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Efficacy of TIPS plus extrahepatic collateral embolisation in real-world data: a validation study. 真实世界数据中 TIPS 加肝外旁路栓塞的疗效:一项验证研究。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-02-23 DOI: 10.1136/bmjgast-2023-001310
Lianhui Zhao, Jun Tie, Guangchuan Wang, Zhengjie Li, Jiao Xu, Yuzheng Zhuge, Feng Zhang, Hao Wu, Bo Wei, Hui Xue, Peijie Li, Wei Wu, Chao Chen, Qiong Wu, Yifu Xia, Xiubin Sun, Chunqing Zhang

Objectives: The efficacy of transjugular intrahepatic portosystemic shunt (TIPS) plus extrahepatic collateral embolisation (TIPS+E) in reducing rebleeding and hepatic encephalopathy (HE) post-TIPS was recently reported in a meta-analysis, but further validation is essential. This study aims to confirm the effectiveness of TIPS+E using real-world data.

Methods: The multicentre retrospective cohort included 2077 patients with cirrhosis who underwent TIPS±E (TIPS: 631, TIPS+E: 1446) between January 2010 and December 2022. Regression and propensity score matching (PSM) were used to adjust for baseline characteristic differences. After PSM, clinical outcomes, including rebleeding, HE, survival and further decompensation (FDC), were analysed. Baseline data from all patients contributed to the construction of prognostic models.

Results: After PSM, 1136 matched patients (TIPS+E: TIPS=568:568) were included. TIPS+E demonstrated a significant reduction in rebleeding (HR 0.77; 95% CI 0.59 to 0.99; p=0.04), HE (HR 0.82; 95% CI 0.68 to 0.99; p=0.04) and FDC (HR 0.85; 95% CI 0.73 to 0.99; p=0.04), comparing to TIPS. Significantly, TIPS+E also reduced rebleeding, HE and FDC in subgroup of using 8 mm diameter stents and embolising of gastric varices+spontaneous portosystemic shunts (GV+SPSS). However, there were no differences in overall or subgroup survival analysis. Additionally, the random forest models showed higher accuracy and AUROC comparing to other models. Controlling post-TIPS portal pressure gradient (pPPG) within 7 mm Hg

Conclusion: Our real-world data validation confirms the high efficacy of TIPS+E in reducing rebleeding and HE, particularly when using 8 mm diameter stents, embolising GV+SPSS and maintaining an optimal pPPG.

研究目的最近一项荟萃分析报告了经颈静脉肝内门体系统分流术(TIPS)加肝外副栓塞术(TIPS+E)在减少TIPS术后再出血和肝性脑病(HE)方面的疗效,但进一步的验证至关重要。本研究旨在利用真实世界的数据证实 TIPS+E 的有效性:多中心回顾性队列包括2010年1月至2022年12月期间接受TIPS±E治疗的2077例肝硬化患者(TIPS:631例,TIPS+E:1446例)。采用回归和倾向评分匹配(PSM)来调整基线特征差异。经过倾向得分匹配后,对包括再出血、高血压、存活率和进一步失代偿(FDC)在内的临床结果进行了分析。所有患者的基线数据都有助于构建预后模型:结果:经过 PSM,共纳入了 1136 例匹配患者(TIPS+E:TIPS=568:568)。与 TIPS 相比,TIPS+E 能显著减少再出血(HR 0.77;95% CI 0.59 至 0.99;P=0.04)、HE(HR 0.82;95% CI 0.68 至 0.99;P=0.04)和 FDC(HR 0.85;95% CI 0.73 至 0.99;P=0.04)。在使用直径 8 毫米支架和栓塞胃静脉曲张+自发性门静脉分流术(GV+SPSS)的亚组中,TIPS+E 也显著减少了再出血、HE 和 FDC。然而,总体或亚组生存率分析没有差异。此外,与其他模型相比,随机森林模型显示出更高的准确性和AUROC。将 TIPS 术后门静脉压力阶差(pPPG)控制在 7 毫米汞柱以内:我们的真实世界数据验证证实了 TIPS+E 在减少再出血和 HE 方面的高效性,尤其是在使用直径 8 毫米的支架、栓塞 GV+SPSS 并保持最佳 pPPG 的情况下。
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引用次数: 0
Role of exhaled hydrogen sulfide in the diagnosis of colorectal cancer. 呼出硫化氢在诊断结直肠癌中的作用。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-02-20 DOI: 10.1136/bmjgast-2023-001229
Peizhun Du, Yujen Tseng, Pengcheng Liu, Huilu Zhang, Guangjian Huang, Cheng'en Hu, Jian Chen

Background: Colorectal cancer (CRC) is often accompanied by increased excretion of hydrogen sulfide (H2S). This study aimed to explore the value of exhaled H2S in the diagnosis of CRC.

Methods: A total of 80 people with normal colonoscopy results and 57 patients with CRC were enrolled into the present observational cohort study. Exhaled oral and nasal H2S were detected by Nanocoulomb breath analyser. Results were compared between the two groups. Receiver operating characteristic (ROC) curves were analysed and area under the curves (AUCs) were calculated to assess the diagnostic value of exhaled H2S. Meanwhile, the clinicopathological features, including gender, lesion location and tumour staging of patients with CRC, were also collected and analysed.

