Journal of Medical Biochemistry

. A systematic review and meta-analysis and Mendelian randomization analysis of serum phosphorus, albumin, CRP as risk factors for death in hemodialysis patients

2026-03-14T13:30:51+01:00

Background

We aimed to identify the main mortality risk factors in hemodialysis patients using data from relevant cross-sectional literature. We used Mendelian randomization (MR) to assess the causality of those identified risk factors using pertinent GWAS SNP data.

Materials and Methods

Sixteen publications detailing hemodialysis-related mortality implicated 32 death-related risk factors. Based on heterogeneity testing, we utilized random- and stratified-effects models for meta-analysis. Sensitivity analysis and bias testing were used to evaluate data reliability. MR analysis identified type-2 diabetes (T2D), serum phosphorus, serum albumin, and age as risk factors, with hematology as the outcome. Inverse-variance weighting (IVW) analysis was used in the main study. The consistency of the IVW analysis results was evaluated simultaneously using four different methods: MR‒Egger regression, weighted median estimator (WME), weighted mode, and simple mode. Horizontal pleiotropy was assessed using the MR‒Egger regression intercept term; heterogeneity was assessed using Cochran’s Q.

Results

Using random- and stratified-effects models, a meta-analysis of 16 published articles revealed that the following factors were associated with a greater mortality risk in hemodialysis patients: T2D; serum phosphorus, albumin, and CRP; and the Charlson comorbidity index (CCI). The results were deemed reliable based on bias (P=0.1186, I2=99.53%) and sensitivity (T=0.39, df=116, P=0.6953) analyses. IVW indicated a genetic-level positive causal relationship between T2D and hematology (OR=1.2572, 95% CI=1.0375-1.5235; P=0.0195). Genetic-level serum pathology and hematology were positively correlated (OR=2.0269, 95% CI=1.0614-3.8708; P=0.0323). However, age (OR=11.1112, 95% CI=0.83) was a factor. No discernible genetic causal relationship occurred between hematology and serum ferritin (OR=0.6707, 95% CI=0.4612-0.9707; P=0.4612) or albumin (OR=1.2933, 95% CI=0.8931-1.8729; P=0.1733).

Conclusions

Meta-analysis identified the number of dialysis sessions, serum CRP, CCI, T2D, serum phosphorus, and serum albumin as mortality risk factors in hemodialysis patients. The MR results showed positive causal relationships of T2D incidence and serum phosphorus with hemodialysis risk.

BIOCHEMICAL INDICATORS OF INFLAMMATORY RESPONSE IN LEUKEMIA PATIENTS WITH PICC-ASSOCIATED PHLEBITIS: EVALUATION OF BASIC FIBROBLAST GROWTH FACTOR COMBINED WITH LIGHT THERAPY

2026-03-14T13:30:51+01:00

Background: The primary objective was to assess the effectiveness and safety of combined bFGF and light therapy for Peripherally Inserted Central Catheters (PICC) phlebitis, measuring improvements in phlebitis grading and Visual Analogue Scale (VAS) scores; evaluating inflammatory regulation through C-reactive protein (CRP), procalcitonin (PCT), erythrocyte sedimentation rate (ESR), and interleukin-6 (IL-6); and determining quality of life changes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), to establish whether combined therapy demonstrates statistically significant advantages over standard care.

Methods: This retrospective study included leukemia patients aged 18-75 years with PICC-associated phlebitis at Huai'an Second People's Hospital between January 2019 and December 2024. Patients were divided into an intervention group (n=33) receiving combined bFGF and light therapy, and a control group (n=32) receiving standard care. Assessment metrics included phlebitis scores and VAS pain scores evaluated on days 3 and 7; inflammatory markers (CRP, PCT, ESR, IL-6) and QLQ-C30 scores assessed on day 7. Data were analyzed using SPSS 26.0, with t-tests for between-group comparisons (P<0.05 considered statistically significant). The study received ethics committee approval, and all participants provided informed consent.

Results: Baseline characteristics were similar between groups. In the intervention group, phlebitis scores decreased from 2.22 (±1.08) at baseline to 0.18 (±0.46), and VAS scores from 5.4 (±2.8) to 0.55 (±1.37), significantly outperforming the control group (p<0.001). Regarding inflammatory markers, by day 7, the intervention group showed reductions in CRP to 4.32 mg/L (±4.20), PCT to 0.15 ng/ml (±0.24), ESR to 8.45 mm/h (±9.25), and IL-6 to 4.79 pg/ml (±6.37), all significantly superior to the control group (P<0.001). In QLQ-C30 scores, the intervention group demonstrated significant improvements in physical, role, cognitive, and social functioning, as well as overall health, with marked reductions in fatigue, pain, insomnia, and appetite loss (P<0.05). No adverse events were reported in the intervention group, while 18.8% of control group patients experienced complications requiring additional intervention.

Conclusion: This study confirms that combined basic fibroblast growth factor and light therapy significantly improves outcomes in managing PICC-associated phlebitis in leukemia patients. This combined approach effectively relieves pain, reduces inflammatory response, and significantly enhances overall comfort and quality of life with excellent safety profiles, offering a promising new strategy for clinical management of PICC phlebitis. Larger prospective studies with longer follow-up periods are needed to further validate the long-term efficacy and optimize clinical applications of this combined treatment regimen.

Oxidative Stress Biomarkers and Chondrocyte Apoptosis as Predictors of Postoperative Outcomes in Osteonecrosis of the Femoral Head

2026-03-14T13:30:52+01:00

Background: Osteonecrosis of the femoral head (ONFH) is a progressive disease where oxidative stress and chondrocyte apoptosis contribute to cartilage degeneration and postoperative complications. Identifying reliable biochemical markers is essential for prognosis after hip resurfacing arthroplasty (HRA).

Methods: A retrospective analysis was conducted in 134 ONFH patients (ARCO stage II–III) treated with HRA. Serum oxidative stress markers—reactive oxygen species (ROS), superoxide dismutase (SOD), and malondialdehyde (MDA)—were measured preoperatively and at serial postoperative timepoints. Chondrocyte apoptosis rates were assessed by flow cytometry. Pain and functional recovery were evaluated using VAS and Harris hip scores. Correlation, univariate, and Cox regression analyses were applied to determine associations with postoperative outcomes.

Results: Patients with high oxidative stress had significantly increased ROS and MDA levels, reduced SOD activity, and elevated chondrocyte apoptosis (P<0.05). These patients showed delayed functional recovery and higher complication rates. Strong correlations were observed between oxidative markers and apoptosis (ROS: r=0.912; MDA: r=0.901; SOD: r=−0.875). Cox regression identified ROS, MDA, reduced SOD, and apoptosis as independent risk factors for postoperative failure (HR range: 1.06–1.49, all P<0.05).

