Application of blood coagulation four-item detection reagent, plasma D dimer detection reagent and AT-III detection reagent in preparation of diabetic microangiopathy detection kit and kit

Abstract

The invention provides application of a blood coagulation four-item detection reagent, a plasma D dimer detection reagent and an AT-III detection reagent in preparation of a diabetic microangiopathy detection kit and the kit, and relates to the technical field of medical biology. The research finds that the microangiopathy of the T2DM patient is obviously associated with the four blood coagulation items, the plasma D dimer and the AT-III level, and the four blood coagulation items, the plasma D dimer and the AT-III all cause independent influence factors of the microangiopathy, so that the risk of the microangiopathy of the T2DM patient can be predicted by detecting related indexes clinically; the clinical auxiliary diagnosis value is relatively high; further, prothrombin time detection results, activated partial thromboplastin time detection results, thrombin time detection results and fibrinogen detection results can be obtained on the basis of a four-item blood coagulation detection reagent, a plasma D dimer detection reagent and an AT-III detection reagent; determining the risk of the diabetic microangiopathy according to at least one of a blood plasma D dimer detection result and an antithrombin III detection result.

Description

Technical Field

[0001] The embodiments of the present invention relate to the field of medical biotechnology, and in particular to an application of a coagulation four-item detection reagent, a plasma D-dimer detection reagent and an AT-III detection reagent in the preparation of a diabetic microangiopathy detection kit and a kit. Background Art

[0002] Microvascular disease is one of the common complications of type 2 diabetes mellitus (T2DM). Its pathogenesis lies in the lesions of microvascular walls, thickening of basement membranes and precipitation of transparent substances. In addition, abnormal microvascular hemodynamics and changes in the physical and chemical properties of blood further increase blood viscosity, aggravate microcirculatory disorders and lumen stenosis. It is very harmful to the human body. Generally, it will cause diabetic retinopathy in patients, induce visual impairment, and in severe cases, diabetic nephropathy and blindness, which will have a serious impact on the quality of life of patients and family finances. Therefore, early diagnosis and risk prevention and control in the early stage of T2DM microvascular disease are of great significance.

[0003] Therefore, there is an urgent need for a technical solution to prevent and control the early risks of T2DM microvascular lesions. Summary of the invention

[0004] The embodiment of the present invention provides an application of a coagulation four-item detection reagent, a plasma D-dimer detection reagent and an AT-III detection reagent in the preparation of a diabetic microangiopathy detection kit and a kit to provide a solution for treating diabetic nephropathy symptoms.

[0005] The first aspect of an embodiment of the present invention provides the use of four coagulation detection reagents, plasma D-dimer detection reagents and AT-III detection reagents in the preparation of a diabetic microangiopathy detection kit, wherein the four coagulation detection reagents include: a prothrombin time detection reagent, an activated partial thromboplastin time detection reagent, a thrombin time detection reagent and a fibrinogen detection reagent, wherein the prothrombin time detection reagent, the activated partial thromboplastin time detection reagent, the thrombin time detection reagent, the fibrinogen detection reagent, the plasma D-dimer detection reagent and the antithrombin III detection reagent are respectively used to obtain a prothrombin time detection result, an activated partial thromboplastin time detection result, a thrombin time detection result, a fibrinogen detection result, a plasma D-dimer detection result and an antithrombin III detection result; based on at least one of the prothrombin time detection result, the activated partial thromboplastin time detection result, the thrombin time detection result, the fibrinogen detection result, the plasma D-dimer detection result and the antithrombin III detection result, the risk of diabetic microangiopathy is determined.

[0006] Alternatively, the risk of diabetic microangiopathy is negatively correlated with prothrombin time, activated partial thromboplastin time, thrombin time and antithrombin III, respectively, and positively correlated with fibrinogen and plasma D-dimer, respectively.

[0007] Optionally, the risk of diabetic microangiopathy is determined based on any one of the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results and the independent critical value corresponding to each test result.

[0008] Optionally, the risk of diabetic microangiopathy is determined based on the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results and the comprehensive critical values ​​corresponding to each test result.

[0009] Optionally, the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results are used as key indicators and input into a corresponding neural network model to obtain the risk of diabetic microangiopathy; the neural network model is trained using the sample prothrombin time test results, sample activated partial thromboplastin time test results, sample thrombin time test results, sample fibrinogen test results, sample plasma D-dimer test results and sample antithrombin III test results as inputs and whether diabetic microangiopathy occurs as a label.

