Cilofexor tromethamine(Cilofexor tromethamine) - 药物靶点：FXR_专利_临床

概要

基本信息

药物类型

小分子化药

别名

CILO、Cilofexor、GS-9674

+ [3]

靶点

FXR

作用方式

激动剂

作用机制

FXR激动剂(胆汁酸受体FXR激动剂)、胰岛素增敏剂

治疗领域

消化系统疾病其他疾病

在研适应症-

非在研适应症

原发性硬化性胆管炎代偿期肝硬化肝纤维化+ [2]

原研机构

Phenex Pharmaceuticals AG

在研机构-

非在研机构

Gilead Sciences, Inc.

Phenex Pharmaceuticals AG

权益机构

Phenex Pharmaceuticals AG

Gilead Sciences, Inc.

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C32H33Cl3N4O8

InChIKeyCUWTTWVBVUZPAP-UHFFFAOYSA-N

CAS号2253764-93-9

关联

12

项与 Cilofexor tromethamine 相关的临床试验

NCT04060147

/ Terminated临床1期

A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.

开始日期2019-10-17

申办/合作机构

Gilead Sciences, Inc.

NCT03987074

/ Completed临床2期

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)

The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).

开始日期2019-07-29

申办/合作机构

Gilead Sciences, Inc.

[+1]

ACTRN12619000655145

/ Completed临床1期

A Phase 1 Open-Label, Parallel-Group, Two-Treatment, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9674 and GS-0976 in Subjects with Normal Renal Function and Severe Renal Impairment

开始日期2019-07-24

申办/合作机构

Gilead Sciences, Inc.

100 项与 Cilofexor tromethamine 相关的临床结果

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100 项与 Cilofexor tromethamine 相关的转化医学

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100 项与 Cilofexor tromethamine 相关的专利（医药）

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67

项与 Cilofexor tromethamine 相关的文献（医药）

2026-01-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

FXR-targeted drug discovery: Recent advances and therapeutic perspectives

Review

作者: Zhou, Xiangyang ; Cao, Yu ; Shan, Lianhai ; Mao, Wu-Yu ; Shang, Weidong ; Li, Qian ; Liu, Zihang

Farnesoid X Receptor (FXR), a pivotal member of the nuclear receptor superfamily, plays a central role in the regulation of crucial physiological processes. These processes encompass bile acid homeostasis, inflammatory responses, fibrosis, as well as lipid and glucose metabolism. Given its extensive physiological functions, FXR has become an extremely promising therapeutic target for bile acid metabolism disorders. In recent years, the progress in medicinal chemistry has significantly expedited the development of FXR agonists. In 2016, obeticholic acid (OCA) received approval from FDA for marketing. As the first small-molecule drug targeting FXR for primary biliary cholangitis (PBC), its approval has spurred the advancement of multiple FXR agonists with diverse chemical structures into clinical trials. Notable candidates include Tropifexor (for non-alcoholic steatohepatitis, NASH), Cilofexor (for PBC), and Nidufexor (for diabetic nephropathy). This review delineates the structural features and biological functions of FXR, analyzes molecular mechanisms underpinning its signal transduction pathways and disease pathogenesis, and highlights molecular design strategies and structure-activity relationship (SAR) advancements in FXR agonists. These insights aim to provide a theoretical foundation for rationally designing novel, potent FXR agonists.

2026-01-01·The Lancet Gastroenterology & Hepatology

Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial

Article

作者: Caldwell, Stephen ; Vuppalanchi, Raj ; Invernizzi, Pietro ; Salminen, Kimmo ; Alani, Muhsen ; Bolbolan, Shahla ; Montano-Loza, Aldo J ; Joshi, Deepak ; Farkkila, Martti ; Tanaka, Atsushi ; Genovese, Mark C ; Xu, Jun ; Barchuk, William T ; Thorburn, Douglas ; Trauner, Michael ; Liu, Xiangyu ; Goodman, Zachary ; Levy, Cynthia ; Danta, Mark ; Gordon, Stuart C ; Hinrichsen, Holger ; Bowlus, Christopher L ; Yimam, Kidist ; Watkins, Timothy R ; Isayama, Hiroyuki ; Lu, Xiaomin ; Gallegos-Orozco, Juan F ; Crans, Gerald ; Boyette, Lisa ; Zhu, Kaiyi

BACKGROUND:

There is currently no pharmacological therapy proven to alter the natural course of primary sclerosing cholangitis (PSC). The PRIMIS trial evaluated the efficacy and harms of the farnesoid X-activated receptor agonist cilofexor in participants with non-cirrhotic PSC.

METHODS:

In this phase 3, double-blind, placebo-controlled, multicentre trial (205 sites across 16 countries), adults aged 18-75 years with non-cirrhotic (F0-F3 [Ludwig classification]) large-duct PSC were randomly assigned (2:1) via an interactive web response system to receive cilofexor 100 mg or placebo (identical in appearance) orally once daily for 96 weeks. Randomisation was stratified by ursodeoxycholic acid use (yes or no) and the presence of bridging fibrosis (F3 vs F0-F2), with a block size of six within each stratum. Participants, personnel directly involved in the conduct of the study, and outcome assessors were masked to treatment assignment. The primary endpoint was the proportion of participants with histological progression of liver fibrosis (a stage increase of one or more [Ludwig classification]) at week 96. After study termination, the primary endpoint analysis set was amended to include all participants in the harms analysis set (all who received at least one dose of the study drug) who had biopsy data at baseline and week 96. This trial is complete (ClincalTrials.gov, NCT03890120).

FINDINGS:

Between June 13, 2019, and July 22, 2021, 419 participants were randomly assigned, and 416 were included in the full and harms analysis sets (cilofexor: n=277; placebo: n=139); 257 (62%) men and 159 (38%) women. The study was terminated early on Sept 26, 2022, after a planned interim futility analysis after 160 patients had reached 96 weeks of follow-up indicated a 6·8% probability of detecting a significant difference between cilofexor over placebo (futility boundary ≤10%). In the final analysis of the primary endpoint, for which 133 patients in the cilofexor group and 64 in the placebo group had liver biopsy results available, fibrosis progression occurred in 41 (31%) participants in the cilofexor group and 21 (33%) in the placebo group at week 96 (treatment difference -1·4% [95% CI -15·2 to 12·3]; p=0·42). The most common adverse events were pruritus (cilofexor: 136 [49%] of 277 patients; placebo: 50 [36%] of 139 patients; grade 3 or higher in 11 [4%] patients in the cilofexor group and one [1%] patient in the placebo group), COVID-19 (cilofexor: 65 [23%]; placebo: 26 [19%]), and upper abdominal pain (cilofexor: 40 [14%]; placebo 20 [14%]). The proportion of serious adverse events was similar between groups (cilofexor: 53 [19%]; placebo: 26 [19%]). There were no treatment-related deaths.

INTERPRETATION:

Cilofexor did not significantly reduce the rate of fibrosis progression (vs placebo) in participants with non-cirrhotic PSC. A greater percentage of cilofexor-treated participants had pruritus than placebo-treated participants; this study provides valuable harms data for cilofexor and other drugs in its class.

FUNDING:

Gilead Sciences.

2025-12-01·HEPATOLOGY

Comparison of pharmacological therapies in metabolic dysfunction–associated steatohepatitis for fibrosis regression and MASH resolution: Systematic review and network meta-analysis

Review

作者: Antunes, Vanio L.J. ; Huang, Daniel Q. ; Souza, Matheus ; Al-Sharif, Lubna ; Loomba, Rohit

Background and Aims::

Metabolic dysfunction–associated steatohepatitis (MASH) is a leading cause of liver disease. With the advent of multiple therapeutic targets in late-phase clinical drug development for MASH, there is a knowledge gap to better understand the comparative efficacy of various pharmacological agents. We conducted an updated network meta-analysis to evaluate the relative rank order of the different pharmacological agents for both fibrosis regression and MASH resolution.

Approach and Results::

We searched PubMed and Embase databases from January 1, 2020 to December 1, 2024, for published randomized controlled trials comparing pharmacological interventions in patients with biopsy-proven MASH. The co-primary endpoints were fibrosis improvement ≥1 stage without MASH worsening and MASH resolution without worsening fibrosis. We conducted surface under the cumulative ranking curve (SUCRA) analysis. A total of 29 randomized controlled trials (n=9324) were included. Pegozafermin, cilofexor + firsocostat, denifanstat, survodutide, obeticholic acid, tirzepatide, resmetirom, and semaglutide were significantly better than placebo in achieving fibrosis regression without worsening MASH. Pegozafermin (SUCRA: 79.92), cilofexor + firsocostat (SUCRA: 71.38), and cilofexor + selonsertib (SUCRA: 69.11) were ranked the most effective interventions. Pegozafermin, survodutide, tirzepatide, efruxifermin, liraglutide, vitamin E + pioglitazone, resmetirom, semaglutide, pioglitazone, denifanstat, semaglutide, and lanifibranor were significantly better than placebo in achieving MASH resolution without worsening fibrosis. Pegozafermin (SUCRA: 91.75), survodutide (SUCRA: 90.87), and tirzepatide (SUCRA: 84.70) were ranked the most effective interventions for achieving MASH resolution without worsening fibrosis.

Conclusions::

This study provides updated rank-order efficacy of MASH pharmacological therapies for fibrosis regression and MASH resolution. These data are helpful to inform practice and clinical trial design.

