1.Study on the risk factors and predictive model for acute kidney injury during tacrolimus treatment for pediatric steroid-resistant nephrotic syndrome
Yuqing LIU ; Lei ZHU ; Zhaohuan HAN ; Lei ZHAO
China Pharmacy 2026;37(1):66-71
OBJECTIVE To explore the risk factors for acute kidney injury (AKI) in children with steroid-resistant nephrotic syndrome (SRNS) during tacrolimus treatment and construct a predictive model. METHODS A retrospective selection was made of 155 children diagnosed with SRNS and treated with tacrolimus at Xuzhou Children’s Hospital from January 1, 2022, to December 31, 2023, serving as the study subjects. Various clinical data of the children were collected by reviewing the medical record system. Children who developed AKI during medication were assigned to the AKI group (n=26), and those who did not develop AKI were assigned to the control group (n=129). Univariate and multivariate Logistic regression analyses were used to screen independent risk factors. A clinical predictive model was constructed based on significant variables, and nomogram, calibration curve, receiver operator characteristic curve, and decision curve were drawn to evaluate the model’s performance. RESULTS Univariate analysis showed that blood urea nitrogen (BUN), serum creatinine (Scr), estimated glomerular filtration rate (eGFR), the maximum trough concentration (cmin) of tacrolimus, CYP3A5*3/*3 genotype, concurrent infection, concurrent hypertension, and the use of non-steroidal anti-inflammatory drugs were influencing factors for AKI in children with SRNS during tacrolimus treatment (P<0.05). Multivariate Logistic regression analysis revealed that BUN≥9.58 mmol/L, Scr≥125 μmol/L, eGFR<37 mL/(min·1.73 m2), tacrolimus maximum cmin≥11.26 ng/mL,CYP3A5*3/*3 genotype, concurrent infection, and concurrent hypertension were independent risk factors for AKI in children with SRNS during tacrolimus treatment (P<0.05). The constructed clinical predictive model had an area under the curve of 0.747, showing good agreement between predicted and actual AKI occurrence and demonstrating favorable clinical net benefit in predicting AKI in children. CONCLUSIONS Impaired baseline renal function (elevated BUN, elevated Scr, and decreased eGFR), elevated maximum cmin of tacrolimus, CYP3A5*3/*3 genotype, concurrent infection, and hypertension during treatment are independent risk factors for AKI in children with SRNS during tacrolimus treatment. The established clinical predictive model provides a scientific basis for implementing risk stratification management.
2.Identification of core genes of osteoarthritis by bioinformatics
Xuekun ZHU ; Heng LIU ; Hui FENG ; Yunlong GAO ; Lei WEN ; Xiaosong CAI ; Ben ZHAO ; Min ZHONG
Chinese Journal of Tissue Engineering Research 2025;29(3):637-644
BACKGROUND:At present,osteoarthritis has become a major disease affecting the quality of life of the elderly,and the therapeutic effect is poor,often focusing on preventing the disease process,and the pathogenesis of osteoarthritis is still not fully understood.Bioinformatics analysis was carried out to explore the main pathogenesis of osteoarthritis and related mechanisms of gene coding regulation. OBJECTIVE:To screen core differential genes with a major role in osteoarthritis by gene expression profiling. METHODS:Datasets were downloaded from the Gene Expression Omnibus(GEO):GSE114007,GSE117999,and GSE129147.Differential genes in the GSE114007 and GSE117999 data collections were screened using R software,performing differential genes to weighted gene co-expression network analysis.The module genes most relevant to osteoarthritis were selected to perform protein interaction analysis.Candidate core genes were selected using the cytocape software.The candidate core genes were subsequently subjected to least absolute shrinkage and selection operator regression and COX analysis to identify the core genes with a key role in osteoarthritis.The accuracy of the core genes was validated using an external dataset,GSE129147. RESULTS AND CONCLUSION:(1)A total of 477 differential genes were identified,265 differential genes associated with osteoarthritis were obtained by weighted gene co-expression network analysis,and 8 candidate core genes were identified.The least absolute shrinkage and selection operator regression analysis finally yielded a differential gene ASPM with core value that was externally validated.(2)It is concluded that abnormal gene ASPM expression screened by bioinformatics plays a key central role in osteoarthritis.
