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Balloon Dilation-assisted Extraction of Embedded Self-Expandable Metal Stents. 球囊扩张辅助取出内埋自膨胀金属支架。
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-04-01 DOI: 10.51821/88.1.14150
M Bronswijk, A Reekmans, S van der Merwe

Background and study aims: Embedded transpapillary self-expandable metal stents (SEMS) may require extraction over time and standard approaches often fail. In the current study we describe a newly developed approach to refractory embedded SEMS, using balloon dilation-assisted extraction. Our aim was to evaluate the feasibility and outcomes of this novel technique.

Patients and methods: This is an exploratory single-center retrospective analysis of all consecutive patients undergoing endoscopic balloon-assisted stent extraction. Baseline, procedural and follow-up data were collected and analyzed.

Results: Twelve patients with embedded transpapillary SEMS were identified (60.0% female, mean age 70.1 [SD±18.1] years, uncovered SEMS 33.3%) with median dwell time of 457.5 (IQR 175.8-1042) days. Previous extraction attempts were undertaken in the majority of cases (83.3%), including SEMS-in-SEMS placement (41.7%). Using the balloon-assisted stent extraction technique, successful SEMS extraction was achieved in 10 out of 12 cases (83.3%). Adverse events occurred in 3 patients (Grade II [n=2, 16.7%] - Grade III [n=1, 8.3%]). After a median follow-up time of 171 (58-260) days, 1 biliary recurrence occurred for which endoscopic re-evaluation was performed.

Conclusions: Our data suggest that endoscopic balloonassisted stent extraction should be considered for extraction of embedded self-expandable metal stents, as it showed high efficacy without any major procedure-related adverse events, using readily available endoscopic tools.

背景和研究目的:随着时间的推移,嵌入式经乳头自膨胀金属支架(SEMS)可能需要拔出,而标准方法往往失败。在目前的研究中,我们描述了一种新开发的方法,使用球囊扩张辅助提取难熔嵌入SEMS。我们的目的是评估这种新技术的可行性和结果。患者和方法:这是一项探索性的单中心回顾性分析,纳入了所有连续接受内镜球囊辅助支架取出术的患者。收集和分析基线、程序和随访数据。结果:共发现12例包埋式经乳头SEMS患者(女性60.0%,平均年龄70.1 [SD±18.1]岁,未覆盖SEMS 33.3%),中位停留时间457.5 (IQR 175.8-1042)天。大多数病例(83.3%)都进行过拔牙尝试,包括SEMS-in-SEMS放置(41.7%)。采用球囊辅助支架提取技术,12例患者中有10例(83.3%)SEMS提取成功。3例患者发生不良事件(II级[n= 2,16.7%] - III级[n= 1,8.3%])。中位随访时间为171(58-260)天,发生1例胆道复发,并进行了内镜下重新评估。结论:我们的数据表明,内镜下球囊辅助支架提取术应该被考虑用于取出嵌入的自膨胀金属支架,因为它显示出高效率,没有任何主要的手术相关不良事件,使用现成的内镜工具。
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引用次数: 0
Belgian consensus on the management of patients with functional dyspepsia. 比利时对功能性消化不良患者处理的共识。
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-04-01 DOI: 10.51821/88.1.14136
S Kindt, J Arts, P Caenepeel, F de Clerck, H De Schepper, H Louis, P Latour, T Mahler, S Nullens, H Piessevaux, K Routhiaux, J Schol, M Surmont, H Vafa, C Van de Bruaene, K Van Malderen, T Vanuytsel, L Wauters, F Wuestenberghs, J Tack

Background: Functional dyspepsia (FD) is a disorder of gutbrain interaction characterised by epigastric pain, epigastric burning, early satiation or postprandial fullness. Despite its high prevalence, clinicians struggle with the diagnosis and management of these patients.

Methods: A Delphi consensus was conducted by 20 experts from Belgium, and consisted of a literature review, summarising the existing evidence, and a voting process on 119 statements. Grading of recommendations, assessment, development and evaluation criteria were applied to evaluate the quality of evidence. Consensus was defined as > 80 % agreement.

