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Effects of prednisolone tapering on effectiveness of infliximab in patients with ulcerative colitis: data from a retrospective cohort 泼尼松龙减量对溃疡性结肠炎患者使用英夫利西单抗疗效的影响:回顾性队列数据
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-05-01 DOI: 10.1136/bmjgast-2024-001343
Pernille Dige Ovesen, Mohamed Attauabi, Johan F K F Ilvemark, Mads Damsgaard Wewer, David J Warren, Johan Burisch, Rolf A Klaasen, Nils Bolstad, Casper Steenholdt, Jakob Benedict Seidelin
Background and objective The influence of concomitant prednisolone on clinical outcomes and safety in infliximab-treated ulcerative colitis (UC) patients is unknown. Design, setting, participants and outcome measures A retrospective cohort study was performed, including 147 UC patients treated with infliximab at a tertiary inflammatory bowel disease (IBD) centre. Primary outcome was corticosteroid-free clinical remission (CFCR) at week 14 and week 52. Patients were grouped according to prednisolone tapering regimens: standard (≤5 mg/week), fast (>5 mg/week), direct discontinuation or no prednisolone. Patients intolerant to corticosteroids and patients stopping corticosteroids in preparation for surgery including colectomy during their initial admission were excluded. Results There was no overall association between prednisolone exposure or no exposure and CFCR at weeks 14 or 52 of infliximab. The proportion of patients with C reactive protein ≤5 mg/L was higher in the standard tapering at week 14 as compared with faster regimens or no prednisolone. In subgroup analyses, the standard tapering was associated with a higher rate of CFCR at week 14 compared with the fast-tapering regimen in patients receiving ≥40 mg prednisolone at initiation of infliximab (64.3% vs 26.3%, p=0.04) and among patients admitted with acute severe UC (66.6% vs 23.5%, p<0.05). Similar data were seen at week 52. Prednisolone did not affect infliximab trough levels but increased infection rates (10/77 vs 2/70, p=0.03), in particular C. difficile infection. Conclusion In UC patients with limited disease burden, prednisolone did not affect effectiveness of infliximab. However, patients with increased disease burden seem to benefit from corticosteroid combination therapy. Data are available upon reasonable request. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
背景和目的 尚不清楚同时使用泼尼松龙对英夫利西单抗治疗的溃疡性结肠炎(UC)患者的临床疗效和安全性的影响。设计、环境、参与者和结果测量 在一家三级炎症性肠病(IBD)中心开展了一项回顾性队列研究,包括147名接受英夫利西单抗治疗的UC患者。主要结果是第14周和第52周的无皮质类固醇临床缓解(CFCR)。根据泼尼松龙减量方案对患者进行分组:标准方案(≤5 毫克/周)、快速方案(>5 毫克/周)、直接停药或不使用泼尼松龙。不耐受皮质类固醇的患者和在初次入院时因准备手术(包括结肠切除术)而停用皮质类固醇的患者除外。结果 在使用英夫利西单抗的第14周或第52周,泼尼松龙暴露或未暴露与CFCR之间总体上没有关联。与快速疗法或不使用泼尼松龙相比,第14周时C反应蛋白≤5 mg/L的患者比例在标准减量疗法中更高。在亚组分析中,在开始使用英夫利西单抗时接受≥40毫克泼尼松龙的患者中(64.3% vs 26.3%,p=0.04),以及在急性重症UC患者中(66.6% vs 23.5%,p<0.05),与快速减量方案相比,标准减量方案在第14周时的C反应蛋白发生率更高。第52周的数据与此相似。泼尼松龙不会影响英夫利西单抗的谷值水平,但会增加感染率(10/77 vs 2/70,p=0.03),尤其是艰难梭菌感染。结论 在疾病负担有限的 UC 患者中,泼尼松龙不会影响英夫利西单抗的疗效。然而,疾病负担加重的患者似乎可从皮质类固醇激素联合疗法中获益。如有合理要求,可提供相关数据。本研究中使用和/或分析的数据集可向通讯作者索取。
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引用次数: 0
Increased rate of pancreatitis in gender diverse and transgender patients on hormone therapy: a case series study 接受激素治疗的不同性别和变性患者胰腺炎发病率增加:一项病例系列研究
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-01 DOI: 10.1136/bmjgast-2023-001312
Alexander Podboy, Catherine Casey, Ross C D Buerlein, Daniel S Strand, Vanessa M Shami, Andrew Y Wang
Background There is limited data on the incidence of gastrointestinal-specific pathology in gender non-conforming (GNC) populations. Methods Retrospective analysis of pancreatitis incidence rates in transgender and GNC persons exposed and not exposed to gender-affirming hormone therapy (GAHT). Results 7 of the 1333 patients on hormone therapy had an incidence of pancreatitis. 0 of the 615 patients with no history of GAHT use developed pancreatitis. Representing a 6.96 (95% CI 2.76 to 848.78) for the development of pancreatitis in patients with exposure to GAHT therapy. Conclusion Clinicians working with GNC individuals should be aware of this possible association Data are available upon reasonable request.