3.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
4.Effect of Gynostemma pentaphyllum Alcohol Extract on Glucose and Lipid Metabolism Disorders in db/db Mice Based on Transcriptomics and Gut Microbiota
Yifei ZHU ; Lei DING ; Wei LIU ; Yahui SUN ; Lingling QIN ; Lili WU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):80-89
ObjectiveTo investigate the efficacy and underlying mechanisms of Gynostemma pentaphyllum alcohol extract in improving glucose and lipid metabolism disorders in db/db mice through transcriptomics and gut microbiota analysis. MethodsEighteen db/db mice were randomly assigned to the model(DM) group, metformin(MET) group, and G. pentaphyllum alcohol extract(GP) group, with six mice in each group, based on stratification of fasting blood glucose and body weight. An additional six db/m mice were selected as the normal control(NC) group. Mice in the NC and DM groups were administered deionized water (10 mL·kg-1) daily. The MET group received metformin (0.195 g·kg-1) by gavage. The GP group was treated with G. pentaphyllum alcohol extract (3.9 g·kg-1) by gavage for six weeks. Fasting blood glucose was measured every two weeks. After six weeks of intervention, serum levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CREA), and blood urea nitrogen (BUN) were assessed. Enzyme-linked immunosorbent assay (ELISA) was used to measure insulin (FINS), adiponectin (ADP), and tumor necrosis factor-α (TNF-α). Hematoxylin-eosin (HE) staining was used to observe liver histomorphology, periodic acid-Schiff (PAS) staining was employed to assess hepatic glycogen synthesis, and Oil Red O staining was used to detect hepatic lipid deposition. Liver transcriptomic data were used to identify differentially expressed genes in the liver and conduct enrichment analysis. Real-time PCR was employed to verify the expression levels of adiponectin gene (Adipoq), peroxisome proliferator-activated receptor gamma coactivator-1α (PGC-1α), AMP-activated protein kinase (AMPK), peroxisome proliferator-activated receptor α (PPARα), glucokinase (GCK), forkhead box (Fox)O1, FoxO3, phosphoenolpyruvate carboxykinase (PEPCK), and glucose-6-phosphatase (G6PC). Metagenomic sequencing was conducted to analyze changes in gut microbiota composition. ResultsCompared with the NC group, the DM group exhibited significantly elevated fasting blood glucose (P<0.01), serum AST, ALT, TC, TG, LDL-C, and HDL-C (P<0.01). FINS, homeostatic model assessment for insulin resistance (HOMA-IR), and the inflammatory cytokine TNF-α were significantly increased (P<0.01), while ADP was significantly decreased (P<0.05). Histological analysis confirmed severe hepatic steatosis and excessive lipid accumulation in the DM group, along with markedly reduced glycogen synthesis. Compared with the DM group, the GP group showed significantly decreased fasting blood glucose (P<0.01), reduced serum TC, LDL-C, and HDL-C levels (P<0.05), significantly decreased serum TG and AST levels (P<0.01), significantly reduced FINS, HOMA-IR, and TNF-α levels (P<0.01), and significantly increased ADP (P<0.01). Hepatic steatosis and lipid deposition were significantly alleviated, while glycogen synthesis was markedly enhanced. Transcriptomic differential and enrichment analyses suggested that the mechanisms by which G. pentaphyllum alcohol extract improved hepatic glucose and lipid metabolism in db/db mice may involve regulation of the AMPK and FoxO signaling pathways. Real-time PCR results confirmed that expression of PGC-1α, PEPCK, G6PC, FoxO1, and FoxO3 was significantly downregulated following treatment with G. pentaphyllum alcohol extract (P<0.05, P<0.01), whereas mRNA expression of Adipoq, PPARα, GCK, and AMPK was significantly upregulated (P<0.05, P<0.01). Metagenomic analysis showed that the relative abundance of Lactobacillus, Alistipes, and Akkermansia species was higher in the GP group than in the DM group. ConclusionG. pentaphyllum alcohol extract may improve glucose and lipid metabolism disorders in db/db mice by regulating the hepatic AMPK/PPARα pathway to suppress lipid deposition and alleviate hepatic steatosis, by inhibiting gluconeogenesis through the AMPK/PGC-1α and FoxO pathways to lower fasting blood glucose, and by increasing the abundance of beneficial gut bacteria such as Lactobacillus, Alistipes, and Akkermansia to restore gut microbiota balance.
