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CN-121978353-A - Biomarker for diagnosing idiopathic inflammatory myopathy and application thereof

CN121978353ACN 121978353 ACN121978353 ACN 121978353ACN-121978353-A

Abstract

The invention relates to the technical field of idiopathic inflammatory myopathy identification, in particular to a biomarker for diagnosing idiopathic inflammatory myopathy and application thereof, wherein the biomarker comprises a serum marker, namely cold-induced RNA binding protein, myeloid cell trigger receptor-1 and Toll-like receptor 4. In the biomarker provided by the invention, CIRP can play a pathological regulation role through a transmembrane receptor. TLR4 serves as an important bridge linking innate and adaptive immunity, mediating the inflammatory driving effects of CIRP in systemic inflammation. TREM-1 is a core action target of CIRP, amplifying tissue damage by activating inflammatory responses of macrophages and neutrophils in a variety of inflammatory diseases.

Inventors

  • LI XIN

Assignees

  • 天津医科大学总医院

Dates

Publication Date
20260505
Application Date
20260409

Claims (9)

  1. 1. A biomarker combination for idiopathic inflammatory myopathy comprising the following serum markers: cold-induced RNA binding protein, myeloid cell trigger receptor-1, toll-like receptor 4.
  2. 2. Use of a biomarker combination according to claim 1, or a detection reagent thereof, for the manufacture of a product for diagnosing or identifying idiopathic inflammatory myopathies, wherein the detection reagent is used to detect the level of the biomarker combination in a sample to be tested.
  3. 3. A test kit for diagnosing or identifying idiopathic inflammatory myopathy, comprising reagents for detecting the combined level of the biomarkers of claim 1 in a test sample.
  4. 4. Use of a biomarker combination according to claim 1, or a detection reagent thereof, for the manufacture of a product for assessing the activity or therapeutic effect of an idiopathic inflammatory myopathy, wherein the detection reagent is used to detect the level of the biomarker combination in a sample to be tested.
  5. 5. A test kit for assessing idiopathic inflammatory myopathy disease activity or treatment efficacy, comprising reagents for detecting the combined levels of the biomarkers of claim 1 in a test sample.
  6. 6. An evaluation system for monitoring idiopathic inflammatory myopathy, comprising a detection module, a data analysis module, and an evaluation module: the detection module is used for detecting the biomarker combination level of claim 1 in a sample to be detected to obtain a detection result; the data analysis module is used for analyzing and calculating the detection result of the detection module to obtain idiopathic inflammatory myopathy scores; the evaluation module is used for identifying the idiopathic inflammatory myopathy according to the idiopathic inflammatory myopathy score of the data analysis module.
  7. 7. An evaluation system for monitoring idiopathic inflammatory myopathy disease activity or treatment effect, comprising a detection module, a data analysis module, and an evaluation module: The detection module is used for detecting the biomarker combination level of claim 1 in a first sample to be detected to obtain a first detection result; the detection module is used for detecting the biomarker combination level of claim 1 in a second sample to be detected to obtain a second detection result; the data analysis module is used for analyzing and calculating the change of the first detection result and the second detection result of the detection module to obtain the idiopathic inflammatory myopathy activity or treatment effect score; The evaluation module is used for evaluating the idiopathic inflammatory myopathy activity or treatment effect according to the idiopathic inflammatory myopathy activity or treatment effect score of the data analysis module.
  8. 8. The use of the biomarker combination or the detection reagent thereof according to claim 1 for preparing a product for screening a high risk group of idiopathic inflammatory myopathy, wherein the expression levels of cold-induced RNA binding protein, myeloid cell trigger receptor-1 and Toll-like receptor 4 in serum of a person to be tested are detected and compared with a preset threshold.
  9. 9. A test kit for screening a population at high risk for idiopathic inflammatory myopathy, comprising reagents for detecting the combined level of biomarkers of claim 1 in a sample to be tested.

