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Ramadan intermittent fasting for patients with gastrointestinal and hepatobiliary diseases: practical guidance for health-care professionals 胃肠和肝胆疾病患者斋月间歇性禁食:卫生保健专业人员实用指南
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-10 DOI: 10.1016/s2468-1253(24)00283-8
Muhammad Usman, Nasir Javed, Aida Jawhari, Nazim Ghouri, Salman Waqar, Fathima Shah, Saqib Ahmad, Ailsa Hart, Bilal Hameed, Mohammad Qasim Khan, Mohammad Farhad Peerally
Ramadan intermittent fasting can pose challenges and risks for some groups of patients. Based on a narrative literature review and our clinical expertise, we provide practical guidance for clinicians managing patients with gastrointestinal and hepatobiliary conditions who wish to fast during Ramadan. Following the established International Diabetes Federation and Diabetes and Ramadan International Alliance risk stratification framework, we categorised patients’ risk as low or moderate, high, or very high. We advise all patients at very high risk and most patients at high risk to not observe fasting due to potential harm. For others, we offer nuanced recommendations on medication rescheduling, lifestyle changes, and tailored fasting advice to minimise adverse effects. Shared decision making that respects patients’ religious motivations is essential, with risks and benefits carefully weighed on an individual basis.
斋月间歇性禁食会给一些患者群体带来挑战和风险。基于叙述性文献回顾和我们的临床专业知识,我们为临床医生管理希望在斋月期间禁食的胃肠道和肝胆疾病患者提供实用指导。根据已建立的国际糖尿病联合会和糖尿病与斋月国际联盟的风险分层框架,我们将患者的风险分为低或中等、高或非常高。由于潜在的危害,我们建议所有高危患者和大多数高危患者不要禁食。对于其他人,我们提供细致入微的建议,如重新安排药物,改变生活方式,以及量身定制的禁食建议,以尽量减少不良影响。尊重患者宗教动机的共同决策至关重要,并在个人基础上仔细权衡风险和收益。
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引用次数: 0
The case for reducing the use of diagnostic upper and lower gastrointestinal endoscopy 减少诊断性上、下消化道内窥镜使用的案例
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-09 DOI: 10.1016/s2468-1253(24)00428-x
Christopher J Black, Alexander C Ford
No Abstract
没有抽象的
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引用次数: 0
Tamuzimod in patients with moderately-to-severely active ulcerative colitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 induction trial Tamuzimod在中度至重度活动性溃疡性结肠炎患者中的应用:一项多中心、双盲、随机、安慰剂对照的2期诱导试验
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-07 DOI: 10.1016/s2468-1253(24)00386-8
Bruce E Sands, Remo Panaccione, Geert D'Haens, Stefan Schreiber, Vipul Jairath, Aaron DuVall, Jaroslaw Kierkus, Michael Walczak, Snehal Naik, Kye Gilder, Beatriz Lindstrom, Kathleen Ogilvie, William J Sandborn, Severine Vermeire, David T Rubin, Laurent Peyrin-Biroulet, Silvio Danese
<h3>Background</h3>Tamuzimod (VTX002) is a selective sphingosine 1-phosphate receptor 1 modulator in development for ulcerative colitis. We aimed to assess the safety and efficacy of tamuzimod in patients with moderately-to-severely active ulcerative colitis.