5.Effect of Gynostemma pentaphyllum Alcohol Extract on Glucose and Lipid Metabolism Disorders in db/db Mice Based on Transcriptomics and Gut Microbiota
Yifei ZHU ; Lei DING ; Wei LIU ; Yahui SUN ; Lingling QIN ; Lili WU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):80-89
ObjectiveTo investigate the efficacy and underlying mechanisms of Gynostemma pentaphyllum alcohol extract in improving glucose and lipid metabolism disorders in db/db mice through transcriptomics and gut microbiota analysis. MethodsEighteen db/db mice were randomly assigned to the model(DM) group, metformin(MET) group, and G. pentaphyllum alcohol extract(GP) group, with six mice in each group, based on stratification of fasting blood glucose and body weight. An additional six db/m mice were selected as the normal control(NC) group. Mice in the NC and DM groups were administered deionized water (10 mL·kg-1) daily. The MET group received metformin (0.195 g·kg-1) by gavage. The GP group was treated with G. pentaphyllum alcohol extract (3.9 g·kg-1) by gavage for six weeks. Fasting blood glucose was measured every two weeks. After six weeks of intervention, serum levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CREA), and blood urea nitrogen (BUN) were assessed. Enzyme-linked immunosorbent assay (ELISA) was used to measure insulin (FINS), adiponectin (ADP), and tumor necrosis factor-α (TNF-α). Hematoxylin-eosin (HE) staining was used to observe liver histomorphology, periodic acid-Schiff (PAS) staining was employed to assess hepatic glycogen synthesis, and Oil Red O staining was used to detect hepatic lipid deposition. Liver transcriptomic data were used to identify differentially expressed genes in the liver and conduct enrichment analysis. Real-time PCR was employed to verify the expression levels of adiponectin gene (Adipoq), peroxisome proliferator-activated receptor gamma coactivator-1α (PGC-1α), AMP-activated protein kinase (AMPK), peroxisome proliferator-activated receptor α (PPARα), glucokinase (GCK), forkhead box (Fox)O1, FoxO3, phosphoenolpyruvate carboxykinase (PEPCK), and glucose-6-phosphatase (G6PC). Metagenomic sequencing was conducted to analyze changes in gut microbiota composition. ResultsCompared with the NC group, the DM group exhibited significantly elevated fasting blood glucose (P<0.01), serum AST, ALT, TC, TG, LDL-C, and HDL-C (P<0.01). FINS, homeostatic model assessment for insulin resistance (HOMA-IR), and the inflammatory cytokine TNF-α were significantly increased (P<0.01), while ADP was significantly decreased (P<0.05). Histological analysis confirmed severe hepatic steatosis and excessive lipid accumulation in the DM group, along with markedly reduced glycogen synthesis. Compared with the DM group, the GP group showed significantly decreased fasting blood glucose (P<0.01), reduced serum TC, LDL-C, and HDL-C levels (P<0.05), significantly decreased serum TG and AST levels (P<0.01), significantly reduced FINS, HOMA-IR, and TNF-α levels (P<0.01), and significantly increased ADP (P<0.01). Hepatic steatosis and lipid deposition were significantly alleviated, while glycogen synthesis was markedly enhanced. Transcriptomic differential and enrichment analyses suggested that the mechanisms by which G. pentaphyllum alcohol extract improved hepatic glucose and lipid metabolism in db/db mice may involve regulation of the AMPK and FoxO signaling pathways. Real-time PCR results confirmed that expression of PGC-1α, PEPCK, G6PC, FoxO1, and FoxO3 was significantly downregulated following treatment with G. pentaphyllum alcohol extract (P<0.05, P<0.01), whereas mRNA expression of Adipoq, PPARα, GCK, and AMPK was significantly upregulated (P<0.05, P<0.01). Metagenomic analysis showed that the relative abundance of Lactobacillus, Alistipes, and Akkermansia species was higher in the GP group than in the DM group. ConclusionG. pentaphyllum alcohol extract may improve glucose and lipid metabolism disorders in db/db mice by regulating the hepatic AMPK/PPARα pathway to suppress lipid deposition and alleviate hepatic steatosis, by inhibiting gluconeogenesis through the AMPK/PGC-1α and FoxO pathways to lower fasting blood glucose, and by increasing the abundance of beneficial gut bacteria such as Lactobacillus, Alistipes, and Akkermansia to restore gut microbiota balance.
