1.Review and reflection on the practice of pre-ethical review for drug clinical trials
Min HOU ; Xiaoyuan SHI ; Rongguo SUN ; Fang LIU ; Lei CHEN ; Zejin ZUO
Chinese Medical Ethics 2026;39(5):594-600
ObjectiveTo sort out the pre-ethical review status of drug clinical trials in a tertiary A hospital, summarize practical experience, and provide references for pre-ethical review. MethodA retrospective analysis was conducted on the ethical review of pre-ethical projects in a tertiary A hospital from 2018 to 2023. ResultsFrom 2018 to 2023, a total of 285 pre-ethical projects were reviewed in this tertiary hospital, including 79 projects where it served as the leading unit. Among these, 279 clinical trials ultimately received approval of the ethical review committee, while 6 projects were not approved due to sponsors’ refusal to modify study protocols. In terms of trial phases, phase III clinical trials constituted the largest proportion, and the oncology center was the department with the highest number of projects. In 2023, the average time for pre-ethical review projects from submission to approval was 43 calendar days, 3 days longer than for other project types. In 2023, this hospital reviewed 75 pre-ethical review projects, including 58 where it served as a participating unit. Among these, 42 projects received approval later than the leading unit, while 9 projects were approved earlier than the leading unit’s ethical approval date. Among the pre-ethical review projects applied in 2023, 70 projects obtained drug clinical trial notifications from the National Medical Products Administration, while 5 projects had unknown notification status due to the lack of ethical approval or discontinuation. Of the projects receiving approval notifications, 16 were annotated with matters requiring enhanced attention during clinical trials, and 7 necessitated protocol improvements. ConclusionThis tertiary A hospital has implemented multiple measures to optimize the management of pre-ethical review. This ethical review model does not compromise the quality of ethical review and contributes to accelerating the initiation of clinical trials. Notably, it is crucial to construct a patient-centered drug development system. Clinical trials guided by this concept align with ethical values, laying the foundation for the smooth conduct of clinical trials, assisting in the drug development process, and safeguarding patients’ medication needs.
2.The Development and Application of Chatbots in Healthcare: From Traditional Methods to Large Language Models
Zixing WANG ; Le QI ; Xiaodan LIAN ; Ziheng ZHOU ; Aiwei MENG ; Xintong WU ; Xiaoyuan GAO ; Yujie YANG ; Yiyang LIU ; Wei ZHAO ; Xiaolin DIAO
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1170-1178
With the rapid advancement of artificial intelligence technology, chatbots have shown great potential in the healthcare sector. From personalized health advice to chronic disease management and psychological support, chatbots have demonstrated significant advantages in improving the efficiency and quality of healthcare services. As the scope of their applications expands, the relationship between technological complexity and practical application scenarios has become increasingly intertwined, necessitating a more comprehensive evaluation of both aspects. This paper, from the perspective of he althcare applications, systematically reviews the technological pathways and development of chatbots in the medical field, providing an in-depth analysis of their performance across various medical scenarios. It thoroughly examines the advantages and limitations of chatbots, aiming to offer theoretical support for future research and propose feasible recommendations for the broader adoption of chatbot technologies in healthcare.
3.A real-world study on the application of modified midline catheter and central venous catheter in medical intensive care unit.
Guo LONG ; Zixi WANG ; Huan PENG ; Xiaoyuan CAO ; Yuxin LIU ; Li TAN
Chinese Critical Care Medicine 2025;37(10):956-961
OBJECTIVE:
To investigate the differences in indwelling duration, clinical scenarios, and complications between the modified midline catheter (MMC) and the central venous catheter (CVC) in the treatment of patients in the medical intensive care unit (ICU) and the risk factors for complications based on real-world data.
METHODS:
A retrospective cohort study was conducted. The adult patients admitted to the medical ICU of the Third Xiangya Hospital of Central South University and had undergone placement of either a MMC or a CVC between January 1, 2023, and July 31, 2024, were consecutively enrolled by querying the hospital's electronic medical record system. Based on the type of catheter inserted, the patients were divided into the MMC group and the CVC group. The two groups were compared regarding the selection of catheters in the context of different underlying diseases, the actual clinical application after catheterization, catheter-related complications, the international normalized ratio (INR) and platelet count (PLT) during puncture and catheterization, the length of ICU stay, total length of hospital stay, catheter indwelling duration, and mortality during hospitalization. Multivariate Logistic regression analysis was employed to identify independent risk factors for catheter removal.
