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BACKGROUND: Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited. METHODS: At 18 centers, we randomly assigned patients who presented with acute pancreatitis to receive goal-directed aggressive or moderate resuscitation with lactated Ringer's solution. Aggressive fluid resuscitation consisted of a bolus of 20 ml per kilogram of body weight, followed by 3 ml per kilogram per hour. Moderate fluid resuscitation consisted of a bolus of 10 ml per kilogram in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 ml per kilogram per hour in all patients in this group. Patients were assessed at 12, 24, 48, and 72 hours, and fluid resuscitation was adjusted according to the patient's clinical status. The primary outcome was the development of moderately severe or severe pancreatitis during the hospitalization. The main safety outcome was fluid overload. The planned sample size was 744, with a first planned interim analysis after the enrollment of 248 patients. RESULTS: A total of 249 patients were included in the interim analysis. The trial was halted owing to between-group differences in the safety outcomes without a significant difference in the incidence of moderately severe or severe pancreatitis (22.1% in the aggressive-resuscitation group and 17.3% in the moderate-resuscitation group; adjusted relative risk, 1.30; 95% confidence interval [CI], 0.78 to 2.18; P = 0.32). Fluid overload developed in 20.5% of the patients who received aggressive resuscitation and in 6.3% of those who received moderate resuscitation (adjusted relative risk, 2.85; 95% CI, 1.36 to 5.94, P = 0.004). The median duration of hospitalization was 6 days (interquartile range, 4 to 8) in the aggressive-resuscitation group and 5 days (interquartile range, 3 to 7) in the moderate-resuscitation group. CONCLUSIONS: In this randomized trial involving patients with acute pancreatitis, early aggressive fluid resuscitation resulted in a higher incidence of fluid overload without improvement in clinical outcomes. (Funded by Instituto de Salud Carlos III and others; WATERFALL ClinicalTrials.gov number, NCT04381169.).
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Desequilíbrio Ácido-Base , Hidratação , Pancreatite , Desequilíbrio Hidroeletrolítico , Desequilíbrio Ácido-Base/etiologia , Desequilíbrio Ácido-Base/terapia , Doença Aguda , Hidratação/efeitos adversos , Hidratação/métodos , Humanos , Pancreatite/complicações , Pancreatite/terapia , Ressuscitação/métodos , Lactato de Ringer/administração & dosagem , Lactato de Ringer/uso terapêutico , Desequilíbrio Hidroeletrolítico/etiologia , Desequilíbrio Hidroeletrolítico/terapiaRESUMO
OBJECTIVE: Pancreatic ductal adenocarcinoma (PDAC) has limited therapeutic options, particularly with immune checkpoint inhibitors. Highly chemoresistant 'stem-like' cells, known as cancer stem cells (CSCs), are implicated in PDAC aggressiveness. Thus, comprehending how this subset of cells evades the immune system is crucial for advancing novel therapies. DESIGN: We used the KPC mouse model (LSL-KrasG12D/+; LSL-Trp53R172H/+; Pdx-1-Cre) and primary tumour cell lines to investigate putative CSC populations. Transcriptomic analyses were conducted to pinpoint new genes involved in immune evasion. Overexpressing and knockout cell lines were established with lentiviral vectors. Subsequent in vitro coculture assays, in vivo mouse and zebrafish tumorigenesis studies, and in silico database approaches were performed. RESULTS: Using the KPC mouse model, we functionally confirmed a population of cells marked by EpCAM, Sca-1 and CD133 as authentic CSCs and investigated their transcriptional profile. Immune evasion signatures/genes, notably the gene peptidoglycan recognition protein 1 (PGLYRP1), were significantly overexpressed in these CSCs. Modulating PGLYRP1 impacted CSC immune evasion, affecting their resistance to macrophage-mediated and T-cell-mediated killing and their tumourigenesis in immunocompetent mice. Mechanistically, tumour necrosis factor alpha (TNFα)-regulated PGLYRP1 expression interferes with the immune tumour microenvironment (TME) landscape, promoting myeloid cell-derived immunosuppression and activated T-cell death. Importantly, these findings were not only replicated in human models, but clinically, secreted PGLYRP1 levels were significantly elevated in patients with PDAC. CONCLUSIONS: This study establishes PGLYRP1 as a novel CSC-associated marker crucial for immune evasion, particularly against macrophage phagocytosis and T-cell killing, presenting it as a promising target for PDAC immunotherapy.
