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4.
Adv Exp Med Biol ; 1307: 417-440, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32424494

RESUMO

Nonalcoholic fatty liver disease (NAFLD) has emerged as the leading liver disease globally. NAFLD patients can have a progressive phenotype, non-alcoholic steatohepatitis (NASH) that could lead to cirrhosis, liver failure and cancer. There is a close bi-directional relationship between NAFLD and type 2 diabetes mellitus (T2DM); NAFLD increases the risk for T2DM and its complications whereas T2DM increases the severity of NAFLD and its complications. The large global impact of NAFLD and T2DM on healthcare systems requires a paradigm shift from specialty care to early identification and risk stratification of NAFLD in primary care and diabetes clinics. Approach to diagnosis, risk stratification and management of NAFLD is discussed. In addition to optimizing the control of coexisting cardiometabolic comorbidities, early referral of NAFLD patients at high risk of having NASH or significant fibrosis to hepatology specialist care may improve management and allow access for clinical trials. Lifestyle modifications, vitamin E, pioglitazone and metformin are currently available options that may benefit patients with T2DM and NAFLD. The burst of clinical trials investigating newer therapeutic agents for NAFLD and NASH offer hope for new, effective and safe therapies in the near future.


Assuntos
Diabetes Mellitus Tipo 2 , Hepatopatia Gordurosa não Alcoólica , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Humanos , Cirrose Hepática , Metformina/uso terapêutico , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/terapia
5.
BMJ Case Rep ; 13(12)2020 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-33370951

RESUMO

Non-alcoholic fatty liver disease (NAFLD) is nowadays the most common liver disease worldwide. Autoimmune hepatitis (AIH) is a relatively rare disease of the liver characterised by female predominance, circulating autoantibodies, polyclonal hypergammaglobulinaemia, interface hepatitis on histology and favourable response to immunosuppression. The possibility of an additional AIH diagnosis in patients with NAFLD (NAFLD/AIH concurrence) or the presence of AIH alone instead of a supposed NAFLD diagnosis represents a challenge for clinicians. We report herein two adult patients (a 33-year-old woman and a 59-year-old man) with a previous NAFLD diagnosis who proved finally to suffer from AIH alone. These two representative cases indicate how difficult and complicated could be sometimes the diagnosis of patients with AIH highlighting the range of disease manifestations and severity while they also underline that although NAFLD is by far the most frequent chronic liver disease this could not be always the case.


Assuntos
Anticorpos Antinucleares/sangue , Hepatite Autoimune/diagnóstico , Síndrome Metabólica/complicações , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Obesidade Mórbida/complicações , Adulto , Anticorpos Antinucleares/imunologia , Biópsia , Diagnóstico Diferencial , Erros de Diagnóstico , Técnicas de Imagem por Elasticidade , Feminino , Hepatite Autoimune/tratamento farmacológico , Hepatite Autoimune/imunologia , Hepatite Autoimune/patologia , Humanos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Imunossupressores/administração & dosagem , Fígado/diagnóstico por imagem , Fígado/imunologia , Fígado/patologia , Testes de Função Hepática , Masculino , Síndrome Metabólica/imunologia , Pessoa de Meia-Idade , Ácido Micofenólico/administração & dosagem , Hepatopatia Gordurosa não Alcoólica/etiologia , Obesidade Mórbida/imunologia , Prednisolona/administração & dosagem
6.
Medicine (Baltimore) ; 99(50): e23619, 2020 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-33327335

