1.Preliminary study on an improved method for constructing internal quality control framework of ELISA
Youbin DUAN ; Rui WANG ; Le CHANG ; Changwen QIU ; Zhiqiang LI ; Gengrui CHEN ; Jingjuan YANG ; Qing HE ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(1):103-108
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.
2.Discussion on processing time for Polygonatum kingianum based on analysis of correlation between sugar components and color changes
GUO Hong ; YAO Rui ; LI Zhe ; FAN Jing ; WANG Ying ; GUO Xiaohan ; CHEN Jia ; DUAN Baozhong ; YANG Jianbo ; JING Wenguang ; CHENG Xianlong ; WEI Feng
Drug Standards of China 2026;27(1):0083-0091
Objective: To investigate the correlation between color parameters (L*, a*, b*, Eab*) and the contents of reducing sugars, total polysaccharides, total oligosaccharides, as well as four saccharides (fructose, glucose, sucrose, and kestose) during the nine cycles of steaming and sun-drying processing of Polygonatum kingianum, and to preliminarily explore the optimal processing duration.
Methods: The color changes were objectively evaluated using a colorimeter. The anthrone-sulfuric acid method was employed to determine total polysaccharides and oligosaccharides. The 3,5-dinitrosalicylic acid (DNS) colorimetric method was used to measure total reducing sugar content. High-performance liquid chromatography coupled with charged aerosol detection (HPLC-CAD) was applied for quantitative analysis of fructose, glucose, sucrose, and kestose. Multivariate statistical analysis was conducted to assess samples from different processing stages.
Results: Significant variations in color and component contents were observed across processing stages. The herbal pieces progressively darkened with increased processing cycles: brightness (L*) and total color difference (Eab*) initially decreased then stabilized, while a* (red-green) and b* (yellow-blue) values first increased then declined. Total polysaccharides and oligosaccharides showed overall decreasing trends, whereas reducing sugars initially increased before stabilizing. Fructose and glucose levels rose continuously, while sucrose and kestose decreased progressively, becoming undetectable after five cycles.
Conclusion: The chromatic alteration and saccharide composition of P. kingianum showed significant correlation with processing duration. Both total color difference (Eab*) and reducing sugar content stabilized after four processing cycles (12 hours), suggesting that four cycles of steaming and sun-drying may represent the optimal processing duration.
3.Analytical research on processing techniques of Polygoni Multiflori Radix Praeparata based on chemical composition and color changes correlation
YAO Rui ; GUO Hong ; LI Zhe ; GUO Xiaohan ; ZHANG Xiaoshu ; DUAN Baozhong ; YANG Jianbo ; CHEN Jia ; JING Wenguang ; CHENG Xianlong ; WEI Feng
Drug Standards of China 2026;27(1):0100-0108
Objective: To investigate the correlation between the color parameters (L*, a*, b*, Eab* values) of Polygoni Multiflori Radix Praeparata powder prepared by different processing techniques and the contents of 2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucopyranoside, emodin, physcion, emodin-8-O-β-D-glucopyranoside, physcion-8-O-β-D-glucopyranoside.
Methods: The L*, a*, b* and Eab* values of Polygoni Multiflori Radix Praeparata powder prepared by different processing techniques were determined by spectrophotometer, and the contents of the five components were determined by high performance liquid chromatography. Secondly, SPSS 26.0 software and Simca 14.1 software were used to analyze the correlation.
Results: Through the hierarchical cluster analysis (HCA), it was found that the steamed samples and black bean steamed samples could be obviously divided into two categories: raw products and processed products. The processed products could be further divided into 2-8 h and 12-48 h. Pearson correlation analysis showed that the content of stilbene glycoside was significantly positively correlated with L*, a* and b* values (P<0.01). The a* value was significantly positively correlated with the content of emodin and physcion (P<0.01). Emodin-8-O-β-D-glucoside was positively correlated with L* value and b* value, while physcion-8-O-β-D-glucoside was negatively correlated with a* value. Partial least squares discriminant analysis (PLS) showed that 2,3,5,4’-tetrahydroxystilbene-2-O-β-D-glucoside (VIP=1.69) and emodin-8-O-β-D-glucoside (VIP=1.06) were the key variables affecting chromaticity characteristics (P<0.01).
Conclusion: The three processes of steaming, black bean steaming and black bean stewing are consistent in composition transformation and chromaticity variation, and stilbene glycoside can be used as a specific index component to characterize the processed color. Chromatic parameters can effectively reflect the processing progression and serve as quality monitoring indicators during production.