Results: Belgian consensus underlines the multifactorial aetiology of FD. In addition to the cardinal symptoms, bloating and weight loss are also observed in FD. Functional dyspepsia co-exists with other DGBIs, including IBS. Subtyping based on the postprandial nature of symptoms is recommended. Patients should receive a positive diagnosis. Additional testing is not routinely required before initiating therapy, except in the presence of alarm features or treatment-refractory symptoms, and can consist of upper GI endoscopy, abdominal imaging and gastric emptying testing. The consensus refuted the role of carbohydrate malabsorption testing, pyloric impedance planimetry, pH/impedance monitoring, food allergy testing and permeability testing in FD. Explanation and reassurance, also addressing lifestyle factors, represent the cornerstone of the management. Proton Pump Inhibitors are considered the firstline pharmacological treatment. With the exception of specific neuromodulators, the panel did not achieve consensus for other therapeutic options. This consensus recommends against restrictive diets, invasive endoscopic or surgical treatment, parenteral nutrition, antibiotics, spasmolytics and opioids in the management of FD.

Conclusion: A panel of Belgian experts summarised the existing evidence on the aetiology, presentation, diagnosis and treatment of FD with attention to the availability within the Belgian healthcare system. Areas of future research are identified.

背景:功能性消化不良(FD)是一种以胃脘痛、胃脘烧灼感、早饱或餐后饱腹为特征的肠脑相互作用紊乱。尽管发病率很高,临床医生仍在努力诊断和管理这些患者。方法:由来自比利时的20位专家进行德尔菲共识,包括文献综述,总结现有证据,并对119项声明进行投票。采用建议、评估、发展和评价标准的分级来评价证据的质量。共识被定义为达成80%的共识。结果:比利时共识强调FD的多因素病因。除了主要症状外,FD患者还观察到腹胀和体重减轻。功能性消化不良与其他dgbi共存,包括肠易激综合征。建议根据餐后症状进行分型。患者应接受阳性诊断。在开始治疗之前,常规不需要额外的检查,除非存在报警特征或治疗难治性症状,并且可以包括上消化道内窥镜检查、腹部成像和胃排空检查。该共识驳斥了碳水化合物吸收不良试验、幽门阻抗平面测量、pH/阻抗监测、食物过敏试验和渗透性试验在FD中的作用。解释和安慰,也解决生活方式的因素,是管理的基石。质子泵抑制剂被认为是第一线的药物治疗。除了特定的神经调节剂外,专家组没有就其他治疗方案达成共识。该共识不建议限制性饮食、侵入性内窥镜或手术治疗、肠外营养、抗生素、解痉药和阿片类药物用于FD的治疗。结论:比利时专家小组总结了关于FD的病因、表现、诊断和治疗的现有证据,并注意了比利时医疗保健系统内的可用性。确定了未来的研究领域。
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引用次数: 0
Clinical analysis of ultrasound-guided warm saline enema in the treatment of pediatric intussusception. 超声引导温盐水灌肠治疗小儿肠套叠的临床分析。
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-04-01 DOI: 10.51821/88.1.13622
Jiankang Guo, Yanhong Bai, You Liang, Ya-Na Liu, Bin Zhang, Zhigang Fan

Objective: Few studies have explored using ultrasound-guided warm saline enema to treat acute intussusception in children. This article aimed to assess the effect of warm saline enema on acute intussusception in children.

Methods: In this study, we retrospectively analyzed 169 children who underwent ultrasound-guided warm saline enema treatment for pediatric intussusception in 3201 Hospital, Shanxi, China between January 1, 2020, and December 31, 2022.

Results: Out of the 169 children included in the study, 156 were successfully treated, while 13 did not respond to the treatment. The success rate was 92.31%, and the failure rate was 7.69%. The reduction time and hospital stay in 169 children ranged from 9 to 54 minutes and 1 to 25 days, respectively. On average, the reduction process took about 20.84±4.86 minutes, and the hospital stay was around 3.79±2.49 days. Among the 169 children, 3 experienced nausea and vomiting, while none had postoperative diarrhea or intestinal perforation. The overall incidence of complications like nausea and vomiting was 1.78%.

Conclusions: A total of 169 children with intussusception underwent treatment using ultrasound-guided warm saline enema. The reduction time was consistent with the existing literature. Complications were small in these cases, only manifested as nausea and vomiting. These findings also provide valuable evidence for clinical management of these diseases.

