Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.

Objective To investigate the effects of obesity-related indexes on cardiovascular autonomic nervous function in type 2 diabetes mellitus(T2DM)patients.Methods A total of 421 T2DM patients treated in the Department of Endocrinology of Gansu Provincial People's Hospital were enrolled in this study from October 2020 to October 2023.All the patients were divided into simple T2DM group with VFA<100 cm2(n=193)and obese group with VFA≥100 cm2(OB,n=228)according to visceral fat area(VFA).BMI,waist-to-height ratio(WHtR),waist-to-hip ratio(WHR),lipid accumulation index(LAP),visceral fat index(VAI),Chinese visceral fat index(CVAI),tapeness index(CI),body shape index(ABSI),and body roundness index(BRI)were calculated.Time domain parameters of heart rate variability(HRV)in 24 h holter electrocardiogram were recorded,including the global standard deviation(SDNN)of normal sinus RR interval,standard deviation of mean value of sinus RR interval(SDANN),root mean square difference(RMSSD)of normal continuous sinus RR interval.The percentage of adjacent RR interval difference>50 ms in total interval(PNN50),the HRV triangle index,the standard deviation of the difference of the entire adjacent NN interval length(SDSD).Results Compared with T2DM group,the OB group showed an increase in age,weight,BMI,WC,hip circumference(HC),neck circumference(NC),SBP,HbA1c,TG,SUA,CI,WHtR,WHR,VFA,SFA,VAI,LAP,CVAI,and BRI(P<0.05 or P<0.01),while a decrease in HDL-C(P<0.05).The SDNN,SDANN,SDSD,RMSSD,HRV trigonometric index,and PNN50 were lower in OB group than in T2DM group(P<0.05 or P<0.01).Spearman correlation analysis showed that SDNN and HRV trigonometric index was negatively correlated with age,DM duration,HR,SBP,PWV,WHtR,TG,SUA,VAI,LAP,BRI,VFA,LAP,and CVAI(P<0.05 or P<0.01).Logistic regression analysis shows that age,VFA,and LAP are influencing factors for cardiac autonomic dysfunction.The analysis of the working characteristic curve of the subjects showed that the area under the curve of VFA,age,and LAP in predicting cardiovascular autonomic dysfunction was 0.680,0.614,and 0.577,with sensitivity of 87.5%,41.7%,and 61.8%,and specificity of 47.3%,73.6%,and 55.6%respectively.Conclusions BMI,HC,NC,WC,TG,SFA,CI,WHtR,WHR,LAP,BRI,VAI,CVAI and VFA are closely related to cardiovascular autonomic nervous function in T2DM patients.As VFA,Ageand LAP increase,the risk of cardiovascular autonomic dysfunction increases.

Objective:To investigate alterations in static regional homogeneity(ReHo) and dynamic regional homogeneity (dReHo) and glucose metabolism in MRI-negative refractory temporal lobe epilepsy (TLE) patients using resting-state PET-MRI, and to evaluate their efficacy in predicting surgical outcomes.Methods:This study was a cross-sectional design. A retrospective analysis was conducted on the clinical and imaging data of 30 patients with MRI-negative refractory TLE (patient group) treated at Xuanwu Hospital, Capital Medical University, between 2016 and 2020, and data from 30 healthy controls (control group). All MRI-negative refractory TLE patients underwent surgical treatment and were further divided into a good prognosis subgroup (Engel Class I, 16 cases) and a poor prognosis subgroup (Engel Class Ⅱ-Ⅳ, 14 cases) based on postoperative Engel classification. Analysis of variance was used to compare differences in static ReHo, dReHo, and glucose metabolism(SUVR) among the three groups. The correlation of static ReHo, dReHo, and SUVR values of differential brain regions with Engel grading was analyzed using Spearman. A support vector machine (SVM) model was constructed using the static ReHo, dReHo, and SUVR values from these differential regions to classify and predict patient prognosis. The predictive performance was evaluated using receiver operating characteristic curves and the area under the curve (AUC).Results:Differential dReHo regions among the good prognosis subgroup, poor prognosis subgroup, and control group were located in the right lateral middle temporal gyrus temporal pole, the right fusiform gyrus, the right insula subfrontal gyrus, the left cuneate lobe, the right medial and paracortical cingulate gyrus, and the right supraparietal gyrus; the differential static ReHo regions were primarily found in the bilateral inferior temporal gyrus, the supraparietal gyrus, and the right subfrontal gyrus, the left medial supraparietal gyrus, the left median frontal gyrus, and the right marginal supraparietal gyrus; SUVR differences were in the affected superior, middle and inferior temporal lobes, the internal olfactory cortex and the temporal pole region. dReHo of right middle temporal gyrus temporal pole in patients with MRI-negative TLE showed a positive correlation with Engel classification ( r=0.421, P=0.020). The SVM model based on dReHo combined with SUVR values classified patients with good and poor prognosis with an AUC of 0.825 and an accuracy of 73.3%. Conclusions:In MRI-negative refractory TLE patients, abnormal dReHo regions are predominantly located in the contralateral default mode network areas and are associated with Engel classification. Combined with glucose metabolism values, dReHo can predict postoperative outcomes in MRI-negative TLE patients.

