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The effect of synbiotics in patients with NAFLD: a systematic review and meta-analysis. 合成抗生素对NAFLD患者的影响:一项系统回顾和荟萃分析。
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231174299
Jiacheng Cai, Jia Dong, Dahua Chen, Hua Ye

Background: Nonalcoholic fatty liver disease (NAFLD) is the highest incidence of chronic liver disease worldwide, seriously endangering human health, and its pathogenesis is still unclear. In the recent years, increasing evidence has shown that intestinal flora plays an important role in the occurrence and development of NAFLD. Synbiotics can alter gut microbiota and may be a treatment option for NAFLD in the future.

Objectives: To systematically investigate the therapeutic effect of synbiotic supplementation on NAFLD patients.

Design: A systematic review and meta-analysis were conducted.

Data sources and methods: We conducted a search on four databases (PubMed, Embase, Cochrane Library, and Web of Science) to identify relevant studies. Eligible studies were then screened, and data from the included studies were extracted, combined, and analyzed.

Result: This study analyzed 10 randomized controlled trials involving 634 patients with NAFLD. The results showed that synbiotic supplementation could significantly reduce the level of alanine aminotransferase (mean difference (MD) = -8.80; (95% CI [-13.06, -4.53]), p < 0.0001), aspartate aminotransferase (MD = -9.48; 95% CI [-12.54, -6.43], p < 0.0001), and γ-glutamyl transferase (MD = -12.55; 95% CI [-19.40, -5.69], p = 0.0003) in NAFLD patients. In the field of metabolism, synbiotic supplementation could significantly reduce the level of total cholesterol (MD = -11.93; 95% CI [-20.43, -3.42], p = 0.006) and low-density lipoprotein cholesterol (MD = -16.2; 95% CI [-19.79, -12.60], p < 0.0001) and increase the level of high-density lipoprotein cholesterol (MD = 1.56; 95% CI [0.43, 2.68], p = 0.007) in NAFLD patients. In addition, synbiotic supplementation could significantly reduce liver stiffness measurement indicator (MD = -1.09; 95% CI [-1.87, -0.30], p = 0.006) and controlled attenuation parameter indicator (MD = -37.04; 95% CI [-56.78, -17.30], p = 0.0002) in NAFLD patients.

Conclusion: Based on the current evidence, synbiotic supplementation can improve liver function, adjust lipid metabolism, and reduce the degree of liver fibrosis in patients with NAFLD, but these effects need to be confirmed by further studies.

背景:非酒精性脂肪性肝病(NAFLD)是世界范围内发病率最高的慢性肝病,严重危害人类健康,其发病机制尚不清楚。近年来,越来越多的证据表明,肠道菌群在NAFLD的发生发展中起着重要作用。合生剂可以改变肠道微生物群,将来可能成为NAFLD的一种治疗选择。目的:系统观察合成制剂对NAFLD患者的治疗效果。设计:进行系统回顾和荟萃分析。数据来源和方法:我们对四个数据库(PubMed、Embase、Cochrane Library和Web of Science)进行了检索,以确定相关研究。然后筛选符合条件的研究,并从纳入的研究中提取、合并和分析数据。结果:本研究分析了10项随机对照试验,涉及634例NAFLD患者。结果表明:饲粮中添加合成菌可显著降低蛋鸡丙氨酸转氨酶水平(平均差值(MD) = -8.80;(95% CI[-13.06, -4.53]),非酒精性脂肪肝患者p p p = 0.0003)。在代谢方面,添加合成菌可显著降低总胆固醇水平(MD = -11.93;95% CI [-20.43, -3.42], p = 0.006)和低密度脂蛋白胆固醇(MD = -16.2;95% CI [-19.79, -12.60], p p = 0.007)。此外,添加合成菌可显著降低肝脏硬度测量指标(MD = -1.09;95% CI [-1.87, -0.30], p = 0.006)和可控衰减参数指标(MD = -37.04;95% CI [-56.78, -17.30], p = 0.0002)。结论:根据目前的证据,补充合成菌可改善NAFLD患者肝功能,调节脂质代谢,降低肝纤维化程度,但这些作用有待进一步研究证实。
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引用次数: 1
Comparison of early aggressive versus nonaggressive fluid resuscitation in acute pancreatitis: a meta-analysis. 急性胰腺炎早期积极与非积极液体复苏的比较:荟萃分析。
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231192144
Jian Guo, Jiaze Hong, Yujing He, Qingyuan Li, Tongmin Huang, Dandi Lou, Jie Zhang

Background: Early fluid resuscitation is one of the main therapeutic strategies for acute pancreatitis (AP). This study investigated the effects of early aggressive and nonaggressive hydration on AP.