目的:超声引导下温盐水灌肠治疗小儿急性肠套叠的研究较少。本文旨在探讨温盐水灌肠治疗小儿急性肠套叠的效果。方法:本研究回顾性分析2020年1月1日至2022年12月31日在中国山西省3201医院接受超声引导下温盐水灌肠治疗小儿肠套叠的169例患儿。结果:在纳入研究的169名儿童中,156人成功治疗,13人对治疗无反应。成功率为92.31%,失败率为7.69%。169名儿童的减少时间和住院时间分别为9至54分钟和1至25天。平均复位时间为20.84±4.86分钟,住院时间为3.79±2.49天。169例患儿中,3例出现恶心呕吐,无一例术后腹泻或肠穿孔。恶心呕吐等并发症的总发生率为1.78%。结论:169例患儿采用超声引导下温盐水灌肠治疗肠套叠。还原时间与已有文献一致。这些病例的并发症很少,仅表现为恶心和呕吐。这些发现也为这些疾病的临床管理提供了有价值的证据。
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引用次数: 0
A slobbering appendix. 一个流口水的阑尾。
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-04-01 DOI: 10.51821/88.1.14237
C Collin, J-P Loly
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引用次数: 0
Indirect calorimetry in canopy mode in healthy subjects: performances of the Q-NRG device compared to the Deltatrac II. 健康受试者冠层模式下的间接量热:Q-NRG装置与Deltatrac II的性能比较
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-01 DOI: 10.51821/88.1.13301
M Fadeur, J F Kaux, J De Flines, B Misset, N Paquot, A F Rousseau

Background: Extensive validation of the Q-NRG indirect calorimeter in canopy mode, especially against reference devices, is lacking. The aim of this study was to test its agreement in canopy mode with the Deltratrac II, which has always been considered as the gold standard indirect calorimeter in daily practice.

Methods: Healthy volunteers underwent indirect calorimetry with two consecutive assessments, using Q-NRG and Deltatrac II, both in canopy mode, in a random order, after careful calibrations. Body position, fasting conditions and environment were standardized. Agreement between the two devices was evaluated by paired Student's t test, correlation coefficients, and Bland-Altman plots.

Results: Sixty-one adults (85.2% male, aged 25.7±8.4 y, BMI 23.3±2.9 kg/m2) were included. Measured energy expenditure was similar whether it was measured using Q-NRG or Deltatrac II: 1816±361 kcal/day or 1809±260 kcal/day (p=0.803), respectively. There was a significant positive correlation between the two measures (ρ=0.78, p= <0.01). The Q-NRG slightly overestimated the energy expenditure compared to the Deltatrac II measure: the bias ± limits of agreement was 7 ± 227 kcal/day.

Conclusion: In healthy volunteers breathing spontaneously, the Q-NRG in canopy mode performed similarly to the Deltatrac II for energy expenditure measurement. The present study confirms the previously demonstrated accuracy of the Q-NRG device, and supports its clinical use in canopy mode.

背景:Q-NRG 间接热量计在天幕模式下的广泛验证,尤其是与参考设备的对比,尚属空白。本研究的目的是测试 Q-NRG 间接热量计在顶棚模式下与 Deltratrac II 间接热量计的一致性,后者一直被认为是日常使用的金标准间接热量计。方法:健康志愿者在经过仔细校准后,使用 Q-NRG 和 Deltatrac II 进行了两次连续的间接热量测量,均采用顶棚模式,顺序随机。体位、空腹条件和环境均已标准化。通过配对学生 t 检验、相关系数和 Bland-Altman 图评估两种设备之间的一致性:共纳入 61 名成年人(85.2% 为男性,年龄为 25.7±8.4 岁,体重指数为 23.3±2.9 kg/m2)。无论是使用 Q-NRG 还是 Deltatrac II 测量的能量消耗都相似:分别为 1816±361 千卡/天或 1809±260 千卡/天(P=0.803)。这两个测量值之间存在明显的正相关性(ρ=0.78,p= 结论):对于自主呼吸的健康志愿者,Q-NRG 在天幕模式下与 Deltatrac II 在能量消耗测量方面的表现相似。本研究证实了 Q-NRG 设备之前所证明的准确性,并支持其在天幕模式下的临床应用。
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引用次数: 0
Precision imaging in chronic liver disease management. 精确影像学在慢性肝病治疗中的应用。
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-01 DOI: 10.51821/88.1.14128
Maxime Nachit