77

项与 Cilofexor tromethamine 相关的新闻（医药）

2026-03-17

·北京医学感染与传染研究

柳叶刀胃肠病学与肝病学 11卷 1-4期

THE LANCET Gastroenterology & Hepatology. Volume 11Number1 柳叶刀胃肠病学与肝病学 11卷 1期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 Accelerating MASH trials: from biopsy to biomarkers 加速MASH（代谢障碍相关脂肪性肝炎）试验：从活检到生物标志物 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p1 COMMENT（述评） 2 Optimising treatment in Crohn's disease: is the main issue early versus late or biologic naive versus biologic experienced? 优化克罗恩病的治疗：主要问题在于早期治疗与晚期治疗，还是生物制剂初治患者与生物制剂经治患者？ Marte Lie Høivik The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p2 3 Ileal bile acid transporter inhibitors for cholestatic pruritus in primary biliary cholangitis 针对原发性胆汁性胆管炎中胆汁淤积性瘙痒的回肠胆汁酸转运蛋白抑制剂 Ansgar W Lohse,David N Assis The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p3 4 Dual targeting of TNF and IL-23 by a bispecific antibody in ulcerative colitis 双特异性抗体在溃疡性结肠炎中同时靶向TNF和IL-23 Raja Atreya,Markus F Neurath The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p5 5 The essential medicines list for inflammatory bowel disease: time to raise the standards of global care 炎症性肠病基本药物清单：是时候提高全球护理标准了 Nanne K de Boer,Richard B Gearry,Charles N Bernstein,Rupa Banerjee,David T Rubin,Gilaad G Kaplanon behalf of the Globalization Cluster of the International Organization of IBD The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p7 NEWS（新闻） 6 The Liver Meeting 2025 2025年肝脏会议 Rob Brierley The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p10 IN FOCUS（焦点） 7 Food Matters 食物很重要 Dietary management of constipation: time for clinical guidelines to catch up with evidence 便秘的饮食治疗：是时候让临床指南跟上证据的步伐了 Eirini Dimidi,Kevin Whelan The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p11 ARTICLES（论著） 8 Vedolizumab in early and late Crohn's disease (LOVE-CD): a phase 4 open-label cohort study 维多珠单抗在早期和晚期克罗恩病中的应用（LOVE-CD）：一项4期开放性队列研究 Geert R D'Haens,Mark Löwenberg,Filip Baert,Peter Bossuyt,Tamás Molnár,Frank Hoentjen,Esmé Clasquin,Krisztina B Gecse,Melanie S Hulshoff,Gert De Hertogh,Matthias Lenfant,Lotte Oldenburg,Séverine Vermeire The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p12 9 Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): 利尼西巴特治疗原发性胆汁性胆管炎和胆汁淤积性瘙痒患者（GLISTEN）：一项随机、多中心、双盲、安慰剂对照的3期试验 a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial Gideon M Hirschfield,Christopher L Bowlus,David E J Jones,Andreas E Kremer,Marlyn J Mayo,Atsushi Tanaka,Pietro Andreone,Jidong Jia,Qinglong Jin,Ricardo U Macías-Rodríguez,Alexander R Cobitz,Brooke M Currie,Ciara Gorey,Ivana Lazic,Danielle Podmore,Andrea Ribeiro,Jennifer B Shannon,Brandon Swift,Megan M McLaughlin,Cynthia Levyfor the GLISTEN Study Group The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p22 10 Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial SOR102（一种口服双特异性肿瘤坏死因子和白细胞介素-23抑制剂）在健康受试者和溃疡性结肠炎患者中的安全性和药代动力学：一项首次人体、双盲、随机、安慰剂对照的1期试验 Vipul Jairath,Silvio Danese,Geert R D’Haens,Brian G Feagan,Laurent Peyrin-Biroulet,Bruce E Sands,Ingrid Gaemers,Matt Westfall,Allyson Q Terry,Kevin J Roberts,Sara Barbat,Pamela Wedel,Jacqueline M Benson,Carlos Sattler The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p34 11 Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial 西洛芬酸在非肝硬化原发性硬化性胆管炎中的应用（PRIMIS）：一项随机、双盲、多中心、安慰剂对照的3期试验 Michael Trauner,Cynthia Levy,Atsushi Tanaka,Zachary Goodman,Douglas Thorburn,Deepak Joshi,Kimmo Salminen,Kidist Yimam,Hiroyuki Isayama,Aldo J Montano-Loza,Stephen Caldwell,Mark Danta,Martti Farkkila,Juan F Gallegos-Orozco,Stuart C Gordon,Holger Hinrichsen,Pietro Invernizzi,Raj Vuppalanchi,Kaiyi Zhu,Jun Xu,Xiangyu Liu,Xiaomin Lu,Gerald Crans,Shahla Bolbolan,Lisa Boyette,Muhsen Alani,William T Barchuk,Timothy R Watkins,Mark C Genovese,Christopher L Bowlus The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p46 REVIEW（综述） 12 Age-related changes of the gastrointestinal tract 胃肠道的年龄相关变化 Alberto Pilotto,Carlo Custodero,Lucilla Crudele,Wanda Morganti,Nicola Veronese,Marilisa Franceschi The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p59 13 Fatigue in people with primary biliary cholangitis: a position paper from the European Reference Network for Rare Liver Diseases 原发性胆汁性胆管炎患者的疲劳问题：欧洲罕见肝病参考网络立场文件 Ozgur M Koc,Anne-Kristin Toussaint,Aurelie Untas,Piotr Milkiewicz,Henriette Ytting,Laura Buck,David E Jones,Gideon Hirschfield,Angela Leburgue,Christoph Schramm,Frederik Nevens,Adriaan J van der Meer,Alessio Gerussi,Jef Verbeek The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p71 THE LANCET Gastroenterology & Hepatology. Volume 11Number2 柳叶刀胃肠病学与肝病学 11卷 2期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 ACIP's HBV birth-dose vaccine recommendations: a fiasco 美国免疫接种咨询委员会（ACIP）的乙肝疫苗出生剂量推荐：一场闹剧 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p87 COMMENT（述评） 2 Expanding the therapeutic arsenal for paediatric ulcerative colitis 扩充儿童溃疡性结肠炎的治疗武器库 Stephanie A Vuijk,Esmée H Boute,Lissy de Ridder The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p88 3 Closing the Middle East and north Africa representation gap in clinical trials in inflammatory bowel disease 缩小炎症性肠病临床试验中中东和北非地区代表不足的差距 Mohammad Shebab,Ahmed Al-Hindawi,Shane W Goodwin,Yuhong Yuan,Talat Bessissow,Laurent Peyrin-Biroulet,Vipul Jairath The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p89 4 Colorectal cancer screening in LGBTQIA+ people: an urgent call for equity 对LGBTQIA+人群进行结直肠癌筛查：迫切呼吁公平 Vidhi Singh,Jayraan Badiee,Alexander Goldowsky,David Russo,Folasade P May The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p91 CORRESPONDENCE（读者来信） 5 Efficacy differentiation of sterile faecal filtrates in Clostridioides difficile infection 无菌粪便滤液在艰难梭菌感染中的疗效差异 Stefan Schreiber,Philip Rosenstiel,Stephan J Ott,Georg H Waetzig The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p94 6 Efficacy differentiation of sterile faecal filtrates in Clostridioides difficile infection – Authors’ reply 无菌粪便滤液在艰难梭菌感染中的疗效差异——作者回复 Dina Kao,Huiping Xu,Thomas Louie The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p94 7 Endoscopic palliation of malignant gastric outlet obstruction: harmonising outcomes 恶性胃出口梗阻的内镜下姑息治疗：统一疗效标准 Zachary L Smith The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p95 8 Clinical remission in ulcerative colitis: restoring precision in trial terminology 溃疡性结肠炎的临床缓解：恢复试验术语的精确性 Sailish Honap,Vipul Jairath,Fernando Magro,Silvio Danese,Laurent Peyrin-Biroulet The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p96 CORRECTIONS（更正） 9 Correction to Lancet Gastroenterol Hepatol 2019; 4: 364–75 对《柳叶刀-胃肠病学与肝病学》2019年；4卷：364-75页的更正 The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：e1 10 Correction to Lancet Gastroenterol Hepatol 2025; 10: 431–41 对《柳叶刀-胃肠病学与肝病学》2025年；10卷：431-41页的更正 The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：e1 NEWS（新闻） 11 Research in Brief 研究简讯 Holly Baker The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p98 IN FOCUS（焦点） 12 Patient Perspectives 患者视角 The label of a diagnosis 诊断标签 Cheryl Reeves The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p99 ARTICLES（论著） 13 Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial Mirikizumab治疗中重度活动性溃疡性结肠炎儿童患者的疗效和安全性（SHINE-1）：一项多中心、开放标签、非随机2期试验 Jess L Kaplan,Athos Bousvaros,Dan Turner,Marla Dubinsky,Amy Larkin,Jordan Johns,Yuki Otani,Wallace Crandall,Wendy J Komocsar,Jeffrey S Hyams The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p100 14 Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials Glecirasib联合或不联合西妥昔单抗治疗既往接受过治疗的KRASG12C突变局部晚期或转移性结直肠癌（JAB-21822-1002和JAB-21822-1007）：两项开放标签、非随机1/2期试验 Jian Li,Zhenghang Wang,Jing Huang,Yi Ba,Baoshan Cao,Suxia Luo,Wenhua Li,Chunmei Bai,Zhengbo Song,Jianping Xiong,Liangjun Zhu,Guangyu An,Yanqiao Zhang,Zhihua Li,Yongsheng Li,Yanhong Gu,Changlu Hu,Xingya Li,Chenghui Huang,Qihan Fu,Xianli Yin,Xinjun Liang,Diansheng Zhong,Huaqiu Shi,Xiaoyan Li,Zhen Li,Lian Liu,Feng Wang,Rong Liang,Guohao Xia,Zhen Wang,Andrea Wang-Gillam,Yuli Ding,Zhiyue Rao,Wenhui Pan,Shuang Lu,Xin Sun,Lin Shen The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p110 15 Adjuvant camrelizumab combined with capecitabine in patients with intrahepatic cholangiocarcinoma after surgical resection in China (ACC): a single-arm, single-centre, open-label, phase 2 trial 卡瑞利珠单抗联合卡培他滨辅助治疗中国肝内胆管癌术后患者（ACC）：一项单臂、单中心、开放标签、2期试验 Zheng Wang,Lixing Li,Peiran Huang,Honghu Tu,Xiangyu Zhang,Lei Yu,Fei Liang,Cheng Huang,Shuangjian Qiu,Qinghai Ye,Zhenbin Ding,Xiaowu Huang,Yinghong Shi,Kang Song,Huichuan Sun,Xiaoying Wang,Yongfeng Xu,Yao Yu,Qiang Gao,Lan Zhang,Jia Fan,Jian Zhou The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p124 16 Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial Tinengotinib治疗晚期或转移性胆管癌成人患者：一项多中心、开放标签、2期试验 Milind Javle,Christos Fountzilas,Chih-Yi Liao,Meredith Pelster,Daneng Li,Dustin Deming,Vaibhav Sahai,Lionel Kankeu Fonkoua,Allen Cohn,Parvez Mantry,Donald Richards,Edwin Kingsley,Frank Wu,Peng Peng,Katie Hennessy,Hui Wang,Caixia Sun,Shumao Ni,Jean Fan,Amit Mahipal The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p137 REVIEW（综述） 17 Current and emerging therapeutic landscape for metabolic dysfunction-associated steatohepatitis 代谢功能障碍相关脂肪性肝炎当前及新兴治疗格局 Wenhao Li,William Alazawi,Rohit Loomba The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p150 VIEWPOINT（观点） 18 Ulcerative colitis: moving beyond the mucosal dogma 溃疡性结肠炎：超越黏膜教条 Elisabeth Eggermont,Krisztina Gecse,Noa Krugliak Cleveland,Frauke Petersen,João Sabino,AndréD'Hoore,Torsten Kucharzik,Mariangela Allocca,Gabriele Bislenghi,Kerri Novak,Gert De Hertogh,Christian Maaser,Bram Verstockt The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p163 THE LANCET Gastroenterology & Hepatology. Volume 11Number3 柳叶刀胃肠病学与肝病学 11卷 3期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 Alcohol guidance in US dietary guidelines: a step backwards 美国膳食指南中的酒精建议：倒退的一步 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p175 2 Thanks to our peer reviewers and contributors 感谢我们的同行评审专家和投稿者 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p175 COMMENT（述评） 3 Appendicectomy: a disease-modifying treatment for ulcerative colitis? 阑尾切除术：溃疡性结肠炎的一种疾病修饰疗法？ Alexandra Damasio Todescatto,Paulo Gustavo Kotze The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p176 4 Cyclic exclusive enteral nutrition: a novel approach to maintaining remission in paediatric Crohn's disease 循环全肠内营养：维持儿童克罗恩病缓解的新方法 Anissa M Armet,Eytan Wine The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p177 5 Viral hepatitis in Roma communities: vulnerabilities and improving care access 罗姆人社区中的病毒性肝炎：易感性及改善医疗可及性 Pavol Kristian,Ivana Hockickova,Monika Halanova,Sylvia Drazilova,Ondrej Zahornacky,Peter Jarcuska The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p179 6 Thank you to The Lancet Gastroenterology & Hepatology's statistical and peer reviewers in 2025 感谢《柳叶刀 - 胃肠病学和肝病学》2025 年的统计学和同行评审专家 The Lancet Gastroenterology & Hepatology's Editors The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e2 CORRESPONDENCE（读者来信） 7 Antipruritic effects of the ileal bile acid transporter inhibitor linerixibat 回肠胆汁酸转运体抑制剂利那西巴特的抗瘙痒作用 Gideon M Hirschfield,Andreas E Kremer,Cynthia Levy The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p182 8 Vedolizumab treatment outcomes in early versus late Crohn's disease 维多珠单抗治疗早期与晚期克罗恩病的疗效 Nurulamin M Noor,Ailsa L Hart,James C Lee,Miles Parkes The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p182 9 Vedolizumab treatment outcomes in early versus late Crohn's disease 维多珠单抗治疗早期与晚期克罗恩病的疗效 Rirong Chen,Kenneth Croitoru,Sun-Ho Lee The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p183 10 Vedolizumab treatment outcomes in early versus late Crohn's disease – Authors' reply 维多珠单抗治疗早期与晚期克罗恩病的疗效——作者回复 Geert R D'Haens,Lotte Oldenburg,Melanie S Hulshoffon behalf of the LOVE-CD collaborators The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p184 11 Global perspectives on sustainable IBD care 全球视角下的可持续炎症性肠病（IBD）诊疗 Olga M Nardone,Silvio Danese,Beatriz Gros,Tommaso L Parigion behalf of the Sustainable IBD Study Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p185 12 The impact of 2025 US NIDDK funding cuts 2025 年美国国家糖尿病、消化及肾脏疾病研究所（NIDDK）经费削减的影响 Rogelio Perez,Christopher W Chan,Aakash Reddy,David T Zhu The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p186 CORRECTIONS（更正） 13 Correction to Lancet Gastroenterol Hepatol 2026; 11: 34–45 对《柳叶刀 - 胃肠病学和肝病学》2026 年；11卷：34 - 45 页的更正 The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e5 14 Correction to Lancet Gastroenterol Hepatol 2026; 11: 89–91 对《柳叶刀 - 胃肠病学和肝病学》2026 年；11卷：89 - 91 页的更正 The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e5 NEWS（新闻） 15 ASCO Gastrointestinal Cancers Symposium 2026 2026 年美国临床肿瘤学会（ASCO）胃肠道肿瘤研讨会 Rob Brierley The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p188 IN FOCUS（焦点） Book（书籍） 16 Stoma: life saver, not a barrier 造口：救命手段，而非障碍 Lucy Mae Spurgeon The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p189 ARTICLES（论著） 17 Appendicectomy versus switching to a JAK inhibitor in inducing remission in patients with active ulcerative colitis after biologic therapy failure (COSTA): 1-year results of a multicentre, prospective, cohort study 生物制剂治疗失败后，阑尾切除术与换用 JAK 抑制剂诱导活动期溃疡性结肠炎患者缓解的对比（COSTA）：一项多中心、前瞻性、队列研究的 1 年结果 Eva Visser,Maud A Reijntjes,Lianne Heuthorst,Merle E Stellingwerf,Rachel West,Koen van Dongen,Rogier M P H Crolla,Susan van Dieren,Jarmila D W van der Bilt,Willem A Bemelman,Geert R D'Haens,Christianne J Buskensfor the COSTA Study Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p190 18 Cyclic exclusive enteral nutrition versus partial enteral nutrition to maintain long-term drug-free remission in paediatric Crohn's disease (CD-HOPE): an open-label, endpoint-blinded, randomised controlled trial 循环全肠内营养与部分肠内营养维持儿童克罗恩病长期无药物缓解的对比（CD - HOPE）：一项开放标签、终点盲法、随机对照试验 Bénédicte Pigneur,Christine Martinez-Vinson,Aurélie Bourmaud,Alain Dabadie,Rémi Duclaux-Loras,Jean-Pierre Hugot,Céline Roman,Clémentine Dumant,Claire Spyckerelle,Vincent Guinard-Samuel,Stéphanie Willot,Claire Dupont,Anne Breton,Nicolas Caron,Emilie Chaillou,Laurent Rebouissoux,Valérie Bertrand,Valérie Triolo,Justine Pages,Djamal Djeddi,Marjorie Bonneton,Stéphanie Uhlen,Natacha Catteau,Stéphanie Coopman,Patricia Lepage,Jérôme Viala,Frank M Ruemmele The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p204 19 ALG-000184 (pevifoscorvir sodium) monotherapy in participants with chronic HBV infection: a phase 1, multicentre, randomised, dose escalation trial ALG - 000184（佩维福司科韦钠）单药治疗慢性乙型肝炎病毒感染者：一项 1 期、多中心、随机、剂量递增试验 Man-Fung Yuen,Kosh Agarwal,Alina Jucov,Jinlin Hou,Junqi Niu,Yanhua Ding,Alexei Haceatrean,Xie'er Liang,Jia Xu,Min Wu,Kha Le,Tse-I Lin,Lawrence Blatt,Sushmita Chanda,John Fry,Ed Gane The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p218 20 Best buys for metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis: a global Delphi study 代谢功能障碍相关脂肪性肝病和代谢功能障碍相关脂肪性肝炎的最佳干预措施：一项全球德尔菲研究 Jeffrey V Lazarus,Leire Agirre-Garrido,Trenton M White,Anish K Arora,Melina I Manolas,Luis Antonio Diaz,Juan Pablo Arab,Shira Zelber-Sagi,Naim Alkhouri,C Wendy Spearman,Jörn M Schattenberg,Loreta A Kondili,Patrizia Carrieri,Holly F Lofton,Priya Jaisinghani,Sonal Kumar,Ajay Duseja,Mohamed El-Kassas,Hirokazu Takahasi,Debbie L Shawcross,Jonathan G Stine,Marcela Villota-Rivas,Juan Emilio Miralles-Sanchez,Silvana Pannain,Paul N BrennanMASLD/MASH Collaborators The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p232 REVIEW（综述） 21 Definitions, diagnosis, management, and outcomes of upper gastrointestinal Crohn's disease: an international, expert RAND/UCLA appropriateness study 上消化道克罗恩病的定义、诊断、治疗和转归：一项国际专家兰德/加州大学洛杉矶分校适用性研究 Nathaniel A Cohen,Dominik Bettenworth,Neta Sror,Raneem Khedraki,Qijun Yang,Maria T Abreu,Raja Atreya,Badr Al-Bawardy,Susan J Connor,Geert D'Haens,Iris Dotan,Axel Dignass,Sara El Ouali,Brian Feagan,Roger Feakins,Richard Gearry,Ilyssa O Gordon,Charlotte R H Hedin,Cristian Hernandez-Rocha,Taku Kobayashi,Haim Leibovitzh,Cathy Lu,Nitsan Maharshak,Maliha Naseer,Jacob Ollech,David T Rubin,Shaji Sebastian,Britta Siegmund,Mark S Silverberg,Flavio Steinwurz,Joana Torres,Gill Watermeyer,Tina Aswani Omprakash,Lior Frenkel,Paige Gurizzian,Alexa Silfen,Roie Tzadok,Katherine Falloon,Florian Riederon behalf of the Study of Upper Gastrointestinal Manifestations and Management of Crohn's Disease (SUMM-CD) Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p243 22 Mechanisms and pathophysiology leading to development of small intestinal microbial dysbiosis 导致小肠微生物群失调的机制和病理生理学 John A Damianos,Xiao Jing Wang,Michael Camilleri The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p256 THE LANCET Gastroenterology & Hepatology. Volume 11Number4 柳叶刀胃肠病学与肝病学 11卷 4期 https://www.thelancet.com/journals/langas/issue/current Editorial（社论） 1 Preventive cholera vaccination resumes 预防性霍乱疫苗接种重新启动 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p267 2 Putting steatotic liver disease on the global NCD agenda 将脂肪变性肝病纳入全球非传染性疾病议程 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p267 Comment（述评） 3 Menopause and inflammatory bowel disease: more questions than answers 绝经与炎症性肠病：疑问多于答案 Samantha Conley,Kendra J Kamp,Sunanda V Kane The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p268 4 Voices from the frontline: how global funding cuts are reshaping the viral hepatitis response 前线之声：全球资金削减如何重塑病毒性肝炎应对策略 Marion Delphin,Monica Fambrough,Jana Manning,Lindsey Hiebert-Suwondo,Jessica Hicks,Philippa C Matthews The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p269 5 Delivering therapeutic diets for gastrointestinal disease to people with intellectual disabilities 为患有胃肠道疾病的智力障碍人群提供治疗性饮食 Lynette Harper,Ian H Walshe,Leigh Donnelly The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p271 6 Making room under the umbrella for microscopic colitis 在伞状范畴下为显微镜下结肠炎留出一席之地 Jillian Horton,Edward V Loftus Jr The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p274 Correspondence（读者来信） 7 The evolving clinical trial landscape in the MENA region 中东和北非地区临床试验格局的演变 Mohammed Nabil Quraishi,Badr Al-Bawardy The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p277 8 The evolving clinical trial landscape in the MENA region 中东和北非地区临床试验格局的演变 Yasser Fouad,Abdulla Al Hassani,Nawal Alkhalidi,Faisal Abaalkhail,Mohammed Eslam The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p278 9 Difficulties in identifying a signal of activity in the adjuvant setting for biliary tract cancer 在胆道癌辅助治疗中识别活性信号的困难 Julien Edeline,John Bridgewater The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p278 10 Difficulties in identifying a signal of activity in the adjuvant setting for biliary tract cancer – Authors' reply 在胆道癌辅助治疗中识别活性信号的困难——作者回复 Lixing Li,Fei Liang,Zheng Wang,Jia Fan,Jian Zhouon behalf of the ACC investigators The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p279 11 Developing policy for steatotic liver disease: an even better buy? 制定脂肪变性肝病政策：更划算的选择？ Oliver D Tavabie,Megan E Rawcliffe,Mads Israelsen The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p280 Corrections（更正） 12 Correction to Lancet Gastroenterol Hepatol 2025; 10: 634–47 《柳叶刀-胃肠病学与肝病学》2025年；第10卷：第634 - 47页勘误 The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：e6 13 Correction to Lancet Gastroenterol Hepatol 2026; 11: 22–33 《柳叶刀-胃肠病学与肝病学》2026年；第11卷：第22 - 33页勘误 The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：e6 News（新闻） 14 ECCO 2026 2026年欧洲克罗恩病和结肠炎组织会议 Rob Brierley The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p281 15 Research in Brief 研究简讯 Holly Baker The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p282 In Focus（焦点） 16 Food Matters 食品问题 Low-carbohydrate diets—how low can we go? 低碳水化合物饮食——我们能低到什么程度？ Sanna Nybacka,Heidi M Staudacher The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p283 Articles（论著） 17 Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial 皮下古塞库单抗诱导治疗中重度活动性溃疡性结肠炎受试者的有效性和安全性（ASTRO研究）：一项双盲、全程治疗、随机、安慰剂对照的3期试验 Millie Long,Jessica R Allegretti,Silvio Danese,Matthew Germinaro,Thomas Baker,Yelina Alvarez,Mary Kavalam,Chenglong Han,Silke Jörgens,Lingjing Jiang,Hongyan Zhang,Tadakazu Hisamatsu,David T Rubin,Laurent Peyrin-Birouleton behalf of the ASTRO Study Group The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p284 18 Safety, pharmacokinetics, and preliminary efficacy of VS-01, an intraperitoneal liposomal infusion, in patients with decompensated liver cirrhosis, ascites, and covert hepatic encephalopathy: a phase 1b, first-in-human, open-label, non-randomised, single ascending and multiple dose study VS - 01（一种腹腔内脂质体输注液）在失代偿期肝硬化、腹水和隐性肝性脑病患者中的安全性、药代动力学和初步疗效：一项1b期、首次人体、开放标签、非随机、单次递增和多次给药研究 Frank Erhard Uschner,Martin McCoy,Olaf Tyc,Wenyi Gu,Philip Ferstl,Maximilian Joseph Brol,Johannes Masseli,Kai-Henrik Peiffer,Fabian Finkelmeier,Stefan Zeuzem,Sophie Biguenet,Katharina Staufer,Meriam Kabbaj,Jonel Trebicka The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p299 19 Ileocaecal resection versus infliximab for ileal Crohn's disease: retrospective 10-year follow-up of the LIR!C trial 回盲部切除术与英夫利昔单抗治疗回肠克罗恩病：LIR!C试验的10年回顾性随访 Lotte Oldenburg,Anouck E G Haanappel,Mahsoem Ali,Carolijn Bosman,Christianne J Buskens,Cyriel Y Ponsioen,Geert R D'Haens,Willem A Bemelmanon behalf of the LIR!C study group The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p314 20 Long-term oncological outcomes following algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection: a post-hoc analysis of a nationwide, stepped-wedge cluster-randomised trial 基于算法的护理与常规护理对胰腺切除术后并发症早期识别和治疗的长期肿瘤学预后：一项全国性、阶梯楔形整群随机试验的事后分析 Thijs J Schouten,Kyra J Prinsze,Anne Claire Henry,Lois A Daamen,Marc G Besselink,Bert A Bonsing,Koop Bosscha,Olivier R Busch,Geert A Cirkel,Ronald M van Dam,Casper H van Eijck,Sebastiaan Festen,Bas Groot Koerkamp,Erwin van der Harst,Ignace H J T de Hingh,Geert Kazemier,Mike S L Liem,Vincent E de Meijer,J Sven D Mieog,Gijs A Patijn,Daphne Roos,Jennifer M J Schreinemakers,Martijn W J Stommel,Fennie Wit,C Henri van Werkhoven,I Quintus Molenaar,F Jasmijn Smits,Hjalmar C van Santvoortfor the Dutch Pancreatic Cancer Group The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p323 Review（综述） 21 Chronic liver disease and hepatology care in transgender and gender diverse populations 跨性别者和性别多元人群的慢性肝病和肝病学护理 Thanh N Nguyen,Whitney E Jackson,Nitzan C Roth,Felice Cinque,Monika Sarkar,Niharika Samala,Rita S Lee,Alexandra T Strauss,Jessica Wisocky,Keyur Patel,Giada Sebastiani,Carl G Streed Jr,Jordan E Lake,Tzu-Hao Lee The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p334

