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Interleukin 12/23 and interleukin 23 inhibitors for moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis. 白细胞介素12/23和白细胞介素23抑制剂治疗中重度溃疡性结肠炎:系统综述和网络荟萃分析
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-11-01 Epub Date: 2025-10-10 DOI: 10.20524/aog.2025.1009
Bisher Sawaf, Mohammad Al Hayek, Ahmad Kassem, Dahham Alsoud, Mulham Alom, Abdelaziz H Salam, Rana H Shembesh, Mohammed S Beshr, Yusuf Hallak, Shahem Abbarh, Elias Batikh, Mosa Shibani, Muhammed Elhadi, Yaseen Alastal, Miguel Regueiro

Background: Ulcerative colitis (UC) is a chronic inflammatory disease affecting ~1.5 million individuals, causing significant impairment in quality of life, psychological well-being, and healthcare burden. Using indirect meta-analysis, this study compared the efficacy and safety of anti-interleukin (IL)-12/23 and IL-23 agents vs. placebo and each other, during induction and maintenance in moderate-to-severe UC.

Methods: A systematic search of PubMed, Cochrane, Scopus, Web of Science, and ClinicalTrials. gov was conducted on October 1, 2024. The randomized controlled trials (RCTs) included evaluated ustekinumab, mirikizumab, risankizumab, and guselkumab. The primary outcomes were clinical remission and endoscopic improvement at both induction and maintenance endpoints. Odds ratios (ORs) with 95% confidence intervals (CIs) and surface under the cumulative ranking (SUCRA) values were used to rank treatment efficacy.

Results: Six RCTs (n=3808) were analyzed for induction and 5 RCTs (n=1697) for maintenance. During induction, risankizumab demonstrated the highest clinical remission rates (OR 3.89, 95%CI 2.24-6.75; SUCRA 80.7%) and endoscopic improvement rates (OR 4.21, 95%CI 2.12-8.35; SUCRA 87.6%) compared to placebo. In maintenance, guselkumab showed the highest clinical remission (OR 4.28, 95%CI 1.58-11.59; SUCRA 81.6%) and endoscopic improvement (OR 4.21, 95%CI 2.12-8.35; SUCRA 93.1%), and was superior to risankizumab (OR 2.05, 95%CI 1.09-3.84) for endoscopic outcomes.

Conclusions: Risankizumab was most effective in induction, while guselkumab was more effective in maintenance. Head-to-head trials are warranted.

背景:溃疡性结肠炎(UC)是一种慢性炎症性疾病,影响约150万人,造成生活质量、心理健康和医疗负担的显著损害。通过间接荟萃分析,本研究比较了抗白细胞介素(IL)-12/23和IL-23药物与安慰剂以及彼此在中重度UC诱导和维持期间的疗效和安全性。方法:系统检索PubMed、Cochrane、Scopus、Web of Science和ClinicalTrials。该调查于2024年10月1日进行。随机对照试验(rct)包括评估ustekinumab, mirikizumab, risankizumab和guselkumab。在诱导和维持终点,主要结局是临床缓解和内镜改善。采用95%置信区间(ci)的优势比(ORs)和累积排序表(SUCRA)值对治疗效果进行排序。结果:6个rct (n=3808)用于诱导,5个rct (n=1697)用于维持。在诱导过程中,与安慰剂相比,risankizumab显示出最高的临床缓解率(OR 3.89, 95%CI 2.24-6.75; SUCRA 80.7%)和内镜下改善率(OR 4.21, 95%CI 2.12-8.35; SUCRA 87.6%)。在维持方面,guselkumab表现出最高的临床缓解(OR 4.28, 95%CI 1.58-11.59; SUCRA 81.6%)和内镜下改善(OR 4.21, 95%CI 2.12-8.35; SUCRA 93.1%),并且在内镜下结果方面优于risankizumab (OR 2.05, 95%CI 1.09-3.84)。结论:利桑单抗在诱导方面最有效,而guselkumab在维持方面更有效。正面交锋的试验是必要的。
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引用次数: 0
RE: Increased capture of post-endoscopic retrograde cholangiopancreatography adverse events by delayed (day 7) follow-up calls: a prospective comparison of physician- and nurse-initiated calls. 通过延迟(第7天)随访电话增加内窥镜逆行胆管造影后不良事件的捕获:医生和护士发起的电话的前瞻性比较。
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-11-01 Epub Date: 2025-10-15 DOI: 10.20524/aog.2025.1016
Andrew A Thomson
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引用次数: 0
Performance of endoscopic submucosal dissection and submucosal tunneling endoscopic resection for esophageal submucosal tumors: A multicenter retrospective cohort study. 内镜下粘膜夹层和粘膜下隧道内镜切除术治疗食管粘膜下肿瘤:一项多中心回顾性队列研究。
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-11-01 Epub Date: 2025-10-10 DOI: 10.20524/aog.2025.1017
Fotios Fousekis, Konstantinos Mpakogiannis, Stamatia Vogli, Maximilien Barret, Flavius-Stefan Marin, Shaimaa Elkholy, Mohamed El-Sherbiny, Karim Essam, Hany Haggag, Sukrit Sud, Arjun Koch, Shivam Khare, Rui Morais, João Santos-Antunes, Oleksandr Kiosov, Alberto Herreros de Tejada, Vladyslav Yakovenko, Mandarino Vito Francesco, Ernesto Fasulo, George Tribonias, Ahmed Altonbary, Federico Barbaro, Biswa Ranjan Patra, Hany Shehab, Georgios Mavrogenis

