验证无创临床途径识别晚期

IF 4.4 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Annals of hepatology Pub Date : 2025-09-01 DOI:10.1016/j.aohep.2025.101949

Luis Antonio Díaz Piga , Natalia Baeza , Francisco Idalsoaga , Xiao-Dong Zhou , Ming-Hua Zheng , Fátima Higuera de la Tijera , Fernando Javier Barreyro , Rakhi Maiwall , Shiv K. Sarin , Anand V. Kulkarni , Ramagundam Ramyasri , Gustavo Ayares , Terry Cheuk-Fung Yip , Vincent Wai-Sun Wong , Grace Lai-Hung Wong , Jimmy Che-To Lai , Yu Jun Wong , Xin En Goh , May Xuan Goh , David Marti-Aguado , Juan Pablo Arab

{"title":"验证无创临床途径识别晚期","authors":"Luis Antonio Díaz Piga , Natalia Baeza , Francisco Idalsoaga , Xiao-Dong Zhou , Ming-Hua Zheng , Fátima Higuera de la Tijera , Fernando Javier Barreyro , Rakhi Maiwall , Shiv K. Sarin , Anand V. Kulkarni , Ramagundam Ramyasri , Gustavo Ayares , Terry Cheuk-Fung Yip , Vincent Wai-Sun Wong , Grace Lai-Hung Wong , Jimmy Che-To Lai , Yu Jun Wong , Xin En Goh , May Xuan Goh , David Marti-Aguado , Juan Pablo Arab","doi":"10.1016/j.aohep.2025.101949","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction and Objectives</h3><div>Limited data exist on non-invasive clinical algorithms for MetALD and ALD. We aimed to (1) quantify the false-negative rate of standard algorithms combining Fibrosis-4 index (FIB-4) and vibration-controlled transient elastography (VCTE) for detecting advanced fibrosis in MetALD and ALD, and (2) evaluate the diagnostic accuracy of FIB-4 for advanced fibrosis in MetALD.</div></div><div><h3>Materials and Methods</h3><div>Retrospective cohort including 764 well-characterized adults with MetALD (n=334, 43.7%) or ALD (n=430, 56.3%) from 14 countries (2003–2025) according to the 2023 criteria; other concomitant liver diseases were excluded. All underwent VCTE (>8 kPa considered elevated); 244 (31.9%) also had liver biopsy. FIB-4 was categorized as low risk <1.3, indeterminate 1.3–2.67 (2.0–2.67 if ≥65 years), and high risk >2.67. Analysis included AUROC curves.</div></div><div><h3>Results</h3><div>Mean age was 49.5 years (IQR 41–59); 73.1% were male; mean BMI 28.0 kg/m<sup>2</sup> (IQR 24.1–31.6); 32.2% had diabetes. Median FIB-4 was 1.57 (IQR 0.92–3.29); median LSM 8.6 kPa (IQR 5.9–22.3). Among those biopsied (n=244), 14.3% had F3 and 11.9% had cirrhosis (F4). Of the low FIB-4 group, 28.1% had elevated VCTE (32.0% MetALD; 24.9% ALD). Sixteen participants classified as low-risk by both FIB-4 and LSM had ≥F3 fibrosis on biopsy—false-negative rate 6.6% overall (5.7% MetALD; 7.4% ALD) (Figure). In MetALD, FIB-4 yielded an AUROC of 0.736 (95%CI:0.610–0.863) for ≥F3 fibrosis; the optimal cut-point was ≥1.65 (sensitivity 74%, specificity 73%). Applying ≥1.65 to participants over 65 years with MetALD reduced the false-negative rate to 2.0%, while the referral rate rose only from 30.3% to 33.6%.</div></div><div><h3>Conclusions</h3><div>Standard noninvasive pathways combining FIB-4 and VCTE had low false-negative rates for advanced fibrosis in MetALD and ALD. In patients with MetALD aged +65 years, lowering the FIB-4 threshold to ≥1.65 may improve advanced fibrosis detection.