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Liver disease-associated biomarkers and methods of use thereof

A technology for biomarkers and liver diseases, applied in the field of biomarkers

Active Publication Date: 2022-06-24
HUMAN METABOLOMICS INST INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To date, no such biomarker combination has been reported in the literature on the diagnosis of nonalcoholic steatohepatitis, liver fibrosis, and cirrhosis, among other liver diseases

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0273] Patient Population for Example 1 Study

[0274] A total of 504 patients diagnosed with liver fibrosis and cirrhosis with an age distribution of 15 were recruited from April 2013 to December 2013 in Shuguang Hospital (Shanghai, China) and Xiamen Traditional Chinese Medicine Hospital (Xiamen, China) affiliated to Shanghai University of Traditional Chinese Medicine. -75 years old. According to 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 "Guidelines for the Prevention and Treatment of Chronic Hepatitis B in China" (2005)" (Engl 2007; 120:2159-73), the patient was clinically diagnosed with liver fibrosis or cirrhosis and infected with chronic hepatitis B. All patients were clinically stable at the time of evaluation. Exclusion criteria include...

Embodiment 2

[0283] Example 2 Liver Biopsy

[0284] Except for patients with liver disease diagnosed with decompensated cirrhosis, the remaining patients with liver disease underwent ultrasound-guided liver biopsy within 1 week of enrollment. Biopsy specimens were fixed with 10% formalin, routinely embedded in paraffin, and histological sections were processed with hematoxylin eosin and eosin and Masson staining. Diagnosis requires a liver biopsy with a minimum length of at least 1.5 cm and at least 6 portal tracts. Histological grading of necrotizing inflammation (G0 to G4) and liver Grading of Fibrosis (S0 to S4). All sections were independently and blindly assessed by three pathologists at Fudan University in Shanghai, China, and observations were processed by the Kappa Concordance Test.

Embodiment 3

[0285] Example 3 Serum sample collection

[0286]Hematology and general biochemical assays were measured using an LH750 hematology analyzer and a Synchron DXC800 clinical system (Beckman Coulter, USA) according to the manufacturer's protocol. Serum hyaluronic acid (HA) and laminin (LN) concentrations were measured with a chemiluminescence immunoassay analyzer (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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Abstract

The present invention provides a biomarker and a combination of biomarkers that can be used to assess the liver disease status of a subject, monitor liver disease, differentiate liver disease, treat a subject evaluated by the method of the present invention, provide a diagnosis of the subject's liver disease status Related detection methods and kits.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [0002] This application claims priority to US Provisional Application Serial No. 62 / 343,010, filed May 29, 2016, and is hereby incorporated by reference. technical field [0003] The present invention relates to biomarkers associated with liver disease (liver disease), methods of using biomarkers to diagnose liver disease, monitor liver disease progression, stratify liver disease, or differentiate liver disease, kits for these methods, and treatment of subjects diagnosed by the methods of the present invention. Background technique [0004] Liver fibrosis is a wound healing response to liver injury (Chang TT, et al. Long-term entecavirtherapy results in the reversal of fibrosis / cirrhosis and continuedhistological 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 outco...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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