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Clinical Care/Education/Nutrition
Combined and sequential non-invasive approach to diagnosing non-alcoholic steatohepatitis in patients with non-alcoholic fatty liver disease and persistently normal alanine aminotransferase levels
  1. Kenneth I Zheng1,
  2. Wen-Yue Liu2,
  3. Xiao-Yan Pan2,
  4. Hong-Lei Ma1,
  5. Pei-Wu Zhu3,
  6. Xi-Xi Wu4,
  7. Giovanni Targher5,
  8. Christopher Byrne6,
  9. Xiao-Dong Wang1,7,8,
  10. Yong-Ping Chen1,7,8,
  11. Fengmin Lu9,
  12. Ming-Hua Zheng1,7,8
  1. 1NAFLD Research Center, Department of Hepatology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  2. 2Department of Endocrinology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  3. 3Department of Laboratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  4. 4Department of Gastroenterology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  5. 5Division of Endocrinology and Metabolism, University of Verona, Ospedale Civile Maggiore, Verona, Italy
  6. 6Southampton National Institute for Health Research Biomedical Research Centre, University Hospital Southampton, Southampton General Hospital, Southampton, UK
  7. 7Institute of Hepatology, Wenzhou Medical University, Wenzhou, China
  8. 8Key Laboratory of Diagnosis and Treatment for The Development of Chronic Liver Disease in Zhejiang Province, Wenzhou, China
  9. 9Department of Microbiology and Infectious Disease Center, School of Basic Medicine, Peking University Health Science Center, Beijing, China
  1. Correspondence to Professor Ming-Hua Zheng; zhengmh{at}wmu.edu.cn; Professor Fengmin Lu; lu.fengmin{at}bjmu.edu.cn

Abstract

Background and aim Imaging-confirmed non-alcoholic fatty liver disease (NAFLD) with normal alanine aminotransferase (nALT) levels is infrequently the subject for further evaluation. Early diagnosis of non-alcoholic steatohepatitis (NASH) is needed to prevent disease progression. Thus, we tested the clinical utility of serum Golgi protein 73 (GP73) levels and developed a new non-invasive score to diagnose NASH in patients with biopsy-confirmed NAFLD and persistent nALT levels.

Methods Serum GP73 and cytokeratin-18 M30 fragments (CK18-M30) levels were measured in 345 patients with biopsy-proven NAFLD. We developed a new score, named G-NASH model (by incorporating serum GP73), and combined it with serum CK18-M30 measurement in a sequential non-invasive approach to accurately identify NASH among patients with NAFLD and persistent nALT levels.

Results 105 (30.4%) patients had persistent nALT, 53 of whom had histologically confirmed NASH. Both serum GP73 and CK18-M30 levels alone had poor diagnostic accuracy in identifying NASH (55.2% and 51.6%, respectively) in these patients. Conversely, G-NASH model performed better than other established non-invasive scoring systems, and by using our proposed sequential non-invasive approach 82.9% of patients with NASH were correctly identified.

Conclusions NASH is highly prevalent in patients with NAFLD with persistent nALT levels. The G-NASH model accurately identifies NASH in this patient group.

  • liver disease
  • nonalcoholic steatohepatitis
  • NAFLD
  • diagnosis
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjdrc-2020-001174

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    Footnotes

    • Contributors Study concept and design: Y-PC, FL and M-HZ. Acquisition of data: W-YL, X-YP, H-LM, P-WZ and X-XW. Pathology analysis: X-DW. Analysis and interpretation of data: KIZ. Drafting of the manuscript: KIZ. Critical revision of the manuscript for important intellectual content: GT and CB. Study supervision: FL and M-HZ. All authors contributed to the manuscript for important intellectual content and approved the submission.

    • Funding This work was supported by grants from the National Natural Science Foundation of China (81500665), High Level Creative Talents from Department of Public Health in Zhejiang Province, and Project of New Century 551 Talent Nurturing in Wenzhou. GT is supported in part by grants from the University School of Medicine of Verona, Verona, Italy. CB is supported in part by the Southampton NIHR Biomedical Research Centre (IS-BRC-20004), UK.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The research protocol of this study was approved by the ethics committee of The First Affiliated Hospital of Wenzhou Medical University. All procedures followed were in accordance with the local ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients for being included in the study.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request.