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Carcinoma Ductal Pancreático , Células-Tronco Neoplásicas , Neoplasias Pancreáticas , Animais , Neoplasias Pancreáticas/imunologia , Neoplasias Pancreáticas/patologia , Neoplasias Pancreáticas/genética , Neoplasias Pancreáticas/metabolismo , Camundongos , Células-Tronco Neoplásicas/imunologia , Células-Tronco Neoplásicas/metabolismo , Carcinoma Ductal Pancreático/imunologia , Carcinoma Ductal Pancreático/patologia , Carcinoma Ductal Pancreático/genética , Carcinoma Ductal Pancreático/metabolismo , Humanos , Linhagem Celular Tumoral , Evasão Tumoral/imunologia , Modelos Animais de Doenças , Evasão da Resposta Imune , Microambiente Tumoral/imunologiaRESUMO
BACKGROUND: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),ß but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. METHODS: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. CLINICALTRIALS: gov, NCT03100578. RESULTS: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88-2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92-1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, - 10 [95% CI - 17.5, - 1]; p = 0.077) and global hospitalization (median difference - 4 [95% CI - 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08-0.83], p = 0.015). CONCLUSIONS: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03100578.
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Drenagem , Stents , Humanos , Resultado do Tratamento , Stents/efeitos adversos , Drenagem/métodos , Tempo de Internação , Necrose/etiologia , Endossonografia/métodosRESUMO
The incidence of pancreatic cancer is increasing, although globally it represents less than 3% of all cancers. Despite advances in medical and surgical management, survival rates have not significantly improved in recent years. Consequently, pancreatic cancer, though relatively uncommon, is the third leading cause of cancer-related deaths. This is primarily due to the disease´s late detection. Symptoms appear late and are nonspecific, and over 80% of cases are diagnosed at an advanced stage and unsuitable for curative surgery, resulting in a five-year survival rate below 10%. However, the exceptional cases that are diagnosed early show five-year survival rates exceeding 80%. Therefore, one of the keys to improving pancreatic cancer prognosis lies in early detection, making screening in high-risk individuals a potentially crucial strategy.
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BACKGROUND AND AIMS: over-the-scope-clips (OTSC®) have been proposed as a rescue treatment for bleeding peptic ulcers. However, their effectiveness has not been evaluated in Spain. METHODS: this retrospective and single-center study (January 2018-December 2021) assessed the technical success, clinical success and safety of the device within 30 days. All patients with upper gastrointestinal bleeding due to a peptic ulcer and treated with the OTSC® clip (OVESCO) as a rescue therapy were included in the study. RESULTS: a total of eleven patients were included in the study, nine due to rebleeding and two due to persistent bleeding. Technical success was 81.9 % (9/11, confidence interval [CI] 95 %: 52-95 %). The per-protocol and intention-to-treat clinical success were 88.9 % (8/9, CI 95 %: 57-98 %) and 72.7 % (8/11, CI 95 %: 43-90 %), respectively. No device-related adverse effects were recorded. CONCLUSION: the OTSC® clip was an effective and safe rescue therapy for bleeding peptic ulcers.