Results: The amount of exhaled H2S from patients with CRC was significantly higher than that of those with normal colonoscopy results. The ROC curve showed an AUC value of 0.73 and 0.71 based on oral and nasal H2S detection, respectively. The exhaled H2S in patients with CRC was correlated with gender, lesion location and tumour progression, including depth of invasion, lymphatic metastasis and TNM (Tumor, Lymph Nodes, Metastasis) staging.

Conclusion: Exhaled H2S analysis is a convenient and non-invasive detection method for diagnosing CRC, suggesting a potential role in population screening for CRC.

背景:大肠癌(CRC)通常伴有硫化氢(H2S)排泄增加。本研究旨在探讨呼出的 H2S 在诊断 CRC 中的价值:本观察性队列研究共纳入了 80 名结肠镜检查结果正常者和 57 名 CRC 患者。采用 Nanocoulomb 呼气分析仪检测口腔和鼻腔呼出的 H2S。两组结果进行了比较。分析了接收者操作特征曲线(ROC),并计算了曲线下面积(AUC),以评估呼出的 H2S 的诊断价值。同时,还收集并分析了 CRC 患者的临床病理特征,包括性别、病变部位和肿瘤分期:结果:CRC 患者呼出的 H2S 量明显高于结肠镜检查结果正常的患者。根据口腔和鼻腔 H2S 检测结果,ROC 曲线的 AUC 值分别为 0.73 和 0.71。结论:CRC 患者呼出的 H2S 与性别、病灶位置和肿瘤进展(包括侵犯深度、淋巴转移和 TNM(肿瘤、淋巴结、转移)分期)相关:结论:呼出的 H2S 分析是诊断 CRC 的一种方便、无创的检测方法,它在人群 CRC 筛查中具有潜在的作用。
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引用次数: 0
Biological therapy for inflammatory bowel disease: cyclical rather than lifelong treatment? 炎症性肠病的生物疗法:周期性治疗而非终身治疗?
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-02-10 DOI: 10.1136/bmjgast-2023-001225
Christian Philipp Selinger, Konstantina Rosiou, Marco V Lenti

Inflammatory bowel disease (IBD) treatment was revolutionised with the arrival of biological therapy two decades ago. There are now multiple biologics and increasingly novel small molecules licensed for the treatment of IBD. Treatment guidelines highlight the need for effective control of inflammation and early escalation to advanced therapies to avoid long-term complications. Consequently, a large proportion of patients with IBD receive advanced therapies for a long time. Despite their beneficial risk-benefit profile, these treatments are not without risk of side effects, are costly to healthcare providers and pose a burden to the patient. It is, therefore, paramount to examine in which circumstances a temporary cessation of therapy can be attempted without undue clinical risk. Some patients may benefit from cyclical rather than continuous treatment. This review examines the risk of relapse after discontinuation of advanced therapies, how to identify patients at the lowest risk of relapse and the chance of recapturing response when flaring after discontinuation.

二十年前,生物疗法的出现彻底改变了炎症性肠病(IBD)的治疗。现在,已有多种生物制剂和越来越多的新型小分子药物获得了治疗 IBD 的许可。治疗指南强调,必须有效控制炎症并尽早升级到先进疗法,以避免长期并发症。因此,很大一部分 IBD 患者长期接受先进疗法。尽管这些疗法具有良好的风险收益特征,但并非没有副作用风险,而且对医疗服务提供者来说成本高昂,对患者来说也是一种负担。因此,最重要的是研究在哪些情况下可以尝试暂时停止治疗,而不会带来不必要的临床风险。有些患者可能会从周期性治疗而非持续治疗中获益。本综述探讨了停用先进疗法后复发的风险、如何识别复发风险最低的患者以及停药后病情复发时重新获得应答的机会。
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引用次数: 0
Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial. 确定溃疡性结肠炎患者的最佳治疗目标:随机对照 VERDICT 试验的原理、设计、方案和中期分析。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-02-08 DOI: 10.1136/bmjgast-2023-001218
Vipul Jairath, Guangyong Zou, Zhongya Wang, Shashi Adsul, Jean-Frederic Colombel, Geert R D'Haens, Marcelo Freire, Gordon W Moran, Laurent Peyrin-Biroulet, William J Sandborn, Shaji Sebastian, Simon Travis, Séverine Vermeire, Gabriela Radulescu, Julie Sigler, Jurij Hanžel, Christopher Ma, Rocio Sedano, Stefanie C McFarlane, Naveen Arya, Melanie Beaton, Peter Bossuyt, Silvio Danese, Daniel Green, William Harlan, Marek Horynski, Maria Klopocka, Rima Petroniene, Mark S Silverberg, Lukasz Wolanski, Brian G Feagan

Introduction: Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC.

Methods and analysis: In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model.

Ethics and dissemination: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings.