背景 有关性别不符(GNC)人群胃肠道特异性病变发病率的数据十分有限。方法 对接受和未接受性别确认激素疗法(GAHT)的变性人和 GNC 患者的胰腺炎发病率进行回顾性分析。结果 在接受激素治疗的 1333 名患者中,有 7 人发生了胰腺炎。在 615 名没有使用过 GAHT 的患者中,0 人患胰腺炎。接受过 GAHT 治疗的患者胰腺炎发病率为 6.96(95% CI 2.76 至 848.78)。结论 临床医生在治疗 GNC 患者时应注意这种可能的关联。
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引用次数: 0
Management of hepatorenal syndrome and associated outcomes: a systematic reviews 肝肾综合征的管理及相关结果:系统性回顾
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-01 DOI: 10.1136/bmjgast-2023-001319
Jamshid Roozbeh, Shahrokh Ezzatzadegan Jahromi, Mohamad Hossein Rezazadeh, Anahid Hamidianjahromi, Leila Malekmakan
Background Hepatorenal syndrome (HRS), a multiorgan condition of acute kidney injury, is seen in advanced liver disease. This study aims to evaluate the current treatment for HRS. Methods The authors searched PubMed, Scopus and Google Scholar literature. After quality assessment, 31 studies were included in this review. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology and the population, intervention, comparison and outcome scheme were used. We included human-controlled trials that evaluate the current treatment for HRS. Two authors independently screened articles for inclusion, extracted data and assessed the quality of included studies. Results This study investigated the studies conducted on the effects of different treatments on follow-up of HRS patients. We gathered 440 articles, so 31 articles remained in our study. Of which 24 articles were conducted on terlipressin versus placebo or other treatments (midodrine/octreotide, norepinephrine, etc) that showed the higher rate of HRS reversal was detected for terlipressin in 17 studies (10 of them were significant), 2 studies achieved an insignificant lower rate of the model for end-stage liver disease score for terlipressin, 15 studies showed a decreased mortality rate in the terlipressin group (4 of them were significant). Conclusion This review showed that terlipressin has a significantly higher reversal rate of HRS than the other treatments. Even the results showed that terlipressin is more efficient than midodrine/octreotide and norepinephrine as a previous medication, in reverse HRS, increasing patient survival. All data relevant to the study are included in the article or uploaded as online supplemental information.
背景 肝肾综合征(HRS)是一种多器官急性肾损伤,常见于晚期肝病。本研究旨在评估目前治疗 HRS 的方法。方法 作者检索了 PubMed、Scopus 和 Google Scholar 文献。经过质量评估,31 项研究被纳入本综述。采用了系统综述和元分析首选报告项目方法以及人群、干预、比较和结果方案。我们纳入了评估当前 HRS 治疗方法的人类对照试验。两位作者独立筛选纳入文章、提取数据并评估纳入研究的质量。结果 本研究调查了不同治疗方法对 HRS 患者随访效果的影响。我们收集了 440 篇文章,因此有 31 篇文章留在了我们的研究中。其中24篇文章是关于特利加压素与安慰剂或其他治疗方法(米多君/奥曲肽,去甲肾上腺素等)的对比研究,结果显示在17项研究中发现特利加压素的HRS逆转率更高(其中10项具有显著性),2项研究发现特利加压素的终末期肝病评分模型降低率不显著,15项研究显示特利加压素组的死亡率降低(其中4项具有显著性)。结论 本综述显示,特利加压素的 HRS 逆转率明显高于其他治疗方法。研究结果还显示,特利加压素比米多君/奥曲肽和去甲肾上腺素更能有效逆转HRS,提高患者生存率。该研究的所有相关数据均包含在文章中或作为在线补充信息上传。
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引用次数: 0
What is the role of out of programme clinical fellowships in the era of Shape of Training? A single-centre cohort study 在 "培训塑造 "时代,课程外临床研究金的作用是什么?单中心队列研究
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-01 DOI: 10.1136/bmjgast-2023-001311
Suneil A Raju, Freya J Bowker-Howell, Imran Aziz, Mo Thoufeeq, Alan J Lobo, Dermot C Gleeson, Amer Al-Joudeh, Mark E McAlindon, Andrew D Hopper, Sampath Kumar, Reena Sidhu, David S Sanders
Background The updated Shape of Training curriculum has shortened the duration of specialty training. We present the potential role of out of programme clinical fellowships. Method An electronic online survey was sent to all current fellows to understand their experiences, training opportunities and motivations. Data were collected on fellows’ endoscopic experiences and publications using PubMed for all previous doctors who have completed the Sheffield Fellowship Programme. Results Since 2004, 39 doctors have completed the Sheffield Fellowship. Endoscopic experience: current fellows completed a median average of 350 (IQR 150–500) gastroscopies and 150 (IQR 106–251) colonoscopies per year. Fellows with special interests completed either 428 hepato-pancreato-biliary procedures or 70 endoscopic mucosal resections per year. Medline publications: Median average 9 publications(IQR 4–17). They have also received multiple national or international awards and 91% achieved a doctoral degree. The seven current fellows in the new Shape of Training era (57% male, 29% Caucasian, aged 31–40 years) report high levels of enjoyment due to their research projects, supervisory teams and social aspects. The most cited reasons for undertaking the fellowship were to develop a subspecialty interest, take time off the on-call rota and develop endoscopic skills. The most reported drawback was a reduced income. All current fellows feel that the fellowship has enhanced their clinical confidence and prepared them to become consultants. Conclusion Out of programme clinical fellowships offer the opportunity to develop the required training competencies, subspecialty expertise and research skills in a supportive environment. Data are available on reasonable request.