Background: Esophageal submucosal tumors (ESTs) were typically managed through surveillance, but there is now a shift towards endoscopic resection. Endoscopic submucosal dissection (ESD) and submucosal tumor endoscopic resection (STER) appear to be safe and effective treatment options; however, evidence from non-East Asian centers is limited.

Methods: This retrospective multicenter study included 97 patients from 15 centers across 9 countries who underwent endoscopic resection of ESTs via ESD or STER. Demographics, tumor characteristics, procedural details, adverse events and follow-up outcomes were recorded and analyzed.

Results: Of the 97 patients, 48 underwent ESD and 49 STER. Most lesions were located in the lower esophagus and originated from the muscularis propria. En bloc resection was achieved in 95% of cases, with no significant difference between techniques (STER: 92% vs. ESD: 98%, P=0.18). The most common histologic diagnosis was leiomyoma (52%), followed by granular cell tumors (22%) and gastrointestinal stromal tumors (6%). Adverse events were infrequent: 9 cases of perforation were recorded, with only 4 being unintentional and all managed endoscopically. Follow-up data revealed only 1 case of local recurrence in a patient with a 50 mm lesion treated by STER. Hospital stay was longer after STER than ESD (3 vs. 2 days, P<0.001).

Conclusions: ESD and STER are effective and safe for ESTs, with high en bloc resection rates, minimal adverse events and very low recurrence during short-term follow up. These findings support the broader adoption of advanced endoscopic resection, which is transforming the management of ESTs from surgical to endoscopic treatment.

背景:食管粘膜下肿瘤(ESTs)通常通过监测进行治疗,但现在转向内镜切除。内镜下粘膜剥离(ESD)和粘膜下肿瘤内镜切除(STER)似乎是安全有效的治疗选择;然而,来自非东亚中心的证据有限。方法:这项回顾性多中心研究包括来自9个国家15个中心的97例患者,他们通过ESD或STER进行了est的内镜切除。记录和分析人口统计学、肿瘤特征、手术细节、不良事件和随访结果。结果:97例患者中,48例行ESD, 49例行STER。大多数病变位于食管下部,起源于固有肌层。95%的病例实现了整体切除,两种技术之间无显著差异(STER: 92% vs. ESD: 98%, P=0.18)。最常见的组织学诊断是平滑肌瘤(52%),其次是颗粒细胞瘤(22%)和胃肠道间质瘤(6%)。不良事件很少:9例穿孔被记录,只有4例是无意的,所有的内镜下处理。随访数据显示,在接受STER治疗的50 mm病变患者中,只有1例局部复发。STER术后住院时间较ESD术后长(3天vs. 2天)。结论:ESD和STER在短期随访中具有整体切除率高、不良事件少、复发率低的优点,是一种安全有效的est治疗方法。这些发现支持更广泛地采用先进的内窥镜切除,这将est的管理从外科手术转变为内窥镜治疗。
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引用次数: 0
Endoscopic ultrasonography-guided gastroenterostomy for malignant and benign gastric outlet obstruction: a systematic review and meta-analysis. 超声内镜引导下的胃造口术治疗恶性和良性胃出口梗阻:系统回顾和荟萃分析。
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-01 Epub Date: 2025-08-12 DOI: 10.20524/aog.2025.0989
Raffaele Manta, Angelo Zullo, Vincenzo De Francesco, Marco Spadaccini, Cesare Hassan, Luigi Gatta

Background: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) with a lumen-apposing metal stent has been proposed as a treatment for patients with gastric outlet obstruction (GOO). We performed a systematic review and meta-analysis to compute the technical success, clinical success and complication rates of EUS-GE in treating GOO due to either neoplastic or benign diseases.