Trial registration number: EudraCT: 2019-002485-12; NCT04259138.

简介:溃疡性结肠炎(UC)的治疗目标包括症状、内镜检查和组织学检查。观察性研究表明,与仅获得内镜下缓解相比,获得组织学缓解可能与较低的并发症风险相关。溃疡性结肠炎行动对照试验(VERDICT)旨在确定 UC 患者的最佳治疗目标:在这项多中心、前瞻性随机研究中,660 名中重度 UC 患者(梅奥直肠出血评分[RBS] ≥1;梅奥内镜评分[MES] ≥2)被随机分配到三种治疗目标:无皮质类固醇症状缓解(梅奥 RBS=0)(第 1 组);无皮质类固醇内镜缓解(MES ≤1)和症状缓解(第 2 组);或无皮质类固醇组织学缓解(Geboes 评分 伦理和传播:该研究已获得国家级伦理委员会的批准,或根据各个国家的要求获得个别研究地点伦理委员会的批准。伦理委员会的完整名单可向我们索取。研究结果将在同行评审期刊和科学会议上公布:EudraCT: 2019-002485-12; NCT04259138.
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引用次数: 0
CD, or not CD, that is the question: a digital interobserver agreement study in coeliac disease 是 CD,还是不是 CD,这就是问题所在:一项关于乳糜泻的数字观察者间一致性研究
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-02-01 DOI: 10.1136/bmjgast-2023-001252
James Denholm, Benjamin A Schreiber, Florian Jaeckle, Mike N Wicks, Emyr W Benbow, Tim S Bracey, James Y H Chan, Lorant Farkas, Eve Fryer, Kishore Gopalakrishnan, Caroline A Hughes, Kathryn J Kirkwood, Gerald Langman, Betania Mahler-Araujo, Raymond F T McMahon, Khun La Win Myint, Sonali Natu, Andrew Robinson, Ashraf Sanduka, Katharine A Sheppard, Yee Wah Tsang, Mark J Arends, Elizabeth J Soilleux
Objective Coeliac disease (CD) diagnosis generally depends on histological examination of duodenal biopsies. We present the first study analysing the concordance in examination of duodenal biopsies using digitised whole-slide images (WSIs). We further investigate whether the inclusion of immunoglobulin A tissue transglutaminase (IgA tTG) and haemoglobin (Hb) data improves the interobserver agreement of diagnosis. Design We undertook a large study of the concordance in histological examination of duodenal biopsies using digitised WSIs in an entirely virtual reporting setting. Our study was organised in two phases: in phase 1, 13 pathologists independently classified 100 duodenal biopsies (40 normal; 40 CD; 20 indeterminate enteropathy) in the absence of any clinical or laboratory data. In phase 2, the same pathologists examined the (re-anonymised) WSIs with the inclusion of IgA tTG and Hb data. Results We found the mean probability of two observers agreeing in the absence of additional data to be 0.73 (±0.08) with a corresponding Cohen’s kappa of 0.59 (±0.11). We further showed that the inclusion of additional data increased the concordance to 0.80 (±0.06) with a Cohen’s kappa coefficient of 0.67 (±0.09). Conclusion We showed that the addition of serological data significantly improves the quality of CD diagnosis. However, the limited interobserver agreement in CD diagnosis using digitised WSIs, even after the inclusion of IgA tTG and Hb data, indicates the importance of interpreting duodenal biopsy in the appropriate clinical context. It further highlights the unmet need for an objective means of reproducible duodenal biopsy diagnosis, such as the automated analysis of WSIs using artificial intelligence. No data are available. The raw data, along with the code and instructions for reproducing all of the analysis and figures presented in this work are available in THIS GITLAB REPOSITORY (). We are not at liberty to share the WSIs, however.
目的:乳糜泻(CD)的诊断通常取决于十二指肠活检组织学检查。我们首次利用数字化全切片图像(WSI)对十二指肠活检组织检查的一致性进行了分析。我们还进一步研究了加入免疫球蛋白 A 组织转谷氨酰胺酶(IgA tTG)和血红蛋白(Hb)数据是否能提高观察者之间的诊断一致性。设计 我们在完全虚拟的报告环境中使用数字化 WSI 对十二指肠活检组织学检查的一致性进行了一项大型研究。我们的研究分为两个阶段:在第一阶段,13 位病理学家在没有任何临床或实验室数据的情况下独立对 100 例十二指肠活检组织(40 例正常;40 例 CD;20 例不确定肠病)进行了分类。在第 2 阶段,同样的病理学家在加入 IgA tTG 和 Hb 数据后检查了(重新匿名的)WSI。结果 我们发现,在没有额外数据的情况下,两名观察者达成一致的平均概率为 0.73 (±0.08),相应的 Cohen's kappa 为 0.59 (±0.11)。我们进一步发现,加入额外数据后,一致性提高到 0.80 (±0.06),科恩卡帕系数为 0.67 (±0.09)。结论 我们的研究表明,加入血清学数据可显著提高 CD 诊断的质量。然而,即使在加入 IgA tTG 和 Hb 数据后,使用数字化 WSI 诊断 CD 的观察者间一致性仍然有限,这表明在适当的临床背景下解释十二指肠活检的重要性。这进一步凸显了对可重复十二指肠活检诊断客观方法的需求尚未得到满足,例如使用人工智能对 WSI 进行自动分析。无数据可用。原始数据、代码以及重现所有分析和图表的说明均可在本 GITLAB REPOSITORY () 中获取。不过,我们不能随意分享 WSI。
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引用次数: 0
Impact of AI-aided colonoscopy in clinical practice: a prospective randomised controlled trial. 人工智能辅助结肠镜检查在临床实践中的影响:前瞻性随机对照试验。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-01-30 DOI: 10.1136/bmjgast-2023-001247
Johanna Schöler, Marko Alavanja, Thomas de Lange, Shunsuke Yamamoto, Per Hedenström, Jonas Varkey