背景 更新后的 "培训课程设置 "缩短了专科培训的时间。我们介绍了课程外临床研究金的潜在作用。方法 我们向所有在读研究员发送了一份电子在线调查,以了解他们的经历、培训机会和动机。我们还通过 PubMed 收集了所有完成谢菲尔德研究金项目的医生的内窥镜经验和发表的论文。结果 自 2004 年以来,共有 39 名医生完成了谢菲尔德奖学金计划。内窥镜检查经验:目前的研究员平均每年完成 350 例(IQR 150-500 例)胃镜检查和 150 例(IQR 106-251 例)结肠镜检查。有特殊兴趣的研究员每年完成 428 例肝胆胰手术或 70 例内镜粘膜切除术。Medline 出版物:中位数平均发表 9 篇论文(IQR 4-17)。他们还获得了多个国家或国际奖项,91%的人获得了博士学位。培训新形态时代的七位现任研究员(57%为男性,29%为白种人,年龄在31-40岁之间)表示,他们对研究项目、指导团队和社交方面都非常满意。获得研究金的最主要原因是培养亚专科兴趣、摆脱值班和发展内窥镜技能。报告最多的缺点是收入减少。所有现任研究员都认为,研究金增强了他们的临床信心,为成为顾问做好了准备。结论 课程外临床研究金提供了在支持性环境中发展所需培训能力、亚专科专业知识和研究技能的机会。如有合理要求,可提供相关数据。
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引用次数: 0
Safety and tolerability of OP-724 in patients with haemophilia and liver cirrhosis due to HIV/HCV coinfection: an investigator-initiated, open-label, non-randomised, single-centre, phase I study OP-724对血友病患者和HIV/HCV合并感染所致肝硬化患者的安全性和耐受性:一项由研究者发起的开放标签、非随机、单中心I期研究
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-01 DOI: 10.1136/bmjgast-2023-001341
Kiminori Kimura, Junko Tanuma, Masamichi Kimura, Jun Imamura, Mikio Yanase, Ichiro Ieiri, Masayuki Kurosaki, Tsunamasa Watanabe, Tomoyuki Endo, Hiroshi Yotsuyanagi, Hiroyuki Gatanaga
Objective Patients with haemophilia and HIV who acquire hepatitis C virus (HCV) after receiving contaminated blood products can experience accelerated progression of liver fibrosis and a poor prognosis, making liver disease a prominent cause of mortality among these patients. In the current study, we aimed to evaluate the safety and tolerability of the potential antifibrotic agent OP-724—a CREB-binding protein/β-catenin inhibitor—in this patient subset. Design In this single-centre, open-label, non-randomised, phase I trial, we sequentially enrolled patients with cirrhosis following HIV/HCV coinfection classified as Child-Pugh (CP) class A or B. Five patients received an intravenous infusion of OP-724 at doses of 140 or 280 mg/m2 for 4 hours two times weekly over 12 weeks. The primary endpoint was the incidence of serious adverse events (SAEs). Secondary endpoints included the incidence of AEs and improved liver stiffness measure (LSM), as determined by vibration-controlled transient elastography. This study was registered at ClinicalTrials.gov ([NCT04688034][1]). Results Between 9 February 2021 and 5 July 2022, five patients (median age: 51 years) were enrolled. All five patients completed 12 cycles of treatment. SAEs were not observed. The most common AEs were fever (60%) and gastrointestinal symptoms (diarrhoea: 20%, enterocolitis: 20%). Improvements in LSM and serum albumin levels were also observed. Conclusion In this preliminary assessment, intravenous administration of 140 or 280 mg/m2/4 hours OP-724 over 12 weeks was well tolerated by patients with haemophilia combined with cirrhosis due to HIV/HCV coinfection. Hence, the antifibrotic effects of OP-724 warrant further assessment in patients with cirrhosis. Trial registration number [NCT04688034][1]. Data are available upon reasonable request. The anonymous data displayed in the manuscript will be made available on request from the corresponding author following the publication of this article. Data displayed in the manuscript or acquired during the clinical trial will be made available in a form that does not deviate from what is accepted by local regulatory authorities with respect to the handling of patient data and in adherence to the policies of the Tokyo Metropolitan Komagome Hospital. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04688034&atom=%2Fbmjgast%2F11%2F1%2Fe001341.atom
目的 血友病和艾滋病患者在接受受污染的血液制品后感染丙型肝炎病毒(HCV),会加速肝纤维化的进展,预后不良,使肝病成为这些患者死亡的主要原因。在本研究中,我们旨在评估潜在抗纤维化药物 OP-724(一种 CREB 结合蛋白/β-catenin 抑制剂)在该患者亚群中的安全性和耐受性。设计 在这项单中心、开放标签、非随机的 I 期试验中,我们按顺序招募了被划分为 Child-Pugh (CP) A 级或 B 级的 HIV/HCV 合并感染后肝硬化患者。五名患者接受了 OP-724 的静脉输注,剂量为 140 或 280 mg/m2,每周两次,每次 4 小时,共 12 周。主要终点是严重不良事件(SAE)的发生率。次要终点包括AEs发生率和肝脏僵硬度(LSM)改善情况,由振动控制瞬态弹性成像确定。该研究已在 ClinicalTrials.gov 注册([NCT04688034][1])。结果 2021 年 2 月 9 日至 2022 年 7 月 5 日期间,五名患者(中位年龄:51 岁)入组。五名患者均完成了 12 个周期的治疗。未观察到 SAE。最常见的不良反应是发热(60%)和胃肠道症状(腹泻:20%;肠炎:20%)。此外,还观察到 LSM 和血清白蛋白水平有所改善。结论 在这项初步评估中,血友病合并肝硬化的患者在12周内静脉注射140或280毫克/平方米/4小时的OP-724耐受性良好。因此,需要进一步评估 OP-724 对肝硬化患者的抗纤维化作用。试验注册号 [NCT04688034][1]。如有合理要求,可提供相关数据。手稿中显示的匿名数据将在本文发表后应通讯作者的要求提供。手稿中显示的数据或临床试验期间获得的数据将以不偏离当地监管机构在处理患者数据方面认可的形式提供,并遵守东京都駒込医院的政策。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04688034&atom=%2Fbmjgast%2F11%2F1%2Fe001341.atom