<h3>Methods</h3>This double-blind, randomised, placebo-controlled, phase 2 induction trial was conducted at 122 centres across 15 countries in Asia, Europe, and North America. Patients aged 18–80 years with a modified Mayo score (MMS) of 4–9 and an inadequate response or a loss of response, or intolerance to one or more approved ulcerative colitis therapies were randomly assigned (1:1:1) to once-daily oral tamuzimod (60 mg or 30 mg) or placebo for 13 weeks. Randomisation was stratified by previous advanced therapy, baseline corticosteroid, and baseline MMS. The primary endpoint was clinical remission (defined as an MMS stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore ≤1, excluding friability) at week 13. Adverse events and laboratory abnormalities were assessed for safety. Efficacy and safety analyses included all randomly assigned patients who received at least one study dose, with the efficacy analysis restricted to patients with a baseline MMS of 5–9 based on regulatory feedback. The study was registered with <span><span>ClinicalTrials.gov</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>, <span><span>NCT05156125</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>, and EudraCT, 2021-003050-23.<h3>Findings</h3>Between Nov 4, 2021, and Aug 30, 2023, 367 patients were screened, and 213 (mean age 40·6 years [SD 14·2]; 116 [54%] males and 97 [46%] females) were randomly assigned to tamuzimod 60 mg (n=70), tamuzimod 30 mg (n=73), or placebo (n=70). Two in the tamuzimod 30 mg group and two in the tamuzimod 60 mg group with baseline modified Mayo score of 4 were excluded from the efficacy analysis. At week 13, clinical remission was reached by 19 (28%) of 68 patients receiving tamuzimod 60 mg, 17 (24%) of 71 patients receiving tamuzimod 30 mg, and eight (11%) of 70 patients receiving placebo (risk difference 16·5% [95% CI 3·2 to 29·4], p=0·018, for tamuzimod 60 mg <em>vs</em> placebo and 12·5% [–0·2 to 24·9], p=0·041, for tamuzimod 30 mg <em>vs</em> placebo). Treatment-emergent adverse events occurred in 33 (47%) of 70 patients receiving tamuzimod 60 mg, 34 (47%) of 73 patients receiving tamuzimod 30 mg, and 24 (34%) of 70 patients receiving placebo. Most adverse events were mild or moderate. The most frequently reported treatment-emergent adverse events (in ≥5% of in any treatment group) were upper respiratory tract infection (six [9%] of 70 p
tamuzimod (VTX002)是一种用于溃疡性结肠炎的选择性鞘氨醇1-磷酸受体1调节剂。我们的目的是评估tamuzimod在中度至重度活动性溃疡性结肠炎患者中的安全性和有效性。这项双盲、随机、安慰剂对照的2期诱导试验在亚洲、欧洲和北美15个国家的122个中心进行。年龄在18-80岁、改良梅奥评分(MMS)为4-9、对一种或多种已获批准的溃疡性结肠炎治疗反应不足或反应丧失或不耐受的患者被随机分配(1:1:1)至每日一次口服tamuzimod (60mg或30mg)或安慰剂组,持续13周。随机化按先前的高级治疗、基线皮质类固醇和基线MMS分层。主要终点是第13周的临床缓解(定义为MMS大便频率亚评分≤1,直肠出血亚评分为0,内窥镜亚评分≤1,不包括易损性)。对不良事件和实验室异常进行安全性评估。疗效和安全性分析包括所有随机分配的接受至少一个研究剂量的患者,疗效分析仅限于基于监管反馈的基线MMS为5-9的患者。该研究已在ClinicalTrials.gov注册,注册号为NCT05156125, eudraft号为2021-003050-23。在2021年11月4日至2023年8月30日期间,筛选了367例患者,其中213例(平均年龄40.6岁[SD 14.2];116名(54%)男性和97名(46%)女性被随机分配到tamuzimod 60mg (n=70)、tamuzimod 30mg (n=73)或安慰剂组(n=70)。tamuzimod 30 mg组2例,tamuzimod 60 mg组2例,基线改良Mayo评分为4分,被排除在疗效分析之外。在第13周,68名接受他莫兹莫60 mg的患者中有19名(28%)达到临床缓解,71名接受他莫兹莫30 mg的患者中有17名(24%)达到临床缓解,70名接受安慰剂的患者中有8名(11%)达到临床缓解(他莫兹莫60 mg与安慰剂的风险差异为16.5% [95% CI 3.2%至29.4],p= 0.018;他莫兹莫30 mg与安慰剂的风险差异为12.5%[- 0.2%至24.9],p= 0.041)。70例接受他莫齐莫60mg的患者中有33例(47%)发生了治疗后出现的不良事件,73例接受他莫齐莫30mg的患者中有34例(47%)发生了不良事件,70例接受安慰剂的患者中有24例(34%)发生了不良事件。大多数不良事件为轻度或中度。最常报告的治疗不良事件(在任何治疗组中发生率≥5%)是上呼吸道感染(70例患者中60mg tamuzimod组6例[9%],73例tamuzimod 30 mg组1例[1%],70例安慰剂组1例[1%]),贫血(3例[3%],4例[5%]和6例[9%]),头痛(4例[6%],5例[7%]和2例[3%])。未发生房室传导阻滞、心动过缓、黄斑水肿、严重或机会性感染、恶性肿瘤或死亡等不良事件。解释:在溃疡性结肠炎患者中,tamamzimod诱导治疗是有效且耐受性良好的。这些结果和tamuzimod有利的风险-收益特征共同支持tamuzimod用于治疗中度至重度活动性溃疡性结肠炎的持续临床开发。FundingVentyx生物科学。
