1.National biological standards for antibiotics: an overview
Bufang MA ; Hui LIU ; Xuan JIN ; Yanchun FENG ; Jin LI
Journal of China Pharmaceutical University 2026;57(1):108-114
National biological standards for antibiotics are critical components of the antibiotic quality control system and serve as reference materials for measuring and calibrating the biological activity of antibiotics. This article systematically reviews the classification, definition of potency units, and current research status of commercially available national antibiotic biological standards in China. At present, these standards can be categorized based on chemical structure, number of components, and development methods. The definition of potency units has evolved from an early “arbitrarily assigned unit” to “being represented by the mass of the antibiotic salt” and, more recently, to the current mainstream approach of “being represented by the mass of the active ingredient”. This evolution reflects a shift in quality control philosophy from primarily biological analysis to a system dominated by chemical analysis supplemented by biological methods. Current research focuses on optimizing potency determination methods, studying the unification of content and potency, and implementing dual quality control of both the potency and the ratio/content of active components in multi-component antibiotics. For complex multi-component antibiotics, the microbiological assay based on biological activity remains irreplaceable in quality control. Future efforts should emphasize further method optimization, ensuring batch-to-batch consistency of standards, and advancing precision quality control as key research priorities for antibiotic biological standards.
2.Correlation of bone metabolic markers with severity of aortic calcification and risk for cardiovascular events in elderly peritoneal dialysis patients
Jinxiu CHENG ; Yanchun CAO ; Shengjun LIU ; Yujie JIN ; Hua LIU ; Linlin WANG ; Shaoqiang QIN
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(2):145-148
Objective To investigate the correlation between novel bone metabolism markers and the degree of aortic calcification as well as cardiovascular event risk in elderly patients treated by PD.Methods A prospective trial was conducted on 230 elderly patients receiving continuous am-bulatory PD in our department from February 2022 to February 2024.According to the occur-rence of cardiovascular events during dialysis treatment,they were divided into a cardiovascular event group(n=92)and a control group(n=138).Relevant clinical data were collected,aortic calcification was assessed using AAC scores,and serum levels of bone metabolism markers,inclu-ding osteoprotegerin,TRACP,and PINP were measured.Results The serum levels of osteoprote-gerin,TRACP and PINP were significantly higher in the cardiovascular event group than the con-trol group(P<0.01).The cardiovascular event group had obviously severe calcification and higher AAC score than the control group(P<0.01).The serum levels of the three bone metabolism markers were notably higher in the patients with severe calcification than those with moderate calcification,followed by mild calcification in turn(P<0.01).Spearman correlation analysis indi-cated that the levels of the three indicators were positively correlated with the degree of aortic cal-cification in elderly PD patients(r=0.465,P=0.000;r=0.396,P=0.000;r=0.434,P=0.000).Multivariate logistic regression analysis showed that these three indicators were risk factors for cardiovascular events in elderly PD patients(P<0.01).Conclusion The three bone metabolism markers are significantly correlated with aortic calcification severity and cardiovascular event risk in elderly PD patients.Monitoring these marker levels may be helpful for the assessment and man-agement of cardiovascular risk.