6.Analysis of phacoemulsification parameters and anterior segment parameters in cataract patients with different blood glucose levels
Xinqi XU ; Ping WANG ; Tong LIU ; Lei WANG ; Xuansheng ZHU ; Huiwen ZHANG ; Lei SHI ; Wen GAO
International Eye Science 2025;25(6):875-885
AIM:To analyze the characteristics and correlation of phacoemulsification parameters and anterior segment parameters in cataract patients with different blood glucose levels.METHODS:A total of 45 type 2 diabetic cataract patients(45 eyes)treated in our hospital from March 2023 to April 2024 were stratified into two groups based on glycosylated hemoglobin(HbA1c)levels: group A: HbA1c <7%(n=18)and group B: 7%≤HbA1c<8.5%(n=27); a total of 94 age-matched age-related cataract patients(94 eyes)were enrolled as the control group(group C). All underwent phacoemulsification with intraocular lens implantation. Anterior segment parameters, including corneal, lens and anterior chamber measurements, were recorded. Correlations between phacoemulsification parameters and anterior segment parameters were analyzed, and differences among groups were compared.RESULTS: In groups A and B, effective phacoemulsification time(EPT)negatively correlated with corneal endothelial cell density(CECD)(r=-0.315, P=0.035). Average phacoemulsification time(APT)positively correlated with the anterior corneal surface radius of curvature(Rm; r=0.402, P=0.006)and negatively correlated with the flat axis meridian curvature(K1), steep axis meridian curvature(K2), mean curvature(Km)of the anterior corneal surface, and lens density at 6 mm zones(PDZ3; all P<0.05). Average phacoemulsification energy(AVE)positively correlated with mean lens density(LD-mean), lens density at 2 mm zones(PDZ1), lens density at 4 mm zones(PDZ2), and PDZ3(all P<0.05), and negatively with pupil diameter(r=-0.385, P=0.009). In the group C, EPT showed a positive correlation with Pentacam nucleus staging(PNS)density grade, PDZ1, PDZ2, and PDZ3(all P<0.05). A positive correlation was observed between AVE and PNS classification(r=0.246, P=0.018). Conversely, AVE exhibited a negative correlation with CECD(r=-0.245, P=0.018). EPT in groups A and B was higher than that in the group C(P<0.05). Both EPT and APT in the group B were higher than those in the group A(P<0.05). In diabetic cataract patients, CECD, corneal density(CD), and posterior corneal surface height positively correlated with diabetes duration(P<0.05). Posterior corneal surface K1 and Rm positively correlated with 7%≤HbA1c<8.5%(P<0.05). Total corneal astigmatism negatively correlated with HbA1c, 2-hour post-breakfast blood glucose(2hPBG), and fasting insulin(FINS; P<0.05). CD and lens thickness(LT)positively correlated with FINS(P<0.05).CONCLUSION: Phacoemulsification parameters and blood glucose-related indices exhibited varying degrees of correlation with anterior segment parameters in cataract patients with different blood glucose levels. EPT in diabetic cataract patients was higher than that in age-related cataract patients, while EPT and APT in diabetic cataract patients with poor glycemic control were higher than those with good glycemic control.
7.Principles of managing wards for patients with internal radionuclide contamination
Fan BAI ; Chao YANG ; Lei ZHU ; Minghao LIU ; Danjie LIU ; Xiaoxin LIU ; Shanshan GUO ; Jianan WANG
Chinese Journal of Radiological Health 2025;34(3):444-449
Based on current national policies, regulations, standards, relevant literature, and departmental experience regarding the protection against radionuclides in China, this study provides a brief overview of key issues in the management of hospital wards for patients with internal radionuclide contamination. The discussion covers the detection of internal contamination, general requirements for internal radionuclide contamination wards, and inpatient management. In addition, the study explores in depth the daily responsibilities, protective measures, and management protocols for both healthcare staff and patients within such wards. This article summarizes a framework for the construction of internal radionuclide contamination wards, along with specific plans and detailed role-based guidelines. These results provide a reference for the management of hospital wards for patients with internal radionuclide contamination.
