Clinical Gastroenterology and Hepatology最新文献

英文中文

Performance of a Multi-cancer Early Detection Test for Detection of Hepatocellular Carcinoma in Patients With Cirrhosis 用于检测肝硬化患者肝细胞癌的多种癌症早期检测试验的性能。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.07.016

Darine Daher, Purva Gopal, Marie V. Coignet, Vivian Xiao , Kathryn N. Kurtzman , Amit G. Singal

引用次数: 0

Disparities for Hispanic Adults With Metabolic Dysfunction-associated Steatotic Liver Disease in the United States: A Systematic Review and Meta-analysis 美国患有代谢功能障碍相关性脂肪性肝病的西班牙裔成年人的差异：系统回顾和元分析

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.06.038

Kaleb Tesfai , Jordan Pace , Nora El-Newihi , Maria Elena Martinez , Monica A. Tincopa , Rohit Loomba

Background & Aims

Prevalence and severity of metabolic dysfunction-associated steatotic liver disease (MASLD) is reported to be higher in Hispanic adults in the United States (U.S.), although rates vary substantially across studies and have increased given the evolving obesity epidemic. This systematic review and meta-analysis quantifies MASLD disease burden and severity in contemporary cohorts to characterize health disparities experienced by adult Hispanic individuals in the U.S.

Methods

We searched the MEDLINE, Embase, and Cochrane databases per the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Studies from 2010 to December 2023 were included to capture data representative of current populations given the obesity epidemic. Studies from overlapping cohorts were excluded. Meta-analyses were conducted using random-effects models to estimate pooled prevalence and relative risk (RR) with 95% confidence intervals (CIs).

Results

We identified 22 studies, comprising 756,088 subjects, of which 62,072 were Hispanic. The pooled prevalence in U.S. Hispanic adults was 41% (95% CI, 30%–52%) for MASLD, 61% (95% CI, 39%–82%) for metabolic dysfunction-associated steatohepatitis (MASH), 27% (95% CI, 15%–39%) for MASH-associated advanced fibrosis (AF), and 5% (95% CI, 1%–8%) for MASH cirrhosis. Compared with non-Hispanic adults, Hispanic adults had a RR of 1.50 (95% CI, 1.32–1.69) for MASLD, 1.42 (95% CI, 1.04–1.93) for MASH, 1.37 (95% CI, 0.96–1.96) for MASH-associated AF, and 0.93 (95% CI, 0.49–1.77) for MASH cirrhosis.

Conclusion

Health disparities for U.S. Hispanic adults continue to worsen with significantly higher relative risk of MASLD and MASH compared with non-Hispanic adults. Public health efforts to optimize screening and care delivery for the adult Hispanic population are urgently needed.

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引用次数: 0

How Artificial Intelligence Will Transform Clinical Care, Research, and Trials for Inflammatory Bowel Disease 人工智能将如何改变炎症性肠病的临床护理、研究和试验。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.05.048

Anna L. Silverman , Dennis Shung , Ryan W. Stidham , Gursimran S. Kochhar , Marietta Iacucci

Artificial intelligence (AI) refers to computer-based methodologies that use data to teach a computer to solve pre-defined tasks; these methods can be applied to identify patterns in large multi-modal data sources. AI applications in inflammatory bowel disease (IBD) includes predicting response to therapy, disease activity scoring of endoscopy, drug discovery, and identifying bowel damage in images. As a complex disease with entangled relationships between genomics, metabolomics, microbiome, and the environment, IBD stands to benefit greatly from methodologies that can handle this complexity. We describe current applications, critical challenges, and propose future directions of AI in IBD.