3.Clinical characteristics of respiratory syncytial virus in children with acute lower respiratory tract infection in Kunming area
Haifeng JIN ; Yanchun WANG ; Shufang XIAO
Chinese Pediatric Emergency Medicine 2025;32(8):579-585
Objective:To analyze the clinical characteristics of children hospitalized with acute lower respiratory tract infections (ALRTI) caused by respiratory syncytial virus (RSV) in Kunming area in 2023.Methods:The clinical data of children with RSV-ALRTI admitted to Kunming Children's Hospital from January to December 2023 were retrospectively analyzed.According to the severity of the disease and whether the children developed severe pneumonia,they were divided into common group and severe group.The general data,clinical manifestations,laboratory indexes,imaging results,treatment and outcomes of the children between the two groups were compared.Multinomial Logistic regression analysis was used to study the risk factors for severe RSV-ALRTI.Results:A total of 696 children with RSV-ALRTI were included,including 432 males (62.1%) and 264 females (37.9%),with a median age of 1.30 (0.40,3.38) years.The onset of RSV-ALRTI occured throughout the year,with a peak incidence in May to August (60.6%).One hundred and seventy-one of 696 samples were tested RSV gene sequence,and two genotypes of RSV A-ON1(60.8%) and RSV B-BA9(39.2%) were detected.Among the 696 children,480 (69.0%) were in the common group and 216 (31.0%) were in the severe group.The age of the children in the severe group was lower than that of the common group,and the proportions of age <1 year,preterm birth,congenital diseases (congenital anomalies of airway development,congenital heart disease),combined Mycoplasma pneumoniae infections,and combined bacterial infections were higher than those of the common group ( P<0.05).There was no statistically significant differences in fever and cough symptoms between the two groups ( P>0.05),but the proportions of children in the severe group with wheezing,shortness of breath,dyspnea,vomiting,and diarrhea were significantly higher than those in the common group ( P<0.05),and the proportions of moist rales and wheezing heard by lung auscultation were significantly higher than those in the common group ( P<0.05).The levels of leukocytes,neutrophils,neutrophil percentage,platelets,procalcitonin,lactate dehydrogenase,alanine aminotransferase,aspartate aminotransferase,creatine kinase isoenzyme,and ferritin in the severe group were higher than those in the common group,while the levels of hemoglobin,lymphocyte percentage,albumin,creatinine,IgG,IgM,IgA,interleukin 6,D-dimer,and fibrin were lower than those in the common group ( P<0.05).The proportions of pulmonary consolidation and pleural effusion in the severe group were higher than those in the common group,and the severe group was more likely to have bilateral pulmonary consolidation ( P<0.05).Both groups of children were given interferon aerosol inhalation for antiviral treatment,and actively symptomatic and supportive treatment.One case in the severe group died during hospitalization,and the remaining 695 cases were cured and discharged.The proportions of children in the severe group using antibiotics,dual antibiotics,intravenous hormones,intravenous immunoglobulin,complications,transfer to PICU,use of invasive mechanical ventilation,length of hospital stay,and treatment costs were significantly higher than those in the common group ( P<0.001).Multinomial Logistic regression analysis showed that low age ( OR=0.878,95% CI 0.800~0.963, P=0.006),congenital diseases (congenital anomalies of airway development,congenital heart disease) ( OR=2.892,95% CI 1.977~4.233, P<0.001),and co-infection with bacteria ( OR=1.846,95% CI 1.268~2.686, P=0.001) were risk factors for the development of severe pneumonia in RSV-infected children. Conclusions:In 2023,RSV-ALRTI in children in Kunming area had an incidence throughout the year,and the peak age group of incidence was predominantly <1 year old,and the main genotype of infection was RSV A-ON1.Children with RSV-ALRTI who are young,suffering from congenital diseases (congenital anomalies of airway development,congenital heart disease) and complicated with bacterial infection are more likely to develop into severe diseases,and should be paid close attention and active intervention to reduce the incidence of critical illness.
4.Experience of master degree nursing students and their supervisors in the dual-supervisor system:a qualitative study
Yuxian ZHENG ; Yeling LIU ; Ziyuan JIN ; Yanchun WU ; Manshan SUN ; Kang LIN ; Hongchun LIN ; Mingming CAI ; Hong ZHANG
Modern Clinical Nursing 2025;24(8):73-79
Objective To explore the experiences of master degree nursing students and their supervisors under the dual-supervisor system.Methods A phenomenological research was adopted in this study eighteen master degree nursing students,five principle supervisors and four assistant supervisors from our university were selected through purposive sampling for semi-structured interviews between July and September 2023.Data acquired from the interviews was analysed using Colaizzi's method to summarise and extract the themes.Results Three main themes and eleven sub-themes were extracted,including the collaborative framework of the dual-mentor system(discrepancies in the perception of the dual-mentor system between faculty and students,the selection and matching process for associate mentors,the division of responsibilities and collaborative dynamics between primary and associate mentors,student-centered personalized training strategies,context-specific guidance provided by associate mentors,and the extent to which inter-role communication relies on student initiative),the benefits of the dual-mentor system(encompassing diversified academic and professional guidance,as well as integrated theoretical and practical support)and the expectations held by faculty and students regarding the dual-mentor system(refining institutional design and reinforcing accountability,enhancing the support infrastructure for associate mentors,and improving the tripartite communication mechanism among faculty,students,and associate mentors).Conclusion In nursing postgraduate education,the roles and responsibilities within the dual-mentor system can be more clearly delineated,and inter-mentor collaboration should be further strengthened.It is recommended to enhance tripartite communication among faculty,students,and associate mentors to foster the effective implementation and development of the dual-mentor system.