[0010] A second aspect of an embodiment of the present invention provides a diabetic microangiopathy detection kit, the kit comprising: at least one of a prothrombin time detection reagent, an activated partial thromboplastin time detection reagent, a thrombin time detection reagent, a fibrinogen detection reagent, a plasma D-dimer detection reagent and an antithrombin III detection reagent, the prothrombin time detection reagent, the activated partial thromboplastin time detection reagent, the thrombin time detection reagent, the fibrinogen detection reagent, the plasma D-dimer detection reagent and the antithrombin III detection reagent being used to obtain a prothrombin time detection result, an activated partial thromboplastin time detection result, a thrombin time detection result, a fibrinogen detection result, a plasma D-dimer detection result and an antithrombin III detection result, respectively; based on at least one of the prothrombin time detection result, the activated partial thromboplastin time detection result, the thrombin time detection result, the fibrinogen detection result, the plasma D-dimer detection result and the antithrombin III detection result, the risk of diabetic microangiopathy is determined.

[0011] Alternatively, the risk of diabetic microangiopathy is negatively correlated with prothrombin time, activated partial thromboplastin time, thrombin time and antithrombin III, respectively, and positively correlated with fibrinogen and plasma D-dimer, respectively.

[0012] Optionally, the risk of diabetic microangiopathy is determined based on any one of the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results and the preset normal values ​​and preset independent critical values ​​corresponding to each test result.

[0013] Optionally, the risk of diabetic microangiopathy is determined based on the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results and the comprehensive critical values ​​corresponding to each test result.

[0014] Optionally, the prothrombin time test result, activated partial thromboplastin time test result, thrombin time test result, fibrinogen test result, plasma D-dimer test result and antithrombin III test result are used as key indicators and input into the corresponding neural network model to obtain the risk of diabetic microangiopathy; the neural network model is trained with the sample prothrombin time test result, sample activated partial thromboplastin time test result, sample thrombin time test result, sample fibrinogen test result, sample plasma D-dimer test result and sample antithrombin III test result as input and whether diabetic microangiopathy occurs as a label.

[0015] In the embodiments of the present invention, the study found that there was a significant correlation between microvascular disease in T2DM patients and four coagulation items, plasma D-dimer, and AT-III levels, and the four coagulation items, plasma D-dimer, and AT-III were all independent influencing factors leading to microvascular disease. The risk of microvascular disease in T2DM patients can be predicted clinically by detecting relevant indicators, which has a high clinical auxiliary diagnosis value. It is further proposed that at least one of the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results, and antithrombin III test results can be obtained based on the four coagulation test reagents, plasma D-dimer test reagents, and AT-III test reagents to determine the risk of diabetic microvascular disease. DETAILED DESCRIPTION

[0016] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below in conjunction with specific implementation methods.

[0017] In recent years, with the gradual improvement of living standards, the incidence of diabetes has also increased year by year, and it has become a major disease that affects human health. Among them, microvascular disease is one of the most influential complications of T2DM. It is not only easy to induce other malignant cardiovascular events, but also causes damage to the patient's nervous system and even sudden death as the disease progresses. Because the early symptoms of microvascular disease are not obvious, especially for the elderly, on the one hand, the sensitivity to the disease is generally low, and on the other hand, some patients' visual impairment is affected by other eye diseases such as presbyopia and glaucoma. Blood lipid tests may be affected by other complications (such as diabetes and metabolic syndrome, etc.), so it is impossible to make an effective diagnosis of microvascular disease.

[0018] In clinical practice, the diagnosis of T2DM microvascular lesions has been explored from different perspectives, for example: exploring the correlation between serum VEGF and microvascular lesions; for example: exploring the expression of relevant serum indicators and lipid metabolism indicators in microvascular lesions.

[0019] The embodiment of the present invention proposes that: since microvascular lesions cause the blood to be in a hypercoagulable state, the anticoagulation mechanism is abnormal and the coagulation function is impaired, the microvascular lesions can be reflected indirectly by detecting the coagulation function. The four coagulation items, plasma D-dimer and antithrombin III (AT-III) are sensitive indicators of coagulation function commonly used in clinical practice, which can better detect human coagulation and secondary fibrinolysis, or can be used as risk indicators for clinical assessment of T2DM microvascular lesions. However, there is a lack of relevant clinical research, and it is impossible to fully prove the correlation between the four coagulation items, plasma D-dimer, AT-III and microvascular lesions.

