A new and simple score to predict adequate and deep response to ursodeoxycholic acid in patients with primary biliary cholangitis: the ALP-A score.

BACKGROUND: Ursodeoxycholic acid (UDCA) is the standard treatment for primary biliary cholangitis (PBC), but a significant proportion of patients do not respond adequately, leading to increased risk of adverse outcomes. This study aims to develop a new and straightforward predictive score to identify PBC patients likely to achieve a complete response to UDCA. METHODS: A logistic regression analysis was conducted using a derivation cohort of PBC patients to identify pre-treatment variables associated with response to UDCA. This analysis led to the development of the ALP-A score, calculated as: Age at diagnosis divided by (alkaline phosphatase at diagnosis/upper limit of normal). ALP-A score accuracy was evaluated using the area under the ROC curve, validated with a large external cohort from Brazil. Additionally, the correlation between the ALP-A score and the previously validated UDCA response score (URS) was assessed. RESULTS: ALP-A score had good predictive power for adequate (AUC 0.794; 95% CI, 0.737-0.852) and deep (0.76; 95% CI, 0.69-0.83) UDCA response at 1 year of treatment. A cutoff score of 17 and 23 points was determined to be the optimal threshold for distinguishing adequate and deep responders, respectively, from non-responders. ALP-A score demonstrated a sensitivity of 73%, specificity of 71%, positive predictive value of 65%, negative predictive value of 78%, and overall accuracy of 72% for biochemical response. The URS displayed similar discriminative ability (AUC 0.798; 95% CI, 0.741-0.855). CONCLUSION: ALP-A score performs comparably to URS but offers the great advantage of simplicity for routine clinical use. It serves as a valuable tool to identify PBC patients less likely to respond to UDCA treatment, facilitating early consideration of alternative therapeutic approaches.

Risk factors for cancer in patients with primary biliary cholangitis and autoimmune hepatitis and primary biliary cholangitis overlap syndrome.

INTRODUCTION AND OBJECTIVES: Primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) and PBC overlap syndrome (AIH/PBC) have been associated with a higher risk of hepatocellular carcinoma (HCC) and extra-hepatic malignancy (EHM). This study aims to assess potential risk factors associated with cancer development in PBC and AIH/PBC. MATERIALS AND METHODS: The Brazilian Cholestasis Study Group database was reviewed to compare clinical and laboratory features of PBC patients with HCC and EHM with those without cancer. RESULTS: Among the 752 PBC patients enrolled, 64 of them with AIH/PBC, 87 cancers were identified in 72 patients, including 20 cases of HCC and 67 of EHM. Patients with HCC had a higher prevalence of cirrhosis (95% vs. 32.5% of those subjects without cancer, p≤0.001), smoking (55% vs. 12.3%, p≤0.001), CREST syndrome (30% vs 7.6%, p=0.003) and prior azathioprine (30% vs 8%, p= 0.005) and prednisone (35% vs 14%, p= 0.018) use, whereas patients with EHM had a higher prevalence of smoking (42.3% vs 12.4% of those subjects without cancer, p= <0.001), AMA positivity (96.6% vs 80.1%, p≤0.001), azathioprine therapy (21% vs 7.9%, p= 0.01) and concurrent other autoimmune diseases. In multivariate analysis, cirrhosis, obesity and prior azathioprine therapy were independent risk factors for HCC, while Sjogren syndrome and psoriasis were associated with EHM. Fibrates reduced EHM risk. CONCLUSIONS: The prevalence of EHM is higher when compared to HCC in PBC patients. Cirrhosis, obesity, prior azathioprine use, and concurrent autoimmune diseases were significantly associated with cancer in PBC.

Response to Ursodeoxycholic Acid May Be Assessed Earlier to Allow Second-Line Therapy in Patients with Unresponsive Primary Biliary Cholangitis.

BACKGROUND: Response to ursodeoxycholic acid (UDCA) in primary biliary cholangitis (PBC) has been traditionally assessed 1 to 2 years after treatment initiation. With the development of new drugs, some patients may benefit from an earlier introduction of second-line therapies. AIMS: This study aims to identify whether well-validated response criteria could correctly identify individuals likely to benefit from add-on second-line therapy at 6 months. METHODS: Analysis of a multicenter retrospective cohort which included only patients with clear-cut PBC. RESULTS: 206 patients with PBC (96.6% women; mean age 54 ± 12 years) were included. Kappa concordance was substantial for Toronto (0.67), Rotterdam (0.65), Paris 1 (0.63) and 2 (0.63) criteria at 6 and 12 months, whereas Barcelona (0.47) and POISE trial (0.59) criteria exhibited moderate agreement. Non-response rates to UDCA was not statistically different when assessed either at 6 or 12 months using Toronto, Rotterdam or Paris 2 criteria. Those differences were even smaller or absent in those subjects with advanced PBC. Mean baseline alkaline phosphatase was 2.73 ± 1.95 times the upper limit of normal (× ULN) among responders versus 5.05 ± 3.08 × ULN in non-responders (p < 0.001). CONCLUSIONS: After 6 months of treatment with UDCA, the absence of response by different criteria could properly identify patients who could benefit from early addition of second-line therapies, especially in patients with advanced disease or high baseline liver enzymes levels.

A Rare Presentation of a Solid Pseudopapillary Neoplasm of the Pancreas.