{"title":"Safety and tolerability of OP-724 in patients with haemophilia and liver cirrhosis due to HIV/HCV coinfection: an investigator-initiated, open-label, non-randomised, single-centre, phase I study","authors":"Kiminori Kimura, Junko Tanuma, Masamichi Kimura, Jun Imamura, Mikio Yanase, Ichiro Ieiri, Masayuki Kurosaki, Tsunamasa Watanabe, Tomoyuki Endo, Hiroshi Yotsuyanagi, Hiroyuki Gatanaga","doi":"10.1136/bmjgast-2023-001341","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001341","url":null,"abstract":"Objective Patients with haemophilia and HIV who acquire hepatitis C virus (HCV) after receiving contaminated blood products can experience accelerated progression of liver fibrosis and a poor prognosis, making liver disease a prominent cause of mortality among these patients. In the current study, we aimed to evaluate the safety and tolerability of the potential antifibrotic agent OP-724—a CREB-binding protein/β-catenin inhibitor—in this patient subset. Design In this single-centre, open-label, non-randomised, phase I trial, we sequentially enrolled patients with cirrhosis following HIV/HCV coinfection classified as Child-Pugh (CP) class A or B. Five patients received an intravenous infusion of OP-724 at doses of 140 or 280 mg/m2 for 4 hours two times weekly over 12 weeks. The primary endpoint was the incidence of serious adverse events (SAEs). Secondary endpoints included the incidence of AEs and improved liver stiffness measure (LSM), as determined by vibration-controlled transient elastography. This study was registered at ClinicalTrials.gov ([NCT04688034][1]). Results Between 9 February 2021 and 5 July 2022, five patients (median age: 51 years) were enrolled. All five patients completed 12 cycles of treatment. SAEs were not observed. The most common AEs were fever (60%) and gastrointestinal symptoms (diarrhoea: 20%, enterocolitis: 20%). Improvements in LSM and serum albumin levels were also observed. Conclusion In this preliminary assessment, intravenous administration of 140 or 280 mg/m2/4 hours OP-724 over 12 weeks was well tolerated by patients with haemophilia combined with cirrhosis due to HIV/HCV coinfection. Hence, the antifibrotic effects of OP-724 warrant further assessment in patients with cirrhosis. Trial registration number [NCT04688034][1]. Data are available upon reasonable request. The anonymous data displayed in the manuscript will be made available on request from the corresponding author following the publication of this article. Data displayed in the manuscript or acquired during the clinical trial will be made available in a form that does not deviate from what is accepted by local regulatory authorities with respect to the handling of patient data and in adherence to the policies of the Tokyo Metropolitan Komagome Hospital. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04688034&atom=%2Fbmjgast%2F11%2F1%2Fe001341.atom","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"10 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140804872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality of reporting inflammatory bowel disease randomised controlled trials: a systematic review 炎症性肠病随机对照试验的报告质量:系统综述
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-01 DOI: 10.1136/bmjgast-2023-001337
Morris Gordon, Jamal Khudr, Vassiliki Sinopoulou, Svetlana Lakunina, Aditi Rane, Anthony Akobeng