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Hemostase Endoscópica , Úlcera Péptica , Humanos , Hemostase Endoscópica/efeitos adversos , Hemostase Endoscópica/métodos , Estudos Retrospectivos , Endoscopia Gastrointestinal/métodos , Resultado do Tratamento , Hemorragia Gastrointestinal/etiologia , Hemorragia Gastrointestinal/cirurgia , Úlcera Péptica/complicações , Úlcera Péptica/terapia , Instrumentos CirúrgicosRESUMO
BACKGROUND & AIMS: Few prospective studies have assessed the safety of direct oral anticoagulants (DOACs) in elective endoscopy. Our primary aim was to compare the risks of endoscopy-related gastrointestinal bleeding and thromboembolic events in patients on DOACs or vitamin K antagonists (VKAs) in this setting. Secondarily, we examined the impact of the timing of anticoagulant resumption on the risk of delayed bleeding in high-risk therapeutic procedures. METHODS: We conducted a multicenter, prospective, observational study from January 2018 to March 2020 of 1602 patients on oral anticoagulants (1004 on VKAs and 598 on DOACs) undergoing 1874 elective endoscopic procedures. Our primary outcomes were 90-day thromboembolic events and 30-day endoscopy-related gastrointestinal bleeding. The inverse probability of treatment weighting propensity score method was used for baseline covariate adjustment. RESULTS: The 2 groups had similar risks of endoscopy-related gastrointestinal bleeding (VKAs vs DOACs, 6.2% vs 6.7%; adjusted odds ratio [OR], 1.05; 95% CI, 0.67-1.65) and thromboembolic events (VKAs vs DOACs, 1.3% vs 1.5%; adjusted OR, 0.90; 95% CI, 0.34-2.38). In high bleeding risk procedures (n = 747), delayed anticoagulant resumption (> 48 hours or 24-48 hours vs < 24 hours) did not reduce the risk of postprocedural bleeding (10.3%, 9%, and 5.8%, respectively; adjusted P = .43). Hot and cold snare polypectomy were the most frequent high-risk interventions (41.8% and 39.8%, respectively). CONCLUSION: In a prospective study of patients on DOACs or VKAs undergoing elective endoscopy, endoscopy-related bleeding and thromboembolic events showed similar risk. Our study suggests that early anticoagulant resumption is safe in most patients, but more data are needed for advanced high-risk therapeutic procedures.
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Pólipos do Colo , Administração Oral , Anticoagulantes/efeitos adversos , Colonoscopia , Hemorragia Gastrointestinal/induzido quimicamente , Hemorragia Gastrointestinal/epidemiologia , Humanos , Estudos Prospectivos , Vitamina KRESUMO
BACKGROUND: Current strategies to prevent colorectal cancer (CRC) vary considerably regarding safety, invasiveness, and patient satisfaction. A known deterrent for patients is the required bowel cleansing for colonoscopy. A new colon-scan capsule system is a unique preparation-free approach that provides structural information on colonic mucosa intended for detection of colorectal polyps and masses. AIMS: The aim of this study was to determine safety and patient satisfaction with the colon-scan capsule. METHODS: Prospective single-arm pilot study conducted at two tertiary care centers. Patients with a pre-scheduled colonoscopy for CRC screening or surveillance were included. Patients participating in this study underwent the colon-scan capsule and colonoscopy. Safety was defined by the occurrence of procedure or device-related adverse events. Satisfaction was based on survey questionnaires using a scoring system 1 (strongly disagree) to 5 (strongly agree). Patient satisfaction with the colon-scan capsule was compared to colonoscopy. RESULTS: Forty patients were included (52.9 [5.7] years; 64.1% females). There were no serious adverse events and no occurrences of capsule retention. The most common (12.5%) complaint was self-limiting abdominal cramping. Satisfaction questionnaires were completed by more than 87% of patients, with patients likely to recommend the capsule (score 4.1 [1.03]) compared to colonoscopy (score 2.8 [1.2]), p = 0.001. CONCLUSIONS: The new prepless colon-scan capsule system is an innovative, minimally invasive technology with demonstrated safety and high patient satisfaction. A multicenter pivotal study is planned to validate the performance, safety, and accuracy of polyp detection using the capsule system in comparison with colonoscopy.
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Endoscopia por Cápsula , Pólipos do Colo , Neoplasias Colorretais , Endoscopia por Cápsula/efeitos adversos , Endoscopia por Cápsula/métodos , Catárticos , Pólipos do Colo/diagnóstico por imagem , Colonoscopia/métodos , Neoplasias Colorretais/diagnóstico por imagem , Neoplasias Colorretais/epidemiologia , Feminino , Humanos , Masculino , Satisfação do Paciente , Projetos Piloto , Estudos ProspectivosRESUMO
Pancreatic cystic lesions (PCL) are composed of a heterogeneous group of entities that are increasingly diagnosed, generally as incidental findings in asymptomatic patients. In conjunction with this growing incidence, the potential for malignant transformation of mucin-producing cysts makes PCL a challenging clinical conundrum for the clinician, patient, and healthcare system. Cyst characterization based on morphology is often difficult and inaccurate. Therefore, several intracystic fluid biomarkers have been evaluated as ancillary testing to enhance the difficult balance between sparing a patient from an unnecessary high-risk pancreatic surgery and missing the opportunity to prevent or diagnose pancreatic adenocarcinoma at an early disease stage. There are two questions that are key to guide the care of patients with PCL: 1) is it a non-mucinous cyst that does not require any follow-up? and 2) if mucinous, does the cyst harbor advanced neoplasia (high-grade dysplasia or invasive carcinoma) that requires surgical resection, or is it a low-risk lesion that will benefit from a surveillance program? The purpose of this review is to give a general and practical overview of the different cyst fluid biomarkers that have been studied to address these specific questions, from classic biochemical markers such as carcinoembryonic antigen to novel genetic and epigenetic markers such as microRNA or intracystic bacterial DNA.