</div></div>","PeriodicalId":7979,"journal":{"name":"Annals of hepatology","volume":"30 ","pages":"Article 101949"},"PeriodicalIF":4.4000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"VALIDATION OF NONINVASIVE CLINICAL PATHWAYS TO IDENTIFY ADVANCED\",\"authors\":\"Luis Antonio Díaz Piga , Natalia Baeza , Francisco Idalsoaga , Xiao-Dong Zhou , Ming-Hua Zheng , Fátima Higuera de la Tijera , Fernando Javier Barreyro , Rakhi Maiwall , Shiv K. Sarin , Anand V. Kulkarni , Ramagundam Ramyasri , Gustavo Ayares , Terry Cheuk-Fung Yip , Vincent Wai-Sun Wong , Grace Lai-Hung Wong , Jimmy Che-To Lai , Yu Jun Wong , Xin En Goh , May Xuan Goh , David Marti-Aguado , Juan Pablo Arab\",\"doi\":\"10.1016/j.aohep.2025.101949\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction and Objectives</h3><div>Limited data exist on non-invasive clinical algorithms for MetALD and ALD. We aimed to (1) quantify the false-negative rate of standard algorithms combining Fibrosis-4 index (FIB-4) and vibration-controlled transient elastography (VCTE) for detecting advanced fibrosis in MetALD and ALD, and (2) evaluate the diagnostic accuracy of FIB-4 for advanced fibrosis in MetALD.</div></div><div><h3>Materials and Methods</h3><div>Retrospective cohort including 764 well-characterized adults with MetALD (n=334, 43.7%) or ALD (n=430, 56.3%) from 14 countries (2003–2025) according to the 2023 criteria; other concomitant liver diseases were excluded. All underwent VCTE (>8 kPa considered elevated); 244 (31.9%) also had liver biopsy. FIB-4 was categorized as low risk <1.3, indeterminate 1.3–2.67 (2.0–2.67 if ≥65 years), and high risk >2.67. Analysis included AUROC curves.</div></div><div><h3>Results</h3><div>Mean age was 49.5 years (IQR 41–59); 73.1% were male; mean BMI 28.0 kg/m<sup>2</sup> (IQR 24.1–31.6); 32.2% had diabetes. Median FIB-4 was 1.57 (IQR 0.92–3.29); median LSM 8.6 kPa (IQR 5.9–22.3). Among those biopsied (n=244), 14.3% had F3 and 11.9% had cirrhosis (F4). Of the low FIB-4 group, 28.1% had elevated VCTE (32.0% MetALD; 24.9% ALD). Sixteen participants classified as low-risk by both FIB-4 and LSM had ≥F3 fibrosis on biopsy—false-negative rate 6.6% overall (5.7% MetALD; 7.4% ALD) (Figure). In MetALD, FIB-4 yielded an AUROC of 0.736 (95%CI:0.610–0.863) for ≥F3 fibrosis; the optimal cut-point was ≥1.65 (sensitivity 74%, specificity 73%). Applying ≥1.65 to participants over 65 years with MetALD reduced the false-negative rate to 2.0%, while the referral rate rose only from 30.3% to 33.6%.</div></div><div><h3>Conclusions</h3><div>Standard noninvasive pathways combining FIB-4 and VCTE had low false-negative rates for advanced fibrosis in MetALD and ALD. In patients with MetALD aged +65 years, lowering the FIB-4 threshold to ≥1.65 may improve advanced fibrosis detection.</div></div>\",\"PeriodicalId\":7979,\"journal\":{\"name\":\"Annals of hepatology\",\"volume\":\"30 \",\"pages\":\"Article 101949\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of hepatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1665268125001747\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of hepatology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1665268125001747","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}