Objectives: The aim of this meta-analysis is to investigate the differences between aggressive and nonaggressive intravenous fluid resuscitation in AP.

Design: This study was based on publicly available data, all of which have been extracted from previous ethically approved studies.

Data sources and methods: Two authors systematically searched PubMed, Embase (via OVID), Web of Science, and Cochrane Library to find all published research before February 2023. In-hospital mortality were set as primary endpoints.

Results: This meta-analysis included seven randomized controlled trials (RCTs) and eight cohort studies with 4072 individuals in nonaggressive (n = 2419) and aggressive (n = 1653) hydration groups. The results showed that patients in the nonaggressive group had a lower mortality rate than those in the aggressive hydration group [relative risks (RR), 0.66; p = 0.02]. Subgroup analysis results showed that patients in the nonaggressive hydration group had lower mortality rates in RCTs (RR, 0.39; p = 0.001), studies conducted in Eastern countries (RR, 0.63; p = 0.002), and studies with severe pancreatitis (RR, 0.65; p = 0.02). In addition, the nonaggressive hydration group had lower rates of infection (RR, 0.62; p < 0.001), organ failure (RR, 0.65; p = 0.02), and shock (RR, 0.21; p = 0.02), as well as a shorter hospital stay (weighted mean difference, -1.63; p = 0.001) than the aggressive hydration group.

Conclusions: Early nonaggressive fluid resuscitation is associated with lower mortality, lower risk of organ failure and infection, and shorter hospital stays than aggressive fluid resuscitation.

Registration prospero registration number: CRD42023396388.

背景:早期液体复苏是急性胰腺炎(AP)的主要治疗策略之一。本研究探讨了早期积极和非积极水合治疗对ap的影响。目的:本荟萃分析的目的是探讨积极和非积极静脉液体复苏在ap中的差异。设计:本研究基于公开可用的数据,所有数据均来自先前经伦理批准的研究。数据来源和方法:两位作者系统地检索了PubMed、Embase(通过OVID)、Web of Science和Cochrane Library,以查找2023年2月之前发表的所有研究。住院死亡率作为主要终点。结果:本荟萃分析包括7项随机对照试验(rct)和8项队列研究,共纳入4072例非侵袭性水合组(n = 2419)和侵袭性水合组(n = 1653)。结果显示,非侵袭性水合治疗组患者死亡率低于侵袭性水合治疗组[相对危险度(RR), 0.66;p = 0.02]。亚组分析结果显示,非侵袭性水合治疗组患者的rct死亡率较低(RR, 0.39;p = 0.001),在东方国家进行的研究(RR, 0.63;p = 0.002),重症胰腺炎研究(RR, 0.65;p = 0.02)。此外,非侵袭性补水组感染发生率较低(RR, 0.62;p p = 0.02),休克(RR, 0.21;P = 0.02),以及更短的住院时间(加权平均差为-1.63;P = 0.001)。结论:与积极液体复苏相比,早期无创液体复苏具有较低的死亡率、较低的器官衰竭和感染风险以及较短的住院时间。注册号:CRD42023396388。
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引用次数: 0
COVID-19 vaccination in adults with inflammatory bowel disease. 成人炎症性肠病患者的COVID-19疫苗接种
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231173130
Megan Lutz, Sarah Lazarus, Freddy Caldera

