Crohn’s

克罗恩氏
  • 文章类型: Journal Article
    背景:尽管药物治疗取得了进展,大约33%的克罗恩病(CD)患者在初次诊断后5年内需要手术治疗.已经提出了几种CD的手术方法,包括小肠切除术,狭窄成形术,手术切除加狭窄成形术。这里,我们利用美国外科医生学会(ACS)国家外科质量登记系统(NSQIP)对这三种CD手术入路之间的30天结局进行了综合分析.
    方法:作者在2015年至2020年之间查询了ACS-NSQIP数据库中所有使用CPT和IC-CM10进行开腹或腹腔镜小肠切除术或狭窄成形术的患者。感兴趣的结果包括逗留时间,放电处理,伤口并发症,30天相关再入院,再操作。
    结果:共确定2578例患者;87%的患者接受了小肠切除术,5%切除合并狭窄成形术,仅狭窄成形术就占8%。切除加狭窄成形术(联合手术)与最长的手术时间有关(p=0.002)。接受小肠切除术的患者住院时间最长(p=0.030),浅表/深部伤口感染发生率最高(44%,p=0.003)以及脓毒症的最高发病率(3.5%,p=0.03)。发现小肠切除术与联合手术(OR2.09,p=0.024)和狭窄成形术(1.9,p=0.005)相比,伤口并发症的几率更高。
    结论:我们的研究表明,在30天相关的再手术和再入院中,各种CD手术入路具有可比性。或在所有三种手术方法之间进行手术后的处置。然而,小肠切除术显示术后伤口并发症的发生率较高。
    BACKGROUND: Despite advances in medical therapy, approximately 33% of Crohn\'s disease (CD) patients will need surgery within 5 years after initial diagnosis. Several surgical approaches to CD have been proposed including small bowel resection, strictureplasty, and combined surgery with resection plus strictureplasty. Here, we utilize the American College of Surgeons (ACS) national surgical quality registry (NSQIP) to perform a comprehensive analysis of 30-day outcomes between these three surgical approaches for CD.
    METHODS: The authors queried the ACS-NSQIP database between 2015 and 2020 for all patients undergoing open or laparoscopic resection of small bowel or strictureplasty for CD using CPT and IC-CM 10. Outcomes of interest included length of stay, discharge disposition, wound complications, 30-day related readmission, and reoperation.
    RESULTS: A total of 2578 patients were identified; 87% of patients underwent small bowel resection, 5% resection with strictureplasty, and 8% strictureplasty alone. Resection plus strictureplasty (combined surgery) was associated with the longest operative time (p = 0.002). Patients undergoing small bowel resection had the longest length of hospital stay (p = 0.030) and the highest incidence of superficial/deep wound infection (44%, p = 0.003) as well as the highest incidence of sepsis (3.5%, p = 0.03). Small bowel resection was found to be associated with higher odds of wound complication compared to combined surgery (OR 2.09, p = 0.024) and strictureplasty (1.9, p = 0.005).
    CONCLUSIONS: Our study shows that various surgical approaches for CD are associated with comparable outcomes in 30-day related reoperation and readmission, or disposition following surgery between all three surgical approaches. However, small bowel resection displayed higher odds of developing post-operative wound complications.
