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Chronic liver disease and hepatology care in transgender and gender diverse populations 跨性别和不同性别人群的慢性肝病和肝病护理
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-13 DOI: 10.1016/s2468-1253(25)00287-0
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, Jordan E Lake, Tzu-Hao Lee
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引用次数: 0
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 guelkumab皮下诱导治疗对中度至重度活动性溃疡性结肠炎(ASTRO)患者的疗效和安全性:一项双盲、全治疗、随机、安慰剂对照的3期试验
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-13 DOI: 10.1016/s2468-1253(25)00322-x
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-Biroulet, Niazy Abu-Farsakh, Lawrence Al-Rousan, Ping An, Marjorie Argollo, Federico Arguelles Arias, Monika Augustyn, Filip Baert, Domingo Balderramo, Rupa Banerjee, Curtis Baum, Emilio Bermudez Villegas, Antonio Blanco, Martin Bortlik, Yoram Bouhnik, Luciana Soledad Brunatto, Julio Chebli, Hong Chen, Ye Chen, Jaehee Cheon, Feng Fan Chiang, Changhwan Choi, Jen-Wei Chou, Gourdas Choudhuri, Crispin Corte, Wit Danilkiewicz, Julio De María, Shigang Ding, Jin Ding, Raina Draganova, George Duvall, Herlon Escorsi Valerio, Miroslav Fedurco, Baisui Feng, Rafal Filip, Cristina Flores, James Fon, Bernardeta Frysna, Yohei Furumoto, Gyula G.Kiss, Dariusz Gajda, Paulino Galvan Castro, Antonio Garcia Herola, Beata Gawdis-Wojnarska, Piotr Gietka, Cyrielle Gilletta De Saint Joseph, Edgardo Gimenez, Chad Gonzales, Florent Gonzalez, Hong Guo, Ylse Gutierrez Grobe, Melissa Haines, Marc Happe, Luciana Harlacher, Xavier Hebuterne, Ida Normiha Hilmi, Tibor Hlavaty, Gerald Holtmann, Connie Hsu, Naizhong Hu, Gaspar Iglesias Miramontes, Hiroyasu Ishida, Takeshi Ishikawa, Soichi Itaba, Hiroaki Ito, Animesh Jain, Byung Ik Jang, Thomas Jarrett, Takashi Kagaya, Roberto Kaiser Jr., Kazunari Kanke, Dan Keret, Jaroslaw Kierkus, Taeoh Kim, Youngho Kim, Ja Seol Koo, Adam Kopon, Reiko Kunisaki, David Laharie, Wilfred Landry, Syed Lateef, Jaroslaw Leszczyszyn, Asaf Levartovsky, Shengbao Li, Manuel Martinez, Hector Martinez Torres, Jan Matous, Muhammad Firdaus Md Salleh, Rajiv Mehta, Shoba Mendu, Bruna Meyer De Mattos Correa, Emese Mihaly, Pal Miheller, Gabriela Moran Faienzo, Vinciane Muls, Narayanachar Murali, Mohamed Naem, Katsuhiko Nakai, Ying Zhuang Ng, Motoji Oki, Yoshifumi Onishi, Michio Onizawa, Yohei Ono, Taro Osada, Danuta Owczarek, Dong Il Park, Bhaktasharan Patel, Rima Petroniene, Laurent Peyrin-Biroulet, Jatinder S. Pruthi, Odery Ramos Jr., Alexander De Sa Rolim, Jacek Romatowski, David Rowbotham, Orlando Enrique Ruffinengo, Souken Sai, Michael Schultz, Joerg Schulze, Ursula Seidler, Abdul Shaikh, Roberto Silva Jr., Joaquim Simoes Neto, Milan Siroky Jr., Artur Soltysiak, Takayoshi Suzuki, Yasuo Suzuki, Ken Takeuchi, Kar Choon Tan, Ludmila Tankova, Kusai Tawalbeh, Luciana Teixeira Campos, Vivek Tharayil, Lena Thin, Feng Tian, Tetsuya Ueo, Kiyotaka Umeki, Nalan Unal, Raquel Vicente Lidon, Yufang Wang, Xiaodi Wang, Horng-Yuan Wang, L. Michael Weiss, Sbeit Wisam, Katarzyna Wojcik, Hui Yang, Shigeto Yoshida, Ligia Yukie Sassaki, Xiaoqi Zhang, Yingjian Zhang, Xiaolan Zhang, Lan Zhong, Qunyan Zhou, Eran Zittan, Duowu Zou
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引用次数: 0
Menopause and inflammatory bowel disease: more questions than answers 更年期与炎症性肠病:问题多于答案
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-13 DOI: 10.1016/s2468-1253(25)00368-1
Samantha Conley, Kendra J Kamp, Sunanda V Kane
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引用次数: 0
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、管理和结局:一项国际专家兰德/加州大学洛杉矶分校的适宜性研究
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-08 DOI: 10.1016/s2468-1253(25)00347-4
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 Rieder,