Patients with inflammatory bowel disease (IBD) are not at increased risk of SARS-CoV-2 infection compared to the general population, and most are not at increased risk for severe disease. COVID-19 is nonetheless common, and vaccination is critical. Four safe and efficacious vaccines are now available for the prevention of COVID-19, with most data available for mRNA vaccines. Patients with IBD have a robust humoral response to vaccination with rates of seroconversion exceeding 95% following a two-dose mRNA vaccine series and 99% following a three-dose mRNA series, although those on certain therapies including anti-tumor necrosis factor α agents may have lower antibody concentrations and waning of antibodies over time. Additionally, rates of cell-mediated immune response, even in those patients with IBD who did not have evidence of humoral immunity, are high. Vaccines are safe and have not been associated with flares in disease activity. Gastroenterology providers should take an active role in ensuring patients with IBD are appropriately vaccinated against COVID-19.

与一般人群相比,炎症性肠病(IBD)患者感染SARS-CoV-2的风险没有增加,而且大多数患者患严重疾病的风险没有增加。尽管如此,COVID-19很常见,接种疫苗至关重要。目前有四种安全有效的疫苗可用于预防COVID-19,其中大多数数据可用于mRNA疫苗。IBD患者对疫苗接种有很强的体液应答,两剂mRNA疫苗系列的血清转换率超过95%,三剂mRNA疫苗系列的血清转换率超过99%,尽管接受某些治疗(包括抗肿瘤坏死因子α药物)的患者可能会出现较低的抗体浓度,抗体随时间的推移会减弱。此外,即使在那些没有体液免疫证据的IBD患者中,细胞介导的免疫应答率也很高。疫苗是安全的,没有与疾病活动的爆发相关联。胃肠病学提供者应在确保IBD患者适当接种COVID-19疫苗方面发挥积极作用。
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引用次数: 0
Is there an optimal sequence of biologic therapies for inflammatory bowel disease? 炎症性肠病的生物治疗是否有最佳顺序?
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231159452
Brian Bressler

Over the past two decades, 11 biologic agents have been approved for use in most countries for the treatment of moderate-to-severe inflammatory bowel disease (IBD). Antitumor necrosis factor α (anti-TNF) agents are commonly used as the first biologic in clinical practice, and nearly all pivotal studies of induction therapy enrolled patients with and without prior use of anti-TNF therapy. This narrative review presents a reasonable approach to devising treatment sequences, examining the magnitude of benefit for each drug versus placebo or active comparator and then considering how that benefit changes with prior anti-TNF treatment. Data from ULTRA 2, GEMINI 1, VARSITY, and True North in patients with ulcerative colitis indicate that induction adalimumab, vedolizumab, and ozanimod showed lower clinical remission rates after anti-TNF therapy, while UNIFI, OCTAVE 1&2, and U-ACHIEVE/U-ACCOMPLISH show ustekinumab, tofacitinib, and upadacitinib did not. In patients with Crohn's disease, endoscopic remission or mucosal healing after induction therapy rather than clinical remission as well as assessment of persistent endoscopic remission are good measures of long-term disease outcomes. Considering the drugs for which data on endoscopic remission rates are available, EXTEND and GEMINI 2&3 show adalimumab and vedolizumab with persistently lower endoscopic remission rates after prior anti-TNF therapy, while IM-UNIFI, SEAVUE, and FORTIFY show ustekinumab and risankizumab did not. Data from the multicenter retrospective EVOLVE study indicate that the effectiveness of anti-TNF therapy does not seem to be significantly impacted by prior vedolizumab therapy, and may further suggest the benefit of using vedolizumab as a first-line biologic. As adverse event rates remain low across all treatments, the magnitude of harm from untreated or poorly treated disease far outweighs harm from any individual therapy. Regardless of the treatment sequence, careful monitoring for early signs of treatment nonresponse and switching to another potentially highly active therapy are critical to effective management of IBD.