RESUMO

Over half of metabolic syndrome (MetS) patients have nonalcoholic fatty liver disease (NAFLD). To prevent its complications, standard routine screening is required, but the human-resource and budgetary implications need to be taken into consideration. This study compared the performances of 4 noninvasive scoring systems in predicting NAFLD in MetS patients. They were the fatty liver index, hepatic steatosis index, lipid accumulation product index, and nonalcoholic fatty liver disease in metabolic syndrome patients scoring system (NAFLD-MS).Scores were determined for 499 MetS patients, including 249 patients in a type 2 diabetes mellitus (T2DM) subgroup. Ultrasonography was used to diagnose NAFLD. The accuracies and performance of the scoring systems were analyzed using published cutoff values, and comparisons were made of their areas under receiver operating characteristic curves, sensitivities, specificities, positive and negative predictive values, and likelihood ratios.NAFLD was detected in 68% of the MetS patients and 77% of the MetS patients with T2DM. According to the areas under receiver operating characteristic curves, fatty liver index and hepatic steatosis index provided better performances in predicting NAFLD. NAFLD-MS provided the highest specificity of 99% among the MetS patients as a whole, and it provided even better accuracy with similar performance when applied to the subgroup of MetS patients with T2DM. The maximum cost avoidance from unnecessary ultrasonography was also reported by using NAFLD-MS. In terms of simplicity and ease of calculation, the lipid accumulation product index and NAFLD-MS are preferred.All 4 scoring systems proved to be acceptable for predicting NAFLD among MetS and T2DM patients in settings where the availability of ultrasonography is limited. NAFLD-MS provided the highest specificity and cost avoidance, and it is simple to use. All 4 systems can help clinicians decide further investigations.


Assuntos
Testes de Função Hepática , Síndrome Metabólica , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Diabetes Mellitus Tipo 2 , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica/fisiopatologia , Valor Preditivo dos Testes , Curva ROC , Sensibilidade e Especificidade , Índice de Gravidade de Doença
7.
Acta Gastroenterol Belg ; 83(4): 565-570, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33321012

RESUMO

Background: Nonalcoholic fatty liver disease (NAFLD) is among the most common causes of chronic liver disease and cirrhosis. In NAFLD, histological course of steatosis is usually macrovesicular (MacroS), but it may be accompanied by varying degrees of microvesicular steatosis (MicroS). Thus, in this study, we aimed to evaluate the prevalence and significance of MicroS in subjects with NAFLD. Methods: A retrospective analysis of clinical and laboratory data of patients with histologically proven NAFLD was performed. The liver biopsy specimens which stained with hematoxylin eosin, reticulin, and Masson's Trichrome stains were evaluated by single expert liver pathologist. Scoring and semiquantitative assessment of steatosis and NAFLD severity was done according to Kleiner scale known as NAFLD activity score (NAS). Grading for steatosis, steatosis type, zonal distribution of steatosis and other histological findings were also determined. Results: The prevalence of MicroS among the study population (n= 191) was 30.4%. There was no difference regarding the demographic and biochemical parameters between patients with or without MicroS. On the other hand, the prevalence of ballooning injury and megamitochondria were higher in patients with MicroS (p= 0.019 and p= 0.036, respectively). There was a significant association of MicroS with ballooning injury (OR 2.65, 95% CI= 1.26-5.55 ; p= 0.005) and the presence of megamitochondria (OR 3.72, 95% CI= 1.00-13.72 ; p= 0.037). Conclusion: MicroS is common in patients with NAFLD and is associated with early histological findings in this clinically relevant condition. Further longitudinal studies are needed to characterize the role of MicroS in the natural history of NAFLD.


Assuntos
Hepatopatia Gordurosa não Alcoólica , Biópsia , Humanos , Fígado/patologia , Cirrose Hepática/patologia , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/patologia , Estudos Retrospectivos , Índice de Gravidade de Doença
8.
Ter Arkh ; 92(8): 29-36, 2020 Sep 03.
Artigo em Russo | MEDLINE | ID: mdl-33346459