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引用次数: 0
No easy way out: blocking lymphocyte egress by the S1P1 receptor 1 modulator tamuzimod in ulcerative colitis 溃疡性结肠炎不容易解决:通过S1P1受体1调节剂tamamzimod阻断淋巴细胞出口
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-07 DOI: 10.1016/s2468-1253(24)00397-2
Raja Atreya, Markus F Neurath
No Abstract
没有抽象的
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引用次数: 0
Maintenance treatment with vedolizumab in paediatric inflammatory bowel disease (VEDOKIDS): 54-week outcomes of a multicentre, prospective, cohort study vedolizumab在儿童炎症性肠病(VEDOKIDS)中的维持治疗:一项多中心前瞻性队列研究的54周结果
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-06 DOI: 10.1016/s2468-1253(24)00319-4
Ohad Atia, Zivia Shavit-Brunschwig, Raffi Lev-Tzion, Ronen Stein, Efrat Broide, Darja Urlep, Jeffrey Hyams, Batia Weiss, Marina Aloi, Amit Assa, Konstantinos Gerasimidis, Ben Nichols, Richard K Russell, Dan Turner
<h3>Background</h3>Infliximab and adalimumab are the only biologics thus far approved for paediatric patients with inflammatory bowel disease (IBD), so other biologics, such as vedolizumab, are prescribed off-label. Despite its frequent use, prospective data for vedolizumab treatment in children are available only for short-term induction outcomes. We aimed to evaluate the long-term efficacy and safety of maintenance therapy with vedolizumab in paediatric patients with IBD.<h3>Methods</h3>In this multicentre, prospective, cohort study (VEDOKIDS), children younger than 18 years with Crohn's disease, ulcerative colitis, or IBD unclassified (analysed with the ulcerative colitis group) who had initiated intravenous vedolizumab were enrolled from 17 centres in six countries (Israel, the USA, Italy, Ireland, Denmark, and Slovenia). Patients initiating vedolizumab to prevent postoperative recurrence were excluded. Vedolizumab dose or schedule were not standardised, and concomitant treatment with any other medication was permitted. Patients were prospectively followed up for 54 weeks, with repeated biosampling. The primary outcome was complete remission at week 54, defined as clinical remission (weighted Paediatric Crohn's Disease Activity Index [wPCDAI] of <12·5 points in Crohn's disease and Paediatric Ulcerative Colitis Activity Index [PUCAI] of <10 in ulcerative colitis) without the need for surgery, exclusive enteral nutrition for children with Crohn's disease, or steroids (steroid-free and exclusive enteral nutrition-free clinical remission) plus CRP concentration lower than 1·5 times the upper limit of normal (ULN) of 0·5 mg/dL. In cases of missing data on CRP, ESR was used instead (concentrations <1·5 times the ULN, which was 25 mm/h). Data were analysed by intention to treat. This study is registered with <span><span>ClinicalTrials.gov</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>, <span><span>NCT02862132</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>.