CN-122017253-A - Marker combination for diagnosis or prognosis evaluation of diabetes and application thereof

Abstract

The invention relates to a marker combination for diagnosis or prognosis evaluation of diabetes and application thereof, belonging to the technical field of disease diagnosis. The technical problem to be solved is that the marker combination in the prior art does not fit the pathophysiological difference between diabetes and diabetic nephropathy, the distinguishing effect of the two is insufficient, and early intervention and accurate diagnosis and treatment of the diabetic nephropathy are difficult to realize. The technical scheme is characterized by comprising a marker combination for diagnosis or prognosis evaluation of diabetes mellitus, wherein the marker combination consists of O43795_MYO1B and O43707 _ACTN4. The invention has excellent effect of distinguishing type 2 diabetes and early diabetic nephropathy, can effectively and accurately distinguish two disease states, and can assist in screening and distinguishing early diabetic nephropathy, thereby improving diagnosis and treatment accuracy and timeliness.

Inventors

• ZHANG MIN
• LANG REN
• YU LING
• NIU HUIMIN
• NI QING
• ZHAO ZONGJIANG
• ZHANG YAN
• HE XIN

Assignees

• 首都医科大学附属北京朝阳医院

Dates

Publication Date

20260512

Application Date

20260212

Claims (10)

1. 1. A marker combination for diagnosis or prognosis of diabetes, characterized in that it consists of O43795_myo1b and O43707 _actn4.
2. 2. The marker combination according to claim 1, wherein the diabetes comprises type 2 diabetes and the prognostic evaluation comprises a risk evaluation of progression of diabetes to diabetic nephropathy.
3. 3. Use of a marker combination according to claim 1 for the preparation of a product for the diagnosis or prognosis of diabetes.
4. 4. Use according to claim 3, wherein the product is used to distinguish between type 2 diabetes and diabetic nephropathy.
5. 5. The use according to claim 3, wherein the product achieves diagnosis or prognosis of diabetes by detecting the expression levels of O43795_myo1b and O43707_actn4 in a biological sample.
6. 6. A product for the diagnosis or prognosis of diabetes, characterized in that it comprises a marker combination according to claim 1 or 2.
7. 7. The product of claim 6, wherein the product comprises any one or more of a kit, a test strip, a chip, a device, a detection system.
8. 8. The product of claim 6, wherein the method of using the product comprises the steps of: s1, processing a sample to be detected to obtain a sample peptide segment; s2, after fractionation treatment is carried out on the sample peptide segment, detecting by adopting a liquid chromatography-mass spectrometry system, and collecting mass spectrum data; S3, analyzing mass spectrum data to obtain expression information of O43795_MYO1B and O43707 _ACTN4; S4, based on the expression information of O43795_MYO1B and O43707_ACTN4, diagnosis of diabetes or prognosis evaluation of diabetes progressing to diabetic nephropathy is completed.
9. 9. The product of claim 8, wherein the sample to be tested in step S1 comprises any one or more of urine, blood spots, oral cells, semen, sperm spots, bone, hair, saliva spots, sweat, amniotic fluid containing fetal cells.
10. 10. The product according to claim 8, wherein the diagnosis and prognosis evaluation criteria in step S4 are that a diagnosis probability value is calculated by constructing a diagnosis model by a logistic regression algorithm, that diabetic nephropathy is determined when the diagnosis probability value is equal to or larger than 0.5, and that type 2 diabetes is determined when the diagnosis probability value is smaller than 0.5.

Description

Marker combination for diagnosis or prognosis evaluation of diabetes and application thereof Technical Field The invention belongs to the technical field of disease diagnosis, and particularly relates to a marker combination for diabetes diagnosis or prognosis evaluation and application thereof. Background Diabetes mellitus (Diabetes Mellitus, DM) is a metabolic disease, and diabetic nephropathy (Diabetic KIDNEY DISEASE, DKD) caused by diabetes mellitus is a primary cause of end-stage kidney disease, seriously harms patient health and places a social medical burden. DKD pathogenesis is complex, involves multiple-channel interaction such as metabolic disorder, oxidative stress and inflammatory reaction, lacks typical symptoms in early stage, has great difficulty in clinical discrimination with simple diabetes, and is easy to cause irreversible damage to renal function due to delayed intervention. At present, indexes such as urine albumin/creatinine ratio, estimated glomerular filtration rate, serum creatinine and the like are commonly used for diagnosis and distinction, but have obvious limitations that part of non-proteinuria type DKD patients are easy to be missed, the indexes such as serum creatinine and the like are obviously changed only when the kidney function is seriously damaged, and the early diagnosis requirement cannot be met. The sensitivity and specificity of a single biomarker are insufficient, so that it is difficult to accurately identify cases of simple diabetes and combined kidney injury, and the disease prognosis cannot be effectively estimated. Although research and exploration of novel markers such as podocyte related proteins and cystatin C are carried out, a large number of the novel markers lack of large-scale clinical verification, stable marker combinations are not formed, and the detection method has the problems of complex operation, high cost and the like, so that the novel markers are difficult to popularize and apply. Therefore, a set of marker combination with high sensitivity and strong specificity is developed, the accurate differential diagnosis and prognosis evaluation of diabetes and DKD are realized, and the method has important clinical value for delaying disease progression and optimizing a treatment scheme. The related patent documents: Publication number CN119979694a, publication date 2025.05.13, which discloses biomarkers of type 2 diabetes and uses thereof. This application provides a new set of biomarkers and therapeutic targets for type 2 diabetes mellitus, namely ACTN4, AHNAK, ATF4, ATP1A1, B2M, CYBA, GNB2, HES1, PRNP, TMBIM6, TSPAN13, VMP1, and a combination of one or more of YWHAE. The relevant non-patent literature: Journal name "laboratory test", literature name "clinical significance study of early diabetic nephropathy patient biomarker combination test", volume No. 2025,3 (14), publication date 2025.09.01, which discloses clinical significance of discussing early diabetic nephropathy patient biomarker combination test. 60 patients with simple diabetes and 60 patients with early diabetic nephropathy were enrolled in the study, creatinine, urea, cystatin C, neutrophil gelatinase-associated lipocalin (NGAL) were detected, the correlation between biomarkers was analyzed using Pearson, and the clinical detection value of the biomarkers for patients with early diabetic nephropathy was analyzed using a subject's working characteristics (ROC) curve. The analysis of creatinine, urea and cystatin C, NGAL shows that the early diabetic nephropathy group is higher than the simple diabetic nephropathy group, P is less than 0.05, the combined detection and diagnosis efficiency is higher than that of single creatinine, urea, NGAL and cystatin C, the creatinine and urea are positively correlated (r=0.632, P is less than 0.001), the cystatin C and the NGAL and cystatin C are positively correlated (r=0.521, P is less than 0.001), and the multiple collinearity analysis shows that the variance expansion coefficient (VIF) of each index is less than 5. The prior art represented by the foregoing documents has at least the following technical problems or drawbacks that have not been solved: the marker combination in the prior art has insufficient pertinence, does not consider the pathophysiological difference of diabetes and diabetic nephropathy, cannot realize effective distinction of the diabetes and the diabetic nephropathy, and is unfavorable for early intervention and accurate treatment. Disclosure of Invention The invention aims to provide that: a marker combination for diagnosis or prognosis evaluation of diabetes and application thereof and related technologies thereof are provided, so as to solve the technical problems that the marker combination in the prior art does not fit the pathophysiological difference of diabetes and diabetic nephropathy, the distinguishing effect of the two is insufficient, early intervention and accurate diagnosis and treatment of the diabetic