Patients with Crohn's disease can have isolated or co-existent upper gastrointestinal involvement, but this is an understudied clinical manifestation. There are neither standardised definitions nor diagnostic or management recommendations to help to guide clinical practice. Therefore, we conducted a RAND/University of California Los Angeles appropriateness study on the definition, diagnosis, management, and appropriate outcomes of upper gastrointestinal Crohn's disease (UGICD). An international expert panel of 30 gastroenterologists and pathologists and two patient representatives were recruited. Following a previously published systematic review, 1061 candidate items were grouped into questions and evaluated for appropriateness. Two modified Delphi rounds of voting with an interposed moderated group discussion were performed. The expert panel defined UGICD as disease occurring in the oesophagus, stomach, and/or duodenum (proximal to the ligament of Treitz) that can occur at any time during the disease course. Upper endoscopy is appropriate only in patients with newly diagnosed or existing Crohn's disease with suspicion for upper gastrointestinal involvement (eg, upper gastrointestinal symptoms or the presence of anaemia). Management of UGICD should be determined on a case-by-case basis and factors, such as disease location and symptomatic, endoscopic, and imaging severity, should guide medical, endoscopic, and surgical intervention. Both clinical and endoscopic response and remission are appropriate treatment targets for routine clinical practice; there is uncertainty about the value of histological outcomes in UGICD.
克罗恩病患者可能有孤立或同时存在的上消化道受累,但这是一个尚未充分研究的临床表现。既没有标准化的定义,也没有诊断或管理建议来帮助指导临床实践。因此,我们对上消化道克罗恩病(UGICD)的定义、诊断、管理和适当结局进行了兰德/加州大学洛杉矶分校的适宜性研究。招募了一个由30名胃肠病学家和病理学家组成的国际专家小组以及两名患者代表。根据先前发表的系统评价,1061个候选项目被分组为问题并评估其适当性。进行了两轮修改的德尔菲投票,并进行了干预的小组讨论。专家小组将UGICD定义为发生在食道、胃和/或十二指肠(Treitz韧带近端)的疾病,可在病程中的任何时间发生。上消化道内窥镜检查仅适用于新诊断或已有克罗恩病且怀疑累及上消化道的患者(如上消化道症状或存在贫血)。UGICD的管理应在个案基础上确定,疾病位置和症状、内窥镜和成像严重程度等因素应指导医疗、内窥镜和手术干预。临床和内镜下的反应和缓解都是常规临床实践中适当的治疗目标;UGICD的组织学结果的价值存在不确定性。
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引用次数: 0
Research in Brief 研究简介
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-06 DOI: 10.1016/s2468-1253(25)00379-6
Holly Baker
<h2>Section snippets</h2><section><section><h2>Perioperative immunotherapy for hepatocellular carcinoma</h2>Perioperative camrelizumab plus rivoceranib shows benefit in patients with hepatocellular carcinoma at intermediate or high risk of relapse, according to the <span><span>CARES-009 phase 2/3 trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>. Zheng Wang and colleagues randomly assigned patients to receive either perioperative therapy comprising two cycles of neoadjuvant camrelizumab plus rivoceranib, followed by surgery and adjuvant camrelizumab plus rivoceranib (n=148), or surgery alone (n=146). At a prespecified interim analysis, with a median</section></section><section><section><h2>Pemvidutide for MASH</h2>Pemvidutide, a GLP-1–glucagon dual receptor agonist, shows promise in treating metabolic dysfunction-associated steatohepatitis (MASH), according to the 24-week results from the ongoing <span><span>IMPACT phase 2b trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>. Mazen Noureddin and colleagues randomly assigned patients to receive once-weekly subcutaneous pemvidutide 1·2 mg (n=41) or 1·8 mg (n=85), administered without dose titration, or placebo (n=86). The primary endpoint of MASH resolution without fibrosis worsening was achieved by a greater</section></section><section><section><h2>Tobevibart plus elebsiran for hepatitis D</h2>Tobevibart plus elebsiran shows promise in patients with chronic hepatitis D virus (HDV) infection, according to the 48-week results of the <span><span>SOLSTICE phase 2 trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>. Tarik Asselah and colleagues randomly assigned patients to receive tobevibart plus elebsiran every 4 weeks (n=32) or tobevibart monotherapy every 2 weeks (n=33).At week 24, a combined response—defined as an HDV RNA level below the limit of detection or a decrease in the HDV RNA level of at least 2 log<sub>10</sub> IU per mL from baseline</section></section><section><section><h2>Combination therapy for metastatic colorectal cancer</h2>Zanzalintinib plus atezolizumab improves overall survival in patients with relapsed or refractory metastatic colorectal cancer, according to results from the <span><span>STELLAR-303 phase 3 trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>. J Randolph Hecht and colleagues randomly assigned patients to rece
