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Glucagon-Like Peptide-1 Receptor Agonists Are Associated With Improved Outcomes in Inflammatory Bowel Disease 胰高血糖素样肽-1受体激动剂与炎症性肠病预后改善相关
Pub Date : 2026-01-06 DOI: 10.1155/ygh2/2239686
Michael Saadeh, Apoorva Krishna Chandar, Revital Gorodeski Baskin, Jeffry Katz, Fabio Cominelli, Emad Mansoor, Miguel Regueiro, Vu Quang Nguyen

Background

The co-existence of diabetes and obesity in patients with inflammatory bowel disease (IBD) increases morbidity and mortality associated with IBD, yet it remains unclear how medications used to treat these metabolic disorders affect IBD course. This study examines the impact of glucagon-like peptide-1 receptor agonists (GLP-1RAs), a predominant class of antidiabetic and antiobesity medications, on IBD outcomes.

Methods

Using TriNetX, a healthcare database comprising over 110 million patients in the United States, we identified cohorts of IBD patients based on their exposure to GLP-1RA as well as a metformin comparator cohort. Cases were IBD patients on GLP-1RA, while controls were IBD patients without exposure to GLP-1RA. The two cohorts were propensity score matched for demographics, comorbidities, and IBD medications. Outcomes of interest were IBD-related surgeries, inpatient hospitalizations, emergency room (ER) visits, and steroid use within 5 years after the index event of GLP-1RA use. Chi-square and t-tests were used for significance testing.

Results

There were 11,559 IBD cases with prior GLP-1RA exposure and 258,046 IBD controls without prior GLP-1RA exposure. After propensity score matching, 9596 cases and controls were evenly matched. Compared to controls, IBD patients on GLP-1RA were less likely to have IBD-related surgeries (OR 0.36, 95% CI 0.29–0.46), inpatient hospitalizations (OR 0.44, 95% CI 0.41–0.46), ER visits (OR 0.56, 95% CI 0.52–0.59), or steroid use (OR 0.56, 95% CI 0.53–0.60). In matched analyses against metformin, GLP-1RA exposure was also associated with lower odds across all endpoints.

Conclusion

Patients with IBD on GLP-1RA therapy had fewer IBD-related surgeries, inpatient hospitalizations, ER visits, and steroid use, even when compared to those on metformin. Further research is needed to investigate the role of GLP-1RA in modulating inflammation in IBD patients.

背景:炎症性肠病(IBD)患者中糖尿病和肥胖的共存增加了与IBD相关的发病率和死亡率,但目前尚不清楚用于治疗这些代谢紊乱的药物如何影响IBD的病程。本研究考察了胰高血糖素样肽-1受体激动剂(GLP-1RAs)对IBD预后的影响,GLP-1RAs是一类主要的抗糖尿病和抗肥胖药物。方法使用TriNetX,一个包含超过1.1亿美国患者的医疗数据库,我们根据暴露于GLP-1RA的IBD患者以及二甲双胍比较物队列确定了IBD患者队列。病例为接受GLP-1RA治疗的IBD患者,对照组为未接受GLP-1RA治疗的IBD患者。这两个队列在人口统计学、合并症和IBD药物方面的倾向评分相匹配。关注的结果是ibd相关手术、住院、急诊室就诊和GLP-1RA使用指标事件后5年内的类固醇使用情况。显著性检验采用卡方检验和t检验。结果有11559例IBD患者有GLP-1RA暴露史,258046例IBD对照组没有GLP-1RA暴露史。倾向评分匹配后,9596例病例与对照组均匀匹配。与对照组相比,使用GLP-1RA的IBD患者较少进行IBD相关手术(OR 0.36, 95% CI 0.29-0.46)、住院治疗(OR 0.44, 95% CI 0.41-0.46)、急诊就诊(OR 0.56, 95% CI 0.52-0.59)或使用类固醇(OR 0.56, 95% CI 0.53-0.60)。在对二甲双胍的匹配分析中,GLP-1RA暴露也与所有终点的较低几率相关。结论:与二甲双胍患者相比,接受GLP-1RA治疗的IBD患者的IBD相关手术、住院、急诊就诊和类固醇使用更少。GLP-1RA在IBD患者炎症调节中的作用有待进一步研究。
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引用次数: 0
Helicobacter pylori VacA, CagA, IceA and DupA Virulence Genes’ Distribution and Accompanying Clinical Outcomes: The Cameroon Situation 幽门螺杆菌VacA、CagA、IceA和DupA毒力基因的分布及其临床结果:喀麦隆情况
Pub Date : 2025-11-18 DOI: 10.1155/ygh2/4034800
Laure Brigitte Kouitcheu Mabeku, Ghislaine Florice Faujo Nintewoue, Lionel Danny Tali Nguefack, Paul Talla, Fernando Greluk Szykman, Livia Jesus Ferreira, Maria Luiza Sato de Castro, Márcia Aparecida Sperança

Background

Helicobacter pylori colonization results in site-specific disorders of the upper digestive tract, such as inflammatory, ulcerative and neoplastic lesions. The development of these disorders is related to the virulence genes carried by the bacterium. This study is aimed at identifying the different virulence genes of H. pylori strains from Cameroon, as well as their association with clinical outcomes.

Methods

A total of 138 H. pylori urease-positive biopsy samples were used in this study. They were collected from patients that underwent an upper gastrointestinal endoscopy for the investigation of dyspepsia in health facilities in Cameroon. The alterations of the gastric mucosa were recorded during the endoscopic procedure. PCR confirmation of H. pylori in biopsy samples was performed, followed by the identification of vacA, cagA, IceA and DupA virulence genes. The results were analysed using the SPSS software Version 22.

Results

Seventy-eight out of the 138 biopsy samples were PCR confirmed as H. pylori positive. VacAs1, vacAm1, vacAs1m1 and vacAm2 were identified in 88.5%, 83.3%, 82.1% and 1.3% of H. pylori strains, respectively, while the vacAs2 genotype was absent. The prevalence of cagA, DupA, IceA1 and IceA2 was 66.7%, 27.4%, 25.7% and 57.5%, respectively, whereas vacAs1m1 and cagA (64.9%) were the most frequent combination. Strains harbouring IceA1 (p = 0.039), IceA1 and vacAs1m1 (p = 0.008) and IceA1 and cagA (p = 0.042) genotype were significantly associated with gastric inflammatory lesions, while those harbouring IceA1 (p = 0.032), vacAs1m1 and IceA1 (p = 0.016), cagA and IceA1 (p = 0.029) and DupA and IceA1 (p = 0.044) genotype were significantly associated with ulcerated lesions.

