A method for assessing vasovagal reaction in blood donors using blood glucose and hormones

Abstract

The application discloses a method for evaluating blood vessel vagus nerve reaction of blood donation by blood sugar and hormones, which comprises the following steps: dividing into VVR-occurring population and non-reaction population, and counting general data of the two groups of population; collecting blood samples of the two groups of population before and after blood donation, and detecting biochemical indexes of the blood samples before and after blood donation respectively; performing difference analysis on general data and various biochemical indexes of the two groups of population by using Mann-Whitney U test; taking whether VVR occurs as dependent variable, and various indexes as independent variable to perform single factor and multi-factor logistic regression analysis, so that it is obtained that which index is a risk factor index of VVR; adopting receiver operating characteristic curve and area under the curve to evaluate diagnostic values of various risk factor indexes on VVR, and analyzing to obtain a prediction index with good prediction value on VVR, so that detection of the prediction index on blood donors can effectively identify VVR high-risk population which has not been found by a conventional evaluation method.

Description

Technical Field

[0001] This invention relates to a method for assessing the occurrence of vasovagal nerve response in blood donation, specifically a method for assessing the occurrence of vasovagal nerve response in blood donation using combined detection of blood glucose and stress hormones, belonging to the field of medical information technology and intelligent risk prediction technology. Background Technology

[0002] Vessel vasovagal reactions (VVR) are the most common adverse reactions associated with blood donation stress, occurring in approximately 8% of late-age adolescent blood donors and 2% to 3% of adult blood donors. Clinical manifestations include dizziness, pallor, sweating, nausea, abdominal discomfort, fatigue, anxiety, hyperventilation, vomiting, convulsions, and loss of consciousness. Effectively preventing VVR has become a critical issue that urgently needs to be addressed to ensure donor safety and improve donor retention rates.

[0003] The intravenous puncture during blood donation is considered a strong stressor, potentially influencing subsequent HPA-related indicators by activating the hypothalamus-pituitary-adrenal (HPA) axis. These indicators include corticotropin-releasing hormone (CRH), adrenocorticotropic hormone (ACTH), growth-hormone-releasing hormone (GHRH), thyrotropin-releasing hormone (TRH), thyroid-stimulating hormone (TSH), somatostatin (SST), growth hormone (GH), and cortisol. Previous studies have shown significantly elevated cortisol levels in volunteers undergoing intravenous puncture (Dalile B et al. 2021, Psychoneuroendocrino 128:105220). This phenomenon suggests that stress hormones may be associated with the occurrence of systemic adverse reactions to blood donation. Changes in HPA axis-related hormone levels, including ACTH, GH, TSH, and cortisol, in individuals who experience systemic adverse reactions to blood donation may reveal a potential association between these hormones and the occurrence of adverse reactions, and may lead to the development of biomarkers for the prevention and early diagnosis of adverse reactions.

[0004] Fear before blood donation is believed to increase the risk of vasovagal response (VVR). Therefore, in 2014, Braz et al. designed a scale containing six items—syncope, dizziness, weakness, blurred vision, lightheadedness, nausea, or vomiting—which they believed could effectively assess VVR associated with blood donation. Furthermore, some studies have proposed using physical imaging techniques to predict VVR, observing elevated temperatures in the subnasal region of blood donors; facial temperature imaging can be used to indicate the occurrence of VVR. However, these indirect assessment scales and imaging indicators have limitations in predicting VVR and cannot directly reflect the true changes in stress response within the blood donor's body. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to address the shortcomings of the existing technology by providing a method for assessing the vagal nerve response of blood donation vessels using blood glucose and hormones. The present invention establishes an assessment method that combines blood glucose and stress hormones, which can effectively identify high-risk groups for VVR that have not been detected by conventional assessment methods.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] This invention provides a method for predicting and assessing the occurrence of vasovagal response in blood donation, comprising the following steps:

[0008] (1) Select blood donors who participated in group voluntary blood donation as the subjects of the investigation, and divide them into two groups: those who experienced blood donation-related VVR and those who did not experience a reaction. Collect general information on the two groups.

[0009] (2) Collect blood samples from two groups of blood donors before and after blood donation, and test the biochemical indicators of their blood samples before and after blood donation;

[0010] (3) Use the Mann-Whitney U test to analyze the differences in general data and various biochemical indicators between the two groups, and compare and analyze which general data and biochemical indicators show significant differences between the two groups.

[0011] (4) Establish a regression model, with whether vasovagal response (VVR) occurs as the dependent variable and general information and various biochemical indicators as independent variables, and perform univariate and multivariate logistic regression analysis to determine which general information and biochemical indicators are risk factors for VVR in blood donors.

[0012] (5) The diagnostic value of various risk factor indicators for VVR was evaluated by using receiver operating characteristic curves and area under the curve. The area under the curve (AUC), 95% confidence interval, cutoff value, sensitivity and specificity of various risk factor indicators were calculated respectively. Predictive indicators with good predictive value for VVR were analyzed.