在过去的二十年中,大多数国家批准了11种生物制剂用于治疗中度至重度炎症性肠病(IBD)。抗肿瘤坏死因子α (anti-TNF)药物通常被用作临床实践中的第一生物制剂,几乎所有诱导治疗的关键研究都纳入了先前使用或未使用抗肿瘤坏死因子治疗的患者。这篇叙述性综述提出了一种合理的方法来设计治疗序列,检查每种药物与安慰剂或活性比较物的获益程度,然后考虑这种获益如何随着先前的抗tnf治疗而变化。来自ULTRA 2、GEMINI 1、VARSITY和True North的溃疡性结肠炎患者的数据表明,抗tnf治疗后诱导阿达单抗、维多单抗和奥扎莫的临床缓解率较低,而UNIFI、OCTAVE 1&2和U-ACHIEVE/U-ACCOMPLISH显示ustekinumab、tofacitinib和upadacitinib没有。在克罗恩病患者中,诱导治疗后的内镜缓解或粘膜愈合,而不是临床缓解,以及评估持续的内镜缓解是长期疾病结局的良好指标。考虑到有内窥镜缓解率数据的药物,EXTEND和GEMINI 2&3显示阿达木单抗和维多单抗在既往抗tnf治疗后的内窥镜缓解率持续较低,而IM-UNIFI、SEAVUE和FORTIFY显示ustekinumab和risankizumab没有。来自多中心回顾性EVOLVE研究的数据表明,抗肿瘤坏死因子治疗的有效性似乎不受既往vedolizumab治疗的显著影响,这可能进一步表明使用vedolizumab作为一线生物制剂的益处。由于所有治疗方法的不良事件发生率仍然很低,未经治疗或治疗不良的疾病造成的伤害远远超过任何一种治疗方法造成的伤害。无论治疗顺序如何,仔细监测治疗无反应的早期迹象并转向另一种潜在的高活性治疗对于IBD的有效管理至关重要。
{"title":"Is there an optimal sequence of biologic therapies for inflammatory bowel disease?","authors":"Brian Bressler","doi":"10.1177/17562848231159452","DOIUrl":"https://doi.org/10.1177/17562848231159452","url":null,"abstract":"<p><p>Over the past two decades, 11 biologic agents have been approved for use in most countries for the treatment of moderate-to-severe inflammatory bowel disease (IBD). Antitumor necrosis factor α (anti-TNF) agents are commonly used as the first biologic in clinical practice, and nearly all pivotal studies of induction therapy enrolled patients with and without prior use of anti-TNF therapy. This narrative review presents a reasonable approach to devising treatment sequences, examining the magnitude of benefit for each drug <i>versus</i> placebo or active comparator and then considering how that benefit changes with prior anti-TNF treatment. Data from ULTRA 2, GEMINI 1, VARSITY, and True North in patients with ulcerative colitis indicate that induction adalimumab, vedolizumab, and ozanimod showed lower clinical remission rates after anti-TNF therapy, while UNIFI, OCTAVE 1&2, and U-ACHIEVE/U-ACCOMPLISH show ustekinumab, tofacitinib, and upadacitinib did not. In patients with Crohn's disease, endoscopic remission or mucosal healing after induction therapy rather than clinical remission as well as assessment of persistent endoscopic remission are good measures of long-term disease outcomes. Considering the drugs for which data on endoscopic remission rates are available, EXTEND and GEMINI 2&3 show adalimumab and vedolizumab with persistently lower endoscopic remission rates after prior anti-TNF therapy, while IM-UNIFI, SEAVUE, and FORTIFY show ustekinumab and risankizumab did not. Data from the multicenter retrospective EVOLVE study indicate that the effectiveness of anti-TNF therapy does not seem to be significantly impacted by prior vedolizumab therapy, and may further suggest the benefit of using vedolizumab as a first-line biologic. As adverse event rates remain low across all treatments, the magnitude of harm from untreated or poorly treated disease far outweighs harm from any individual therapy. Regardless of the treatment sequence, careful monitoring for early signs of treatment nonresponse and switching to another potentially highly active therapy are critical to effective management of IBD.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"16 ","pages":"17562848231159452"},"PeriodicalIF":4.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10087655/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9674905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
PERFUSE: a French non-interventional study of patients with inflammatory bowel disease receiving infliximab biosimilar SB2: a 12-month analysis. PERFUSE:法国一项接受英夫利昔单抗生物类似药SB2的炎症性肠病患者的非介入性研究:一项为期12个月的分析。
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848221145654
Yoram Bouhnik, Bruno Fautrel, Laurent Beaugerie, Anne-Laure Pelletier, Christine Martinez-Vinson, Ulrich Freudensprung, Amira Brigui, Janet Addison

Background: FlixabiTM (SB2) is a biosimilar of the reference infliximab (IFX), Remicade®. Published evidence on long-term, real-world use of SB2 in patients either IFX naive or transitioned from prior IFX is scarce.