Objective: Colorectal cancer (CRC) has a significant role in cancer-related mortality. Colonoscopy, combined with adenoma removal, has proven effective in reducing CRC incidence. However, suboptimal colonoscopy quality often leads to missed polyps. The impact of artificial intelligence (AI) on adenoma and polyp detection rate (ADR, PDR) is yet to be established.

Design: We conducted a randomised controlled trial at Sahlgrenska University Hospital in Sweden. Patients underwent colonoscopy with or without the assistance of AI (AI-C or conventional colonoscopy (CC)). Examinations were performed with two different AI systems, that is, Fujifilm CADEye and Medtronic GI Genius. The primary outcome was ADR.

Results: Among 286 patients, 240 underwent analysis (average age: 66 years). The ADR was 42% for all patients, and no significant difference emerged between AI-C and CC groups (41% vs 43%). The overall PDR was 61%, with a trend towards higher PDR in the AI-C group. Subgroup analysis revealed higher detection rates for sessile serrated lesions (SSL) with AI assistance (AI-C 22%, CC 11%, p=0.004). No difference was noticed in the detection of polyps or adenomas per colonoscopy. Examinations were most often performed by experienced endoscopists, 78% (n=86 AI-C, 100 CC).

Conclusion: Amidst the ongoing AI integration, ADR did not improve with AI. Particularly noteworthy is the enhanced detection rates for SSL by AI assistance, especially since they pose a risk for postcolonoscopy CRC. The integration of AI into standard colonoscopy practice warrants further investigation and the development of improved software might be necessary before enforcing its mandatory implementation.

Trial registration number: NCT05178095.

目的:结肠直肠癌(CRC)在癌症相关死亡率中占有重要地位。事实证明,结肠镜检查结合腺瘤切除术可有效降低 CRC 发病率。然而,结肠镜检查质量不达标往往会导致漏诊息肉。人工智能(AI)对腺瘤和息肉检出率(ADR、PDR)的影响尚未确定:设计:我们在瑞典 Sahlgrenska 大学医院进行了一项随机对照试验。患者在有人工智能辅助或无人工智能辅助的情况下接受结肠镜检查(AI-C 或传统结肠镜检查 (CC))。检查由两种不同的人工智能系统进行,即富士胶片 CADEye 和美敦力 GI Genius。主要结果是 ADR:在 286 名患者中,240 人接受了分析(平均年龄:66 岁)。所有患者的 ADR 为 42%,AI-C 组和 CC 组之间无明显差异(41% 对 43%)。总体 PDR 为 61%,AI-C 组的 PDR 呈上升趋势。亚组分析显示,在 AI 辅助下,无柄锯齿状病变(SSL)的检出率更高(AI-C 组 22%,CC 组 11%,P=0.004)。在每次结肠镜检查中,息肉或腺瘤的检出率没有差异。检查通常由经验丰富的内镜医师进行,占 78%(n=86 AI-C,100 CC):结论:在人工智能不断融合的过程中,ADR 并未随着人工智能的发展而改善。特别值得注意的是,人工智能辅助提高了 SSL 的检出率,尤其是因为 SSL 会带来结肠镜检查后患上 CRC 的风险。将人工智能整合到标准结肠镜检查实践中值得进一步研究,在强制实施前可能需要开发改进的软件:NCT05178095.
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引用次数: 0
Mental Imagery to Reduce Alcohol-related harm in patients with alcohol use disorder and alcohol-related liver damaGE: the MIRAGE randomised pilot trial results. 心理想象减少酒精使用障碍和酒精相关肝损伤患者的酒精相关伤害:MIRAGE 随机试点试验结果。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-01-29 DOI: 10.1136/bmjgast-2023-001267
Ashwin Dhanda, Jackie Andrade, Hannah Allende, Victoria Allgar, Matthew Bailey, Lynne Callaghan, Laura Cocking, Elizabeth Goodwin, Annie Hawton, Christopher Hayward, Ben Hudson, Wendy Ingram, Alison Jeffery, Angela King, Victoria Lavers, Joe Lomax, C Anne McCune, Crispin Musicha, Richard Parker, Christopher Rollinson, Jonny Wilks, E Siobhan Creanor

Objective: The healthcare burden of alcohol-related liver disease (ARLD) is increasing. ARLD and alcohol use disorder (AUD) is best managed by reduction or cessation of alcohol use, but effective treatments are lacking. We tested whether people with ARLD and AUD admitted to hospital could be recruited to and retained in a trial of Functional Imagery Training (FIT), a psychological therapy that uses mental imagery to reduce alcohol craving. We conducted a multicentre randomised pilot trial of treatment as usual (TAU) versus FIT+TAU in people admitted to hospital with ARLD and AUD.