Metabolic dysfunction-associated fatty liver disease (MAFLD) affects over a quarter of the global population, with up to 30% developing Metabolic Dysfunction-Associated Steatohepatitis (MASH), a progressive form that can silently lead to fibrosis, cirrhosis, and liver cancer. Current diagnostic methods, including blood-based scores and imaging, are insufficient for early detection, leading to late-stage diagnoses in most patients. Liver biopsy remains the diagnostic gold standard but is invasive, costly, and prone to high inter- and intra-reader variability, limiting its utility in routine care and clinical trials. Our research highlights myosteatosis-fat infiltration in skeletal muscle-as a potential early, non-invasive marker of MASH. In preclinical models and clinical studies, myosteatosis correlated with the presence of MASH and distinguished it from isolated steatosis. Notably, reductions in myosteatosis following interventions such as bariatric surgery or dietary regimens were associated with histological improvements in MASH, suggesting a potential role in predicting treatment response. In larger cohorts, myosteatosis was identified as a strong predictor of all-cause mortality. In parallel, we utilized a VCAM- 1-targeted molecular imaging technique and demonstrated a high accuracy in detecting inflammation in preclinical MASH models. This technology is now advancing to clinical trials for validation in humans. Taken together, our data support that targeted medical imaging may enable early, non-invasive diagnosis and monitoring of MASH, reducing reliance on liver biopsy and improving patient outcomes.

代谢功能障碍相关脂肪性肝病(MAFLD)影响着全球超过四分之一的人口,其中高达30%的人发展为代谢功能障碍相关脂肪性肝炎(MASH),这是一种进行性形式,可悄无声息地导致纤维化、肝硬化和肝癌。目前的诊断方法,包括基于血液的评分和成像,不足以早期发现,导致大多数患者的晚期诊断。肝活检仍然是诊断的金标准,但它是侵入性的,昂贵的,并且容易在阅读器之间和阅读器内部发生高度变异性,限制了它在常规护理和临床试验中的应用。我们的研究强调骨骼肌脂肪浸润是一种潜在的早期、非侵入性的MASH标志物。在临床前模型和临床研究中,肌骨化症与MASH的存在相关,并将其与孤立的脂肪变性区分开来。值得注意的是,在减肥手术或饮食方案等干预措施后,肌骨化症的减少与MASH的组织学改善有关,这表明在预测治疗反应方面具有潜在作用。在更大的队列中,肌骨化病被确定为全因死亡率的一个强有力的预测因子。同时,我们利用VCAM- 1靶向分子成像技术,在临床前MASH模型中检测炎症具有很高的准确性。这项技术目前正在推进人体临床试验。综上所述,我们的数据支持有针对性的医学成像可以实现早期、非侵入性诊断和监测MASH,减少对肝活检的依赖,改善患者的预后。
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引用次数: 0
Decision making in technical evaluation and treatment of pelvic floor multidisciplinary team discussion. Will multidisciplinary team discussion change policy? 决策技术评价和治疗盆底多学科小组讨论。多学科团队讨论会改变政策吗?
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-01 DOI: 10.51821/88.1.13210
C Steger, S Vanden Broeck, H De Schepper

Pelvic floor multidisciplinary team (MDT) discussion is emerging as a standard part of care for patients with pelvic floor disorders. Although its use is encouraged by guidelines, there is still a lack of solid evidence supporting its benefits. The aim of this study is to evaluate the impact of pelvic floor MDT discussions on the diagnostic approach and treatment of a patient population at Antwerp University Hospital. After reviewing 26 patient cases, the study demonstrated a change in technical investigations in 69% of cases and a change in diagnostics in 85% of cases. These findings indicate that pelvic floor MDT discussions have a significant impact on both the diagnostic and treatment approaches for pelvic floor disorders.

盆底多学科小组(MDT)讨论正逐渐成为盆底疾病患者护理的标准组成部分。尽管指南鼓励使用该方法,但仍缺乏确凿证据证明其益处。本研究旨在评估盆底 MDT 讨论对安特卫普大学医院患者诊断方法和治疗的影响。在回顾了 26 例患者的病例后,研究显示 69% 的病例改变了技术检查方法,85% 的病例改变了诊断方法。这些研究结果表明,盆底MDT讨论对盆底疾病的诊断和治疗方法都有重大影响。
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引用次数: 0
An unusual case of acute cholestatic hepatitis: visceral leishmaniasis with secondary haemophagocytic lymphohistiocytosis. 急性胆汁淤积性肝炎罕见病例:内脏利什曼病伴继发性噬血细胞淋巴组织细胞增多症。
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-01 DOI: 10.51821/88.1.13361
N Gestels, E Bottieau, A De Vooght, S van Ierssel, S Libbrecht, A Driessen, S Francque, T Vanwolleghem, W J Kwanten