Objectives: We evaluated persistence, effectiveness, and safety of SB2 over 12 months in adults with IBD [Crohn's disease (CD) and ulcerative colitis (UC)], participating in PERFUSE.

Design: PERFUSE is a long-term, non-interventional, multicenter study of patients receiving SB2 at specialist sites across France.

Methods: SB2 treatment was initiated in September 2017, either as first IFX treatment (IFX naive), after transition from treatment with reference IFX (IFX ref) or another IFX biosimilar (IFX bs), or both IFX ref and IFX bs (IFX multiswitch). Outcomes up to Month 12 (±2) include persistence on SB2 (primary outcome measure), SB2 dose, disease status, immunogenicity, and safety.

Results: This final 12-month analysis of patients with IBD includes 569 with CD and 168 with UC. Persistence [95% confidence interval (CI)] at Month 12 was CD: 89% (77.2; 94.9), UC: 78.5% (58.2; 89.8) for IFX naive; CD: 94% (91.0; 96.1), UC: 92.8% (84.8; 96.7) for IFX ref; CD: 91.6% (86.0; 95.0), UC: 94.2% (83.1; 98.1) for IFX bs; and CD 100% (100; 100), UC 100% (100; 100) for IFX multiswitch. In the CD and UC cohorts, disease activity among IFX naive patients declined from baseline to Month 12; with any prior IFX, the proportions of patients in remission at baseline, Month 6, and Month 12 remained unchanged in the UC cohort, and were comparable or higher in the CD cohort. No immunogenicity or safety signals were detected.

Conclusions: Patients with IBD can be initiated on SB2 or transitioned from IFX ref and/or IFX bs to SB2, with no loss of disease control or safety concerns, with >75% of naive and >90% of transitioned patients continuing on SB2 treatment at 12 months.