肝细胞癌的手术免疫治疗根据CARES-009 2/3期试验,手术camrelizumab + rivoeranib对中高复发风险的肝细胞癌患者有益处。Zheng Wang及其同事随机分配患者接受围手术期治疗,包括两个周期的新辅助camrelizumab + rivoeranib,随后进行手术和辅助camrelizumab + rivoeranib (n=148),或单独手术(n=146)。在一项预先指定的中期分析中,根据正在进行的IMPACT 2b期试验的24周结果,pemvidutide是一种glp -1 -胰高血糖素双受体激动剂,在治疗代谢功能障碍相关脂肪性肝炎(MASH)方面显示出希望。Mazen Noureddin及其同事将患者随机分配为每周一次皮下注射培维肽1.2 mg (n=41)或1.8 mg (n=85),不进行剂量滴定或安慰剂(n=86)。根据为期48周的SOLSTICE 2期试验结果,tobevibart + elebsiran治疗慢性丁型肝炎的主要终点是没有纤维化恶化的MASH解决,tobevibart + elebsiran治疗慢性丁型肝炎病毒(HDV)感染的患者显示出希望。Tarik Asselah及其同事随机分配患者每4周接受一次tobevibart + elebsiran (n=32)或每2周接受一次bevibart单药治疗(n=33)。根据star -303 iii期试验的结果,在第24周,联合缓解-定义为HDV RNA水平低于检测极限或从基线联合治疗转移性结直肠癌中HDV RNA水平降低至少2log10 IU / mL - zanzalinib + atezolizumab改善复发或难治性转移性结直肠癌患者的总生存期。J Randolph Hecht及其同事随机分配患者接受每日口服zanzalinib 100 mg +静脉注射atezolizumab 1200 mg每3周(n=451)或每日口服regorafenib 160 mg,每28天周期的第1-21天(n=450)。中位随访18.0个月,给予赞扎替尼治疗
{"title":"Research in Brief","authors":"Holly Baker","doi":"10.1016/s2468-1253(25)00379-6","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00379-6","url":null,"abstract":"&lt;h2&gt;Section snippets&lt;/h2&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Perioperative immunotherapy for hepatocellular carcinoma&lt;/h2&gt;Perioperative camrelizumab plus rivoceranib shows benefit in patients with hepatocellular carcinoma at intermediate or high risk of relapse, according to the &lt;span&gt;&lt;span&gt;CARES-009 phase 2/3 trial&lt;/span&gt;&lt;svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"&gt;&lt;path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;. Zheng Wang and colleagues randomly assigned patients to receive either perioperative therapy comprising two cycles of neoadjuvant camrelizumab plus rivoceranib, followed by surgery and adjuvant camrelizumab plus rivoceranib (n=148), or surgery alone (n=146). At a prespecified interim analysis, with a median&lt;/section&gt;&lt;/section&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Pemvidutide for MASH&lt;/h2&gt;Pemvidutide, a GLP-1–glucagon dual receptor agonist, shows promise in treating metabolic dysfunction-associated steatohepatitis (MASH), according to the 24-week results from the ongoing &lt;span&gt;&lt;span&gt;IMPACT phase 2b trial&lt;/span&gt;&lt;svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"&gt;&lt;path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;. Mazen Noureddin and colleagues randomly assigned patients to receive once-weekly subcutaneous pemvidutide 1·2 mg (n=41) or 1·8 mg (n=85), administered without dose titration, or placebo (n=86). The primary endpoint of MASH resolution without fibrosis worsening was achieved by a greater&lt;/section&gt;&lt;/section&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Tobevibart plus elebsiran for hepatitis D&lt;/h2&gt;Tobevibart plus elebsiran shows promise in patients with chronic hepatitis D virus (HDV) infection, according to the 48-week results of the &lt;span&gt;&lt;span&gt;SOLSTICE phase 2 trial&lt;/span&gt;&lt;svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"&gt;&lt;path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;. Tarik Asselah and colleagues randomly assigned patients to receive tobevibart plus elebsiran every 4 weeks (n=32) or tobevibart monotherapy every 2 weeks (n=33).At week 24, a combined response—defined as an HDV RNA level below the limit of detection or a decrease in the HDV RNA level of at least 2 log&lt;sub&gt;10&lt;/sub&gt; IU per mL from baseline&lt;/section&gt;&lt;/section&gt;&lt;section&gt;&lt;section&gt;&lt;h2&gt;Combination therapy for metastatic colorectal cancer&lt;/h2&gt;Zanzalintinib plus atezolizumab improves overall survival in patients with relapsed or refractory metastatic colorectal cancer, according to results from the &lt;span&gt;&lt;span&gt;STELLAR-303 phase 3 trial&lt;/span&gt;&lt;svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"&gt;&lt;path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;. J Randolph Hecht and colleagues randomly assigned patients to rece","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"29 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2026-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145947506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Appendicectomy: a disease-modifying treatment for ulcerative colitis? 阑尾切除术:溃疡性结肠炎的改善治疗方法?