Conclusion

Our data showed a higher prevalence of vacAs1, vacAm1, vacAs1m1, cagA and IceA2 genotype, lower prevalence of DupA and IceA1, absence of vacAs2 and vacAs1m1 and cagA as the most frequent genotype combination among H. pylori strains circulating in Cameroon. Strains harbouring IceA1, IceA1 and vacAs1m1, IceA1 and cagA and IceA1 and DupA genotype are highly predictive of gastric injuries in our context.

背景幽门螺杆菌的定植导致上消化道特定部位的疾病,如炎症、溃疡和肿瘤病变。这些疾病的发生与细菌携带的毒力基因有关。本研究旨在鉴定来自喀麦隆的幽门螺杆菌菌株的不同毒力基因,以及它们与临床结果的关系。方法采用138例幽门螺杆菌尿酶阳性活检标本进行研究。它们是从喀麦隆卫生机构为调查消化不良而接受上消化道内窥镜检查的患者中收集的。胃镜检查过程中记录胃粘膜的改变。对活检标本中幽门螺杆菌进行PCR确认,随后对vacA、cagA、IceA和DupA毒力基因进行鉴定。使用SPSS软件第22版对结果进行分析。结果138份活检标本中78份PCR检测为幽门螺杆菌阳性。VacAs1、vacAm1、vacAs1m1和vacAm2分别在88.5%、83.3%、82.1%和1.3%的幽门螺杆菌中检出,而vacAs2基因型缺失。cagA、DupA、IceA1和IceA2的患病率分别为66.7%、27.4%、25.7%和57.5%,而vacAs1m1和cagA的合并患病率最高(64.9%)。基因型为IceA1 (p = 0.039)、IceA1与vacAs1m1 (p = 0.008)、IceA1与cagA (p = 0.042)的菌株与胃炎性病变显著相关,而基因型为IceA1 (p = 0.032)、vacAs1m1与IceA1 (p = 0.016)、cagA与IceA1 (p = 0.029)、DupA与IceA1 (p = 0.044)的菌株与溃疡病变显著相关。结论vacAs1、vacAm1、vacAs1m1、cagA和IceA2基因型的流行率较高,DupA和IceA1基因型的流行率较低,vacAs2基因型缺失,vacAs1m1和cagA基因型组合是喀麦隆流行的幽门螺杆菌中最常见的基因型组合。在我们的研究中,含有IceA1、IceA1和vacAs1m1、IceA1和cagA以及IceA1和DupA基因型的菌株对胃损伤有很高的预测作用。
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引用次数: 0
Measuring Excretion of Gluten Immunogenic Peptides (GIPs): An Assay for Monitoring Gluten Exposure 测量谷蛋白免疫原肽(GIPs)的排泄:一种监测谷蛋白暴露的检测方法
Pub Date : 2025-03-19 DOI: 10.1155/ygh2/3859529
Sunari Kulasekera, Jaymini Pankhania, Carol Leppard, Jacquita Affandi, Sue Critchley, Glen Lichtenberger, Dewruwan Gammanpila, Christopher Reid, Geoffrey Forbes, Narelle Hadlow, Mina John

Individuals with coeliac disease are required to exclude all gluten from their diet to prevent small bowel inflammation and associated complications. Life-long adherence to a gluten-free diet is challenging because of the potential presence of gluten in common noncereal foods, cross-contamination, and potentially small amounts of gluten in cereal-based foods formally labelled as “gluten-free.” For people living with coeliac disease, current tests to monitor the efficacy of a gluten-free diet may not detect ongoing, low level, or intermittent unintentional gluten exposure. The iVYCHECK and iVYLISA assays by Biomedal detect gluten-derived peptides, which are resistant to digestion, known to be immunogenic and are excreted in urine and stool. The urine test is qualitative for recent short-term exposure while the faecal test is quantitative and reflects gluten exposure over a longer interval. Several studies have validated the performance of these assays in monitoring compliance to gluten-free diets. We sought to evaluate these assays in a community-based pathology service by comparing values obtained in individuals with no dietary restrictions compared with those following a gluten-free diet. We performed 124 assays in 21 subjects over 9 days. The quantitative faecal gluten immunogenic peptide assay was highly precise. Faecal gluten immunogenic peptide assays were moderately sensitive (66%) and highly specific (97%) while the urine assay had sensitivity of 100% and lesser specificity (48%). Both assays had very high negative predictive value (90%) for detection of clinically relevant levels of oral gluten, as verified by participant self-reported diet diary over a 9-day period. An episode of inadvertent gluten exposure in one individual on an otherwise gluten-free diet was associated with temporally high gluten immunogenic peptide levels in stool. The majority of participants regarded accidental gluten exposures as important to their health and rated monitoring for gluten contamination as their strongest reason for utilizing this assay. Our study was limited by use of self-report rather than independent tests of gluten intake or clinical disease markers; however, our findings do provide support for implementation of these assays to assist in monitoring efficacy of a gluten-free diet.

