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BACKGROUND & AIMS: The dynamic response of serum fibrosis biomarkers to histological changes within the liver following lifestyle intervention (LI) is unknown. We explored relationships between changes in serum biomarkers and liver fibrosis in NASH patients undergoing LI. METHODS: Paired liver biopsies were performed in 261 NASH patients to assess fibrosis change after 1 year of LI. We explored the utility of serum fibrosis markers to predict changes in hepatic fibrosis and developed and internally validated a model for predicting fibrosis improvement in patients with baseline fibrosis. RESULTS: Regression, stabilization and worsening of fibrosis occurred in 51 (20%), 165 (63%) and 45 (17%) patients respectively. By multivariable analysis, change in HbA1c (OR, 0.39, P<.01), platelets (OR, 1.22, P<.01) and NFS (OR, 0.27, P<.01), as well as ALT normalization (OR, 9.7, P<.01) were independently associated with fibrosis improvement, whereas change in platelets (OR, 0.96, P<.01), and NFS (OR, 1.8, P<.01) as well as ALT normalization (OR, 0.21, P<.01) were linked to fibrosis progression. A model, including change in HbA1c, platelet and ALT normalization, was significantly more accurate (AUC of 0.96, 95% CI, l0.94-0.99) than NFS, FIB-4 and APRI for predicting fibrosis improvement. Using a threshold of ≥0.497, positive and negative predictive values were 94% (95% CI, 84-98) and 91% (95% CI, 81-96) respectively. CONCLUSIONS: Change in NFS, platelets and ALT normalization are associated with change in liver fibrosis after 1 year of LI. A model including change in HbA1c, platelet and ALT normalization discriminated patients with fibrosis improvement significantly better than other biomarkers.
Assuntos
Biomarcadores/sangue , Cirrose Hepática/sangue , Hepatopatia Gordurosa não Alcoólica/terapia , Adulto , Estudos de Coortes , Progressão da Doença , Feminino , Fibrose , Humanos , Fígado/patologia , Cirrose Hepática/etiologia , Masculino , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica/sangue , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/patologia , Comportamento de Redução do RiscoRESUMO
UNLABELLED: Liver biopsy is the gold standard method to assess nonalcoholic steatohepatitis (NASH) resolution after therapeutic interventions. We developed and validated a simple and noninvasive scoring system to predict NASH resolution without fibrosis worsening after 1 year of lifestyle intervention. This was a prospective cohort study conducted in 261 patients with histologically proven NASH who were treated with lifestyle changes for 52 weeks and underwent a second liver biopsy to confirm NASH resolution. We divided the data into development (140 subjects) and validation (121 individuals) sets. NASH resolution occurred in 28% (derivation group) and 27% (validation group). At the multivariable analysis, weight loss (odds ratio [OR] = 2.75, 95% confidence interval [CI] 1.65-4.58; P < 0.01), type 2 diabetes (OR = 0.04, 95% CI 0.005-0.49; P = 0.01), normal levels of alanine aminotransferase at the end of intervention (OR = 9.84, 95% CI 2.21-44.1; P < 0.01), age (OR = 0.89, 95% CI 0.83-0.97; P = 0.01), and a nonalcoholic fatty liver activity score ≥5 (OR = 0.08, 95% CI 0.01-0.43; P < 0.01) were independent predictors of NASH resolution. The area under the receiver operating characteristic curve of the selected model was 0.956 and 0.945 in the derivation and validation cohorts, respectively. Using a score threshold of ≤46.15, negative predictive values were 92% in the derivation and validation groups, respectively. By applying a cutoff ≥69.72, positive predictive values were 92% and 89% in the derivation and validation groups, respectively. Using both cutoffs, a liver biopsy would have been avoided in 229 (88%) of 261 patients, with a correct prediction in 209 (91%) CONCLUSIONS: A noninvasive prediction model including weight loss, type 2 diabetes, alanine aminotransferase normalization, age, and a nonalcoholic fatty liver activity score ≥5 may be useful to identify NASH resolution in patients under lifestyle intervention. (Hepatology 2016;63:1875-1887).