Solid pseudopapillary neoplasms (SPN) are rare and represent a minority of all pancreatic cystic tumors. Symptoms, if present, are generally nonspecific and upper gastrointestinal bleeding is extremely uncommon as an initial presentation. A 31-year-old woman with no prior medical history presented with a 3-week period of epigastric pain, which she reported as persistent, exacerbated by eating, and associated with progressive asthenia, fatigue, and exertional dyspnea. One month prior, she had had experienced 2 episodes of melena. Upon physical examination her skin was pale, with no other changes. Through diagnostic investigation, an esophagogastroduodenoscopy showed a giant ulcer in the duodenal bulb and a suspect fistulous orifice localized on the posterior wall of the duodenal bulb. In addition, a bulge on the duodenal bulb, suggestive of an extrinsic compression, was noticed. An abdominal computed tomography scan and magnetic resonance imaging showed a mixed solid and cystic lesion in the head of the pancreas in direct proximity to the duodenum, which contained an image compatible with a fistula. The patient successfully underwent pancreaticoduodenectomy. The histopathology, including microscopic analysis and immunohistochemistry, was consistent with an SPN of the pancreas. This case emphasizes that the evaluation of patients presenting with upper gastrointestinal bleeding due to a giant duodenal ulcer and an extrinsic mass effect noted on the duodenum should include cross-sectional images of the abdomen. In this case, the finding of a large well-encapsulated pancreatic solid and cystic mass on abdominal images was suggestive of a pancreatic neoplasm diagnosis, including an SPN.

Neoplasias sólidas pseudopapilares (NSP) são raras e representam uma minoria de todos os tumores císticos do pâncreas. Os sintomas, se presentes, geralmente são inespecíficos e a hemorragia gastrointestinal superior é extremamente incomum como apresentação inicial. Uma mulher de 31 anos sem história médica prévia apresentava a três semanas dor epigástrica, a qual ela relatava como persistente, exacerbada pela alimentação e acompanhada de astenia progressiva, fadiga e dispneia aos esforços. Além disso, um mês antes, ela teve dois episódios de melenas. Ao exame físico havia palidez cutânea, sem outras alterações. Através da investigação diagnóstica, uma esofagogastroduodenoscopia mostrou uma úlcera gigante no bulbo duodenal e a suspeita de um orifício fistuloso localizado na parede posterior do bulbo duodenal. Adicionalmente, um abaulamento sobre o bulbo duodenal, sugestivo de uma compressão extrínsica, foi notado. A tomografia computadorizada de abdome e a imagem de ressonância magnética mostraram uma lesão mista de aparência sólida e cística na cabeça do pâncreas, em proximidade direta com o duodeno, a qual continha uma imagem compatível com uma fístula. A paciente foi submetida a pancreaticoduodenectomia com sucesso. A histopatologia, incluindo análise microscópica e imunohistoquímica, foi compatível com NSP do pâncreas. Este caso enfatiza que a avaliação dos pacientes, que apresentam hemorragia gastrointestinal superior devido à úlcera duodenal gigante e um efeito de massa extrínseco notado sobre o duodeno, deve incluir imagem abdominal. Neste caso, o achado de uma grande massa pancreática sólida e cística bem encapsulada na imagem abdominal, sugeria o diagnóstico de uma neoplasia pancreática, incluindo a NSP.

Anti-mitochondrial Antibody-Negative Primary Biliary Cholangitis Is Part of the Same Spectrum of Classical Primary Biliary Cholangitis.

BACKGROUND: Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease in which anti-mitochondrial antibodies (AMA) are the diagnostic hallmark. Whether AMA-negative PBC patients represent a different phenotype of disease is highly debated. AIMS: The purpose of our study was to compare AMA-positive and AMA-negative PBC patients in a large non-white admixed Brazilian cohort. METHODS: The Brazilian Cholestasis Study Group multicentre database was reviewed to assess demographics, clinical features and treatment outcomes of Brazilian PBC patients, stratifying data according to AMA status. RESULTS: A total of 464 subjects (95.4% females, mean age 56 ± 5 years) with PBC were included. Three hundred and eighty-four (83%) subjects were AMA-positive, whereas 80 (17%) had AMA-negative PBC. Subjects with AMA-negative PBC were significantly younger (52.2 ± 14 vs. 59.6 ± 11 years, p = 0.001) and had their first symptom at an earlier age (43.2 ± 13 vs. 49.5 ± 12 years, p = 0.005). Frequency of type 2 diabetes was significantly increased in subjects with AMA-negative PBC (22.5% vs. 12.2%, p = 0.03). Lower IgM (272.2 ± 183 vs. 383.2 ± 378 mg/dL, p = 0.01) and triglycerides (107.6 ± 59.8 vs.129.3 ± 75.7 mg/dL, p = 0.025) and higher bilirubin (3.8 ± 13.5 vs. 1.8 ± 3.4 mg/dL, p = 0.02) levels were also observed in this subgroup. Response to ursodeoxycholic acid varied from 40.5 to 63.3% in AMA-positive and 34 to 62.3% in AMA-negative individuals, according to different response criteria. Outcomes such as development of liver-related complications, death and requirement for liver transplantation were similar in both groups. CONCLUSIONS: AMA-negative PBC patients are similar to their AMA-positive counterparts with subtle differences observed in clinical and laboratory features.

Clinical features and treatment outcomes of primary biliary cholangitis in a highly admixed population.