背景:FlixabiTM (SB2)是参考药物英夫利昔单抗(IFX) Remicade®的生物仿制药。关于首次IFX或从先前IFX过渡的患者长期、实际使用SB2的公开证据很少。目的:我们评估了参与PERFUSE的成人IBD[克罗恩病(CD)和溃疡性结肠炎(UC)]患者服用SB2超过12个月的持续性、有效性和安全性。PERFUSE是一项长期、非介入性、多中心研究,研究对象是在法国各地的专科医院接受SB2治疗的患者。方法:SB2治疗于2017年9月开始,作为IFX的首次治疗(IFX naive),在参考IFX (IFX ref)或另一种IFX生物仿制药(IFX bs)治疗过渡后,或IFX ref和IFX bs (IFX multiswitch)治疗。截至第12个月(±2)的结局包括SB2持续治疗(主要结局指标)、SB2剂量、疾病状态、免疫原性和安全性。结果:最后12个月的IBD患者分析包括569例CD和168例UC。第12个月的持续性[95%置信区间(CI)]为CD: 89% (77.2;94.9), uc: 78.5% (58.2;IFX naive为89.8);Cd: 94% (91.0;96.1), uc: 92.8% (84.8;96.7) for IFX ref;Cd: 91.6% (86.0;95.0), uc: 94.2% (83.1;98.1)为IFX bs;CD 100% (100;100), uc 100% (100;100)用于IFX多路开关。在CD和UC队列中,IFX初始患者的疾病活动性从基线到第12个月下降;对于任何先前的IFX, UC队列患者在基线、第6个月和第12个月的缓解比例保持不变,而CD队列患者的缓解比例相当或更高。未检测到免疫原性或安全性信号。结论:IBD患者可以开始接受SB2治疗或从IFX ref和/或IFX bs过渡到SB2,没有疾病控制或安全问题,>75%的初始患者和>90%的过渡患者在12个月时继续接受SB2治疗。
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引用次数: 0
Use of imaging modalities for decision-making in inflammatory bowel disease. 炎症性肠病的影像学诊断
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231151293
Stéphane Nancey, Mathurin Fumery, Mathias Faure, Gilles Boschetti, Claire Gay, Laurent Milot, Xavier Roblin
Cross-sectional magnetic resonance enterography (MRE) and intestinal ultrasonography (IUS) provide valuable and noninvasive information to accurately assess disease activity, severity, and extent; detect complications; and monitor the response to treatment, as well as predict the postoperative recurrence of Crohn’s disease and a negative disease course. Therefore, both imaging modalities are emerging as pivotal diagnostic tools to achieve the emerging therapeutic target of transmural healing associated with better disease outcomes. Despite its numerous potential advantages over endoscopy and even MRE and its good availability, IUS is still widely underused to monitor and manage inflammatory bowel disease (IBD) patients and help in making clinical decisions in routine practice. This situation is clearly due to the absence of validated, reliable, and responsive indices, as well as the lack of trained gastroenterologists and radiologists, as IUS is a component of radiologist expertise in several countries but not yet integrated into the training program of gastroenterologists. However, there is an increasing body of evidence in the literature that IUS and MRE are both becoming essential imaging resources to help clinicians in making reliable decisions. Here, we discuss the up-to-date evidence about the usefulness and performance of cross-sectional imaging, focusing on the ability of bowel US and MRE to aid clinical decision-making for the optimal management and monitoring of IBD.
横断面磁共振肠图(MRE)和肠超声(IUS)提供有价值的、无创的信息,以准确评估疾病的活动、严重程度和范围;发现并发症;监测对治疗的反应,以及预测克罗恩病的术后复发和阴性病程。因此,这两种成像方式正在成为关键的诊断工具,以实现与更好的疾病预后相关的跨壁愈合的新治疗目标。尽管它比内窥镜甚至MRE有许多潜在的优势,而且它的可用性也很好,但在常规实践中,IUS仍然广泛未被用于监测和管理炎症性肠病(IBD)患者,并帮助做出临床决策。这种情况显然是由于缺乏经过验证的、可靠的、反应灵敏的指标,以及缺乏训练有素的胃肠病学家和放射科医生,因为IUS在一些国家是放射科医生专业知识的组成部分,但尚未纳入胃肠病学家的培训计划。然而,文献中有越来越多的证据表明,IUS和MRE都已成为帮助临床医生做出可靠决策的重要影像资源。在这里,我们讨论了关于横截面成像的有用性和性能的最新证据,重点是肠US和MRE在帮助IBD最佳管理和监测的临床决策方面的能力。
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引用次数: 7
The effect of starch- and sucrose-reduced diet accompanied by nutritional and culinary recommendations on the symptoms of irritable bowel syndrome patients with diarrhoea. 减少淀粉和蔗糖的饮食以及营养和烹饪建议对肠易激综合征腹泻患者症状的影响
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231156682
Lucia Gayoso, Koldo Garcia-Etxebarria, Teresa Arzallus, Isabel Montalvo, Jacobo Lizasoain, Mauro D'Amato, Usune Etxeberria, Luis Bujanda

Background: Irritable bowel syndrome (IBS) is a common gastrointestinal condition which entails a high burden in the quality of life (QoL) of patients. Nutritional interventions have been proposed to alleviate symptoms, since still no effective treatments exist for IBS.

Objectives: Our aim is to analyse the feasibility of the use of starch- and sucrose-reduced diet (SSRD).

Design: In this study, we used a SSRD accompanied by nutritional and culinary recommendations to measure the effects in IBS patients with diarrhoea.

Methods: In all, 34 participants completed a 4-week nutritional intervention based on SSRD. Symptoms, QoL and dietary habits were assessed by several questionnaires that were completed at the beginning, daily, after 2 weeks, at the end, and after 2 months.

Results: 85.29% of the participants reached the primary endpoint [reduction of 50 points or more in IBS-symptom severity scale (SSS)], and 58.82% the secondary endpoint (reduction of 50% or more in IBS-SSS). The relief of symptoms and improvement of the QoL were significant after 2 weeks of intervention, at the end and after 2 months. Dietary habits were consistent with the diet and high adherence was achieved.