患有乳糜泻的人需要从他们的饮食中排除所有麸质以防止小肠炎症和相关并发症。终身坚持无麸质饮食是具有挑战性的,因为普通非谷物食品中可能存在麸质,交叉污染,并且在正式标记为“无麸质”的谷物食品中可能含有少量麸质。对于患有乳糜泻的人来说,目前监测无麸质饮食效果的试验可能无法检测到持续的、低水平的或间歇性的无意的麸质暴露。生物医学公司的iVYCHECK和iVYLISA检测检测谷蛋白衍生肽,这些肽抵抗消化,已知具有免疫原性,并通过尿液和粪便排出。尿液测试对近期的短期接触是定性的,而粪便测试是定量的,反映了较长时间内的谷蛋白接触。几项研究证实了这些检测在监测无麸质饮食依从性方面的性能。我们试图在一个以社区为基础的病理服务中通过比较没有饮食限制的个体与无麸质饮食的个体获得的值来评估这些检测。我们在9天内对21名受试者进行了124次检测。定量测定粪谷蛋白免疫原性肽具有较高的准确性。粪便谷蛋白免疫原性肽检测具有中等敏感性(66%)和高度特异性(97%),而尿液检测的敏感性为100%,特异性较低(48%)。这两项检测在检测临床相关的口服谷蛋白水平方面都有很高的阴性预测值(90%),这一点得到了参与者在9天内自我报告的饮食日记的证实。一个人在无麸质饮食中不慎接触麸质与粪便中临时性高麸质免疫原性肽水平有关。大多数参与者认为意外接触谷蛋白对他们的健康很重要,并将监测谷蛋白污染作为他们使用该试验的最重要原因。我们的研究受限于使用自我报告而不是麸质摄入或临床疾病标志物的独立测试;然而,我们的研究结果确实为这些检测的实施提供了支持,以帮助监测无谷蛋白饮食的功效。
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引用次数: 0
Hepatitis D Virus Status Among People With Hepatitis B Virus Infection: A Disconnect Between Guidelines and Practice 乙型肝炎病毒感染者中的 D 型肝炎病毒感染状况:指南与实践脱节
Pub Date : 2024-11-01 DOI: 10.1155/2024/6622276
Kathryn Jack, Rachel Jackson, William Lucien Irving

Background: Hepatitis D virus (HDV) infection is an important cause of chronic liver disease yet remains a poorly met clinical challenge. The current European and UK guidelines recommend that all patients with hepatitis B virus (HBV) are tested for HDV, but emerging UK data indicates that only approximately 20% have been tested. The World Health Organization viral hepatitis elimination strategy first requires the systematic testing of people with relevant risk factors, so there is a need to understand factors contributing to low anti-HDV rates of testing.

Methods: An audit was conducted to ascertain the perspectives of patients and healthcare professionals about identifying HDV infection. During a 4-month period, 39 hepatology healthcare professionals and 70 patients with chronic HBV were recruited. The attitudes of healthcare professionals about HDV testing were surveyed according to the seven constructs of the theoretical framework of acceptability (TFA). Patients were surveyed by telephone about their knowledge of HDV and their own testing status.

Results: Among the 39 healthcare professionals, only 66.6% and 53.8% were able to correctly cite EASL (European) HDV and NICE (UK) testing guidelines, respectively, although there were high levels of anti-HDV testing acceptability according to the TFA. Among the patients, 95.7% (67/70) had been tested for anti-HDV and all were seronegative. Only 23% (16/70) knew of the existence of HDV. There was extensive ethnic heterogeneity with 23 countries of birth and 24 different primary languages.

Conclusion: Some clinicians lack familiarity with clinical guideline recommendations for universal testing of all HBsAg-positive patients. Similarly, most patients lack knowledge about HDV. Staff and patient education are required to increase HDV diagnosis.

背景:丁型肝炎病毒(HDV)感染是慢性肝病的一个重要病因,但仍是一个难以解决的临床难题。现行的欧洲和英国指南建议所有乙型肝炎病毒(HBV)患者都接受 HDV 检测,但英国的新数据显示,只有约 20% 的患者接受了检测。世界卫生组织消除病毒性肝炎战略首先要求对具有相关风险因素的人群进行系统检测,因此有必要了解导致抗 HDV 检测率低的因素:方法:我们进行了一次审计,以确定患者和医疗保健专业人员对识别 HDV 感染的看法。在为期 4 个月的时间里,共招募了 39 名肝病医护人员和 70 名慢性 HBV 患者。根据可接受性理论框架(TFA)的七个构架调查了医护人员对 HDV 检测的态度。通过电话调查了患者对 HDV 的了解程度及其自身的检测情况:结果:在 39 名医疗保健专业人员中,只有 66.6% 和 53.8% 的人能够分别正确引用 EASL(欧洲)HDV 检测指南和 NICE(英国)检测指南,尽管根据 TFA,抗 HDV 检测的可接受性很高。在患者中,95.7%(67/70)的人接受过抗-HDV 检测,所有患者的血清反应均为阴性。只有 23%(16/70)的患者知道存在 HDV。患者的种族差异很大,有 23 个出生国和 24 种不同的主要语言:结论:一些临床医生不了解临床指南关于对所有 HBsAg 阳性患者进行普遍检测的建议。同样,大多数患者对 HDV 也缺乏了解。需要对工作人员和患者进行教育,以提高 HDV 诊断率。
{"title":"Hepatitis D Virus Status Among People With Hepatitis B Virus Infection: A Disconnect Between Guidelines and Practice","authors":"Kathryn Jack,&nbsp;Rachel Jackson,&nbsp;William Lucien Irving","doi":"10.1155/2024/6622276","DOIUrl":"https://doi.org/10.1155/2024/6622276","url":null,"abstract":"<p><b>Background:</b> Hepatitis D virus (HDV) infection is an important cause of chronic liver disease yet remains a poorly met clinical challenge. The current European and UK guidelines recommend that all patients with hepatitis B virus (HBV) are tested for HDV, but emerging UK data indicates that only approximately 20% have been tested. The World Health Organization viral hepatitis elimination strategy first requires the systematic testing of people with relevant risk factors, so there is a need to understand factors contributing to low anti-HDV rates of testing.</p><p><b>Methods:</b> An audit was conducted to ascertain the perspectives of patients and healthcare professionals about identifying HDV infection. During a 4-month period, 39 hepatology healthcare professionals and 70 patients with chronic HBV were recruited. The attitudes of healthcare professionals about HDV testing were surveyed according to the seven constructs of the theoretical framework of acceptability (TFA). Patients were surveyed by telephone about their knowledge of HDV and their own testing status.</p><p><b>Results:</b> Among the 39 healthcare professionals, only 66.6% and 53.8% were able to correctly cite EASL (European) HDV and NICE (UK) testing guidelines, respectively, although there were high levels of anti-HDV testing acceptability according to the TFA. Among the patients, 95.7% (67/70) had been tested for anti-HDV and all were seronegative. Only 23% (16/70) knew of the existence of HDV. There was extensive ethnic heterogeneity with 23 countries of birth and 24 different primary languages.</p><p><b>Conclusion:</b> Some clinicians lack familiarity with clinical guideline recommendations for universal testing of all HBsAg-positive patients. Similarly, most patients lack knowledge about HDV. Staff and patient education are required to increase HDV diagnosis.</p>","PeriodicalId":12480,"journal":{"name":"GastroHep","volume":"2024 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/2024/6622276","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574118","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
The Use of Antibiotics for the Prophylaxis of Spontaneous Bacterial Peritonitis: A Retrospective Review and Quality Improvement Study 使用抗生素预防自发性细菌性腹膜炎:回顾与质量改进研究
Pub Date : 2024-07-05 DOI: 10.1155/2024/9271718
Ariana Tagliaferri, Nida Ansari, Gabriel Melki, Yana Cavanagh