INTRODUCTION AND OBJECTIVES: Little is known about primary biliary cholangitis (PBC) in non-whites. The purpose of this study was to evaluate clinical features and outcomes of PBC in a highly admixed population. MATERIAL AND METHODS: The Brazilian Cholestasis Study Group multicentre database was reviewed to assess demographics, clinical features and treatment outcomes of Brazilian patients with PBC. RESULTS: 562 patients (95% females, mean age 51 ± 11 years) with PBC were included. Concurrent autoimmune diseases and overlap with autoimmune hepatitis (AIH) occurred, respectively, in 18.9% and 14%. After a mean follow-up was 6.2 ± 5.3 years, 32% had cirrhosis, 7% underwent liver transplantation and 3% died of liver-related causes. 96% were treated with ursodeoxycholic acid (UDCA) and 12% required add-on therapy with fibrates, either bezafibrate, fenofibrate or ciprofibrate. Response to UDCA and to UDCA/fibrates therapy varied from 39%-67% and 42-61%, respectively, according to different validated criteria. Advanced histological stages and non-adherence to treatment were associated with primary non-response to UDCA, while lower baseline alkaline phosphatase (ALP) and aspartate aminotransferase (AST) levels correlated with better responses to both UDCA and UDCA/fibrates. CONCLUSIONS: Clinical features of PBC in highly admixed Brazilians were similar to those reported in Caucasians and Asians, but with inferior rates of overlap syndrome with AIH. Response to UDCA was lower than expected and inversely associated with histological stage and baseline AST and ALP levels. Most of patients benefited from add-on fibrates, including ciprofibrate. A huge heterogeneity in response to UDCA therapy according to available international criteria was observed and reinforces the need of global standardization.

REDUCED PERIPHERAL AND INSPIRATORY MUSCLE ENDURANCE IN PATIENTS WITH LIVER CIRRHOSIS: A CROSS-SECTIONAL STUDY.

BACKGROUND: Liver cirrhosis (LC) causes several musculoskeletal changes. OBJECTIVE: To test the hypothesis that the peripheral and inspiratory muscle endurance are reduced in patients with liver cirrhosis. METHODS: Twenty-one patients with LC (LC group; 61±14 years) and 18 age-matched subjects (control group; 56±17 years) had accepted to participate in this cross-sectional observational study. To assess peripheral muscle endurance, all volunteers performed a rhythmic handgrip exercise at 45% of their maximum voluntary contraction. A metronome was used to control the contraction-relaxation cycles at 60/min. The inspiratory muscle endurance was assessed using PowerBreath®. Participants underwent inspiratory muscle exercise at 60% of their maximal inspiratory muscle strength. The time until failure characterized the muscle endurance for both handgrip and inspiratory muscle exercises. Additionally, the quality of life of the participants was assessed. RESULTS: The muscle endurance was lower in the LC group when compared to the control group for both handgrip (67 vs 130 s, P<0.001) and inspiratory muscle exercises (40 vs 114 s, P<0.001). The peripheral muscle endurance was directly correlated with the total quality of life score (r=0.439, P=0.01) and to the following domains: fatigue (r=0.378 e P=0.030), activity (r=0.583, P=0.001), systemic symptoms (r=0.316, P=0.073) and preoccupation (r=0.370, P=0.034). The inspiratory muscle endurance was inversely correlated with the total quality of life score (r=0.573, P=0.001) and the following domains: fatigue (r=0.503, P=0.002), activity (r=0.464, P=0.004), systemic symptoms (r=0.472, P=0.004), abdominal symptoms (r=0.461, P=0.005), emotional function (r=0.387, P=0.02) and preoccupation (r=0.519, P=0.001). CONCLUSION: Both peripheral and inspiratory muscle endurance were lower in LC patients when compared to the control group.

Resistência muscular periférica e inspiratória reduzida em pacientes com cirrose hepática: um estudo transversal / Reduced peripheral and inspiratory muscle endurance in patients with liver cirrhosis: a cross-sectional study

ABSTRACT BACKGROUND: Liver cirrhosis (LC) causes several musculoskeletal changes. OBJECTIVE: To test the hypothesis that the peripheral and inspiratory muscle endurance are reduced in patients with liver cirrhosis. METHODS: Twenty-one patients with LC (LC group; 61±14 years) and 18 age-matched subjects (control group; 56±17 years) had accepted to participate in this cross-sectional observational study. To assess peripheral muscle endurance, all volunteers performed a rhythmic handgrip exercise at 45% of their maximum voluntary contraction. A metronome was used to control the contraction-relaxation cycles at 60/min. The inspiratory muscle endurance was assessed using PowerBreath®. Participants underwent inspiratory muscle exercise at 60% of their maximal inspiratory muscle strength. The time until failure characterized the muscle endurance for both handgrip and inspiratory muscle exercises. Additionally, the quality of life of the participants was assessed. RESULTS: The muscle endurance was lower in the LC group when compared to the control group for both handgrip (67 vs 130 s, P<0.001) and inspiratory muscle exercises (40 vs 114 s, P<0.001). The peripheral muscle endurance was directly correlated with the total quality of life score (r=0.439, P=0.01) and to the following domains: fatigue (r=0.378 e P=0.030), activity (r=0.583, P=0.001), systemic symptoms (r=0.316, P=0.073) and preoccupation (r=0.370, P=0.034). The inspiratory muscle endurance was inversely correlated with the total quality of life score (r=0.573, P=0.001) and the following domains: fatigue (r=0.503, P=0.002), activity (r=0.464, P=0.004), systemic symptoms (r=0.472, P=0.004), abdominal symptoms (r=0.461, P=0.005), emotional function (r=0.387, P=0.02) and preoccupation (r=0.519, P=0.001). CONCLUSION: Both peripheral and inspiratory muscle endurance were lower in LC patients when compared to the control group.