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  • 文章类型: Journal Article
    目的:据报道,与其他CD表型相比,孤立的小肠克罗恩病(SBCD)的预后较差。这项研究的目的是了解分离的SBCD和回肠结肠疾病与血液和粪便生物标志物之间的相关性,并确定两种表型之间的结果和管理差异。
    方法:从现有的胶囊内镜(CE)数据库中确定了回肠结肠或孤立性小肠克罗恩病(SBCD)患者。哈维·布拉德肖指数(HBI),生物标志物:C反应蛋白(CRP)和粪便钙卫蛋白(FC),收集Lewis评分和CE的发现以及随后的随访数据。采用SPSS进行数据分析。
    结果:共248例患者纳入研究。将患者分为两组:分离的SBCD患者178例(中位年龄44岁(IQR31-56);男性占41.5%),结肠克罗恩病患者70例(中位年龄31岁(IQR22.7-49);男性占31.5%)。新诊断为SBCD的占38.7%(n=96),而60.0%(n=144)已建立CD。与孤立的SBCD相比,回肠结肠疾病患者的HBI较高[HBI=7(IQR5-10)vsHBI=6(IQR4-9);P=0.04]。分离的SBCD和回肠结肠疾病之间的FC水平没有显着差异[136ug/g(IQR53.8-363.3)与171ug/g(IQR68.5-485.5);p=0.98]。在孤立的SBCD组中,30.3%(n=54)CE显示近端疾病,96%(n=171)显示远端疾病,26.4%(n=47)显示广泛疾病。SBCE诊断近端SBCD优于MRI(P<0.01)。在多元逻辑回归中,我们没有发现任何定义为Lewis评分>790的疾病严重程度预测因子.在SBCE之后,68.5%(n=170)的患者有管理变更。这包括123例(49.5%)患者开始使用皮质类固醇或剂量递增,硫唑嘌呤在80例(33.3%)患者中,甲氨蝶呤治疗22例(9.1%),生物治疗110例(44.3%)。HBI预测了管理的变化(p<0.01)。
    结论:CE是诊断活动性SBCD的重要方法。它还有助于指导确定患有活动性疾病的患者的治疗。
    OBJECTIVE: Isolated small bowel Crohn\'s disease (SBCD) is reported to have a worse prognosis compared to other CD phenotypes. The aim of this study was to understand the correlation between Isolated SBCD and ileocolonic disease with blood and faecal biomarkers and also to identify differences in outcome and management between the two phenotypes.
    METHODS: Patients with ileocolonic or isolated small bowel Crohn\'s Disease (SBCD) were identified from an existing capsule endoscopy (CE) database. Harvey Bradshaw Index (HBI), biomarkers: c-reactive protein (CRP) and faecal calprotectin (FC), Lewis score and findings on CE and subsequent follow up data were collected. SPSS was used to analyse the data.
    RESULTS: In total 248 patients were included in the study. Patients were split into two groups- Isolated SBCD with 178 patient (median age 44 years (IQR 31-56); 41.5 % male) and Ileocolonic Crohn\'s with 70 patients (median age 31 years (IQR 22.7-49); 31.5 % male). A new diagnosis of SBCD was made in 38.7 % (n = 96), whilst 60.0 % (n = 144) had established CD. Patients with ileocolonic disease had a higher HBI in comparison to isolated SBCD [HBI = 7 (IQR 5-10) vs HBI = 6(IQR 4-9); P = 0.04 ]. There was no significant difference in the FC levels between isolated SBCD and ileocolonic disease [136ug/g (IQR 53.8-363.3) vs 171ug/g (IQR 68.5-485.5); p = 0.98]. In isolated SBCD group, 30.3 % (n = 54) CE showed proximal disease, 96 % (n = 171) showed distal disease and 26.4 % (n = 47) showed extensive disease. SBCE was superior to MRI at diagnosing proximal SBCD (P < 0.01). On multivariate logistic regression, we did not identify any predictors of disease severity defined as Lewis score > 790. Following SBCE, 68.5 % (n = 170) of the total patients had a management change. This included commencement or dose escalation of corticosteroids in 123 (49.5 %) patients, azathioprine in 80 (33.3 %) patients, methotrexate in 22 (9.1 %) patients and biological therapy in 110 (44.3 %) patients. HBI predicted a change in management (p < 0.01).