临床3期临床2期临床结果

2026-03-12

·北京医学感染与传染研究

柳叶刀胃肠病学与肝病学 11卷 1-4期（2026年3月12日更新）

THE LANCET Gastroenterology & Hepatology. Volume 11Number1 柳叶刀胃肠病学与肝病学 11卷 1期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 Accelerating MASH trials: from biopsy to biomarkers 加速MASH（代谢障碍相关脂肪性肝炎）试验：从活检到生物标志物 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p1 COMMENT（述评） 2 Optimising treatment in Crohn's disease: is the main issue early versus late or biologic naive versus biologic experienced? 优化克罗恩病的治疗：主要问题在于早期治疗与晚期治疗，还是生物制剂初治患者与生物制剂经治患者？ Marte Lie Høivik The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p2 3 Ileal bile acid transporter inhibitors for cholestatic pruritus in primary biliary cholangitis 针对原发性胆汁性胆管炎中胆汁淤积性瘙痒的回肠胆汁酸转运蛋白抑制剂 Ansgar W Lohse,David N Assis The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p3 4 Dual targeting of TNF and IL-23 by a bispecific antibody in ulcerative colitis 双特异性抗体在溃疡性结肠炎中同时靶向TNF和IL-23 Raja Atreya,Markus F Neurath The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p5 5 The essential medicines list for inflammatory bowel disease: time to raise the standards of global care 炎症性肠病基本药物清单：是时候提高全球护理标准了 Nanne K de Boer,Richard B Gearry,Charles N Bernstein,Rupa Banerjee,David T Rubin,Gilaad G Kaplanon behalf of the Globalization Cluster of the International Organization of IBD The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p7 NEWS（新闻） 6 The Liver Meeting 2025 2025年肝脏会议 Rob Brierley The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p10 IN FOCUS（焦点） 7 Food Matters 食物很重要 Dietary management of constipation: time for clinical guidelines to catch up with evidence 便秘的饮食治疗：是时候让临床指南跟上证据的步伐了 Eirini Dimidi,Kevin Whelan The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p11 ARTICLES（论著） 8 Vedolizumab in early and late Crohn's disease (LOVE-CD): a phase 4 open-label cohort study 维多珠单抗在早期和晚期克罗恩病中的应用（LOVE-CD）：一项4期开放性队列研究 Geert R D'Haens,Mark Löwenberg,Filip Baert,Peter Bossuyt,Tamás Molnár,Frank Hoentjen,Esmé Clasquin,Krisztina B Gecse,Melanie S Hulshoff,Gert De Hertogh,Matthias Lenfant,Lotte Oldenburg,Séverine Vermeire The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p12 9 Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): 利尼西巴特治疗原发性胆汁性胆管炎和胆汁淤积性瘙痒患者（GLISTEN）：一项随机、多中心、双盲、安慰剂对照的3期试验 a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial Gideon M Hirschfield,Christopher L Bowlus,David E J Jones,Andreas E Kremer,Marlyn J Mayo,Atsushi Tanaka,Pietro Andreone,Jidong Jia,Qinglong Jin,Ricardo U Macías-Rodríguez,Alexander R Cobitz,Brooke M Currie,Ciara Gorey,Ivana Lazic,Danielle Podmore,Andrea Ribeiro,Jennifer B Shannon,Brandon Swift,Megan M McLaughlin,Cynthia Levyfor the GLISTEN Study Group The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p22 10 Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial SOR102（一种口服双特异性肿瘤坏死因子和白细胞介素-23抑制剂）在健康受试者和溃疡性结肠炎患者中的安全性和药代动力学：一项首次人体、双盲、随机、安慰剂对照的1期试验 Vipul Jairath,Silvio Danese,Geert R D’Haens,Brian G Feagan,Laurent Peyrin-Biroulet,Bruce E Sands,Ingrid Gaemers,Matt Westfall,Allyson Q Terry,Kevin J Roberts,Sara Barbat,Pamela Wedel,Jacqueline M Benson,Carlos Sattler The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p34 11 Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial 西洛芬酸在非肝硬化原发性硬化性胆管炎中的应用（PRIMIS）：一项随机、双盲、多中心、安慰剂对照的3期试验 Michael Trauner,Cynthia Levy,Atsushi Tanaka,Zachary Goodman,Douglas Thorburn,Deepak Joshi,Kimmo Salminen,Kidist Yimam,Hiroyuki Isayama,Aldo J Montano-Loza,Stephen Caldwell,Mark Danta,Martti Farkkila,Juan F Gallegos-Orozco,Stuart C Gordon,Holger Hinrichsen,Pietro Invernizzi,Raj Vuppalanchi,Kaiyi Zhu,Jun Xu,Xiangyu Liu,Xiaomin Lu,Gerald Crans,Shahla Bolbolan,Lisa Boyette,Muhsen Alani,William T Barchuk,Timothy R Watkins,Mark C Genovese,Christopher L Bowlus The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p46 REVIEW（综述） 12 Age-related changes of the gastrointestinal tract 胃肠道的年龄相关变化 Alberto Pilotto,Carlo Custodero,Lucilla Crudele,Wanda Morganti,Nicola Veronese,Marilisa Franceschi The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p59 13 Fatigue in people with primary biliary cholangitis: a position paper from the European Reference Network for Rare Liver Diseases 原发性胆汁性胆管炎患者的疲劳问题：欧洲罕见肝病参考网络立场文件 Ozgur M Koc,Anne-Kristin Toussaint,Aurelie Untas,Piotr Milkiewicz,Henriette Ytting,Laura Buck,David E Jones,Gideon Hirschfield,Angela Leburgue,Christoph Schramm,Frederik Nevens,Adriaan J van der Meer,Alessio Gerussi,Jef Verbeek The Lancet Gastroenterology & Hepatology. Nov 2025, Vol 11(1):p71 THE LANCET Gastroenterology & Hepatology. Volume 11Number2 柳叶刀胃肠病学与肝病学 11卷 2期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 ACIP's HBV birth-dose vaccine recommendations: a fiasco 美国免疫接种咨询委员会（ACIP）的乙肝疫苗出生剂量推荐：一场闹剧 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p87 COMMENT（述评） 2 Expanding the therapeutic arsenal for paediatric ulcerative colitis 扩充儿童溃疡性结肠炎的治疗武器库 Stephanie A Vuijk,Esmée H Boute,Lissy de Ridder The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p88 3 Closing the Middle East and north Africa representation gap in clinical trials in inflammatory bowel disease 缩小炎症性肠病临床试验中中东和北非地区代表不足的差距 Mohammad Shebab,Ahmed Al-Hindawi,Shane W Goodwin,Yuhong Yuan,Talat Bessissow,Laurent Peyrin-Biroulet,Vipul Jairath The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p89 4 Colorectal cancer screening in LGBTQIA+ people: an urgent call for equity 对LGBTQIA+人群进行结直肠癌筛查：迫切呼吁公平 Vidhi Singh,Jayraan Badiee,Alexander Goldowsky,David Russo,Folasade P May The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p91 CORRESPONDENCE（读者来信） 5 Efficacy differentiation of sterile faecal filtrates in Clostridioides difficile infection 无菌粪便滤液在艰难梭菌感染中的疗效差异 Stefan Schreiber,Philip Rosenstiel,Stephan J Ott,Georg H Waetzig The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p94 6 Efficacy differentiation of sterile faecal filtrates in Clostridioides difficile infection – Authors’ reply 无菌粪便滤液在艰难梭菌感染中的疗效差异——作者回复 Dina Kao,Huiping Xu,Thomas Louie The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p94 7 Endoscopic palliation of malignant gastric outlet obstruction: harmonising outcomes 恶性胃出口梗阻的内镜下姑息治疗：统一疗效标准 Zachary L Smith The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p95 8 Clinical remission in ulcerative colitis: restoring precision in trial terminology 溃疡性结肠炎的临床缓解：恢复试验术语的精确性 Sailish Honap,Vipul Jairath,Fernando Magro,Silvio Danese,Laurent Peyrin-Biroulet The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p96 CORRECTIONS（更正） 9 Correction to Lancet Gastroenterol Hepatol 2019; 4: 364–75 对《柳叶刀-胃肠病学与肝病学》2019年；4卷：364-75页的更正 The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：e1 10 Correction to Lancet Gastroenterol Hepatol 2025; 10: 431–41 对《柳叶刀-胃肠病学与肝病学》2025年；10卷：431-41页的更正 The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：e1 NEWS（新闻） 11 Research in Brief 研究简讯 Holly Baker The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p98 IN FOCUS（焦点） 12 Patient Perspectives 患者视角 The label of a diagnosis 诊断标签 Cheryl Reeves The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p99 ARTICLES（论著） 13 Efficacy and safety of mirikizumab in paediatric participants with moderately-to-severely active ulcerative colitis (SHINE-1): a multicentre, open-label, non-randomised phase 2 trial Mirikizumab治疗中重度活动性溃疡性结肠炎儿童患者的疗效和安全性（SHINE-1）：一项多中心、开放标签、非随机2期试验 Jess L Kaplan,Athos Bousvaros,Dan Turner,Marla Dubinsky,Amy Larkin,Jordan Johns,Yuki Otani,Wallace Crandall,Wendy J Komocsar,Jeffrey S Hyams The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p100 14 Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials Glecirasib联合或不联合西妥昔单抗治疗既往接受过治疗的KRASG12C突变局部晚期或转移性结直肠癌（JAB-21822-1002和JAB-21822-1007）：两项开放标签、非随机1/2期试验 Jian Li,Zhenghang Wang,Jing Huang,Yi Ba,Baoshan Cao,Suxia Luo,Wenhua Li,Chunmei Bai,Zhengbo Song,Jianping Xiong,Liangjun Zhu,Guangyu An,Yanqiao Zhang,Zhihua Li,Yongsheng Li,Yanhong Gu,Changlu Hu,Xingya Li,Chenghui Huang,Qihan Fu,Xianli Yin,Xinjun Liang,Diansheng Zhong,Huaqiu Shi,Xiaoyan Li,Zhen Li,Lian Liu,Feng Wang,Rong Liang,Guohao Xia,Zhen Wang,Andrea Wang-Gillam,Yuli Ding,Zhiyue Rao,Wenhui Pan,Shuang Lu,Xin Sun,Lin Shen The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p110 15 Adjuvant camrelizumab combined with capecitabine in patients with intrahepatic cholangiocarcinoma after surgical resection in China (ACC): a single-arm, single-centre, open-label, phase 2 trial 卡瑞利珠单抗联合卡培他滨辅助治疗中国肝内胆管癌术后患者（ACC）：一项单臂、单中心、开放标签、2期试验 Zheng Wang,Lixing Li,Peiran Huang,Honghu Tu,Xiangyu Zhang,Lei Yu,Fei Liang,Cheng Huang,Shuangjian Qiu,Qinghai Ye,Zhenbin Ding,Xiaowu Huang,Yinghong Shi,Kang Song,Huichuan Sun,Xiaoying Wang,Yongfeng Xu,Yao Yu,Qiang Gao,Lan Zhang,Jia Fan,Jian Zhou The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p124 16 Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial Tinengotinib治疗晚期或转移性胆管癌成人患者：一项多中心、开放标签、2期试验 Milind Javle,Christos Fountzilas,Chih-Yi Liao,Meredith Pelster,Daneng Li,Dustin Deming,Vaibhav Sahai,Lionel Kankeu Fonkoua,Allen Cohn,Parvez Mantry,Donald Richards,Edwin Kingsley,Frank Wu,Peng Peng,Katie Hennessy,Hui Wang,Caixia Sun,Shumao Ni,Jean Fan,Amit Mahipal The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p137 REVIEW（综述） 17 Current and emerging therapeutic landscape for metabolic dysfunction-associated steatohepatitis 代谢功能障碍相关脂肪性肝炎当前及新兴治疗格局 Wenhao Li,William Alazawi,Rohit Loomba The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p150 VIEWPOINT（观点） 18 Ulcerative colitis: moving beyond the mucosal dogma 溃疡性结肠炎：超越黏膜教条 Elisabeth Eggermont,Krisztina Gecse,Noa Krugliak Cleveland,Frauke Petersen,João Sabino,AndréD'Hoore,Torsten Kucharzik,Mariangela Allocca,Gabriele Bislenghi,Kerri Novak,Gert De Hertogh,Christian Maaser,Bram Verstockt The Lancet Gastroenterology & Hepatology. Feb 2026, Vol 11(2)：p163 THE LANCET Gastroenterology & Hepatology. Volume 11Number3 柳叶刀胃肠病学与肝病学 11卷 3期 https://www.thelancet.com/journals/langas/issue/current EDITORIAL(社论) 1 Alcohol guidance in US dietary guidelines: a step backwards 美国膳食指南中的酒精建议：倒退的一步 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p175 2 Thanks to our peer reviewers and contributors 感谢我们的同行评审专家和投稿者 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p175 COMMENT（述评） 3 Appendicectomy: a disease-modifying treatment for ulcerative colitis? 阑尾切除术：溃疡性结肠炎的一种疾病修饰疗法？ Alexandra Damasio Todescatto,Paulo Gustavo Kotze The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p176 4 Cyclic exclusive enteral nutrition: a novel approach to maintaining remission in paediatric Crohn's disease 循环全肠内营养：维持儿童克罗恩病缓解的新方法 Anissa M Armet,Eytan Wine The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p177 5 Viral hepatitis in Roma communities: vulnerabilities and improving care access 罗姆人社区中的病毒性肝炎：易感性及改善医疗可及性 Pavol Kristian,Ivana Hockickova,Monika Halanova,Sylvia Drazilova,Ondrej Zahornacky,Peter Jarcuska The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p179 6 Thank you to The Lancet Gastroenterology & Hepatology's statistical and peer reviewers in 2025 感谢《柳叶刀 - 胃肠病学和肝病学》2025 年的统计学和同行评审专家 The Lancet Gastroenterology & Hepatology's Editors The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e2 CORRESPONDENCE（读者来信） 7 Antipruritic effects of the ileal bile acid transporter inhibitor linerixibat 回肠胆汁酸转运体抑制剂利那西巴特的抗瘙痒作用 Gideon M Hirschfield,Andreas E Kremer,Cynthia Levy The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p182 8 Vedolizumab treatment outcomes in early versus late Crohn's disease 维多珠单抗治疗早期与晚期克罗恩病的疗效 Nurulamin M Noor,Ailsa L Hart,James C Lee,Miles Parkes The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p182 9 Vedolizumab treatment outcomes in early versus late Crohn's disease 维多珠单抗治疗早期与晚期克罗恩病的疗效 Rirong Chen,Kenneth Croitoru,Sun-Ho Lee The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p183 10 Vedolizumab treatment outcomes in early versus late Crohn's disease – Authors' reply 维多珠单抗治疗早期与晚期克罗恩病的疗效——作者回复 Geert R D'Haens,Lotte Oldenburg,Melanie S Hulshoffon behalf of the LOVE-CD collaborators The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p184 11 Global perspectives on sustainable IBD care 全球视角下的可持续炎症性肠病（IBD）诊疗 Olga M Nardone,Silvio Danese,Beatriz Gros,Tommaso L Parigion behalf of the Sustainable IBD Study Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p185 12 The impact of 2025 US NIDDK funding cuts 2025 年美国国家糖尿病、消化及肾脏疾病研究所（NIDDK）经费削减的影响 Rogelio Perez,Christopher W Chan,Aakash Reddy,David T Zhu The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p186 CORRECTIONS（更正） 13 Correction to Lancet Gastroenterol Hepatol 2026; 11: 34–45 对《柳叶刀 - 胃肠病学和肝病学》2026 年；11卷：34 - 45 页的更正 The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e5 14 Correction to Lancet Gastroenterol Hepatol 2026; 11: 89–91 对《柳叶刀 - 胃肠病学和肝病学》2026 年；11卷：89 - 91 页的更正 The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：e5 NEWS（新闻） 15 ASCO Gastrointestinal Cancers Symposium 2026 2026 年美国临床肿瘤学会（ASCO）胃肠道肿瘤研讨会 Rob Brierley The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p188 IN FOCUS（焦点） Book（书籍） 16 Stoma: life saver, not a barrier 造口：救命手段，而非障碍 Lucy Mae Spurgeon The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p189 ARTICLES（论著） 17 Appendicectomy versus switching to a JAK inhibitor in inducing remission in patients with active ulcerative colitis after biologic therapy failure (COSTA): 1-year results of a multicentre, prospective, cohort study 生物制剂治疗失败后，阑尾切除术与换用 JAK 抑制剂诱导活动期溃疡性结肠炎患者缓解的对比（COSTA）：一项多中心、前瞻性、队列研究的 1 年结果 Eva Visser,Maud A Reijntjes,Lianne Heuthorst,Merle E Stellingwerf,Rachel West,Koen van Dongen,Rogier M P H Crolla,Susan van Dieren,Jarmila D W van der Bilt,Willem A Bemelman,Geert R D'Haens,Christianne J Buskensfor the COSTA Study Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p190 18 Cyclic exclusive enteral nutrition versus partial enteral nutrition to maintain long-term drug-free remission in paediatric Crohn's disease (CD-HOPE): an open-label, endpoint-blinded, randomised controlled trial 循环全肠内营养与部分肠内营养维持儿童克罗恩病长期无药物缓解的对比（CD - HOPE）：一项开放标签、终点盲法、随机对照试验 Bénédicte Pigneur,Christine Martinez-Vinson,Aurélie Bourmaud,Alain Dabadie,Rémi Duclaux-Loras,Jean-Pierre Hugot,Céline Roman,Clémentine Dumant,Claire Spyckerelle,Vincent Guinard-Samuel,Stéphanie Willot,Claire Dupont,Anne Breton,Nicolas Caron,Emilie Chaillou,Laurent Rebouissoux,Valérie Bertrand,Valérie Triolo,Justine Pages,Djamal Djeddi,Marjorie Bonneton,Stéphanie Uhlen,Natacha Catteau,Stéphanie Coopman,Patricia Lepage,Jérôme Viala,Frank M Ruemmele The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p204 19 ALG-000184 (pevifoscorvir sodium) monotherapy in participants with chronic HBV infection: a phase 1, multicentre, randomised, dose escalation trial ALG - 000184（佩维福司科韦钠）单药治疗慢性乙型肝炎病毒感染者：一项 1 期、多中心、随机、剂量递增试验 Man-Fung Yuen,Kosh Agarwal,Alina Jucov,Jinlin Hou,Junqi Niu,Yanhua Ding,Alexei Haceatrean,Xie'er Liang,Jia Xu,Min Wu,Kha Le,Tse-I Lin,Lawrence Blatt,Sushmita Chanda,John Fry,Ed Gane The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p218 20 Best buys for metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis: a global Delphi study 代谢功能障碍相关脂肪性肝病和代谢功能障碍相关脂肪性肝炎的最佳干预措施：一项全球德尔菲研究 Jeffrey V Lazarus,Leire Agirre-Garrido,Trenton M White,Anish K Arora,Melina I Manolas,Luis