Methods: The literature search was conducted in PubMed, EMBASE and the Cochrane Central Register of Controlled Trials, from inception until January 23, 2025, according to the PRISMA and MOOSE statement guidelines. The primary objective was to assess both technical and clinical success. A secondary outcome was to rate the adverse events.

Results: Data from 39 studies involving 2845 patients were analyzed. The pooled technical success rate was 95.1%, and the procedure was successful in 95.3% and 95.1% of patients with malignant or benign diseases, respectively. Clinical success was achieved in 93.5% of all patients where the procedure had technical success, and in 93.1% and 94.4% of those treated for malignant and benign conditions, respectively. The overall rate of adverse events was 18.5%, including perforation (4.4%), bleeding (2.7%), stent migration (1.4%), stent closure (3.3%), infection (4.4%), and fistula (2.3%). The procedure-related mortality was 1.4%.

Conclusion: EUS-GE appears to be a viable approach for the treatment of GOO patients, for both malignant and benign diseases, with favorable outcomes and an acceptable safety profile.

背景:超声内镜引导下的胃造口术(EUS-GE)联合腔内金属支架已被提出作为胃出口梗阻(GOO)患者的一种治疗方法。我们进行了一项系统回顾和荟萃分析,以计算EUS-GE治疗肿瘤或良性疾病引起的粘粘症的技术成功率、临床成功率和并发症发生率。方法:根据PRISMA和MOOSE声明指南,在PubMed、EMBASE和Cochrane中央对照试验注册库(Central Register of Controlled Trials)中进行文献检索,检索时间从成立到2025年1月23日。主要目的是评估技术和临床成功。次要结果是评价不良事件。结果:分析了39项研究的数据,涉及2845例患者。合并技术成功率为95.1%,恶性和良性疾病患者的手术成功率分别为95.3%和95.1%。在手术取得技术成功的所有患者中,93.5%的患者取得了临床成功,恶性和良性疾病的患者分别取得了93.1%和94.4%的临床成功。总体不良事件发生率为18.5%,包括穿孔(4.4%)、出血(2.7%)、支架移位(1.4%)、支架闭合(3.3%)、感染(4.4%)和瘘(2.3%)。手术相关死亡率为1.4%。结论:EUS-GE似乎是治疗GOO患者的一种可行方法,无论是恶性还是良性疾病,都具有良好的结果和可接受的安全性。
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引用次数: 0
Evaluating spleen volume in inflammatory bowel disease. 评价炎症性肠病的脾体积。
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-01 Epub Date: 2025-08-14 DOI: 10.20524/aog.2025.0993
Konstantinos C Mpakogiannis, Fotios S Fousekis, Viktoria-Efthymia C Mpakogianni, Ioanna Nefeli Mastorogianni, Konstantinos H Katsanos

Crohn's disease (CD) and ulcerative colitis (UC), known as inflammatory bowel disease (IBD), are characterized by immune system dysregulation. The spleen holds a primary role in systemic inflammation and immune responses. Splenic involvement or splenomegaly in IBD patients may result from secondary causes, such as portal hypertension, myeloproliferative diseases, amyloidosis, splenic abscesses or granulomas. Current research on the direct association between IBD and spleen volume (SV) has expanded significantly. In CD, SV is predominantly increased, and is associated with worsen clinical outcomes. Successful treatment with infliximab often leads to a reduction in the elevated SV. Patients with UC often present spleens with invariant SV, or smaller spleens than those observed in CD, as UC typically affects a more limited part of the gastrointestinal tract compared to CD. However, reduction of SV in UC can also indicate relapsing pancolitis. Recent genetic data also suggest that an increased SV serves as a potential risk factor for the development of IBD, emphasizing the possible bidirectional causal relationship between IBD and SV. Shared pathogenic pathways, including intestinal immune activation, tumor necrosis factor-α activation, bowel toxin absorption and lymphatic tissue involvement, might explain the splenic and intestinal immune dysfunction. Thus, the measurement of SV and its adjustment for body mass index or weight, factors that affect the spleen size, may serve as a potential indicator for IBD monitoring, predicting disease-related flares and complications, and evaluating the response to current biologics. Nonetheless, further insights into the underlying pathogenic pathways linking SV and IBD are considered imperative.