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Estilo de Vida , Modelos Teóricos , Hepatopatia Gordurosa não Alcoólica/terapia , Adulto , Feminino , Previsões , Humanos , Masculino , Pessoa de Meia-Idade , Análise MultivariadaRESUMO
BACKGROUND: Glucose metabolism abnormalities frequently coexist with liver cirrhosis; however, the impact of these on liver-related outcomes has not been fully investigated. AIMS: We examined the influence of glucose abnormalities on overall mortality and liver-related complications in cirrhotic patients. METHODS: A prospective cohort of 250 subjects with compensated hepatitis C virus-related cirrhosis and without known diabetes underwent an oral glucose tolerance test and were subsequently followed for a median 201 weeks. RESULTS: At baseline, 67 (27%) had type 2 diabetes. During follow-up, 28 deaths and 55 first events of decompensation occurred. After adjustment for potential confounding covariates, overall mortality/liver transplant (sHR: 2.2, 95% CI: 1.04-4.6, P=0.04) and hepatic decompensation events (sHR: 1.9, 95% CI: 1.05-3.3, P=0.03) were significantly higher in diabetic patients. Subjects with a HOMA-IR >5 showed higher rates of mortality (sHR: 2.2, 95% CI: 1.03-4.8, P=0.04). The rates of hepatic decompensation were higher in patients with HOMA-IR >3 (sHR: 1.7, 95% CI: 1.04-2.9, P=0.03). Overall, 2h-plasma glucose was the most robust predictor of overall mortality (sHR: 2.5, 95% CI: 1.03-6, P=0.04) and decompensation (sHR: 2.7, 95% CI: 1.4-5.5, P<0.01). CONCLUSIONS: In compensated HCV-related cirrhotic patients, diabetes and marked insulin resistance are independently associated with poorer overall survival and increased risk of hepatic decompensation.
Assuntos
Glicemia/metabolismo , Diabetes Mellitus Tipo 2/metabolismo , Hepatite C Crônica/metabolismo , Resistência à Insulina , Cirrose Hepática/metabolismo , Falência Hepática/metabolismo , Idoso , Estudos de Coortes , Diabetes Mellitus Tipo 2/complicações , Progressão da Doença , Feminino , Teste de Tolerância a Glucose , Hepatite C Crônica/complicações , Humanos , Cirrose Hepática/complicações , Cirrose Hepática/mortalidade , Falência Hepática/etiologia , Falência Hepática/mortalidade , Falência Hepática/cirurgia , Transplante de Fígado , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Prognóstico , Modelos de Riscos Proporcionais , Estudos Prospectivos , Taxa de SobrevidaRESUMO
CONTEXT: Acute pancreatitis is the most common complication in ERCP, and some risk factors were associated with the development of hyperamylasemia and post-ERCP pancreatitis. OBJECTIVES: identifying new factors associated with the development of hyperamylasemia or post-ERCP pancreatitis in patients attended at our center. MATERIAL AND METHODS: A (retrospective) cohort study was carried out in 170 patients on which a diagnostic-therapeutic ERCP was done due to biliopancreatic disease. 67 patients developed hyperamylasemia (39.4%) and 6 post-ERCP pancreatitis (3.5%). The following diagnostic criteria were applied: Hyperamylasemia: increase in the serum amylase level above the normal value (90 I/U). Acute post-ERCP pancreatitis: clinical: continuous abdominal pain for over 24 hours and biochemical: elevation of amylase3 times above normal value (90 U/I). RESULTS: The number of cannulations more than 4 (19 patients), (p=0.006; RR= 3.00) was associated significantly with the development of hyperamylasemia and the placing of biliary stent (14 patients), (p=0.00; RR= 0.39) was a protective factor. The factors associated with the development of post-ERCP pancreatitis were related with the patient (peridiverticular location of the papilla (p=0.00; RR= 2.00) and the sphincter of Oddi dysfunction (p=0.000; RR=1.20). CONCLUSION: Technical factors were associated with the development of hyperamylasemia, however, the factors associated with the development of post-ERCP pancreatitis in our universe of study were related mainly with the patient.