    CONCLUSIONS: CE is an important modality for the diagnosis of active SBCD. It also helps guide treatment in patients identified with active disease.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    脐带或L3椎体水平通常用于使用计算机断层扫描对身体脂肪进行定量。探讨利用临床获得的盆腔磁共振成像(MRI)测量内脏脂肪的可行性,我们检查了脐部和L5椎体水平的内脏脂肪参数的相关性。我们回顾性分析了在三年内接受腹部和骨盆MRI小肠造影的克罗恩病患者的T2加权半傅立叶采集单发涡轮自旋回波(HASTE)MR轴向图像。我们从脐带和L5水平确定皮下和内脏脂肪的面积/体积,并计算内脏脂肪比率(VFR=内脏脂肪/皮下脂肪)和内脏脂肪指数(VFI=内脏脂肪/总脂肪)。统计分析涉及两个水平之间的相关性分析,两名调查人员之间的评估者间分析,以及两个图像分析平台之间的平台间分析。32例患者的相关性分析得出VFI(r=0.85;p<0.0001)和VFR(r=0.74;p<0.0001)的显著相关性。研究人员之间的VFI和VFR的组内系数分别为0.846和0.875(良好的一致性),平台之间为0.831和0.728(良好和中等的一致性)。我们的研究表明,临床上获得的盆腔MRI的L5水平可以作为内脏脂肪定量的参考点。
    The umbilical or L3 vertebral body level is often used for body fat quantification using computed tomography. To explore the feasibility of using clinically acquired pelvic magnetic resonance imaging (MRI) for visceral fat measurement, we examined the correlation of visceral fat parameters at the umbilical and L5 vertebral body levels. We retrospectively analyzed T2-weighted half-Fourier acquisition single-shot turbo spin echo (HASTE) MR axial images from Crohn\'s disease patients who underwent MRI enterography of the abdomen and pelvis over a three-year period. We determined the area/volume of subcutaneous and visceral fat from the umbilical and L5 levels and calculated the visceral fat ratio (VFR = visceral fat/subcutaneous fat) and visceral fat index (VFI = visceral fat/total fat). Statistical analyses involved correlation analysis between both levels, inter-rater analysis between two investigators, and inter-platform analysis between two image-analysis platforms. Correlational analysis of 32 patients yielded significant associations for VFI (r = 0.85; p < 0.0001) and VFR (r = 0.74; p < 0.0001). Intraclass coefficients for VFI and VFR were 0.846 and 0.875 (good agreement) between investigators and 0.831 and 0.728 (good and moderate agreement) between platforms. Our study suggests that the L5 level on clinically acquired pelvic MRIs may serve as a reference point for visceral fat quantification.
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  • 文章类型: Journal Article
    背景:在克罗恩病(CD)中使用专有肠内营养(EEN)治疗的免疫学效果仍然未知。我们表征了CD和溃疡性结肠炎(UC)儿童与非炎症对照(非IBD)的血浆炎症相关蛋白(IRP)水平,并探讨了EEN在CD中的作用。
    方法:使用Olink蛋白质组学对CD儿童(n=53)中的92个IRP进行定量,UC(n=11),和非IBD(n=19)。对于18名活跃CD的儿童,在EEN之前和之后8周测量IRP。研究了与疾病表型和对EEN反应的关系。
    结果:与非IBD相比,活动性UC和CD患者的水平不同,为27(24个升高,3减少)和29(26增加,3个减少)IRPs,分别。独家肠内营养改变了19个IRPs的水平(13个增加,6降低,包括CCL23,白介素-24,白介素-6和MMP-1)。与结肠受累且粪便钙卫蛋白降低<50%的患者相比,在EEN期间回肠受累且粪便钙卫蛋白降低≥50%的患者中观察到IRP分布的变化更明显,分别。利用基线IRP轮廓的机器学习模型预测对EEN的响应,灵敏度为89%,特异性为57%,准确率为73%。胸腺基质淋巴细胞生成素是模型中最重要的IRP,这在响应者中更高。
    结论:炎症相关蛋白可能对IBD的鉴别诊断有用。独家肠内营养可广泛调节活动性CD儿童的IRP水平,在FC减少和回肠疾病受累的患者中观察到更明显的效果。
    炎症性肠病患儿血浆炎症相关蛋白发生改变。在活动性克罗恩病中,独家肠内营养修饰了这些蛋白质中的几种,特别是在涉及回肠的疾病和粪便钙卫蛋白水平显着降低的患者中。
    BACKGROUND: The immunological effects of treatment with exclusive enteral nutrition (EEN) in Crohn\'s disease (CD) remain unknown. We characterized the plasma levels of inflammation-related proteins (IRPs) in children with CD and ulcerative colitis (UC) compared with noninflammatory controls (non-IBD) and explored the effect of EEN in CD.