5.Correlation of bone metabolic markers with severity of aortic calcification and risk for cardiovascular events in elderly peritoneal dialysis patients
Jinxiu CHENG ; Yanchun CAO ; Shengjun LIU ; Yujie JIN ; Hua LIU ; Linlin WANG ; Shaoqiang QIN
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(2):145-148
Objective To investigate the correlation between novel bone metabolism markers and the degree of aortic calcification as well as cardiovascular event risk in elderly patients treated by PD.Methods A prospective trial was conducted on 230 elderly patients receiving continuous am-bulatory PD in our department from February 2022 to February 2024.According to the occur-rence of cardiovascular events during dialysis treatment,they were divided into a cardiovascular event group(n=92)and a control group(n=138).Relevant clinical data were collected,aortic calcification was assessed using AAC scores,and serum levels of bone metabolism markers,inclu-ding osteoprotegerin,TRACP,and PINP were measured.Results The serum levels of osteoprote-gerin,TRACP and PINP were significantly higher in the cardiovascular event group than the con-trol group(P<0.01).The cardiovascular event group had obviously severe calcification and higher AAC score than the control group(P<0.01).The serum levels of the three bone metabolism markers were notably higher in the patients with severe calcification than those with moderate calcification,followed by mild calcification in turn(P<0.01).Spearman correlation analysis indi-cated that the levels of the three indicators were positively correlated with the degree of aortic cal-cification in elderly PD patients(r=0.465,P=0.000;r=0.396,P=0.000;r=0.434,P=0.000).Multivariate logistic regression analysis showed that these three indicators were risk factors for cardiovascular events in elderly PD patients(P<0.01).Conclusion The three bone metabolism markers are significantly correlated with aortic calcification severity and cardiovascular event risk in elderly PD patients.Monitoring these marker levels may be helpful for the assessment and man-agement of cardiovascular risk.
6.Experience of master degree nursing students and their supervisors in the dual-supervisor system:a qualitative study
Yuxian ZHENG ; Yeling LIU ; Ziyuan JIN ; Yanchun WU ; Manshan SUN ; Kang LIN ; Hongchun LIN ; Mingming CAI ; Hong ZHANG
Modern Clinical Nursing 2025;24(8):73-79
Objective To explore the experiences of master degree nursing students and their supervisors under the dual-supervisor system.Methods A phenomenological research was adopted in this study eighteen master degree nursing students,five principle supervisors and four assistant supervisors from our university were selected through purposive sampling for semi-structured interviews between July and September 2023.Data acquired from the interviews was analysed using Colaizzi's method to summarise and extract the themes.Results Three main themes and eleven sub-themes were extracted,including the collaborative framework of the dual-mentor system(discrepancies in the perception of the dual-mentor system between faculty and students,the selection and matching process for associate mentors,the division of responsibilities and collaborative dynamics between primary and associate mentors,student-centered personalized training strategies,context-specific guidance provided by associate mentors,and the extent to which inter-role communication relies on student initiative),the benefits of the dual-mentor system(encompassing diversified academic and professional guidance,as well as integrated theoretical and practical support)and the expectations held by faculty and students regarding the dual-mentor system(refining institutional design and reinforcing accountability,enhancing the support infrastructure for associate mentors,and improving the tripartite communication mechanism among faculty,students,and associate mentors).Conclusion In nursing postgraduate education,the roles and responsibilities within the dual-mentor system can be more clearly delineated,and inter-mentor collaboration should be further strengthened.It is recommended to enhance tripartite communication among faculty,students,and associate mentors to foster the effective implementation and development of the dual-mentor system.