人工智能（AI）是指基于计算机的方法，它利用数据教计算机解决预定义的任务；这些方法可用于识别大型多模态数据源中的模式。人工智能在炎症性肠病（IBD）中的应用包括预测对治疗的反应、内窥镜检查的疾病活动评分、药物发现以及识别图像中的肠道损伤。IBD 是一种复杂的疾病，基因组学、代谢组学、微生物组和环境之间的关系错综复杂，能够处理这种复杂性的方法将使 IBD 受益匪浅。我们介绍了人工智能在 IBD 领域的当前应用、关键挑战，并提出了未来的发展方向。

引用次数: 0

The Future of Clinical Trials in Inflammatory Bowel Disease 炎症性肠病临床试验的未来。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.06.036

Christopher Ma , Virginia Solitano , Silvio Danese , Vipul Jairath

The medical management of inflammatory bowel disease (IBD) has been transformed over the past few decades by the approval of multiple classes of advanced therapies and the integration of more targeted treatment strategies for Crohn’s disease and ulcerative colitis. These changes have been driven by an increasing number of pivotal randomized controlled trials, which have grown in size and complexity over time. Several landmark studies that are anticipated to change current IBD management paradigms have recently been completed or are on-going, including the first head-to-head biologic trials, advanced combination treatment trials, therapeutic strategy and treatment target trials, and multiple phase 3 registrational programs of novel compounds. Despite these advances, the future of IBD trials also faces major challenges with respect to cost, feasibility, and recruitment. Accordingly, innovative methods for early and late phase randomized controlled trials must be adopted. In this review, we provide a comprehensive overview of the evolution of modern IBD trials, discuss methods for improving trial efficiency in early and late phase development, and provide insights into the interpretation and implications of these data for clinical care.

在过去的几十年里，炎症性肠病（IBD）的医疗管理发生了巨大变化，既有多类先进疗法获得批准，也有针对克罗恩病（CD）和溃疡性结肠炎（UC）的更具针对性的治疗策略被整合进来。这些变化是由越来越多的关键性随机对照试验（RCT）推动的，随着时间的推移，这些试验的规模和复杂性都在不断增加。一些有望改变当前 IBD 治疗模式的里程碑式研究最近已经完成或正在进行中，包括首次头对头生物试验、先进的联合治疗试验、治疗策略和治疗靶点试验，以及多个新型化合物的 3 期注册计划。尽管取得了这些进展，但未来的 IBD 试验还面临着成本、可行性和招募方面的重大挑战。因此，早期和晚期 RCT 都必须采用创新方法。在本综述中，我们将全面概述现代 IBD 试验的发展历程，讨论在早期和晚期开发阶段提高试验效率的方法，并深入分析这些数据对临床治疗的解释和影响。

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引用次数: 0

All FODMAPs Aren’t Created Equal: Results of a Randomized Reintroduction Trial in Patients With Irritable Bowel Syndrome 并非所有的 FODMAP 都是一样的：肠易激综合征患者随机再引入试验的结果。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.03.047

Shanti Eswaran , Kara J. Jencks , Prashant Singh , Samara Rifkin , Theresa Han-Markey , William D. Chey

Background & Aims

A diet low in fermentable oligo, di, monosaccharides, and polyols (FODMAPs) is one of the recommended management strategies for irritable bowel syndrome (IBS). However, while effective, adherence to restricting dietary FODMAPs can be challenging and burdensome. The question remains whether limiting all FODMAPs during the restrictive phase of the diet is necessary for symptomatic improvement in the dietary treatment of IBS, or if targeting selected groups of FODMAPs for restriction is sufficient for clinical response. Our study aimed to determine which individual FODMAPs are most likely to lead to symptom generation in patients with IBS who have improved with fodmap restriction.

Methods

Patients meeting Rome IV criteria for IBS were invited to participate in a 12-week study to identify individual FODMAP sensitivities. Those subjects who demonstrated symptom improvement after a 2- to 4-week open-label FODMAP elimination period were recruited to a 10-week blinded-phased FODMAP reintroduction phase of 7 days for each FODMAP. Throughout the study period, daily symptom severity (0–10 point numerical rating system) was recorded. A mixed effect statistical analysis model was used.