Background: Primary and secondary prophylaxis for spontaneous bacterial peritonitis (SBP) should be reserved for high-risk cirrhotic patients, such as those with a history of SBP, gastrointestinal (GI) hemorrhage, high Child–Pugh score, or low ascitic fluid protein (AFP) with liver and renal failure. Due to a multitude of reasons, many patients who require prophylaxis do not receive it. We present a retrospective analysis and quality improvement project. High-risk cirrhotic patients were identified to see if antibiotic prophylaxis was initiated upon admission and the 1-year outcomes for those individuals.

Methods and Results: One hundred twenty-six patients were included in the study. The mean age was 57.38 years. A total of 59.5% (n = 75) of patients were current or former alcohol users. A total of 54.8% (n = 69) of patients met the criteria for SBP prophylaxis; however, only 26% (n = 18) received it (p ≤ 0.073). Ciprofloxacin and cephalosporins were the most used antibiotics. Although none of the analyses for readmissions produced statistical significance, there were clinically more patients readmitted for SBP when prophylaxis was not prescribed. No patients who received prophylaxis were hospitalized within 6 months following a discharge for SBP. Only two of the 18 patients who received prophylaxis died compared to 30 of the 51 patients who did not (p ≤ 0.001). Twenty-eight of the 32 who met the criteria but did not receive prophylaxis were deceased within 1 year following discharge (p ≤ 0.042). When stratified by basic demographics, mortality was significant in the nonprophylaxis groups for males (p ≤ 0.0001), 25–30 body mass index (BMI) group (p ≤ 0.003), and alcohol use (p ≤ 0.002).

Conclusion: We intend to educate providers on the appropriate time to intervene to reduce mortality and subsequent hospitalizations for those with advanced liver disease.

背景:自发性细菌性腹膜炎(SBP)的一级和二级预防应保留给高危肝硬化患者,如那些有 SBP 病史、消化道(GI)出血、Child-Pugh 评分高或腹水蛋白(AFP)低并伴有肝肾功能衰竭的患者。由于多种原因,许多需要预防性治疗的患者并未接受治疗。我们介绍一项回顾性分析和质量改进项目。我们对高危肝硬化患者进行了鉴定,以了解这些患者在入院时是否开始了抗生素预防治疗,以及这些患者一年后的治疗效果:研究共纳入 126 名患者。平均年龄为 57.38 岁。59.5%的患者(75 人)目前或曾经酗酒。共有 54.8%(n = 69)的患者符合 SBP 预防标准,但只有 26%(n = 18)的患者接受了预防(p ≤ 0.073)。环丙沙星和头孢菌素是使用最多的抗生素。虽然对再入院情况的分析都没有统计学意义,但临床上,未使用预防药物的 SBP 再入院患者更多。没有接受预防治疗的患者在因 SBP 出院后 6 个月内再次住院。接受预防治疗的 18 名患者中只有 2 人死亡,而未接受预防治疗的 51 名患者中有 30 人死亡(P ≤ 0.001)。符合标准但未接受预防性治疗的 32 名患者中有 28 人在出院后 1 年内死亡(p ≤ 0.042)。根据基本人口统计学特征进行分层后,未接受预防治疗组中男性(p ≤ 0.0001)、体重指数(BMI)25-30 组(p ≤ 0.003)和饮酒组(p ≤ 0.002)的死亡率显著高于未接受预防治疗组:我们希望教育医疗服务提供者在适当的时间进行干预,以降低晚期肝病患者的死亡率和后续住院率。
{"title":"The Use of Antibiotics for the Prophylaxis of Spontaneous Bacterial Peritonitis: A Retrospective Review and Quality Improvement Study","authors":"Ariana Tagliaferri,&nbsp;Nida Ansari,&nbsp;Gabriel Melki,&nbsp;Yana Cavanagh","doi":"10.1155/2024/9271718","DOIUrl":"https://doi.org/10.1155/2024/9271718","url":null,"abstract":"<p><b>Background:</b> Primary and secondary prophylaxis for spontaneous bacterial peritonitis (SBP) should be reserved for high-risk cirrhotic patients, such as those with a history of SBP, gastrointestinal (GI) hemorrhage, high Child–Pugh score, or low ascitic fluid protein (AFP) with liver and renal failure. Due to a multitude of reasons, many patients who require prophylaxis do not receive it. We present a retrospective analysis and quality improvement project. High-risk cirrhotic patients were identified to see if antibiotic prophylaxis was initiated upon admission and the 1-year outcomes for those individuals.</p><p><b>Methods and Results:</b> One hundred twenty-six patients were included in the study. The mean age was 57.38 years. A total of 59.5% (<i>n</i> = 75) of patients were current or former alcohol users. A total of 54.8% (<i>n</i> = 69) of patients met the criteria for SBP prophylaxis; however, only 26% (<i>n</i> = 18) received it (<i>p</i> ≤ 0.073). Ciprofloxacin and cephalosporins were the most used antibiotics. Although none of the analyses for readmissions produced statistical significance, there were clinically more patients readmitted for SBP when prophylaxis was not prescribed. No patients who received prophylaxis were hospitalized within 6 months following a discharge for SBP. Only two of the 18 patients who received prophylaxis died compared to 30 of the 51 patients who did not (<i>p</i> ≤ 0.001). Twenty-eight of the 32 who met the criteria but did not receive prophylaxis were deceased within 1 year following discharge (<i>p</i> ≤ 0.042). When stratified by basic demographics, mortality was significant in the nonprophylaxis groups for males (<i>p</i> ≤ 0.0001), 25–30 body mass index (BMI) group (<i>p</i> ≤ 0.003), and alcohol use (<i>p</i> ≤ 0.002).</p><p><b>Conclusion:</b> We intend to educate providers on the appropriate time to intervene to reduce mortality and subsequent hospitalizations for those with advanced liver disease.</p>","PeriodicalId":12480,"journal":{"name":"GastroHep","volume":"2024 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/2024/9271718","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141536738","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
Management of Antithrombotic Agents During Emergency Endoscopy for Upper Gastrointestinal Bleeding: A Propensity Score Matching Analysis 上消化道出血急诊内镜检查期间的抗血栓药物管理:倾向得分匹配分析
Pub Date : 2024-06-30 DOI: 10.1155/2024/7561793
Daisuke Yamaguchi, Satoshi Ishida, Kasumi Gondo, Tadahiro Nomura, Azuki Yamaguchi, Ryosuke Asahi, Yumi Mizuta, Goshi Nagatsuma, Shota Fukami, Shunichiro Kimura, Shun Fujimoto, Akane Shimakura, Amane Jubashi, Yuki Takeuchi, Kei Ikeda, Yuichiro Tanaka, Wataru Yoshioka, Naoyuki Hino, Tomohito Morisaki, Keisuke Ario, Seiji Tsunada