[0020] Based on this, the present invention proposes to explore the relationship between the four coagulation tests and plasma D-dimer, AT-III levels and microvascular lesions in patients with T2DM, so as to provide objective reference indicators for the diagnosis and risk prevention of clinical microvascular lesions.

[0021] Specifically, in the embodiment of the present invention, clinical data of 80 patients with T2DM diagnosed between September 2023 and February 2024 were collected, and they were divided into a vascular lesion group (41 cases) and a non-vascular lesion group (39 cases) according to the presence or absence of microvascular lesions. All patients met the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)" formulated by the Diabetes Branch of the Chinese Medical Association, that is, fasting blood glucose ≥ 7.0mmol / L, 2h postprandial blood glucose ≥ 11.1mmol / L, and glycosylated hemoglobin ≥ 6.5%. In the embodiment of the present invention, the inclusion criteria are: ① Both men and women, aged 18 years or above, meet the above diagnostic criteria; ② No intervention treatment related to T2DM or microvascular lesions was received in the 6 months before enrollment; ③ Normal coagulation function, no anticoagulants were taken in the 3 months before enrollment; ④ No missing clinical data. Exclusion criteria were: ① disease progression or acute stage of T2DM complications (such as ketoacidosis, lactic acidosis, etc.); ② combined with thyroid disease, liver and kidney dysfunction, acute infection, etc.; ③ no major surgery within 3 months before enrollment; ④ women in lactation or pregnancy.

[0022] In the embodiment of the present invention, 2 ml of fasting venous anticoagulated whole blood was drawn from all patients in the early morning and placed in a sodium citrate anticoagulation tube. After the specimen was sent for examination, it was centrifuged in time. The centrifuge was selected from Sichuan Shuke Centrifuge Co., Ltd., the speed was set to 1500g (2685 rpm) / min, the time was 15min, and after centrifugation, a fully automatic coagulation analyzer (Sysmex Biotechnology Co., Ltd.) was used to detect four coagulation items [prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB)], plasma D-dimer, and antithrombin III (AT-III) levels. The supporting kits used were selected from Sysmex Biotechnology Co., Ltd. and Siemens Biotechnology Co., Ltd., and the operation was performed in accordance with the instructions.

[0023] In the embodiment of the present invention, the observation indicators are as follows: ① Comparison of four coagulation parameters, plasma D-dimer, and AT-Ⅲ levels between the two groups: Statistical analysis and comparison of four coagulation parameters, plasma D-dimer, and AT-Ⅲ levels between the two groups; ② Correlation analysis between the four coagulation tests, plasma D-dimer, AT-III levels and microvascular lesions: Pearson correlation analysis was performed on the test results of the two groups to evaluate the correlation between the four coagulation tests, plasma D-dimer, AT-III levels and microvascular lesions in patients with T2DM; ③Multivariate analysis of four coagulation tests, plasma D-dimer, AT-III levels and microvascular lesions: Logistic regression analysis was performed on the test results of the two groups to evaluate the effects of four coagulation tests, plasma D-dimer, and AT-III levels on microvascular lesions in patients with T2DM.

[0024] In the embodiment of the present invention, the statistical calculation was performed using SPSS Statistics 24.0 software, the count data were expressed as cases (%), the chi-square test was performed, and the measurement data were expressed as mean ± standard deviation ( ±s), t-test was used, Pearson correlation analysis was used for correlation, and logistics regression model was used for multivariate analysis. P < 0.05 was considered statistically significant.

[0025] In the embodiment of the present invention, the basic data of the two groups of patients were compared as follows: the age range of the vascular lesion group was 31-76 years old, the course of disease was 1-12 years, and the body mass index (BMI) ranged from 22 to 27 kg / m2; the age range of the non-vascular lesion group was 32-78 years old, the course of disease was 1-13 years, and the body mass index (BMI) ranged from 23 to 27 kg / m2. There was no significant difference in the basic data of the two groups of patients (P>0.05), as shown in Table 1.

[0026] Table 1 Comparison of basic data of patients in the two groups

[0027] In the present embodiment, it was found that the levels of PT, APTT, TT and AT-Ⅲ in the four coagulation tests in the vascular lesion group were significantly lower than those in the group without vascular lesions (P < 0.05), and the levels of FIB and plasma D-dimer were significantly higher than those in the group without vascular lesions (P < 0.05), as shown in Table 2.