Conclusions: SSRD and individualized nutritional and culinary guidance improved symptoms and QoL of IBS patients with diarrhoea, with a high adherence.

背景:肠易激综合征(IBS)是一种常见的胃肠道疾病,对患者的生活质量(QoL)造成了很高的负担。由于目前还没有有效的治疗肠易激综合征的方法,营养干预已被提议用于缓解症状。目的:我们的目的是分析使用淀粉和蔗糖还原饮食(SSRD)的可行性。设计:在这项研究中,我们使用SSRD并结合营养和烹饪建议来衡量IBS腹泻患者的效果。方法:总共有34名参与者完成了为期4周的基于SSRD的营养干预。症状、生活质量和饮食习惯通过几份问卷进行评估,这些问卷分别在开始、每天、2周后、结束时和2个月后完成。结果:85.29%的参与者达到了主要终点[ibs -症状严重程度量表(SSS)降低50分或以上],58.82%的参与者达到了次要终点(IBS-SSS降低50%或以上)。干预2周后、结束时和2个月后症状缓解和生活质量改善均显著。饮食习惯与饮食一致,并且达到了高依从性。结论:SSRD和个体化营养和烹饪指导可改善IBS腹泻患者的症状和生活质量,且依从性高。
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引用次数: 2
Gastrointestinal injury induced by immunomodulators: A review article. 免疫调节剂诱导的胃肠道损伤:综述。
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231158549
Pingxin Zhang, Ren Mao, Chuhan Zhang, Yun Qiu, Minhu Chen

An increasing number of immunomodulators, either anti-inflammatory or immunity-enhancing, have brought about a revolutionary effect in the management of a variety of autoimmune disorders and malignancies. However, their ability to cause gastrointestinal (GI) injury and induce GI symptoms has been increasingly and unexpectedly recognized. GI injury associated with immunomodulators may demonstrate various histologic and endoscopic patterns. Optimal diagnosis and treatment require a multidisciplinary approach. This review aims to provide an overview of the literature on its pathogenesis, the clinical, endoscopic, and histologic features, and suggested approaches to manage these newly recognized immunomodulator-induced GI adverse effects (AEs). We also reviewed current biomarkers predictive of GI toxicity and potential risk factors to identify susceptible patients. In addition, these immune-mediated AEs were compared with inflammatory bowel disease, a well-documented form of inflammation-driven GI injury. We hope this review will raise awareness and vigilance among clinicians of these entities to increase early diagnosis and rapid referral to specialist care.

越来越多的免疫调节剂,无论是抗炎还是增强免疫,在各种自身免疫性疾病和恶性肿瘤的治疗中带来了革命性的影响。然而,它们引起胃肠道(GI)损伤和诱导胃肠道症状的能力已被越来越多的和意想不到的认识到。与免疫调节剂相关的胃肠道损伤可能表现出不同的组织学和内镜模式。最佳诊断和治疗需要多学科的方法。本文旨在综述其发病机制、临床、内镜和组织学特征的文献,并提出处理这些新认识的免疫调节剂诱导的胃肠道不良反应(ae)的方法。我们还回顾了目前预测胃肠道毒性和潜在危险因素的生物标志物,以识别易感患者。此外,这些免疫介导的ae与炎症性肠病进行了比较,炎症性肠病是炎症驱动的胃肠道损伤的一种有充分记录的形式。我们希望这篇综述将提高临床医生对这些实体的认识和警惕,以增加早期诊断和快速转诊到专科护理。
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引用次数: 0
Rights and wrongs of Helicobacter pylori testing and treatment in children. 儿童幽门螺杆菌检测与治疗的对与错。
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231195251
Toshihiko Kakiuchi
Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the Sage and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). TherapeuTic advances in Gastroenterology
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引用次数: 0
Safety of fecal microbiota, live-jslm (REBYOTA) in individuals with recurrent Clostridioides difficile infection: data from five prospective clinical trials. 复发性艰难梭菌感染患者粪便微生物群live-jslm (REBYOTA™)的安全性:来自五项前瞻性临床试验的数据
IF 4.2 3区 医学 Pub Date : 2023-01-01 DOI: 10.1177/17562848231174277
Christine Lee, Thomas Louie, Lindy Bancke, Beth Guthmueller, Adam Harvey, Paul Feuerstadt, Sahil Khanna, Robert Orenstein, Erik R Dubberke

Background: Microbiota-based treatments reduce the incidence of recurrent Clostridioides difficile infections (rCDIs), but prospectively collected safety data needed to broaden patient access and protect public health have been limited.