Objective To investigate the association between body roundness index(BRI)and hyperuricemia(HUA)in patients with type 2 diabetes mellitus(T2DM).Methods 555 T2DM inpatients were selected from July 2022 to October 2023 in Gansu Province People's Hospital Endocrinology.According to BRI,the T2DM patients were divided into four group:low BRI(L-BRI,BRI≤3.579,n=140)group,moderate BRI(M-BRI,3.579

Objective To investigate the relationship between interventricular septal dimensions(IVSd)and urinary albumin/creatinine ratio(UACR)in patients with type 2 diabetes mellitus(T2DM).Methods A total of 757 patients with T2DM hospitalized in the Department of Endocrinology of Gansu Provincial People's Hospital from March 2021 to April 2024 were enrolled in this study.All the patients were divided into T2DM patients without proteinuria(n=388),microproteinuria group(Mic,n=260)and macroproteinuria group(Mac,n=109)according to the UACR levels.General clinical data and biochemical indexes were collected from all the patients.Color Doppler echocardiography was used to record left ventricular ejection fraction(LVEF),left ventricular fraction shortening(LVFS),IVSd,left ventricular posterior wall dimensions(LVPWd),and left atrial diameter(LAD).Pearson correlation analysis was conducted to analyze the correlation between IVSd,LVPWd and related indicators of renal function.Logistic regression analysis was conducted to analyze the influencing factors for T2DM patients with proteinuria.The receiver operating characteristic(ROC)curve was used to analyze the predictive value of the DM duration and IVSd in patients with T2DM and proteinuria.Results The DM duration,SBP,FIns,HbA1c,Scr,24 hUTP,UACR,UAER,IVSd,LVPWd were increased successively(P<0.05),while LVEF and eGFR were decreased successively(P<0.05)in T2DM,Mic,Mac group.Age was higher in Mic group than in T2DM group(P<0.05).DBP and FPG were higher in Mac group than in T2DM and Mic group(P<0.05).Pearson correlation analysis showed that IVSd and LVPWd were positively correlated with 24 hUTP,UACR,UAER and Scr(P<0.05),and negatively correlated with eGFR(P<0.05).Logistic regression analysis indicated that the DM duration and IVSd were significant influencing factors for proteinuria in patients with T2DM.ROC curve showed that the area under ROC curve of IVSd was 0.620,with sensitivity 43.3%and specificity 76.8%,respeictively.Conclusions The DM duration and IVSd are influencing factors for UACR in patients with T2DM.The risk of proteinuria in T2DM patients increases with rising IVSd.

