1.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.
2.Efficacy and safety of glofitamab monotherapy in the treatment of relapsed/refractory diffuse large B-cell lymphoma
Yu WANG ; Rong XIAO ; Yan MAO ; Xuemei YE ; Boyue ZHENG ; Hui LI
Journal of Leukemia & Lymphoma 2025;34(10):601-605
Objective:To investigate the efficacy and safety of glofitamab in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL).Methods:A retrospective case series study was performed. The clinical data of 11 patients with relapsed/refractory DLBCL who were treated with glofitamab in Sichuan Provincial People's Hospital from March 2024 to October 2024 were retrospectively analyzed. All patients received glofitamab monotherapy. Dose escalation was required in the first course, and glofitamab at a dose of 30 mg was administered from the second to the 12th course. The general data, clinical manifestations, laboratory examination results, Eastern Cooperative Oncology Group (ECOG) performance score, previous treatment history, therapeutic effect after medication and adverse reactions were collected.Results:Among 11 patients, there were 8 males and 3 females, with the median age [ M ( Q1, Q3)] of 60 (51, 76) years; 1 case was primary central nervous system DLBCL. The median number of prior treatment lines was 3 (2, 3) lines, and 6 cases received ≥3 lines of therapy; 1 case was double DLBCL and 3 cases was complicated with p53 mutations. The median follow-up time was 5 months (2-7 months). After treatment of the median number of glofitamab, 3 cases achieved complete remission, among which 1 case successfully bridged to autologous hematopoietic stem cell transplantation; 1 case had the stable disease and 7 cases achieved partial remission. Grade 1-2 adverse events included mild leukopenia in 3 patients, mild anemia in 4 patients, thrombocytopenia in 1 patient, and lymphopenia in 8 patients. Grade 3 hematologic adverse events included thrombocytopenia in 1 patient and severe lymphopenia in 1 patient. Non-hematological toxicities included mild rash in 1 patient, grade 1 liver dysfunction in 3 patients and inflammatory factor storm in 4 patients. No medication stop or deferral was found in patients due to severe adverse events. Conclusions:Glofitamab demonstrates a high response rate in the treatment of relapsed/refractory DLBCL, with manageable adverse events and a favorable safety.
3.Danzhi Jiangtang Capsule improves renal vascular endothelial function in rats with diabetic nephropathy by downregulating the Notch1/NICD/MAML1 signaling pathway.
Sijia ZHU ; Jingcheng MA ; Yujiao ZHENG ; Chuanyun WU ; Jiangen ZHAO ; Lingxiu LI ; Li WANG ; Xuemei ZHOU
Journal of Southern Medical University 2025;45(10):2250-2257
OBJECTIVES:
To investigate the therapeutic mechanism of Danzhi Jiangtang Capsule (DZJTC) for repairing renal vascular endothelial injury in rats with diabetic nephropathy (DN).
METHODS:
Fifty male SD rat models of DN, established by left nephrectomy, high-sugar and high-fat diet and streptozotocin injection, were randomized into DN model group, low-, medium-, and high-dose DZJTC treatment groups, and DAPT (a γ-secretase inhibitor) treatment group, with 10 rats with normal feeding as the control group. DZJTC was administered by daily gavage at 0.315, 0.63, or 1.26 g/kg, and DAPT (20 mg/kg, dissolved in 50% CMC-Na solution) was given by gavage every other day for 4 weeks; normal saline was given in the control and model groups. After treatment, the levels of creatinine (CRE), blood urea nitrogen (BUN), and microalbuminuria (mALB) were detected with ELISA, and renal pathologies were observed by transmission electron microscopy. Renal expressions of vascular endothelial growth factor (VEGF) and endothelin-1 (ET-1) were measured by immunohistochemistry, and the protein expressions of CD31 and Notch signaling pathway components were detected using Western blotting.
RESULTS:
The rat models of DN showed significantly increased CRE, BUN, and mALB levels, obvious renal pathologies under electron microscopy, increased renal VEGF, ET-1 and CD31 expressions, and upregulated Notch1, NICD, and MAML1 protein levels. Treatment with DZJTC at the 3 doses and DAPT significantly reduced CRE, BUN, and mALB levels, improved renal pathology, decreased VEGF, ET-1 and CD31 expressions, and lowered Notch1, NICD and MAML1 levels, and the effects were the most pronounced with high-dose DZJTC.