克罗恩病(CD)和溃疡性结肠炎(UC),被称为炎症性肠病(IBD),以免疫系统失调为特征。脾脏在全身炎症和免疫反应中起主要作用。IBD患者脾受累或脾肿大可能由继发性原因引起,如门静脉高压、骨髓增生性疾病、淀粉样变、脾脓肿或肉芽肿。目前关于IBD与脾体积(SV)直接相关的研究已经有了显著的扩展。在乳糜泻中,SV主要增加,并与更差的临床结果相关。用英夫利昔单抗成功治疗通常会导致升高的SV降低。UC患者的脾脏常伴有固定的SV,或比CD患者的脾脏更小,因为UC与CD相比通常只影响胃肠道的有限部分。然而,UC患者的SV减少也可能预示着复发性结肠炎。最近的遗传数据也表明,SV升高是IBD发展的潜在危险因素,强调IBD和SV之间可能存在双向因果关系。包括肠道免疫激活、肿瘤坏死因子-α激活、肠道毒素吸收和淋巴组织参与在内的共同致病途径可能解释脾和肠道免疫功能障碍。因此,SV的测量及其对身体质量指数或体重的调整(影响脾脏大小的因素)可能作为IBD监测、预测疾病相关的发作和并发症以及评估对当前生物制剂的反应的潜在指标。尽管如此,进一步了解连接SV和IBD的潜在致病途径被认为是必要的。
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引用次数: 0
Impact of overt and subclinical hepatogenous diabetes and metformin treatment on circulatory function, renal function and hemodynamics, inflammatory activity, and prognosis in patients with cirrhosis and ascites. 显性和亚临床肝源性糖尿病及二甲双胍治疗对肝硬化腹水患者循环功能、肾功能和血流动力学、炎症活动及预后的影响
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-01 Epub Date: 2025-08-14 DOI: 10.20524/aog.2025.0990
Ilias Tsiakas, Maria Kosmidou, Grigorios Despotis, Dimitrios Biros, Spiridon Tsiouris, Xanthi Xourgia, Lampros Lakkas, Georgios S Markopoulos, Eleni Bairaktari, Georgios Kolios, Haralampos Milionis, Georgios Kalambokis

Background: Hepatogenous diabetes (HD) is common in advanced cirrhosis. The oral glucose tolerant test (OGTT) is frequently diagnostic, as fasting blood glucose (FBG) may be normal. We investigated the impact of FBG- and OGTT-diagnosed HD, and metformin treatment, on circulatory function, renal function and perfusion, and inflammatory activity in patients with cirrhosis and ascites. Also, long-term prognosis of HD under metformin/metformin-based treatment was assessed.

Methods: Mean arterial pressure (MAP), cardiac output (CO), systemic vascular resistance (SVR) as MAP/CO ratio, plasma renin activity (PRA), plasma aldosterone, glomerular filtration rate (GFR), renal blood flow (RBF), and plasma levels of lipopolysaccharide-binding protein (LBP), tumor-necrosis factor-α (TNF-α) and interleukin-6 were evaluated at baseline in patients with and without HD, and after 6 months of metformin treatment for newly diagnosed HD.

Results: Compared to OGTT-HD (n=34) and no-HD (n=37), FBG-HD patients (n=35; newly-diagnosed, n=13) had significantly lower SVR (P=0.02/P=0.01), GFR (P=0.01/P=0.008) and RBF (P=0.02/P=0.01), and significantly higher CO (P=0.04/P=0.03), PRA (P=0.009/P=0.006), and levels of LBP (P=0.01/P=0.008) and TNF-α (P=0.03/P=0.02). Initiation of metformin in OGTT-HD and FBG-HD patients induced significant increases in SVR (P=0.02/P=0.04), GFR (P=0.02/P=0.04) and RBF (P=0.04/P=0.05), and significant decreases in PRA (P=0.02/P=0.03) and LBP (P=0.02/P=0.04). Three-year survival in OGTT-HD was significantly higher than in FBG-HD (75.3% vs. 55.3%; P=0.03) and similar to no-HD (81.7%).

Conclusions: Circulatory function and renal function and perfusion are aggravated by FBG-HD compared to OGTT-HD or no-HD, possibly because of greater inflammatory activity, while they improve significantly after metformin treatment. Early treatment of HD with metformin may improve prognosis.