8.Interpretation of the CONSORT 2025 statement: Updated guideline for reporting randomized trials
Geliang YANG ; Xiaoqin ZHOU ; Fang LEI ; Min DONG ; Tianxing FENG ; Li ZHENG ; Lunxu LIU ; Yunpeng ZHU ; Xuemei LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(06):752-759
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
9.Construction of a key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury
Liu LIU ; Bei HOU ; Yanan ZHU ; Lei ZHU ; Yan GAO ; Yingfeng LIANG ; Shanshan GUO
Chinese Journal of Radiological Health 2025;34(4):595-601
Objective To construct a key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury, and provide a basis for the implementation of such treatment and nursing. Methods The draft of the key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury was determined by literature review, case study, and field investigation. The indicators of the system were determined through two rounds of Delphi consultation and using the precedence chart method. According to the criteria of indicator evaluation, the reliability of expert opinions, and the opinions of the research group, the indicators were refined and evaluated. Results Twenty experts were included for two rounds of consultation via mailed inquiries, with a 100% effective response rate in both rounds. The expert authority coefficients were both 0.945, and the Kendall’s W values were 0.347 and 0.448, respectively (P < 0.05). Following the expert consultations, 1 indicator was deleted, 12 indicators were added, and 6 indicators were modified. The key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury established in this study included 4 first-level indicators, 17 second-level indicators, and 73 third-level indicators. The means of importance assignment for all indicators were > 4.00, and the coefficients of variation were < 0.25. Conclusion The key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury established in this study is scientifically rigorous and practically grounded. The indicators demonstrate strong professional relevance and provide important guidance for in-hospital treatment and nursing of patients with nuclear radiation injury.
10.Mediating effects of self-efficacy and self-management behaviors on depressive symptoms and glycemic control among elderly patients with type 2 diabetes mellitus
LU Lijun ; YUAN Lei ; LI Dianjiang ; LU Kun ; ZHU Yixuan ; WANG Zhiyong ; LIU Sijun
Journal of Preventive Medicine 2025;37(5):455-459
Objective:
To analyze the mediating effects of self-efficacy and self-management behaviors on the relationship between depression symptoms and glycemic control among elderly patients with type 2 diabetes mellitus (T2DM), so as to provide references for optimizing health management of elderly T2DM patients.
Methods:
T2DM patients aged ≥60 years from 8 community health service centers in Nanjing City were selected using a convenience sampling method. Basic information such as gender and age was collected through questionnaires. Depressive symptoms, self-efficacy, and self-management behaviors were assessed using the Patient Health Questionnaire, the Diabetes Self-Efficacy Scale, and the Diabetes Self-Management Behavior Scale, respectively. Glycated hemoglobin (HbA1c) was measured to evaluate glycemic control. A mediating effect model was constructed to analyze the mediating effects of self-efficacy and self-management behaviors on the relationship between depressive symptoms and glycemic control.
Results:
A total of 567 elderly T2DM patients were included, with a median age of 70.00 (interquartile range, 7.50) years. There were 248 males (43.74%) and 319 females (56.26%). The median scores of self-efficacy, self-management behaviors, depressive symptoms, and HbA1c were 3.89 (interquartile range, 0.78), 4.45 (interquartile range, 1.55), 4.00 (interquartile range, 6.00), and 6.80% (interquartile range, 1.40%), respectively. The mediating effect analysis showed that depressive symptoms indirectly affected glycemic control among elderly T2DM patients through the independent mediating effects of self-efficacy (β=0.028, 95%CI: 0.016-0.043) and self-management behaviors (β=0.009, 95%CI: 0.003-0.016), as well as the chain mediating effect of both (β=0.025, 95%CI: 0.017-0.035). The mediating effects of self-efficacy and self-management behaviors accounted for 36.66% and 11.35% of the total effect, respectively, while the chain mediating effect accounted for 32.15% of the total effect.
Conclusion
Self-efficacy and self-management behaviors play mediating roles in the relationship between depressive symptoms and glycemic control among elderly T2DM patients.


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