RESUMO

AIM: To determine the diagnostic value of clinical features of the comorbid course of non-alcoholic fatty liver disease (NAFLD) and gallstone disease (GD) to improve the effectiveness of patient management. MATERIALS AND METHODS: 183 patients with NAFLD were included into the open comparative study. The main group was represented by patients with NAFLD and GD (n=88), of which 53 patients underwent cholecystectomy (CE). The comparison group was represented by patients with NAFLD without GD (n=95). A standard laboratory and instrumental examinations were performed, including elastometry to assess of the stage of liver fibrosis. RESULTS: There were more women in the main group (2=8.48; p0.01). There were positive correlations between the age of patients and the duration of NAFLD with the presence of GD and CE (rs=0.135; p0.01 and rs=0.168; p0.01 respectively). Patients of the main group had the general weakness and fatigue (2=11.33, rs=0.234; p0.01 and 2=15.68, rs=0.281; p0.01 respectively), as well as a bitter taste in the mouth (2=11.66; p0.01; rs=0.147; p0.01). Coronary heart disease was diagnosed more often among people suffering from NAFLD and GD (25% vs 9.47% in patients of the comparison group, p0.01). Both of NAFLD and GD were associated with the development of type 2 diabetes (rs=0.164; p0.01). Individuals suffering from GD after CE had higher LDL and GGT values (rs=0.228; p0.01 and rs=0.298; p0.01 respectively). The number of people with advanced fibrosis were significantly higher (26.31%) in the GD group, especially among people after CE (30.18%). The stage of liver fibrosis had a positive significant relationship with CE (rs=0.366; p0.01). CONCLUSION: Patients suffering from GD and NAFLD had a symptom of dyspepsia and general weakness. High prevalence of type 2 diabetes and сoronary heart disease, high level of LDL and GGT were found in patients with GD and after CE. CE in patients suffering from GD and NAFLD was associated with the formation of progressive stages of liver fibrosis.


Assuntos
Colelitíase , Diabetes Mellitus Tipo 2 , Hepatopatia Gordurosa não Alcoólica , Colecistectomia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Feminino , Humanos , Cirrose Hepática/diagnóstico , Cirrose Hepática/epidemiologia , Cirrose Hepática/etiologia , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Prevalência , Fatores de Risco
9.
Ter Arkh ; 92(8): 73-78, 2020 Sep 03.
Artigo em Russo | MEDLINE | ID: mdl-33346465

RESUMO

AIM: To evaluate the frequency of liver fibrosis progression to stage 34 among patients with non-alcoholic fatty liver disease (NAFLD), type 2 diabetes and obesity, to identify predictors of severe liver fibrosis, to propose an algorithm for diagnosing fibrosis in this category of patients. MATERIALS AND METHODS: 160 patients with NAFLD, type 2 diabetes mellitus (DM) and obesity and 50 patients with NAFLD without diabetes were comprehensively examined. Patients underwent laboratory examination (clinical blood test, biochemical analysis, immunoglobulins G, M, autoantibody assay, coagulogram), liver ultrasound. All patients underwent determination of the liver fibrosis stage by two methods: the serological test FibroMax and indirect ultrasound elastometry of the liver; 40 patients underwent a liver biopsy. Statistical data processing was performed using the programming language and statistical calculations R: we used correlation analysis, multiple logistic regression method, one-way analysis of variance, multi-factor analysis, the Kruskal-Wallis method, and comparison of the number of patients using the Fisher test. RESULTS: DM is a risk factor for the liver fibrosis progression in patients with NAFLD. Significant markers of severe fibrosis in this category of patients are increased levels of GGTP, haptoglobin and alpha-2-macroglobulin, lower platelet and prothrombin levels. Obesity and isolated steatosis without steatohepatitis are not markers of severe liver fibrosis at present, but obesity can be considered a risk factor for the progression of fibrosis in the future. CONCLUSION: All patients with NAFLD in combination with diabetes need screening to detect advanced liver fibrosis: it is advisable to determine the levels of GGTP, haptoglobin and alpha-2-macroglobulin.


Assuntos
Diabetes Mellitus Tipo 2 , Hepatopatia Gordurosa não Alcoólica , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Humanos , Fígado/diagnóstico por imagem , Fígado/patologia , Cirrose Hepática/diagnóstico , Cirrose Hepática/epidemiologia , Cirrose Hepática/etiologia , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/patologia , Obesidade/patologia
12.
Rev Med Suisse ; 16(704): 1544-1547, 2020 Sep 02.
Artigo em Francês | MEDLINE | ID: mdl-32880109

RESUMO

Non-alcoholic fatty liver disease (NAFLD) includes a spectrum of hepatic pathology ranging from non-alcoholic fatty liver, non-alcoholic steatohepatitis (NASH) occasionally complicated with hepatic fibrosis or even cirrhosis. In order to propose a diagnosis with positive criteria, a panel of experts recently proposed the use of an alternative nomenclature, metabolic-dysfunction-associated fatty liver disease (MAFLD) whose use remains debated. In addition, in Switzerland and elsewhere, there is strong epidemiological growth of NAFLD. The next years will probably see the approval of new therapies for NAFLD/NASH but, at present, management remains focused on lifestyle interventions and joint monitoring by the primary care physician and, when necessary, the specialist.