背景:肝源性糖尿病(HD)在晚期肝硬化中很常见。口服葡萄糖耐量试验(OGTT)经常用于诊断,因为空腹血糖(FBG)可能是正常的。我们研究了FBG和ogtt诊断的HD以及二甲双胍治疗对肝硬化和腹水患者循环功能、肾功能和灌注以及炎症活动的影响。此外,还评估了在二甲双胍/二甲双胍为基础的治疗下HD的长期预后。方法:对有、无HD患者以及新诊断的HD患者在接受二甲双胍治疗6个月后的平均动脉压(MAP)、心输出量(CO)、全身血管阻力(SVR) (MAP /CO比值)、血浆肾素活性(PRA)、血浆醛固酮、肾小球滤过率(GFR)、肾血流量(RBF)、血浆脂多糖结合蛋白(LBP)、肿瘤坏死因子-α (TNF-α)和白细胞介素-6水平进行基线评估。结果:与OGTT-HD (n=34)和no-HD (n=37)相比,FBG-HD患者(n=35,新诊断患者n=13) SVR (P=0.02/P=0.01)、GFR (P=0.01/P=0.008)、RBF (P=0.02/P=0.01)显著降低,CO (P=0.04/P=0.03)、PRA (P=0.009/P=0.006)、LBP (P=0.01/P=0.008)、TNF-α (P=0.03/P=0.02)显著升高。OGTT-HD和FBG-HD患者开始使用二甲双胍导致SVR (P=0.02/P=0.04)、GFR (P=0.02/P=0.04)和RBF (P=0.04/P=0.05)显著升高,PRA (P=0.02/P=0.03)和LBP (P=0.02/P=0.04)显著降低。OGTT-HD的3年生存率显著高于FBG-HD (75.3% vs. 55.3%, P=0.03),与no-HD相似(81.7%)。结论:与OGTT-HD或no-HD相比,FBG-HD可加重循环功能、肾功能和血流灌注,可能是由于FBG-HD的炎症活性更大,而二甲双胍治疗后循环功能、肾功能和血流灌注均有明显改善。早期应用二甲双胍治疗HD可改善预后。
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引用次数: 0
Reassessing Clostridioides difficile trends and racial disparities. 重新评估艰难梭菌趋势和种族差异。
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-01 Epub Date: 2025-08-11 DOI: 10.20524/aog.2025.0984
Rebecca Parry
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引用次数: 0
The effects of empagliflozin on diuresis and natriuresis in patients with type 2 diabetes mellitus and liver cirrhosis. 恩格列净对2型糖尿病合并肝硬化患者利尿和利钠的影响。
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-01 Epub Date: 2025-08-14 DOI: 10.20524/aog.2025.0992
Christos Siafarikas, Chris J Kapelios, Margarita Papatheodoridi, Evangelos Cholongitas, Theodoros Androutsakos, John Vlachogiannakos, Nikolaos Tentolouris, George Papatheodoridis

Background: We investigated the short-term diuretic and natriuretic effect of empagliflozin, a sodium-glucose linked transporter 2 inhibitor, in patients with cirrhosis and type 2 diabetes mellitus (T2DM).

Methods: This was a prospective, single-arm study including 30 patients with T2DM and cirrhosis (Child-Pugh class A/B). Participants received empagliflozin 10 mg for 15 days while continuing their standard treatment. Clinical and biochemical parameters, and urinary samples, using 24-h urine collection, were recorded before and after treatment. Twenty-seven patients continued empagliflozin for 6 months and were assessed for glycemic control and renal function.

Results: Empagliflozin increased median daily urine volume by 475 mL (P=0.010) and fractional sodium excretion (FENa) by 16% at day 15 (P=0.030), but the 8 mmol/L increase in 24-h sodium excretion was not significant. Empagliflozin also reduced body weight (-0.8 kg, P<0.001) and systolic blood pressure (-4 mmHg, P=0.029). Glycemic control remained unremarkable at day 15, but improved at 6 months (baseline vs. 6 months: fasting glucose 146 vs. 116 mg/dL, P=0.016; glycosylated hemoglobin 6.2% vs. 6%, P=0.011). Compared to baseline (89.1±20.6 mL/min/1.73m2, estimated glomerular filtration rate declined numerically but not statistically significantly at day 15 (85.2±21.8, P=0.056 and at 6 months (82.8±23.7, P=0.035. No serious adverse events were noticed.