Background/Aims: This study is aimed at comparing the outcomes of upper gastrointestinal bleeding (UGIB) during emergency endoscopy between patients taking and not taking antithrombotic agents to inform antithrombotic management.

Methods: We conducted a retrospective analysis of 389 patients who underwent emergency endoscopy for UGIB from 2016 to 2021. The patients were categorized into group A (taking antithrombotic agents) and group NA (not taking antithrombotic agents). The clinical characteristics, types of antithrombotic agents, patient status upon admission, and causes of UGIB were examined. Treatment outcomes and adverse events were assessed by propensity score matching (PSM).

Results: Group A was significantly older and the primary antithrombotic agent was low-dose aspirin, with multiple antithrombotics taken by 38 patients (29.0%). Peptic ulcers were the most common cause of UGIB in both groups. PSM generated 83 matched pairs. The success rate of endoscopic hemostasis in group A was significantly higher than in group NA (96.4% vs. 84.3%, P = 0.02). Despite promptly resuming antithrombotic agent posthemostasis, there was no significant difference in the rebleeding rate or 30-day mortality.

Conclusion: The high success rate of endoscopic hemostasis and no difference in adverse events made the prompt resumption of antithrombotic medications after emergency endoscopy for UGIB acceptable.

Trial Registration: ClinicalTrials.gov identifier: UMIN000053561

背景/目的:本研究旨在比较服用和未服用抗血栓药物的患者在急诊内镜检查期间发生上消化道出血(UGIB)的结果,为抗血栓治疗提供参考:我们对 2016 年至 2021 年期间因 UGIB 而接受急诊内镜检查的 389 名患者进行了回顾性分析。患者被分为A组(服用抗血栓药物)和NA组(未服用抗血栓药物)。研究人员对患者的临床特征、抗血栓药物类型、入院时的状态以及导致 UGIB 的原因进行了调查。通过倾向得分匹配法(PSM)对治疗结果和不良事件进行了评估:结果:A 组患者年龄明显偏大,主要抗血栓药物为小剂量阿司匹林,38 名患者(29.0%)服用了多种抗血栓药物。消化性溃疡是两组 UGIB 最常见的病因。PSM 产生了 83 对配对。A 组的内镜止血成功率明显高于 NA 组(96.4% 对 84.3%,P = 0.02)。尽管止血后及时恢复使用抗血栓药物,但再出血率和30天死亡率没有显著差异:结论:内镜止血成功率高,且不良反应无差异,因此UGIB急诊内镜术后及时恢复抗血栓药物治疗是可以接受的:试验注册:ClinicalTrials.gov identifier:UMIN000053561
{"title":"Management of Antithrombotic Agents During Emergency Endoscopy for Upper Gastrointestinal Bleeding: A Propensity Score Matching Analysis","authors":"Daisuke Yamaguchi,&nbsp;Satoshi Ishida,&nbsp;Kasumi Gondo,&nbsp;Tadahiro Nomura,&nbsp;Azuki Yamaguchi,&nbsp;Ryosuke Asahi,&nbsp;Yumi Mizuta,&nbsp;Goshi Nagatsuma,&nbsp;Shota Fukami,&nbsp;Shunichiro Kimura,&nbsp;Shun Fujimoto,&nbsp;Akane Shimakura,&nbsp;Amane Jubashi,&nbsp;Yuki Takeuchi,&nbsp;Kei Ikeda,&nbsp;Yuichiro Tanaka,&nbsp;Wataru Yoshioka,&nbsp;Naoyuki Hino,&nbsp;Tomohito Morisaki,&nbsp;Keisuke Ario,&nbsp;Seiji Tsunada","doi":"10.1155/2024/7561793","DOIUrl":"https://doi.org/10.1155/2024/7561793","url":null,"abstract":"<p><b>Background/Aims:</b> This study is aimed at comparing the outcomes of upper gastrointestinal bleeding (UGIB) during emergency endoscopy between patients taking and not taking antithrombotic agents to inform antithrombotic management.</p><p><b>Methods:</b> We conducted a retrospective analysis of 389 patients who underwent emergency endoscopy for UGIB from 2016 to 2021. The patients were categorized into group A (taking antithrombotic agents) and group NA (not taking antithrombotic agents). The clinical characteristics, types of antithrombotic agents, patient status upon admission, and causes of UGIB were examined. Treatment outcomes and adverse events were assessed by propensity score matching (PSM).</p><p><b>Results:</b> Group A was significantly older and the primary antithrombotic agent was low-dose aspirin, with multiple antithrombotics taken by 38 patients (29.0%). Peptic ulcers were the most common cause of UGIB in both groups. PSM generated 83 matched pairs. The success rate of endoscopic hemostasis in group A was significantly higher than in group NA (96.4% vs. 84.3%, <i>P</i> = 0.02). Despite promptly resuming antithrombotic agent posthemostasis, there was no significant difference in the rebleeding rate or 30-day mortality.</p><p><b>Conclusion:</b> The high success rate of endoscopic hemostasis and no difference in adverse events made the prompt resumption of antithrombotic medications after emergency endoscopy for UGIB acceptable.</p><p><b>Trial Registration:</b> ClinicalTrials.gov identifier: UMIN000053561</p>","PeriodicalId":12480,"journal":{"name":"GastroHep","volume":"2024 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/2024/7561793","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141489016","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
High Technical Success Rate of Endoscopic Balloon Dilatation Reduces Surgical Requirement for Patients With Stricturing Crohn’s Disease 内镜下球囊扩张术技术成功率高,可减少克罗恩病患者的手术需求
Pub Date : 2024-06-09 DOI: 10.1155/2024/3686618
Emily Lim, Maxter Thai, Yoon-Kyo An, Peter Hendy, Mahmoud Alchlaihawi, Rupert Leong, Susan Connor, Watson Ng, Bonita Gu, Lena Thin, Miles Sparrow, Robert Gilmore, Kirstin Taylor, Olivia Sallis, Jane M. Andrews, Charlotte Daker, Richard B. Gearry, Gabrielle Wark, Simon Ghaly, Matt Begun, Krupa Krishnaprasad, Tianhong Wu, Leonie Ruddick-Collins, Veronika Schreiber, Satomi Okano, Graham Radford-Smith, Julien Schulberg, Daniel van Langenberg, Jakob Begun