Results

Between 2018 and 2020, 45 subjects were enrolled. Twenty-five subjects improved with FODMAP elimination, and 21 patients continued into the reintroduction phase of the study. Fructans and galacto-oligosaccharides (GOS) both were associated with worsened abdominal pain (P = .007 and P = .04, respectively). GOS were associated with an increase in bloating (P = 03). Both bloating and abdominal pain worsened throughout the study, regardless of the FODMAP reintroduction (P = .006).

Conclusion

Our results suggest that the reintroduction of select FODMAPs may be responsible for symptom generation in patients with IBS who have responded to a low FODMAP diet, and provide a strong rationale for performing a future trial comparing the treatment effects of a limited low-FODMAP diet and a standard low-FODMAP diet.

Clinicaltrials.gov

NCT03052439

可发酵低聚糖、双糖、单糖和多元醇（FODMAPs）含量低的饮食是肠易激综合征（IBS）的推荐治疗策略之一。然而，限制膳食中的 FODMAPs 虽然有效，但坚持食用却可能是一项挑战和负担。在肠易激综合征的饮食治疗中，在饮食限制阶段限制所有的 FODMAPs 是否是改善症状的必要条件，或者针对选定的 FODMAPs 组进行限制是否足以产生临床反应，这仍然是一个问题。我们的研究旨在确定哪些单个 FODMAPs 最有可能导致肠易激综合征患者在限制 Fodmap 后症状得到改善：方法：我们邀请符合罗马IV标准的肠易激综合征患者参加为期12周的研究，以确定他们对哪些FODMAP敏感。经过 2-4 周开放标签 FODMAP 禁食期后症状有所改善的受试者被招募参加为期 10 周的盲法 FODMAP 重引入期，每种 FODMAP 重引入期为 7 天。在整个研究期间，每天都会记录症状的严重程度（0-10 分数字评级系统）。采用混合效应统计分析模型：2018-2020 年间，共有 45 名受试者入组。25名受试者在消除 FODMAP 后病情有所改善，21 名患者继续进入研究的重新引入阶段。果聚糖和半乳寡糖（GOS）均与腹痛加剧有关（p=0.007 和 0.04）。半乳寡糖与腹胀加剧有关（p= 0.03）。在整个研究过程中，无论是否重新引入 FODMAP，腹胀和腹痛都会加剧（p=0.006）：我们的研究结果表明，重新引入特定的 FODMAPs 可能是对低 FODMAP 饮食有反应的肠易激综合征患者产生症状的原因，并为今后比较有限的低 FODMAP 饮食和标准的低 FODMAP 饮食的治疗效果提供了有力的依据。

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引用次数: 0

Baseline and Dynamic MAF-5 Score to Predict Liver Fibrosis and Liver-Related Events in General Population With MASLD 用基线和动态 MAF-5 评分预测患有 MASLD 的普通人群的肝纤维化和肝脏相关事件。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.07.005

Shanghao Liu , Xuanwei Jiang , Junliang Fu, Vincent Wai-Sun Wong, Victor W. Zhong, Xiaolong Qi

引用次数: 0

MetALD: The Outcome of Living Under the Shadow of Alcohol for 4 Decades MetALD：在酒精阴影下生活了 40 年的结果。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.05.009

Nahum Méndez-Sánchez, Mariana M. Ramírez-Mejía

引用次数: 0

FODMAPs in IBS: Revisiting Restriction 关于肠易激综合征中的 FODMAPs 的社论：重新审视限制。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.06.019

Andrea Shin

引用次数: 0

Setting a Value for Novel GERD Treatments 为新型胃食管反流疗法设定价值。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.06.039

Fouad Otaki, John O. Clarke

引用次数: 0

Endoscopic, Histologic, and Composite Endpoints in Patients With Ulcerative Colitis Treated With Etrasimod 接受依曲莫德治疗的溃疡性结肠炎患者的内镜、组织学和综合终点 [106/120 字符，包括空格]。

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Clinical Gastroenterology and Hepatology