Objective Our objective was to perform a systemic evaluation of the risk of bias in randomised controlled trial (RCT) reports published on inflammatory bowel disease (IBD). Design We assessed the risk of bias using the Cochrane tool, as indicators of poor methodology or subsequently poor reporting. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings. Results 563 full texts were included after selection and review. No abstract publications were free of any source of bias. Full-text publications still fared badly, as only 103 full-text papers exhibited a low risk of bias in all reporting domains when excluding blinding. RCTs published in journals with higher impact factor (IF) were associated with an overall reduced rate of being at high risk. However, only 6% of full RCT publications in journals with an IF greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with a lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p=0.037). Conclusion These findings are consistent with those of other specialties in the literature. While this unclear risk of bias may represent poor reporting of methods instead of poor methodological quality, it leaves readers and future secondary researchers with significant questions regarding such key issues. Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The protocol for the review has been uploaded to a repository (Repository ID: 33117). Further methodological components and results are included in the appendix. Other data are available upon reasonable request.
目标 我们的目的是对已发表的有关炎症性肠病(IBD)的随机对照试验(RCT)报告的偏倚风险进行系统评估。设计 我们使用 Cochrane 工具评估了偏倚风险,将其作为方法不当或随后报告不当的指标。我们通过双重独立判断,系统地选择了所有已发表的无时间限制的 IBD 研究,并再次通过独立的双重评分对纳入研究的方法学质量进行了评估。结果 经过筛选和审查,共纳入 563 篇全文。没有一篇摘要出版物不存在任何偏见。全文出版物的表现仍然不佳,因为在排除盲法的情况下,只有 103 篇全文论文在所有报告领域的偏倚风险都较低。在影响因子(IF)较高的期刊上发表的 RCT 论文总体上降低了高风险率。然而,在过去 5 年中,在影响因子大于 10 的期刊上发表的 RCT 论文中,只有 6% 不存在偏倚。随着时间的推移,所有领域的报告都有改进的趋势。作者团队规模较大、以全文形式发表的试验以及获得行业和公共赞助的试验与较低的偏倚风险呈正相关。随着时间的推移,只有分配隐藏在统计学上有显著改善(p=0.037)。结论 这些发现与其他专业的文献一致。虽然这种不明确的偏倚风险可能是方法报告不完善而不是方法质量不高,但它给读者和未来的二次研究人员留下了有关这些关键问题的重大疑问。数据可在合理要求下提供。所有与研究相关的数据都包含在文章中或作为补充信息上传。综述协议已上传至资料库(资料库 ID:33117)。更多的方法论内容和结果载于附录。其他数据可应合理要求提供。
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引用次数: 0
Risk of cancer in patients with bile acid diarrhoea: a Danish nationwide matched cohort study 胆汁酸腹泻患者罹患癌症的风险:一项丹麦全国性匹配队列研究
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-01 DOI: 10.1136/bmjgast-2023-001340
Nynne Nyboe Andersen, Signe Wildt, Aske Thorn Iversen, Gry Poulsen, Tine Jess, Lars Kristian Munck, Christian Borup
Objective Bile acid diarrhoea is a common cause of chronic diarrhoea. Increased levels of potentially carcinogenic bile acids in faeces, theoretically, may increase the risk of colorectal cancer in particular, but the long-term disease course is unknown. We aimed to investigate the overall and site-specific cancer risk in bile acid diarrhoea. Design Adult patients with bile acid diarrhoea were identified using nationwide Danish registries from 2003 to 2020 by a diagnostic gold-standard 75-selenium tauroselcholic acid procedure followed within 6 months by sequestrant prescription. The risk of overall and site-specific cancers in cases with bile acid diarrhoea was compared with sex, age and comorbidity-adjusted matched controls. A competing risk model estimated cumulative incidence functions and cause-specific HRs. Results We identified 2260 patients with bile acid diarrhoea with a mean follow-up of 5.5 years (SD 4.2). The overall cancer risk was increased by an HR of 1.32 (95% CI 1.12 to 1.54). The risk of site-specific cancer was increased in 3 of 10 cancer groups: haematological, HR 2.41 (1.36 to 4.02); skin, HR 1.33 (1.01 to 1.71); and male genital cancers, HR 1.85 (1.11 to 2.92). No increased risk of colorectal cancer was detected in patients with bile acid diarrhoea, HR 0.73 (0.34 to 1.63). Conclusions Bile acid diarrhoea was associated with an increased overall risk of cancer, especially haematological cancers, but the risk of colorectal cancer was not increased. The lack of a diagnostic code for bile acid diarrhoea and potential residual confounding are limitations, and the findings should be replicated in other cohorts. All data relevant to the study are included in the article or uploaded as supplemental information.