RESUMO CONTEXTO: A cirrose hepática (CH) causa várias alterações musculoesqueléticas. OBJETIVO: Testar a hipótese de que as resistências dos músculos periféricos e inspiratórios estão reduzidas em pacientes com CH. MÉTODOS: Vinte e um pacientes com CH (grupo CH; 61±14 anos) e 18 indivíduos pareados por idade (grupo controle; 56±17 anos) aceitaram participar deste estudo observacional transversal. Para avaliar a resistência muscular periférica, todos os voluntários realizaram um exercício de preensão manual rítmica a 45% de sua contração voluntária máxima. Um metrônomo foi usado para controlar os ciclos de contração-relaxamento a 60/min. A resistência muscular inspiratória foi avaliada com o PowerBreath®. Os participantes foram submetidos a exercícios musculares inspiratórios a 60% de sua força muscular inspiratória máxima. O tempo até a falha caracterizou a resistência muscular para os exercícios de preensão manual e de músculos inspiratórios. Além disso, foi avaliada a qualidade de vida dos participantes. RESULTADOS: A resistência muscular foi menor no grupo CH quando comparada ao grupo controle tanto para os exercícios de preensão manual (67 vs 130 s, P<0,001) quanto para os músculos inspiratórios (40 vs 114 s, P<0,001). A resistência muscular periférica foi diretamente correlacionada com o escore total de qualidade de vida (r=0,439, P=0,01) e com os seguintes domínios: fadiga (r=0,030, P=0,378), atividade (r=0,378 e P=0,030), sintomas sistêmicos (r=0,316, P=0,073) e preocupação (r=0,370, P=0,034). A resistência muscular inspiratória foi inversamente correlacionada com o escore total de qualidade de vida (r=0,573, P=0,001) e com os seguintes domínios: fadiga (r=0,503, P=0,002), atividade (r=0,464, P=0,004), sintomas sistêmicos (r=0,472, P=0,004), sintomas abdominais (r=0,461, P=0,005), função emocional (r=0,387, P=0,02) e preocupação (r=0,519, P=0,001). CONCLUSÃO: As resistências musculares periférica e inspiratória foram menores nos pacientes com CH quando comparados ao grupo controle.

Factors associated with the perceived benefits and barriers to physical activity in liver cirrhosis.

OBJECTIVE: To analyze the sociodemographic and clinical factors associated with the perceived benefits and barriers to physical activity (PA) in subjects with liver cirrhosis. METHODS: This cross-sectional study assessed 102 outpatients with liver cirrhosis regarding the clinical and sociodemographic profile and the perceived benefits and barriers to PA by the Exercise Benefits and Barriers Scale and muscle strength. A Generalized Step-Forward linear regression analysis was used to identify the factors associated. RESULTS: The participants were 59±10 years and 60.8% were men. Around 29.4% had ascites decompensation. Perceived benefits and barriers were associated with the presence of ascites (95%CI -0.079 - 0.03; p=0.06 and 95%CI 0.003 - 0.217; p=0.045, respectively). In the group with ascites, both benefits and barriers were associated with muscle strength. In the group without ascites, benefits were associated with cardiovascular risks and no association was observed with barriers to physical activity. CONCLUSIONS: Perceived benefits and barriers to physical activity are associated with intrinsic factors such as the presence of ascites and cardiovascular risk in individuals with liver cirrhosis. The results of this study highlight key elements that must be considered for increasing physical activity in this population.

Factors associated with the perceived benefits and barriers to physical activity in liver cirrhosis

SUMMARY OBJECTIVE: To analyze the sociodemographic and clinical factors associated with the perceived benefits and barriers to physical activity (PA) in subjects with liver cirrhosis. METHODS: This cross-sectional study assessed 102 outpatients with liver cirrhosis regarding the clinical and sociodemographic profile and the perceived benefits and barriers to PA by the Exercise Benefits and Barriers Scale and muscle strength. A Generalized Step-Forward linear regression analysis was used to identify the factors associated. RESULTS: The participants were 59±10 years and 60.8% were men. Around 29.4% had ascites decompensation. Perceived benefits and barriers were associated with the presence of ascites (95%CI −0.079 - 0.03; p=0.06 and 95%CI 0.003 - 0.217; p=0.045, respectively). In the group with ascites, both benefits and barriers were associated with muscle strength. In the group without ascites, benefits were associated with cardiovascular risks and no association was observed with barriers to physical activity. CONCLUSIONS: Perceived benefits and barriers to physical activity are associated with intrinsic factors such as the presence of ascites and cardiovascular risk in individuals with liver cirrhosis. The results of this study highlight key elements that must be considered for increasing physical activity in this population.

Blunted blood pressure response to exercise and isolated muscle metaboreflex activation in patients with cirrhosis.