Objectives: We provide cumulative safety data from five prospective clinical trials evaluating fecal microbiota, live-jslm (RBL) - the first microbiota-based live biotherapeutic product approved by the US Food and Drug Administration - for preventing rCDI in adults.

Design: Integrated safety analysis includes three phase II trials (PUNCH CD, PUNCH CD2, PUNCH Open-Label) and two phase III trials (PUNCH CD3, PUNCH CD3-OLS) of RBL.

Methods: Trial participants were at least 18 years of age with documented rCDI who completed standard-of-care antibiotic therapy before treatment with RBL. Assigned study treatment regimen was one or two doses of RBL (or placebo) administered rectally, depending on the trial design. In four of the five trials, participants with CDI recurrence within 8 weeks after RBL or placebo administration were eligible for treatment with open-label RBL. Treatment-emergent adverse events (TEAEs) were recorded for at least 6 months following last study treatment; in PUNCH CD2 and PUNCH Open-Label trials, TEAEs and serious TEAEs were collected through 12 and 24 months, respectively.

Results: Among the five trials, 978 participants received at least one dose of RBL (assigned treatment or after recurrence) and 83 participants received placebo only. TEAEs were reported in 60.2% of Placebo Only participants and 66.4% of RBL Only participants. Only abdominal pain, nausea, and flatulence were significantly higher in the RBL Only group compared with the Placebo Only group. Most TEAEs were mild or moderate in severity and were most frequently related to preexisting conditions. There were no reported infections for which the causative pathogen was traced to RBL. Potentially life-threatening TEAEs were infrequent (3.0% of participants).

Conclusion: Across five clinical trials, RBL was well tolerated in adults with rCDI. In aggregate, these data consistently demonstrated the safety of RBL.

背景:以微生物群为基础的治疗可降低复发性艰难梭菌感染(rcdi)的发生率,但扩大患者可及性和保护公众健康所需的前瞻性安全性数据收集有限。目的:我们提供来自5项前瞻性临床试验的累积安全性数据,评估粪便微生物群,活jslm (RBL) -美国食品和药物管理局批准的第一个基于微生物群的活生物治疗产品-预防成人rCDI。设计:RBL的综合安全性分析包括3个II期试验(PUNCH CD、PUNCH CD2、PUNCH Open-Label)和2个III期试验(PUNCH CD3、PUNCH CD3- ols)。方法:试验参与者至少18岁,有记录的rCDI,在RBL治疗前完成了标准护理抗生素治疗。根据试验设计,指定的研究治疗方案是直肠给药一剂或两剂RBL(或安慰剂)。在五项试验中的四项中,RBL或安慰剂治疗后8周内CDI复发的参与者有资格接受开放标签RBL治疗。治疗后出现的不良事件(teae)记录在最后一次研究治疗后至少6个月;在PUNCH CD2和PUNCH开放标签试验中,分别在12个月和24个月收集teae和严重teae。结果:在5项试验中,978名参与者接受了至少一剂RBL(指定治疗或复发后),83名参与者仅接受安慰剂。60.2%的安慰剂组参与者和66.4%的RBL组参与者报告了teae。仅RBL组的腹痛、恶心和肠胃胀气明显高于安慰剂组。大多数teae的严重程度为轻度或中度,并且最常与先前存在的疾病有关。没有报告的感染病原被追踪到RBL。可能危及生命的teae很少发生(占参与者的3.0%)。结论:在五项临床试验中,RBL在成年rCDI患者中耐受性良好。总的来说,这些数据一致地证明了RBL的安全性。
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引用次数: 8
期刊
Therapeutic Advances in Gastroenterology
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