目标 胆汁酸性腹泻是慢性腹泻的常见病因。从理论上讲,粪便中潜在致癌胆汁酸含量的增加可能会增加罹患结直肠癌的风险,但其长期病程尚不清楚。我们的目的是调查胆汁酸腹泻的总体癌症风险和特定部位癌症风险。设计 从 2003 年到 2020 年,我们通过丹麦全国范围内的登记册确定了胆汁酸腹泻的成年患者,他们接受了金标准 75 硒牛磺胆酸诊断程序,并在 6 个月内接受了螯合剂处方。将胆汁酸腹泻病例的总体癌症风险和特定部位癌症风险与性别、年龄和合并症调整后的匹配对照组进行了比较。竞争风险模型估算了累积发病率函数和病因特异性 HR。结果 我们确定了 2260 名胆汁酸腹泻患者,平均随访时间为 5.5 年(SD 4.2)。总体癌症风险增加的HR为1.32(95% CI为1.12至1.54)。在 10 个癌症组别中,有 3 个组别发生特定部位癌症的风险增加:血液癌症,HR 值为 2.41(1.36 至 4.02);皮肤癌,HR 值为 1.33(1.01 至 1.71);男性生殖器癌症,HR 值为 1.85(1.11 至 2.92)。未发现胆汁酸腹泻患者罹患结直肠癌的风险增加,HR 为 0.73(0.34 至 1.63)。结论 胆汁酸腹泻与癌症(尤其是血液癌症)总风险的增加有关,但结肠直肠癌的风险并没有增加。缺乏胆汁酸腹泻的诊断代码和潜在的残余混杂因素是研究的局限性,研究结果应在其他队列中重复。与该研究相关的所有数据均包含在文章中或作为补充信息上传。
{"title":"Risk of cancer in patients with bile acid diarrhoea: a Danish nationwide matched cohort study","authors":"Nynne Nyboe Andersen, Signe Wildt, Aske Thorn Iversen, Gry Poulsen, Tine Jess, Lars Kristian Munck, Christian Borup","doi":"10.1136/bmjgast-2023-001340","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001340","url":null,"abstract":"Objective Bile acid diarrhoea is a common cause of chronic diarrhoea. Increased levels of potentially carcinogenic bile acids in faeces, theoretically, may increase the risk of colorectal cancer in particular, but the long-term disease course is unknown. We aimed to investigate the overall and site-specific cancer risk in bile acid diarrhoea. Design Adult patients with bile acid diarrhoea were identified using nationwide Danish registries from 2003 to 2020 by a diagnostic gold-standard 75-selenium tauroselcholic acid procedure followed within 6 months by sequestrant prescription. The risk of overall and site-specific cancers in cases with bile acid diarrhoea was compared with sex, age and comorbidity-adjusted matched controls. A competing risk model estimated cumulative incidence functions and cause-specific HRs. Results We identified 2260 patients with bile acid diarrhoea with a mean follow-up of 5.5 years (SD 4.2). The overall cancer risk was increased by an HR of 1.32 (95% CI 1.12 to 1.54). The risk of site-specific cancer was increased in 3 of 10 cancer groups: haematological, HR 2.41 (1.36 to 4.02); skin, HR 1.33 (1.01 to 1.71); and male genital cancers, HR 1.85 (1.11 to 2.92). No increased risk of colorectal cancer was detected in patients with bile acid diarrhoea, HR 0.73 (0.34 to 1.63). Conclusions Bile acid diarrhoea was associated with an increased overall risk of cancer, especially haematological cancers, but the risk of colorectal cancer was not increased. The lack of a diagnostic code for bile acid diarrhoea and potential residual confounding are limitations, and the findings should be replicated in other cohorts. All data relevant to the study are included in the article or uploaded as supplemental information.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":"29 1","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140841197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Validity and reliability of the Persian version of the Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire 波斯语版胃食管反流病健康相关生活质量问卷的有效性和可靠性
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-04-01 DOI: 10.1136/bmjgast-2023-001298
Seyed Ali Ebrahimi, Zahra Mostafavian, Elahe Karazhian, Fereshteh Najafi, Rasam Mashoufi, Tooraj Zandbaf, Elham Mokhtari