We sought to test the hypothesis that the cardiovascular responses to isolated muscle metaboreflex activation would be blunted in patients with cirrhosis. Eleven patients with cirrhosis and 15 healthy controls were evaluated. Blood pressure (BP; oscillometric method), contralateral forearm blood flow (FBF; venous occlusion plethysmography), and heart rate (HR; electrocardiogram) were measured during baseline, isometric handgrip at 30% of maximal voluntary contraction followed by postexercise ischemia (PEI). Forearm vascular conductance (FVC) was calculated as follows: (FBF / mean BP) × 100. Changes in HR during handgrip were similar between groups but tended to be different during PEI (controls: Δ 0.5 ± 1.1 bpm vs. cirrhotic patients: Δ 3.6 ± 1.0 bpm, P = 0.057). Mean BP response to handgrip (controls: Δ 20.9 ± 2.7 mm Hg vs. cirrhotic patients: Δ 10.6 ± 1.5 mm Hg, P = 0.006) and PEI was attenuated in cirrhotic patients (controls: Δ 16.1 ± 1.9 mm Hg vs. cirrhotic patients: Δ 7.2 ± 1.4 mm Hg, P = 0.001). In contrast, FBF and FVC increased during handgrip and decreased during PEI similarly between groups. These results indicate that an abnormal muscle metaboreflex activation explained, at least partially, the blunted pressor response to exercise exhibited by cirrhotic patients. Novelty: Patients with cirrhosis present abnormal muscle metaboreflex activation. BP response was blunted but forearm vascular response was preserved. HR response was slightly elevated.

Health-related quality of life and fatigue in patients with chronic hepatitis C with therapy with direct-acting antivirals agents interferon-free.

INTRODUCTION: Interferon (IFN)-free regimens for the treatment of chronic hepatitis C have shown high rates of sustained virological response (SVR) and improved patient-reported outcomes (PROs). The aim of this study was to evaluate the health-related quality of life (HRQoL) and fatigue of patients with chronic hepatitis C (HCV) treated with IFN-free direct-acting antiviral (DAA) agents that achieved SVR following treatment and identify the predictive factors related to HRQoL. METHODS: Prospective cohort study that included patients with HCV treated with DAA who obtained an SVR. The patients answered three self-reported questionnaires (PROs): Short Form 36 (SF-36), the Chronic Liver Diseases Questionnaire (CLDQ), and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire at baseline, weeks 6 and 12 of treatment, and at 12 weeks after therapy. Patients were treated with DAA with or without ribavirin (RBV). The PRO scores were compared using analysis of variance (ANOVA). A comparison of PROs and serum hemoglobin levels was performed between the group that used ribavirin and the one that did not use ribavirin using the t student test. Predictive factors were calculated using a multiple linear regression model. RESULTS: Among the 113 patients selected, 105 presented an SVR and were included in the study, in which, 54% men, 80% genotype 1, 44% cirrhosis and 46% with RBV. At 12 weeks after the end of treatment, there was a significant improvement in the scores of the patient self-reports (PROs) when compared with baseline for the CLDQ (+10.52%, p<0.001), SF-36-Physical Summary (+19%, p<0.001), and FACIT (+17.34%, p<0.001). Patients who used RBV had worse PROs and serum hemoglobin levels compared to the group that did not use RBV (p<0,05). As predictors of worsening of the PROs we had the presence of diabetes mellitus, liver cirrhosis and HIV co-infected. CONCLUSION: Patients treated with IFN free regimens presents significant improvement in PROs. The presence of diabetes mellitus, cirrhosis, and HIV co-infected has a negative effect on HRQoL before, during and after treatment of hepatitis C. The addition of ribavirin to the antiviral regimens used compromises the HRQoL indexes during antiviral therapy.

Impact of superimposed Clostridium difficile infection in Crohn's or ulcerative colitis flares in the outpatient setting.

PURPOSE: The prospective assessment of Clostridium difficile infection (CDI) impact in inflammatory bowel disease (IBD) flare in outpatient setting has been poorly investigated. We aimed to evaluate the prevalence and the associated factors with CDI in IBD outpatients presenting colitis flares as well as the outcomes following treatment. METHODS: In this prospective cohort study, conducted from October, 2014, to July, 2016, 120 IBD patients (55% presenting colitis flare) and 40 non-IBD controls were assessed for CDI. Multivariate regression analysis was performed to identify predictors of CDI. Outcome analysis was estimated for recurrent CDI, hospitalization, colectomy, and CDI-associated mortality. RESULTS: The number of patients with CDI was significantly higher in IBD patients experiencing flares than in both inactive IBD and non-IBD groups (28.8 vs. 5.6 vs. 0%, respectively; p = 0.001). Females (OR = 1.39, 95% CI, 1.13-17.18), younger age (OR = 0.77, 95% CI, 0.65-0.92), steroid treatment (OR = 7.42, 95% CI, 5.17-40.20), and infliximab therapy (OR = 2.97, 95% CI, 1.99-24.63) were found to be independently associated with CDI. There was a dose-related increase in the risks of CDI on patients which had taken prednisone. Those treated with vancomycin had a satisfactory response to therapy, but 21% presented recurrent CDI and 16% were hospitalized. Neither necessity of colectomy nor mortality was noticed in any patient during the investigation. CONCLUSIONS: In IBD outpatients presenting colitis flares, CDI is highly prevalent. Females, younger age, infliximab, and notably steroid therapy were independently associated with CDI. Most patients with CDI experienced mild-to-moderate disease, and prompt treatment with vancomycin was highly effective, which seems to reduce the serious complication risks.

DEPRESSIVE EPISODE INCIDENCE IN PATIENTS WITH CHRONIC HEPATITIS C TREATED WITH PEGYLATED INTERFERON AND RIBAVIRIN.

