1.Issues and recommendations in the implementation of mutual recognition for ethical review outcomes in multicenter clinical research: a case study of 10 contracting institutions in Guangdong province
Xu LU ; Feng CAO ; Xuan DUAN ; Junrong LIU
Chinese Medical Ethics 2026;39(1):64-70
ObjectiveTo investigate the current situation of mutual recognition for ethical review outcomes in multicenter clinical research across 10 contracting medical institutions in Guangdong Province, analyze existing issues and propose improvement recommendations, thereby promoting the standardized management of mutual recognition for ethical review outcomes in medical institutions. MethodsData from 381 multicenter clinical studies conducted in these 10 medical institutions from January 24 to October 31, 2024, were collected. Text visualization was performed using Python and the WordCloud library, and statistical analyses were conducted with SPSS 25.0. ResultsOf the 381 studies investigated, industry-sponsored clinical trials (ISTs) accounted for 51.71%, while investigator-initiated clinical trials (IITs) constituted 48.29%. The proportions of ethical committees serving as primary reviewers and collaborative reviewers were 33.33% and 66.67%, respectively. The confirmation methods of mutual recognition outcomes were primarily expedited reviews (50.66%) and meeting reviews (49.34%), and no cases of “direct confirmation” were found. The Chi-square test revealed statistically significant differences in review confirmation methods based on project type (χ²=14.851, P<0.001) and ethics committee role (χ²= 69.435, P<0.001). The frequency distribution trend of the contingency table showed that IST projects and primary ethics committees preferred to employ meeting review (58.88% and 79.53% respectively, both higher than the average level of 49.34%), while IIT projects and the collaborative ethics committees more frequently utilized expedited review (60.87% and 65.75% respectively, both higher than the average level of 50.66%). ConclusionThe confirmation methods of mutual recognition for ethical review outcomes in multicenter clinical research are significantly associated with the role of the ethics committee and the type of project. It is recommended to improve management systems, enhance information construction and personnel training, as well as clarify mutual recognition responsibilities and strengthen supervision. This aims to ensure review quality while improving mutual recognition efficiency, thereby safeguarding the rights and interests of research participants.
2.Guidelines for ethical review of cadaveric organ donation
Xiaohong QIU ; Yuan LIAO ; Jipin JIANG ; Junrong LIU
Organ Transplantation 2025;16(5):665-671
The"Regulations on Human Organ Donation and Transplantation"clearly stipulate that medical institutions may only obtain cadaveric organs with the consent of the Human Organ Transplantation Ethics Committee.In order to better safeguard human life and health and uphold human dignity,and on the basis of respecting and protecting the legitimate rights and interests of(potential)donors and their families,as well as organ transplant recipients,this work Guidelines for Ethical Review of Cadaveric Organ Donation is formulated to guide the ethical review committees of Organ Procurement Organization or their affiliated medical institutions to conduct ethical reviews of cadaveric organ donation in a standardized and orderly manner,with the participation of all relevant parties.This manual,oriented by the organizational structure,procedures,content,and supervision of ethical review of cadaveric organ donation,as well as the prominent ethical dilemmas encountered in practice,has been developed through a review of domestic and international literature and in combination with practical experience in the ethical review of cadaveric organ donation.It consists of 10 recommendations aimed at providing a standardized and practical guide for the ethical review of cadaveric organ donation and ensuring the procedural protection of cadaveric organ donation.
3.Research progresses in imaging evaluation on changes of body composition in prostate cancer patients after androgen deprivation treatment
Na JIANG ; Junrong YAN ; Tao LIU ; Lixia QIAN
Chinese Journal of Interventional Imaging and Therapy 2025;22(5):355-359
Prostate cancer is a common malignant tumor in males.Androgen deprivation treatment(ADT)is the main therapeutic method for prostate cancer,which often leads to changes of body composition(BC)characterized by sarcopenia,centripetal fat redistribution and osteoporosis.Imaging techniques can accurately and conveniently assess changes of BC.The research progresses of imaging evaluation on BC changes in prostate cancer patients after ADT were reviewed in this article.
4.Association between TMED4 and the Immune Microenvironment in Colorectal Cancer
Dang ZHOU ; Junrong LI ; Qi LIU
Journal of Medical Research 2025;54(6):127-132
Objective To explore the clinical significance of TMED4 expression in colorectal cancer and its relationship with the im-mune microenvironment.Methods Based on the cancer genome atlas(TCGA)database,the expression level of TMED4 in colorectal cancer and its prognostic value were analyzed using R language.Clinical samples were collected for polymerase chain reaction(PCR)ex-periments to verify its expression,and the correlation with clinicopathological features and prognostic value were analyzed.The functional role of TMED4 was detected through gene set enrichment analysis(GSEA)and immune infiltration analysis.Results The expression level of TMED4 was upregulated in colorectal cancer samples.The expression level of TMED4 was closely associated with the pathological stage,lymphatic metastasis,and distant metastasis of colorectal cancer.The increase in TMED4 expression was closely related to the over-all survival(OS)and disease-specific survival(DSS)of patients.Univariate analysis and multivariate COX analysis found that TMED4might be an independent high-risk factor for DSS in colorectal cancer patients.Receiver operating characteristic(ROC)curve a-nalysis showed that TMED4has the potential to become a potential biomarker for the diagnosis of colorectal cancer.GSEA revealed that TMED4might be involved in multiple pathways,mainly concentrated in transport and catabolic pathways,glycan biosynthesis and metabo-lism pathways,and lipid metabolism pathways.Conclusion High expression of TMED4 is closely related to poor prognosis of colorectal cancer and immune cell infiltration.It may serve as an independent biomarker for predicting the prognosis of colorectal cancer and a poten-tial therapeutic target.