4.Effect of tirofiban on prognosis in acute anterior circulation large vessel occlusion stroke patients with unsuccessful recanalization after endovascular treatment
Anyu LIAO ; Minxing ZHAO ; Kang YUAN ; Kangmo HUANG ; Zhiliang GUO ; Xianjun HUANG ; Zhenhui DUAN ; Rui LIU ; Guodong XIAO ; Wenhua LIU ; Zhiming ZHOU ; Wusheng ZHU
Chinese Journal of Cerebrovascular Diseases 2025;22(8):515-523,578
Objective To analyze the effects of intravenous tirofiban following endovascular treatment on the prognosis of patients with acute anterior circulation large vessel occlusion stroke who did not achieve successful recanalization.Methods This retrospective study included consecutive patients with acute anterior circulation ischemic stroke who underwent endovascular treatment but did not achieve successful recanalization.These patients were retrospectively enrolled from the Department of Neurology at Nanjing Jinling Hospital,Affiliated Hospital of Medical School,Nanjing University,the Second Affiliated Hospital of Soochow University,Wuhan No.1 Hospital,and Yijishan Hospital of Wannan Medical College(the First Affiliated Hospital of Wannan Medical College)between January 2015 and April 2023.Baseline and clinical data were collected including age,sex,medical history(hypertension,diabetes,atrial fibrillation,hyperlipidemia),personal history(smoking and drinking),National Institutes of Health stroke scale(NIHSS)score at admission,trial of Org 10172 in acute stroke treatment(TOAST)classification(large artery atherosclerosis,cardioembolism,or other types),Alberta stroke program early CT score(ASPECTS)on admission,intravenous thrombolysis,onset-to-puncture time(OTP),collateral circulation status(poor collaterals:American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology[ASTIN/SIR]score 0-2;good collateral:ASTIN/SIR score 3-4),procedure duration(from femoral or radial artery puncture to device removal),occlusion site,number of passes for thrombus retrieval,and post-procedural modified thrombolysis in cerebral infarction(mTICI)grade.Patients were divided into a tirofiban group and a non-tirofiban group based on whether they received post-procedural intravenous tirofiban.The primary outcome is a favorable functional outcome at 90-day since onset(modified Rankin scale[mRS]score ≤ 3).Safety outcomes included mortality at 90-day since onset(mRS score 6),any intracranial hemorrhage within 24 h post-procedure,and symptomatic intracranial hemorrhage within 24 h post-procedure.1∶1 propensity score matchings using the nearest neighbor method was performed based on variables with P<0.05 in the comparison between the tirofiban and non-tirofiban groups.Differences in primary and safety outcomes between the matched groups were compared.Univariate and multivariate Logistic regression analyses were conducted with favorable outcomes at 90 days as the dependent variable to evaluate the effect of intravenous tirofiban administration after endovascular therapy on 90-day prognosis in patients without successful recanalization.Results A total of 356 patients without successful recanalization after endovascular treatment were included,comprising 195 males and 161 females,with a median age of 70(61,78)years(32-92 years).Among them,76 and 280patients were assigned to the tirofiban and non-tirofiban groups,respectively.At 90 days,114 patients had favorable outcomes,while 242 had unfavorable outcomes.(1)Before the 1∶1 propensity score matching,significant differences were observed between the tirofiban and non-tirofiban groups in terms of admission NIHSS score,ASPECTS,good collateral circulation,intravenous thrombolysis,and mTICI grade(all P<0.05).After 1∶1 propensity score matching,66 matched pairs(132 patients)were obtained.No significant differences in the baseline and clinical characteristics were found between the two groups after matching(all P>0.05).(2)After 1∶1 matching,a significant difference was observed in the rate of favorable outcomes at 90 days between the two groups(48.5%[32/66]vs.30.3%[20/66],P=0.033)after propensity score matching,while no significant differences were found in 90-day mortality,intracranial hemorrhage within 24h,or symptomatic intracranial hemorrhage within 24h(all P>0.05).(3)Univariate analysis after 1∶1 matching indicated that age,atrial fibrillation,smoking history,admission NIHSS score,M2 segment middle cerebral artery occlusion,good collateral circulation,number of passes for thrombus retrieval,and tirofiban treatment were factors influencing favorable outcomes at 90 days.Multivariate Logistic regression analysis showed that younger age(aOR,0.942,95%CI 0.906-0.978,P=0.002),lower admission NIHSS score(aOR,0.855,95%CI 0.777-0.941,P=0.001),good collateral circulation(aOR,5.534,95%CI 2.141-14.301,P<0.01),tirofiban treatment(aOR,2.774,95%CI 1.092-7.046,P=0.032),and M2 segment MCA occlusion(reference:internal carotid artery occlusion;aOR,4.874,95%CI 1.428-16.632,P=0.011)were independent predictors of favorable outcomes at 90 days.Conclusions Intravenous tirofiban administration after endovascular therapy may improve 90-day neurological outcomes in patients with acute anterior circulation large vessel occlusion stroke who did not achieve successful recanalization without increasing the risk of hemorrhage.Further large-scale randomized controlled trials are warranted to validate these findings.