BACKGROUND: The effectiveness of antiviral therapy with pegylated interferon and ribavirin for chronic hepatitis C is far from ideal and presents several adverse events. Among such events, there is the depressive episode that can even lead to treatment discontinuity. OBJECTIVE: Analyze the incidence of depressive episodes in patients with chronic hepatitis C treated with pegylated interferon (IFN-PEG) and ribavirin, as well as the possible factors associated with its occurrence and its impact on patients' sustained virological response. METHODS: People with chronic hepatitis C undergoing antiviral therapy were interviewed at the baseline, at the 4th, 12th, 24th and 48th treatment weeks and 4 weeks after the end of it, using the HADS scale for tracking the depressive episode. Patients with HADS ≥9 were subjected to Beck Depression Inventory (BDI-II) to grade the episode. Clinical, sociodemographic, laboratorial and histological variables were obtained to identify factors related to the onset of depression. The sustained virological response rate (negative HCV-RNA 6 months after end of therapy) was compared among patients with and without depressive symptoms. RESULTS: The study comprised 32 patients, most men (59%) with mean age of 54±11.13 years old. Genotype non-1 was prevalent (56%) and 81% of the patients were non-cirrhotic. The depressive episode was diagnosed in 25% of the patients and the peak incidence was found in the 12th treatment week. The depressive episode was moderate in 87% of the patients and only one patient abandoned the treatment. None of the analyzed factors was associated with depressive episode onset. A trend was observed in female patients ( P =0.08). The sustained virological response rate was of 75% and 67% in patients with and without depressive episode, respectively ( P =0.66). CONCLUSION: The incidence of depressive episodes in patients with chronic hepatitis C undergoing antiviral therapy was of 25% and the 12th treatment week was the most critical one. The presence of depressive episode did not affect the sustained virological response rate.

Colonoscopy sedation: clinical trial comparing propofol and fentanyl with or without midazolam / Sedação para colonoscopia: ensaio clínico comparando propofol e fentanil associado ou não ao midazolam

ABSTRACT Colonoscopy is one of the most common procedures. Sedation and analgesia decrease anxiety and discomfort and minimize risks. Therefore, patients prefer to be sedated when undergoing examination, although the best combination of drugs has not been determined. The combination of opioids and benzodiazepines is used to relieve the patient's pain and discomfort. More recently, propofol has assumed a prominent position. This randomized prospective study is unique in medical literature that specifically compared the use of propofol and fentanyl with or without midazolam for colonoscopy sedation performed by anesthesiologists. The aim of this study was to evaluate the side effects of sedation, discharge conditions, quality of sedation, and propofol consumption during colonoscopy, with or without midazolam as preanesthetic. The study involved 140 patients who underwent colonoscopy at the University Hospital of the Federal University of Juiz de Fora. Patients were divided into two groups: Group I received intravenous midazolam as preanesthetic 5 min before sedation, followed by fentanyl and propofol; Group II received intravenous anesthesia with fentanyl and propofol. Patients in Group II had a higher incidence of reaction (motor or verbal) to the colonoscope introduction, bradycardia, hypotension, and increased propofol consumption. Patient satisfaction was higher in Group I. According to the methodology used, the combination of midazolam, fentanyl, and propofol for colonoscopy sedation reduces propofol consumption and provides greater patient satisfaction.

RESUMO A colonoscopia é um dos procedimentos mais feitos. Sedação e analgesia diminuem a ansiedade e o desconforto e minimizam riscos. Em razão disso, os pacientes preferem que o exame seja feito sob anestesia, embora não tenha sido determinada a melhor combinação de fármacos. A associação de benzodiazepínicos com opioides é usada para aliviar a dor e o desconforto do paciente. Mais recentemente, o propofol assumiu posição de destaque. Este estudo, prospectivo e randomizado, é único na literatura médica e especificamente comparou o uso do propofol e fentanil associado ou não ao midazolam na sedação para colonoscopia feita por anestesiologistas. Os objetivos do estudo foram avaliar os efeitos colaterais da sedação, as condições de alta, a qualidade da sedação e o consumo de propofol durante a colonoscopia, com ou sem o midazolam como pré-anestésico. Envolveu 140 pacientes submetidos à colonoscopia, no Hospital Universitário da Universidade Federal de Juiz de Fora. Os pacientes foram divididos em dois grupos. O Grupo I recebeu, por via endovenosa, midazolam como pré-anestésico, cinco minutos antes da sedação, seguido do fentanil e propofol. O Grupo II recebeu, por via endovenosa, anestesia com fentanil e propofol. Os pacientes do Grupo II apresentaram maior incidência de reação (motora ou verbal) à introdução do colonoscópio, bradicardia, hipotensão arterial e maior consumo de propofol. A satisfação dos pacientes foi maior no Grupo I. De acordo com a metodologia empregada, a associação de midazolam ao propofol e fentanil para sedação em colonoscopia reduz o consumo de propofol e cursa com maior satisfação do paciente.

Colonoscopy sedation: clinical trial comparing propofol and fentanyl with or without midazolam.

Colonoscopy is one of the most common procedures. Sedation and analgesia decrease anxiety and discomfort and minimize risks. Therefore, patients prefer to be sedated when undergoing examination, although the best combination of drugs has not been determined. The combination of opioids and benzodiazepines is used to relieve the patient's pain and discomfort. More recently, propofol has assumed a prominent position. This randomized prospective study is unique in medical literature that specifically compared the use of propofol and fentanyl with or without midazolam for colonoscopy sedation performed by anesthesiologists. The aim of this study was to evaluate the side effects of sedation, discharge conditions, quality of sedation, and propofol consumption during colonoscopy, with or without midazolam as preanesthetic. The study involved 140 patients who underwent colonoscopy at the University Hospital of the Federal University of Juiz de Fora. Patients were divided into two groups: Group I received intravenous midazolam as preanesthetic 5min before sedation, followed by fentanyl and propofol; Group II received intravenous anesthesia with fentanyl and propofol. Patients in Group II had a higher incidence of reaction (motor or verbal) to the colonoscope introduction, bradycardia, hypotension, and increased propofol consumption. Patient satisfaction was higher in Group I. According to the methodology used, the combination of midazolam, fentanyl, and propofol for colonoscopy sedation reduces propofol consumption and provides greater patient satisfaction.