7.Clinical characteristics of respiratory syncytial virus in children with acute lower respiratory tract infection in Kunming area
Haifeng JIN ; Yanchun WANG ; Shufang XIAO
Chinese Pediatric Emergency Medicine 2025;32(8):579-585
Objective:To analyze the clinical characteristics of children hospitalized with acute lower respiratory tract infections (ALRTI) caused by respiratory syncytial virus (RSV) in Kunming area in 2023.Methods:The clinical data of children with RSV-ALRTI admitted to Kunming Children's Hospital from January to December 2023 were retrospectively analyzed.According to the severity of the disease and whether the children developed severe pneumonia,they were divided into common group and severe group.The general data,clinical manifestations,laboratory indexes,imaging results,treatment and outcomes of the children between the two groups were compared.Multinomial Logistic regression analysis was used to study the risk factors for severe RSV-ALRTI.Results:A total of 696 children with RSV-ALRTI were included,including 432 males (62.1%) and 264 females (37.9%),with a median age of 1.30 (0.40,3.38) years.The onset of RSV-ALRTI occured throughout the year,with a peak incidence in May to August (60.6%).One hundred and seventy-one of 696 samples were tested RSV gene sequence,and two genotypes of RSV A-ON1(60.8%) and RSV B-BA9(39.2%) were detected.Among the 696 children,480 (69.0%) were in the common group and 216 (31.0%) were in the severe group.The age of the children in the severe group was lower than that of the common group,and the proportions of age <1 year,preterm birth,congenital diseases (congenital anomalies of airway development,congenital heart disease),combined Mycoplasma pneumoniae infections,and combined bacterial infections were higher than those of the common group ( P<0.05).There was no statistically significant differences in fever and cough symptoms between the two groups ( P>0.05),but the proportions of children in the severe group with wheezing,shortness of breath,dyspnea,vomiting,and diarrhea were significantly higher than those in the common group ( P<0.05),and the proportions of moist rales and wheezing heard by lung auscultation were significantly higher than those in the common group ( P<0.05).The levels of leukocytes,neutrophils,neutrophil percentage,platelets,procalcitonin,lactate dehydrogenase,alanine aminotransferase,aspartate aminotransferase,creatine kinase isoenzyme,and ferritin in the severe group were higher than those in the common group,while the levels of hemoglobin,lymphocyte percentage,albumin,creatinine,IgG,IgM,IgA,interleukin 6,D-dimer,and fibrin were lower than those in the common group ( P<0.05).The proportions of pulmonary consolidation and pleural effusion in the severe group were higher than those in the common group,and the severe group was more likely to have bilateral pulmonary consolidation ( P<0.05).Both groups of children were given interferon aerosol inhalation for antiviral treatment,and actively symptomatic and supportive treatment.One case in the severe group died during hospitalization,and the remaining 695 cases were cured and discharged.The proportions of children in the severe group using antibiotics,dual antibiotics,intravenous hormones,intravenous immunoglobulin,complications,transfer to PICU,use of invasive mechanical ventilation,length of hospital stay,and treatment costs were significantly higher than those in the common group ( P<0.001).Multinomial Logistic regression analysis showed that low age ( OR=0.878,95% CI 0.800~0.963, P=0.006),congenital diseases (congenital anomalies of airway development,congenital heart disease) ( OR=2.892,95% CI 1.977~4.233, P<0.001),and co-infection with bacteria ( OR=1.846,95% CI 1.268~2.686, P=0.001) were risk factors for the development of severe pneumonia in RSV-infected children. Conclusions:In 2023,RSV-ALRTI in children in Kunming area had an incidence throughout the year,and the peak age group of incidence was predominantly <1 year old,and the main genotype of infection was RSV A-ON1.Children with RSV-ALRTI who are young,suffering from congenital diseases (congenital anomalies of airway development,congenital heart disease) and complicated with bacterial infection are more likely to develop into severe diseases,and should be paid close attention and active intervention to reduce the incidence of critical illness.