RESULTS:
Among the 274 patients, 52 received a MMC and 222 received a CVC. The utilization rate of MMC was significantly higher than that of CVC in patients with acute respiratory distress syndrome (ARDS), cardiovascular disease, and cancer [ARDS: 92.3% (48/52) vs. 70.3% (156/222), cardiovascular disease: 84.6% (44/52) vs. 54.5% (121/222), cancer: 30.8% (16/52) vs. 17.1% (38/222), all P < 0.05]. However, the use of MMC was significantly lower than CVC when vasoactive drug infusion was required [57.7% (30/52) vs. 79.7% (177/222), P < 0.05]. A significantly higher proportion of patients in the MMC group had a catheter indwelling time ≥ 12 days as compared with the CVC group [32.7% (17/52) vs. 13.5% (30/222), P < 0.05]. There were no statistically significant differences in other underlying diseases, venous access usage, INR and PLT during puncture and catheterization, length of ICU stay, total length of hospital stay, and in-hospital mortality of patients between the two groups. Regarding catheter-related complications, although the incidence of partial or complete catheter removal in the MMC group was significantly higher than that in the CVC group [36.5% (19/52) vs. 5.4% (12/222), P < 0.05], the incidence of puncture site fluid leakage, puncture site skin allergy, and deep vein thrombosis were significantly lower than those in the CVC group [puncture site fluid leakage: 1.9% (1/52) vs. 22.1% (49/222), puncture site skin allergy: 0% (0/52) vs. 20.7% (46/222), deep vein thrombosis: 3.8% (2/52) vs. 16.7% (37/222), all P < 0.05]. Furthermore, the proportion of patients experiencing three or more types of complications in the MMC group was significantly lower than that in the CVC group [5.8% (3/52) vs. 17.6% (39/222), P < 0.05]. Multivariate Logistic regression analysis of risk factors for catheter removal identified the use of a MMC [odds ratio (OR) = 8.518, 95% confidence interval (95%CI) was 3.710-19.560, P < 0.001] and a catheter indwelling time ≥ 12 days (OR = 3.133, 95%CI was 1.297-7.567, P = 0.011) as independent risk factors.
CONCLUSIONS
MMC was more frequently used in patients with ARDS, cardiovascular disease, and cancer, whereas CVC was primarily employed for vasoactive drug infusion. The use of MMC and a longer indwelling time were identified as independent risk factors for catheter removal. Despite a higher removal rate, the overall incidence of complications was significantly lower with MMC than with CVC. These findings suggest that MMC could serve as a routine alternative to CVC in most of clinical scenarios, provided that measures are implemented to prevent removal.
Humans
;
Retrospective Studies
;
Intensive Care Units
;
Catheterization, Central Venous/methods*
;
Central Venous Catheters
;
Risk Factors
;
Length of Stay
;
Male
;
Female
;
Middle Aged
;
Adult
;
Catheters, Indwelling
;
Aged
4.Consensus recommendation on Comprehensive Geriatric Assessment for elderly cancer patients from Peking Union Medical College Hospital
Qiumei WANG ; Xiaoyuan LI ; Lin KANG ; Xiaohong SUN ; Hailong LI ; Yanping DUAN ; Ying LIU ; Mei GUAN ; Lin ZHAO
Basic & Clinical Medicine 2025;45(9):1122-1131
In the context of an aging society,the number of elderly cancer patients is constantly increasing,and geriatric oncology has garnered significant attention in recent years.Given the heterogeneity in the health status of older patients,it has become increasingly important to provide individualized diagnosis,treatment,follow-up,and care.Thus,it must be emphasized the Comprehensive Geriatric Assessment(CGA)for elderly patients,which encompasses their physical function,nutritional status,cognitive function,emotional state,comorbidities,polypharmacy,social situation,and treatment preferences.This article provides consensus recommendations on CGA tools for elderly patients prior to anticancer treatment,offering valuable references and insights for clinical practice in China.