Pub Date : 2025-02-01 DOI: 10.1016/j.cgh.2024.07.010

Fernando Magro , Laurent Peyrin-Biroulet , Bruce E. Sands , Silvio Danese , Vipul Jairath , Martina Goetsch , Abhishek Bhattacharjee , Joseph Wu , Diogo Branquinho , Irene Modesto , Brian G. Feagan

Background & Aims

Histologic remission, a potentially important treatment target in ulcerative colitis (UC), is associated with favorable long-term outcomes. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)_1,4,5 receptor modulator for the treatment of moderately to severely active UC. This post-hoc analysis of the ELEVATE UC program evaluated the efficacy of etrasimod according to histologic and composite (histologic/endoscopic/symptomatic) endpoints and examined their prognostic value.

Methods

Patients with moderately to severely active UC were randomized 2:1 to once-daily oral etrasimod 2 mg or placebo. Histologic and composite endpoints, including disease clearance (endoscopic/histologic/symptomatic remission), were assessed at Weeks 12 (ELEVATE UC 52; ELEVATE UC 12) and 52 (ELEVATE UC 52). Logistic regressions examined associations between baseline and Week 12 histologic/composite endpoints and Week 52 outcomes.

Results

At Weeks 12 and 52, significant improvements with etrasimod vs placebo were observed in histologic/composite outcomes, including endoscopic improvement-histologic remission and disease clearance. The proportion of patients treated with etrasimod achieving clinical remission at Week 52 was higher among those with disease clearance at Week 12 vs those without disease clearance (73.9% [17/23] vs 28.3% [71/251]). Histologic improvement and endoscopic improvement at Week 12 were moderately and strongly associated with clinical remission at Week 52 (odds ratio [OR], 2.37; 95% confidence interval [CI], 1.27–4.41; and OR, 6.36; 95% CI, 3.47–11.64, respectively). Histologic remission and endoscopic improvement at Week 12 were strongly associated with endoscopic improvement-histologic remission at Week 52 (OR, 3.21; 95% CI, 1.70–6.06 and OR, 5.47; 95% CI, 2.89–10.36, respectively).

Conclusions

Etrasimod was superior to placebo for achievement of stringent histologic and composite endpoints.

ClinicalTrials.gov, Number: NCT03945188; ClinicalTrials.gov, Number: NCT03996369.

背景与目的：组织学缓解是溃疡性结肠炎（UC）潜在的重要治疗目标，与良好的长期疗效相关。Etrasimod是一种口服、每日一次的选择性1-磷酸鞘磷脂（S1P）1,4,5受体调节剂，用于治疗中度至重度活动性UC。这项ELEVATE UC项目的事后分析根据组织学和复合（组织学/内镜/症状）内点评估了依曲莫德的疗效，并研究了它们的预后价值：中度至重度活动性 UC 患者按 2:1 随机分配到每日一次口服依曲莫德 2 毫克或安慰剂。在第12周（ELEVATE UC 52；ELEVATE UC 12）和第52周（ELEVATE UC 52）评估组织学终点和复合终点，包括疾病清除（内镜/组织学/症状缓解）。逻辑回归分析了基线和第12周组织学/综合终点与第52周结果之间的关联：结果：在第12周和第52周，观察到依曲莫德与安慰剂相比在组织学/综合结果方面有显著改善，包括内镜改善-组织学缓解（EIHR）和疾病清除。接受依拉西莫德治疗的患者在第52周达到临床缓解（CR）的比例在第12周疾病清除的患者中高于未清除的患者（73.9% [17/23] vs 28.3% [71/251]）。第12周的组织学改善和内镜改善（EI）与第52周的CR呈中度和高度相关，几率比（OR）（95% 置信区间[CI]）分别为2.37（1.27, 4.41）和6.36（3.47, 11.64）。第12周的组织学缓解和EI与第52周的EIHR密切相关，OR（95% CI）分别为3.21（1.70，6.06）和5.47（2.89，10.36）：在达到严格的组织学终点和复合终点方面，Etrasimod优于安慰剂；NCT03945188、NCT03996369。

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