Background: Endoscopic balloon dilatation (EBD) is an alternative therapy to avoid or delay surgery in stricturing Crohn’s disease (CD); however, certain factors determining outcomes remain poorly defined, and conflicting evidence exists in current studies. In one of the largest cohorts to date, we assess outcomes following EBD for stricturing CD for both anastomotic and de novo strictures.

Methods: A retrospective cohort study of CD patients undergoing EBD was conducted at 12 hospitals across Australia and New Zealand. Local databases were used to identify cases from February 1999 to November 2019. Data from patient endoscopy reports and medical records were used to determine patient medical details and EBD outcomes. Multivariable analysis was undertaken to identify factors associated with technical and long-term success.

Results: A total of 273 patients with stricturing CD were identified (48% female; 49.6% Montreal L3 disease). Of 695 EBD procedures (355 anastomotic, 340 de novo strictures), the majority (80.1% of strictures with identified length) was performed on short strictures (< 4 cm). Technical success, defined as the ability to traverse the stricture with a colonoscope after dilation, was achieved in 577 (83%) of endoscopic procedures, with success more likely with de novo strictures compared with anastomotic strictures (aOR: 3.21, P = 0.010). A significantly higher failure rate was noted with long strictures (aOR: 0.09, P < 0.001). A total of 74 patients (27%) required surgery within 5 years with stricture length, the only significant factor associated with increased surgery risk (aHR: 2.37, P < 0.01).

Conclusion: EBD is a highly effective and safe procedure in both de novo and anastomotic strictures < 4 cm that can prevent or delay the need for surgical treatment.

背景:内镜下球囊扩张术(EBD)是避免或推迟手术治疗克罗恩病(CD)狭窄的一种替代疗法;然而,决定治疗效果的某些因素仍未得到很好的界定,目前的研究中也存在相互矛盾的证据。在迄今为止规模最大的队列研究中,我们对EBD治疗CD吻合口狭窄和新生狭窄的效果进行了评估:方法:我们在澳大利亚和新西兰的 12 家医院对接受 EBD 的 CD 患者进行了回顾性队列研究。当地数据库用于识别 1999 年 2 月至 2019 年 11 月期间的病例。患者内镜检查报告和医疗记录中的数据用于确定患者的医疗细节和 EBD 结果。进行了多变量分析,以确定与技术和长期成功相关的因素:共确定了273名严格意义上的CD患者(48%为女性;49.6%为蒙特利尔L3疾病)。在695例EBD手术(355例吻合,340例新发狭窄)中,大部分(80.1%的狭窄长度已确定)是针对短狭窄(4厘米)实施的。577例(83%)内镜手术取得了技术成功,技术成功的定义是扩张后能用结肠镜穿过狭窄处,与吻合口狭窄相比,新发狭窄的成功率更高(aOR:3.21,P = 0.010)。长狭窄的失败率明显更高(aOR:0.09,P = 0.001)。共有 74 名患者(27%)需要在 5 年内进行手术,狭窄长度是唯一与手术风险增加相关的重要因素(aHR:2.37,P < 0.01):EBD是一种高效、安全的治疗方法,适用于新发和吻合口狭窄< 4厘米的患者,可避免或推迟手术治疗的需要。
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引用次数: 0
The Suitability of Stool Antigen Testing in the Detection of Helicobacter pylori in a Regional and Rural Area of Australia 粪便抗原检测在澳大利亚地区和农村幽门螺杆菌检测中的适用性
Pub Date : 2023-10-20 DOI: 10.1155/2023/6642474
Timothy Wearne, Safaa Nadeem, Bruce Wilson, Kylie J. Mansfield, Caitlin Keighley

Background. Helicobacter pylori is considered the most widespread bacterial pathogen worldwide. Successful eradication protocols are well established, highlighting the importance of appropriate infection detection. Noninvasive testing (NIT) methods are commonly used to detect infection, with test selection dependent on access and previous infection. This study examined trends in NIT by age group and test selection for eradication screening as well as examining H. pylori area prevalence by socioeconomic status (SES) in the Illawarra Shoalhaven and surrounding region. Materials and Methods. This retrospective cohort quantitative study is based on 20,998 NIT including stool antigen test (SAT), urea breath test (UBT), or H. pylori serology via Southern.IML Pathology between 2018 and 2020. Test percentage positives per and total test percentages within age groups were calculated for each NIT. Positive sample postcode data was assigned to socioeconomic percentiles. Total test utilisation and prevalence were calculated and depicted as geospatial representations. Results. Overall: 58.5% UBT, 31% serology, and 10.5% SAT were performed, with 14.7% positive for any NIT. Highest percent positive age group: SAT 80-89yo (18.6%), UBT 0-9yo (20.8%), and serology 90–99yo (32.6%). Test majority per age group: SAT 0-9yo (67.4%), UBT 10-89yo (59.4%), and serology 90-99yo (48.3%). A trend was seen between increasing infection prevalence and increasing socioeconomic disadvantage (p = 0.161, R2 = 0.0361). Prevalence rates visually correlated with total test utilisation. Conclusions. SAT was underutilised compared to UBT or serology. Serology was inappropriately used in older age groups, and the result validity was questioned following confirmed infection. SAT is a viable alternative for use in these settings. No significant correlation was seen between lower SES areas and higher H. pylori infection prevalence, but low-test utilisation suggests likely prevalence underestimation within the studied area and may indicate reduced accessibility to healthcare.