Assuntos
Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Hiperamilassemia/epidemiologia , Hiperamilassemia/etiologia , Pancreatite/epidemiologia , Pancreatite/etiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Cuba , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Adulto JovemRESUMO
Contexto: La pancreatitis aguda es la complicación más frecuente de la PCRE y algunos factores de riesgo son asociados con el desarrollo de hiperamilasemia y pancreatitis post PCRE. Objetivos: Identificar factores nuevos asociados con hiperamilasemia y pancreatitis post PCRE en pacientes que acudieron a nuestro centro. Material y métodos: Un estudio retrospectivo de cohorte se llevó a cabo en 170 pacientes en quienes se realizó una CPRE diagnóstico-terapéutica por enfermedad biliopancreática. 67 pacientes desarrollaron hiperamilasemia (39,4%) y 6 pancreatitis post PCRE (3,5%). Se aplicaron los siguientes criterios diagnósticos: Hiperamilasemia: elevación de la amilasa sérica por encima del valor normal (90IU).Pancreatitis aguda post PCRE: dolor abdominal continuo por más de 24 horas y elevación de la amilasa tres veces por encima del valor normal. Resultados: El número de canulaciones, más de 4 (19 pacientes), (p=0,006; RR= 3,00) se asoció significativamente con el desarrollo de la hiperamilasemia y la puesta de stents biliares (14 pacientes) se asoció como un factor protector (p=0,00; RR= 0,39). Los factores asociados con el desarrollo de la pancreatitis post PCRE se relacionaron con el paciente (localización peridiverticular de la papila (p=0,00; RR= 2,00) y disfunción del Esfinter de Oddi (p=0,000; RR=1,20). Conclusiones: Factores técnicos fueron asociados con el desarrollo de la hiperamilasemia, sin embargo, los relacionados con el desarrollo de la pancreatitis post PCRE fueron mayoritariamente relacionados al paciente.
Context: Acute pancreatitis is the most common complication in ERCP, and some risk factors were associated with the development of hyperamylasemia and post-ERCP pancreatitis. Objectives: identifying new factors associated with the development of hyperamylasemia or post-ERCP pancreatitis in patients attended at our center. Material and methods: A (retrospective) cohort study was carried out in 170 patients on which a diagnostic-therapeutic ERCP was done due to biliopancreatic disease. 67 patients developed hyperamylasemia (39.4%) and 6 post-ERCP pancreatitis (3.5%). The following diagnostic criteria were applied: Hyperamylasemia: increase in the serum amylase level above the normal value (90I/U). Acute post-ERCP pancreatitis: clinical: continuous abdominal pain for over 24 hours and biochemical: elevation of amylase 3 times above normal value (90U/I). Results: The number of cannulations more than 4 (19 patients), (p=0.006; RR= 3.00) was associated significantly with the development of hyperamylasemia and the placing of biliary stent (14 patients), (p=0.00; RR= 0.39) was a protective factor. The factors associated with the development of post-ERCP pancreatitis were related with the patient (peridiverticular location of the papilla (p=0.00; RR= 2.00) and the sphincter of Oddi dysfunction (p=0.000; RR=1.20). Conclusion: Technical factors were associated with the development of hyperamylasemia, however, the factors associated with the development of post-ERCP pancreatitis in our universe of study were related mainly with the patient.