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Adenocarcinoma , Cisto Pancreático , Neoplasias Pancreáticas , Biomarcadores Tumorais/análise , Líquido Cístico/química , Humanos , Cisto Pancreático/diagnóstico , Neoplasias Pancreáticas/diagnóstico , Medição de RiscoRESUMO
BACKGROUND: drug-induced pancreatitis is an unexplored entity. METHODS: a retrospective cohort study was performed at a referral center. Patients with drug-induced acute pancreatitis between 2008 and 2018 were included. Baseline patient characteristics, involved drugs, clinical course and recurrence were analyzed. RESULTS: drug-induced pancreatitis represented 2.8 % of acute pancreatitis (47/1,665) and 18 different drugs were involved (thiopurines 61.8 %). The latency period was less than one month in 87.2 % of cases. Pancreatitis was mild in 89.3 % and recurrence risk was 2.3 %. CONCLUSION: drugs are a rare cause of pancreatitis, which mostly occurs within the first month of treatment, is usually mild and is associated with a low risk of recurrence.
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Pancreatite , Preparações Farmacêuticas , Doença Aguda , Humanos , Pancreatite/induzido quimicamente , Pancreatite/epidemiologia , Recidiva , Estudos RetrospectivosRESUMO
BACKGROUND: Idiopathic acute pancreatitis (IAP) in patients with inflammatory bowel disease (IBD) is not well characterized. Our purpose was to better understand this condition and its natural history. METHODS: Retrospective cohort study conducted at nine Spanish IBD referral centers. Patients with IBD and a first episode of acute pancreatitis (AP) between 1998 and 2018 were included. Patients with a previous episode of AP or a diagnosis of chronic pancreatitis were excluded. IAP and non-IAP were compared by multivariate logistic regression and survival analysis. RESULTS: We identified 185 patients with IBD (68.7% Crohn's disease) and a first episode of AP. Thirty-eight of those 185 (20.6%) fulfilled criteria for IAP. There were no severe cases of IAP. On multivariate analysis, AP before IBD diagnosis (21.1% vs. 3.4%, p = 0.04) and ulcerative colitis (52.6% vs. 23.1%, p = 0.002) were significantly more common in IAP. Further work-up was performed in 16/38 (42%) IAP patients, and a cause was identified in 6/16 (37.5%). Median time from AP to the end of follow-up was 6.3 years (3.1-10). Five-year risk of AP recurrence was significantly higher in IAP group (28% vs. 5.1%, log-rank p = 0.001), with a median time to first recurrence of 4.4 months (2.9-12.2). CONCLUSIONS: IAP represents the second cause of AP in patients with IBD. It is more frequent in ulcerative colitis, and presents a high risk of recurrence. Additional imaging work-up after a first episode of IAP in IBD patients is highly advisable, as it identifies a cause in more than one-third of cases.
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Doenças Inflamatórias Intestinais/etiologia , Pancreatite/complicações , Adulto , Estudos de Coortes , Colite Ulcerativa/complicações , Colite Ulcerativa/epidemiologia , Doença de Crohn/complicações , Doença de Crohn/epidemiologia , Determinação de Ponto Final , Feminino , Seguimentos , Humanos , Doenças Inflamatórias Intestinais/epidemiologia , Masculino , Pessoa de Meia-Idade , Pancreatite/epidemiologia , Recidiva , Estudos Retrospectivos , Espanha/epidemiologiaRESUMO
Pancreatic fluid collections frequently occur in the context of moderate and severe acute pancreatitis, and may also appear as a complication of chronic pancreatitis, pancreatic surgery or trauma. It is essential to adhere to the Atlanta classification nomenclature that subclassifies them into four categories (acute peripancreatic fluid collections, acute necrotic collections, pseudocysts, and walled-off necrosis) since it has an impact on prognosis and management. Pseudocysts and walled-off pancreatic necrosis are encapsulated pancreatic fluid collections characterized by a surrounding inflammatory wall, which typically develops three to four weeks after the onset of acute pancreatitis. Most pancreatic fluid collections resolve spontaneously and do not require intervention. However, when they become symptomatic or complicated drainage is indicated, and endoscopic ultrasound-guided drainage has become first-line treatment of encapsulated collections. Drainage of pseudocysts is relatively straightforward due to their liquid content. However, in walled-off necrosis the presence of solid necrotic debris can make treatment more challenging and therefore multidisciplinary management in experienced centers is recommended, being a step-up approach the current standard of care. In this review, we aim to address the management of pancreatic fluid collections with an especial focus on endoscopic drainage.