5.Meta-synthesis of qualitative studies on the experience of bowel symptoms in patients undergoing sphincter-preserving surgery for rectal cancer
Tingting LIU ; Qiaohong NIU ; Xueping JIAO ; Jiawei WEI ; Shaoming DUAN ; Congli HU ; Rui SU
Chinese Journal of Nursing 2025;60(5):603-610
Objective To systematically evaluate and synthesize the experience and coping process of bowel symptoms in patients after sphincter-preserving surgery for rectal cancer,and to provide the evidence for the subsequent development of bowel symptom management strategies.Methods A comprehensive search was conducted across the Pubmed,Cochrane Library,CINAHL,Embase,Web of Science,CNKI,Wanfang Database,VIP Database and CBM Database for qualitative studies on the experience of bowel symptoms in post-sphincter-preserving surgery patients with rectal cancer.The search period was from database inception to October 2024.The quality of the included literature was assessed according to the Australian Joanna Briggs Institute Center for Evidence-Based Health Care Quality Assessment Criteria for Qualitative Research,and the results were synthesized through the aggregative integration method.Results 14 studies were included,yielding 52 research findings,which were grouped into 10 subcategories and further synthesized into 4 results:the physical and psychological experiences of patients with bowel symptoms;the impact of bowel symptoms on patients'daily lives;coping styles for bowel symptoms in patients;facilitators of patients bowel symptom coping.Conclusion Bowel symptoms have significant negative impacts on the lives of patients following sphincter-preserving surgery for rectal cancer,and healthcare professionals should address these patients'needs by developing effective symptom management strategies and supporting patients in enhancing self-management abilities to improve quality of life.
6.Trends and Risk Factors of Cardiovascular Disease Burden in China From 1990 to 2021 and Disease Burden Prediction
Dongdong ZHENG ; Yingzhu DUAN ; Rui YU
Chinese Circulation Journal 2025;40(5):501-507
Objectives:To explore the trends of cardiovascular disease(CVD)burden in China from 1990 to 2021 and to provide a basis for the scientific development of corresponding preventive and curative measures.Methods:Based on the Global Burden of Disease(GBD)2021 database,we conducted descriptive analyses of age-standardized incidence rate(ASIR),age-standardized prevalence rate(ASPR),disability-adjusted life years(DALY)and other indicators of CVD in China.Indicators were descriptively analysed,trends in CVD burden were analysed using the Joinpoint regression model,the burden of CVD was decomposed according to demographic,ageing and epidemiological changes,and changes in the burden of CVD in 2040 were predicted using the Bayesian age-period-cohort(BAPC)model.Results:In 2021,the ASIR,ASPR,DALY and DALY rates of CVD in China were 811.81 per 100 000,6 603.72 per 100 000,100.2087 million person-years and 5 120.06 per 100 000,respectively.Compared to 1990,the ASIR,ASPR,and DALYs increased by 3.56%,9.62%,and 58.42%,respectively,while the DALYs rate decreased by 36.59%.Additionally,the burden of CVD was higher in males than in females;the ASIR increased rapidly for the first time in 1995-2005,the ASPR increased rapidly from 2000 to 2004,and the DALYs rate increased rapidly from 2000 to 2004,and DALYs rates were generally on a downward trend,but showed a rapid upward trend in 1998-2004.Population growth and aging are the main factors leading to changes in DALYs,43.73%and 172.31%,respectively;in 2021,hypertension and environmental particulate matter are the top two risk factors for CVD in China;projections show that the number of CVD incidence,disease,and cases of DALYs in China in 2040 will be 28.7901 million,226.6148 million,and 169.4057 million person-years,respectively,and the number of cases is on the upward trend.Conclusions:The burden of CVD in China increased overall from 1990 to 2021,and the burden was higher in men than in women,mainly due to population growth,aging,and risk factors.High systolic blood pressure remains the main cause of CVD.