5.Research progresses in imaging evaluation on changes of body composition in prostate cancer patients after androgen deprivation treatment
Na JIANG ; Junrong YAN ; Tao LIU ; Lixia QIAN
Chinese Journal of Interventional Imaging and Therapy 2025;22(5):355-359
Prostate cancer is a common malignant tumor in males.Androgen deprivation treatment(ADT)is the main therapeutic method for prostate cancer,which often leads to changes of body composition(BC)characterized by sarcopenia,centripetal fat redistribution and osteoporosis.Imaging techniques can accurately and conveniently assess changes of BC.The research progresses of imaging evaluation on BC changes in prostate cancer patients after ADT were reviewed in this article.
6.Association between TMED4 and the Immune Microenvironment in Colorectal Cancer
Dang ZHOU ; Junrong LI ; Qi LIU
Journal of Medical Research 2025;54(6):127-132
Objective To explore the clinical significance of TMED4 expression in colorectal cancer and its relationship with the im-mune microenvironment.Methods Based on the cancer genome atlas(TCGA)database,the expression level of TMED4 in colorectal cancer and its prognostic value were analyzed using R language.Clinical samples were collected for polymerase chain reaction(PCR)ex-periments to verify its expression,and the correlation with clinicopathological features and prognostic value were analyzed.The functional role of TMED4 was detected through gene set enrichment analysis(GSEA)and immune infiltration analysis.Results The expression level of TMED4 was upregulated in colorectal cancer samples.The expression level of TMED4 was closely associated with the pathological stage,lymphatic metastasis,and distant metastasis of colorectal cancer.The increase in TMED4 expression was closely related to the over-all survival(OS)and disease-specific survival(DSS)of patients.Univariate analysis and multivariate COX analysis found that TMED4might be an independent high-risk factor for DSS in colorectal cancer patients.Receiver operating characteristic(ROC)curve a-nalysis showed that TMED4has the potential to become a potential biomarker for the diagnosis of colorectal cancer.GSEA revealed that TMED4might be involved in multiple pathways,mainly concentrated in transport and catabolic pathways,glycan biosynthesis and metabo-lism pathways,and lipid metabolism pathways.Conclusion High expression of TMED4 is closely related to poor prognosis of colorectal cancer and immune cell infiltration.It may serve as an independent biomarker for predicting the prognosis of colorectal cancer and a poten-tial therapeutic target.
7.Investigation and refection on anxiety status of medical staff during field training
Shuying LI ; Junrong ZHU ; Xin LIANG ; Xinyan LIU
Journal of Navy Medicine 2025;46(8):759-762
Objective To investigate the anxiety and its related factors in medical staff during field training,so as to provide evidence for psychological education before field training.Methods A total of 81 medical staff who participated in field training were recruited in this cross-sectional study as research objects.The Hamilton Anxiety Scale(HAMA)and self-compiled questionnaires of related factors were used to measure the general states of the staff.Univariate analysis was used to screen relevant variables that affect anxiety,and then a logistic regression model was used for multivarate analysis to determine independent influencing factors.Results The detection rate of anxiety was 14.81%in the research objects.There were significant differences in the degree of anxiety among the medical staff with different variables such as gender,the number of exercises attended,childlessness,parental physical condition,tolerable training time,pastime activities,and personal title(P<0.05).Multivariate regression analysis indicated that gender and parental physical status were independent factors affecting anxiety(P<0.05).Conclusion During field training,a part of medical staff has anxiety,which may affect by multi-factors such as personal,family,and training environment.Therefore,psychological education and counseling before field training should be performed from multiple aspects.