Objective The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is one of the most widely used questionnaires for assessing typical gastro-oesophageal reflux disease (GORD) symptoms. It is simple, concise, and treatment responsive, yet it has not been validated in the Persian language. This study aimed to translate the GERD-HRQL questionnaire into Persian and assess its validity and reliability. Design In this cross-sectional validation study, a team of gastroenterologists, general surgeons, and professional translators conducted the forward-backward translation. A gastroenterologist interviewed 10 patients with GORD to insure understandability of the questionnaire. Fifty-four patients with GORD and 60 patients with gastrointestinal complaints other than GORD were enrolled using convenience sampling method. To assess concurrent validity, patients with GORD completed the Persian GERD-HRQL and the WHO Quality of Life Brief Version (WHOQOL-BREF) questionnaires. To assess discriminant validity, GERD-HRQL scores were compared between GORD and non-GORD patients. After 2 weeks, the patients with GORD completed the GERD-HRQL questionnaire again to assess test–retest reliability. The internal consistency was measured using Cronbach’s alpha. Results The mean age of the GORD participants was 36.90±10.44, and the majority were women (78%). All GERD-HRQL domains and total scores exhibited significant negative correlations with WHOQOL-BREF domains (ranging from −0.28 to −0.97). The GERD-HRQL scores were significantly different in GORD and non-GORD patients (p<0.001). Test and retest scores did not show any significant differences (p=0.49). Cronbach’s alpha was 0.85. Conclusion The Persian GERD-HRQL questionnaire is valid and reliable and can effectively assess the GORD symptoms in Persian-speaking individuals. Data are available upon reasonable request. Unnamed patient data are available upon request.
目的 胃食管反流病健康相关生活质量(GERD-HRQL)是评估典型胃食管反流病(GORD)症状最广泛使用的问卷之一。该问卷简单、简明,对治疗反应灵敏,但尚未在波斯语中得到验证。本研究旨在将 GERD-HRQL 问卷翻译成波斯语,并评估其有效性和可靠性。设计 在这项横断面验证研究中,由胃肠病学专家、普外科医生和专业翻译人员组成的团队进行了正向-反向翻译。一名胃肠病学专家对 10 名 GORD 患者进行了访谈,以确保问卷的可理解性。采用方便抽样法,共招募了 54 名 GORD 患者和 60 名 GORD 以外的胃肠道不适患者。为评估并发效度,胃食管反流患者填写了波斯文胃食管反流-HRQL 和世界卫生组织生活质量简易版(WHOQOL-BREF)问卷。为评估判别效度,对胃食管反流患者和非胃食管反流患者的 GERD-HRQL 评分进行了比较。2 周后,胃食管反流患者再次填写胃食管反流-HRQL 问卷,以评估重测可靠性。内部一致性采用 Cronbach's alpha 进行测量。结果 胃食管反流患者的平均年龄为(36.90±10.44)岁,大多数为女性(78%)。所有 GERD-HRQL 领域和总分均与 WHOQOL-BREF 领域呈显著负相关(范围从 -0.28 到 -0.97)。胃食管反流-HRQL得分在胃食管反流患者和非胃食管反流患者中存在显著差异(p<0.001)。测试和重测得分未显示任何显著差异(p=0.49)。Cronbach's alpha 为 0.85。结论 波斯语胃食管反流-HRQL 问卷有效可靠,能有效评估波斯语患者的胃食管反流症状。如有合理要求,可提供相关数据。未具名患者数据可应要求提供。
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引用次数: 0
Retrograde tubing as a rescue treatment for megaoesophagus: a case report. 逆行插管作为巨食道的抢救疗法:病例报告。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-03-27 DOI: 10.1136/bmjgast-2023-001285
Chedva S Weiss, Jonathan Abraham Demma, Benjamin Koplewitz, Channa Maayan, Mordechai Slae

Familial dysautonomia (FD) is a genetic disease of the autonomous and sensory nervous systems. Severe gastro-oesophageal reflux is common and one of the major complications. Some patients with FD develop megaoesophagus. Oesophageal malfunction, accompanied by oesophageal food and secretion retention, results in recurrent aspiration and other severe respiratory complications. Through a traditional case report, we wish to show how reverse tubing of the oesophagus can lead to significant symptomatic improvement in these patients. Moreover, this technique can serve as an alternative treatment for other oesophageal motility disorders.