Visceral leishmaniasis (VL) is a severe vector-borne parasiti disease, endemic in various tropical countries but also in the Mediterranean Basin. We report the case of a 64-year-old immunocompetent male, who presented with jaundice, fever, splenomegaly, hyperferritinaemia and cytopenias after a recent trip to Portugal. Clinical and biochemical findings were consistent with the diagnosis of an acute cholestatic hepatitis and haemophagocytic lymphohistiocytosis (HLH), secondary to visceral Leishmania infantum which was later confirmed by bone marrow examination. Despite adequate therapy with liposomal amphotericin B, the disease and HLH relapsed. Retreatment with higher dosing was eventually successful. This case highlights the risk of acquiring VL in southern Europe and its possible unusual presentations, causing diagnostic delay, as well as its complex management that requires appropriate multidisciplinary communication.

内脏利什曼病(VL)是一种严重的病媒寄生虫病,在多个热带国家和地中海盆地流行。我们报告了一例 64 岁免疫功能正常的男性病例,他最近去葡萄牙旅行后出现黄疸、发热、脾肿大、高铁蛋白血症和细胞减少症。临床和生化检查结果与急性胆汁淤积性肝炎和嗜血细胞淋巴组织细胞增多症(HLH)的诊断一致,继发于婴儿内脏利什曼病,后经骨髓检查确诊。尽管使用脂质体两性霉素 B 进行了充分治疗,但疾病和 HLH 还是复发了。使用更大剂量的再治疗最终获得成功。该病例凸显了在南欧感染 VL 的风险及其可能出现的异常表现,从而导致诊断延误,以及需要进行适当的多学科沟通的复杂治疗。
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引用次数: 0
Selective internal radiation therapy for neuroendocrine liver metastases: efficacy, safety and prognostic factors. A retrospective single institution study. 选择性内放疗治疗神经内分泌性肝转移:疗效、安全性及预后因素。回顾性单机构研究。
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-01 DOI: 10.51821/88.1.13706
D Briol, A Ceratti, R Lhommel, L Annet, C Dragean, E Danse, P Trefois, M Van Den Eynde, A De Cuyper, P Goffette, I Borbath

Background and study aims: Selective internal radiation therapy (SIRT) has shown good results in unresectable liver metastases from neuroendocrine neoplasms (NELM) with a high disease control rate (DCR) reported. The aims of the study is to assess retrospectively the efficacy and safety of 10y of SIRT for NELM.

Patients and methods: Primary endpoint was objective response rate (ORR) and DCR by RECIST 1.1 at 2, 4 and 12 months (m). Secondary endpoints were overall survival (OS), liver progressionfree survival (liver-PFS), clinical response (NEN-related symptoms improvement) and safety.

Results: 50 consecutive patients with NELM who got SIRT from 2011 to 2021 in one center. The two major NEN primary sites were pancreas (46%) and small intestine (36%). Histological NEN grades were 10%, 46% and 44% for grades 1, 2 and 3 respectively. ORR and DCR were 16% and 80% at 2m, 22% and 92% at 4m and 32% and 82% at 12m. Survival rates at 1 and 2 y were 76% and 72% respectively. Prognostic factors for OS and liver-PFS were NEN histological grade (3 vs 1+2) (hazard ratio (HR) for OS: 4.33 [1.8-10.6], for liver-PFS: 3.91 [1.3-11.4]), and early (2m) DCR (HR for OS: 0.14 [0.1-0.4], for liver-PFS: 0.016 [0.003-0.08]). Clinical response occurred in 7 of the 10 symptomatic patients. One patient died from radioembolization-induced liver disease.

Conclusion: SIRT showed efficacy in NELM pts, with a high DCR and an good safety profile. G1-2 grade and early DCR were associated with a better OS and liver-PFS.