<h3>Findings</h3>Between May 19, 2016, and April 1, 2022, we enrolled 142 patients. Five children who had received only one or two infusions of their three-infusion induction before switching drugs due to COVID-19 pandemic-related reasons were excluded, leaving 137 children (64 [47%] with Crohn's disease, 64 [47%] with ulcerative colitis, and nine [7%] with IBD unclassified; 63 [46%] male and 74 [54%] female; age range of 0·7–17·6 years) in the intention-to-treat population. The median wPCDAI score in children with Crohn's disease decreased from 35 (IQR 18 to 49) at baseline to 13 (0 to 25; median of differences –14 [95% CI –33 to 0]) at week 54, and the median PUCA
背景:到目前为止,呋利昔单抗和阿达木单抗是唯一被批准用于治疗儿童炎症性肠病(IBD)的生物制剂,因此其他生物制剂,如维多单抗,是在标签外开处方的。尽管vedolizumab经常被使用,但儿童vedolizumab治疗的前瞻性数据仅可用于短期诱导结果。我们的目的是评估维多单抗维持治疗在小儿IBD患者中的长期疗效和安全性。方法在这项多中心、前瞻性队列研究(VEDOKIDS)中,从6个国家(以色列、美国、意大利、爱尔兰、丹麦和斯洛文尼亚)的17个中心招募了18岁以下的克罗恩病、溃疡性结肠炎或IBD未分类(与溃疡性结肠炎组进行分析)患者。排除使用维多单抗预防术后复发的患者。Vedolizumab的剂量或时间表没有标准化,并且允许与任何其他药物同时治疗。患者前瞻性随访54周,反复进行生物采样。主要终点是第54周完全缓解,定义为临床缓解(克罗恩病加权儿科克罗恩病活动指数[wPCDAI]为12.5分,溃疡性结肠炎儿童溃疡性结肠炎活动指数[PUCAI]为10分),无需手术,克罗恩病儿童完全肠内营养,或类固醇(无类固醇和独家肠内营养无临床缓解)加CRP浓度低于1.5倍正常上限(ULN) 0.5 mg/dL。在缺少CRP数据的情况下,使用ESR代替(浓度为ULN的1.5倍,即25 mm/h)。数据按意向治疗进行分析。本研究已在ClinicalTrials.gov注册,编号NCT02862132。在2016年5月19日至2022年4月1日期间,我们招募了142名患者。排除5例因COVID-19大流行相关原因仅接受1次或2次诱导后切换药物的患儿,留下137例患儿(64例[47%]为克罗恩病,64例[47%]为溃疡性结肠炎,9例[7%]为IBD未分类;男性63人(46%),女性74人(54%);意向治疗人群的年龄范围为0.7 - 17.6岁。克罗恩病儿童的wPCDAI评分中位数从基线时的35 (IQR 18 - 49)降至13 (IQR 0 - 25);54周时,差异中位数为-14 [95% CI -33至0]),溃疡性结肠炎患儿的PUCAI评分中位数从基线时的25 (IQR 15至50)降至54周时的5(0至25)(差异中位数为-10[-30至0])。到第6周,疾病活动性的改善是显著的,两次访问之间没有进一步的显著变化。在第54周,64名克罗恩病患儿中的16名(25%)和73名溃疡性结肠炎或IBD未分类患儿中的34名(47%)完全缓解。137例患儿中有29例(21%)记录了38例维多单抗相关不良事件,最常见的是头痛(n=7)、肌痛(n=4)和发烧(n=4),均无严重不良事件。vedolizumab维持在儿童中似乎是安全有效的,溃疡性结肠炎患者的疗效高于克罗恩病患者。资助欧洲克罗恩病和结肠炎组织,欧洲儿科胃肠病学肝病学和营养学会,以及武田。
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引用次数: 0
Long-term VEDOKIDS results: implications for practice and research VEDOKIDS的长期结果:对实践和研究的启示
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-06 DOI: 10.1016/s2468-1253(24)00381-9
Elizabeth A Spencer
No Abstract
没有抽象的
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引用次数: 0
Widening access to recombinant zoster vaccination in IBD 扩大重组带状疱疹疫苗在IBD中的可及性
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-12-19 DOI: 10.1016/s2468-1253(24)00429-1
James L Alexander, Nick Powell, Freddy Caldera, Nick Kennedy, Shahida Din
No Abstract
没有抽象的
{"title":"Widening access to recombinant zoster vaccination in IBD","authors":"James L Alexander, Nick Powell, Freddy Caldera, Nick Kennedy, Shahida Din","doi":"10.1016/s2468-1253(24)00429-1","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00429-1","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"65 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142857697","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
The urgent need to end hepatitis B stigma and discrimination 迫切需要消除对乙型肝炎的偏见和歧视
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-12-17 DOI: 10.1016/s2468-1253(24)00389-3
Catherine Freeland, Jack Wallace, Su Wang, Prince Okinedo, Kenneth Kabagambe, Theobald Owusu-Ansah, Dee Lee, Charles Ampong Adjei, Thomas Tu, Chari Cohen
No Abstract
无摘要