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-06 DOI: 10.1016/s2468-1253(25)00303-6
Alexandra Damasio Todescatto,Paulo Gustavo Kotze
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引用次数: 0
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. 阑尾切除术与改用JAK抑制剂诱导生物治疗失败(COSTA)后活动性溃疡性结肠炎患者缓解:一项为期1年的多中心前瞻性队列研究结果
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-06 DOI: 10.1016/s2468-1253(25)00291-2
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 Buskens,
BACKGROUNDAlthough retrospective and limited prospective observational studies have suggested a potential benefit of appendicectomy in therapy-refractory ulcerative colitis, its effectiveness compared with advanced medical therapy in active, biologic-exposed patients has not been evaluated prospectively. We evaluated the efficacy of laparoscopic appendicectomy in inducing remission, compared with JAK inhibitor therapy, in patients with active ulcerative colitis who had persistent disease activity despite previous advanced therapy exposure (a small molecule or a biologic).METHODSIn this multicentre, patient-preference, interventional cohort study, conducted in five hospitals in the Netherlands, patients with a total Mayo score (TMS) of 5-12 and an endoscopic subscore of 2 or higher despite treatment with an advanced therapy were offered one of three treatments: laparoscopic appendicectomy while continuing their existing advanced therapy at a stable dose; switching their advanced therapy to a JAK inhibitor; or colectomy. This analysis focuses on patients who chose appendicectomy or to switch their advanced therapy; patients who chose colectomy were included in a non-comparative registry cohort, and outcomes in this group were recorded but not included in the comparative analyses. The primary outcome was the proportion of patients in clinical remission (TMS ≤2, no subscore >1) at 12 months without therapy failure (defined as start or restart of oral corticosteroids; switch to other advanced therapies; initiation of experimental treatment in a clinical trial; or colectomy), assessed in the modified intention-to-treat population (all patients who underwent appendicectomy or received at least one dose of the JAK inhibitor, excluding patients who had a change in disease diagnosis from ulcerative colitis to Crohn's disease). The primary endpoint was analysed by χ2 test, with an additional analysis using logistic regression adjusting for baseline confounding variables. Safety outcomes were assessed in all patients who underwent appendicectomy or received at least one dose of the JAK inhibitor. This study was registered with ClinicalTrials.gov, NCT03912714.FINDINGSBetween Aug 24, 2018, and Dec 15, 2023, 211 patients were screened for eligibility, of whom 125 (59%) patients were enrolled in the study; 116 patients were included in the modified intention-to-treat-analysis (67 received appendicectomy and 49 received JAK inhibitor). 22 (32·8%) of 67 patients in the appendicectomy group were in clinical remission without therapy failure at 12 months compared with six (12·2%) of 49 patients in the JAK inhibitor group (unadjusted difference of 20·6 percentage points [95% CI 6·1-35·1]; p=0·010; adjusted difference of 22·9 percentage points [95% CI 6·1-39·8]; p=0·016). At 12 months, corticosteroid-free clinical remission without therapy failure was attained in 22 (32·8%) of 67 patients in the appendicectomy group compared with six (12·2%) of 49 patients in the JAK