Objective To investigate the effects of obesity-related indexes on cardiovascular autonomic nervous function in type 2 diabetes mellitus(T2DM)patients.Methods A total of 421 T2DM patients treated in the Department of Endocrinology of Gansu Provincial People's Hospital were enrolled in this study from October 2020 to October 2023.All the patients were divided into simple T2DM group with VFA<100 cm2(n=193)and obese group with VFA≥100 cm2(OB,n=228)according to visceral fat area(VFA).BMI,waist-to-height ratio(WHtR),waist-to-hip ratio(WHR),lipid accumulation index(LAP),visceral fat index(VAI),Chinese visceral fat index(CVAI),tapeness index(CI),body shape index(ABSI),and body roundness index(BRI)were calculated.Time domain parameters of heart rate variability(HRV)in 24 h holter electrocardiogram were recorded,including the global standard deviation(SDNN)of normal sinus RR interval,standard deviation of mean value of sinus RR interval(SDANN),root mean square difference(RMSSD)of normal continuous sinus RR interval.The percentage of adjacent RR interval difference>50 ms in total interval(PNN50),the HRV triangle index,the standard deviation of the difference of the entire adjacent NN interval length(SDSD).Results Compared with T2DM group,the OB group showed an increase in age,weight,BMI,WC,hip circumference(HC),neck circumference(NC),SBP,HbA1c,TG,SUA,CI,WHtR,WHR,VFA,SFA,VAI,LAP,CVAI,and BRI(P<0.05 or P<0.01),while a decrease in HDL-C(P<0.05).The SDNN,SDANN,SDSD,RMSSD,HRV trigonometric index,and PNN50 were lower in OB group than in T2DM group(P<0.05 or P<0.01).Spearman correlation analysis showed that SDNN and HRV trigonometric index was negatively correlated with age,DM duration,HR,SBP,PWV,WHtR,TG,SUA,VAI,LAP,BRI,VFA,LAP,and CVAI(P<0.05 or P<0.01).Logistic regression analysis shows that age,VFA,and LAP are influencing factors for cardiac autonomic dysfunction.The analysis of the working characteristic curve of the subjects showed that the area under the curve of VFA,age,and LAP in predicting cardiovascular autonomic dysfunction was 0.680,0.614,and 0.577,with sensitivity of 87.5%,41.7%,and 61.8%,and specificity of 47.3%,73.6%,and 55.6%respectively.Conclusions BMI,HC,NC,WC,TG,SFA,CI,WHtR,WHR,LAP,BRI,VAI,CVAI and VFA are closely related to cardiovascular autonomic nervous function in T2DM patients.As VFA,Ageand LAP increase,the risk of cardiovascular autonomic dysfunction increases.

Objective To investigate the relationship between interventricular septal dimensions(IVSd)and urinary albumin/creatinine ratio(UACR)in patients with type 2 diabetes mellitus(T2DM).Methods A total of 757 patients with T2DM hospitalized in the Department of Endocrinology of Gansu Provincial People's Hospital from March 2021 to April 2024 were enrolled in this study.All the patients were divided into T2DM patients without proteinuria(n=388),microproteinuria group(Mic,n=260)and macroproteinuria group(Mac,n=109)according to the UACR levels.General clinical data and biochemical indexes were collected from all the patients.Color Doppler echocardiography was used to record left ventricular ejection fraction(LVEF),left ventricular fraction shortening(LVFS),IVSd,left ventricular posterior wall dimensions(LVPWd),and left atrial diameter(LAD).Pearson correlation analysis was conducted to analyze the correlation between IVSd,LVPWd and related indicators of renal function.Logistic regression analysis was conducted to analyze the influencing factors for T2DM patients with proteinuria.The receiver operating characteristic(ROC)curve was used to analyze the predictive value of the DM duration and IVSd in patients with T2DM and proteinuria.Results The DM duration,SBP,FIns,HbA1c,Scr,24 hUTP,UACR,UAER,IVSd,LVPWd were increased successively(P<0.05),while LVEF and eGFR were decreased successively(P<0.05)in T2DM,Mic,Mac group.Age was higher in Mic group than in T2DM group(P<0.05).DBP and FPG were higher in Mac group than in T2DM and Mic group(P<0.05).Pearson correlation analysis showed that IVSd and LVPWd were positively correlated with 24 hUTP,UACR,UAER and Scr(P<0.05),and negatively correlated with eGFR(P<0.05).Logistic regression analysis indicated that the DM duration and IVSd were significant influencing factors for proteinuria in patients with T2DM.ROC curve showed that the area under ROC curve of IVSd was 0.620,with sensitivity 43.3%and specificity 76.8%,respeictively.Conclusions The DM duration and IVSd are influencing factors for UACR in patients with T2DM.The risk of proteinuria in T2DM patients increases with rising IVSd.