7.Trends and Risk Factors of Cardiovascular Disease Burden in China From 1990 to 2021 and Disease Burden Prediction
Dongdong ZHENG ; Yingzhu DUAN ; Rui YU
Chinese Circulation Journal 2025;40(5):501-507
Objectives:To explore the trends of cardiovascular disease(CVD)burden in China from 1990 to 2021 and to provide a basis for the scientific development of corresponding preventive and curative measures.Methods:Based on the Global Burden of Disease(GBD)2021 database,we conducted descriptive analyses of age-standardized incidence rate(ASIR),age-standardized prevalence rate(ASPR),disability-adjusted life years(DALY)and other indicators of CVD in China.Indicators were descriptively analysed,trends in CVD burden were analysed using the Joinpoint regression model,the burden of CVD was decomposed according to demographic,ageing and epidemiological changes,and changes in the burden of CVD in 2040 were predicted using the Bayesian age-period-cohort(BAPC)model.Results:In 2021,the ASIR,ASPR,DALY and DALY rates of CVD in China were 811.81 per 100 000,6 603.72 per 100 000,100.2087 million person-years and 5 120.06 per 100 000,respectively.Compared to 1990,the ASIR,ASPR,and DALYs increased by 3.56%,9.62%,and 58.42%,respectively,while the DALYs rate decreased by 36.59%.Additionally,the burden of CVD was higher in males than in females;the ASIR increased rapidly for the first time in 1995-2005,the ASPR increased rapidly from 2000 to 2004,and the DALYs rate increased rapidly from 2000 to 2004,and DALYs rates were generally on a downward trend,but showed a rapid upward trend in 1998-2004.Population growth and aging are the main factors leading to changes in DALYs,43.73%and 172.31%,respectively;in 2021,hypertension and environmental particulate matter are the top two risk factors for CVD in China;projections show that the number of CVD incidence,disease,and cases of DALYs in China in 2040 will be 28.7901 million,226.6148 million,and 169.4057 million person-years,respectively,and the number of cases is on the upward trend.Conclusions:The burden of CVD in China increased overall from 1990 to 2021,and the burden was higher in men than in women,mainly due to population growth,aging,and risk factors.High systolic blood pressure remains the main cause of CVD.
8.Impact of hydroxy-safflower yellow A on regeneration and repair capabilities of human umbilical cord mesenchymal stem cells
Yu-kang SUN ; Yan-zhe DUAN ; Jian-lin HUA ; Wei-hao JIA ; Jie-zhong YU ; Cun-gen MA ; Lei JIA ; Rui-ping ZHANG ; Xiao-yan ZHAI
Chinese Pharmacological Bulletin 2025;41(9):1643-1650
Aim To investigate the effects of hydroxyl-safflor yellow A(HSYA)on the regenerative and re-pair functions of human umbilical cord mesenchymal stem cells(hUC-MSCs).Methods hUC-MSCs were mechanically isolated,and their morphology was ob-served.Cell surface marker expression was analyzed u-sing flow cytometry.Osteogenic differentiation was used to confirm the multipotency of the cells.The cells were treated with various concentrations of HSYA(0,100,200,400,600 μmol·L-1),and the optimal con-centration and duration of treatment were determined u-sing the CCK-8 assay.Cells were divided into four groups:control,100,200,and 400 μmol·L-1.The proliferative capacity of hUC-MSCs was assessed by EdU incorporation.Vascular endothelial growth factor(VEGF)and brain-derived neurotrophic factor(BD-NF)levels in the culture supernatant were measured u-sing enzyme-linked immunosorbent assays.Cell migra-tion ability was evaluated by Scratch assays.The ex-pression levels of VEGF,BDNF,and fibroblast growth factor 2(FGF2)were detected by Western blotting.Results The isolated cells exhibited characteristics consistent with stem cell surface markers and demon-strated osteogenic and adipogenic differentiation poten-tial.After 48 hours of treatment,no cytotoxicity was observed at concentrations of 100,200,and 400 μmol·L-1compared to the control group.HSYA signifi-cantly increased the number of EdU-positive cells and cell migration rate,with the most pronounced effect was achieved at 200 μmol·L-1(P<0.01).VEGF and BDNF levels in the supernatant were elevated,with the highest expression observed at 200 μmol·L-1(P<0.01).Similarly,the expression levels of BDNF,VEGF,and FGF2 were significantly upregulated in the HSYA groups,with the highest levels at 200 μmol·L-1(P<0.01).Conclusion HSYA promotes the proliferation,migration and angiogenesis of hUC-MSCs,with an optimal concentration of 200 μmol·L-1.