Assuntos
Hepatopatia Gordurosa não Alcoólica , Terminologia como Assunto , Humanos , Cirrose Hepática , Hepatopatia Gordurosa não Alcoólica/classificação , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/terapia , Suíça
15.
PLoS One ; 15(9): e0238717, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32915852

RESUMO

INTRODUCTION: Association between elevated cytokeratin 18 (CK-18) levels and hepatocyte death has made circulating CK-18 a candidate biomarker to differentiate non-alcoholic fatty liver from non-alcoholic steatohepatitis (NASH). Yet studies produced variable diagnostic performance. We aimed to provide summary estimates with increased precision for the accuracy of CK-18 (M30, M65) in detecting NASH and fibrosis among non-alcoholic fatty liver disease (NAFLD) adults. METHODS: We searched five databases to retrieve studies evaluating CK-18 against a liver biopsy in NAFLD adults. Reference screening, data extraction and quality assessment (QUADAS-2) were independently conducted by two authors. Meta-analyses were performed for five groups based on the CK-18 antigens and target conditions, using one of two methods: linear mixed-effects multiple thresholds model or bivariate logit-normal random-effects model. RESULTS: We included 41 studies, with data on 5,815 participants. A wide range of disease prevalence was observed. No study reported a pre-defined cut-off. Thirty of 41 studies provided sufficient data for inclusion in any of the meta-analyses. Summary AUC [95% CI] were: 0.75 [0.69-0.82] (M30) and 0.82 [0.69-0.91] (M65) for NASH; 0.73 [0.57-0.85] (M30) for fibrotic NASH; 0.68 (M30) for significant (F2-4) fibrosis; and 0.75 (M30) for advanced (F3-4) fibrosis. Thirteen studies used CK-18 as a component of a multimarker model. CONCLUSIONS: For M30 we found lower diagnostic accuracy to detect NASH compared to previous meta-analyses, indicating a limited ability to act as a stand-alone test, with better performance for M65. Additional external validation studies are needed to obtain credible estimates of the diagnostic accuracy of multimarker models.


Assuntos
Queratina-18/genética , Cirrose Hepática/diagnóstico , Fígado/metabolismo , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Fragmentos de Peptídeos/genética , Adulto , Biomarcadores/metabolismo , Biópsia , Morte Celular/genética , Feminino , Hepatócitos/metabolismo , Hepatócitos/patologia , Humanos , Fígado/patologia , Masculino , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica/genética , Hepatopatia Gordurosa não Alcoólica/metabolismo , Hepatopatia Gordurosa não Alcoólica/patologia
18.
Hepatol Int ; 14(5): 701-710, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32734407

RESUMO

BACKGROUND AND AIM: Cytokine storm has been reported in patients with coronavirus disease 2019 (COVID-19) due to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. We examine the incidence of acute on chronic liver failure (ACLF) in COVID-19 patients with pre-existing compensated chronic liver disease (CLD). METHODS: From 20 Jan 2020 to 7 Feb 2020, we studied 140 consecutive COVID-19 patients admitted to either Fuyang Second People's Hospital (FYSPH), Anhui or the Fifth Medical Center of Chinese PLA General Hospital (PLAGH) in Beijing, China. Pre-existing CLD includes those with liver cirrhosis assessed by APRI/FIB-4 score and /or ultrasound; NAFLD as identified by either ultrasound or hepatic steatosis index with significant liver fibrosis and chronic hepatitis B (CHB) or hepatitis C (CHC) infection. The diagnosis, grading of severity and clinical management of COVID-19 patients complied to the guideline and clinical protocol issued by the China National Health Commission. All patients had liver function test at least twice weekly till discharge with full recovery or death. RESULTS: In total, 3 had liver cirrhosis, 6 patients had CHB, 13 had NAFLD with significant liver fibrosis (one also had CHB). On admission, none had liver decompensation. COVID-19 disease progression was significantly less frequent in non-CLD patients (10/118 8.5%) than CLD patients (13/22 59.1%, p < 0.001). One patient with CLD had acute-on-chronic liver failure (ACLF). CONCLUSION: Disease progression is significantly higher in those COVID-19 patients with CLD as compared to those with no CLD. ACLF can also occur in patient with pre-existing compensated CLD who had severe COVID-19.