    METHODS: Ninety-two IRPs were quantified using Olink proteomics in children with CD (n = 53), UC (n = 11), and non-IBD (n = 19). For 18 children with active CD, IRPs were measured before and after 8 weeks of EEN. Relationships with disease phenotype and response to EEN were studied.
    RESULTS: Compared with non-IBD, patients with active UC and CD had different levels of 27 (24 raised, 3 decreased) and 29 (26 raised, 3 decreased) IRPs, respectively. Exclusive enteral nutrition modified the levels of 19 IRPs (13 increased, 6 decreased including CCL23, interleukin-24, interleukin-6, and MMP-1). More pronounced changes in IRP profile were observed in patients with ileal involvement and a ≥50% decrease in fecal calprotectin during EEN compared with those with colonic involvement and a <50% decrease in fecal calprotectin, respectively. A machine-learning model utilizing baseline IRP profile predicted response to EEN with a sensitivity of 89%, specificity of 57%, and accuracy of 73%. Thymic stromal lymphopoietin was the most important IRP in the model, this being higher in responders.
    CONCLUSIONS: Inflammation-related proteins may be useful in the differential diagnosis of IBD. Exclusive enteral nutrition extensively modulated IRPs levels in children with active CD with more pronounced effects observed in patients who showed a reduction in FC and had ileal disease involvement.
    Plasma inflammation-related proteins are altered in children with inflammatory bowel disease. In active Crohn’s disease, exclusive enteral nutrition modified several of these proteins, particularly in disease involving the ileum and in patients whose fecal calprotectin levels significantly decreased.
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  • 文章类型: Journal Article
    克罗恩病(CD)是一种进行性疾病,多因素,以胃肠道(GI)任何部分的慢性炎症为特征的免疫介导的疾病。儿科患者表现出更广泛的疾病形式,尤其是在有各种组织病理学炎症模式的上消化道。我们的研究旨在分析临床,实验室,内窥镜,以及诊断为CD的儿童的组织病理学发现,并比较初始测试和随访测试的结果。我们纳入了100名儿童和青少年的CD,进行内窥镜和组织病理学(HP)程序。匹配并比较了这8年中执行的多次活检的结果。我们发现粪便变化的频率显着减少(65.52%至18.18%),体重减轻(35.24%至4%),和腹痛(41.86%至6.67%)表现为症状。所有实验室值均有所改善:粪便钙卫蛋白(1000至60,8μg/g),C反应蛋白(12.2至1.9mg/L),和白蛋白(36至41g/L)。在食管胃十二指肠镜检查和回肠结肠镜检查中,36.59%和64.86%的患者有特定的发现,分别。共有32例患者在上消化道有克罗恩病的证据。在9%的食道上发现了非干酪性肉芽肿,18%的胃,和12%的十二指肠活检。在下胃肠道,我们观察到直肠(72.29~82.22%)和降结肠(73.49~80%)的疾病进展.在上胃肠道没有登记的疾病进展。我们的研究表明,在后续检查中,症状的频率显着下降,实验室值也有所提高。超过三分之一的患者在上消化道有特定的内镜和HP检查结果,另有23%的HP发现高度提示CD。我们证明了常规临床的重要性,实验室,内窥镜,和儿童CD患者的组织病理学评估。
