AIM:To evaluate the pharmacokinet-ics(PK)and pharmacodynamics(PD)of two recom-binant human insulin injection by euglycemic clamp technology in healthy male subjects after a single subcutaneous injection.METHODS:We con-ducted a randomized,open-label,single dose,two period,crossover study.A total of 24 healthy male subjects were enrolled and randomized to receive single subcutaneous doses(0.2 U/kg)of the investi-gational products every period.The PK and PD characteristics were assessed by euglycemic clamp up to 14 hours after dosing.RESULTS:Euglycemic clamp technique was successfully established.C-peptide levels detected at each time point before and after administration indicated that endoge-nous insulin secretion was inhibited in the two groups after administration.The geometric mean ratio of Cmax and AUC0-tand 90％confidence interval(CI)of test preparation and reference preparation under fasting condition were in the range of 80.00％-125.00％.CONCLUSION:The human insulin produced by KP Biotech demonstrated similarity to the reference preparation Humulin? in PK and PD characteristics in healthy Chinese subjects.

Spine fracture and dislocation are common traumatic spinal conditions that often require surgical intervention due to compromised spinal stability. Surgical approaches include anterior, posterior, and combined anterior-posterior spinal procedures. According to the specific surgical requirements, patients may be placed in the prone position or repositioned between prone and supine positions during surgery. Intraoperative repositioning has become an essential step in patient positioning. However, during repositioning, patients with spinal fracture and dislocation are at increased risk for complications such as hemodynamic instability, nerve injury, and pressure injuries to the skin and soft tissue. Notably, due to the instability of the spinal cord, even minor manipulations can further exacerbate the damage, potentially leading to severe outcomes like paraplegia. Although the current clinical guidelines provide instructive recommendations for standard position, there remains no specific protocols for intraoperative repositioning in patients with spine fracture and dislocation. With a concern for the lack of clinical studies on positioning techniques, risk prevention, and operational norms for special patients, no applicable guidelines or standards are available. A consensus was required to provide clinical reference, meet the requirements of surgical treatment, and minimize the safety risks of patients caused by improper placement of positions. Professional Committee of Operating Room Nursing of Shaanxi Nursing Association organized experts in nursing management and operating room nursing from major hospitals across China to formulate Expert consensus on intraoperative repositioning for patients with spinal fracture and dislocation ( version 2025). The consensus provides 11 recommendations covering pre-repositioning preparation, intraoperative maneuvers, and post-repositioning observation, aiming to provide references for clinical standardization of the intraoperative repositioning process and protection of patients′ safety.

[Objective]To investigate the association between Eya3 expression and CD8+T cell infiltration levels in the tumor microenvironment,as well as their prognosis in esophageal carcinoma(EC)patients following neoadjuvant chemoradiation(neo-CRT).[Methods]The pathological specimens before treatment and after surgery and clinical data were collected from 50 patients with EC who received neo-CRT combined with surgery.The correlation between the Eya3 expression and postoperative pathological features,CD8+T cell infiltration levels,disease-free survival(DFS)and overall survival(OS)were analyzed using immunohistochemistry(IHC)and multicolor immunofluorescence staining.[Results]The rate of pathological complete response(pCR)was higher in patients with low baseline Eya3 expression in the EC before treatment(P=0.001 8).Both median DFS(37.2 months vs.15.3 months,HR:2.731,95%CI:1.167-6.394,P=0.021)and median OS(not reached vs.26.7 months,HR:3.959,95%CI:1.539-10.18,P=0.004 3)are significantly longer for patients with low Eya3 than those with high Eya3.The expression of Eya3 significant negatively correlated with tumor-infiltrating CD8+T lymphocytes(P＜0.001),GZMB+CD8+T lymphocytes P=0.002)in surgical pathological specimens.The patients with high CD8+T lymphocytes and GZMB+CD8+T lymphocytes had significantly longer DFS than those with low level.[Conclusion]Patients with EC who have high expression of Eya3 have a poorer prognosis,and the infiltration levels of CD8+T lymphocytes and GZMB+CD8+T lymphocytes in the tumor microenvironment are lower.This suggests that the expression of Eya3 may affect the tumor immune microenvironment and thereby influence the prognosis of EC patients,and it may become a molecular marker for predicting the prognosis of EC patients..