5.Application Effect of an Intelligent Medical Record Writing Assistant in Inpatient Medical Record Practice
Xiaoyuan GAO ; Landi SUN ; Xiaolei QIN ; Lei ZUO ; Shihao LIAO ; Qianqian LIU ; Wei ZHAO ; Xiaolin DIAO
Medical Journal of Peking Union Medical College Hospital 2025;17(1):217-222
To investigate the effectiveness of a self-developed intelligent medical record writing assistant in enhancing the efficiency of discharge record writing and improving the quality of discharge records, and to assess physicians' satisfaction with the assistant. This study was conducted as a prospective cluster-randomized controlled trial. From January 25 to June 25, 2024, clinicians in the coronary heartdisease ward of Fuwai Hospital, Chinese Academy of Medical Sciences were selected as the research object. Using the method of cluster-randomized allocation, the four wards were randomly assigned 1∶1, with physicians and their medical records assigned to the corresponding group based on the ward. The experimental group utilized the intelligent medical record writing assistant, with 46 physicians included and 4105 medical records collected. The control group used traditional writing methods, with 41 physicians included and 4680 medical records collected. Primary outcome measures included quantitative analysis of medical record writing efficiency and medical record writing quality. Secondary outcomes assessed physicians' satisfaction with the use of the intelligent medical record writing assistant. The average writing time for discharge records in the experimental group was significantly shorter than that in the control group(5.73 min The intelligent medical record writing assistant can significantly enhance the writing efficiency and optimize medical record quality concurrently, and physicians are highly satisfied with it. This study validates the effectiveness of the new model of intelligent medical record writing applied to clinical practice, and provides a paradigm for the in-depth application and promotion of this model in the future.
6.Impact of childhood trauma on internet addiction in medical students: the mediating role of perceived stress
Xiaohong PENG ; Xiaoyuan LIAO ; Dantong WU ; Yanyin ZHOU ; Yelu LIU ; Yuxiang WANG ; Luoya ZHANG ; Juan DENG ; Yanjie PENG ; Kezhi LIU ; Jing CHEN ; Wei LEI
Sichuan Mental Health 2025;38(3):267-272
BackgroundWith the rapid development of the networking technologies, internet addiction has increasingly become a serious mental health issue. Previous studies have revealed the link between childhood trauma and internet addiction, while the mediating role of perceived stress in this link is not yet clear. ObjectiveTo investigate the role of medical students' perceived stress in the relationship between childhood trauma and internet addiction, so as to provide references for the intervention of internet addiction. MethodsFrom February to March 2023, a random sampling technique was used to select 1 232 undergraduate students from the School of Clinical Medical Sciences of Southwest Medical University as research subjects. The Childhood Trauma Questionnaire-Short Form (CTQ-SF), Perceived Stress Scale (PSS), Internet Gaming Disorder Scale (IGDS), and Bergen Social Media Addiction Scale (BSMAS) were used for assessment. Pearson's correlation coefficients were calculated. The mediation effect of perceived stress in the relationship between childhood trauma and internet addiction was tested using Model 4 in the SPSS Process 4.1, and Bootstrapping procedure involving 5 000 replicates was employed to confirm the statistical significance. ResultsA total of 1 016 (82.47%) valid completed questionnaires were gathered. The CTQ-SF scores of medical students were positively correlated with PSS scores, IGD scores, and BSMAS scores (r=0.583, 0.474, 0.465, P<0.01). PSS scores were positively correlated with IGD scores and BSMAS scores (r=0.369, 0.479, P<0.01). Childhood trauma in medical students was found to positively predict perceived stress (β=0.191, P<0.01), social media addiction (β=0.160, P<0.01), and internet gaming disorder (β=0.106, P<0.01). Perceived stress played a significant mediating role in the relationship between childhood trauma and internet gaming disorder, indirect effect value was 0.018 (95% CI: 0.009~0.027), accounting for 16.98%. Perceived stress also exhibited a significant mediating role in the relationship between childhood trauma and social media addiction, indirect effect value was 0.063 (95% CI: 0.048~0.079), accounting for 39.38%. ConclusionChildhood trauma in medical students may affect internet gaming disorder and social media addiction through perceived stress. [Funded by 2022 Annual Research Project of Sichuan Applied Psychology Research Center,(number,CSXL-22102)]
7.A Comparison Study Between Flexible Ureteroscopy and Non-retrograde Percutaneous Nephrolithotomy in the Treatment of 1.5-2.0 cm Upper Ureteral Stones
Guangyuan YANG ; Xiaosong SUN ; Dongcao LIU ; Xiaoyuan QIAN ; Fuchao LIANG ; Linghui QIN
Chinese Journal of Minimally Invasive Surgery 2025;25(8):480-484
Objective To compare the efficacy and safety of flexible ureteral lithotripsy(FURL)and non-retrograde percutaneous nephrolithotomy(NR-PCNL)for treating1.5-2.0 cm upper ureteral stones.Methods We retrospectively analyzed clinical data of 130 patients with upper ureteral stones treated between October 2022 and October 2024.Sixty-two patients underwent FURL and 68 underwent NR-PCNL.Comparisons included operative time,pre-and postoperative changes in white blood cells(WBC),hemoglobin(Hb),and creatinine(Cr),postoperative C-reactive protein(CRP)levels,stone-free rate after primary surgery,postoperative hospitalization duration,pain scores,complications,and need for auxiliary treatments.Results Compared to the FURL group,the NR-PCNL group demonstrated advantages in operative time[54.0(44.3,69.3)min vs.82.5(66.0,101.0)min,Z=-5.565,P<0.001],WBC elevation[1.9(0.5,3.5)×109/L vs.4.5(3.0,6.0)×109/L,Z=-4.528,P<0.001],and secondary surgery rate[0%(0/68)vs.14.5%(9/62),P<0.001].The FURL group showed lower Hb reduction[3.0(2.0,6.3)g/L vs.8.0(5.0,11.0)g/L,Z=-4.262,P<0.001],less postoperative Visual Analogue Scale(VAS)pain scores[1.0(1.0,2.0)points vs.2.0(1.0,2.0)points,Z=-2.840,P=0.005],and shorter hospitalization duration[2.0(1.0,2.0)d vs.3.0(2.0,3.0)d,Z=-5.815,P<0.001].No significant differences were observed in Cr elevation,CRP levels,stone-free rate after primary surgery,complications,or analgesic requirements(P≥0.05).Conclusions Both NR-PCNL and FURL are safe and effective for 1.5-2.0 cm upper ureteral stones.FURL offers better patient comfort,while NR-PCNL shows superior overall safety.