    Crohn\'s disease (CD) is a progressive, multifactorial, immune-mediated disease characterized by chronic inflammation of any part of the gastrointestinal (GI) tract. Pediatric patients present with a more extensive form of the disease, especially in the upper GI tract with various histopathological inflammatory patterns. Our study aims to analyze the clinical, laboratory, endoscopic, and histopathological findings in children with diagnosed CD and compare results on the initial and follow-up tests. We have included 100 children and adolescents with CD, with performed endoscopic and histopathological (HP) procedures. The results of multiple biopsies executed in these 8 years were matched and compared. We found a statistically significant frequency reduction in stool changes (65.52% to 18.18%), weight loss (35.24% to 4%), and abdominal pain (41.86% to 6.67%) as presenting symptoms. There was an improvement in all laboratory values: fecal calprotectin (1000 to 60,8 μg/g), C-reactive protein (12.2 to 1.9 mg/L), and albumin (36 to 41 g/L). On esophagogastroduodenoscopy and ileo-colonoscopy 36.59% and 64.86% patients had specific findings, respectively. A total of 32 patients had evidence of Crohn\'s disease in the upper GI tract. Non-caseating granulomas were found on 9% of oesophageal, 18% of gastric, and 12% of duodenal biopsies. In the lower GI tract, we have observed a disease progression in the rectum (72.29 to 82.22%) and descending colon (73.49 to 80%). There was no registered disease progression in the upper GI tract. Our study demonstrated a significant decline in the frequency of symptoms and an improvement in laboratory values on the follow-up examinations. More than a third of our patients had specific endoscopic and HP findings in the upper GI tract, and an additional 23% had HP findings highly suggestive of CD. We demonstrated the importance of regular clinical, laboratory, endoscopic, and histopathological assessments of pediatric CD patients.
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  • 文章类型: Journal Article
    背景:在过去的25年中,小儿炎症性肠病(pIBD)的发病率有所增加。我们的目标是报告整个英国西南部的同期趋势。
    方法:数据来自英国西南部的中心(布里斯托尔,牛津,卡迪夫,埃克塞特,和南安普敦),高危人群(<18岁)的总面积为2947534。从2013年到2022年检索了病例。报告的事件发生率为每10万风险人群,通过相关性分析时间趋势。对年龄组(0-6、6-11和12-17岁)进行亚组分析,性别,和疾病亚型。Choropleth地图是为当地地区创建的。
    结果:总计,在2013年至2022年之间诊断出2497例pIBD病例,平均年龄为12.6岁(38.7%为女性)。诊断人数从187增加到376,相应的发病率为每年每10万人口6.0(2013年)到每年每10万人口12.4(2022年)(b=0.918,P<0.01)。女性比率从2013年的每年每10万人口5.1人增加到2022年的每年每10万人口11.0人(b=0.865,P=0.01)。男性比率从每年每10万人口5.7增加到每年每10万人口14.4(b=0.832,P=0.03)。克罗恩病发病率从每年3.1/10万人口增加到每年6.3/10万人口(b=0.897,P<.01)。溃疡性结肠炎从每年每10万人口2.3增加到每年每10万人口4.3(b=0.813,P=.04)。未分类的炎症性肠病也有所增加,从每年每10万人口0.6到每年每10万人口1.8(b=0.851,P=.02)。在≥12至17岁的人群中观察到统计学上的显着增加,从每年每10万人口11.2到每年每10万人口24.6(b=0.912,P<0.01),以及7至11岁的年龄组,发病率从每年每100000人口4.4上升到每年每100000人口7.6(b=0.878,P=0.01)。非常早发性炎症性肠病(≤6岁)没有统计学上的显着增加(b=0.417,P=0.231)。
    结论:我们证明,在包括多个转诊中心在内的广大地理区域,pIBD发病率显著增加。发病率的增加对管理pIBD的服务提供有影响。
    儿童时期炎症性肠病的发病率持续增加,尤其是年龄较大的儿童。这在10年期间收集的当代数据集中得到了证明,并覆盖了近3000000的高危人群。这些数据对服务提供具有重要意义。
    BACKGROUND: Pediatric inflammatory bowel disease (pIBD) incidence has increased over the last 25 years. We aim to report contemporaneous trends across the South West United Kingdom.