[0028] Table 2 Comparison of four coagulation parameters, plasma D-dimer, and AT-Ⅲ levels between the two groups ( ±s)

[0029] In the examples of the present invention, the correlation analysis between the four coagulation items, plasma D-dimer, AT-III levels and microangiopathy is as follows: Pearson correlation analysis showed that microvascular lesions were directly negatively correlated with PT, APTT, TT, and AT-Ⅲ (P < 0.05), and positively correlated with FIB and plasma D-dimer (P < 0.05), as shown in Table 3.

[0030] Table 3 Multivariate analysis of the four coagulation parameters, plasma D-dimer, AT-Ⅲ level and microangiopathy

[0031] In the embodiment of the present invention, the multifactorial analysis of the four coagulation items, plasma D-dimer, AT-III level and microvascular lesions is as follows: After logistics regression analysis, the four coagulation items, plasma D-dimer, and AT-III are all independent influencing factors leading to microvascular lesions in patients with T2DM (P < 0.05), as shown in Table 4.

[0032] Table 4 Multivariate analysis of the four coagulation parameters, plasma D-dimer, AT-Ⅲ level and microangiopathy

[0033] The present invention explores the relationship between coagulation indexes and microvascular lesions from the perspective of coagulation function in T2DM patients, and the results are as follows: The present invention embodiment study found that the PT, APTT, TT, and AT-Ⅲ levels of the vascular lesion group were lower than those of the non-vascular lesion group, and the FIB and plasma D-dimer levels were higher than those of the non-vascular lesion group. The decrease of PT, APTT, and TT in the four coagulation items indicated that the endogenous and exogenous coagulation systems of the body were abnormal, and the time for fibrinogen to convert into fibrin in the blood was significantly shortened. FIB, as a coagulation factor, can reflect the changes in human pathological hemolysis and fibrinolysis, and its increased level further indicates that the body is in a hypercoagulable state or has a risk of thrombosis. T2DM patients have abnormal hypercoagulation due to microvascular lesions, increased blood viscosity, and increased risk of thrombosis, so PT, APTT, and TT are shortened, and FIB increases. Plasma D-dimer is a fibrin degradation product, and its increased level indicates hyperfibrinolysis in the body, that is, it is in a hypercoagulable state; AT-Ⅲ is an important component of the human anticoagulation system, and its reduced content can reflect the weakening of blood anticoagulation and the increased risk of thrombosis. Both are important indicators for clinical evaluation of thrombotic diseases. Therefore, in the research results of the embodiments of the present invention, the plasma D-dimer content in the vascular lesion group is higher than that in the group without vascular lesions, and the AT-Ⅲ level is lower than that in the group without vascular lesions, which further indicates that the body has abnormal anticoagulation due to microvascular lesions and increased blood viscosity. Through correlation analysis, the results show that there is a certain correlation between microvascular lesions in T2DM patients and four coagulation items, AT-Ⅲ, and plasma D-dimer. The embodiments of the present invention also carried out multifactorial analysis, and the results showed that four coagulation items, plasma D-dimer, and AT-Ⅲ are all independent influencing factors leading to microvascular lesions in T2DM patients, so that the risk of early microvascular lesions in T2DM patients can be pre-controlled by detecting the levels of relevant indicators, inhibiting the progression of complications, and ensuring the quality of life of patients.

[0034] In summary, there is a significant correlation between microvascular disease in T2DM patients and the four coagulation tests, plasma D-dimer, and AT-III levels. The four coagulation tests, plasma D-dimer, and AT-III are all independent influencing factors for microvascular disease. The risk of microvascular disease in T2DM patients can be predicted clinically by testing relevant indicators, which has a high clinical auxiliary diagnostic value.

[0035] In the embodiments of the present invention, based on the above research findings, it is further proposed that four coagulation detection reagents, plasma D-dimer detection reagents and AT-III detection reagents can be used to detect diabetic patients, and the risk of diabetic microangiopathy can be determined based on at least one of the prothrombin time detection results, activated partial thromboplastin time detection results, thrombin time detection results, fibrinogen detection results, plasma D-dimer detection results and antithrombin III detection results.

[0036] Based on this, the embodiments of the present invention provide the use of four coagulation detection reagents, plasma D-dimer detection reagents and AT-III detection reagents in the preparation of a diabetic microangiopathy detection kit, wherein the four coagulation detection reagents include: prothrombin time detection reagent, activated partial thromboplastin time detection reagent, thrombin time detection reagent and fibrinogen detection reagent, and the prothrombin time detection reagent, activated partial thromboplastin time detection reagent, thrombin time detection reagent, fibrinogen detection reagent, plasma D-dimer detection reagent and antithrombin III detection reagent are respectively used to obtain prothrombin time detection results, activated partial thromboplastin time detection results, thrombin time detection results, fibrinogen detection results, plasma D-dimer detection results and antithrombin III detection results; based on at least one of the prothrombin time detection results, activated partial thromboplastin time detection results, thrombin time detection results, fibrinogen detection results, plasma D-dimer detection results and antithrombin III detection results, the risk of diabetic microangiopathy is determined.