Design: Participants were randomised to TAU (a single session of brief intervention) or FIT+TAU (TAU with one hospital-based FIT session then eight telephone sessions over 6 months). Pilot outcomes included recruitment rate and retention at day 180. Secondary outcomes included fidelity of FIT delivery, alcohol use, and severity of alcohol dependence.

Results: Fifty-four participants (mean age 49; 63% male) were recruited and randomised, 28 to TAU and 26 to FIT+TAU. The retention rate at day 180 was 43%. FIT was delivered adequately by most alcohol nurses. 50% of intervention participants completed FIT sessions 1 and 2. There were no differences in alcohol use or severity of alcohol dependence between treatment groups at day 180.

Conclusion: Participants with ARLD and AUD could be recruited to a trial of FIT versus FIT+TAU. However, retention at day 180 was suboptimal. Before conducting a definitive trial of FIT in this patient group, modifications in the intervention and recruitment/retention strategy must be tested.

Trial registration number: ISRCTN41353774.

目的:酒精相关肝病(ARLD)造成的医疗负担日益加重。控制酒精相关性肝病和酒精使用障碍(AUD)的最佳方法是减少或停止饮酒,但目前缺乏有效的治疗方法。我们测试了入院的酒精相关性肝病(ARLD)和酒精使用障碍(AUD)患者能否被招募并继续参加功能想象训练(FIT)试验,这是一种利用心理想象来减少酒精渴求的心理疗法。我们对入院的ARLD和AUD患者进行了一项多中心随机试点试验,对通常治疗(TAU)与FIT+TAU进行了对比:参与者被随机分配到TAU(一次简短干预)或FIT+TAU(TAU加上一次医院FIT疗程,然后在6个月内进行8次电话疗程)。试验结果包括招募率和第180天的保留率。次要结果包括 FIT 实施的忠实度、酒精使用情况和酒精依赖的严重程度:共招募并随机分配了 54 名参与者(平均年龄 49 岁;63% 为男性),其中 28 人接受 TAU 治疗,26 人接受 FIT+TAU 治疗。第 180 天的保留率为 43%。大多数酒精护理人员都能充分开展 FIT。50%的干预参与者完成了 FIT 第 1 和第 2 个疗程。治疗组之间在第180天的酒精使用或酒精依赖严重程度方面没有差异:结论:FIT 与 FIT+TAU 的试验可以招募到患有 ARLD 和 AUD 的参与者。然而,第 180 天的保留率并不理想。在对这一患者群体进行FIT的最终试验之前,必须对干预措施和招募/保留策略的修改进行测试。试验注册号:ISRCTN41353774。
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引用次数: 0
Controversies in the management of anti-TNF therapy in patients with Crohn's disease: a Delphi consensus. 克罗恩病患者抗肿瘤坏死因子疗法管理中的争议:德尔菲共识。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-01-23 DOI: 10.1136/bmjgast-2023-001246
Yago González-Lama, Elena Ricart, Daniel Carpio, Guillermo Bastida, Daniel Ceballos, Daniel Ginard, Ignacio Marin-Jimenez, Luis Menchen, Fernando Muñoz

Background: Despite research, there are still controversial areas in the management of Crohn's disease (CD).

Objective: To establish practical recommendations on using anti-tumour necrosis factor (TNF) drugs in patients with moderate-to-severe CD.

Methods: Clinical controversies in the management of CD using anti-TNF therapies were identified. A comprehensive literature review was performed, and a national survey was launched to examine current clinical practices when using anti-TNF therapies. Their results were discussed by expert gastroenterologists within a nominal group meeting, and a set of statements was proposed and tested in a Delphi process.

Results: Qualitative study. The survey and Delphi process were sent to 244 CD-treating physicians (response rate: 58%). A total of 14 statements were generated. All but two achieved agreement. These statements cover: (1) use of first-line non-anti-TNF biological therapy; (2) role of HLA-DQA1*05 in daily practice; (3) attitudes in primary non-response and loss of response to anti-TNF therapy due to immunogenicity; (4) use of ustekinumab or vedolizumab if a change in action mechanism is warranted; (5) anti-TNF drug level monitoring; (6) combined therapy with an immunomodulator.

Conclusion: This document sought to pull together the best evidence, experts' opinions, and treating physicians' attitudes when using anti-TNF therapies in patients with CD.

