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Liver disease-related biomarkers and methods of use thereof

A biomarker, liver disease technology, applied in the field of biomarkers

Active Publication Date: 2018-12-11
HUMAN METABOLOMICS INST INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To date there are no reports in the literature of a combination of biomarkers for the diagnosis of nonalcoholic steatohepatitis, liver fibrosis and cirrhosis, and other liver diseases

Method used

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  • Liver disease-related biomarkers and methods of use thereof
  • Liver disease-related biomarkers and methods of use thereof
  • Liver disease-related biomarkers and methods of use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0267] Example 1 Study population

[0268] Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (Shanghai, China) and Xiamen Hospital of Traditional Chinese Medicine (Xiamen, China) enrolled 504 patients diagnosed with liver fibrosis and cirrhosis, aged 15-75 years. The above diagnosis is based on the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B in China" (Chinese Society of Hepatology, Chinese Medical Association, Chinese Society of Hepatology, Chinese Society of Hepatology, Chinese Society of Infectious Diseases, Chinese Medical Association) and "Chinese Chronic Hepatitis B Guidelines for Prevention and Treatment (2005)" (Chinese Journal of Medicine (Engl) 2007; 120:2159-73). Exclusion criteria included: age less than 15 years or greater than 75 years, pregnant or lactating women, infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or hepatitis E virus co-infection (HEV)...

Embodiment 2

[0276] Example 2 liver biopsy

[0277] Except for patients with liver disease diagnosed as decompensated cirrhosis, the remaining patients with liver disease received ultrasound-guided liver biopsy within 1 week after enrollment. Samples were fixed in 10% formalin, embedded in paraffin, and histological sections were stained with hematoxylin and eosin and Masson. A minimum length of at least 1.5 cm and at least 6 portal areas are required for diagnosis. Histological grade of inflammation (G0 to G4) and liver fibrosis according to Scheuer's staging (Scheuer PJ, Standish RA, Dhillon AP. Scoring of chronic hepatitis. Clinics in liver disease 2002; 6:335-47, v-vi.) The stages (S0 to S4). The above classifications were independently and blindly evaluated by three pathologists from Fudan University in Shanghai, China, and the results passed the Kappa consistency test.

Embodiment 3

[0278] Example 3 Serum Sample Collection

[0279] Use LH750 hematology analyzer and Synchron DXC800 clinical system (Beckman Coulter, USA) for hematology and biochemical routine testing. Serum hyaluronic acid (HA) and laminin (LN) concentrations were measured with a chemiluminescent immunoassay (CLIA) system (LUMO, Shinova Systems, Shanghai, China). Coagulation function was measured using an automatic coagulation analyzer (STAGO Compact, Diagnostica Stago, France). Serum HBV-DNA levels were detected using a real-time polymerase chain reaction (PCR) system (LightCycler, 480, Roche, USA).

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PUM

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Abstract

The present invention provides biomarker and biomarker panels useful for diagnostic methods evaluating liver disease status in a subject, monitoring liver disease, distinguishing between liver diseases, treating subjects evaluated by diagnostic methods of the invention, providing diagnostic tests for evaluating liver disease status in a subject, and kits there for.

Description

[0001] This application claims priority to US Provisional Application No. 62 / 343,010, filed May 29, 2016 and is hereby incorporated by reference. technical field [0002] The present invention relates to biomarkers, the use of biomarkers to diagnose liver diseases, monitor liver disease progression, liver disease stages, differential diagnosis of liver diseases and other diseases, kits, and treatment methods for diagnosed objects. Background technique [0003] Liver fibrosis is a wound healing response caused by liver injury (Chang TT, et al. Long-term entecavirtherapy results in the reversal of fibrosis / cirrhosis and continued histological improvement in patients with chronic hepatitis B. Hepatology 52, 886-893 (2010); George SL, Bacon BR, Brunt EM, Mihindukulasuriya KL, Hoffmann J, DiBisceglie AM. Clinical, virologic, histologic, and biochemical outcomes after successful HCV therapy: a 5-year follow-up of 150 patients. Hepatology 49, 729-738 (2009) ), is a common cause of ...

Claims

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Application Information

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IPC IPC(8): G01N33/58
CPCG01N27/62G01N30/02G01N30/72A61K45/00A61P1/16G01N33/6893G01N2800/085G01N2800/52G01N30/7233G01N2030/025G01N2030/027
Inventor 伟·贾
Owner HUMAN METABOLOMICS INST INC
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