患者在基线时接受了VCTE检查（平均[SD]年龄:52.5[13.7]岁；9600名[57.8%]为男性）。中位随访时间为51.7（IQR，25.2-85.2）个月，316名患者（1.9%）发展为LRES。与大多数纤维化评分相比，AGILE 3+和AGILE 4评分在低和高临界值之间分类的患者较少，并且在预测LRES（时间依赖性受试者工作特征曲线下的综合面积，0.89）方面获得了最高的判别能力。共有10920名患者（65.8%）在中位间隔15（IQR，11.3-27.7）个月内进行了重复VCTE检查，并被纳入系列分析。共有81.9%的患者（7208/8810）具有稳定的敏捷3+评分，92.6%的患者（8163/8810）具有稳定的敏捷4评分（两次评估的风险类别相同）。在持续低Agile 3+评分的患者中，LRES的发生率为0.6/1000人-年，在持续高Agile 3+评分的患者中，LRES的发生率为30.1/1000人-年。在基线时具有高敏捷3+评分的患者中，评分下降超过20%与LRES风险的显著降低相关。在敏捷4评分中也观察到了类似的趋势，尽管它在低风险组中遗漏了更多的LRE。

结论和相关性

这项研究的结果表明，单个或系列敏捷评分在预测MASLD患者的LRES方面具有很高的准确性，使其在常规临床实践和脂肪性肝炎的2B期和3期临床试验中成为肝活检的合适替代方案。

英文原文如下：

Abstracts

Importance  Metabolic dysfunction-associated steatotic liver disease (MASLD) is currently the most common chronic liver disease worldwide. It is important to develop noninvasive tests to assess the disease severity and prognosis.

Objective  To study the prognostic implications of baseline levels and dynamic changes of the vibration-controlled transient elastography (VCTE)-based scores developed for the diagnosis of advanced fibrosis (Agile 3+) and cirrhosis (Agile 4) in patients with MASLD.

Design, Setting, and Participants  This cohort study included data from a natural history cohort of patients with MASLD who underwent VCTE examination at 16 tertiary referral centers in the US, Europe, and Asia from February 2004 to January 2023, of which the data were collected prospectively at 14 centers. Eligible patients were adults aged at least 18 years with hepatic steatosis diagnosed by histologic methods (steatosis in ≥5% of hepatocytes) or imaging studies (ultrasonography, computed tomography or magnetic resonance imaging, or controlled attenuation parameter ≥248 dB/m by VCTE).

Main Outcomes and Measures  The primary outcome was liver-related events (LREs), defined as hepatocellular carcinoma or hepatic decompensation (ascites, variceal hemorrhage, hepatic encephalopathy, or hepatorenal syndrome), liver transplant, and liver-related deaths. The Agile scores were compared with histologic and 8 other noninvasive tests.

Results  A total of 16 603 patients underwent VCTE examination at baseline (mean [SD] age, 52.5 [13.7] years; 9600 [57.8%] were male). At a median follow-up of 51.7 (IQR, 25.2-85.2) months, 316 patients (1.9%) developed LREs. Both Agile 3+ and Agile 4 scores classified fewer patients between the low and high cutoffs than most fibrosis scores and achieved the highest discriminatory power in predicting LREs (integrated area under the time-dependent receiver-operating characteristic curve, 0.89). A total of 10 920 patients (65.8%) had repeated VCTE examination at a median interval of 15 (IQR, 11.3-27.7) months and were included in the serial analysis. A total of 81.9% of patients (7208 of 8810) had stable Agile 3+ scores and 92.6% of patients (8163 of 8810) had stable Agile 4 scores (same risk categories at both assessments). The incidence of LREs was 0.6 per 1000 person-years in patients with persistently low Agile 3+ scores and 30.1 per 1000 person-years in patients with persistently high Agile 3+ scores. In patients with high Agile 3+ score at baseline, a decrease in the score by more than 20% was associated with substantial reduction in the risk of LREs. A similar trend was observed for the Agile 4 score, although it missed more LREs in the low-risk group.

Conclusions and Relevance  Findings of this study suggest that single or serial Agile scores are highly accurate in predicting LREs in patients with MASLD, making them suitable alternatives to liver biopsy in routine clinical practice and in phase 2b and 3 clinical trials for steatohepatitis.

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