Biomarker for early stage discovery and early warning of liver injury, method and application thereof

A biomarker and early detection technology, applied in the field of biomarkers for early detection and early warning of liver damage, can solve the problems of aggravating the double burden on the patient's body and economy, failure to early warning, poor specificity, etc., to improve purity and good storage , improve efficiency and accuracy, and facilitate the effect of later detection

Active Publication Date: 2018-09-18
BEIJING CHAOYANG HOSPITAL CAPITAL MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Current clinical diagnostic indicators and defects: There is no uniform and recognized diagnostic criteria for drug-induced liver injury in clinical practice, only based on alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and other traditional indicators to judge, the specificity is poor, it is difficult to fully reflect the severity of liver injury, and it is impossible to distinguish the type of liver injury and the inducing factors
In addition, histopathological examination is invasive, and it cannot provide timely and accurate early warning before liver damage occurs.
The hysteresis of traditional indicators makes it unsuitable as a standard for early warning and curative effect evaluation, and cannot achieve effective prevention and prognosis judgment, which increases the double burden on the patient's body and economy

Method used

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  • Biomarker for early stage discovery and early warning of liver injury, method and application thereof
  • Biomarker for early stage discovery and early warning of liver injury, method and application thereof
  • Biomarker for early stage discovery and early warning of liver injury, method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0056] (1) This project was reviewed and approved by the Ethics Committee of Beijing Chaoyang Hospital Affiliated to Capital Medical University.

[0057] (2) Inclusion criteria for healthy volunteers (20) Age: 18-60 years old; Gender: male or female; Weight: BMI within 19-24 (BMI=weight / height 2 (kg / m 2 )), people who are overweight or underweight should be avoided, the weight of men should not be less than 50kg, and the weight of women should not be less than 45kg; good health, no heart, liver, kidney, digestive tract, nervous system, mental abnormalities and metabolic abnormalities, etc. Medical history, blood pressure, heart rate, electrocardiogram, respiratory status, liver and kidney function, blood routine, urine routine, and chest X-ray are normal or abnormal without clinical significance. Have not taken antibiotics, anti-tumor, anti-tuberculosis, hypoglycemic, hormones, anti-arrhythmic drugs, Chinese herbal medicines and other drugs recently.

[0058] (3) Inclusion c...

Embodiment 2

[0108] Diagnostic Sensitivity and Specificity Evaluation of Phenylalanine

[0109] In this embodiment, the changes of serum amino acid content in healthy volunteers and patients with drug-induced liver injury are provided, as shown in the following table,

[0110] Table 3. Changes of serum amino acid content in healthy volunteers and patients with drug-induced liver injury ( μmol / L)

[0111]

[0112] Compared with healthy group, *P<0.05, **P<0.01.

[0113] The clinical diagnostic performance of phenylalanine, a potential drug-induced liver injury biomarker, was evaluated by ROC curve. The area under the ROC curve (AUC) can reflect the ability of the diagnostic index to distinguish positive and negative diagnoses. The larger the AUC value, the higher the diagnostic accuracy. It is generally believed that when 0.5

[0114] Input the pheny...

Embodiment 3

[0116] This example provides biomarkers for early detection and early warning of liver damage, the biomarkers include: phenylalanine, tyrosine, glutamic acid, ornithine, cysteine, isoleucine , lysine, serine, beta-alanine, taurine and aspartic acid.

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Abstract

The invention discloses a biomarker for early stage discovery and early warning of liver injury. The biomarker is prepared from phenylalanine, tyrosine, glutamic acid, ornithine and cysteine. A methodof the biomarker used for early stage discovery and early warning of liver injury comprises the following steps of detecting the concentration of the biomarker in the human body serum; if the concentration of phenylalanine in the human body is higher than the normal level by 41 percent or more, the concentration of tyrosine is higher than the normal level by 19 percent or more, the concentrationof glutamic acid is higher than the normal level by 65 percent or more, the concentration of ornithine is higher than the normal level by 30 percent or more, and the concentration of cysteine is higher than the normal level by 43 percent or more, the result shows that the human body has the drug-induced liver injury. The invention also provides application of the biomarker in the preparation of aliver injury diagnosis kit. The amino acid biomarker provided by the invention has the high diagnosis value. Meanwhile, the diagnosis method and the diagnosis agent provided by the invention greatly improve the liver injury diagnosis efficiency and accuracy.

Description

technical field [0001] The invention belongs to the technical field of liver injury diagnosis, and relates to a biomarker, method and application for early detection and early warning of liver injury. Background technique [0002] Current clinical diagnostic indicators and defects: There is no uniform and recognized diagnostic criteria for drug-induced liver injury in clinical practice, only based on alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and other traditional indicators, the specificity is poor, it is difficult to fully reflect the severity of liver injury, and it is impossible to identify the type of liver injury and the inducing factors. In addition, histopathological examination is invasive and cannot provide timely and accurate early warning before liver injury occurs. The hysteresis of traditional indicators makes it unsuitable as a standard for early warning and curative effect evaluation, and cannot achieve effec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 安卓玲刘丽宏吕亚丽李鹏飞
Owner BEIJING CHAOYANG HOSPITAL CAPITAL MEDICAL UNIV
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