Conclusion: Serum oxidative stress markers and chondrocyte apoptosis rates are closely linked to joint recovery and complications after HRA in ONFH patients. These biochemical indicators may serve as prognostic biomarkers, supporting early identification of high-risk individuals and guiding personalized postoperative interventions.

Thyroid Hormone Sensitivity Indices and hs-CRP as Biochemical Predictors of Arteriovenous Fistula Maturation in Diabetic Nephropathy

2026-03-14T13:30:52+01:00

Background: Autogenous arteriovenous fistula (AVF) maturation is essential for successful hemodialysis in patients with diabetic nephropathy (DN). However, its outcome is often unpredictable. Thyroid hormone sensitivity indices and biochemical markers may provide valuable laboratory predictors for AVF maturation.

Methods: A total of 102 DN patients undergoing AVF surgery were retrospectively analyzed and classified into mature and immature AVF groups. Laboratory data, including thyroid hormone sensitivity indices [free triiodothyronine (FT3), free thyroxine (FT4), thyroid-stimulating hormone (TSH), FT3/FT4 ratio, thyroid-stimulating hormone index (TSHI), thyroxine resistance index (TT4RI), thyroid feedback quantile index (TFQI), and parameterized TFQI (PFTQI)], as well as biochemical markers such as high-sensitivity C-reactive protein (hs-CRP), albumin, total cholesterol, triglycerides, and LDL-C, were compared. Doppler ultrasonography was used as supportive assessment. Logistic regression identified independent predictors of AVF maturation.

Results: Patients in the AVF Maturity Group exhibited significantly lower FT3, TSH, FT3/FT4 ratio, TSHI, TFQI, and PFTQI levels, along with reduced hs-CRP values (all P < 0.05). Multivariate logistic regression revealed that higher FT4, TFQI, and PFTQI, lower hs-CRP, larger cephalic vein diameter, and younger age were independently associated with successful AVF maturation.

Conclusion: Thyroid hormone sensitivity indices and hs-CRP serve as important biochemical predictors of AVF maturation in DN patients. These laboratory parameters may assist in risk stratification and clinical decision-making, providing a biochemical perspective for optimizing dialysis access outcomes.

Variations and Implications of Irisin, FGF-23, and N-MID Osteocalcin in Diabetic Osteoporosis Patients Undergoing Acarbose Plus Sitagliptin Therapy: A Prospective Cohort Analysis

2026-03-14T13:30:52+01:00

Objective: The present study intends to explore the dynamic variations in Irisin, fibroblast growth factor 23 (FGF-23), and N-terminal propeptide of osteocalcin (N-MID) among diabetes mellitus osteoporosis (DOP) patients undergoing treatment with acarbose plus sitagliptin, as well as their ability to predict bone metabolic status and fracture risk. The ultimate objective is to identify potential biomarkers for optimizing DOP therapy.

Methods: From January 2023 to March 2024, 124 DOP patients admitted to our hospital were administered acarbose in combination with sitagliptin. For comparison, 119 uncomplicated diabetes mellitus (DM) patients were recruited as controls. Serum levels of Irisin, FGF-23, and N-MID were tested both at baseline and post-treatment. Data on bone mineral density (BMD), bone metabolic markers, and fracture occurrences during follow-up were also collected.

Results: Compared with uncomplicated DM individuals, DOP patients exhibited a rise in FGF-23 (P<0.05) and a decrease in Irisin and N-MID (P<0.05). Irisin + FGF-23 + N-MID combination demonstrated 87.10% sensitivity and 74.58% specificity in diagnosing DOP (AUC=0.867). Treatment with acarbose and sitagliptin contributed to reduced FGF-23 in DOP patients, along with increased Irisin and N-MID (P<0.05). BMD was positively influenced by irisin but negatively affected by FGF-23. Fracture prediction efficacy was markedly enhanced (AUC=0.822) by combining the three indices, with statistical superiority over single-index analysis (P<0.05).

Conclusion: The combined detection of Irisin, FGF-23, and N-MID enables early detection of DOP while allowing for dynamic assessment of treatment outcomes and fracture risk.

Pramipexole Enhances Levodopa's Therapeutic Efficacy in Parkinson’s Disease: role of glutaredoxin-1 (Grx1), peroxiredoxin-3 (Prx3), thioredoxin (Trx), 8-hydroxy-2′-deoxyguanosine (8-OHdG), and neurosteroid dehydroepiandrosterone sulfate (DHEA-S)

2026-03-14T13:30:52+01:00

Background: Parkinson's disease (PD) is characterized by progressive neurodegeneration and dopamine deficiency. Levodopa remains a cornerstone treatment, but its long-term use is associated with motor complications and reduced efficacy. This study investigates the clinical benefits of combining pramipexole with levodopa in PD patients, focusing on improvements in oxidative stress, cognitive function, and motor control. Additionally, the study explores the role of novel biomarkers, including glutaredoxin-1 (Grx1), peroxiredoxin-3 (Prx3), thioredoxin (Trx), 8-hydroxy-2′-deoxyguanosine (8-OHdG), and neurosteroid dehydroepiandrosterone sulfate (DHEA-S), in evaluating oxidative stress and neuroprotection.

Methods: A total of 92 PD patients were enrolled and assigned to either a levodopa monotherapy group (n=46) or a pramipexole-levodopa combination group (n=46). Clinical efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Cognitive function was evaluated using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Oxidative stress markers (SOD, GSH, GSH-PX, CAT, along with Grx1, Prx3, Trx, and 8-OHdG) were measured in serum samples. Additionally, DHEA-S was analyzed as a neurosteroid biomarker to assess its potential role in cognitive and motor function improvements. Quality of life (QOL) was assessed using the PDQ-39 questionnaire.

Results: The combination therapy group exhibited a significantly higher effective rate (93.48%) compared to the levodopa group (78.26%) (P < 0.05). UPDRS scores were significantly lower in the combination group at 6 and 12 weeks post-treatment (P < 0.05). The combination group also showed a significantly lower incidence of adverse drug reactions (6.52% vs. 23.91%, P < 0.05). After 3 months, the combination group displayed significantly higher levels of SOD, GSH, GSH-PX, CAT, Grx1, Prx3, and Trx, while 8-OHdG levels were significantly reduced, indicating enhanced neuroprotection and reduced oxidative stress. DHEA-S levels were also elevated, correlating with improved MMSE and MoCA scores (P < 0.05), suggesting a neurosteroid-mediated cognitive benefit. QOL was significantly better in the combination group after 3 months of intervention (P < 0.05).