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引用次数: 0
The liver–brain axis in metabolic dysfunction-associated steatotic liver disease 代谢功能障碍相关脂肪肝中的肝脑轴
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-12-16 DOI: 10.1016/s2468-1253(24)00320-0
Anne Catrine Daugaard Mikkelsen, Kristoffer Kjærgaard, Anthony H V Schapira, Rajeshwar P Mookerjee, Karen Louise Thomsen
Metabolic dysfunction-associated steatotic liver disease (MASLD) affects around 30% of the global population. Studies suggest that MASLD is associated with compromised brain health and cognitive dysfunction, initiating a growing interest in exploring the liver–brain axis mechanistically within MASLD pathophysiology. With the prevalence of MASLD increasing at an alarming rate, leaving a large proportion of people potentially at risk, cognitive dysfunction in MASLD is a health challenge that requires careful consideration and awareness. This Review summarises the current literature on cognitive function in people with MASLD and discusses plausible causes for its impairment. It is likely that a multifaceted spectrum of factors works collectively to affect cognition in patients with MASLD. We describe the role of inflammation, vascular disease, and brain ageing and neurodegeneration as possible key players. This Review also highlights the need for future studies to identify the optimal test for diagnosing cognitive dysfunction in patients with MASLD, to examine the correlation between MASLD progression and the severity of cognitive dysfunction, and to evaluate whether new MASLD-targeted therapies also improve brain dysfunction.
代谢功能障碍相关性脂肪肝(MASLD)影响着全球约 30% 的人口。研究表明,代谢性脂肪肝与大脑健康受损和认知功能障碍有关,这使人们对从机制上探索代谢性脂肪肝病理生理学中的肝脑轴的兴趣与日俱增。随着MASLD发病率以惊人的速度增长,使很大一部分人面临潜在风险,MASLD患者的认知功能障碍是一项健康挑战,需要认真考虑和认识。本综述总结了有关 MASLD 患者认知功能的现有文献,并讨论了造成认知功能障碍的可能原因。MASLD患者的认知功能可能受到多方面因素的共同影响。我们描述了炎症、血管疾病、大脑老化和神经变性等可能的关键因素。本综述还强调了未来研究的必要性,以确定诊断MASLD患者认知功能障碍的最佳检测方法,研究MASLD进展与认知功能障碍严重程度之间的相关性,并评估新的MASLD靶向疗法是否也能改善脑功能障碍。
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引用次数: 0
Elimination of hepatitis B requires recognition of catastrophic costs for patients and their families 消除乙型肝炎需要认识到患者及其家属所付出的灾难性代价
IF 35.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-12-13 DOI: 10.1016/s2468-1253(24)00384-4
Julie Jemutai, Louise Downs, Motswedi Anderson, Chari Cohen, Janet Seeley, Binta Sultan, Joy Ko, Stuart Flanagan, Collins Iwuji, Rachel Halford, Oriel Fernandes, Peter Vickerman, Asgeir Johannessen, Philippa C Matthews
No Abstract
没有抽象的
{"title":"Elimination of hepatitis B requires recognition of catastrophic costs for patients and their families","authors":"Julie Jemutai, Louise Downs, Motswedi Anderson, Chari Cohen, Janet Seeley, Binta Sultan, Joy Ko, Stuart Flanagan, Collins Iwuji, Rachel Halford, Oriel Fernandes, Peter Vickerman, Asgeir Johannessen, Philippa C Matthews","doi":"10.1016/s2468-1253(24)00384-4","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00384-4","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"20 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142820675","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
期刊
Lancet Gastroenterology & Hepatology
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