Conclusions: Up to 6 months' empagliflozin administration in patients with cirrhosis and T2DM seems safe and increases urine output and FENa, but its impact on renal function requires further investigation. Larger randomized controlled trials are needed to confirm its long-term efficacy and safety in this setting.

背景:我们研究了恩格列净(钠-葡萄糖转运蛋白2抑制剂)在肝硬化和2型糖尿病(T2DM)患者中的短期利尿和利钠作用。方法:这是一项前瞻性单臂研究,包括30例T2DM和肝硬化患者(Child-Pugh a /B级)。参与者在继续标准治疗的同时接受10毫克恩帕列净15天。记录治疗前后临床生化指标及采集24 h尿液样本。27例患者持续使用恩格列净6个月,并评估血糖控制和肾功能。结果:在第15天,恩格列净使中位日尿量增加475 mL (P=0.010),使分数钠排泄量(FENa)增加16% (P=0.030),但使24 h钠排泄量增加8 mmol/L不显著。依帕列净也降低了体重(-0.8 kg, P2),估算的肾小球滤过率在第15天(85.2±21.8,P=0.056)和第6个月(82.8±23.7,P=0.035)数值上下降,但无统计学意义。未发现严重的不良事件。结论:肝硬化和T2DM患者给予长达6个月的恩格列净似乎是安全的,并可增加尿量和fea,但其对肾功能的影响有待进一步研究。需要更大规模的随机对照试验来证实其在这种情况下的长期疗效和安全性。
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引用次数: 0
Device failures and patient-related adverse events with small bowel capsule endoscopy: a 20-year MAUDE database analysis. 器械故障和小肠胶囊内窥镜患者相关不良事件:20年MAUDE数据库分析
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-01 Epub Date: 2025-08-12 DOI: 10.20524/aog.2025.0988
Eric S Tatro, Sherif E Elhanafi, Douglas G Adler, Andrew C Stuart, Marc J Zuckerman

Background: Small bowel capsule endoscopy (SBCE) is a critical tool in the evaluation of small bowel bleeding, detection of small bowel neoplasms and diagnosing Crohn's disease. The object of this study was to examine device failures (DF) and patient-related adverse events (PRAE) in SBCE, including those involving the patency capsule system, using user-generated reports from the US Food and Drug Administration's (FDA) Manufacturer and User facility Device Experience (MAUDE) database.

Method: We analyzed post marketing surveillance data for SBCE data for all of the SBCE systems from the FDA's MAUDE database from January 2000 until December 2023.

Results: A total of 352 reports were obtained during the study period, pertaining to the following SBCE systems, in descending order of frequency: Pillcam SB® system, Pillcam® Patency Capsule, Endocapsule®, CapsoCam® and MiroCam®. The vast majority pertained to the Pillcam® and Pillcam® Patency system: a total of 307 medical device reports with 398 DFs and 569 PRAEs. The most reported DFs were entrapment of the device (n=212, 53.2%), failure to transmit record (n=38, 9.5%), and failure to record (n=35, 8.7%). The most commonly reported PRAEs were a foreign body retained in the patient (n=140, 24.6%), unintentional exposure to radiation (n=104, 18.2%), and unintended exposure to anesthesia (n=58, 10.2%).

Conclusions: Findings from the MAUDE database regarding SBCE devices provide valuable information on DFs and PRAEs. This knowledge can help operators optimize patient selection and reduce patient risk.