Antonio Diaz,Juan Pablo Arab,Shira Zelber-Sagi,Naim Alkhouri,C Wendy Spearman,Jörn M Schattenberg,Loreta A Kondili,Patrizia Carrieri,Holly F Lofton,Priya Jaisinghani,Sonal Kumar,Ajay Duseja,Mohamed El-Kassas,Hirokazu Takahasi,Debbie L Shawcross,Jonathan G Stine,Marcela Villota-Rivas,Juan Emilio Miralles-Sanchez,Silvana Pannain,Paul N BrennanMASLD/MASH Collaborators The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p232 REVIEW（综述） 21 Definitions, diagnosis, management, and outcomes of upper gastrointestinal Crohn's disease: an international, expert RAND/UCLA appropriateness study 上消化道克罗恩病的定义、诊断、治疗和转归：一项国际专家兰德/加州大学洛杉矶分校适用性研究 Nathaniel A Cohen,Dominik Bettenworth,Neta Sror,Raneem Khedraki,Qijun Yang,Maria T Abreu,Raja Atreya,Badr Al-Bawardy,Susan J Connor,Geert D'Haens,Iris Dotan,Axel Dignass,Sara El Ouali,Brian Feagan,Roger Feakins,Richard Gearry,Ilyssa O Gordon,Charlotte R H Hedin,Cristian Hernandez-Rocha,Taku Kobayashi,Haim Leibovitzh,Cathy Lu,Nitsan Maharshak,Maliha Naseer,Jacob Ollech,David T Rubin,Shaji Sebastian,Britta Siegmund,Mark S Silverberg,Flavio Steinwurz,Joana Torres,Gill Watermeyer,Tina Aswani Omprakash,Lior Frenkel,Paige Gurizzian,Alexa Silfen,Roie Tzadok,Katherine Falloon,Florian Riederon behalf of the Study of Upper Gastrointestinal Manifestations and Management of Crohn's Disease (SUMM-CD) Group The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p243 22 Mechanisms and pathophysiology leading to development of small intestinal microbial dysbiosis 导致小肠微生物群失调的机制和病理生理学 John A Damianos,Xiao Jing Wang,Michael Camilleri The Lancet Gastroenterology & Hepatology. Mar 2026, Vol 11(3)：p256 THE LANCET Gastroenterology & Hepatology. Volume 11Number4 柳叶刀胃肠病学与肝病学 11卷 4期 https://www.thelancet.com/journals/langas/issue/current Editorial（社论） 1 Preventive cholera vaccination resumes 预防性霍乱疫苗接种重新启动 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p267 2 Putting steatotic liver disease on the global NCD agenda 将脂肪变性肝病纳入全球非传染性疾病议程 The Lancet Gastroenterology & Hepatology The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p267 Comment（述评） 3 Menopause and inflammatory bowel disease: more questions than answers 绝经与炎症性肠病：疑问多于答案 Samantha Conley,Kendra J Kamp,Sunanda V Kane The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p268 4 Voices from the frontline: how global funding cuts are reshaping the viral hepatitis response 前线之声：全球资金削减如何重塑病毒性肝炎应对策略 Marion Delphin,Monica Fambrough,Jana Manning,Lindsey Hiebert-Suwondo,Jessica Hicks,Philippa C Matthews The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p269 5 Delivering therapeutic diets for gastrointestinal disease to people with intellectual disabilities 为患有胃肠道疾病的智力障碍人群提供治疗性饮食 Lynette Harper,Ian H Walshe,Leigh Donnelly The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p271 6 Making room under the umbrella for microscopic colitis 在伞状范畴下为显微镜下结肠炎留出一席之地 Jillian Horton,Edward V Loftus Jr The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p274 Correspondence（读者来信） 7 The evolving clinical trial landscape in the MENA region 中东和北非地区临床试验格局的演变 Mohammed Nabil Quraishi,Badr Al-Bawardy The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p277 8 The evolving clinical trial landscape in the MENA region 中东和北非地区临床试验格局的演变 Yasser Fouad,Abdulla Al Hassani,Nawal Alkhalidi,Faisal Abaalkhail,Mohammed Eslam The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p278 9 Difficulties in identifying a signal of activity in the adjuvant setting for biliary tract cancer 在胆道癌辅助治疗中识别活性信号的困难 Julien Edeline,John Bridgewater The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p278 10 Difficulties in identifying a signal of activity in the adjuvant setting for biliary tract cancer – Authors' reply 在胆道癌辅助治疗中识别活性信号的困难——作者回复 Lixing Li,Fei Liang,Zheng Wang,Jia Fan,Jian Zhouon behalf of the ACC investigators The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p279 11 Developing policy for steatotic liver disease: an even better buy? 制定脂肪变性肝病政策：更划算的选择？ Oliver D Tavabie,Megan E Rawcliffe,Mads Israelsen The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p280 Corrections（更正） 12 Correction to Lancet Gastroenterol Hepatol 2025; 10: 634–47 《柳叶刀-胃肠病学与肝病学》2025年；第10卷：第634 - 47页勘误 The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：e6 13 Correction to Lancet Gastroenterol Hepatol 2026; 11: 22–33 《柳叶刀-胃肠病学与肝病学》2026年；第11卷：第22 - 33页勘误 The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：e6 News（新闻） 14 ECCO 2026 2026年欧洲克罗恩病和结肠炎组织会议 Rob Brierley The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p281 15 Research in Brief 研究简讯 Holly Baker The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p282 In Focus（焦点） 16 Food Matters 食品问题 Low-carbohydrate diets—how low can we go? 低碳水化合物饮食——我们能低到什么程度？ Sanna Nybacka,Heidi M Staudacher The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p283 Articles（论著） 17 Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial 皮下古塞库单抗诱导治疗中重度活动性溃疡性结肠炎受试者的有效性和安全性（ASTRO研究）：一项双盲、全程治疗、随机、安慰剂对照的3期试验 Millie Long,Jessica R Allegretti,Silvio Danese,Matthew Germinaro,Thomas Baker,Yelina Alvarez,Mary Kavalam,Chenglong Han,Silke Jörgens,Lingjing Jiang,Hongyan Zhang,Tadakazu Hisamatsu,David T Rubin,Laurent Peyrin-Birouleton behalf of the ASTRO Study Group The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p284 18 Safety, pharmacokinetics, and preliminary efficacy of VS-01, an intraperitoneal liposomal infusion, in patients with decompensated liver cirrhosis, ascites, and covert hepatic encephalopathy: a phase 1b, first-in-human, open-label, non-randomised, single ascending and multiple dose study VS - 01（一种腹腔内脂质体输注液）在失代偿期肝硬化、腹水和隐性肝性脑病患者中的安全性、药代动力学和初步疗效：一项1b期、首次人体、开放标签、非随机、单次递增和多次给药研究 Frank Erhard Uschner,Martin McCoy,Olaf Tyc,Wenyi Gu,Philip Ferstl,Maximilian Joseph Brol,Johannes Masseli,Kai-Henrik Peiffer,Fabian Finkelmeier,Stefan Zeuzem,Sophie Biguenet,Katharina Staufer,Meriam Kabbaj,Jonel Trebicka The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p299 19 Ileocaecal resection versus infliximab for ileal Crohn's disease: retrospective 10-year follow-up of the LIR!C trial 回盲部切除术与英夫利昔单抗治疗回肠克罗恩病：LIR!C试验的10年回顾性随访 Lotte Oldenburg,Anouck E G Haanappel,Mahsoem Ali,Carolijn Bosman,Christianne J Buskens,Cyriel Y Ponsioen,Geert R D'Haens,Willem A Bemelmanon behalf of the LIR!C study group The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p314 20 Long-term oncological outcomes following algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection: a post-hoc analysis of a nationwide, stepped-wedge cluster-randomised trial 基于算法的护理与常规护理对胰腺切除术后并发症早期识别和治疗的长期肿瘤学预后：一项全国性、阶梯楔形整群随机试验的事后分析 Thijs J Schouten,Kyra J Prinsze,Anne Claire Henry,Lois A Daamen,Marc G Besselink,Bert A Bonsing,Koop Bosscha,Olivier R Busch,Geert A Cirkel,Ronald M van Dam,Casper H van Eijck,Sebastiaan Festen,Bas Groot Koerkamp,Erwin van der Harst,Ignace H J T de Hingh,Geert Kazemier,Mike S L Liem,Vincent E de Meijer,J Sven D Mieog,Gijs A Patijn,Daphne Roos,Jennifer M J Schreinemakers,Martijn W J Stommel,Fennie Wit,C Henri van Werkhoven,I Quintus Molenaar,F Jasmijn Smits,Hjalmar C van Santvoortfor the Dutch Pancreatic Cancer Group The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p323 Review（综述） 21 Chronic liver disease and hepatology care in transgender and gender diverse populations 跨性别者和性别多元人群的慢性肝病和肝病学护理 Thanh N Nguyen,Whitney E Jackson,Nitzan C Roth,Felice Cinque,Monika Sarkar,Niharika Samala,Rita S Lee,Alexandra T Strauss,Jessica Wisocky,Keyur Patel,Giada Sebastiani,Carl G Streed Jr,Jordan E Lake,Tzu-Hao Lee The Lancet Gastroenterology & Hepatology. Apr 2026, Vol 11(4)：p334