背景:尽管开展了相关研究,但克罗恩病(CD)的治疗仍存在争议:尽管开展了相关研究,但在克罗恩病(CD)的治疗方面仍存在争议:为中重度克罗恩病患者使用抗肿瘤坏死因子(TNF)药物制定实用建议:方法:确定使用抗肿瘤坏死因子疗法治疗 CD 的临床争议。进行了全面的文献综述,并发起了一项全国性调查,以研究目前使用抗肿瘤坏死因子疗法的临床实践。胃肠病专家在名义小组会议上对调查结果进行了讨论,提出了一套声明,并在德尔菲程序中进行了测试:定性研究。调查和德尔菲程序共发送给 244 名接受 CD 治疗的医生(回复率:58%)。共产生了 14 项陈述。除两份声明外,其他声明均达成一致。这些声明包括:(1) 一线非抗 TNF 生物疗法的使用;(2) HLA-DQA1*05 在日常实践中的作用;(3) 对因免疫原性导致的抗 TNF 治疗原发性无应答和失应的态度;(4) 如果需要改变作用机制,则使用乌司替尼或维多珠单抗;(5) 抗 TNF 药物水平监测;(6) 与免疫调节剂联合治疗:本文件旨在汇集 CD 患者使用抗肿瘤坏死因子疗法时的最佳证据、专家意见和主治医生的态度。
{"title":"Controversies in the management of anti-TNF therapy in patients with Crohn's disease: a Delphi consensus.","authors":"Yago González-Lama, Elena Ricart, Daniel Carpio, Guillermo Bastida, Daniel Ceballos, Daniel Ginard, Ignacio Marin-Jimenez, Luis Menchen, Fernando Muñoz","doi":"10.1136/bmjgast-2023-001246","DOIUrl":"10.1136/bmjgast-2023-001246","url":null,"abstract":"<p><strong>Background: </strong>Despite research, there are still controversial areas in the management of Crohn's disease (CD).</p><p><strong>Objective: </strong>To establish practical recommendations on using anti-tumour necrosis factor (TNF) drugs in patients with moderate-to-severe CD.</p><p><strong>Methods: </strong>Clinical controversies in the management of CD using anti-TNF therapies were identified. A comprehensive literature review was performed, and a national survey was launched to examine current clinical practices when using anti-TNF therapies. Their results were discussed by expert gastroenterologists within a nominal group meeting, and a set of statements was proposed and tested in a Delphi process.</p><p><strong>Results: </strong>Qualitative study. The survey and Delphi process were sent to 244 CD-treating physicians (response rate: 58%). A total of 14 statements were generated. All but two achieved agreement. These statements cover: (1) use of first-line non-anti-TNF biological therapy; (2) role of HLA-DQA1*05 in daily practice; (3) attitudes in primary non-response and loss of response to anti-TNF therapy due to immunogenicity; (4) use of ustekinumab or vedolizumab if a change in action mechanism is warranted; (5) anti-TNF drug level monitoring; (6) combined therapy with an immunomodulator.</p><p><strong>Conclusion: </strong>This document sought to pull together the best evidence, experts' opinions, and treating physicians' attitudes when using anti-TNF therapies in patients with CD.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10870792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139545569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of metabolic dysfunction-associated fatty liver disease with gastrointestinal infections: insights from National Inpatient Sample Database. 代谢功能障碍相关性脂肪肝与胃肠道感染的关系:全国住院病人抽样数据库的启示。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-01-17 DOI: 10.1136/bmjgast-2023-001224
Jay Patel, Aalam Sohal, Kanwal Bains, Hunza Chaudhry, Isha Kohli, Tejasvini Khanna, Dino Dukovic, Marina Roytman

Objectives: The study aimed to compare the risk of gastrointestinal infections among patients with and without metabolic dysfunction-associated fatty liver disease (MAFLD).

Methods: This was a population-based, retrospective, observational study using data from the National Inpatient Sample (NIS), the largest all-payer US inpatient care database.

Setting: Hospitalisation of adults aged ≥18 years old admitted in 2020 was identified using the NIS. Patients were stratified by the presence and absence of MAFLD.

Participants: 26.4 million adults aged ≥18 years old were included in the study. Patients younger than 18 and those with missing demographic or mortality data were excluded.

Primary and secondary outcomes: Primary outcome was to assess the overall risk of gastrointestinal infections in patients with and without MAFLD. Secondary outcomes were demographics and comorbidities stratified by the presence or absence of gastrointestinal infection, and the risk of specific gastrointestinal pathogens.

Results: Of 26.4 million patients admitted in 2020, 755 910 (2.85%) had the presence of MAFLD. There was a higher prevalence of bacterial gastrointestinal infections in patients with MAFLD than those without (1.6% vs 0.9%, p<0.001). The incidence of Clostridioides difficile (1.3% vs 0.8%, p<0.001), Escherichia coli (0.3% vs 0.01%, p<0.001), and Salmonella (0.07% vs 0.03%, p<0.001) was higher in patients with MAFLD. The presence of MAFLD was associated with higher odds of developing gastrointestinal infections (adjusted OR (aOR) -1.75, 95% CI -1.68 to 1.83, p<0.001). After adjusting for confounders, results remained statistically significant (aOR -1.36, 95% CI - 1.30-1.42, p<0.001).