Conclusions: Pramipexole combined with levodopa significantly improves clinical outcomes, reduces adverse effects, enhances cognitive function, and alleviates oxidative stress in PD patients. The inclusion of novel biomarkers such as Grx1, Prx3, Trx, 8-OHdG, and DHEA-S provides deeper insight into the molecular mechanisms underlying these therapeutic effects. This combination therapy represents a valuable strategy for improving PD management and warrants wider clinical application.

Correlation analysis of serum Glycosylphosphatidylinositol Mannosyltransferase 1 (GMP1) levels in type 2 diabetes mellitus

2026-03-14T13:30:53+01:00

Objective: To investigate the serum expression of Glycosylphosphatidylinositol Mannosyltransferase 1 (GMP1) in type 2 diabetes mellitus (T2DM) patients and its correlation with hypertriglyceridemia (HTG) to shed light on lipid metabolism disorders in T2DM.

Methods: A total of 239 subjects were included, among whom 92 patients were in the T2DM combined with HTG group and 147 patients were in the T2DM without HTG group. The concentration of the serum GMP1 protein was quantitatively detected via enzyme-linked immunosorbent assay (ELISA). Moreover, the levels of serum triglycerides (TGs) and other related metabolic indicators (such as blood glucose, glycated hemoglobin (HbA1c), total cholesterol, and high/low-density lipoprotein cholesterol) were detected via conventional biochemical methods. To evaluate the potential impact of GMP1 on the occurrence of T2DM combined with HTG.

Results: Both the DM group and the DM+HTG group had significantly higher serum GMP1 levels (P<0.01), and the GMP1 level in the DM+HTG group was considerably higher (P<0.05 or 0.01) than in the simple DM group. The serum GMP1 levels in T2DM and HTG patients were significantly higher. Serum GMP1 level (OR=1.527, 95% CI 1.200--1.943) were all determined by binary logistic regression analysis. 95% CI 1.003–1.010) was a separate risk factor for HTG and T2DM. Correlation analysis revealed that in patients with T2DM (especially those in the DM+HTG group). Multiple regression analysis further indicated that after controlling for factors such as age, sex, disease duration, BMI, and HbA1c, Higher blood GMP1 levels continued to be a predictor or independent factor for patients with T2DM complicated by HTG (P<0.05).

Conclusion: Serum GMP1 levels are markedly elevated in T2DM patients, especially those with hypertriglyceridemia, and they are independently positively linked with triglycerides.

Risk correlation analysis of serum adiponectin (APN), D-dimer (DD) and the neutrophil‒lymphocyte ratio (NLR) with the prognosis of diabetic foot ulcer infection

2026-03-14T13:30:53+01:00

Objective: Investigating the connections between diabetic foot ulcer infection patients' prognosis and disease severity, we measured serum adiponectin (APN), D-dimer (D-D), and the neutrophil-to-lymphocyte ratio (NLR).

Methods: A total of 292 patients with diabetic foot ulcer infection admitted to our hospital from February 2024 to February 2025 were selected and divided into mild (n=95), moderate (n=139) and severe (n=58) patients according to the severity of the disease. The levels of serum APN, D-D and the NLR in patients with different severity levels were compared. To analyze serum APN, D-D and the NLR, patients were followed up for one year, and the prognoses of the patients were statistically analyzed.

Results: Comparisons of the serum APN, D-D and NLR levels among patients with different severity, and the serum APN levels in moderate conditions were lower than those in patients with mild conditions (P<0.05). The serum APN of severe patients was 5.35±0.98, and that of moderate patients was 7.64±1.25, which was lower than that of mild patients (9.19±1.73; P<0.05), and the serum APN level of severe patients was lower than that of moderate patients (P<0.05). Comparisons of the serum D-D and NLR levels revealed that the serum D-D and NLR in severe patients were 3.49±0.72 and 2.86±0.58, respectively, and those in moderate patients were 3.02±0.63 and 2.24±0.46, respectively, both of which were greater than those in mild patients, which were 2.43±0.51 and 1.71±0.33 (P<0.05). The levels of serum D-D and the NLR were greater in severe patients than in moderate patients (P<0.05). According to Spearman correlation analysis, the severity of the disease in diabetic foot ulcer infection patients was positively connected with the serum D-D level and NLR (r=0.387, P<0.001; r=0.461, P<0.001) and negatively connected with the serum APN level (r=-0.414, P<0.001). ROC analysis revealed that the optimal cutoff values of the serum APN, D-D and NLR for predicting poor prognosis in patients were 5.73 mg/L, 3.06 mg/L and 2.12, respectively; the sensitivities were 78.57%, 82.14% and 85.71%, respectively; and the specificities were 76.56%, 67.19% and 73.44%, respectively. The areas under the curve (AUCs) were 0.793, 0.784, and 0.818, respectively. The specificity and AUC of the combination of the three methods were 98.44% and 0.918, respectively.

Conclusion: Serum APN and D-D levels and the NLR in patients with diabetic foot ulcer infection are related to disease severity. The serum APN, D-D and NLR can be used as sensitive indicators for predicting poor patient prognosis.

The The Importance of Elevated Basal 17-hydroxyprogesterone in the Diagnosis of Children with Congenital Adrenal Hyperplasia

2026-03-14T13:30:53+01:00

Introduction: Congenital adrenal hyperplasia (CAH) is characterized by a deficiency of 21α-hydroxylase causing a deficiency of cortisol and aldosterone and overproduction of 17-hydroxyprogesterone. The classic and non-classical forms of the disease present with signs of precocious puberty (PP) and accelerated body and bone growth. Elevated basal and stimulated 17-hydroxyprogesterone and genetic testing are crucial for confirming a definitive diagnosis.

Aim: To determine the significance of elevated basal 17-hydroxyprogesterone in children with signs of precocious puberty in the final diagnosis of Congenital Adrenal Hyperplasia.

Material and methods: A prospective study was conducted at the University Children's Clinic and the Institute of Molecular Genetics and Genetic Engineering in Belgrade from 2019 to 2024. The study involved 64 subjects of both sexes, aged up to 18 years, with precocious puberty, accelerated bone and body growth, elevated basal 17-hydroxyprogesterone, who were divided into two groups based on the presence/absence of pathogenic variants in the CYP21A2 gene. The anthropometric measures, skeletal maturation and hormone levels were compared between those two groups.