2026-03-05

·医学论坛网消化肝病

禁区探路：代偿期肝硬化PSC患者能否接住新药研发的橄榄枝？

导语：当胆汁在硬化的胆管中艰难流淌，当肝移植成为悬在头顶的倒计时，这群患者却被挡在每一次新药试验的门外——难道代偿期肝硬化注定是创新疗法的"死亡禁区"？ PSC的治疗版图长期荒芜。非肝硬化患者尚能企及临床试验的曙光，而一旦迈入肝硬化门槛，药代动力学的顾虑、失代偿的恐惧、监管的谨慎，便交织成一张无形的排斥之网。最需干预的人群，反而成为证据最稀缺的孤岛。这种悖论不仅折射出肝病药物开发的系统性困境，更暗示着一个被忽视的临床真相：我们对"肝硬化患者能否耐受新型靶向药"的认知，或许从未真正经过检验。本研究的独特价值，正在于它敢于正面叩问这一禁忌。它不满足于在低风险人群中重复验证，而是将剂量递增的探针伸入代偿期肝硬化的"无人区"，用12周的严密监测回答了一个关键命题——FXR激动剂的核心靶点激活效应，能否在纤维化最重的肝脏中依然起效？安全性轮廓是否足以支撑后续探索？这些问题的答案，不仅关乎cilofexor自身的开发前景，更可能重塑整个行业对肝硬化人群临床试验风险-获益评估的范式。在肝纤维化不可逆的悲观叙事中，这项研究悄然撕开了一道口子：或许，干预的窗口从未真正关闭，只是我们迟迟不敢推开那扇门。 01 ▼ 肝硬化PSC的"无药之困"：当临床试验的大门向最需要的患者关闭" 原发性硬化性胆管炎（PSC）是一种令人揪心的疾病——它在胆管中悄然编织纤维化的牢笼，让胆汁淤积成殇。作为一种罕见的慢性进行性肝病，美国患者不足20万，却与炎症性肠病如影随形，并悄然抬高了肝胆恶性肿瘤的风险。当疾病滑向代偿期肝硬化阶段，患者正站在悬崖边缘：门脉高压、肝功能衰竭、肝移植需求接踵而至，然而医学界却只能眼睁睁看着——迄今尚无获批药物能延缓PSC的病程进展。这片临床荒原上，法尼醇X受体（FXR）激动剂曾燃起希望之火。FXR是胆汁酸代谢的"总调度师"，其激活可经肠道释放FGF19激素，抑制肝脏胆汁酸合成。Cilofexor作为高效选择性FXR激动剂，在非肝硬化PSC患者中已展现改善胆汁淤积标志物的潜力（2019年Hepatology报道）。然而，一个令人尴尬的悖论长期存在：肝硬化患者医疗需求最迫切，却因药代动力学顾虑（肝功能不全者血浆暴露量翻倍）被系统性地排除在临床试验之外。他们真的无法耐受有效剂量吗？100mg是否仍是疗效所需？这些悬而未决的疑问，让最脆弱的患者群体沦为"治疗孤儿"。 2024年7月1日，Clinical and Translational Gastroenterology在线发表了一篇题为"Cilofexor in Patients With Compensated Cirrhosis Due to Primary Sclerosing Cholangitis: An Open-Label Phase 1B Study"的文章，恰似刺破阴霾的一道光——研究者大胆将代偿期肝硬化PSC患者纳入试验，通过创新的剂量递增设计，首次系统评估了cilofexor在这一"禁区"人群中的安全性与疗效，为FXR靶向治疗向疾病终末期前移提供了关键概念验证。 02 ▼ 阶梯式增量破禁区，多维度探索筑安全"：一项开创性的开放标签1b期概念验证试验本研究是一项开放标签、单臂、剂量递增的1b期概念验证试验，旨在评估cilofexor在代偿期肝硬化PSC患者中的安全性、耐受性及初步疗效。研究架构由美国8个中心共同完成，采用"筛选期-治疗期-随访期"三段式设计：4周筛选后进入12周核心治疗期，最后4周随访。患者纳入标准体现严谨与创新的平衡——需经影像学、肝活检或无创检测（FibroScan≥14.4 kPa、ELF≥11.3或FibroTest≥0.75）确证肝硬化，同时肝功能储备尚可（总胆红素≤2 mg/dL、INR≤1.4、血小板≥75,000/μL），以排除高风险静脉曲张及失代偿事件。关键排除标准锁定失代偿病史、MELD>12分、Child-Pugh>6分及活动性恶性肿瘤者。干预策略体现对肝硬化人群的审慎：采用30mg→60mg→100mg的四周阶梯式增量口服方案，而非直接启用目标剂量。这一设计源于前期药代研究——虽然肝硬化患者cilofexor血浆暴露量升高（因肝摄取减少及CYP2C8/3A4代谢下降），但摄取与代谢的平行下降使肝内暴露预计保持中性，故仍需100mg靶剂量追求充分疗效。剂量调整权赋予主要研究者，允许药物相关不良事件导致最长4周中断。合规性通过药片计数监测，瘙痒管理方案涵盖非药物干预、外用激素、抗组胺药及胆汁酸螯合剂（需与cilofexor间隔4小时）。评价指标体系层次分明：首要终点为安全性（TEAEs、实验室检查、生命体征）；探索性终点涵盖肝生化（ALP、GGT、ALT、AST、胆红素）、无创纤维化标志物（FibroScan、ELF及其组分TIMP1、PIIINP、透明质酸）、药效学生物标志物（空腹及给药后2/4小时的FGF19、C4、胆酸、总胆汁酸），以及健康相关生活质量（CLDQ、EQ-5D、SIBDQ）和瘙痒评分（VAS、5D itch量表）。统计学采用重复测量混合效应模型分析纵向标志物变化。图1：研究设计 03 ▼ 安全性轮廓清可辨，胆汁淤积缓初现： cilofexor在肝硬化领地站稳脚跟安全性轮廓reassuring（令人安心）。11例患者（中位年龄48岁，55%男性，55%合并IBD）完成中位12.1周暴露，9例（81.8%）接受完整12周治疗，1例因外周水肿短暂中断2日后完成疗程，另1例因个人决定提前退出。无死亡、无严重不良事件、无永久性停药——这组"三无"数据在肝硬化药物试验中堪称珍贵。最常见治疗期不良事件为瘙痒（8/11，72.7%），其中7例判定为药物相关，1例达3级但未达严重标准；其他常见事件包括疲劳、头痛、恶心及上呼吸道感染（各18.2%）。实验室异常多为1-2级，仅1例3级贫血。更关键的是，无失代偿事件、无胆管炎、无肝癌或胆管癌发生，肝硬化患者的"安全红线"未被触碰。疗效信号在胆汁淤积标志物中浮现。作者指出："肝酶浓度呈下降趋势，GGT降低尤为显著"。具体而言，第12周时ALP中位下降13.0%（IQR -21.9%至8.6%），GGT下降43.5%（-52.1%至-30.8%），ALT下降24.8%（-35.7%至7.4%），AST下降11.6%（-28.7%至7.3%）；总胆红素及直接胆红素亦分别下降12.7%和21.2%。然而作者坦诚，"与非肝硬化PSC患者既往研究中观察到的肝生化标志物降低相比，本研究ALP、ALT、AST未见临床有意义变化"——这或许源于肝硬化阶段更严重的病理基础，样本量限制亦不可忽视。所有标志物在4周随访期复归基线，提示药效的可逆性。药效学生物标志物确证靶点激活。作者强调："Cilofexor在第8周及第12周的谷浓度显著降低血清C4及胆酸水平"——C4（7α-羟基-4-胆甾烯-3-酮，胆汁酸合成限速步骤产物）的LS均值降幅达55.3%（95%CI -70.8%至-31.6%），胆酸降幅60.5%（-81.8%至-14.2%）。更精妙的是FGF19动态：尽管空腹谷浓度无显著变化，但给药后2-4小时出现"显著一过性升高"——这与健康志愿者及非肝硬化PSC患者中的发现一致，完美复现FXR-FGF19-胆汁酸合成的调控轴，证明即使在肝硬化背景下，cilofexor仍能精准拨动其分子靶点。纤维化标志物呈现波动性。ELF评分在30-60mg阶段轻度上升，至100mg阶段回落近基线（第12周中位变化+0.1）；肝脏硬度变化中位+0.2 kPa。作者审慎提示："短期试验中ELF评分的微小变异不应过度解读"，TIMP1、PIIINP、透明质酸的变化亦在检测变异性范围内。瘙痒与生活质量：表象与实质的分离。72.7%的瘙痒发生率看似骇人，但作者发现"瘙痒TEAE未显著增加患者负担"——VAS及5D itch评分自基线至第12周无临床相关变化，健康相关生活质量各维度亦稳定。这一"discordance（不一致性）"现象被归因于：瘙痒TEAE记录可能包含既往既存症状（未必为恶化），且积极的管理方案有效缓冲了症状冲击；基线瘙痒评分较高的患者indeed更易报告TEAE。图2：随访第4–16周时，疗效结局较基线的纵向变化 04 ▼ 总结本研究作为首项聚焦代偿期肝硬化PSC患者的cilofexor临床试验，以创新的剂量递增设计跨越了"肝硬化exclusion（排除）"的行业惯例，在11例患者中稳健验证了100mg cilofexor的安全耐受性——无失代偿、无严重事件、无不可逆停药，同时确证了FXR靶点激活（FGF19一过性升高、C4及胆酸持续抑制）及胆汁淤积标志物的改善趋势。作者直言其核心价值："本研究的优势在于纳入了肝硬化患者——这一通常被排除于临床试验之外、却具有最高医疗需求的群体"，尽管样本量小、缺乏对照、周期短等局限存在，但cilofexor在此"禁区"人群中建立的初步安全档案，不仅为后续更大规模确证性试验铺就基石，更向肝病领域传递了一个重要信号：代偿期肝硬化不应再是创新疗法的不可逾越的屏障，而应是精准干预的关键窗口。在PSC药物治疗长期空白的版图上，这项1b期研究或许只是微小的一步，却为最需要帮助的患者群体重新打开了希望之门。参考文献 Levy C, Caldwell S, Mantry P, Luketic V, Landis CS, Huang J, Mena E, Maheshwari R, Rank K, Xu J, Malkov VA, Billin AN, Liu X, Lu X, Barchuk WT, Watkins TR, Chung C, Myers RP, Kowdley KV. Cilofexor in Patients With Compensated Cirrhosis Due to Primary Sclerosing Cholangitis: An Open-Label Phase 1B Study. Clin Transl Gastroenterol. 2024 Aug 1;15(8):e00744. doi: 10.14309/ctg.0000000000000744. PMID: 38976363; PMCID: PMC11346858. “医学论坛网”发布医学领域研究成果和解读，供专业人员科研参考，不作为诊疗标准，使用需根据具体情况评估。编辑：常寂光审核：梨九排版：蓝桉封面图源：CMT