Conclusion: Even after adjusting for confounding factors, our study demonstrates an increased risk of gastrointestinal infections in patients with MAFLD, specifically of C. difficile, E. coli, and Salmonella. The immune and microbiota changes seen within MAFLD potentially contribute to the increased risk of gastrointestinal infections.

研究目的该研究旨在比较代谢功能障碍相关性脂肪肝(MAFLD)患者和非代谢功能障碍相关性脂肪肝患者的胃肠道感染风险:这是一项基于人群的回顾性观察研究,使用的数据来自全美住院病人抽样调查(NIS),这是美国最大的全付费住院病人护理数据库:通过国家住院病人抽样调查(NIS)确定了 2020 年住院的年龄≥18 岁的成年人。参与者:2640 万名年龄≥18 岁的成人被纳入研究。小于 18 岁的患者和人口统计或死亡率数据缺失的患者被排除在外:主要结果是评估MAFLD患者和非MAFLD患者发生胃肠道感染的总体风险。次要结果是根据是否存在胃肠道感染对人口统计学和合并症进行分层,以及特定胃肠道病原体的风险:在2020年收治的2640万名患者中,755 910人(2.85%)患有MAFLD。MAFLD患者的细菌性胃肠道感染率高于非MAFLD患者(1.6% vs 0.9%、艰难梭状芽孢杆菌(1.3% vs 0.8%、大肠埃希菌(0.3% vs 0.01%、沙门氏菌(0.07% vs 0.03%、pConclusion)):即使对混杂因素进行了调整,我们的研究仍表明 MAFLD 患者的胃肠道感染风险增加,尤其是艰难梭菌、大肠杆菌和沙门氏菌。在 MAFLD 中出现的免疫和微生物群变化可能是导致胃肠道感染风险增加的原因。
{"title":"Association of metabolic dysfunction-associated fatty liver disease with gastrointestinal infections: insights from National Inpatient Sample Database.","authors":"Jay Patel, Aalam Sohal, Kanwal Bains, Hunza Chaudhry, Isha Kohli, Tejasvini Khanna, Dino Dukovic, Marina Roytman","doi":"10.1136/bmjgast-2023-001224","DOIUrl":"10.1136/bmjgast-2023-001224","url":null,"abstract":"<p><strong>Objectives: </strong>The study aimed to compare the risk of gastrointestinal infections among patients with and without metabolic dysfunction-associated fatty liver disease (MAFLD).</p><p><strong>Methods: </strong>This was a population-based, retrospective, observational study using data from the National Inpatient Sample (NIS), the largest all-payer US inpatient care database.</p><p><strong>Setting: </strong>Hospitalisation of adults aged ≥18 years old admitted in 2020 was identified using the NIS. Patients were stratified by the presence and absence of MAFLD.</p><p><strong>Participants: </strong>26.4 million adults aged ≥18 years old were included in the study. Patients younger than 18 and those with missing demographic or mortality data were excluded.</p><p><strong>Primary and secondary outcomes: </strong>Primary outcome was to assess the overall risk of gastrointestinal infections in patients with and without MAFLD. Secondary outcomes were demographics and comorbidities stratified by the presence or absence of gastrointestinal infection, and the risk of specific gastrointestinal pathogens.</p><p><strong>Results: </strong>Of 26.4 million patients admitted in 2020, 755 910 (2.85%) had the presence of MAFLD. There was a higher prevalence of bacterial gastrointestinal infections in patients with MAFLD than those without (1.6% vs 0.9%, p<0.001). The incidence of <i>Clostridioides difficile</i> (1.3% vs 0.8%, p<0.001), <i>Escherichia coli</i> (0.3% vs 0.01%, p<0.001), and <i>Salmonella</i> (0.07% vs 0.03%, p<0.001) was higher in patients with MAFLD. The presence of MAFLD was associated with higher odds of developing gastrointestinal infections (adjusted OR (aOR) -1.75, 95% CI -1.68 to 1.83, p<0.001). After adjusting for confounders, results remained statistically significant (aOR -1.36, 95% CI - 1.30-1.42, p<0.001).</p><p><strong>Conclusion: </strong>Even after adjusting for confounding factors, our study demonstrates an increased risk of gastrointestinal infections in patients with MAFLD, specifically of <i>C. difficile</i>, <i>E. coli</i>, and <i>Salmonella</i>. The immune and microbiota changes seen within MAFLD potentially contribute to the increased risk of gastrointestinal infections.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10870785/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139490730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Validity assessment of the POLARS score tool in the prediction of post rectal cancer surgery LARS score in a population-based Swedish cohort. 在瑞典人群中评估 POLARS 评分工具在预测直肠癌术后 LARS 评分方面的有效性。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-01-10 DOI: 10.1136/bmjgast-2023-001274
Boglarka Rethy, Caroline Nordenvall, Emil Pieniowski, Gabriella Jansson-Palmer, Asif Johar, Pernilla Lagergren, Mirna Abraham-Nordling

Objective: Low anterior resection syndrome (LARS) is one of the most common functional impairments after rectal cancer surgery with a high impact on quality of life. The Pre-Operative LARS score (POLARS) nomogram and its online tool has been developed to predict the degree of postoperative LARS. The aim of this study was to analyse how accurately the POLARS score could predict LARS scores when compared with actual patient-reported LARS (PR-LARS) scores in a population-based Swedish cohort.