Assuntos
Insuficiência Hepática Crônica Agudizada , Infecções por Coronavirus , Hepatite B Crônica , Cirrose Hepática , Hepatopatia Gordurosa não Alcoólica , Pandemias , Pneumonia Viral , Insuficiência Hepática Crônica Agudizada/diagnóstico , Insuficiência Hepática Crônica Agudizada/epidemiologia , Insuficiência Hepática Crônica Agudizada/etiologia , Betacoronavirus/isolamento & purificação , China/epidemiologia , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Progressão da Doença , Feminino , Hepatite B Crônica/complicações , Hepatite B Crônica/diagnóstico , Humanos , Incidência , Fígado/diagnóstico por imagem , Cirrose Hepática/diagnóstico , Cirrose Hepática/epidemiologia , Cirrose Hepática/etiologia , Testes de Função Hepática/métodos , Masculino , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Ultrassonografia/métodos
19.
Diabetes Res Clin Pract ; 167: 108358, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32745698

RESUMO

AIM: Nonalcoholic fatty liver disease (NAFLD) is prevalent in patients with type 2 diabetes mellitus (T2DM), but controversy exists on whether to screen and how to manage these patients in clinical practice. Here, we estimate the number of patients with T2DM and NAFLD in the United States that should be evaluated for advanced liver fibrosis according to proposed screening strategies. METHODS: In this cross-sectional analysis of 2940 adult patients with T2DM (projected to 15.3 million) from the 2005-2016 National Health and Nutrition Examination Survey (NHANES) we applied validated noninvasive scores of liver steatosis and fibrosis to estimate the number of referrals to hepatologists. We followed two different approaches: (1) the flow-chart from the European Association for the Study of the Liver (EASL), Diabetes (EASD) and Obesity (EASO) guidelines; (2) a strategy recently proposed in patients with T2DM aimed at excluding advanced liver fibrosis with a negative predictive value of 100%. RESULTS: NAFLD (based on fatty liver index) was present in 78% of patients (projected to 11.9 million). According to the EASL-EASD-EASO guidelines 37.2-48.5% of patients (projected to 5.7-7.4 million) should be referred to experts, depending on the specific biomarker of fibrosis used. The second strategy, which is based sequentially on aspartate aminotransferase and Fibrosis-4 was able to exclude advanced fibrosis in 67.0% of patients. CONCLUSIONS: Screening strategies based on noninvasive scores are able to exclude advanced liver fibrosis in 50-67% of patients with T2DM. Novel biomarkers or combination of tests may be necessary to reduce the need for liver biopsy and related bleeding episodes in the remaining 33-50%.


Assuntos
Diabetes Mellitus Tipo 2/epidemiologia , Cirrose Hepática/epidemiologia , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Adulto , Idoso , Aspartato Aminotransferases/sangue , Biomarcadores/sangue , Biópsia , Estudos Transversais , Feminino , Humanos , Cirrose Hepática/diagnóstico , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Inquéritos Nutricionais , Obesidade/epidemiologia , Guias de Prática Clínica como Assunto , Prevalência , Encaminhamento e Consulta , Estados Unidos
20.
Lancet Gastroenterol Hepatol ; 5(11): 970-985, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32763196