Depressive episode incidence in patients with chronic hepatitis c treated with pegylated interferon and ribavirin

ABSTRACT Background The effectiveness of antiviral therapy with pegylated interferon and ribavirin for chronic hepatitis C is far from ideal and presents several adverse events. Among such events, there is the depressive episode that can even lead to treatment discontinuity Objective Analyze the incidence of depressive episodes in patients with chronic hepatitis C treated with pegylated interferon (IFN-PEG) and ribavirin, as well as the possible factors associated with its occurrence and its impact on patients' sustained virological response. Methods People with chronic hepatitis C undergoing antiviral therapy were interviewed at the baseline, at the 4th, 12th, 24th and 48th treatment weeks and 4 weeks after the end of it, using the HADS scale for tracking the depressive episode. Patients with HADS ≥9 were subjected to Beck Depression Inventory (BDI-II) to grade the episode. Clinical, sociodemographic, laboratorial and histological variables were obtained to identify factors related to the onset of depression. The sustained virological response rate (negative HCV-RNA 6 months after end of therapy) was compared among patients with and without depressive symptoms. Results The study comprised 32 patients, most men (59%) with mean age of 54±11.13 years old. Genotype non-1 was prevalent (56%) and 81% of the patients were non-cirrhotic. The depressive episode was diagnosed in 25% of the patients and the peak incidence was found in the 12th treatment week. The depressive episode was moderate in 87% of the patients and only one patient abandoned the treatment. None of the analyzed factors was associated with depressive episode onset. A trend was observed in female patients ( P=0.08). The sustained virological response rate was of 75% and 67% in patients with and without depressive episode, respectively (P =0.66). Conclusion The incidence of depressive episodes in patients with chronic hepatitis C undergoing antiviral therapy was of 25% and the 12th treatment week was the most critical one. The presence of depressive episode did not affect the sustained virological response rate.

RESUMO Contexto A terapia antiviral para a hepatite C crônica com interferon peguilado e ribavirina tem eficácia longe do ideal e é repleta de eventos adversos. Entre estes, destaca-se o transtorno depressivo que pode inclusive levar a interrupção do tratamento. Objetivos Em pacientes com hepatite C crônica tratados com interferon peguilado (IFN-PEG) e ribavirina, verificar a incidência de episódio depressivo, os possíveis fatores associados ao seu surgimento e o impacto deste sobre a resposta virológica sustentada. Métodos Portadores de hepatite C crônica submetidos à terapia antiviral foram entrevistados no Baseline, nas semanas 4, 12, 24, 48 de tratamento e quatro semanas após o término do mesmo utilizando a escala HADS para rastreamento do episódio depressivo e naqueles com HADS ≥9 o Inventário de Depressão de Beck (BDI-II) para graduação do episódio. Variáveis clínicas, sociodemográficas, laboratoriais e histológicas foram obtidas com o objetivo de identificar os fatores relacionados ao surgimento da depressão. A taxa de resposta virológica sustentada (HCV-RNA negativo seis meses após a interrupção da terapia) foi comparada entre os pacientes com e sem sintomas depressivos. Resultados Foram incluídos 32 pacientes, a maioria do sexo masculino (59%) e com média de idade de 54±11,13 anos. Prevaleceu o genótipo não 1 (56%) e 81% dos pacientes foram não cirróticos. Episódio depressivo foi diagnosticado em 25% dos pacientes sendo o pico de incidência observado na semana 12 de tratamento. O episódio depressivo foi moderado em 87% dos pacientes e motivou a interrupção em somente 1 deles. Nenhum dos fatores analisados foi associado ao surgimento de episódio depressivo observando-se uma tendência com relação ao sexo feminino ( P =0,08). A taxa de resposta virológica sustentada foi 75% e 67% nos pacientes com e sem episódio depressivo, respectivamente ( P =0,66). Conclusão A incidência de episódio depressivo em pacientes com hepatite C crônica submetidos à terapia antiviral foi de 25% e a semana 12 é a mais crítica. A presença de episódio depressivo não interferiu na taxa de resposta virológica sustentada.

[Colonoscopy sedation: clinical trial comparing propofol and fentanyl with or without midazolam]. / Sedação para colonoscopia: ensaio clínico comparando propofol e fentanil associado ou não ao midazolam.

Colonoscopy is one of the most common procedures. Sedation and analgesia decrease anxiety and discomfort and minimize risks. Therefore, patients prefer to be sedated when undergoing examination, although the best combination of drugs has not been determined. The combination of opioids and benzodiazepines is used to relieve the patient's pain and discomfort. More recently, propofol has assumed a prominent position. This randomized prospective study is unique in medical literature that specifically compared the use of propofol and fentanyl with or without midazolam for colonoscopy sedation performed by anesthesiologists. The aim of this study was to evaluate the side effects of sedation, discharge conditions, quality of sedation, and propofol consumption during colonoscopy, with or without midazolam as preanesthetic. The study involved 140 patients who underwent colonoscopy at the University Hospital of the Federal University of Juiz de Fora. Patients were divided into two groups: Group I received intravenous midazolam as preanesthetic five minutes before sedation, followed by fentanyl and propofol; Group II received intravenous anesthesia with fentanyl and propofol. Patients in Group II had a higher incidence of reaction (motor or verbal) to the colonoscope introduction, bradycardia, hypotension, and increased propofol consumption. Patient satisfaction was higher in Group I. According to the methodology used, the combination of midazolam, fentanyl, and propofol for colonoscopy sedation reduces propofol consumption and provides greater patient satisfaction.