100 项与 Cilofexor tromethamine 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15168

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
原发性硬化性胆管炎	临床3期	美国	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	日本	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	澳大利亚	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	奥地利	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	比利时	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	加拿大	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	丹麦	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	芬兰	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	法国	Gilead Sciences, Inc.	2019-03-27
原发性硬化性胆管炎	临床3期	德国	Gilead Sciences, Inc.	2019-03-27

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03890120 (PRIMIS, Pubmed \| Lancet Gastroenterol Hepatol)	临床3期	原发性硬化性胆管炎	416	Cilofexor 100 mg	製鹹範顧顧壓鹽衊鹹繭(醖願齋淵艱選蓋壓淵選) = The most common adverse events were pruritus (cilofexor: 136 [49%] of 277 patients; placebo: 50 [36%] of 139 patients; grade 3 or higher in 11 [4%] patients in the cilofexor group and one [1%] patient in the placebo group), COVID-19 (cilofexor: 65 [23%]; placebo: 26 [19%]), and upper abdominal pain (cilofexor: 40 [14%]; placebo 20 [14%]). 簾製鏇壓顧醖夢鑰願範 (築築齋鹽繭齋選選衊觸 )	不佳	2026-01-01
				Placebo
NCT03890120 (PRIMIS, Pubmed \| Lancet Gastroenterol Hepatol)	临床3期	原发性硬化性胆管炎	416	Cilofexor 100 mg	鑰選範積壓築網顧醖繭(範廠糧夢積夢蓋鑰憲繭) = The most common adverse events were pruritus (cilofexor: 136 [49%] of 277 patients; placebo: 50 [36%] of 139 patients; grade 3 or higher in 11 [4%] patients in the cilofexor group and one [1%] patient in the placebo group), COVID-19 (cilofexor: 65 [23%]; placebo: 26 [19%]), and upper abdominal pain (cilofexor: 40 [14%]; placebo 20 [14%]). 窪築製壓壓窪願構醖憲 (糧襯觸廠構膚襯壓餘範 )	不佳	2025-10-01
				Placebo
NCT04060147 (Phase 1B Study, Pubmed)	临床1期	原发性硬化性胆管炎 alanine transaminase \| alkaline phosphatase \| gamma-glutamyl transferase ... 更多	11	Cilofexor 30 mg	壓網齋蓋衊觸餘鬱鑰壓(鑰夢積夢淵蓋鏇範築鹽) = fatigue (2/11 [18.2%]) 網鬱廠夢願壓鬱壓窪網 (範壓積衊鑰鹹鑰淵夢遞 ) 更多	积极	2024-07-01
				Cilofexor 60 mg
NCT03890120 (PRIMIS, CTgov)	临床3期	原发性硬化性胆管炎	419	Cilofexor (Cilofexor 100 mg (Blinded Phase))	顧廠齋簾積壓醖構顧夢 = 衊簾鹽淵築顧窪艱膚夢積築壓襯遞構構築壓糧 (範獵衊網簾築憲艱鑰網, 襯憲積積壓醖襯範範廠 ~ 醖憲襯鹹鹽鬱簾廠築鹹) 更多	-	2023-11-29
				Placebo (Placebo (Blinded Phase))	顧廠齋簾積壓醖構顧夢 = 衊齋夢齋構襯簾獵襯蓋積築壓襯遞構構築壓糧 (範獵衊網簾築憲艱鑰網, 獵顧艱選願網願願觸獵 ~ 齋鏇醖壓襯觸獵鏇遞鏇) 更多
NCT04060147 (Phase 1B Study, CTgov)	临床1期	肝纤维化 \| 纤维化 \| 原发性硬化性胆管炎 ... 更多	11	Cilofexor	構醖壓膚艱膚衊鹽襯鬱 = 齋廠糧艱淵遞獵餘鑰願窪獵壓觸齋齋襯觸艱蓋 (鏇獵衊憲夢網醖網襯壓, 繭壓憲觸廠遞願夢膚鹹 ~ 製選願製願齋繭簾壓壓) 更多	-	2023-07-27
NCT03890120 (PRIMIS, EASL2022)	临床3期	原发性硬化性胆管炎	11	Cilofexor 30 mg	顧製醖蓋醖簾鏇蓋鏇構(獵遞襯製鏇獵糧糧糧夢) = 鬱願艱餘糧艱遞構廠廠夢蓋醖顧鑰網獵齋觸鏇 (鬱遞願鏇遞憲鑰鬱蓋顧 ) 更多	积极	2022-06-23
NCT03987074 (Pubmed \| J Hepatol) 人工标引	临床2期	代谢功能障碍相关脂肪性肝炎	108	Semaglutide+Cilofexor tromethamine	鏇獵窪製襯膚鬱淵範觸(獵壓積顧膚齋繭醖網鏇) = Treatments were well tolerated - the incidence of adverse events was similar across groups (73-90%) and most events were gastrointestinal in nature. 鏇繭廠襯範遞願鏇醖製 (齋願廠選糧壓鑰繭觸鏇 ) 更多	积极	2022-04-16
				Semaglutide+Firsocostat+Cilofexor tromethamine
NCT02781584 (Pubmed \| Clin Gastroenterol Hepatol) 人工标引	临床2期	高甘油三酯血症 \| 代谢功能障碍相关脂肪性肝炎	66	Fenofibrate+Cilofexor tromethamine+Firsocostat	醖窪鹽鏇觸餘鹽蓋壓簾(簾襯鑰蓋獵廠鏇範蓋醖) = most treatment-emergent adverse events were Grade 1 to 2 severity 窪廠壓夢艱廠製憲顧獵 (製餘繭齋鏇範糧餘鏇壓 ) 更多	积极	2022-01-06
				Icosapent Ethyl+Cilofexor tromethamine+Firsocostat
NCT03987074 (CTgov)	临床2期	代谢功能障碍相关脂肪性肝炎	109	Semaglutide (Semaglutide)	憲繭餘鏇夢製襯觸襯繭 = 獵膚鹽窪觸壓築願艱艱構簾繭夢淵構餘網獵糧 (窪獵襯齋製衊繭獵鹽範, 鑰窪壓製選網網蓋製艱 ~ 鑰壓醖廠襯艱醖鑰膚膚) 更多	-	2021-07-15
				Semaglutide+Firsocostat (Semaglutide + Firsocostat 20 mg)	憲繭餘鏇夢製襯觸襯繭 = 衊繭積鬱鏇淵選鑰獵簾構簾繭夢淵構餘網獵糧 (窪獵襯齋製衊繭獵鹽範, 窪醖繭鑰範蓋蓋齋壓築 ~ 顧鏇淵襯蓋夢鏇襯壓繭) 更多
NCT01999101 (Pubmed \| Wien Klin Wochenschr) 人工标引	临床2期	代谢功能障碍相关的脂肪肝病	12	PX-104	衊糧窪鑰觸淵積窪網醖(壓夢鬱襯襯醖網鬱衊構) = There were no serious adverse events but short intervals of cardiac arrhythmia recorded in 2 patients led to termination of the study. 齋淵鹽廠遞簾顧鬱構壓 (顧構鏇選衊鹹觸積簾窪 )	积极	2021-05-01