Objective:To provide reference for improving the ability of Investigator-Initiated Trials (IIT) research ethics review in the new era by analyzing the situation of clinical research projects and ethical review in hospitals under the increasingly standardized management requirements of clinical research.Methods:Taking the IIT projects reviewed by the Ethics Committee of our Institute from 2012 to 2023 as examples, the development trend, types, characteristics and the situation of ethical review were comprehensively compared and analyzed.Results:From 2012 to 2023, the number of IIT projects in our hospital increased rapidly, especially the multi-center and high-risk projects. IIT researches in the field of oncology and neurology are hot topics at present. After the addition of scientific review, the passing rate of ethical review increased. After the promulgation of the new regulations, the application rate of follow-up examination increased to a certain extent.Conclusions:In view of the current types and distribution characteristics of IIT, as well as key weaknesses in ethical review, the ethics Committee should strengthen the qualification management of main researchers and research teams, standardize the annual follow-up review of IIT research through multiple channels such as research ethics education and information platform, promote the establishment of the responsibility system of research liaison officers, and improve the review process of off-label drug use research. High-risk IIT projects should strengthen ethical supervision, case-by-case reporting and tracking system, and vulnerable groups projects should strengthen ethical review and supervision of informed consent process, and explore the establishment of a high-quality ethical management system from the above aspects.

Objective:To explore the experiences of post-traumatic growth in patients with failed assisted reproductive technology (ART), providing a basis for individualized nursing interventions.Methods:This study was a qualitative study. From November to December 2023, purposive sampling was used to select ART failed patients at Reproductive Medicine Center of Affiliated Hospital of Nantong University as participants. Data was collected through semi-structured in-depth interviews, and Colaizzi 7-step analysis method was used to summarize and analyze the data and extract themes.Results:A total of 15 ART failed patients were included, their age was (31.8±3.6) years, years of infertility was (4.7±1.7) years. After analysis, a total of four themes and nine sub-themes were extracted, namely negative emotional experiences in the early stages of trauma (anxiety and depression, psychological stress) ; diversified support systems (family support, social support) ; positive coping styles (positive binary coping between spouses, individual coping) ; post-traumatic growth experiences (mobilizing one's own positive strength, strengthening altruistic awareness, and re-planning the future) .Conclusions:Infertility patients exhibit negative emotions after experiencing ART failure, but also experience post-traumatic growth. Medical and nursing staff should provide targeted guidance based on the psychological state of ART failed patients at different stages to improve their mental health.

Objective:To carry out a scoping review on eHealth literacy in patients with cardiovascular disease to sort out eHealth literacy from four aspects of concepts, assessment tools, influencing factors and interventions, with a view to informing future research and practice.Methods:Based on Arksey and O'Malley's framework for reporting scoping reviews, the literature on eHealth literacy in patients with cardiovascular disease was systematically searched in PubMed, Web of Science, Embase, Cochrane Library, CINAHL, China National Knowledge Infrastructure, VIP, Wanfang Data, and China Biomedical Database. The search period was from database establishment to May 3, 2024. Literature was screened, summarized and analyzed.Results:A total of 23 papers were included. The concepts and theoretical frameworks on eHealth literacy had their own focus, but no consensus was reached. The most commonly used tool to assess eHealth literacy in patients with cardiovascular disease was the eHealth Literacy Scale. The influencing factors included four aspects of demographic sociological and disease-related factors, psycho-cognitive factors, eHealth literacy knowledge and skills, and other factors. Interventions to improve eHealth literacy among patients with cardiovascular disease primarily included eHealth literacy training and use of portal-related digital toolkit.Conclusions:Currently there is no specific assessment tool for eHealth literacy for cardiovascular disease patients. In the future, eHealth literacy assessment tools need to be revised and improved according to the population characteristics and cultural background of cardiovascular disease patients. E-health literacy among patients with cardiovascular disease is at a moderately low level and is influenced by multiple factors. The influencing factors can be analyzed in depth through large-sample cross-sectional studies or longitudinal studies, and then a variety of intervention programs can be constructed at home or in the community with the help of multimedia and apps, with a view to improving the e-health literacy of patients with cardiovascular diseases.

Objective:To systematically analyze the prevalence and influencing factors of psychiatric comorbidities in refractory epilepsy (RE) .Methods:The literature on the prevalence and/or influencing factors of psychiatric comorbidities in adults with RE was electronically searched in China National Knowledge Infrastructure, WanFang Data, VIP, China Biomedical Database, PubMed, Web of Science, Embase, CINAHL, OVID, UpToDate, and Cochrane Library. The search period was from the establishment of the database to July 31, 2024. Two researchers independently conducted literature screening, quality assessment and data extraction, and used RevMan 5.4 for Meta-analysis.Results:A total of 11 papers were included, with a total sample size of 1 953 cases, with a prevalence of 52.00% (cross sectional studies) and 53.00% (cohort studies) . Gender [ OR=4.76, 95% CI (3.69, 6.15) ] , epilepsy disease perception [ OR=1.10, 95% CI (1.01, 1.19) ] , seizure type [ OR=1.63, 95% CI (1.23, 2.15) ] , seizure frequency [ OR=1.54, 95% CI (1.04, 2.29) ] , epileptogenic foci location [ OR=2.72, 95% CI (1.69, 4.37) ] , disease duration [ OR=1.76, 95% CI (1.39, 2.24) ] , and medication [ OR=3.26, 95% CI (2.09, 5.08) ] were the influencing factors of psychiatric comorbidity in RE. Conclusions:The prevalence of psychiatric comorbidities in patients with RE is high, and studies of influencing factors lack specificity. Clinical monitoring of this population should be strengthened, and relevant influencing factors should be comprehensively analyzed to provide intervention targets for early preventive management and to safeguard the long-term management of patients with epilepsy.