背景。幽门螺杆菌被认为是世界上分布最广的细菌病原体。成功的根除方案已经建立,这突出了适当的感染检测的重要性。非侵入性检测(NIT)方法通常用于检测感染,检测选择取决于获取途径和既往感染。本研究在Illawarra Shoalhaven及周边地区按年龄组和根除筛查的测试选择检查了NIT的趋势,并按社会经济地位(SES)检查了幽门螺杆菌地区的流行情况。材料与方法。本回顾性队列定量研究基于20,998份NIT,包括粪便抗原测试(SAT),尿素呼气测试(UBT)或南方幽门螺杆菌血清学。2018年至2020年的IML病理学。计算每个NIT年龄组的每个检测阳性百分比和总检测百分比。阳性样本邮编数据被分配到社会经济百分位数。计算总测试利用率和流行率,并将其描述为地理空间表示。结果。总体而言:58.5%的UBT, 31%的血清学和10.5%的SAT, 14.7%的NIT阳性。阳性比例最高的年龄组:SAT 80-89岁(18.6%),UBT 0- 90岁(20.8%),血清学90 - 99岁(32.6%)。每个年龄组的测试多数:SAT 0- 90岁(67.4%),UBT 10-89岁(59.4%),血清学90-99岁(48.3%)。感染率增加与社会经济劣势增加之间存在趋势(p = 0.161, R2 = 0.0361)。流行率与总测试使用率在视觉上相关。结论。与UBT或血清学相比,SAT未得到充分利用。血清学在老年人群中应用不当,确诊感染后结果的有效性受到质疑。SAT是在这些环境中使用的可行替代方案。社会经济地位较低的地区与较高的幽门螺杆菌感染率之间没有显著相关性,但低检测使用率表明,研究地区的患病率可能被低估,并可能表明获得医疗保健的机会减少。
{"title":"The Suitability of Stool Antigen Testing in the Detection of Helicobacter pylori in a Regional and Rural Area of Australia","authors":"Timothy Wearne,&nbsp;Safaa Nadeem,&nbsp;Bruce Wilson,&nbsp;Kylie J. Mansfield,&nbsp;Caitlin Keighley","doi":"10.1155/2023/6642474","DOIUrl":"10.1155/2023/6642474","url":null,"abstract":"<div>\u0000 <p><i>Background</i>. <i>Helicobacter pylori</i> is considered the most widespread bacterial pathogen worldwide. Successful eradication protocols are well established, highlighting the importance of appropriate infection detection. Noninvasive testing (NIT) methods are commonly used to detect infection, with test selection dependent on access and previous infection. This study examined trends in NIT by age group and test selection for eradication screening as well as examining <i>H. pylori</i> area prevalence by socioeconomic status (SES) in the Illawarra Shoalhaven and surrounding region. <i>Materials and Methods</i>. This retrospective cohort quantitative study is based on 20,998 NIT including stool antigen test (SAT), urea breath test (UBT), or <i>H. pylori</i> serology via Southern.IML Pathology between 2018 and 2020. Test percentage positives per and total test percentages within age groups were calculated for each NIT. Positive sample postcode data was assigned to socioeconomic percentiles. Total test utilisation and prevalence were calculated and depicted as geospatial representations. <i>Results</i>. Overall: 58.5% UBT, 31% serology, and 10.5% SAT were performed, with 14.7% positive for any NIT. Highest percent positive age group: SAT 80-89yo (18.6%), UBT 0-9yo (20.8%), and serology 90–99yo (32.6%). Test majority per age group: SAT 0-9yo (67.4%), UBT 10-89yo (59.4%), and serology 90-99yo (48.3%). A trend was seen between increasing infection prevalence and increasing socioeconomic disadvantage (<i>p</i> = 0.161, <i>R</i><sup>2</sup> = 0.0361). Prevalence rates visually correlated with total test utilisation. <i>Conclusions</i>. SAT was underutilised compared to UBT or serology. Serology was inappropriately used in older age groups, and the result validity was questioned following confirmed infection. SAT is a viable alternative for use in these settings. No significant correlation was seen between lower SES areas and higher <i>H. pylori</i> infection prevalence, but low-test utilisation suggests likely prevalence underestimation within the studied area and may indicate reduced accessibility to healthcare.</p>\u0000 </div>","PeriodicalId":12480,"journal":{"name":"GastroHep","volume":"2023 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/2023/6642474","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135568075","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
Visualized Quantitative Evaluation of Gastrointestinal Activity in Healthy Volunteers Using a Noninvasive Single-Channel Electroamplifier 使用无创单通道电放大器对健康志愿者胃肠道活动进行可视化定量评估
Pub Date : 2023-09-14 DOI: 10.1155/2023/6902635
Gen Aikawa, Misaki Kotani, Hideaki Sakuramoto, Akira Ouchi, Mitsuki Ikeda, Tetsuya Hoshino, Nobuyuki Araki, Yuki Enomoto, Nobutake Shimojo, Yoshiaki Inoue