[0013] (6) After obtaining the predictive indicators that have good predictive value for VVR, set the warning value of the predictive indicators. If the predictive indicator detection value of the blood donor reaches the high risk threshold before blood donation, risk assessment and intervention measures need to be carried out. Detecting these predictive indicators on blood donors can effectively identify high-risk groups of vasovagal response (VVR) that have not been found by conventional assessment methods.

[0014] In the above technical solution, the general information mentioned in step (1) includes age, gender, education level, blood type, blood pressure, pulse, weight and blood donation volume.

[0015] In the above technical solution, the biochemical indicators in step (2) include blood glucose and stress hormone-related indicators.

[0016] The stress hormone-related indicators mentioned in the above technical solution include: ACTH, cortisol, triiodothyronine (T3), thyroxine (T4), and GH.

[0017] In the above technical solution, in step (4), the risk factor indicators for vasovagal reaction (VVR) in blood donors are pulse, blood glucose, triiodothyronine (T3), thyroxine (T4) and ACTH.

[0018] In the above technical solution, in step (5), the predictive indicators with good predictive value for VVR are pulse, blood glucose, T3, T4, and ACTH.

[0019] Compared with existing technologies, it has the following beneficial effects:

[0020] This invention, through the combined detection of blood glucose and stress hormones, can effectively identify high-risk individuals for VVR (Vacuum-Vacuum Retention) that have not been detected by conventional assessment methods. Under the premise of maintaining consistent blood donation environment and conditions, the application of this invention's combined blood glucose and stress hormone VVR assessment method significantly reduces the incidence of VVR among blood donors, providing strong support for improving the safety of the blood donation process. Detailed Implementation

[0021] The following describes in detail the specific embodiments of the technical solution of the present invention, but the present invention is not limited to the following description:

[0022] Unless otherwise specified, the materials and reagents used in this embodiment are commercially available.

[0023] Example 1:

[0024] A method for assessing vasovagal nerve response in blood donations using blood glucose and hormones includes the following steps:

[0025] (1) The inventors selected and collected data from 292 voluntary blood donors (all of whom signed informed consent forms). Among them, 47 cases experienced blood donation-related VVR, including general malaise, weakness, pallor, sweating, anxiety, dizziness, nausea, transient loss of consciousness (syncope), convulsions, or urinary and fecal incontinence. The remaining 245 cases were in the normal blood donation group without VVR. General information of all participants was collected, including age, gender, education level, blood type, blood pressure, pulse, weight, and blood donation volume. Blood samples were collected from the 47 donors in the VVR reaction group and from 50 randomly selected donors in the non-VVR group.

[0026] (2) The entire blood donation process, from physical examination to completion of blood donation, takes approximately 40 minutes. Samples are collected at the beginning and end of the blood donation for testing. Specific sample collection method: The operation is carried out according to the blood collection bags with bypass systems in the "Blood Bank Technical Operation Procedures (2019 Edition)". After successful puncture, 15-20 mL of blood flows into the side-channel sample bag. Immediately, a vacuum blood collection tube (5 mL) with separating gel is used to collect the pre-donation sample from the sample bag. After blood donation, a post-donation sample is collected first for biochemical and hormone testing; then other samples are collected for testing of four infectious diseases, etc. The collected samples are immediately centrifuged at 4000 rpm for 10 minutes to separate one serum sample for testing stress hormone-related indicators, including ACTH, cortisol, triiodothyronine (T3), thyroxine (T4), and GH. ACTH, cortisol, T3, T4, and GH indicators are detected using a fully automated microparticle chemiluminescence immunoassay analyzer.

[0027] (3) The Mann-Whitney U test was used to analyze the differences in general information and stress hormone levels between the two groups: those who experienced VVR and those who did not.

[0028] 3.1 Differences in baseline population data: Significant differences existed in pulse rate and blood donation volume between donors who experienced VVR and those who did not. Specifically, the pulse rate of donors experiencing VVR was 71.17 ± 7.93 beats / min, while the pulse rate of those who did not experience VVR was 74.78 ± 8.36 beats / min, with the latter being significantly higher (P < 0.001). Among donors who experienced VVR, the proportion donating 200 mL of blood was 91.49%, significantly higher than the proportion donating 200 mL of blood among those who did not experience VVR (42.45%) (P < 0.0001).

[0029] 3.2 Significant differences in hormone and blood glucose levels were observed between donors who experienced and did not undergo VVR reactions. Specifically, the expression of T3, T4, and ACTH differed significantly between the two groups (P<0.05). The VVR reaction group exhibited higher levels of T3, T4, and ACTH (P<0.05), and ACTH levels after blood donation showed a significant difference between the two groups, with the VVR reaction group showing significantly higher levels (P<0.05). A comparison before and after blood donation in the VVR reaction group revealed a decreasing trend in T3 and a continued increase in ACTH (P<0.05).

[0030] (4) Establish a regression model and perform univariate and multivariate logistic regression analysis to identify risk factors and protective factors for VVR: pulse, blood glucose, T4, and ACTH are high-risk factors for VVR. That is, whether VVR occurs is used as the dependent variable and pulse, blood glucose, T3, T4, and ACTH are used as independent variables. Univariate and multivariate logistic regression analysis was performed to assess the correlation.