Constipation is a common functional gastrointestinal disorder with a global prevalence of approximately 10％to 20％.Its causes include functional disorders,organic diseases,and drug factors,with the majority being functional constipation.In recent years,driven by advancements in biomedicine,artificial intelligence(AI),and microbiome research,significant progress has been made in the diagnosis and treatment of constipation.This review systematically explores the latest developments in constipation treatment,including the role of the gut microbiota in constipation,the metabolic regulatory effects of short-chain fatty acids(SCFAs),the impact of mental factors on intestinal motility.Additionally,it discusses future development directions such as AI-assisted diagnosis,AI-based consultation systems,personalized microbiota transplantation,and minimally invasive neuromodulation,providing new insights for precision medicine in constipation.

BACKGROUND:In recent years,human pluripotent stem cell derived kidney organoids and rodent models of diabetic kidney disease have also made some progress.However,because the pathogenesis of diabetic kidney disease is affected by environmental factors and genetic factors,the pathogenesis is complex,and the clinical treatment for diabetic kidney disease patients needs to vary from person to person.Therefore,more flexible and integrated approaches need to be developed,leading to the discovery of strong preclinical evidence to support more targeted interventions in patients with diabetic kidney disease.OBJECTIVE:To reviewthe research progress of diabetic kidney disease model from the aspects of diabetic kidney disease animal model,two-dimensional cell culture simulation diabetic kidney disease model,and three-dimensional organoid diabetic kidney disease model,to provide clues and ideas for further research.METHODS:China National Knowledge Network and PubMed databases were searched with"diabetes,diabetic nephropathy,diabetic kidney diseases,diabetic nephropathy models,diabetic nephropathy animal models,organoids,diabetic and organoids,diabetic and kidney organoids,kidney organoids,diabetic nephropathy cell models,diabetic nephropathy syndrome combined animal models"as Chinese and English search terms.Totally 101 articles were finally included for review and analysis.RESULTS AND CONCLUSION:Both in vivo and in vitro models of diabetic kidney disease are powerful tools to further study the pathogenesis of diabetic kidney disease.The interactions between multiple systems can be observed in animal models.Two-dimensional cell culture is easy to operate and low cost.The emerging kidney organoids fill the gap between two-dimensional and global levels,without species differences,and simulate the complexity of human kidney to a certain extent.With the continuous development of organoid technology,kidney organoids are expected to provide a new perspective for exploring the pathogenesis,pathophysiology,and drug screening of diabetic kidney disease.

Spine fracture and dislocation are common traumatic spinal conditions that often require surgical intervention due to compromised spinal stability. Surgical approaches include anterior, posterior, and combined anterior-posterior spinal procedures. According to the specific surgical requirements, patients may be placed in the prone position or repositioned between prone and supine positions during surgery. Intraoperative repositioning has become an essential step in patient positioning. However, during repositioning, patients with spinal fracture and dislocation are at increased risk for complications such as hemodynamic instability, nerve injury, and pressure injuries to the skin and soft tissue. Notably, due to the instability of the spinal cord, even minor manipulations can further exacerbate the damage, potentially leading to severe outcomes like paraplegia. Although the current clinical guidelines provide instructive recommendations for standard position, there remains no specific protocols for intraoperative repositioning in patients with spine fracture and dislocation. With a concern for the lack of clinical studies on positioning techniques, risk prevention, and operational norms for special patients, no applicable guidelines or standards are available. A consensus was required to provide clinical reference, meet the requirements of surgical treatment, and minimize the safety risks of patients caused by improper placement of positions. Professional Committee of Operating Room Nursing of Shaanxi Nursing Association organized experts in nursing management and operating room nursing from major hospitals across China to formulate Expert consensus on intraoperative repositioning for patients with spinal fracture and dislocation ( version 2025). The consensus provides 11 recommendations covering pre-repositioning preparation, intraoperative maneuvers, and post-repositioning observation, aiming to provide references for clinical standardization of the intraoperative repositioning process and protection of patients′ safety.