Assuntos
Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Hiperamilassemia/epidemiologia , Hiperamilassemia/etiologia , Pancreatite/epidemiologia , Pancreatite/etiologia , Estudos de Coortes , Cuba , Estudos Retrospectivos , Fatores de RiscoRESUMO
ANTECEDENTES: el cáncer colorrectal es prevenible y responde de manera efectiva al tratamiento cuando se diagnostica en etapas tempranas. La determinación de sangre oculta en heces es un método usado para el cribado de este en etapas precoces y de su lesión precursora, el adenoma. ,OBJETIVOS: 1) determinar la validez y reproducibilidad del test inmunoquímico RapiLat-Hemo en el diagnóstico de cáncer colorrectal y adenomas y comparar con el reactivo de referencia (SPIN-FOB). 2) describir los hallazgos endoscópicos más frecuentes en pacientes con sangre oculta en heces positiva, 3) describir la localización del cáncer colorrectal en los pacientes con test inmunoquímico RapiLat-Hemo positivo. MÉTODOS: se realizó un estudio de validación de un nuevo test inmunoquímico cubano (RapiLat-Hemo), para detectar SOH, incluyendo a 161 pacientes atendidos en consulta de colon, del Instituto de Gastroenterología de la Habana, en el período 2008-2010, con indicación de colonoscopia, quienes reunieron los criterios de inclusión. A todos los pacientes se les realizó determinación de SOH (RapiLat-Hemo), y se correlacionaron estos resultados con los del reactivo de referencia y la colonoscopia. RESULTADOS: predominó sexo femenino y ≤ 60 años de edad. Se obtuvo una sensibilidad de la prueba para identificar a pacientes con CCR de 88,2% y una especificidad de 92,4 %; una sensibilidad de 60,0 % para pacientes con adenomas ≥10 mm y una especificidad de 85,3 %. CONCLUSIONES: el test demostró validez y reproducibilidad adecuadas en el diagnóstico de cáncer colorrectal y adenomas ≥ 10 mm. Hubo concordancia con el reactivo de referencia (SPIN-FOB). Los hallazgos endoscópicos más frecuentes fueron: pólipos, cáncer colorrectal, y divertículos. La localización más frecuente del cáncer colorrectal en pacientes con sangre oculta en heces positiva fue hacia segmentos más distales del colon.
BACKGROUND: colorectal cancer is preventable and responds effectively to treatment when diagnosed at an early stage. Determination of fecal occult blood is a method used to screen for early colorectal cancer and its precursor lesion, the adenoma. OBJECTIVES: 1) determine the validity and reproducibility of the RapiLat-Hemo immunochemical test to diagnose colorectal cancer and adenomas, and compare it with the reference reagent (SPIN-FOB), 2) describe the most frequent endoscopic findings in patients with positive fecal occult blood, 3) describe the location of colorectal cancer in patients with positive RapiLat-Hemo immunochemical tests. METHODS: A validation study was conducted of a new Cuban immunochemical test (RapiLat-Hemo) to detect FOB. The study sample was composed of 161 patients attending colon consultation at the Institute of Gastroenterology of Havana in the period 2008-2010 who were undergoing colonoscopy and met the inclusion criteria. All patients underwent FOB determination (RapiLat-Hemo), and results were correlated with those of the reference reagent and colonoscopy. RESULTS: There was a predominance of the female sex and the ≤ 60 age group. The test for detection of colorectal cancer had a sensitivity of 88.2% and a specificity of 92.4%. For detection of ≥10 mm adenomas, sensitivity was 60.0% and specificity 85.3%. CONCLUSIONS: The test showed adequate validity and reproducibility for the diagnosis of colorectal cancer and ≥ 10 mm adenomas. There was concordance with the reference reagent (SPIN-FOB). The most common endoscopic findings were polyps, colorectal cancer and diverticula. The most common colorectal cancer location in patients with positive fecal occult blood was the most distal segments of the colon.
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Masculino , Feminino , Neoplasias Colorretais/diagnóstico , Adenocarcinoma/diagnóstico , Fezes/microbiologia , Sangue Oculto , CubaRESUMO
A review about nonalcoholic fatty liver disease is presented, considering the updated aspects related to pathophysiology, diagnosis and management of this medical condition.
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Fígado Gorduroso , Fígado Gorduroso/diagnóstico , Fígado Gorduroso/tratamento farmacológico , Fígado Gorduroso/fisiopatologia , Humanos , Hepatopatia Gordurosa não Alcoólica , Índice de Gravidade de DoençaRESUMO
A review about nonalcoholic fatty liver disease is presented, considering the updated aspects related to pathophysiology, diagnosis and management of this medical condition.