背景:小肠胶囊内镜(SBCE)是评估小肠出血、检测小肠肿瘤和诊断克罗恩病的重要工具。本研究的目的是使用来自美国食品和药物管理局(FDA)制造商和用户设施设备体验(MAUDE)数据库的用户生成报告,检查SBCE中的设备故障(DF)和患者相关不良事件(PRAE),包括那些涉及通畅胶囊系统的事件。方法:我们分析了2000年1月至2023年12月FDA MAUDE数据库中所有SBCE系统的SBCE数据的上市后监测数据。结果:在研究期间共获得352份报告,涉及以下SBCE系统,按频率由高到低依次为:Pillcam SB®系统、Pillcam®Patency Capsule、Endocapsule®、CapsoCam®和MiroCam®。绝大多数与Pillcam®和Pillcam®专利系统有关:共有307份医疗器械报告,其中398份df和569份PRAEs。报告最多的DFs是设备卡套(n=212, 53.2%)、传输记录失败(n=38, 9.5%)和记录失败(n=35, 8.7%)。最常见的PRAEs报告是患者体内残留异物(n=140, 24.6%),意外暴露于辐射(n=104, 18.2%)和意外暴露于麻醉(n=58, 10.2%)。结论:来自MAUDE数据库关于SBCE器械的发现提供了关于DFs和PRAEs的有价值的信息。这些知识可以帮助操作员优化患者选择并降低患者风险。
{"title":"Device failures and patient-related adverse events with small bowel capsule endoscopy: a 20-year MAUDE database analysis.","authors":"Eric S Tatro, Sherif E Elhanafi, Douglas G Adler, Andrew C Stuart, Marc J Zuckerman","doi":"10.20524/aog.2025.0988","DOIUrl":"10.20524/aog.2025.0988","url":null,"abstract":"<p><strong>Background: </strong>Small bowel capsule endoscopy (SBCE) is a critical tool in the evaluation of small bowel bleeding, detection of small bowel neoplasms and diagnosing Crohn's disease. The object of this study was to examine device failures (DF) and patient-related adverse events (PRAE) in SBCE, including those involving the patency capsule system, using user-generated reports from the US Food and Drug Administration's (FDA) Manufacturer and User facility Device Experience (MAUDE) database.</p><p><strong>Method: </strong>We analyzed post marketing surveillance data for SBCE data for all of the SBCE systems from the FDA's MAUDE database from January 2000 until December 2023.</p><p><strong>Results: </strong>A total of 352 reports were obtained during the study period, pertaining to the following SBCE systems, in descending order of frequency: Pillcam SB<sup>®</sup> system, Pillcam<sup>®</sup> Patency Capsule, Endocapsule<sup>®</sup>, CapsoCam<sup>®</sup> and MiroCam<sup>®</sup>. The vast majority pertained to the Pillcam<sup>®</sup> and Pillcam<sup>®</sup> Patency system: a total of 307 medical device reports with 398 DFs and 569 PRAEs. The most reported DFs were entrapment of the device (n=212, 53.2%), failure to transmit record (n=38, 9.5%), and failure to record (n=35, 8.7%). The most commonly reported PRAEs were a foreign body retained in the patient (n=140, 24.6%), unintentional exposure to radiation (n=104, 18.2%), and unintended exposure to anesthesia (n=58, 10.2%).</p><p><strong>Conclusions: </strong>Findings from the MAUDE database regarding SBCE devices provide valuable information on DFs and PRAEs. This knowledge can help operators optimize patient selection and reduce patient risk.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"497-504"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039074","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
Effectiveness of upadacitinib in ulcerative colitis patients with prior tofacitinib exposure: a systematic review and meta-analysis. upadacitinib对先前暴露于托法替尼的溃疡性结肠炎患者的有效性:一项系统评价和荟萃分析。
IF 2.2 Q3 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2025-09-01 Epub Date: 2025-08-14 DOI: 10.20524/aog.2025.0991
Fariha Hasan, Ayesha Liaquat, Ahmed Raza, Zain Ali Nadeem, Fatima Farooqi, Hassam Ali, Dushyant Singh Dahiya, Zeina Issa, Bhanu Siva Mohan Pinnam, Saqr Alsakarneh, Islam Mohamad, Gursimran S Kocchar

Background: Upadacitinib, a selective Janus kinase (JAK) inhibitor, is a recently approved therapy for moderate-to-severe ulcerative colitis (UC). Limited data are available on its efficacy in patients previously exposed to tofacitinib, a non-selective JAK inhibitor. Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy of upadacitinib in UC patients with prior tofacitinib treatment.

Methods: PubMed, Embase, Web of Science, and Cochrane Library were queried for studies evaluating the effectiveness of upadacitinib in UC patients with prior tofacitinib treatment. Primary outcomes included clinical remission, steroid-free clinical remission (SFCR), and clinical response. Secondary outcomes were the mean decrease in fecal calprotectin, and adverse events. Statistical analyses were performed using R, calculating pooled proportions with 95% confidence intervals (CI) for dichotomous outcomes and mean differences with 95%CI for continuous outcomes using a random-effects model.

Results: Five studies, with 127 patients, were included in the final analysis. Upadacitinib increased pooled clinical remission rates by 57% (95%CI 0.32-0.80), SFCR rates by 52% (95%CI 0.26-0.78), and clinical response rates by 75% (95%CI 0.44-0.96). Upadacitinib reduced mean fecal calprotectin levels by 597.59% (95%CI 350.94-844.324). Adverse events, such as headache, acne vulgaris, rash, nasopharyngitis and infections, were reported in 34% of patients (95%CI 0.11-0.62).