[0037] Specifically, the risk of diabetic microangiopathy was negatively correlated with prothrombin time, activated partial thromboplastin time, thrombin time and antithrombin III, and positively correlated with fibrinogen and plasma D-dimer, respectively.

[0038] In the embodiment of the present invention, considering that the four coagulation items, plasma D-dimer, and AT-Ⅲ can all be used as independent influencing factors leading to microangiopathy, therefore, in the embodiment of the present invention, the relationship between the prothrombin time test results, the activated partial thromboplastin time test results, the thrombin time test results, the fibrinogen test results, the plasma D-dimer test results, and the antithrombin III test results and the risk of diabetic microangiopathy are studied, and the independent critical values ​​of each test result on diabetic microangiopathy are obtained. Then, the risk of microangiopathy of the patient can be judged based on each test result and the corresponding independent critical value.

[0039] Specifically, in an embodiment of the present invention, the independent critical value of the prothrombin time is 10 seconds, and the patient's prothrombin time can be judged to be at risk of microangiopathy when it is lower than 10 seconds; the independent critical value of the activated partial thromboplastin time is 20 seconds, and the patient's activated partial thromboplastin time can be judged to be at risk of microangiopathy when it is lower than 20 seconds; the independent critical value of the thrombin time is 20 seconds, and the patient's thrombin time can be judged to be at risk of microangiopathy when it is lower than 14 seconds; the independent critical value of the antithrombin III is 75%, and the patient's antithrombin III can be judged to be at risk of microangiopathy when it is lower than 75%; the independent critical value of the plasma D-dimer is 1ug / mL, and the patient's plasma D-dimer can be judged to be at risk of microangiopathy when it is higher than 1ug / mL; the independent critical value of the fibrinogen is 4g / L, and the patient's fibrinogen can be judged to be at risk of microangiopathy when it is higher than 4g / L.

[0040] It should be noted that in the embodiment of the present invention, the determined risk of microvascular disease is only a preliminary prediction, which requires a doctor to perform a further diagnosis and confirmation. Accordingly, although only a preliminary prediction is obtained in the embodiment of the present invention, the patient can also be managed in advance according to the risk prediction results to achieve a preventive effect.

[0041] In an embodiment of the present invention, a comprehensive study can be conducted on the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results to obtain the comprehensive critical values ​​of each test result regarding diabetic microangiopathy, and then a comprehensive judgment can be made on the patient's microangiopathy risk based on each test result and the corresponding independent critical value.

[0042] In the embodiments of the present invention, it is also proposed that the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results can be used as key indicators to predict the risk of microvascular disease in diabetic patients using a neural network model. Specifically, any mature neural network framework can be used, and the test results of the above-mentioned vascular lesion group are used as positive samples, and the test results of the non-vascular lesion group are used as negative samples, and the neural network framework is trained to obtain a prediction model. The prediction model learns the corresponding relationship between the prothrombin time test results, the activated partial thromboplastin time test results, the thrombin time test results, the fibrinogen test results, the plasma D-dimer test results and the antithrombin III test results as key indicators and whether there is a vascular lesion. Therefore, the prediction model can predict the probability of diabetic patients developing diabetic microangiopathy based on the key indicators of diabetic patients: prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results.

[0043] Although the preferred embodiments of the present invention have been described, those skilled in the art may make additional changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the embodiments of the present invention.

[0044] The above describes in detail the application of a coagulation four-item detection reagent, a plasma D-dimer detection reagent and an AT-III detection reagent provided by the present invention in the preparation of a diabetic microangiopathy detection kit and the kit. Specific examples are used in this article to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea; at the same time, for those skilled in the art, according to the idea of ​​the present invention, there will be changes in the specific implementation methods and application scopes. In summary, the content of this specification should not be understood as a limitation on the present invention.