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Pseudocisto Pancreático , Pancreatite Necrosante Aguda , Doença Aguda , Drenagem , Humanos , Pseudocisto Pancreático/diagnóstico por imagem , Pseudocisto Pancreático/terapiaRESUMO
BACKGROUND: this study aimed to evaluate the diagnostic accuracy of the Endofaster® for the detection of Helicobacter pylori. METHODS: during upper gastrointestinal endoscopy, gastric juice was aspirated to perform an analysis using the Endofaster®. This test was considered as positive when the ammonium concentration was > 67 ppm, negative when < 57 ppm and weakly positive between 57 and 67. Biopsy specimens were also taken as the gold standard. RESULTS: among the 86 patients enrolled in the study, the Endofaster® result was positive in 23.7%, negative in 54.7% and weakly positive in 11.6%, whereas infection was detected via histology in 38.4% of patients. The accuracy was 81.4%, with a Kappa value of 0.57. CONCLUSIONS: the Endofaster® could be useful to perform a rapid diagnosis of Helicobacter pylori infection (area under the curve = 0.81).
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Amônia/análise , Técnicas de Diagnóstico do Sistema Digestório/instrumentação , Suco Gástrico/química , Infecções por Helicobacter/diagnóstico , Helicobacter pylori/metabolismo , Adolescente , Adulto , Idoso , Amônia/metabolismo , Área Sob a Curva , Técnicas Bacteriológicas/instrumentação , Feminino , Humanos , Concentração de Íons de Hidrogênio , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sensibilidade e Especificidade , Ureia/metabolismo , Adulto JovemRESUMO
INTRODUCTION: In Europe, gastric adenocarcinoma (GADC) is commonly regarded as a disease of the elderly. This study aims to assess the proportion, characteristics, and survival of patients diagnosed with GADC under the age of 60. MATERIALS AND METHODS: This is a retrospective, multicentric, and analytical study conducted at four tertiary Spanish hospitals. All patients diagnosed with GADC between 2008 and 2015 were included. Demographic, clinical, endoscopic, histologic, and survival data were retrieved. A multivariate analysis was performed to compare GADC in young (age≤60 years) and elderly patients. RESULTS: A total of 1374 patients with GADC were included. The mean age was 74 years (SD:11.1); 62.2% were males. There were 177 patients under the age of 60 (12.9%, 95% CI: 11.2-14.8%). GADC was frequently encountered as a metastatic disease in both young and elderly patients (Stage IV: 45.7% and 41%, respectively). In the multivariate analysis, alcohol abuse, ASA functional status I-II, diffuse subtype, neoadjuvant, and palliative therapy were independently associated (P<0.05) with age ≤60 years. No differences were found in 2-year survival (GADC ≤60: 39% vs. 35%, P=0.45). Curative-intent surgery, TNM stage I-II, body mass index<30kg/m2, and better functional status at diagnosis were independent predictors of survival in GADC under the age of 60. CONCLUSIONS: One out of eight cases of GADC were diagnosed under the age of 60. Metastatic disease was frequent at diagnosis and overall survival was poor regardless of age. Factors associated with localized disease correlated with improved survival in younger patients. Our results underline the need for early diagnosis strategies in our country.