Conclusions: Our meta-analysis indicates that upadacitinib may be an effective treatment for patients with prior tofacitinib exposure, demonstrating significant clinical remission, SFCR, and clinical response. Larger clinical trials are needed to establish long-term outcomes.

背景:Upadacitinib是一种选择性Janus激酶(JAK)抑制剂,最近被批准用于治疗中重度溃疡性结肠炎(UC)。对于先前暴露于非选择性JAK抑制剂tofacitinib的患者,其疗效的数据有限。因此,我们进行了系统回顾和荟萃分析,以评估upadacitinib对既往接受过托法替尼治疗的UC患者的疗效。方法:对PubMed、Embase、Web of Science和Cochrane Library进行查询,以评估upadacitinib对既往接受过托法替尼治疗的UC患者的有效性。主要结局包括临床缓解、无类固醇临床缓解(SFCR)和临床反应。次要结局是粪钙保护蛋白的平均减少和不良事件。使用R进行统计分析,使用随机效应模型计算二分结果95%置信区间(CI)的合并比例和连续结果95%置信区间(CI)的平均差异。结果:5项研究,127例患者被纳入最终分析。Upadacitinib使合并临床缓解率提高57% (95%CI 0.32-0.80), SFCR率提高52% (95%CI 0.26-0.78),临床缓解率提高75% (95%CI 0.44-0.96)。Upadacitinib降低粪钙保护蛋白水平597.59% (95%CI 350.94-844.324)。34%的患者报告了头痛、寻常痤疮、皮疹、鼻咽炎和感染等不良事件(95%CI 0.11-0.62)。结论:我们的荟萃分析表明,upadacitinib可能是先前暴露于托法替尼的患者的有效治疗方法,表现出显著的临床缓解、SFCR和临床反应。需要更大规模的临床试验来确定长期结果。
{"title":"Effectiveness of upadacitinib in ulcerative colitis patients with prior tofacitinib exposure: a systematic review and meta-analysis.","authors":"Fariha Hasan, Ayesha Liaquat, Ahmed Raza, Zain Ali Nadeem, Fatima Farooqi, Hassam Ali, Dushyant Singh Dahiya, Zeina Issa, Bhanu Siva Mohan Pinnam, Saqr Alsakarneh, Islam Mohamad, Gursimran S Kocchar","doi":"10.20524/aog.2025.0991","DOIUrl":"10.20524/aog.2025.0991","url":null,"abstract":"<p><strong>Background: </strong>Upadacitinib, a selective Janus kinase (JAK) inhibitor, is a recently approved therapy for moderate-to-severe ulcerative colitis (UC). Limited data are available on its efficacy in patients previously exposed to tofacitinib, a non-selective JAK inhibitor. Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy of upadacitinib in UC patients with prior tofacitinib treatment.</p><p><strong>Methods: </strong>PubMed, Embase, Web of Science, and Cochrane Library were queried for studies evaluating the effectiveness of upadacitinib in UC patients with prior tofacitinib treatment. Primary outcomes included clinical remission, steroid-free clinical remission (SFCR), and clinical response. Secondary outcomes were the mean decrease in fecal calprotectin, and adverse events. Statistical analyses were performed using R, calculating pooled proportions with 95% confidence intervals (CI) for dichotomous outcomes and mean differences with 95%CI for continuous outcomes using a random-effects model.</p><p><strong>Results: </strong>Five studies, with 127 patients, were included in the final analysis. Upadacitinib increased pooled clinical remission rates by 57% (95%CI 0.32-0.80), SFCR rates by 52% (95%CI 0.26-0.78), and clinical response rates by 75% (95%CI 0.44-0.96). Upadacitinib reduced mean fecal calprotectin levels by 597.59% (95%CI 350.94-844.324). Adverse events, such as headache, acne vulgaris, rash, nasopharyngitis and infections, were reported in 34% of patients (95%CI 0.11-0.62).</p><p><strong>Conclusions: </strong>Our meta-analysis indicates that upadacitinib may be an effective treatment for patients with prior tofacitinib exposure, demonstrating significant clinical remission, SFCR, and clinical response. Larger clinical trials are needed to establish long-term outcomes.</p>","PeriodicalId":7978,"journal":{"name":"Annals of Gastroenterology","volume":"38 5","pages":"511-518"},"PeriodicalIF":2.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421357/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145038849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Annals of Gastroenterology
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