虽然回顾性和有限的前瞻性观察性研究表明阑尾切除术对治疗难治性溃疡性结肠炎有潜在的益处,但与先进的药物治疗相比,其在活性、生物暴露患者中的有效性尚未得到前瞻性评价。我们评估了腹腔镜阑尾切除术在诱导缓解方面的疗效,与JAK抑制剂治疗相比,这些患者尽管先前接受过先进的治疗(小分子或生物药物),但仍有持续的疾病活动。方法:在荷兰的5家医院进行的这项多中心、患者偏好、介入性队列研究中,梅奥总评分(TMS)为5-12,内镜亚评分为2或更高的患者,尽管接受了先进的治疗,但仍接受三种治疗中的一种:腹腔镜阑尾切除术,同时继续现有的稳定剂量的先进治疗;将他们的先进疗法转换为JAK抑制剂;或结肠切除术。本分析的重点是选择阑尾切除术或转换高级治疗的患者;选择结肠切除术的患者被纳入非比较登记队列,该组的结果被记录,但不包括在比较分析中。主要结局是12个月内临床缓解(TMS≤2,无亚评分>1)的患者比例,无治疗失败(定义为口服皮质类固醇开始或重新开始;切换到其他先进疗法;在临床试验中开始实验性治疗;或结肠切除术),在修改意向治疗人群(所有接受阑尾切除术或至少接受一剂JAK抑制剂的患者,不包括疾病诊断从溃疡性结肠炎转变为克罗恩病的患者)中进行评估。主要终点采用χ2检验进行分析,并对基线混杂变量进行logistic回归校正。对所有接受阑尾切除术或至少接受一剂JAK抑制剂的患者的安全性结果进行了评估。本研究已在ClinicalTrials.gov注册,编号NCT03912714。在2018年8月24日至2023年12月15日期间,211例患者进行了资格筛选,其中125例(59%)患者入组研究;116例患者纳入改良意向治疗分析(67例接受阑尾切除术,49例接受JAK抑制剂治疗)。阑尾切除术组67例患者中22例(32.8%)12个月临床缓解,无治疗失败,而JAK抑制剂组49例患者中6例(12.2%)(未调整差异为20.6个百分点[95% CI 6.1 ~ 35.1]; p= 0.010;调整差异为22.9个百分点[95% CI 6.1 ~ 39.8]; p= 0.016)。12个月时,阑尾切除术组67例患者中有22例(32.8%)达到无糖皮质激素临床缓解,而JAK抑制剂组49例患者中有6例(12.2%)达到无治疗失败(差异为20.6个百分点[95% CI 6.1 - 35.1]; p= 0.010), 67例患者中有49例(73.1%)达到临床缓解,49例患者中有26例(53.1%)达到临床缓解(20.1个百分点[2.5 - 37.6];P = 0.025), 64例患者中31例(48.4%)有内镜反应,43例患者中11例(25.6%;22.9个百分点[5.0 - 40.7];P = 0.018)有内镜反应。到症状缓解的时间(风险比1.06 [95% CI 0.62 ~ 1.82]; p= 0.82)、治疗失败(67例患者中39例[58.2%]vs 49例患者中28例[57.1%];差异1.1个百分点[95% CI - 17.1 ~ 19.3]; p= 0.91)和结肠切除术率(67例患者中6例[9.0%]vs 49例患者中4例[8.2%];差异0.8个百分点[95% CI - 9.5 ~ 11.1]; p= 1.0)在阑尾切除术和JAK抑制剂组之间相似。阑尾切除术组69例患者中有39例(56.5%)报告不良事件,JAK抑制剂组50例患者中有30例(60%)报告不良事件(差异为3.5个百分点[95% CI - 21.4 ~ 14.4]; p= 0.70])。69例患者中有3例(4.3%)发生阑尾切除术相关并发症,均为Clavien-Dindo II级或以下。与改用JAK抑制剂相比,阑尾切除术作为生物暴露的活动性溃疡性结肠炎患者高级治疗的辅助治疗与12个月时更高的临床缓解率相关,表明潜在的有效性,并且该手术可以安全地在该患者组中进行。
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引用次数: 0
Accelerating MASH trials: from biopsy to biomarkers. 加速MASH试验:从活组织检查到生物标志物。
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-01 DOI: 10.1016/s2468-1253(25)00352-8
The Lancet Gastroenterology Hepatology
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引用次数: 0
Dietary management of constipation: time for clinical guidelines to catch up with evidence. 便秘的饮食管理:临床指南的时间赶上证据。
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2026-01-01 DOI: 10.1016/s2468-1253(25)00350-4
Eirini Dimidi,Kevin Whelan
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引用次数: 0
ACIP's HBV birth-dose vaccine recommendations: a fiasco. ACIP的乙肝出生剂量疫苗建议:惨败。
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-12-16 DOI: 10.1016/s2468-1253(25)00377-2
The Lancet Gastroenterology Hepatology
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Lancet Gastroenterology & Hepatology
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