Results: The research includes 64 subjects, divided into two groups, with confirmed CAH (30 subjects) and with PP as the control group (34 subjects). A statistically significant difference was shown in basal (p=0.000000807) and stimulated 17-hydroxyprogesterone (p= 0.0125), cortisol (p= 0.0148) and androstenedione (p= 0.014) in homozygous carriers of pathogenic variants in the CYP21A2 gene.

Conclusion: Clinical and laboratory parameters such as precocious puberty and 17-hydroxyprogesterone may be significant hints to consider a carrier mutation for congenital adrenal hyperplasia.

Association of Serum Inflammatory Factors and Hematologic Parameters With Lower Limb Deep Vein Thrombosis in Neurocritical Patients: A Retrospective Cohort Study

2026-03-14T13:30:54+01:00

Objective: The aim of this study was to investigate the mechanisms of postoperative deep vein thrombosis (DVT) of the lower extremities in neurocritical care patients, focusing on the interaction of inflammatory factors [D-dimer (DD), prothrombin time (PT), blood cell parameters (lymphocytes, platelets, plateletcrit) and coagulation function.

Methods: A retrospective cohort study design was used to include 261 neurocritical care patients who underwent surgery between August 2019 and August 2021. They were categorized into DVT group (n=121) and non-DVT group (n=140) based on postoperative lower limb Doppler ultrasound findings. Preoperative coagulation indices (TT, DD), inflammatory markers [C reactive protein (CRP), procalcitonin (PCT), fibrinogen (FIB)], and blood cell parameters (hemoglobin, neutrophils, lymphocytes, platelet counts, and plateletcrit) were collected from the patients.

Results: DD levels were significantly higher and TT shorter in the DVT group than in the non-DVT group (P<0.05); DD was positively correlated with PT-INR (P<0.001). In addition, lymphocyte and plateletcrit were significantly lower in the DVT group (P<0.05). Multifactorial analysis showed that age (OR=1.027), days of hemostatic medication (OR=1.203), postoperative infections (OR=2.728), elevated DD (OR=1.056), and shortened TT (OR=0.840) were independent risk factors (P<0.05).

Conclusion: The development of DVT in neurocritical patients is the result of a combination of hypercoagulation, inflammatory response, and immunosuppression.

The application value of serum Th1/Th2 cytokines combined with tumor markers in the diagnosis of HR-HPV-positive cervical cancer

2026-03-14T13:30:54+01:00

Objective: To analyze the value of serum helper T-cell 1 (Th1)/helper T-cell 2 (Th2) cytokines combined with tumor markers in the diagnosis of high-risk human papillomavirus (HR-HPV)-positive cervical cancer.

Methods: Forty-nine patients with HR-HPV-positive cervical cancer admitted to the hospital from January 2020 to June 2024 were selected as the study group, and 49 patients with HR-HPV-positive benign cervical diseases of the same age group admitted to the hospital during the same period were selected as the control group.

The basic data, serum Th1/Th2 cytokines [interleukin (IL)-10, IL-6, interferon-γ (IFN-γ), and tumor necrosis factor-α (TNF-α)], and tumor markers [squamous cell carcinoma antigen (SCCAg), carbohydrate antigen 199 (CA199) levels and cytokeratin 19 fragment antigen 21-1 (CYFRA21-1)] of the two groups were compared, and the serum Th1/Th2 cytokine levels of patients with different clinicopathological characteristics in the study group were compared. Pearson correlation analysis was used to analyze the correlation between the levels of serum Th1/Th2 cytokines and tumor markers in patients with HR-HPV-positive cervical cancer. A receiver operating characteristic (ROC) curve was drawn to analyze the value of serum Th1/Th2 cytokines and tumor markers in the diagnosis of HR-HPV-positive cervical cancer.

Results: The levels of serum IL-10, IL-6, IFN-Y, TNF-a, SCC-Ag, CA199 and CYFRA21-1 in the study group were greater than those in the control group (P<0.05). The levels of serum IL-10, IL-6, IFN-γ and TNF-α in patients at stages III–IV of the International Federation of Obstetrics and Gynecology (FIGO) in the study group were all greater than those in patients at stages ⅰ–II (P<0.05), and the levels of serum IL-10, IL-6, IFN-γ and TNF-A in patients with a myometrial invasion depth ≥1/2 were all greater than those in patients with a myometrial invasion depth <1/2 (P<0.05). The levels of serum IL-10, IL-6, IFN-Y and TNF-an in patients with HR-HPV-positive cervical cancer were positively correlated with the levels of SCC-Ag, CA199 and CYFRA21-1 (P<0.05). The AUCs of IL-10, IL-6, IFN-Y and TNF-a for the single diagnosis of HR-HPV-positive cervical cancer were 0.809, 0.773, 0.801 and 0.794, respectively, and the AUCs of SCC-Ag, CA199 and CYFRA21-1 for the single diagnosis of HR-HPV-positive cervical cancer were 0.831 and 0, respectively. 728, 0.789. The AUC of the combined diagnosis of HR-HPV-positive cervical cancer by serum IL-10, IL-6, IFN-Y, TNF-a, SCC-Ag, CA199, and CYFRA21-1 was 0.927. The AUC of the combined diagnosis was greater than that of the individual diagnosis of each index (Z=2.116, 2.690, 2).341, 2.565, 1.957, 3.351, 2.631, P=0.034, 0.007, 0.019, 0.010, 0.039, 0.001, 0.009).

Conclusion: The combined detection of serum Th1/Th2 cytokine imbalance (elevated IL-6 and IL-10) and tumor markers (SCC, CA125) can significantly improve the diagnostic accuracy of HR-HPV-positive cervical cancer and provide a high-value serological auxiliary basis for the early identification of cervical cancer progression.

The influence of Platelet-rich fibrin on the inflammatory response, bone metabolism and cell differentiation ability of Temporomandibular joint osteoarthritis

2026-03-14T13:30:54+01:00

Objective: This study aims to explore the regulatory effects of platelet-rich fibrin (PRF) on serum inflammatory response, bone metabolic balance and cell differentiation ability in patients with temporomandibular joint osteoarthritis (TMJ-OA) at the molecular levels.

Methods: Sixty patients randomly divided into Group A and Group B (30 cases in each group). Group A was treated with meloxicam dispersible combined with hydroxychloroquine sulfate (HCQ); Group B was supplemented with autologous PRF intra-articular injection on the basis of Group A. Fasting venous blood was collected before treatment and 3 months after treatment. Inflammatory and bone metabolism markers such as IL-1β, IL-6, TNF-α, OPN, ALP, and Runx2 were detected by ELISA, and coagulation indicators such as APTT and PT were determined by an automatic coagulation analyzer.

