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      Hepatocyte apoptosis fragment product cytokeratin-18 M30 level and non-alcoholic steatohepatitis risk diagnosis: an international registry study

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      1 , 2 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 10 , 12 , 13 , 14 , 18 , 2 , 19 , 20 , 21 , 22 , 2 , 23 , 24
      Chinese Medical Journal
      Lippincott Williams & Wilkins
      Apoptosis, Diagnosis, Cytokeratin-18, Liver histology, Non-alcoholic steatohepatitis, Non-alcoholic fatty liver disease

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          Abstract

          Background:

          Liver biopsy for the diagnosis of non-alcoholic steatohepatitis (NASH) is limited by its inherent invasiveness and possible sampling errors. Some studies have shown that cytokeratin-18 (CK-18) concentrations may be useful in diagnosing NASH, but results across studies have been inconsistent. We aimed to identify the utility of CK-18 M30 concentrations as an alternative to liver biopsy for non-invasive identification of NASH.

          Methods:

          Individual data were collected from 14 registry centers on patients with biopsy-proven non-alcoholic fatty liver disease (NAFLD), and in all patients, circulating CK-18 M30 levels were measured. Individuals with a NAFLD activity score (NAS) ≥5 with a score of ≥1 for each of steatosis, ballooning, and lobular inflammation were diagnosed as having definite NASH; individuals with a NAS ≤2 and no fibrosis were diagnosed as having non-alcoholic fatty liver (NAFL).

          Results:

          A total of 2571 participants were screened, and 1008 (153 with NAFL and 855 with NASH) were finally enrolled. Median CK-18 M30 levels were higher in patients with NASH than in those with NAFL (mean difference 177 U/L; standardized mean difference [SMD]: 0.87 [0.69–1.04]). There was an interaction between CK-18 M30 levels and serum alanine aminotransferase, body mass index (BMI), and hypertension ( P < 0.001, P = 0.026 and P = 0.049, respectively). CK-18 M30 levels were positively associated with histological NAS in most centers. The area under the receiver operating characteristics (AUROC) for NASH was 0.750 (95% confidence intervals: 0.714–0.787), and CK-18 M30 at Youden's index maximum was 275.7 U/L. Both sensitivity (55% [52%–59%]) and positive predictive value (59%) were not ideal.

          Conclusion:

          This large multicenter registry study shows that CK-18 M30 measurement in isolation is of limited value for non-invasively diagnosing NASH.

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          Most cited references48

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          Design and validation of a histological scoring system for nonalcoholic fatty liver disease.

          Nonalcoholic fatty liver disease (NAFLD) is characterized by hepatic steatosis in the absence of a history of significant alcohol use or other known liver disease. Nonalcoholic steatohepatitis (NASH) is the progressive form of NAFLD. The Pathology Committee of the NASH Clinical Research Network designed and validated a histological feature scoring system that addresses the full spectrum of lesions of NAFLD and proposed a NAFLD activity score (NAS) for use in clinical trials. The scoring system comprised 14 histological features, 4 of which were evaluated semi-quantitatively: steatosis (0-3), lobular inflammation (0-2), hepatocellular ballooning (0-2), and fibrosis (0-4). Another nine features were recorded as present or absent. An anonymized study set of 50 cases (32 from adult hepatology services, 18 from pediatric hepatology services) was assembled, coded, and circulated. For the validation study, agreement on scoring and a diagnostic categorization ("NASH," "borderline," or "not NASH") were evaluated by using weighted kappa statistics. Inter-rater agreement on adult cases was: 0.84 for fibrosis, 0.79 for steatosis, 0.56 for injury, and 0.45 for lobular inflammation. Agreement on diagnostic category was 0.61. Using multiple logistic regression, five features were independently associated with the diagnosis of NASH in adult biopsies: steatosis (P = .009), hepatocellular ballooning (P = .0001), lobular inflammation (P = .0001), fibrosis (P = .0001), and the absence of lipogranulomas (P = .001). The proposed NAS is the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores. In conclusion, we present a strong scoring system and NAS for NAFLD and NASH with reasonable inter-rater reproducibility that should be useful for studies of both adults and children with any degree of NAFLD. NAS of > or =5 correlated with a diagnosis of NASH, and biopsies with scores of less than 3 were diagnosed as "not NASH."
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            Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention

            NAFLD is one of the most important causes of liver disease worldwide and will probably emerge as the leading cause of end-stage liver disease in the coming decades, with the disease affecting both adults and children. The epidemiology and demographic characteristics of NAFLD vary worldwide, usually parallel to the prevalence of obesity, but a substantial proportion of patients are lean. The large number of patients with NAFLD with potential for progressive liver disease creates challenges for screening, as the diagnosis of NASH necessitates invasive liver biopsy. Furthermore, individuals with NAFLD have a high frequency of metabolic comorbidities and could place a growing strain on health-care systems from their need for management. While awaiting the development effective therapies, this disease warrants the attention of primary care physicians, specialists and health policy makers.
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              Association Between Fibrosis Stage and Outcomes of Patients with Non-Alcoholic Fatty Liver Disease: a Systematic Review and Meta-Analysis

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                Author and article information

                Journal
                Chin Med J (Engl)
                Chin Med J (Engl)
                CM9
                Chinese Medical Journal
                Lippincott Williams & Wilkins (Hagerstown, MD )
                0366-6999
                2542-5641
                5 February 2023
                27 February 2023
                : 136
                : 3
                : 341-350
                Affiliations
                [1 ]Department of Biostatistics and Medical Record, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China
                [2 ]Department of Hepatology, MAFLD Research Center, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China
                [3 ]Service d’Hépato-Gastroentérologie et Oncologie Digestive, Centre Hospitalier Universitaire d’Angers, Angers, France
                [4 ]Laboratoire HIFIH, UPRES EA3859, SFR ICAT 4208, Université d’Angers, Angers, France
                [5 ]Université Côte d’Azur, CHU, INSERM, U1065, C3M, 06204 Nice, France
                [6 ]Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
                [7 ]Storr Liver Centre, Westmead Institute for Medical Research, Westmead Hospital and University of Sydney, Sydney, NSW, Australia
                [8 ]Department of Gastroenterology, School of Medicine, Marmara University, Istanbul, Turkey
                [9 ]Department of Gastroenterology, School of Medicine, Recep Tayyip Erdoğan University, Rize, Turkey
                [10 ]Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong 999077, China
                [11 ]Department of Gastroenterology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200000, China
                [12 ]University Clinic for Visceral Surgery and Medicine, Inselspital, University Hospital Bern, Bern, Switzerland
                [13 ]Graduate School for Health Sciences, University of Bern, Bern, Switzerland
                [14 ]Academic Department of Gastroenterology, Medical School of National and Kapodistrian University of Athens, General Hospital, of Athens “Laiko”, Athens, Greece
                [15 ]Department of Gastroenterology, Ruijin Hospital, Shanghai 200000, China
                [16 ]Metabolic Liver Research Program I, Department of Medicine, University Medical Center Mainz, Mainz, Germany
                [17 ]The Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang 310000, China
                [18 ]Tianjin Second People's Hospital, Tianjin 300000, China
                [19 ]Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200000, China
                [20 ]Southampton National Institute for Health and Care Research Biomedical Research Centre, University Hospital Southampton, Southampton General Hospital, Southampton, UK
                [21 ]Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy
                [22 ]Xi’an Medical University, Xi’an, Shaanxi 710000, China
                [23 ]Institute of Hepatology, Wenzhou Medical University, Wenzhou, Zhejiang 325000, China
                [24 ]Key Laboratory of Diagnosis and Treatment for the Development of Chronic Liver Disease in Zhejiang Province, Wenzhou, Zhejiang 325000, China.
                Author notes
                Correspondence to: Minghua Zheng, Department of Hepatology, MAFLD Research Center, The First Affiliated Hospital of Wenzhou Medical University; No. 2, Fuxue Lane, Wenzhou, Zhejiang 325000, China E-Mail: zhengmh@ 123456wmu.edu.cn
                Article
                CMJ-2022-2498 00010
                10.1097/CM9.0000000000002603
                10106257
                36848175
                b3008b74-a30b-4610-9d98-657721b0dc94
                Copyright © 2023 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0

                History
                : 8 September 2022
                Categories
                Original Articles
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                apoptosis,diagnosis,cytokeratin-18,liver histology,non-alcoholic steatohepatitis,non-alcoholic fatty liver disease

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