CONCLUSIONS
DZJTC ameliorates hyperproliferation and dysfunction of renal vascular endothelium in DN rats possibly by regulating renal VEGF and ET-1 levels via inhibiting NICD- and MAML1-mediated Notch signaling pathway.
Animals
;
Male
;
Drugs, Chinese Herbal/therapeutic use*
;
Rats
;
Rats, Sprague-Dawley
;
Signal Transduction/drug effects*
;
Diabetic Nephropathies/drug therapy*
;
Receptor, Notch1/metabolism*
;
Kidney/blood supply*
;
Diabetes Mellitus, Experimental
;
Down-Regulation
;
Endothelium, Vascular/metabolism*
;
Nuclear Proteins/metabolism*
4.Impact of different renal artery clamping strategies on postoperative renal function in patients with pre-existing renal insufficiency in robotic partial nephrectomy
Linfei LI ; Cong WANG ; Ling WEI ; Jun ZHENG ; Juan SHEN ; Xuemei LI ; Jianli FENG ; Daodong SUN ; Yongquan WANG
Journal of Army Medical University 2025;47(15):1800-1805
Objective To compare the effects of main artery clamping(MAC)and selective artery clamping(SAC)strategies on postoperative renal function in patients with chronic renal insufficiency undergoing robot-assisted partial nephrectomy.Methods A retrospective cohort study was conducted on 231 patients with preoperative chronic renal insufficiency[eGFR<90 mL/(min·1.73 m2)with renal injury markers or eGFR<60 mL/(min·1.73 m2)]who underwent robot-assisted partial nephrectomy in the Department of Urology of the First Affiliated Hospital of Army Medical University from February 2018 to February 2024.According to intraoperative renal artery clamping strategy,they were divided into a MAC group(n=129)and a SAC group(n=102).Preoperatively,individualized renal artery clamping strategies were developed using a machine learning-based multimodal holographic 3-D reconstruction technique.Serum creatinine(Scr)level was measured at 3 d and 3 months after surgery,and estimated glomerular filtration rate(eGFR)was calculated using the chronic kidney disease epidemiology collaboration equation(CKD-EPI)formula.Renal dynamic imaging with 99mTc-DTPA or 99mTc-MAG3 was used to assess the GFR of the affected kidney.Results At 3 d after surgery,the decrease in GFR of the affected kidney was significantly lower[(8.3±7.7)vs(16.0±10.2)mL/(min·1.73 m2),95%CI:-10.2~-5.2,P<0.001]in the SAC group than the MAC group.Scr increment analysis showed that the SAC group exhibited notably lower Scr increase[8.2(2.5,18.7)vs 15.5(5.8,28.3)μmol/L,95%CI:-12.3~-1.8,P=0.027],and milder eGFR decline[3.0(0.5,7.8)vs 7.5(2.0,14.3)mL/(min·1.73 m2),95%CI:-6.2~-0.8,P=0.015].And,in 3 months after surgery,the SAC group had lower Scr level[(89.2±23.1)vs(95.3±22.1)μmol/L,95%CI:-11.9~-0.3,P=0.042],and higher GFR of the affected kidney[(33.5±10.5)vs(26.1±10.9)mL/(min·1.73 m2),95%CI:4.6~10.2,P<0.001].Conclusion For patients with chronic renal insufficiency undergoing robot-assisted partial nephrectomy,SAC strategy is superior to MAC strategy in protecting postoperative renal function without increasing surgical risk.