Results: After treatment, the inflammatory factors (IL-1β, IL-6, TNF-α) in both groups decreased significantly, but the decrease in group B was more significant (P<0.001). Bone metabolism indicators showed that the improvement in group B was significantly better than that in group A (P<0.05). Among the cell differentiation-related factors, the expression levels of Runx2, TGF-β1 and Sox9 in group B were significantly increased compared with those before treatment (P<0.05), and were higher than those in group A (P<0.05). In terms of coagulation function, the APTT and PT in group B were prolonged (P<0.001), and the levels of FIB and D-D decreased (P<0.001).

Conclusion: The use of PRF can optimize the therapeutic effect of TMJ-OA, improve inflammatory responses, promote cell differentiation and reverse the hypercoagulable state of the blood.

Values of Coagulation Function Indices in Distinguishing between Acute Ischemic Stroke Patients with and without Non-Valvular Atrial Fibrillation

2026-03-14T13:30:55+01:00

Background: Treatment strategies differ in acute ischemic stroke (AIS) patients with and without non-valvular atrial fibrillation (NVAF). It remains unclear whether coagulation function indices can be used to distinguish between the two conditions.

Methods: In this retrospective study, AIS patients with NVAF (AIS with NVAF group, n=43) and without NVAF (AIS without NVAF group, n=90) admitted to Lianyungang Affiliated Hospital of Nanjing University of Chinese Medicine, were enrolled for final analysis. The levels of coagulation function indices, including DD, APTT, PT, INR, TT, and fibrinogen were tested before or on admission and compared between the two groups.

Results: Compared with AIS without NVAF group, DD, PT, and INR were increased and APTT was decreased in AIS with NVAF group (P<0.05), whereas, there were no significantly statistical differences of TT and fibrinogen (P<0.05); next, the AUC in distinguishing between AIS with and without NVAF were 0.753, 0.761, 0.775, and 0.770 for DD, APTT, PT, and INR, respectively (P<0.05).

Conclusions: DD, APTT, PT and INR showed certain reference value for the differential diagnosis of AIS patients with or without NVAF.

First-Trimester Biochemical Inflammatory Markers (NHR and NLR) as Predictors of Preeclampsia Risk

2026-03-14T13:30:55+01:00

Background: Preeclampsia (PE) remains a leading cause of maternal and perinatal morbidity. Early identification of high-risk pregnancies requires accessible and cost-effective laboratory markers. This study aimed to evaluate first-trimester blood count–derived inflammatory indices, with a focus on the neutrophil-to-HDL ratio (NHR) and neutrophil-to-lymphocyte ratio (NLR), for PE risk prediction.

Methods: Ninety patients with PE and 90 healthy pregnant women were retrospectively analyzed. Routine hematological and biochemical parameters were measured using an automated biochemical analyzer, and derived indices (NLR, NHR, MHR, SII) were calculated. Independent risk factors were determined through multivariate logistic regression, and a predictive model was validated by receiver operating characteristic (ROC) curve analysis.

Results: PE patients exhibited significantly higher NLR, NHR, and SII compared with controls (all p < 0.001). Logistic regression identified NLR, NHR, and body mass index (BMI) as independent predictors of PE. The combined model incorporating these factors achieved excellent predictive performance, with an area under the ROC curve of 0.909 (95% CI: 0.866–0.952).

Conclusion: First-trimester laboratory indices, particularly NHR and NLR, provide reliable biochemical markers for early PE risk assessment. The proposed laboratory-based model may facilitate cost-effective screening, improve risk stratification, and support preventive strategies in clinical practice.

Leukocyte telomere dynamic change in patients with mild to moderate COVID-19 during three weeks of follow-up: relation with therapy

2026-03-14T13:30:55+01:00

Summary

Background: A three-year COVID-19 pandemic revealed a spectrum of disease severity and clinical manifestations. The most intriguing part of this phenomenon lays in inter-individual variability in COVID-19 course among patients, which is attributable to patient's age, comorbidities and general health status. Focus of this follow-up study was to assess leukocyte telomere length change in mild-to-moderate COVID-19 patients and concomitant influence of inflammation, oxidative stress (OS), pulmonary involvement and implemented therapy on the course of the disease.

Methods: Routine biochemical/haematological parameters, markers of OS (prooxidants and antioxidants), vitamin D, IgM and IgG antibodies level and relative length of leukocyte telomeres (rLTL) were measured at three time-points (at diagnosis, after 14 and 21 days from the disease onset) in blood samples of 31 consecutive COVID-19 patients, with a mild (n=16) and moderate (n=15) form of the disease, treated on an outpatient basis.

Results: Although the patients had reduced rLTL at baseline (median: 0.592; 25^th – 75^th percentiles: 0.518-0.724), it significantly increased during the follow-up (median: 0.773; 25^th – 75^th percentiles: 0.615-0.923; P<0.01). The rate of telomere attrition was associated with the extent of OS and pulmonary involvement. During follow-up, the burden of OS was reduced, while antioxidant defence mechanisms were recovered. The use of antibiotics and N-acetylcysteine-propolis supplementation was associated with telomere lengthening.

Conclusions: Results of this study revealed significant interaction between OS, inflammation and leukocyte telomere length attrition in COVID-19. Our data suggest that rRTL can be a biomarker that enables more precise therapy decision and accurate patient status estimation.

Serum Oxidative Stress Biomarkers (MDA, SOD, GSH-Px) and IL-6/TNF-α Ratio as Biochemical Indicators of Disease Progression in Pediatric Cariogenic Pulpitis

2026-03-14T13:30:55+01:00

Background: Cariogenic pulpitis is a common pediatric oral disease in which oxidative stress and inflammatory imbalance are increasingly recognized as important pathogenic mechanisms. Biochemical markers such as malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), and the serum IL-6/TNF-α ratio may provide insight into disease severity and progression.

Methods: A total of 64 children with cariogenic pulpitis admitted between May 2023 and October 2024 were included, along with 64 healthy children as controls. Serum MDA, SOD, GSH-Px, and IL-6/TNF-α ratio were measured using standard biochemical assays (TBA colorimetry, xanthine oxidase method, NADPH-coupled assay, and ELISA). Group comparisons were performed, and correlations with disease stage and caries depth were analyzed using Pearson correlation coefficients.