背景和研究目的:选择性内放射治疗(SIRT)对神经内分泌肿瘤(NELM)不可切除的肝转移瘤效果良好,疾病控制率(DCR)较高。本研究旨在回顾性评估SIRT治疗神经内分泌肿瘤10年的疗效和安全性:主要终点是2、4和12个月(m)时的客观反应率(ORR)和RECIST 1.1标准的DCR。次要终点为总生存期(OS)、无肝进展生存期(liver-PFS)、临床反应(NEN相关症状改善)和安全性:结果:2011年至2021年,一个中心连续收治了50例接受SIRT治疗的NELM患者。NEN的两个主要原发部位是胰腺(46%)和小肠(36%)。组织学NEN分级为1级、2级和3级的比例分别为10%、46%和44%。2米时的ORR和DCR分别为16%和80%,4米时分别为22%和92%,12米时分别为32%和82%。1年和2年的存活率分别为76%和72%。OS和肝脏-PFS的预后因素为NEN组织学分级(3 vs 1+2)(OS的危险比(HR)为4.33 [1.8-10.8]:4.33[1.8-10.6],肝脏-生存期:3.91[1.3-11.4]),以及早期(2米)DCR(OS的危险比(HR):0.14[0.1-0.4],肝脏-生存期:0.016[0.003-0.08])。10 名无症状患者中有 7 人出现临床反应。一名患者死于放射性栓塞引起的肝病:结论:SIRT对NELM患者有疗效,DCR高,安全性好。G1-2级和早期DCR与较好的OS和肝脏PFS相关。
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引用次数: 0
Switching intravenous to subcutaneous infliximab was safe and successful during 1-year follow up in Ulcerative Colitis and Crohn patients - a Belgian single center experience. 在溃疡性结肠炎和克罗恩患者的1年随访中,将静脉注射改为皮下注射英夫利昔单抗是安全且成功的-比利时单中心经验。
IF 1.3 4区 医学 Q4 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-01-01 DOI: 10.51821/88.1.13222
L Cornelis, E De Jonckere, J Bossuyt, H Vanpoucke, L Desomer, D De Wulf, F Baert

Background: Subcutaneous (SC) infliximab CT-P13 (IFX) has recently been registered for the treatment of moderate-to-severe inflammatory bowel disease (IBD). The SC route is an attractive option for patients. However, many open questions remain on how to safely switch patients from maintenance IV to SC administration.

Objective: to assess switching from IV to SC IFX therapy in IBD patients through clinical and biochemical evaluation.

Methods: Patients in durable remission on eight-weekly (or six-weekly) IV infliximab and therapeutic IFX trough levels were switched to SC therapy every two weeks. All patients were monitored prospectively every 3 months with patient reported outcomes (PRO), labs including IFX concentrations and faecal calprotectin every 6 months for minimum one-year follow up.

Results: 55 patients (21 UC, 34 CD) agreed to switch to SC therapy. The median follow up in CD patients was 15.5 months, respectively 20 months in UC patients. All patients remained in deep remission according to PRO2, CRP and calprotectin. IFX serum concentrations more than tripled 3 months after the switch (18.31 ± 10.53 μg/mL vs. 4.82 ± 3.06 μg/mL at the start) and remained stable during further follow up. Local pain and injection site reactions both transient were reported in 47% and 42% patients respectively but disappeared in > 50% when injecting in the abdomen or when changing pen to syringe.

Conclusion: Switching UC and Crohn patients in clinical remission and adequate trough levels from maintenance IV tot SC infliximab therapy was successful for at least one year. A proportion of patients experienced pain and or injection site reactions.

背景:皮下(SC)英夫利昔单抗CT-P13 (IFX)最近被注册用于治疗中度至重度炎症性肠病(IBD)。SC途径对患者来说是一个有吸引力的选择。然而,关于如何安全地将患者从维持静脉注射切换到SC给药,仍然存在许多悬而未决的问题。目的:通过临床和生化评价来评估IBD患者从静脉注射到SC IFX治疗的转换。方法:持续缓解的患者每8周(或6周)静脉注射英夫利昔单抗和治疗性IFX谷底水平,每2周切换到SC治疗。所有患者每3个月进行一次前瞻性监测,并报告患者预后(PRO),每6个月进行一次实验室检查,包括IFX浓度和粪便钙保护蛋白,至少随访1年。结果:55例患者(21例UC, 34例CD)同意改用SC治疗。CD患者中位随访时间为15.5个月,UC患者中位随访时间为20个月。根据PRO2、CRP和钙保护蛋白,所有患者仍处于深度缓解期。转换3个月后,IFX血清浓度增加了两倍多(18.31±10.53 μg/mL vs.开始时的4.82±3.06 μg/mL),并在进一步随访期间保持稳定。47%和42%的患者报告局部疼痛和注射部位反应都是短暂的,但在腹部注射或将笔改为注射器时,50%的患者报告局部疼痛和注射部位反应消失。结论:将UC和Crohn患者从维持IV转入SC英夫利昔单抗治疗至少一年是成功的。一部分患者出现疼痛和/或注射部位反应。
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引用次数: 0
期刊
Acta gastro-enterologica Belgica
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