5.Effect of lactate dehydrogenase and β2-microglobulin levels on the clinical efficacy of first-line chemotherapy regimen for Waldenstr?m Macroglobulinemia
Xufu HUANG ; Yirong ZHU ; Xuemei WEN ; Zhihong ZHENG
Immunological Journal 2025;41(8):551-556
Objective To analyze the effect of serum lactate dehydrogenase(LDH)and β2-microglobulin(β2-MG)on therapeutic efficacy of the first-line chemotherapy regimen for Waldenstr?m Macroglobulinemia(WM).Methods Data were collected from 113 WM patients admitted from March 2019 to February 2024.All patients completed the established first-line chemotherapy regimen and were divided into the response group(n=85)and the non-response group(n=28).The general data between the two groups were compared,with a focus on analyzing the risk factors for non-response to first-line chemotherapy in WM patients and evaluating the predictive value of serum LDH and β2-MG for the efficacy of first-line chemotherapy.Result The non-responsive group had a higher risk of prognosis based on International Prognostic Scoring System(IPSS),a higher rate of MYD88 L265P mutation,higher TP53 deletion/mutation ratio,and higher proportion of bone marrow lymphoplasmacytic cells,as well as higher serum LDH and β2-MG expression than the response group(P<0.01).Multivariate logistic regression analysis revealed that risk factors for non-response to first-line chemotherapy in WM patients included a high-risk prognosis based on IPSS,an increased proportion of bone marrow lymphoplasmacytic cells,and higher rate of MYD88 L265P mutation and TP53 deletion/mutation,as well as elevated serum LDH and β2-MG levels(P<0.05).The area under the curve of serum LDH and β2-MG for predicting the risk of non-response to first-line chemotherapy in WM patients was 0.796 and 0.783 respectively.Through interaction analysis,serum LDH and β2-MG had a positive interaction effect on non-response to chemotherapy in WM patients.Conclusion The non-response to first-line chemotherapy in WM patients is related to abnormal increase in serum LDH and β2-MG.Pre-chemotherapy detection of LDH and β2-MG level has certain predictive value for the risk of non-response to chemotherapy,and the simultaneous increase of both may lead to a higher risk of non-response to chemotherapy.
6.Correlation Between Neutrophil to Lymphocyte Ratio and eGFR in Diabetic Patients: A Cross-sectional Analysis Based on NHANES Data
Chunyu JIA ; Gangan WANG ; Jiahui WANG ; Gang CHEN ; Ke ZHENG ; Xuemei LI
Medical Journal of Peking Union Medical College Hospital 2025;16(2):379-385
To investigate the association between neutrophil to lymphocyte ratio (NLR) andestimated glomerular filtration rate (eGFR) in patients with diabetes using large-scale data. Across-sectional analysis was conducted using data from diabetic patients in the National Health and Nutrition Examination Survey database from 2009 to 2014. Differences in NLR between patients with and without chronickidney disease (CKD) were compared. Pearson correlation analysis and multiple linear regression models wereapplied to assess the relationship between NLR and eGFR. A total of 857 diabetic patients were included, with 190 (22.2%) having CKD and 667 (77.8%) without CKD. NLR was significantly higher in patients with CKD compared to those without CKD (2.94±1.69 vs.2.36±1.98, NLR is independently negatively associatedwith eGFR in diabetic patients, demonstrating potential clinical value as an indicator of kidney function declineand CKD risk in this population.
7.Applications and advances of lipidomics in kidney disease
Jiahui WANG ; Ke ZHENG ; Xuemei LI
The Journal of Practical Medicine 2025;41(1):1-6
Kidney disease constitutes a significant global public health issue,with its associated healthcare burden escalating annually.Lipid metabolism disorders play a crucial role in the onset and progression of various kidney diseases.Given the diversity of lipid species and the complexity of metabolic pathways,traditional research methods often fall short in fully elucidating the intricate roles of lipids in kidney diseases.In this context,lipido-mics,the systematic analysis of lipid molecules and their metabolic alterations in biological samples,emerges as a powerful tool with unique research value and clinical potential.This review summarizes the latest findings in lipido-mics across various kidney diseases and discusses the challenges encountered in clinical application and future research directions.
8.Practical Application of Scenario-Based Learning in the Laboratory Teaching of Medical Parasitology for Undergraduate Non-Clinical Medical Students
Jia MA ; Lijie SHEN ; Lijun YANG ; Xuemei JIA ; Zheng XIANG ; Xi CHEN
Journal of Kunming Medical University 2025;46(2):164-170
Objective To investigate the impact of scenario class teaching on language expression,communication skills,and final exam performance of non-clinical majors students in the course of Medical Parasitology.Method Undergraduate students of non-clinical medical programs from Kunming Medical University in 2022 were selected as the subjects and randomly divided into a scenario class group and a non-scenario class group.Questionnaires were administered to compare the two groups regarding their interest in the laboratory classes,enjoyment levels,and knowledge retention.Additionally,the final exam scores of the two groups were compared.Results Students in the scenario class group showed significantly higher interest(82.6%)and enjoyment levels(88.3%)for laboratory classes compared to the non-scenario class group(73.0%and 60.1%,respectively,P<0.05).Students in the scenario class group believed that situational teaching enhanced their self-learning ability(82.06%),interest in learning(83.2%),willingness to express themselves(83.2%),confidence in expression(81.8%),and communication skills(87.9%).Additionally,It effectively facilitated their understanding of the occurrence and development of parasitic diseases(85.9%)and familiarity with the diagnosis and treatment process(86.8%),thereby cultivating clinical thinking.In terms of final exam scores,the scenario class group had a higher average score(22.80±0.18)than the non-situational classroom group(21.47±0.17,P<0.05).Conclusion Sc-enario class teaching in Medical Parasitology can effectively improve students'self-learning ability,language expression,and communication skills,cultivate clinical thinking,and enhance academic performance,demonstrating significant teaching advantages.