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Adenocarcinoma , Neoplasias Gástricas , Adenocarcinoma/diagnóstico , Adenocarcinoma/mortalidade , Adenocarcinoma/terapia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Espanha/epidemiologia , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/mortalidade , Neoplasias Gástricas/terapia , Análise de Sobrevida , Taxa de SobrevidaRESUMO
BACKGROUND & AIMS: Cellulitis is a common infection in patients with cirrhosis but its impact on progression of liver disease has been hardly addressed. This study examines the incidence of acute kidney injury (AKI), predictive factors and its impacts on mortality in cirrhotic patients hospitalized for cellulitis. METHODS: Retrospective data from cirrhotic patients hospitalized for cellulitis over the period January 2006 to September 2015 were analysed. AKI was defined according to revised criteria of the International Club of Ascites. RESULTS: A total of 101 episodes of cellulitis were examined (70.3% men; mean age 60.6 ± 13.6 years). Of patients, 27% met criteria for acute on chronic liver failure (ACLF) (grade 1: 63%; grade 2: 22%; grade 3: 15%). AKI was recorded in 50.5% (type 1: 67%; type 2: 19%; type 3: 14%). AKI was present on admission in 21 of the 51 patients (41%) who developed it. In the remaining 30 patients (59%), AKI appeared during hospitalization and its development was associated with a MELD score >14 (70% vs 30%, P=.024). In-hospital mortality was 10% and all patients who died had AKI. A high MELD score on admission, AKI and ACLF were associated with in-hospital mortality (P<.05). One-month transplant-free survival was 84% (70% vs 98% in patients with and without AKI, P=.001). CONCLUSIONS: In cirrhotic patients, cellulitis is a serious infection that often leads to AKI and ACLF. AKI is a strong predictor of mortality in this setting.
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Injúria Renal Aguda/epidemiologia , Celulite (Flegmão)/epidemiologia , Hospitalização , Cirrose Hepática/epidemiologia , Injúria Renal Aguda/microbiologia , Injúria Renal Aguda/mortalidade , Injúria Renal Aguda/terapia , Idoso , Celulite (Flegmão)/microbiologia , Celulite (Flegmão)/mortalidade , Celulite (Flegmão)/terapia , Progressão da Doença , Feminino , Mortalidade Hospitalar , Humanos , Incidência , Cirrose Hepática/microbiologia , Cirrose Hepática/mortalidade , Cirrose Hepática/terapia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Espanha/epidemiologia , Fatores de TempoRESUMO
BACKGROUND: Helicobacter pylori antibiotic resistance is an increasing problem worldwide. Pylera® may be an option as salvage therapy. AIM: To assess the effectiveness, safety, and tolerance of Pylera® as a third-line in clinical practice. MATERIALS AND METHODS: This was a multicenter, observational, prospective database study in four Spanish hospitals. Consecutive H. pylori-infected individuals treated with Pylera® and a proton-pump inhibitor (PPI) were invited to participate if they had failed to respond to PPI-clarithromycin-amoxicillin as first-line and to levofloxacin-amoxicillin-PPI as second-line therapy. Eradication was tested 4-8 weeks after Pylera® using a C13 -urea breath test. Treatment-related adverse effects (TRAEs) were assessed through a questionnaire and by reviewing databases. A questionnaire on patient satisfaction was completed in the last visit. RESULTS: Of 103 subjects fulfilling the selection criteria, 101 were included in the intention-to-treat (ITT) analysis and 97 in the per-protocol (PP) analysis. A 10 day course was prescribed in all patients. Esomeprazole 40 mg b.i.d. was the most used PPI regimen (ITT=94.1%). Ninety-seven individuals (ITT=96.04%) completed more than 90% of the treatment. Overall eradication rates were ITT=80.2% (95% confidence interval [CI]: 72.3%-88.1%) and PP=84.4% (95% CI: 76.8%-91.8%). One or more TRAEs were experienced by 67.3% (95% CI: 57.7%-75.7%), all mild or moderate. TRAEs and the number of pills were the main complaints. CONCLUSION: In an area of high antibiotic resistance to H. pylori, 10-day Pylera® plus double-dose PPI emerged as an alternative as third-line therapy, although not achieving optimal eradication rates. TRAEs were common but were neither severe nor did they condition compliance.