8.Microbiome study of deep invasive endometriosis lesions
Ping HUANG ; Kangyun LAN ; Yanchun LIANG ; Qing CHEN ; Ying JIN ; Guangyuan CHEN ; Gang NIU
The Journal of Practical Medicine 2024;40(21):3023-3030
Objective To investigate the microbiome composition of deep invasive endometriosis lesions,offering novel insights into its pathogenesis,diagnosis,and treatment strategies.Methods From May 2021 to May 2022,we collected samples of normal endometrium(normal group,n=10),endometrium from patients with deep infiltrating endometriosis(DIE endometrium group,n=14),and lesions from these patients(DIE lesion group,n=10)for 16s rRNA sequencing analysis.We employed the bacterial community diversity algorithm(alpha diversity and beta diversity),principal coordinate analysis(PCoA)distance matrix algorithms(Bray-Curtis and Unifrac matrices),as well as the biological identification algorithm(LeFSe)to investigate microbiome differences between groups and identify differentially abundant bacteria and enriched KEGG functions.Results The diversity of the three groups did not show any significant difference,while the β diversity exhibited a statistically significant distinc-tion(P=0.005 5).The focus group had a relatively low abundance of Firmicutes at the phylum level and a relatively increased abundance of Fusobacteria.At the genus level,there was an increased relative abundance of Enterococcus and Prevotella.LEFse analysis suggested that Proteobacteria and Gammaproteobacteria were the main dominant in the lesion group.Notably,Gamma proteobacteria emerged as a key differential species among the three groups'microbial flora with statistical significance(P=0.021 2).Conclusion Compared to the normal group and DIE group,there was a significant increase in the abundance of Fusobacteria,Proteobacteria,Gammaproteobacteria,Enterococcus,and Prevotella.These findings offer novel therapeutic targets for the prevention and intervention of deep infiltrating endometriosis.
9.Effectiveness of fibrosis-4 versus aspartate aminotransferase-to-platelet ratio index in evaluating liver fibrosis degree in patients with chronic HBV infection
Xiaoting LI ; Bobin HU ; Hongyu LIU ; Chao JIN ; Cailian CAI ; Keshan WANG ; Yanchun WEI ; Jianning JIANG ; Minghua SU
Journal of Clinical Hepatology 2024;40(12):2424-2429
ObjectiveTo investigate the performance of fibrosis-4 (FIB-4) versus aspartate aminotransferase-to-platelet ratio index (APRI) in predicting advanced liver fibrosis and disease progression in patients with chronic HBV infection. MethodsA total of 497 patients with chronic HBV infection who underwent liver biopsy in The First Affiliated Hospital of Guangxi Medical University from February 2013 to December 2022 were enrolled, among whom 404 were enrolled in a retrospective study and 75 were enrolled in a prospective study. Related indicators were collected, including demographic features (sex and age), biochemical indices (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]), and platelet count, and FIB-4 and APRI were calculated. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the Kruskal-Wallis H test was used for comparison between multiple groups; the chi-square test was used for comparison of categorical data between groups. The area under the ROC curve (AUC) was used to assess the ability of APRI and FIB-4 in evaluating liver fibrosis degree and disease progression in patients with chronic HBV infection. ResultsIn the retrospective analysis, compared with the FIB-4<2.67 group, the FIB-4≥2.67 group had a significantly higher proportion of the patients who were diagnosed with liver cirrhosis or hepatocellular carcinoma (66.19% vs 47.54%, χ²=12.75, P<0.001). The medians of FIB-4 and APRI increased significantly with liver fibrosis degree from F0 to F4 (H=42.5 and 35.9, both P<0.001). As for the fibrosis stage of F0-F4, the median of FIB-4 was significantly higher than that of APRI in the patients with the same fibrosis stage (H=59.71, P<0.001). FIB-4 and APRI had a similar AUC for predicting stage F3 fibrosis (0.67 vs 0.65, Z=0.71, P=0.480), while FIB-4 had a higher AUC for predicting stage F4 fibrosis than APRI (0.72 vs 0.64, Z=10.50, P<0.001). In the prospective study cohort, FIB-4 and APRI showed an increasing trend over time in predicting disease progression (chronic hepatitis B to liver cirrhosis), with an AUC of 0.718 (95% confidence interval [CI]: 0.476 — 0.760) and 0.555 (95%CI: 0.408 — 0.703), respectively, and FIB-4 had a significantly higher accuracy than APRI in predicting disease progression (χ2=12.44, P<0.001). ConclusionFIB-4 and APRI can be used to evaluate advanced liver fibrosis (F3 and F4) and predict disease progression, and FIB-4 is superior to APRI in certain aspects.