9.Application of ropivacaine combined with dezocine in painless delivery of primiparas with epidural anesthesia
Dong-dong YANG ; Xiao-yi GONG ; Yun-zhi LING ; Ya-xiang WANG ; Mei SUN ; Rui DUAN ; Xia YE ; Ya ZHANG
Journal of Regional Anatomy and Operative Surgery 2025;34(6):535-539
Objective To investigate the impacts of epidural anesthesia with ropivacaine combined with dezocine on lower limb motor nerve block and maternal and infant outcomes in primipara undergoing painless delivery.Methods A total of 159 primiparas who delivered in Nanjing Jiangbei Hospital were selected as the research objects,and divided into the blank group(53 cases),the ropivacaine group(53 cases)and the combined group(53 cases)by the random number table method.Parturients in the blank group were given natural delivery mode,parturients in the ropivacaine group were given ropivacaine epidural anesthesia,and parturients in the combined group were given dezocine anesthesia on the basis of ropivacaine.Analgesic effect at different time points,time of the first,second and third stage of labor,pressing times of analgesic pump,lower limbs motor nerve block,maternal and infant outcomes,and adverse reactions of parturients were compared among the three groups.Results At 10 minutes after analgesia,60 minutes after analgesia,when the cervix was fully dilated and when the fetus was delivered,the VAS scores of the parturients in the ropivacaine group and the combined group were lower than those in the blank group(P<0.05),and the VAS scores of the parturients in the combined group were significantly lower than those in the ropivacaine group(P<0.05).There was no significant difference in the time of the first,second or third stage of labor of parturients among the three groups(P>0.05);The pressing times of analgesic pump of parturients in the combined group was significantly less than that in the ropivacaine group(P<0.05).There was no statistically significant difference in terms of low limb motor nerve block after painless labor of parturients among the three groups(P>0.05).There were no statistically significant differences in the perineal incision rate or the Apgar scores of newborns at 1 minute and 5 minutes after birth among the three groups(P>0.05).The usage rate of forceps and the rate of conversion to cesarean section in the combined group were significantly lower than those in the ropivacaine group and the blank group(P<0.05).There was no statistically significant difference in the incidence of total adverse reactions among the blank group,the ropivacaine group and the combined group(P>0.05).Conclusion The combination of ropivacaine and dezocine for epidural anesthesia has a better analgesic effect on primiparas with painless delivery,has a smaller impact on lower limb motor nerve block in parturients,and can achieve better maternal and infant outcomes.
10.Impact of hydroxy-safflower yellow A on regeneration and repair capabilities of human umbilical cord mesenchymal stem cells
Yu-kang SUN ; Yan-zhe DUAN ; Jian-lin HUA ; Wei-hao JIA ; Jie-zhong YU ; Cun-gen MA ; Lei JIA ; Rui-ping ZHANG ; Xiao-yan ZHAI
Chinese Pharmacological Bulletin 2025;41(9):1643-1650
Aim To investigate the effects of hydroxyl-safflor yellow A(HSYA)on the regenerative and re-pair functions of human umbilical cord mesenchymal stem cells(hUC-MSCs).Methods hUC-MSCs were mechanically isolated,and their morphology was ob-served.Cell surface marker expression was analyzed u-sing flow cytometry.Osteogenic differentiation was used to confirm the multipotency of the cells.The cells were treated with various concentrations of HSYA(0,100,200,400,600 μmol·L-1),and the optimal con-centration and duration of treatment were determined u-sing the CCK-8 assay.Cells were divided into four groups:control,100,200,and 400 μmol·L-1.The proliferative capacity of hUC-MSCs was assessed by EdU incorporation.Vascular endothelial growth factor(VEGF)and brain-derived neurotrophic factor(BD-NF)levels in the culture supernatant were measured u-sing enzyme-linked immunosorbent assays.Cell migra-tion ability was evaluated by Scratch assays.The ex-pression levels of VEGF,BDNF,and fibroblast growth factor 2(FGF2)were detected by Western blotting.Results The isolated cells exhibited characteristics consistent with stem cell surface markers and demon-strated osteogenic and adipogenic differentiation poten-tial.After 48 hours of treatment,no cytotoxicity was observed at concentrations of 100,200,and 400 μmol·L-1compared to the control group.HSYA signifi-cantly increased the number of EdU-positive cells and cell migration rate,with the most pronounced effect was achieved at 200 μmol·L-1(P<0.01).VEGF and BDNF levels in the supernatant were elevated,with the highest expression observed at 200 μmol·L-1(P<0.01).Similarly,the expression levels of BDNF,VEGF,and FGF2 were significantly upregulated in the HSYA groups,with the highest levels at 200 μmol·L-1(P<0.01).Conclusion HSYA promotes the proliferation,migration and angiogenesis of hUC-MSCs,with an optimal concentration of 200 μmol·L-1.

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