Claims

1. The use of four coagulation detection reagents, plasma D-dimer detection reagents and AT-III detection reagents in the preparation of a diabetic microangiopathy detection kit, characterized in that: The four coagulation detection reagents include: prothrombin time detection reagent, activated partial thromboplastin time detection reagent, thrombin time detection reagent and fibrinogen detection reagent. The prothrombin time detection reagent, activated partial thromboplastin time detection reagent, thrombin time detection reagent, fibrinogen detection reagent, plasma D-dimer detection reagent and antithrombin III detection reagent are used to obtain prothrombin time detection results, activated partial thromboplastin time detection results, thrombin time detection results, fibrinogen detection results, plasma D-dimer detection results and antithrombin III detection results, respectively; based on at least one of the prothrombin time detection results, activated partial thromboplastin time detection results, thrombin time detection results, fibrinogen detection results, plasma D-dimer detection results and antithrombin III detection results, the risk of diabetic microangiopathy is determined.

2. The use of the coagulation four-item detection reagent, plasma D-dimer detection reagent and AT-III detection reagent according to claim 1 in the preparation of a diabetic microangiopathy detection kit, characterized in that: The risk of diabetic microangiopathy was negatively correlated with prothrombin time, activated partial thromboplastin time, thrombin time and antithrombin III, and positively correlated with fibrinogen and plasma D-dimer, respectively.

3. The use of the coagulation four-item detection reagent, plasma D-dimer detection reagent and AT-III detection reagent according to claim 1 in the preparation of a diabetic microangiopathy detection kit, characterized in that: The risk of diabetic microangiopathy is determined based on any one of the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results and the independent critical value corresponding to each test result.

4. The use of the coagulation four-item detection reagent, plasma D-dimer detection reagent and AT-III detection reagent according to claim 1 in the preparation of a diabetic microangiopathy detection kit, characterized in that: The risk of diabetic microangiopathy is determined based on the results of prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, plasma D-dimer and antithrombin III and the comprehensive critical values ​​corresponding to each test result.

5. The use of the coagulation four-item detection reagent, plasma D-dimer detection reagent and AT-III detection reagent according to claim 1 in the preparation of a diabetic microangiopathy detection kit, characterized in that: The prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results are used as key indicators and input into the corresponding neural network model to obtain the risk of diabetic microangiopathy; the neural network model is trained with the sample prothrombin time test results, sample activated partial thromboplastin time test results, sample thrombin time test results, sample fibrinogen test results, sample plasma D-dimer test results and sample antithrombin III test results as inputs and whether diabetic microangiopathy occurs as a label.

6. A diabetic microangiopathy detection kit, characterized in that: The kit comprises: at least one of a prothrombin time detection reagent, an activated partial thromboplastin time detection reagent, a thrombin time detection reagent, a fibrinogen detection reagent, a plasma D-dimer detection reagent and an antithrombin III detection reagent; the prothrombin time detection reagent, the activated partial thromboplastin time detection reagent, the thrombin time detection reagent, the fibrinogen detection reagent, the plasma D-dimer detection reagent and the antithrombin III detection reagent are used to obtain the prothrombin time detection result, the activated partial thromboplastin time detection result, the thrombin time detection result, the fibrinogen detection result, the plasma D-dimer detection result and the antithrombin III detection result, respectively; based on at least one of the prothrombin time detection result, the activated partial thromboplastin time detection result, the thrombin time detection result, the fibrinogen detection result, the plasma D-dimer detection result and the antithrombin III detection result, the risk of diabetic microangiopathy is determined.

7. The diabetic microangiopathy detection kit according to claim 6, characterized in that: The risk of diabetic microangiopathy was negatively correlated with prothrombin time, activated partial thromboplastin time, thrombin time and antithrombin III, and positively correlated with fibrinogen and plasma D-dimer, respectively.

8. The diabetic microangiopathy detection kit according to claim 6, characterized in that: The risk of diabetic microangiopathy is determined based on any one of the prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results and the preset normal value and preset independent critical value corresponding to each test result.

9. The diabetic microangiopathy detection kit according to claim 6, characterized in that: The risk of diabetic microangiopathy is determined based on the results of prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, plasma D-dimer and antithrombin III and the comprehensive critical values ​​corresponding to each test result.

10. The diabetic microangiopathy detection kit according to claim 6, characterized in that: The prothrombin time test results, activated partial thromboplastin time test results, thrombin time test results, fibrinogen test results, plasma D-dimer test results and antithrombin III test results are used as key indicators and input into the corresponding neural network model to obtain the risk of diabetic microangiopathy; the neural network model is trained with the sample prothrombin time test results, sample activated partial thromboplastin time test results, sample thrombin time test results, sample fibrinogen test results, sample plasma D-dimer test results and sample antithrombin III test results as inputs and whether diabetic microangiopathy occurs as a label.

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