Prevalência de colelitíase em portadores de cirrose hepática. Disfunção hepática é um fator de risco? / Cholelithiasis's prevalence in patients with liver cirrhosis. Liver dysfunction is a risk factor?

Aproximadamente 10% da população ocidental adulta apresentam colelitíase. A frequência entre os portadores de cirrose hepática parece ser maior e os fatores associados são incertos. O presente estudo tem por objetivo determinar a prevalência de colelitíase e os possíveis fatores associados em portadores de cirrose hepática. Foram incluídos 101 portadores de cirrose hepática em seguimento no Ambulatório de Hepatologia do Hospital Universitário da Universidade Federal de Juiz de Fora (HU-UFJF) e o diagnóstico de colelitíase foi estabelecido pela Ultrassonografia. As seguintes variáveis foram analisadas: idade, sexo, Índice de Massa Corporal (IMC), grau de disfunção hepática (Meld/Child-Pugh), presença de varizes esofágicas e nível de aminotransferases. Entre os pacientes avaliados 58 (62%) foram classificados como Child-Pugh A e a média observada do escore Meld foi 11,5 ± 3,6. A presença de colelitíase foi observada em 21 (20,8%) pacientes. Não foi possível demonstrar associação entre a presença de colelitíase e as variáveis analisadas. Conclui-se que a prevalência de colelitíase entre portadores de cirrose hepática é elevada, porém não foi possível demonstrar associação entre disfunção hepática e presença de cálculos biliares.

Health-Related Quality of Life in patients with hepatitis C in double and triple therapy / Calidad de vida relacionada con la salud en pacientes con hepatitis c en terapia doble y triple / Qualidade de vida relacionada à saúde em pacientes com hepatite C em terapia dupla e tripla

Abstract OBJECTIVE Comparing Health-Related Quality of Life (HRQoL) scores in patients with chronic hepatitis C undergoing double and triple antiviral therapy and analyzing possible factors related to HRQoL. METHOD HRQoL was assessed using the Short Form 36 and Chronic Liver Disease Questionnaire, which were applied at baseline and at weeks 4, 12 and 16 of treatment to 32 patients divided into two groups: double therapy with pegylated interferon (IFN-PEG) and ribavirin, and triple therapy with PEG-IFN, ribavirin and telaprevir. RESULTS The reduction of HRQoL was greater in patients receiving triple therapy compared to those treated with two drugs, the most critical time is at 12 weeks in both groups. After removal of telaprevir, the triple therapy group significantly improved their HRQoL scores. Anxiety and depression before treatment, employment status and race are significantly related to diminished HRQoL. CONCLUSION Patients undergoing double and triple therapy have diminished HRQoL indexes, but the addition of telaprevir chooses a more significant decrease.

Resumen OBJETIVO Comparar los puntajes de Calidad de Vida Relacionada con la Salud (CVRS) en pacientes con hepatitis C crónica sometidos a la terapia antiviral doble y triple y analizar los posibles factores relacionados con la CVRS. MÉTODO La CVRS fue evaluada utilizando el Short Form 36 y elChronic Liver Disease Questionnaire , que fueron aplicados antes y en las semanas 4, 12 y 16 de tratamiento, en 32 pacientes divididos en 2 grupos: terapia doble con interferón pegilado (IFN-PEG) y ribavirina, y triple con IFN-PEG, ribavirina y telaprevir. RESULTADOS La reducción de la CVRS fue mayor en pacientes en terapia triple cuando comparados con los tratados con dos drogas, siendo el momento más crítico la 12ª semana en ambos grupos. Después de la retirada del telaprevir, el grupo de terapia triple mejoró de modo significativo los puntajes de CVRS. Ansiedad y depresión en el pre tratamiento, situación de empleo y raza se mostraron relacionados con la reducción de la CVRS. CONCLUSIÓN Pacientes sometidos a la terapia doble y triple presentan reducción de los índices de CVRS, pero la adición del telaprevir les proporciona una caída más expresiva.

Resumo OBJETIVO Comparar os escores de Qualidade de Vida Relacionada à Saúde (QVRS) em pacientes com hepatite crônica C submetidos à terapia antiviral dupla e tripla e analisar os possíveis fatores relacionados à QVRS. MÉTODO A QVRS foi avaliada utilizando o Short Form 36 e oChronic Liver Disease Questionnaire , que foram aplicados antes e nas semanas 4, 12 e 16 de tratamento, em 32 pacientes divididos em 2 grupos: terapia dupla com interferon peguilado (IFN-PEG) e ribavirina e tripla com IFN-PEG, ribavirina e telaprevir. RESULTADOS A redução da QVRS foi maior em pacientes em terapia tripla quando comparados àqueles tratados com duas drogas, sendo o momento mais crítico a 12ª semana em ambos os grupos. Após a retirada do telaprevir, o grupo terapia tripla melhorou de modo significativo os escores de QVRS. Ansiedade e depressão no pré-tratamento, status empregatício e raça se mostraram relacionados à redução da QVRS. CONCLUSÃO Pacientes submetidos à terapia dupla e tripla apresentam redução dos índices de QVRS, mas a adição do telaprevir confere uma queda mais expressiva.