    METHODS: Data were provided from centers covering the South West United Kingdom (Bristol, Oxford, Cardiff, Exeter, and Southampton), with a total area at-risk population (<18 years of age) of 2 947 534. Cases were retrieved from 2013 to 2022. Incident rates were reported per 100 000 at-risk population, with temporal trends analyzed through correlation. Subgroup analysis was undertaken for age groups (0-6, 6-11, and 12-17 years of age), sex, and disease subtype. Choropleth maps were created for local districts.
    RESULTS: In total, 2497 pIBD cases were diagnosed between 2013 and 2022, with a mean age of 12.6 years (38.7% female). Diagnosis numbers increased from 187 to 376, with corresponding incidence rates of 6.0 per 100 000 population per year (2013) to 12.4 per 100 000 population per year (2022) (b = 0.918, P < .01). Female rates increased from 5.1 per 100 000 population per year in 2013 to 11.0 per 100 000 population per year in 2022 (b = 0.865, P = .01). Male rates increased from 5.7 per 100 000 population per year to 14.4 per 100 000 population per year (b = 0.832, P = .03). Crohn\'s disease incidence increased from 3.1 per 100 000 population per year to 6.3 per 100 000 population per year (b = 0.897, P < .01). Ulcerative colitis increased from 2.3 per 100 000 population per year to 4.3 per 100 000 population per year (b = 0.813, P = .04). Inflammatory bowel disease unclassified also increased, from 0.6 per 100 000 population per year to 1.8 per 100 000 population per year (b = 0.851, P = .02). Statistically significant increases were seen in those ≥12 to 17 years of age, from 11.2 per 100 000 population per year to 24.6 per 100 000 population per year (b = 0.912, P < .01), and the 7- to 11-year-old age group, with incidence rising from 4.4 per 100 000 population per year to 7.6 per 100 000 population per year (b = 0.878, P = .01). There was no statistically significant increase in very early onset inflammatory bowel disease (≤6 years of age) (b = 0.417, P = .231).
    CONCLUSIONS: We demonstrate significant increases in pIBD incidence across a large geographical area including multiple referral centers. Increasing incidence has implications for service provision for services managing pIBD.
    Incidence of inflammatory bowel disease continues to increase in childhood, particularly in older children. This is demonstrated in a contemporary dataset collected over a 10-year period, and covering an at-risk population of nearly 3 000 000. These data have significant implications for service provision.
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  • 文章类型: Journal Article
    我们介绍了通过向嘴唇病灶内注射肿瘤坏死因子α抑制剂成功治疗口面肉芽肿的首例文献。我们的患者在3次注射后症状迅速改善,并在抗肿瘤坏死因子α治疗4个月内接近消退。
    We present the first documented case of successful treatment of orofacial granulomatosis by intralesional injections of a tumor necrosis factor α inhibitor to the lip. Our patient had rapid symptomatic improvement after 3 injections, and near resolution within 4 months of anti-tumor necrosis factor α therapy.
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  • 文章类型: Journal Article
    CMV感染仍然是IBD患者关注的问题,特别是关于疾病的复发管理。为什么IBD患者,特别是那些受溃疡性结肠炎影响的人,更容易被CMV再激活并没有完全解释,尽管免疫系统减弱可能是原因。各种技术,从血清学到组织学,可用于检测肠道CMV感染;然而,目前文献中关于最有效的诊断试验存在分歧.此外,CMV参与类固醇耐药性已被广泛讨论,但是CMV感染是否是疾病严重程度的原因或后果,因此,类固醇难治性仍有争议。必须更加重视和全面探索其对高级疗法和小分子缺乏反应的潜在贡献。在这次审查中,我们看看IBD患者CMV的实际文献,我们提出了一种实用的CMV感染临床实践管理算法。
    CMV infection is still a matter of concern in IBD patients, especially regarding the disease\'s relapse management. Why IBD patients, particularly those affected by ulcerative colitis, are more susceptible to CMV reactivation is not totally explained, although a weakened immune system could be the reason. Various techniques, ranging from serology to histology, can be employed to detect intestinal CMV infection; however, there is currently disagreement in the literature regarding the most effective diagnostic test. Furthermore, CMV involvement in steroid resistance has been broadly discussed, but whether CMV infection is a cause or consequence of the disease severity and, consequently, steroid refractoriness is still debated. Its potential contribution to the lack of response to advanced therapy and small molecules must be more valued and wholly explored. In this review, we look at the actual literature on CMV in IBD patients, and we suggest a pragmatic algorithm for clinical practice management of CMV infection.