Background. Electrogastrography and electroenterography are noninvasive methods for measuring gastric and intestinal electrical activities, respectively. Few studies have measured electroenterography in healthy humans; however, no studies have measured electrogastrography and electroenterography simultaneously. This study was performed to provide basic electrogastrography and electroenterography data for comparison with future studies in patients. Methods. Simultaneous preprandial and postprandial measurements of electrogastrography and electroenterography were taken for 30 min each in 50 healthy volunteers. Power spectrum analysis was performed to calculate dominant frequency, dominant power, and power ratio. Results. Gastric and small intestinal dominant frequencies were not significantly different between preprandial and postprandial periods. In preprandial and postprandial periods, normogastria was seen in 49 (98%) and 44 (88%) patients (p = 0.063), bradygastria in 1 (2%) and 6 (12%) patients (p = 0.063), and tachygastria in 0 (0%) patients, respectively. Dominant power was significantly increased in the stomach (828 [460–3203] μV2 vs. 1526 [759–2958] μV2, p = 0.016) and small intestine (49 [27–86] μV2 vs. 68 [37–130] μV2, p < 0.001). The power ratio was 1.6 (0.9–2.5) in the stomach and 1.4 (1.0–2.5) in the small intestine. Body mass index showed a negative correlation with the stomach and small intestinal dominant power in preprandial and postprandial periods (rs = −0.566, p < 0.001; rs = −0.534, p < 0.001; rs = −0.459, p < 0.001; and rs = −0.529, p < 0.001, respectively). The Bristol Stool Form Scale correlated positively with the small intestinal power ratio (rs = −0.430, p = 0.002). Conclusion. There was no change in frequency in the stomach or small intestine, but power significantly increased in both the stomach and small intestine.

背景。胃电图和肠电图分别是测量胃和肠电活动的无创方法。很少有研究测量健康人的肠电图;然而,没有研究同时测量胃电图和肠电图。本研究的目的是提供基本的胃电图和肠电图数据,以便与未来的患者研究进行比较。方法。对50名健康志愿者分别进行30分钟的餐前和餐后胃电图和肠电图测量。功率谱分析计算主导频率、主导功率和功率比。结果。胃和小肠的优势频率在餐前和餐后无显著差异。在餐前和餐后,正常胃痛49例(98%)和44例(88%)(p = 0.063),胃缓1例(2%)和6例(12%)(p = 0.063),胃过速0例(0%)。胃(828 [460-3203]μV2 vs. 1526 [759-2958] μV2, p = 0.016)和小肠(49 [27-86]μV2 vs. 68 [37-130] μV2, p <;0.001)。胃的功率比为1.6(0.9 ~ 2.5),小肠的功率比为1.4(1.0 ~ 2.5)。在餐前和餐后,体重指数与胃和小肠主导力呈负相关(rs = - 0.566, p <;0.001;Rs =−0.534,p <;0.001;Rs =−0.459,p <;0.001;rs =−0.529,p <;分别为0.001)。布里斯托大便形态量表与小肠功率比呈正相关(rs = - 0.430, p = 0.002)。结论。胃和小肠的频率没有变化,但胃和小肠的功率显著增加。
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引用次数: 0
Clinical Outcomes and Patient Experience of Biosimilar to Biosimilar Infliximab Switching in Patients with Inflammatory Bowel Disease: A Prospective, Single-Centre, Phase IV Interventional Study with a Nested Qualitative Study 炎症性肠病患者从生物类似药转向英夫利昔单抗的临床结果和患者体验:一项前瞻性、单中心、IV期介入性研究和嵌套定性研究
Pub Date : 2023-08-25 DOI: 10.1155/2023/1248526
Clare Harris, Richard James Harris, David Young, Martin McDonnell, Bridget Clancy, Justin Harvey, Carlos Araujo, Ines Iria, Joao Goncalves, Susan Latter, J. R. Fraser Cummings

Background and Aims. Regulatory pathways compare biosimilars with originator molecules only and not with other biosimilars. With the development of multiple infliximab biosimilars, patients may be asked to transition between them. Data is emerging but there is still a gap in the evidence on switching between infliximab biosimilars. Our aim was to conduct a full evaluation of switching a cohort of IBD patients from one biosimilar (CT-P13) to another (SB2) in a real-world setting including clinical and patient experience and molecular and drug immunogenicity aspects of the process. Methods. Prospective, phase IV interventional study of patients on CT-P13 switched to SB2. Demographics, disease history, validated disease activity scores, PROMs, and laboratory measurements were collected. Semistructured qualitative interviews were also conducted. Results. 133 out of 158 patients agreed to participate. Mean disease duration was 9.2 years. There was no difference in mean haemoglobin, platelet count, albumin, and C-reactive protein before and after switching. Mean faecal calprotectin at baseline and at week 30/32 was 306 μg/g versus 210 μg/g. Mean pMCS and mHBI at baseline were 1.54 and 3.14 versus 1.18 and 2.91 at week 30/32, respectively. Thirty-five subjects discontinued. There were 16 serious adverse events. Thematic analysis identified six major themes that reflected the patient experience—trust, clinical status at the point of switching, past experience, general disposition, information provision, and concerns/anxiety. Conclusions. Switching from CT-P13 to SB2 is safe and effective. Certain factors must be considered in supporting patient decision-making. These results support the development of clear, streamlined, and well-monitored biosimilar switching programmes.

背景和目的。调控途径仅将生物仿制药与原始分子进行比较,而不与其他生物仿制药进行比较。随着多种英夫利昔单抗生物类似药的开发,患者可能会被要求在它们之间进行转换。数据正在出现,但在英夫利昔单抗生物类似药之间切换的证据仍然存在差距。我们的目的是在现实环境中对IBD患者队列从一种生物仿制药(CT-P13)切换到另一种生物仿制药(SB2)进行全面评估,包括临床和患者经验以及该过程的分子和药物免疫原性方面。方法。CT-P13转为SB2的前瞻性IV期介入研究收集了人口统计学、病史、已验证的疾病活动评分、prom和实验室测量数据。还进行了半结构化定性访谈。结果:158名患者中有133名同意参与。平均病程为9.2年。转换前后的平均血红蛋白、血小板计数、白蛋白和c反应蛋白均无差异。基线和第30/32周时的粪钙保护蛋白平均值分别为306 μg/g和210 μg/g。基线时的平均pMCS和mHBI分别为1.54和3.14,而第30/32周时分别为1.18和2.91。35个研究对象停止了。严重不良事件16例。主题分析确定了六个主要主题,反映了患者的经验-信任,临床状态在转换点,过去的经验,一般处置,信息提供,和担忧/焦虑。结论。从CT-P13切换到SB2是安全有效的。在支持患者决策时必须考虑某些因素。这些结果支持开发清晰、简化和良好监测的生物类似药转换计划。
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