Results: Compared with controls, children with pulpitis had significantly higher MDA and IL-6/TNF-α levels (t = 18.542 and 20.639, both P < 0.001) and lower SOD and GSH-Px activities (t = 8.279 and 12.449, both P < 0.001). Within the pulpitis group (30 early stage, 24 middle stage, 10 late stage), MDA levels were positively correlated with both caries depth and disease severity (r = 0.82, P < 0.05), while SOD (r = –0.78, P < 0.05) and GSH-Px (r = –0.75, P < 0.05) were negatively correlated. The IL-6/TNF-α ratio was positively correlated with both stage and depth (r = 0.71, P < 0.05), increasing significantly with lesion depth (r = 0.56, P < 0.05).

Conclusion: Elevated MDA and IL-6/TNF-α ratio reflect greater oxidative and inflammatory burden and are associated with advanced stages of pediatric cariogenic pulpitis, whereas higher SOD and GSH-Px activities are associated with earlier disease. These biochemical indices may serve as adjunctive laboratory markers for evaluating disease progression and guiding therapeutic monitoring in pediatric pulpitis.

Biochemical and Clinical Effects of Continuous Positive Airway Pressure Combined with Sildenafil on Inflammatory and Hemodynamic Profiles in Obese Asthma Patients with Pulmonary Arterial Hypertension

2026-03-14T13:30:56+01:00

Background: Obesity-associated asthma complicated by pulmonary arterial hypertension (PAH) involves multifactorial biochemical dysregulation, including endothelial dysfunction, oxidative stress, and chronic inflammation. This study aimed to evaluate the combined biochemical and clinical effects of continuous positive airway pressure (CPAP) and sildenafil on pulmonary function, inflammatory biomarkers, and hemodynamic parameters in obese asthma patients with PAH.

Methods: A total of 134 patients (BMI ≥30 kg/m², FEV₁ < 70% predicted, PASP ≥ 30 mmHg) were enrolled and divided into a treatment group (n = 63, CPAP + sildenafil) and a comparison group (n = 71, sildenafil alone). Pulmonary and hemodynamic indices (PaO₂, FiO₂, PASP, OI, and PaO₂/FiO₂), lung function parameters (FEV₁, PEF), and asthma control test (ACT) scores were assessed at baseline and follow-up (6 and 12 months). Serum interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and fractional exhaled nitric oxide (FeNO) were quantified to evaluate biochemical inflammation. Correlation analysis was performed between biomarker changes and ACT improvements.

Results: The CPAP + sildenafil group showed significantly higher post-treatment PaO₂ levels, lower PASP and FiO₂ values, improved OI, and greater increases in PaO₂/FiO₂ and FEV₁ percentages compared with the sildenafil-only group (P < 0.001). Biochemical assays revealed substantial reductions in serum IL-6 and TNF-α levels, as well as FeNO concentrations, in the combination group. Post-treatment changes in IL-6 (r = 0.68, P < 0.0001), TNF-α (r = 0.59, P < 0.0001), and FeNO (r = 0.72, P < 0.0001) were strongly correlated with improved ACT scores, suggesting a close biochemical–clinical relationship between airway inflammation and therapeutic response.

Conclusion: CPAP combined with sildenafil exerts dual biochemical and clinical benefits in obese asthma patients with PAH by enhancing oxygenation, lowering pulmonary artery pressure, and suppressing inflammatory cytokine activity. The observed reductions in IL-6, TNF-α, and FeNO highlight the biochemical basis of treatment efficacy and the potential of these markers as laboratory indicators for monitoring therapeutic outcomes.

Biochemical Evaluation of Jihua Hemostatic Suppository in Hemorrhagic Internal Hemorrhoids: Modulation of Xpo1, VEGF, and Collagen I/III Expression and Inflammatory Biomarkers

2026-03-14T13:30:56+01:00

Background: Hemorrhagic internal hemorrhoids involve abnormal vascular remodeling, inflammatory activation, and extracellular matrix dysregulation. Exportin-1 (Xpo1), vascular endothelial growth factor (VEGF), and collagen types I and III are key biochemical markers associated with these processes. This study aimed to evaluate the therapeutic efficacy of Jihua Hemostatic Suppository compared with Gangtai Suppository and to investigate their differential effects on biochemical and inflammatory parameters in patients with hemorrhagic internal hemorrhoids.

Methods: A total of 98 patients diagnosed with hemorrhagic internal hemorrhoids were enrolled between January 2024 and January 2025 and randomly divided into two groups (n = 49 each) using the envelope randomization method. The Jihua group received Jihua Hemostatic Suppository, whereas the control group received Gangtai Suppository for two weeks. Serum levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP) were determined by ELISA. Xpo1 levels were measured by ELISA, VEGF by chemiluminescence assay, and collagen types I and III by the hydroxyproline method. Clinical efficacy, traditional Chinese medicine (TCM) syndrome scores, and adverse reactions were also recorded.

Results: The total effective rate in the Jihua group (93.88%) was significantly higher than that in the Gangtai group (77.55%) (χ² = 5.968, P = 0.015). After treatment, the Jihua group showed markedly lower serum IL-6 (70.50 ± 5.82 ng/mL), CRP (23.06 ± 2.71 mg/L), and TNF-α (60.81 ± 5.72 ng/mL) levels compared with the Gangtai group (P < 0.001). Biochemically, Xpo1, VEGF, collagen I, and collagen III concentrations were significantly reduced in the Jihua group (12.31 ± 1.35 ng/mL, 389.64 ± 34.32 pg/mL, 154.39 ± 15.19 pg/L, and 36.13 ± 3.06 μg/L, respectively) compared with the Gangtai group (P < 0.05). The incidence of adverse reactions was lower with Jihua suppository (4.08%) than with Gangtai suppository (20.41%) (χ² = 4.242, P = 0.039).

Conclusion: Jihua Hemostatic Suppository exerts superior therapeutic and biochemical effects in hemorrhagic internal hemorrhoids compared with Gangtai Suppository. Its efficacy is likely mediated by suppression of the Xpo1/NF-κB inflammatory axis, inhibition of VEGF-driven angiogenesis, and normalization of collagen I/III-dependent extracellular matrix remodeling. These findings highlight the value of integrating biochemical biomarkers into clinical assessment of hemorrhoidal disease and suggest Xpo1, VEGF, and collagen I/III as potential molecular indicators of treatment efficacy.

Prognostic Value of the HALP Index, Erythrocyte Sedimentation Rate, and Rheumatoid Factor in Rheumatoid Arthritis: A Laboratory-Based Multivariate Analysis

2026-03-14T13:30:56+01:00

Background: Biochemical and hematological indices play a critical role in evaluating systemic inflammation and disease activity in rheumatoid arthritis (RA). This study investigated the prognostic value of the hemoglobin–albumin–lymphocyte–platelet (HALP) index, in combination with erythrocyte sedimentation rate (ESR) and rheumatoid factor (RF), for predicting RA disease progression.