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Anti-Infecciosos/administração & dosagem , Bismuto/administração & dosagem , Infecções por Helicobacter/tratamento farmacológico , Helicobacter pylori/isolamento & purificação , Terapia de Salvação/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Testes Respiratórios , Quimioterapia Combinada/métodos , Feminino , Hospitais , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Estudos Prospectivos , Inibidores da Bomba de Prótons/administração & dosagem , Espanha , Inquéritos e Questionários , Resultado do Tratamento , Ureia/análise , Adulto JovemRESUMO
OBJECTIVE: To describe how mesalazine (MSZ) is used in our practice in ulcerative colitis (UC), at what dose, and the success rate (regarding adherence to therapy). METHODS: Observational, transversal study, including all patients with UC and with MSZ maintenance therapy seen from September 2014 to February 2015 at two IBD units in Spain. Treatment adherence was measured by the Morisky-Green scale. RESULTS: We included 203 patients (mean MSZ dose: 2.6 ± 1.0 g/d; median of treatment: 19.5 months [IQR: 8-48]). Doses < 2 g/d were used in 15.3% of cases, 2-2.9 g/d doses in 35.0%, 3-3.9 doses in 29.5%, and ≥ 4 g/d doses in the remaining 20.2%. A single daily dose was preferred in 51.2% of cases, two doses in 33.0% and three doses in 15.8%. A different MSZ brand had been previously used in 36.6% of patients. In 134 cases (66%), the maintenance dose had been increased during a flare-up, and in 49 (36.6% of cases) this higher dose had been kept for maintenance (dose ≥ 4 g/d in 36 patients). During the MSZ therapy, 14 patients (6.9%) suffered mild side effects (21.4% altered liver function tests). Therapy adherence was good in 81.8% of cases. CONCLUSIONS: Half of our UC patients take high MSZ doses (≥ 3 g/d) as maintenance therapy, with acceptable safety and good adherence. Half of all patients take a single daily dose, and one third needed a different commercial brand during therapy. Opting for a higher MSZ maintenance dose is a possible strategy for a satisfactory maintenance therapy.
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Antiulcerosos/administração & dosagem , Antiulcerosos/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Mesalamina/administração & dosagem , Mesalamina/uso terapêutico , Adulto , Idoso , Antiulcerosos/efeitos adversos , Esquema de Medicação , Feminino , Humanos , Masculino , Conduta do Tratamento Medicamentoso , Mesalamina/efeitos adversos , Pessoa de Meia-IdadeRESUMO
INTRODUCTION: Recurrent Clostridium difficile infection (CDI) is common and often difficult to manage. Faecal microbiota transplant (FMT) is an effective therapeutic tool in these cases, although its applicability and effectiveness in Spain is currently unknown. AIM: To analyse the technical aspects, safety and effectiveness of the first consolidated FMT programme in Spain. METHODS: Retrospective descriptive study of all patients with recurrent CDI treated with FMT performed by colonoscopy in a tertiary centre after the implementation of a multidisciplinary protocol between March 2015 and September 2016. RESULTS: A total of 13 FMT were performed in 12 patients (11/12; 91.7% women) with a median age of 84.6 years (range: 38.2-98.2). Recurrence of CDI was the indication for FMT in all cases. Patients had suffered a median of 3 previous episodes of CDI (range: 2-6) and all had failed treatment with fidaxomicin. All procedures were performed by colonoscopy. Effectiveness with one session of FMT was 91.7% (11/12; 95% CI: 64.6 to 98.5%). In the non-responder patient, a second FMT was performed 17 days after the first procedure, with disappearance of symptoms. No side effects related to the endoscopic procedure or the FMT were recorded after a median follow-up of 6.5 months (range: 1-16 months). Two patients died during follow-up due to causes unrelated to FMT. CONCLUSION: FMT by colonoscopy is an effective and safe therapeutic alternative in recurrent CDI. It is a simple procedure that should be implemented in more centres in Spain.
Assuntos
Infecções por Clostridium/terapia , Colonoscopia , Transplante de Microbiota Fecal/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Transplante de Microbiota Fecal/efeitos adversos , Feminino , Humanos , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde , Recidiva , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Bacteria can no longer be seen as an enemy. Nowadays, there is enough evidence to place the microbiota as a key element in human homeostasis. Despite initial skepticism, fecal microbiota transplantation (FMT) is a real therapeutic alternative for patients with recurrent Clostridium difficile infection. Moreover, this procedure has shown promising results in ulcerative colitis and other non-gastrointestinal disorders. There is still a lack of knowledge and clinical trials with long- term follow-up. Therefore, the available data should be interpreted with caution. In this document we provide a detailed review of the literature on the intestinal microbiota and FMT.