Objective To investigate the association between body roundness index(BRI)and hyperuricemia(HUA)in patients with type 2 diabetes mellitus(T2DM).Methods 555 T2DM inpatients were selected from July 2022 to October 2023 in Gansu Province People's Hospital Endocrinology.According to BRI,the T2DM patients were divided into four group:low BRI(L-BRI,BRI≤3.579,n=140)group,moderate BRI(M-BRI,3.579

Objective:To investigate alterations in static regional homogeneity(ReHo) and dynamic regional homogeneity (dReHo) and glucose metabolism in MRI-negative refractory temporal lobe epilepsy (TLE) patients using resting-state PET-MRI, and to evaluate their efficacy in predicting surgical outcomes.Methods:This study was a cross-sectional design. A retrospective analysis was conducted on the clinical and imaging data of 30 patients with MRI-negative refractory TLE (patient group) treated at Xuanwu Hospital, Capital Medical University, between 2016 and 2020, and data from 30 healthy controls (control group). All MRI-negative refractory TLE patients underwent surgical treatment and were further divided into a good prognosis subgroup (Engel Class I, 16 cases) and a poor prognosis subgroup (Engel Class Ⅱ-Ⅳ, 14 cases) based on postoperative Engel classification. Analysis of variance was used to compare differences in static ReHo, dReHo, and glucose metabolism(SUVR) among the three groups. The correlation of static ReHo, dReHo, and SUVR values of differential brain regions with Engel grading was analyzed using Spearman. A support vector machine (SVM) model was constructed using the static ReHo, dReHo, and SUVR values from these differential regions to classify and predict patient prognosis. The predictive performance was evaluated using receiver operating characteristic curves and the area under the curve (AUC).Results:Differential dReHo regions among the good prognosis subgroup, poor prognosis subgroup, and control group were located in the right lateral middle temporal gyrus temporal pole, the right fusiform gyrus, the right insula subfrontal gyrus, the left cuneate lobe, the right medial and paracortical cingulate gyrus, and the right supraparietal gyrus; the differential static ReHo regions were primarily found in the bilateral inferior temporal gyrus, the supraparietal gyrus, and the right subfrontal gyrus, the left medial supraparietal gyrus, the left median frontal gyrus, and the right marginal supraparietal gyrus; SUVR differences were in the affected superior, middle and inferior temporal lobes, the internal olfactory cortex and the temporal pole region. dReHo of right middle temporal gyrus temporal pole in patients with MRI-negative TLE showed a positive correlation with Engel classification ( r=0.421, P=0.020). The SVM model based on dReHo combined with SUVR values classified patients with good and poor prognosis with an AUC of 0.825 and an accuracy of 73.3%. Conclusions:In MRI-negative refractory TLE patients, abnormal dReHo regions are predominantly located in the contralateral default mode network areas and are associated with Engel classification. Combined with glucose metabolism values, dReHo can predict postoperative outcomes in MRI-negative TLE patients.

Objective To explore the correlation between brachial and ankle pulse wave conduction velocity(baPWV)and cardiac structure and function in patients with type 2 diabetes mellitus(T2DM).Methods A total of 443 patients with T2DM who were treated in The Endocrinology Department of Gansu Provincial People's Hospital were enrolled in this study from June 2022 to October 2023.All the patients were divided into simple T2DM group(T2DM,baPWV<1400 cm/s,n=221)and atherosclerosis group(AS,baPWV≥1400 cm/s,n=222)based on baPWV.The cardiac ultrasound diagnostic instrument was used to record left ventricular ejection fraction(LVEF),end diastolic left ventricular diameter(LVd),end diastolic interventricular septal thickness(IVSd),end diastolic left ventricular posterior wall thickness(LVPWd),ratio of early to late diastolic peak velocity of mitral valve annulus(E/A),and ratio of early diastolic peak velocity of mitral valve orifice to early diastolic peak velocity of mitral valve annulus(E/E').Results Age,DM duration,SBP,DBP,HbA1c,TG,ABI,LVEF,IVSd,LVPWd,E/A<1,E/E'＞14,were higher in AS group than in T2DM group(P<0.05 or P<0.01).Spearman correlation analysis shows that E/A<1 was positively correlated with age,DM duration,BMI,SBP,DBP,and ABI(P<0.05 or P<0.01),while negatively correlated with baPWV(P<0.01).Pearson correlation analysis shows that LVPWd was positively correlated with age,DM duration,BMI,SBP,DBP,baPWV,and Scr(P<0.05 or P<0.01).Logistic regression analysis shows that baPWV,ABI,and SBP were the influencing factors for left ventricular diastolic dysfunction.The analysis of the working characteristic curve of the subjects shows that the area under the curve of baPWV,SBP and ABI for predicting left ventricular diastolic dysfunction is 0.647,0.643,and 0.624,with the best cutoff points being 1398.5 cm/s,125.5 mmHg,and 1.107.Conclusions baPWV is closely related to cardiac structure and function in T2DM patients.As baPWV increases,the risk of left ventricular diastolic insufficiency and hypertrophy rises.