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  • 文章类型: Journal Article
    背景:本系统综述旨在描述肠造口(IS)患者的研究现状,并强调克罗恩病(CD)和IS的临床研究未满足的需求。
    方法:我们搜索了ClinicalTrials.gov,从开始到2022年5月25日,以确定评估IS患者干预措施的临床试验,还有那些有IS和CD的。根据干预类型对研究进行分组。我们排除了没有治疗臂的观察性研究。
    结果:共有253项研究纳入最终分析。大多数研究调查了设备(n=122[48.2%]),或外科手术(n=63[24.9%]),其次是行为干预(n=30[11.8%]),药物(n=20[7.9%]),饮食干预(n=2[0.8%]),护肤品(n=20.8%]),和其他(n=14[5.5%])。共有50.9%(n=129)的研究完成了招聘,招募11116名参与者。只有6项研究(手术:n=3;生理研究:n=2;药物:n=1)仅包括炎症性肠病(IBD)患者,16项研究评论说,IBD患者的入选标准被排除在外.没有研究评估药物在CD和IS患者中的疗效。大约四分之一的研究(253项研究中的65项)将生活质量作为结果指标。
    结论:关于IBD合并IS患者的研究很少,大多数人专注于设备和外科手术。尚无评估CD和IS患者疗效的药物试验。迫切需要确定注册障碍,并制定资格和结果措施,以使具有造口的CD患者纳入临床试验。
    我们分析了肠造口患者的注册试验,特别关注克罗恩病患者,以探索研究和未满足的需求。我们的结果表明,该领域的研究很少,大多数研究仅限于外科手术和设备。
    BACKGROUND: This systematic review was performed to characterize the landscape of research conducted in patients with intestinal stoma (IS) and highlight unmet needs for clinical research in Crohn\'s disease (CD) and IS.
    METHODS: We searched ClinicalTrials.gov from inception to May 25, 2022, to identify clinical trials assessing interventions in patients with an IS, as well as those with an IS and CD. Studies were grouped according to type of intervention. We excluded observational studies with no treatment arm.
    RESULTS: A total of 253 studies were included in the final analysis. Most studies investigated devices (n = 122 [48.2%]), or surgical procedures (n = 63 [24.9%]), followed by behavioral interventions (n = 30 [11.8%]), drugs (n = 20 [7.9%]), dietary interventions (n = 2 [0.8%]), skin care products (n = 2 0.8%]), and others (n = 14 [5.5%]). A total of 50.9% (n = 129) of studies had completed recruitment, enrolling 11 116 participants. Only 6 studies (surgery: n = 3; physiological studies: n = 2; drugs: n = 1) exclusively included patients with inflammatory bowel disease (IBD), and 16 studies commented that patients with IBD were excluded in their eligibility criteria. No study assessed efficacy of drugs in patients with CD and IS. Approximately one-quarter of studies (n = 65 of 253) included quality of life as an outcome measure.
    CONCLUSIONS: There is a paucity of research in IBD patients with IS, with the majority focusing on devices and surgical procedures. There have been no drug trials evaluating efficacy in patients with CD and IS. There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures that enable the inclusion of patients with CD with stoma into clinical trials.
    We analyzed registered trials for patients with intestinal stoma with special focus on Crohn’s disease patients to explore research and unmet needs. Our results indicate a scarcity of studies in this area with most studies limited to surgical procedures and devices.
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