Methods: A retrospective analysis was performed on 146 RA patients admitted between December 2022 and December 2023. Laboratory variables included HALP index, ESR, RF, C-reactive protein, anti-CCP antibodies, hemoglobin, albumin, lymphocyte and platelet counts, and serum creatinine. Measurements were obtained using standardized automated hematology and biochemical analyzers. Disease activity and radiographic joint damage scores were also assessed. Statistical approaches included correlation analysis, regression analysis, and receiver operating characteristic (ROC) curve evaluation.

Results: The HALP index, ESR, and RF were significantly associated with RA disease progression. The HALP index demonstrated a strong correlation with disease activity (r=0.602, P<0.001). ROC analysis showed an area under the curve (AUC) of 0.858 for HALP, 0.841 for ESR, and 0.924 for RF. When combined in a multivariate regression model, the predictive performance improved (AUC=0.943).

Conclusion: The HALP index, as a composite biochemical marker, in combination with ESR and RF, provides significant prognostic information for RA progression. These findings underscore the importance of laboratory-based indices in refining prognostic assessments and highlight their potential role in personalized disease management.

Biochemical Effects of Personalized Clinical Interventions on Hepatorenal Function, Immune Response, and Inflammatory Markers in Patients with Infections

2026-03-14T13:30:56+01:00

Background: Hepatic and renal dysfunction, immune imbalance, and excessive inflammatory activation are common complications in postoperative infections. This study evaluated the biochemical effects of personalized clinical interventions on hepatorenal function, immune responses, and inflammatory cytokines in infected patients.

Methods: A total of 110 patients with postoperative infections admitted between January 2023 and January 2025 were randomly assigned to an experimental group or a control group (n = 55 each). The control group received standard clinical care, while the experimental group underwent additional individualized intervention measures. Serum hepatic (AST, ALT) and renal (BUN, SCr, UA) biochemical markers, T-lymphocyte subsets (CD3⁺, CD4⁺, CD8⁺), inflammatory factors (IL-6, CRP, TNF-α), and SF-36 quality-of-life scores were assessed before and after intervention. Adverse events were recorded.

Results: Post-intervention, AST and ALT levels were significantly lower in the experimental group compared with the control group (P < 0.05). BUN, SCr, and UA were also significantly reduced after individualized intervention (P < 0.05). The experimental group demonstrated higher CD3⁺ and CD4⁺ levels and lower CD8⁺ levels than the control group (P < 0.05). Levels of IL-6, CRP, and TNF-α were markedly decreased in the experimental group (P < 0.05). Quality-of-life scores across all domains were significantly higher following individualized intervention (P < 0.05). The incidence of adverse reactions was notably lower in the experimental group (5.45% vs. 20.00%; χ² = 4.010, P = 0.045).

Conclusion: Personalized clinical interventions significantly improved hepatic and renal biochemical indices, enhanced immune function, and reduced systemic inflammatory cytokines in patients with postoperative infections. These findings support the integration of individualized strategies into infection management to optimize biochemical and clinical outcomes.

Correlations of p53, SLC7A11, and CD3+/CD8+ T cells with pathological features and prognosis in endometrial carcinoma

2026-03-14T13:30:57+01:00

Objective: This study investigates the clinical significance of SLC7A11, p53, and CD3+/CD8+ T cells in endometrial carcinoma (EC). By evaluating their expression patterns and correlations with histopathological parameters and patient outcomes, we aim to develop a prognostic risk model integrating these biomarkers.

Methods: We enrolled 134 EC patients (observation group) diagnosed between February 2023 and January 2024 and 128 concurrent healthy controls. Quantitative and qualitative assessments were conducted to measure SLC7A11, p53, and CD3+/CD8+ T cell levels. Diagnostic performance of individual and combined markers was analyzed using receiver operating characteristic (ROC) curves, while a logistic regression-based predictive model was developed. Associations of these biomarkers with EC histopathological features and 1-year survival outcomes were further evaluated.

Results: Compared to controls, EC patients exhibited notable reductions in CD3+/CD8+ T-cell infiltration but elevations in SLC7A11 and p53 expression (P<0.05). According to qualitative analysis, CD3 and CD8 positivity were similarly lower in tumor tissues than in adjacent normal tissue, whereas SLC7A11 and p53 staining were more frequent in malignant lesions (P<0.05). For EC diagnosis, the combined AUC of p53, SLC7A11, and CD3+/CD8+ T cells reached 0.883 (72.4% sensitivity, 88.3% specificity). Their combination also effectively predicted 1-year mortality risk (AUC = 0.889), with 82.4% sensitivity and 81.0% specificity.

Conclusion: p53, SLC7A11, and CD3+/CD8+ T cells show intimate connections with EC. A diagnostic model incorporating these biomarkers enhances the accuracy of EC detection, offering improved clinical utility.

The diagnostic value of IRF4 and FGF23 in gingival crevicular fluid and serum for dentin hypersensitivity was compared

2026-03-14T13:30:57+01:00

Objective: The aim of this study is to investigate the diagnostic value of interferon regulatory factor 4 (IRF4) and fibroblast growth factor 23 (FGF23) in gingival crevular fluid (GCF) and serum for dentin hypersensitivity (DH), and to analyze the relationship between IRF4, FGF23 and inflammatory factors and T lymphocyte subsets.

Methods: 24 DH patients receiving orthodontic treatment at our institution between 2022 and early 2025 were enrolled as the study cohort, along with 124 healthy controls matched for age and sex. GCF and serum samples were obtained 48 hours post-desensitization therapy to quantify IRF4 and FGF23 levels (via enzyme-linked immunosorbent assay), along with serum inflammatory markers (interleukin [IL]-1β, IL-6, high-sensitivity C-reactive protein [hs-CRP]) and T-cell subpopulations (CD3⁺, CD4⁺, CD8⁺). Statistical analyses included Pearson's correlation to examine relationships between IRF4/FGF23 and clinical parameters, with receiver operating characteristic (ROC) curve analysis determining diagnostic accuracy.