RESUMO

BACKGROUND: Non-invasive tests that can identify patients with non-alcoholic steatohepatitis (NASH) at higher risk of disease progression are lacking. We report the development and validation of a blood-based diagnostic test to non-invasively rule in and rule out at-risk NASH (defined as non-alcoholic fatty liver disease [NAFLD] activity score [NAS] ≥4 and fibrosis stage ≥2). METHODS: In this prospective derivation and global validation study, blood samples, clinical data, and liver biopsy results from three independent cohorts with suspected NAFLD were used to develop and validate a non-invasive blood-based diagnostic test, called NIS4. Derivation was done in the discovery cohort, which comprised 239 prospectively recruited patients with biopsy-confirmed NASH (NAFLD NAS ≥3; fibrosis stage 0-3) from the international GOLDEN-505 phase 2b clinical trial. A complete matrix based on 23 variables selected for univariate association with the presence of at-risk NASH and avoiding high multi-collinearity was used to derive the model in a bootstrap-based process that minimised the Akaike information criterion. The overall diagnostic performance of NIS4 was externally validated in two independent cohorts: RESOLVE-IT diag and Angers. The RESOLVE-IT diag cohort comprised the first 475 patients screened for potential inclusion into the RESOLVE-IT phase 3 clinical trial. Angers was a retrospective cohort of 227 prospectively recruited patients with suspected NAFLD and clinical risk factors for NASH or fibrosis stage 2 or more according to abnormal elastography results or abnormal liver biochemistry. Both external validation cohorts were independently analysed and were combined into a pooled validation cohort (n=702) to assess clinical performance of NIS4 and other non-invasive tests. FINDINGS: The derived NIS4 algorithm comprised four independent NASH-associated biomarkers (miR-34a-5p, alpha-2 macroglobulin, YKL-40, and glycated haemoglobin; area under the receiver operating characteristics curve [AUROC] 0·80, 95% CI 0·73-0·85), and did not require adjustment for age, sex, body-mass index (BMI), or aminotransferase concentrations. Clinical cutoffs were established within the discovery cohort to optimise both rule out and rule in clinical performance while minimising indeterminate results. NIS4 was validated in the RESOLVE-IT diag cohort (AUROC 0·83, 95% CI 0·79-0·86) and the Angers cohort (0·76, 0·69-0·82). In the pooled validation cohort, patients with a NIS4 value less than 0·36 were classified as not having at-risk NASH (ruled out) with 81·5% (95% CI 76·9-85·3) sensitivity, 63·0% (57·8-68·0) specificity, and a negative predictive value of 77·9% (72·5-82·4), whereas those with a NIS4 value of more than 0·63 were classified as having at-risk NASH (ruled in) with 87·1% (83·1-90·3) specificity, 50·7% (45·3-56·1) sensitivity, and a positive predictive value of 79·2% (73·1-84·2). The diagnostic performance of NIS4 within the external validation cohorts was not influenced by age, sex, BMI, or aminotransferase concentrations. INTERPRETATION: NIS4 is a novel blood-based diagnostic that provides an effective way to non-invasively rule in or rule out at-risk NASH in patients with metabolic risk factors and suspected disease. Use of NIS4 in clinical trials or in the clinic has the potential to greatly reduce unnecessary liver biopsies in patients with lower risk of disease progression. FUNDING: Genfit.


Assuntos
Proteína 1 Semelhante à Quitinase-3/análise , Hemoglobina A Glicada/análise , Cirrose Hepática , Fígado , MicroRNAs/análise , Hepatopatia Gordurosa não Alcoólica , alfa-Macroglobulinas/análise , Área Sob a Curva , Biomarcadores/sangue , Biópsia/métodos , Testes de Química Clínica/métodos , Testes de Química Clínica/normas , Regras de Decisão Clínica , Progressão da Doença , Técnicas de Imagem por Elasticidade/métodos , Humanos , Fígado/metabolismo , Fígado/patologia , Cirrose Hepática/sangue , Cirrose Hepática/diagnóstico , Hepatopatia Gordurosa não Alcoólica/sangue , Hepatopatia Gordurosa não Alcoólica/diagnóstico , Gravidade do Paciente , Valor Preditivo dos Testes , Medição de Risco/métodos
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