引用次数: 0

摘要

介绍和目的关于MetALD和ALD的无创临床算法的数据有限。我们的目的是(1)量化结合纤维化-4指数（FIB-4）和振动控制瞬时弹性成像（VCTE）检测MetALD和ALD晚期纤维化的标准算法的假阴性率，(2)评估FIB-4对MetALD晚期纤维化的诊断准确性。材料和方法回顾性队列研究，包括来自14个国家（2003-2025年）的764例特征明确的MetALD （n=334, 43.7%）或ALD （n=430, 56.3%）患者。排除其他伴发肝脏疾病。所有患者均行VCTE （>； 8kpa升高）；244例（31.9%）同时行肝活检。FIB-4分为低风险<；1.3，不确定1.3 - 2.67(≥65岁为2.0-2.67)，高风险>；2.67。分析采用AUROC曲线。结果平均年龄49.5岁（IQR 41 ~ 59）；男性占73.1%；平均BMI 28.0 kg/m2 (IQR 24.1-31.6)；32.2%患有糖尿病。中位FIB-4为1.57 (IQR 0.92-3.29)；中位LSM 8.6 kPa （IQR 5.9-22.3）。244例活检患者中，14.3%为F3, 11.9%为肝硬化（F4）。在低FIB-4组中，28.1%的患者VCTE升高（32.0% MetALD; 24.9% ALD）。16名被FIB-4和LSM分类为低风险的参与者，活检假阴性率为6.6% （MetALD为5.7%，ALD为7.4%）。在MetALD中，FIB-4对≥F3级纤维化的AUROC为0.736 (95%CI: 0.610-0.863)；最佳切点≥1.65（敏感性74%，特异性73%）。对65岁以上的MetALD患者应用≥1.65，假阴性率降至2.0%，而转诊率仅从30.3%上升至33.6%。结论联合FIB-4和VCTE的标准无创途径对MetALD和ALD的晚期纤维化假阴性率较低。在65岁以上的MetALD患者中，将FIB-4阈值降低至≥1.65可能会改善晚期纤维化的检测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

VALIDATION OF NONINVASIVE CLINICAL PATHWAYS TO IDENTIFY ADVANCED

Introduction and Objectives

Limited data exist on non-invasive clinical algorithms for MetALD and ALD. We aimed to (1) quantify the false-negative rate of standard algorithms combining Fibrosis-4 index (FIB-4) and vibration-controlled transient elastography (VCTE) for detecting advanced fibrosis in MetALD and ALD, and (2) evaluate the diagnostic accuracy of FIB-4 for advanced fibrosis in MetALD.

Materials and Methods

Retrospective cohort including 764 well-characterized adults with MetALD (n=334, 43.7%) or ALD (n=430, 56.3%) from 14 countries (2003–2025) according to the 2023 criteria; other concomitant liver diseases were excluded. All underwent VCTE (>8 kPa considered elevated); 244 (31.9%) also had liver biopsy. FIB-4 was categorized as low risk <1.3, indeterminate 1.3–2.67 (2.0–2.67 if ≥65 years), and high risk >2.67. Analysis included AUROC curves.

Results

Mean age was 49.5 years (IQR 41–59); 73.1% were male; mean BMI 28.0 kg/m² (IQR 24.1–31.6); 32.2% had diabetes. Median FIB-4 was 1.57 (IQR 0.92–3.29); median LSM 8.6 kPa (IQR 5.9–22.3). Among those biopsied (n=244), 14.3% had F3 and 11.9% had cirrhosis (F4). Of the low FIB-4 group, 28.1% had elevated VCTE (32.0% MetALD; 24.9% ALD). Sixteen participants classified as low-risk by both FIB-4 and LSM had ≥F3 fibrosis on biopsy—false-negative rate 6.6% overall (5.7% MetALD; 7.4% ALD) (Figure). In MetALD, FIB-4 yielded an AUROC of 0.736 (95%CI:0.610–0.863) for ≥F3 fibrosis; the optimal cut-point was ≥1.65 (sensitivity 74%, specificity 73%). Applying ≥1.65 to participants over 65 years with MetALD reduced the false-negative rate to 2.0%, while the referral rate rose only from 30.3% to 33.6%.

Conclusions

Standard noninvasive pathways combining FIB-4 and VCTE had low false-negative rates for advanced fibrosis in MetALD and ALD. In patients with MetALD aged +65 years, lowering the FIB-4 threshold to ≥1.65 may improve advanced fibrosis detection.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Annals of hepatology 医学-胃肠肝病学

CiteScore

7.90

自引率

2.60%

发文量

183

审稿时长

4-8 weeks

期刊介绍： Annals of Hepatology publishes original research on the biology and diseases of the liver in both humans and experimental models. Contributions may be submitted as regular articles. The journal also publishes concise reviews of both basic and clinical topics.