10.Coronary CT Angiography-Based Mechanomics Predicts Atherosclerotic Plaque Formation in Regions Proximal to Myocardial Bridging
Yanchun CHEN ; Jin ZHENG ; Zhongzhao TENG ; Longjiang ZHANG
Journal of Sichuan University (Medical Sciences) 2024;55(6):1378-1385
Objective To assess with machine learning the predictive value of mechanomics derived from coronary CT angiography(CCTA)for atherosclerotic plaque formation in regions proximal to myocardial bridging(MB)in the left anterior descending coronary artery(LAD).Methods This retrospective study included a cohort of patients with MB in LAD and no atherosclerotic plaque formation in LAD as confirmed by two CCTA conducted between January 2007 and April 2021 at our hospital.The interval between the two CCTA examinations was more than 3 months.The primary endpoint was the formation of atherosclerotic plaques in regions proximal to the myocardial bridging.Patient demographic characteristics and clinical risk factors were documented.Then,the patients were matched by age and sex in a 1-to-1 ratio and divided into two groups,those with plaque formation and those without plaque formation.Computational fluid dynamics analysis was performed based on CCTA.Key anatomical parameters of MB,including location,length,depth,and systolic compression index,were meticulously measured on the CCTA images.Mechanomic data were extracted from the region proximal to the MB.A multivariate Cox regression analysis was performed to identify significant features.A random forest algorithm was used to select mechanomic features for subsequent modeling and to assign scores for each patient's mechanomic features.The log-rank test and Kaplan-Meier curves were used to investigate the mechanomic model's predictive performance concerning plaque formation.Additionally,the operator characteristic curves were applied to evaluate how well the model could predict plaque formation across various myocardial bridge subgroups.Results A total of 104 patients with LAD MB were recruited.The mean age of the subjects were(54.56±10.56)years and 75.00%(78/104)of them were male.Among them,52 developed plaque formation over a median follow-up period of 3.0 years.Apart from a smoking history,which was more prevalent in the group with plaque formation than that in the group without plaque formation(21.15%vs.5.77%,P=0.04),no significant differences between the groups were observed in terms of the other clinical or anatomical characteristics(all P≤0.05).The participants were divided into a training set(n=74)and a validation set(n=30)at a 7∶3 ratio.With the mechanomics model constructed using the random forest algorithm,the patients were classified into a high-score group(≥0.46)and a low-score group(<0.46)based on a cutoff score of 0.46.The mechanomics model achieved a sensitivity of 0.87(0.58-0.98)and an accuracy of 0.63(0.44-0.79)in the validation set.The multivariate Cox regression model revealed a strong positive association between mechanomics and plaque formation(hazards ratio[HR]:10.58;95%confidence interval[CI]:3.23-34.64,P<0.001).The log-rank test showed that the high-score group in the mechanomics model was more likely to develop plaques at the proximal regions of the myocardial bridge compared to the low-score group(P<0.001).The area under the curve(AUC)for plaque formation,as predicted by the model,was 0.88(95%CI:0.82-0.95)for the entire population,0.89(95%CI:0.82-0.96)for the training set,0.86(95%CI:0.74-0.99)for the validation set,0.92(95%CI:0.86-0.97)for the superficial MB group,0.86(95%CI:0.74-0.98)for the long MB group,and 0.91(95%CI:0.83-0.98)for the short MB group.Conclusion The mechanomic assessment holds substantial potential as a predictive tool for atherosclerotic plaque formation in regions proximal to MB in LAD.

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