8.Mechanism of Zuogui Jiangtang Jieyu Prescription Against Damage to Hippocampal Synaptic Microenvironment via Suppressing GluR2/Parkin Signal-mediated Mitophagy in Rats with Diabetes-related Depression
Jian LIU ; Lin LIU ; Xiaoyuan LIN ; Wei LI ; Yuhong WANG ; Hui YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):104-112
ObjectiveTo reveal the mechanism of Zuogui Jiangtang Jieyu prescription against damage to hippocampal synaptic microenvironment via suppressing glutamate receptor 2 (GluR2)/Parkin signal-mediated mitophagy in rats with diabetes-related depression (DD). MethodsEighty male SD rats underwent adaptive feeding for 5 days before the study. Ten rats were randomly assigned to the normal group. The model of DD rats was established with the rest by 2-week high-fat diet + streptozotocin (STZ) tail intravenous injection + 28 days of chronic unpredictable mild stress (CUMS) combined with isolation. The rats were randomly divided into a normal group, a model group, a GluR2 blocker group (5 μg·kg-1), a GluR2 agonist group (10 μg·kg-1), a metformin + fluoxetine group (0.18 g·kg-1 metformin + 1.8 mg·kg-1 fluoxetine), and high- and low-dose Zuogui Jiangtang Jieyu prescription groups (20.52 and 10.26 g·kg-1, respectively). The rats in the GluR2 blocker group and the GluR2 agonist group were continuously injected with CNQX and Cl-HIBO in the dentate gyrus of the hippocampus once a week starting from stress modeling, respectively, while the metformin + fluoxetine group and the high- and low-dose Zuogui Jiangtang Jieyu prescription groups were continuously given intragastric administration for 28 d at the same time of stress modeling. Depression-like behavior was evaluated by open field and forced swimming experiments. The levels of serum insulin and adenosine triphosphate (ATP) in hippocampus were detected by biochemical analysis. The levels of 5-hydroxytryptamine (5-HT) and dopamine (DA) in hippocampus were detected by enzyme-linked immunosorbent assay (ELISA). The autophagosomes of hippocampal neurons were observed by transmission electron microscopy. The morphology and structure of dendrites and spines of hippocampal neurons were evaluated by Golgi staining. Western blot detected the expression levels of GluR2 and Parkin proteins in hippocampus. The expression levels of GluR2, Parkin, regulating synaptic membrane exocytosis protein 3 (RIMS3), and postsynaptic density protein 95 (PSD95) in the dentate gyrus of the hippocampus were detected by immunofluorescence. ResultsCompared with the normal group, the model group exhibited reduced total activity distance in the open field and increased immobility time in forced swimming (P<0.01), lowered levels of serum insulin and ATP, 5-HT, and DA in hippocampus (P<0.01), increased autophagosomes of hippocampal neurons, significantly damaged morphology and structure of dendrites and spines of hippocampal neurons, decreased expression levels of GluR2, RIMS3, and PSD95 in hippocampus, and an increased Parkin expression level (P<0.05, P<0.01). Compared with the model group, the GluR2 blocker group and the GluR2 agonist group showed aggravation and alleviation of the above abnormal changes, respectively (P<0.05, P<0.01). The above depression-like behavior was significantly improved in the high- and low-dose Zuogui Jiangtang Jieyu prescription groups to different degrees. Specifically, the two groups saw elevated levels of serum insulin and ATP, 5-HT, and DA in hippocampus (P<0.05, P<0.01), restrained increase in autophagosomes and damage to morphology and structure of dendrites and spines of hippocampal neurons, up-regulated protein expression levels of GluR2, RIMS3, and PSD95, and down-regulated Parkin expression level (P<0.05, P<0.01). ConclusionZuogui Jiangtong Jieyu prescription can ameliorate the mitophagy-mediated damage to hippocampal synaptic microenvironment in DD rats, the mechanism of which might be related to the regulation of GluR2/Parkin signaling pathway.