Description

Biomarker for diagnosing idiopathic inflammatory myopathy and application thereof Technical Field The invention relates to the technical field of idiopathic inflammatory myopathy identification, in particular to a biomarker for diagnosing idiopathic inflammatory myopathy and application thereof. Background Idiopathic inflammatory myopathy (idiopathic inflammatory myopathy, IIM) is a type of autoimmune disease with significant heterogeneity and is characterized by the involvement of skin and skeletal muscles of extremities, often accompanied by multiple system involvement, including organic lesions of joints, lungs and heart. IIM can be classified into subtypes of Dermatomyositis (DM), anti-synthetase syndrome (ASS), immune-mediated necrotizing myopathy (IMNM), polymyositis (PM), inclusion Body Myositis (IBM), and the like according to clinical manifestations and myositis-specific antibodies. Epidemiological investigation has shown that the incidence of IIM is about 0.2-2/10 ten thousand years, with an prevalence of 2-25/10 ten thousand people. The overall mortality risk ratio for IIM patients compared to the general population was 3.7, with the highest mortality rate at the first year after diagnosis. Current diagnosis of IIM is based primarily on clinical manifestations, laboratory examinations, imaging examinations, and muscle pathology results, including symmetric proximal muscle weakness, typical skin lesions, muscle biopsies and electromyographic features, serum myoenzyme levels, and the like. However, the existing diagnostic methods have limitations in that muscle biopsies are invasive procedures, patient acceptance is low, myoenzyme levels such as Creatine Kinase (CK) may be normal in certain IIM subtypes, and clinical manifestations of some patients are atypical and prone to missed or misdiagnosis. Therefore, the development of the serological biomarker with early diagnosis value and the innovative treatment strategy have important clinical significance for effectively reducing the death risk of the disease and optimizing the long-term clinical outcome of patients. Disclosure of Invention Aiming at the defects of the prior art, the invention aims to provide a biomarker for diagnosing idiopathic inflammatory myopathy and application thereof, which can effectively reduce the death risk of the disease and optimize the long-term clinical outcome of patients. In order to achieve the above purpose, the invention adopts the following technical scheme: According to a first aspect of the present invention there is provided a biomarker comprising the following serum markers: Cold-induced RNA binding protein (CIRP), myeloid cell trigger receptor-1 (TREM-1), toll-like receptor 4 (TLR 4). According to a second aspect of the present invention there is provided the use of a biomarker combination, or a detection reagent thereof, for detecting the level of said biomarker combination in a sample to be tested, in the manufacture of a product for diagnosing or identifying idiopathic inflammatory myopathy. According to a third aspect of the present invention there is provided a test kit for diagnosing or identifying idiopathic inflammatory myopathy comprising reagents for detecting the level of biomarker combinations in a sample to be tested. According to a fourth aspect of the present invention there is provided the use of a biomarker combination, or a detection reagent thereof, for detecting the level of said biomarker combination in a sample to be tested, in the manufacture of a product for assessing the activity or effect of a treatment of an idiopathic inflammatory myopathy. According to a fifth aspect of the present invention there is provided a test kit for assessing the activity or effect of a treatment of an idiopathic inflammatory myopathy, the test kit comprising reagents for detecting the level of biomarker combinations in a sample to be tested. According to a sixth aspect of the present invention, there is provided an evaluation system for monitoring Idiopathic Inflammatory Myopathy (IIM), comprising a detection module, a data analysis module, and an evaluation module: the detection module is used for detecting the biomarker combination level in the sample to be detected to obtain a detection result; the data analysis module is used for analyzing and calculating the detection result of the detection module to obtain idiopathic inflammatory myopathy scores; the evaluation module is used for identifying the idiopathic inflammatory myopathy according to the idiopathic inflammatory myopathy score of the data analysis module. According to a seventh aspect of the present invention, there is provided an evaluation system for monitoring idiopathic inflammatory myopathy disease activity or treatment effect, comprising a detection module, a data analysis module, and an evaluation module: the detection module is used for detecting the biomarker combination level in a first sample to be detected to obtain a first detec