[0031] Univariate logistic regression analysis showed that pulse (OR=7.150; 95% CI, 0.909–0.985), blood glucose (OR=4.219; 95% CI, 1.087–35.84), T4 (OR=4.031; 95% CI, 1.002–1.144), and ACTH (OR=6.739; 95% CI, 1.044–1.364) were high-risk factors for VVR (P<0.05). Multivariate logistic regression analysis further showed that ACTH (OR=3.923; 95% CI, 1.002–1.497) was a high-risk factor for VVR (P<0.05).

[0032] (5) Further use receiver operating characteristic curves and area under the curve (AUC) to evaluate the diagnostic value of blood glucose and stress hormones for VVR, and calculate the AUC, 95% confidence interval, cutoff value, sensitivity and specificity of each indicator.

[0033] Pulse, blood glucose, T3, T4, and ACTH have good predictive value for VVR. Specifically, pulse, blood glucose, T3, T4, and ACTH indicators that showed significant differences in ANOVA and multivariate logistic regression analysis were included in ROC curve analysis. The results showed that the AUC area of ​​the ROC curve for pulse was 0.616, with a cutoff value of 75.50 beats / min, a sensitivity of 74.5%, and a specificity of 44.1%; the AUC area for blood glucose was 0.749, with a cutoff value of 4.350 mmol / L, a sensitivity of 76.9%, and a specificity of 69.2%; the AUC area for T3 was 0.772, with a cutoff value of 1.545 nom / L, a sensitivity of 69.2%, and a specificity of 76.9%; the AUC area for T4 was 0.775, with a cutoff value of 85.87 nom / L, a sensitivity of 92.3%, and a specificity of 61.5%; the AUC area for ACTH was 0.846, with a cutoff value of 28.31 pg / mL, a sensitivity of 84.6%, and a specificity of 76.9%; and the AUC area for the comprehensive index was 0.953, with both sensitivity and specificity of 92.3% (P<0.001).

[0034] (6) After obtaining the predictive indicators that have good predictive value for VVR, set the warning value of the predictive indicators. If the predictive indicator detection value of the blood donor reaches the high risk threshold before blood donation, risk assessment and intervention measures need to be carried out. Detecting these predictive indicators on blood donors can effectively identify high-risk groups of vasovagal response (VVR) that have not been found by conventional assessment methods.

[0035] The above examples are merely illustrative of the technical concept and features of the present invention and should not be construed as limiting the scope of protection of the present invention. All equivalent transformations or modifications made in accordance with the essence of the present invention should be included within the scope of protection of the present invention.

Claims

1. A method for assessing vasovagal nerve response in blood donation using blood glucose and hormones, characterized in that, Includes the following steps: (1) Select blood donors who participated in group voluntary blood donation as the subjects of the investigation, and divide them into two groups: those who experienced blood donation-related VVR and those who did not experience a reaction. Collect general information on the two groups. (2) Collect blood samples from two groups of blood donors before and after blood donation, and test the biochemical indicators of their blood samples before and after blood donation; (3) Use the Mann-Whitney U test to analyze the differences in general data and various biochemical indicators between the two groups, and compare and analyze which general data and biochemical indicators show significant differences between the two groups. (4) Establish a regression model, with whether vasovagal response (VVR) occurs as the dependent variable and general information and various biochemical indicators as independent variables, and perform univariate and multivariate logistic regression analysis to determine which general information and biochemical indicators are risk factors for VVR in blood donors. (5) The diagnostic value of various risk factor indicators for VVR was evaluated by using receiver operating characteristic curves and area under the curve. The area under the curve (AUC), 95% confidence interval, cutoff value, sensitivity and specificity of various risk factor indicators were calculated respectively, and predictive indicators with good predictive value for VVR were analyzed. (6) After obtaining the predictive indicators that have good predictive value for VVR, set the warning value of the predictive indicators. If the predictive indicator detection value of the blood donor reaches the high risk threshold before blood donation, risk assessment and intervention measures need to be carried out. Detecting these predictive indicators on blood donors can effectively identify high-risk groups of vasovagal response (VVR) that have not been found by conventional assessment methods.

2. The method according to claim 1, characterized in that, In step (1), the general information includes age, gender, education level, blood type, blood pressure, pulse, weight, and blood donation volume.

3. The method according to claim 1, characterized in that, In step (2), the biochemical indicators include blood glucose and stress hormone-related indicators.

4. The method according to claim 3, characterized in that, The stress hormone-related indicators mentioned include: ACTH, cortisol, triiodothyronine (T3), thyroxine (T4), and GH.

5. The method according to claim 1, characterized in that, In step (4), the risk factors for vasovagal response (VVR) in blood donors are pulse, blood glucose, triiodothyronine (T3), thyroxine (T4), and ACTH.

6. The method according to claim 1, characterized in that, In step (5), the predictive indicators with good predictive value for VVR are pulse, blood glucose, T3, T4, and ACTH.