Design: This retrospective cohort study included patients who underwent curative rectal cancer surgery between 2007 and 2013 in Stockholm County and were identified using the Swedish Colorectal Cancer Registry (SCRCR). Information regarding preoperative risk factors, patient and treatment characteristics, and presence of LARS postoperatively were collected from patient charts, SCRCR and patient questionnaires. The POLARS model formula was used to predict LARS scores, which then were compared with the actual PR-LARS scores. Individual LARS score differences between the two estimates were shown with a modified Bland-Altman plot of difference.

Results: The cohort included 477 patients, of whom 359 (75%) of patients were categorised as having no/minor LARS based on the POLARS score. The correctly identified patients by the POLARS score were 80/255 (31%) in the major LARS group and 184/222 (83%) no/minor LARS group. The sensitivity was 31% for major LARS and the positive predictive value was 68%.

Conclusion: The POLARS score has a low sensitivity for major LARS in this Swedish cohort. Other methods to predict the risk of LARS need to be developed.

目的:低位前切除综合征(LARS)是直肠癌术后最常见的功能障碍之一,对生活质量影响很大。为预测术后 LARS 的程度,我们开发了术前 LARS 评分(POLARS)提名图及其在线工具。本研究旨在分析 POLARS 评分与患者报告的实际 LARS(PR-LARS)评分相比,在瑞典人群中预测 LARS 评分的准确性:这项回顾性队列研究纳入了 2007 年至 2013 年期间在斯德哥尔摩县接受治愈性直肠癌手术的患者,这些患者是通过瑞典结直肠癌登记处 (SCRCR) 确定的。从病历、SCRCR 和患者问卷中收集了有关术前风险因素、患者和治疗特点以及术后是否出现 LARS 的信息。使用 POLARS 模型公式预测 LARS 评分,然后与实际的 PR-LARS 评分进行比较。通过改良的布兰-阿尔特曼(Bland-Altman)差值图显示两种估计值之间的单个 LARS 分数差异:结果:队列中有 477 名患者,其中 359 名(75%)患者根据 POLARS 评分被归类为无/轻度 LARS。根据 POLARS 评分正确识别的患者中,重度 LARS 组为 80/255(31%),无/轻度 LARS 组为 184/222(83%)。重度 LARS 的灵敏度为 31%,阳性预测值为 68%:结论:在这组瑞典人中,POLARS 评分对重度 LARS 的灵敏度较低。结论:在这组瑞典人中,POLARS 评分对重度 LARS 的敏感性较低,需要开发其他方法来预测 LARS 的风险。
{"title":"Validity assessment of the POLARS score tool in the prediction of post rectal cancer surgery LARS score in a population-based Swedish cohort.","authors":"Boglarka Rethy, Caroline Nordenvall, Emil Pieniowski, Gabriella Jansson-Palmer, Asif Johar, Pernilla Lagergren, Mirna Abraham-Nordling","doi":"10.1136/bmjgast-2023-001274","DOIUrl":"10.1136/bmjgast-2023-001274","url":null,"abstract":"<p><strong>Objective: </strong>Low anterior resection syndrome (LARS) is one of the most common functional impairments after rectal cancer surgery with a high impact on quality of life. The Pre-Operative LARS score (POLARS) nomogram and its online tool has been developed to predict the degree of postoperative LARS. The aim of this study was to analyse how accurately the POLARS score could predict LARS scores when compared with actual patient-reported LARS (PR-LARS) scores in a population-based Swedish cohort.</p><p><strong>Design: </strong>This retrospective cohort study included patients who underwent curative rectal cancer surgery between 2007 and 2013 in Stockholm County and were identified using the Swedish Colorectal Cancer Registry (SCRCR). Information regarding preoperative risk factors, patient and treatment characteristics, and presence of LARS postoperatively were collected from patient charts, SCRCR and patient questionnaires. The POLARS model formula was used to predict LARS scores, which then were compared with the actual PR-LARS scores. Individual LARS score differences between the two estimates were shown with a modified Bland-Altman plot of difference.</p><p><strong>Results: </strong>The cohort included 477 patients, of whom 359 (75%) of patients were categorised as having no/minor LARS based on the POLARS score. The correctly identified patients by the POLARS score were 80/255 (31%) in the major LARS group and 184/222 (83%) no/minor LARS group. The sensitivity was 31% for major LARS and the positive predictive value was 68%.</p><p><strong>Conclusion: </strong>The POLARS score has a low sensitivity for major LARS in this Swedish cohort. Other methods to predict the risk of LARS need to be developed.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"11 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10870788/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139416372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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BMJ Open Gastroenterology
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