家族性自律神经失调症(FD)是一种遗传性自主和感觉神经系统疾病。严重的胃食管反流是常见病,也是主要并发症之一。一些 FD 患者会出现巨食道。食道功能失调,伴有食道食物和分泌物潴留,导致反复吸入和其他严重的呼吸道并发症。我们希望通过一份传统的病例报告,说明食管反向置管如何能显著改善这些患者的症状。此外,这项技术还可作为其他食道运动障碍的替代治疗方法。
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引用次数: 0
Online tools to predict individualised survival for primary oesophageal cancer patients with and without pathological complete response after neoadjuvant therapy followed by oesophagectomy: development and external validation of two independent nomograms. 新辅助治疗后进行食管切除术的原发性食管癌患者中,有病理完全反应和无病理完全反应患者的个体化生存率预测在线工具:两个独立提名图的开发和外部验证。
IF 3.1 Q2 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2024-03-27 DOI: 10.1136/bmjgast-2023-001253
Yuqin Cao, Binhao Huang, Han Tang, Dong Dong, Tianzheng Shen, Xiang Chen, Xijia Feng, Jiahao Zhang, Liqiang Shi, Chengqiang Li, Heng Jiao, Lijie Tan, Jie Zhang, Hecheng Li, Yajie Zhang

Objective: This study aimed to develop and validate robust predictive models for patients with oesophageal cancer who achieved a pathological complete response (pCR) and those who did not (non-pCR) after neoadjuvant therapy and oesophagectomy.

Design: Clinicopathological data of 6517 primary oesophageal cancer patients who underwent neoadjuvant therapy and oesophagectomy were obtained from the National Cancer Database for the training cohort. An independent cohort of 444 Chinese patients served as the validation set. Two distinct multivariable Cox models of overall survival (OS) were constructed for pCR and non-pCR patients, respectively, and were presented using web-based dynamic nomograms (graphical representation of predicted OS based on the clinical characteristics that a patient could input into the website). The calibration plot, concordance index and decision curve analysis were employed to assess calibration, discrimination and clinical usefulness of the predictive models.

Results: In total, 13 and 15 variables were used to predict OS for pCR and non-pCR patients undergoing neoadjuvant therapy followed by oesophagectomy, respectively. Key predictors included demographic characteristics, pretreatment clinical stage, surgical approach, pathological information and postoperative treatments. The predictive models for pCR and non-pCR patients demonstrated good calibration and clinical utility, with acceptable discrimination that surpassed that of the current tumour, node, metastases staging system.

Conclusions: The web-based dynamic nomograms for pCR (https://predict-survival.shinyapps.io/pCR-eso/) and non-pCR patients (https://predict-survival.shinyapps.io/non-pCR-eso/) developed in this study can facilitate the calculation of OS probability for individual patients undergoing neoadjuvant therapy and radical oesophagectomy, aiding clinicians and patients in making personalised treatment decisions.

研究目的本研究旨在开发和验证针对新辅助治疗和食管切除术后获得病理完全反应(pCR)和未获得病理完全反应(非CCR)的食管癌患者的稳健预测模型:设计:从全国癌症数据库中获取6517名接受新辅助治疗和食管切除术的原发性食管癌患者的临床病理数据,作为培训队列。由 444 名中国患者组成的独立队列作为验证集。针对pCR和非pCR患者分别建立了两种不同的总生存期(OS)多变量Cox模型,并使用基于网络的动态提名图(根据患者输入网站的临床特征预测OS的图形表示)进行展示。校准图、一致性指数和决策曲线分析被用来评估预测模型的校准性、区分度和临床实用性:共有13个和15个变量分别用于预测接受新辅助治疗后进行食管切除术的pCR和非PCR患者的OS。主要预测因素包括人口统计学特征、治疗前临床分期、手术方式、病理信息和术后治疗。对pCR和非pCR患者的预测模型显示出良好的校准性和临床实用性,具有可接受的区分度,超过了目前的肿瘤、结节、转移分期系统:本研究为pCR患者(https://predict-survival.shinyapps.io/pCR-eso/)和非pCR患者(https://predict-survival.shinyapps.io/non-pCR-eso/)开发的基于网络的动态提名图有助于计算接受新辅助治疗和根治性食管切除术患者的OS概率,帮助临床医生和患者做出个性化的治疗决策。
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引用次数: 0
期刊
BMJ Open Gastroenterology
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