8.NR4A1 ameliorates the inflammation of postoperative ileus through inhibiting p38MAPK/ NF-κB pathway
Xinchang SHANGGUAN ; Jin YE ; Xianqiang CHEN ; Junrong ZHANG ; Jiawen LIU ; Yong WEI
Chinese Journal of Emergency Medicine 2025;34(6):811-818
Objective:To examine the therapeutic effects and molecular mechanisms of nuclear receptor NR4A1 in alleviating postoperative ileus (POI) in a rat model.Methods:Twenty-four Sprague-Dawley rats were randomly(random number) divided into four groups ( n=6/group): sham-operated control, POI model, POI model + NR4A1 stimultior (Cytosporone B, 13 mg/kg), and POI model + NR4A1 antagonist (DIM-C-pPhCO2Me, 2 mg/kg). After 24 hours, intestinal tissues and serum were collected for analysis. We assessed: (1) histopathological changes, (2) intestinal motility via propulsion rate, (3) NR4A1 expression by immunohistochemistry, (4) epithelial apoptosis via TUNEL assay, (5) inflammatory cytokines (IL-6, IL-4) by ELISA, (6) tight junction protein (occludin) by Western blot, and (7) p38MAPK/NF-κB pathway activation through combined western blot and immunofluorescence analyses. Results:Compared with sham controls, POI model rats showed (all P<0.05): significantly reduced NR4A1 expression, severe mucosal damage, increased inflammatory infiltration, elevated epithelial apoptosis, decreased occludin expression, impaired intestinal motility, upregulated pro-inflammatory cytokines (IL-6, IL-4), and activated p38MAPK/NF-κB signaling. NR4A1 activation with Cytosporone B significantly reversed these pathological changes (all P<0.05), while NR4A1 inhibition exacerbated them. Conclusions:NR4A1 activation attenuates POI by suppressing p38MAPK/NF-κB-mediated inflammation and preserving intestinal barrier function, suggesting its potential as a therapeutic target for postoperative ileus.
9.Guidelines for ethical review of cadaveric organ donation
Xiaohong QIU ; Yuan LIAO ; Jipin JIANG ; Junrong LIU
Organ Transplantation 2025;16(5):665-671
The"Regulations on Human Organ Donation and Transplantation"clearly stipulate that medical institutions may only obtain cadaveric organs with the consent of the Human Organ Transplantation Ethics Committee.In order to better safeguard human life and health and uphold human dignity,and on the basis of respecting and protecting the legitimate rights and interests of(potential)donors and their families,as well as organ transplant recipients,this work Guidelines for Ethical Review of Cadaveric Organ Donation is formulated to guide the ethical review committees of Organ Procurement Organization or their affiliated medical institutions to conduct ethical reviews of cadaveric organ donation in a standardized and orderly manner,with the participation of all relevant parties.This manual,oriented by the organizational structure,procedures,content,and supervision of ethical review of cadaveric organ donation,as well as the prominent ethical dilemmas encountered in practice,has been developed through a review of domestic and international literature and in combination with practical experience in the ethical review of cadaveric organ donation.It consists of 10 recommendations aimed at providing a standardized and practical guide for the ethical review of cadaveric organ donation and ensuring the procedural protection of cadaveric organ donation.
10.The value of the modified 5-factor frailty index in assessing postoperative complications and mortality in elderly patients with hip fractures
Zongyan XIE ; Shuyu ZHANG ; Xuhong WANG ; Junrong GUO ; Jian XI ; Feifei ZHAO ; Lu JIN ; Liang LIU
Chinese Journal of Geriatrics 2024;43(1):50-55
Objective:To analyze the value of the modified 5-factor frailty index in assessing postoperative complications and mortality in elderly hip fracture patients.Methods:In this retrospective study, clinical data were collected of hip fracture patients aged 60 years and above surgically treated at Beijing Luhe Hospital affiliated to Capital Medical University between January 2015 and December 2019.Patients' group assignment was based on whether the modified frailty index score was ≤1 or ≥2, and a post-surgery follow-up was conducted for survival at 30 days, 1 year, 2 years, and 4 years, which was analyzed by the Kaplan-Meier method.Multivariate Cox regression analysis was used to identify factors affecting death in elderly patients.Results:A total of 1 208 patients were included, with 890 in the group with the index score ≤1 and 318 in the group with the index score ≥2.There was no difference in mortality at 30 days(1.6% or 14/890 vs.1.9% or 6/318, P=0.707), 1-year(11.3% or 99/874 vs.11.6% or 36/310, P=0.917), 2-years(19.7% or 168/852 vs.24.3% or 73/300, P=0.099)and 4-years(44.0% or 238/541 vs.51.5% or 106/206, P=0.071). The incidence of postoperative complications in the group with the score ≥2 was higher(14.8% or 47/318 vs.9.7% or 86/890, P=0.012), including the incidence of stroke(6.3% or 20/318 vs.1.8% or 16/890, P<0.001)and the incidence of postoperative pneumonia(6.0% or 19/318 vs.3.1% or 28/890, P=0.029), and the differences were statistically significant.Multivariate Cox regression analysis showed that age, being female, the Charlson comorbidity index score and low hemoglobin at admission were risk factors for 1-year, 2-year and 4-year mortality post-surgery(all P<0.05), while the modified frailty index score had no correlation with postoperative mortality. Conclusions:A modified frailty index ≥2 is predictive of increased risk of postoperative pneumonia and stroke in patients with hip fractures, but is not correlated with the risk of postoperative mortality.

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