Results: The study revealed that GCF and serum levels of IRF4 and FGF23 were markedly elevated in DH patients compared to healthy controls (P<0.05), with a strong positive correlation between the two biomarkers (P<0.001). Diagnostic analysis revealed that GCF testing outperformed serum assessment, with the highest accuracy (AUC = 0.846) achieved through combined detection. Notably, IRF4 and FGF23 levels in gingival crevicular fluid were positively correlated with inflammatory markers (IL-1β, IL-6, and hs-CRP). Further immune profiling indicated reduced CD3⁺ and CD4⁺ T-cell populations in DH patients versus controls, with IRF4 and FGF23 levels inversely related to these T-cell subsets (P<0.05).

Conclusion: Detection of IRF4 and FGF23 in GCF is a more accurate diagnosis of DH than in serum. These findings provide new insights into the future clinical diagnosis of DH.

Diagnostic value and risk correlation of serum heart-type fatty acid-binding protein (H-FABP) and osteoprotegerin (OPG) in chronic heart failure

2026-03-14T13:30:57+01:00

Objective: To analyze the value of H-FABP and OPG in determining severity of heart function in those suffering from long-term heart failure.

Method: 196 patients with persistent heart failure who were admitted to our hospital between June 2023 and October 2024 were chosen. A comparison was made between the three groups of chronic heart failure patients' general clinical information, H-FABP, and OPG levels. The associations between OPG and H-FABP and various clinical forms of chronic heart failure, heart failure severity, and measurement markers related to echocardiography were examined. To assess NT-proBNP, H-FABP, and OPG detection alone and in combination for HFrEF and HFpEF in order to determine their diagnostic utility. Following their discharge, all patients were monitored for three to six months.

Results: There was a positive correlation (r=0.61) between H-FABP and the NYHA classification, LA (r=0.46), LV (r=0.51), HS-TnT (r=0.31), NT-proBNP (r=0.58), SUA (r=0.38), etc., and negatively correlated with the LVEF (r=-0.76), NT-proBNP (r=0.49), etc., and negatively correlated with the LVEF (r=-0.60) (P<0.05). Binary logistic regression analysis of NT-proBNP, H-FABP, and OPG levels and endpoint events revealed that NT-proBNP had a high value in predicting endpoint events. The readmission rate and mortality rate of patients with chronic heart failure increased with increasing NT-proBNP concentration. Serum H-FABP and OPG all have high diagnostic value for HFrEF. Compared with the traditional biomarker NT-proBNP, H-FABP had a greater sensitivity (94.9%) and specificity (83.1%) in the diagnosis of HFrEF, whereas OPG had a greater sensitivity (92.3%) and a lower specificity (57.7%). H-FABP and OPG can significantly improve the sensitivity (86.44%) and specificity (89.74%) in the diagnosis of patients with HFrEF. Serum NT-proBNP, H-FABP and OPG all have high diagnostic value for HFpEF. Compared with the traditional biomarker NT-proBNP, H-FABP has greater sensitivity (91.7%) and specificity (82.0) in the diagnosis of HFpEF, whereas OPG has greater specificity (82.0%) and lower sensitivity (58.3%).

Conclusion: The combined detection of H-FABP, OPG and NT-proBNP can be used as an important strategy for the early detection of heart failure patients' declining cardiac function.

Cardiac function, heart failure indicators and inflammatory factors in continuous mild hypothermic hemodialysis patients after valvular heart disease surgery

2026-03-14T13:30:57+01:00

Objective: To compare the effects of continuous hemodialysis at normal temperature and mild hypothermia in the treatment of cardiogenic shock after valvular heart disease surgery and its influences on patients' cardiac function, heart failure indicators and inflammatory factors.

Methods: After surgery for valvular heart disease, 180 patients with cardiogenic shock were brought to our hospital between January 2023 and December 2024. Patients in the control group received continuous hemodialysis treatment at normal temperature, whereas patients in the observation group received continuous hemodialysis treatment at mild hypothermia. The postoperative drainage volume, blood purification time, ventilator assistance time, ICU stay time, and occurrence of death, arrhythmia and infection were compared between the two groups. Cardiac function indicators, laboratory indicators of heart failure, serum creatinine (Cr), and inflammatory factor data were compared between the two patient groups prior to and following therapy.

Results: Postoperative drainage volume, ventilator assistance time, intensive care unit (ICU) stay, blood purification time and mortality rate (P<0.05) were analyzed. The laboratory measurements of BNP, hs-CRP, and CR-related heart failure did not differ prior to treatment (P>0.05). BNP, hs-CRP, and CR-related heart failure were laboratory markers that were reduced in both groups after treatment; the levels in the observation group were lower than those in the control group (P<0.05). Tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1 (IL-1) were present at the same pretreatment levels in both groups (P>0.05). The levels decreased after treatment and were lower in the observation group than in the control group (P<0.05).

Conclusion: For patients with cardiogenic shock after valvular heart disease surgery, mild hypothermia hemodialysis treatment can further reduce the postoperative drainage volume and hemopurification time, promote early recovery, and reduce the mortality rate. Moreover, mild hypothermia hemodialysis treatment can further improve the cardiac function of patients and alleviate heart failure. The levels of inflammatory factors in the patient's body should be reduced.

Application of the Latest CLSI EP Guidelines in light-initiated chemiluminescent assay for testosterone

2026-03-14T13:30:57+01:00

Background: A commercial light-initiated chemiluminescent assay (LiCA) for testosterone (T) measurement was developed. This study comprehensively evaluated the analytical performance of LiCA-T following the Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocols (EP) series guidelines.

Methods: From 1st July 2023, both the manufacturer and clinical end-users conducted rigorous performance evaluations in accordance with CLSI EP guidelines. Assessments included precision, linearity, accuracy/trueness, detection limits, and interference testing using collected clinical samples.

Results: Manufacturer evaluations demonstrated excellent assay performance: repeatability (1.41-4.39%), intermediate imprecision (1.62-7.29%), and reproducibility (1.62-7.22%). The method showed linearity across 0.10-16.64 ng/mL (ADL=10%). Method comparison with MS reference yielded a limit of agreement (LoA) of -19.5% to 14.4%, with ≤10.00% bias at medical decision points. Sensitivity parameters included: LoB (0.041 ng/mL), LoD (0.049 ng/mL), and LoQ (0.060 ng/mL at 20% imprecision). The assay demonstrated robust interference resistance against hemoglobin (2 mg/mL), biotin (20 ng/mL), triglyceride (3 mg/mL), and bilirubin (0.157 mg/mL). All manufacturer claims were successfully verified by independent clinical end-user testing.

Conclusion: The LiCA-T assay satisfies all performance criteria specified in CLSI latest EP guidelines (including EP06-Ed2 and EP07-Ed3), demonstrating reliable analytical performance across all critical validation parameters for clinical testosterone measurement.