CN-121995065-A - Biomarker for systemic vasculitis diagnosis and application thereof

Abstract

The invention relates to the technical field of identification of systemic vasculitis, in particular to a biomarker for diagnosing systemic vasculitis and application thereof, wherein the biomarker combination comprises serum markers including cold-induced RNA binding protein, myeloid cell trigger receptor-1 and Toll-like receptor 4. The biomarker provided by the invention is used for diagnosing systemic vasculitis, evaluating disease activity, early warning renal injury risk and monitoring treatment effect, so as to solve the technical problem of lack of specific and sensitive biomarkers in the prior art.

Inventors

• LI XIN

Assignees

• 天津医科大学总医院

Dates

Publication Date

20260508

Application Date

20260409

Claims (8)

1. 1.A biomarker combination for systemic vasculitis diagnosis, 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 diagnosis or assisted diagnosis of systemic vasculitis, wherein the detection reagent is used to detect the level of the biomarker combination in a sample to be tested.
3. 3. The method of diagnosing or aiding in the diagnosis of systemic vasculitis, comprising administering to a subject in need thereof a biomarker combination or a detection reagent thereof according to claim 2, wherein the systemic vasculitis is anti-neutrophil cytoplasmic antibody associated vasculitis or Takayasu arteritis.
4. 4. A test kit for diagnosing or aiding in the diagnosis of systemic vasculitis, comprising reagents for detecting the level of a combination of biomarkers according to claim 1 in a sample to be tested.
5. 5. Use of a biomarker combination according to claim 1, or a detection reagent thereof, for the manufacture of a product for assessing the risk of kidney damage in a patient suffering from anti-neutrophil cytoplasmic antibody related vasculitis, wherein the detection reagent is used to detect the level of the biomarker combination in a sample to be tested.
6. 6. A kit for assessing the risk of kidney damage in a patient suffering from anti-neutrophil cytoplasmic antibody associated vasculitis, said kit comprising reagents for detecting the level of the biomarker combination according to claim 1 in a test sample.
7. 7. Use of a biomarker combination according to claim 1, or a detection reagent thereof, for the manufacture of a product for monitoring the therapeutic effect of a patient suffering from systemic vasculitis, wherein the detection reagent is used to detect the level of the biomarker combination in a sample to be tested.
8. 8. A kit for monitoring the efficacy of a treatment of a patient suffering from systemic vasculitis, said kit comprising reagents for detecting the level of a biomarker combination according to claim 1 in a sample to be tested.

Description

Biomarker for systemic vasculitis diagnosis and application thereof Technical Field The invention relates to the technical field of identification of systemic vasculitis, in particular to a biomarker for diagnosing systemic vasculitis and application thereof. Background Systemic vasculitis (SystemicVasculitis, SV) is a group of heterogeneous diseases characterized by inflammation and necrosis of the vessel wall as core pathologies, which can involve the systemic organ systems. Depending on the size and type of affected vessels, the disease lineages mainly include anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associatedvasculitis, AAV) and aortic inflammation (Takayasu' SARTERITIS, TAK), among others. AAV is a representative subtype of small vasculitis, including Granulomatous Polyangiitis (GPA), microscopic Polyangiitis (MPA) and Eosinophilic Granulomatous Polyangiitis (EGPA), while TAK mainly involves the aorta and its major branches, which are most common in young females. Although the overall incidence of the disease is low, its mortality and disability rates remain high. Epidemiological data show that AAV patients have a 2.6-fold risk of mortality compared to the matched general population, with a survival rate of only 78% in 5 years. The core challenge facing this field is that the pathogenesis is not yet fully elucidated and the clinical lack of specific biomarkers that can accurately reflect disease activity, predict recurrence risk, and guide personalized therapy. Although the existing detection indexes such as ANCA have important value for identifying the small vasculitis subtype, about 10 percent of patients have negative ANCA detection, the level of the ANCA is not completely consistent with the correlation of disease activity, and the large vasculitis has no specific blood laboratory detection index so far. 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 systemic vasculitis and application thereof, so as to solve the technical problem of lack of specific and sensitive biomarkers in the prior art, effectively reduce the risk of mortality 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 combination for the diagnosis of systemic vasculitis 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 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 aiding in the diagnosis of systemic vasculitis. According to an embodiment of the invention, the systemic vasculitis is anti-neutrophil cytoplasmic Antibody Associated Vasculitis (AAV) or TAK. According to a third aspect of the present invention there is provided a test kit for the diagnosis or assisted diagnosis of systemic vasculitis, the test kit comprising reagents for detecting the level of a biomarker combination 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 risk of renal impairment in a patient suffering from anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). According to a fifth aspect of the invention there is provided a kit for assessing the risk of kidney damage in an anti-neutrophil cytoplasmic Antibody Associated Vasculitis (AAV) patient, the kit comprising reagents for detecting the level of biomarker combinations in a test sample. According to a sixth 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 monitoring the therapeutic effect of a patient suffering from systemic vasculitis. According to a seventh aspect of the present invention there is provided a kit for monitoring the effect of a treatment in a patient suffering from systemic vasculitis, the kit comprising reagents for detecting the level of a biomarker combination in a sample to be tested. The invention systematically detects the expression levels of CIRP, TLR4 and TREM-1 in serum of AA