9.Danzhi Jiangtang Capsule improves renal vascular endothelial function in rats with diabetic nephropathy by downregulating the Notch1/NICD/MAML1 signaling pathway
Sijia ZHU ; Jingcheng MA ; Yujiao ZHENG ; Chuanyun WU ; Jiangen ZHAO ; Lingxiu LI ; Li WANG ; Xuemei ZHOU
Journal of Southern Medical University 2025;45(10):2250-2257
Objective To investigate the therapeutic mechanism of Danzhi Jiangtang Capsule(DZJTC)for repairing renal vascular endothelial injury in rats with diabetic nephropathy(DN).Methods Fifty male SD rat models of DN,established by left nephrectomy,high-sugar and high-fat diet and streptozotocin injection,were randomized into DN model group,low-,medium-,and high-dose DZJTC treatment groups,and DAPT(a γ-secretase inhibitor)treatment group,with 10 rats with normal feeding as the control group.DZJTC was administered by daily gavage at 0.315,0.63,or 1.26 g/kg,and DAPT(20 mg/kg,dissolved in 50%CMC-Na solution)was given by gavage every other day for 4 weeks;normal saline was given in the control and model groups.After treatment,the levels of creatinine(CRE),blood urea nitrogen(BUN),and microalbuminuria(mALB)were detected with ELISA,and renal pathologies were observed by transmission electron microscopy.Renal expressions of vascular endothelial growth factor(VEGF)and endothelin-1(ET-1)were measured by immunohistochemistry,and the protein expressions of CD31 and Notch signaling pathway components were detected using Western blotting.Results The rat models of DN showed significantly increased CRE,BUN,and mALB levels,obvious renal pathologies under electron microscopy,increased renal VEGF,ET-1 and CD31 expressions,and upregulated Notch1,NICD,and MAML1 protein levels.Treatment with DZJTC at the 3 doses and DAPT significantly reduced CRE,BUN,and mALB levels,improved renal pathology,decreased VEGF,ET-1 and CD31 expressions,and lowered Notch1,NICD and MAML1 levels,and the effects were the most pronounced with high-dose DZJTC.Conclusion DZJTC ameliorates hyperproliferation and dysfunction of renal vascular endothelium in DN rats possibly by regulating renal VEGF and ET-1 levels via inhibiting NICD-and MAML1-mediated Notch signaling pathway.
10.Advances in the role of anticipatory anxiety in the diagnosis and treatment of anxiety disorders
Xuemei QIN ; Su SHU ; Qianqian ZHANG ; Xiaotian ZHAO ; Lingsi ZENG ; Mohan MA ; Wenwen OU ; Guanyi LYU ; Qi ZHENG ; Shuyin XU ; Mi WANG ; Mei LIAO ; Li ZHANG ; Yumeng JU ; Jin LIU ; Bangshan LIU ; Yan ZHANG
Chinese Journal of Psychiatry 2025;58(4):292-296
Anticipatory anxiety is a negative emotion that arises when individuals encounter potential threats or uncertainties in the future. It is the core symptom of a variety of anxiety disorders, and is closely associated with the occurrence, severity, treatment outcome, and prognosis of anxiety disorders, which has garnered a growing amount of focus in clinical practice. Nevertheless, scientific research on anticipatory anxiety continues to face obstacles such as unclear pathological mechanisms, the absence of simple and consistent self-assessment tools, and effective interventions. To improve understanding of the role of anticipatory anxiety in the diagnosis and treatment of anxiety disorders, this study reviews pertinent domestic and international literature, and briefly introduces the concept, assessment and measurement, activation paradigm, pathological mechanisms, and interventions of anticipatory anxiety.

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