Assuntos
Fígado Gorduroso , Fígado Gorduroso/diagnóstico , Fígado Gorduroso/tratamento farmacológico , Fígado Gorduroso/fisiopatologia , Humanos , Hepatopatia Gordurosa não Alcoólica , Índice de Gravidade de DoençaRESUMO
A review about nonalcoholic fatty liver disease is presented, considering the updated aspects related to pathophysiology, diagnosis and management of this medical condition.
Assuntos
Fígado Gorduroso , Fígado Gorduroso/diagnóstico , Fígado Gorduroso/fisiopatologia , Fígado Gorduroso/tratamento farmacológico , Hepatopatia Gordurosa não Alcoólica , Humanos , Índice de Gravidade de DoençaRESUMO
OBJECTIVES: Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties which could have beneficial effects on cirrhosis-related clinical outcomes such as survival, disease progression and development of hepatocellular carcinoma (HCC). This study evaluated the efficacy and safety of viusid in patients with HCV-related decompensated cirrhosis. DESIGN: A randomised double-blind and placebo-controlled study was conducted in a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). The authors randomly assigned 100 patients with HCV-related decompensated cirrhosis to receive viusid (three oral sachets daily, n=50) or placebo (n=50) during 96 weeks. The primary outcome of the study was overall survival at 96 weeks, and the secondary outcomes included time to disease progression, time to HCC diagnosis, time to worsening of the prognostic scoring systems Child-Pugh and Model for End-Stage Liver Disease, and time to a new occurrence or relapse for each one of the main clinical complications secondary to portal hypertension at 96 weeks. RESULTS: Viusid led to a significant improvement in overall survival (90%) versus placebo (74%) (HR 0.27, 95% CI 0.08 to 0.92; p=0.036). A similar improvement in disease progression was seen in viusid-treated patients (28%), compared with placebo-treated patients (48%) (HR 0.47, 95% CI 0.22 to 0.89; p=0.044). However, the beneficial effects of viusid were wholly observed among patients with Child-Pugh classes B or C, but not among patients with Child-Pugh class A. The cumulative incidence of HCC was significantly reduced in patients treated with viusid (2%) as compared with placebo (12%) (HR 0.15, 95% CI 0.019 to 0.90; p=0.046). Viusid was well tolerated. CONCLUSIONS: The results indicate that treatment with viusid leads to a notable improvement in overall clinical outcomes such as survival, disease progression and development of HCC in patients with HCV-related decompensated cirrhosis. Trial registration number http://ClinicalTrials.gov (NCT00502086).
RESUMO
Los modelos pronósticos representan un pilar importante en la evaluación de los pacientes con cirrosis hepática, sobre todo a la hora de tomar decisiones como el trasplante hepático. Los 2 modelos más utilizados al nivel mundial, el Child Pugh Turcotte y el Model for end stage liver disease (MELD), presentan ventajas y desventajas en su aproximación a los pacientes. El objetivo de este trabajo fue revisar estos modelos pronósticos utilizados en la enfermedad hepática terminal, así como comparar el modelo MELD y el Child Pugh Turcotte sobre la base del diseño, eficacia predictiva y aplicación practica. Se concluye que ambos modelos son útiles para predecir la mortalidad en los pacientes con cirrosis hepática y que se deben realizar futuras investigaciones para mejorar su poder discriminativo
The prognostic models are a significant pillar in assessment of patients presenting hepatic cirrhosis, mainly at moment to make a decision related to liver transplantation. The two more used models at international level, the Child Pugh Turcotte and the Model for end stage liver disease ( MELD) have advantages and disadvantages in its approximation to patients. The aim of present paper was to review these prognostic models used in the end-terminal liver disease, as well as to compare the above mentioned models on the base of the design, predictive effectiveness and practical application. We conclude that both models are useful to predict mortality in patients presenting with hepatic cirrhosis and also that more future researches must to be performed to improve its discriminatory power