9.Resveratrol activates extracellular-regulated protein kinase 5 signaling protein to promote proliferation of mouse MC3T3-E1 cells
Yongkang NIU ; Zhiwei FENG ; Yaobin WANG ; Zhongcheng LIU ; Dejian XIANG ; Xiaoyuan LIANG ; Zhi YI ; Hongwei ZHAN ; Bin GENG ; Yayi XIA
Chinese Journal of Tissue Engineering Research 2025;29(5):908-916
BACKGROUND:The extracellular-regulated protein kinase 5(ERK5)signaling protein is essential for the survival of organisms,and resveratrol can promote osteoblast proliferation through various pathways.However,whether resveratrol can regulate osteoblast function through the ERK5 signaling protein needs further verification. OBJECTIVE:To explore the regulatory effect of ERK5 on the proliferation of MC3T3-E1 cells and related secreted proteins,and to further verify whether resveratrol can complete the above process by activating ERK5. METHODS:Mouse MC3T3-E1 preosteoblasts were treated with complete culture medium,XMD8-92(an ERK5 inhibitor),epidermal growth factor(an ERK5 activator),resveratrol alone,XMD8-92+EGF,and resveratrol+XMD8-92,respectively.Western blot assay was used to detect the expression of ERK5 and p-ERK5 proteins,proliferation-related proteins Cyclin D1,CDK4 and PCNA,and osteoblast-secreted proteins osteoprotegerin and receptor activator of nuclear factor-κB ligand in MC3T3-E1 cells of each group.The fluorescence intensity of ERK5,osteoprotegerin and receptor activator of nuclear factor-κB ligand in each group was detected by cell immunofluorescence staining,and cell proliferation was detected by EdU staining,respectively.The appropriate concentration and time of resveratrol intervention in MC3T3-E1 cells were determined by cell morphology observation and cell counting kit-8 assay. RESULTS AND CONCLUSION:The activation of ERK5 signaling protein could effectively promote the proliferation of MC3T3-E1 cells,up-regulate the osteoprotegerin/receptor activator of nuclear factor-κB ligand ratio.The appropriate concentration and time for resveratrol intervention in MC3T3-E1 cells was 5 μmol/L and 24 hours,respectively.Resveratrol could activate ERK5 signaling protein,thereby promoting osteoblast proliferation and up-regulating the osteoprotegerin/RANKL ratio.All these results indicate that resveratrol can promote the proliferation of MC3T3-E1 cells and up-regulate the osteoprotegerin/RANKL ratio by activating the ERK5 signaling protein.
10.Prevalence survey of implementation process of special campaign for enhancing pathogen detection rate before antimicrobial therapy in hospitalized patients of 31 hospitals
Jiao SHAN ; Na LIU ; Yulong CAO ; Yukun CHEN ; Yingchun LIU ; Meng JIN ; Xiaoyuan BAO
Chinese Journal of Nosocomiology 2025;35(20):3142-3146
OBJECTIVE To understand the current management status of the special campaign for enhancing the pathogen detection rate before antimicrobial therapy in hospitalized patients in China,analyze identified issues dur-ing implementation,and propose improvement suggestions.METHOD A questionnaire survey was conducted to collect data from medical institutions participating in the special campaign within the region from May to Jul.2024,covering aspects such as quality control management,coordination mechanisms,data sources,indicator connotations and existing issues.RESULTS Variations were observed among medical institutions in the manage-ment of pathogen detection rates,primarily reflected in inconsistent usage of detection rate indicators,varying im-plementation levels of quality control measures and differences in multi-departmental participation.Additionally,discrepancies in data sources,statistical methods and interpretations of indicator connotations limited the compara-bility of data.CONCLUSIONS To address these issues,improvement measures such as strengthening informatiza-tion construction,standardizing indicator statistical methods and enhancing multi-departmental coordination mech-anisms should be implemented.These efforts will provide a scientific basis for the implementation of special cam-paign and robust support for the rational use of antimicrobial agents.

Result Analysis
Print
Save
E-mail