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.Analysis of clinical applicability and implementation of expert consensus on the implementation and removal of protective restraints in psychiatry
Jianing GU ; Dongmei XU ; Jing SHAO ; Jing GAO ; Zhuang CAI ; Yanhua QU ; Xiaolu YE ; Mengqian ZHANG ; Dongli MEI ; Yanhong ZHANG ; Bo YANG ; Gen CHENG ; Lina WANG ; Junrong YE ; Ruiyue LIN ; Yongling ZHOU ; Runjuan MA
Chinese Journal of Nursing 2025;60(11):1359-1365
Objective To understand the clinical applicability and implementation of expert consensus on the implementation and removal of protective restraints in psychiatry,and to provide references for promoting the standardized practice of psychiatric protective restraints and updating the consensus.Methods By the convenience sampling method,a questionnaire survey was conducted among nurses from 480 hospitals in 30 provinces from June 15 to July 15,2024.The survey was conducted using the instrument for evaluating clinical applicability of guide-lines(version 2.0)and a self-compiled questionnaire on the clinical implementation of the restraint consensus.Results A total of 7,844 valid questionnaires were collected,with a valid questionnaire recovery rate of 93.78%.The results of clinical applicability scoring showed that the consensus had the lowest availability score(64.72%)and the highest acceptability score(76.74%).The results showed that nurses' receiving training and the level of their hospitals were the main influencing factors for scores in various dimensions(P<0.05).4,774 participants(87.42%)believed that the application of consensus could enhance the standardization of nurses' restraint operations.The safety rate of the restraint consensus was 79.51%,and the economic ratio was 76.87%.Among the evaluators,1,739(22.17%)believed that there were implementation obstacles in the consensus.Conclusion The clinical applicability of the consensus is relatively good,and the application of the consensus helps to improve the standardization of clinical operations.In the future,efforts should be made to strengthen the promotion and training of the consensus,develop hierarchical promotion strategies according to the characteristics of medical institutions,and improve the quality of evidence for the consensus,so as to further enhance the clinical application effect of the consensus.
3.Analysis of clinical applicability and implementation of expert consensus on the implementation and removal of protective restraints in psychiatry
Jianing GU ; Dongmei XU ; Jing SHAO ; Jing GAO ; Zhuang CAI ; Yanhua QU ; Xiaolu YE ; Mengqian ZHANG ; Dongli MEI ; Yanhong ZHANG ; Bo YANG ; Gen CHENG ; Lina WANG ; Junrong YE ; Ruiyue LIN ; Yongling ZHOU ; Runjuan MA
Chinese Journal of Nursing 2025;60(11):1359-1365
Objective To understand the clinical applicability and implementation of expert consensus on the implementation and removal of protective restraints in psychiatry,and to provide references for promoting the standardized practice of psychiatric protective restraints and updating the consensus.Methods By the convenience sampling method,a questionnaire survey was conducted among nurses from 480 hospitals in 30 provinces from June 15 to July 15,2024.The survey was conducted using the instrument for evaluating clinical applicability of guide-lines(version 2.0)and a self-compiled questionnaire on the clinical implementation of the restraint consensus.Results A total of 7,844 valid questionnaires were collected,with a valid questionnaire recovery rate of 93.78%.The results of clinical applicability scoring showed that the consensus had the lowest availability score(64.72%)and the highest acceptability score(76.74%).The results showed that nurses' receiving training and the level of their hospitals were the main influencing factors for scores in various dimensions(P<0.05).4,774 participants(87.42%)believed that the application of consensus could enhance the standardization of nurses' restraint operations.The safety rate of the restraint consensus was 79.51%,and the economic ratio was 76.87%.Among the evaluators,1,739(22.17%)believed that there were implementation obstacles in the consensus.Conclusion The clinical applicability of the consensus is relatively good,and the application of the consensus helps to improve the standardization of clinical operations.In the future,efforts should be made to strengthen the promotion and training of the consensus,develop hierarchical promotion strategies according to the characteristics of medical institutions,and improve the quality of evidence for the consensus,so as to further enhance the clinical application effect of the consensus.
4.Autonomic Nervous System Dysfunction Is Related to Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Hailan HE ; Hui LUO ; Biao QIAN ; Hui XU ; Guoxi ZHANG ; Xiaofeng ZOU ; Junrong ZOU
The World Journal of Men's Health 2024;42(1):1-28
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common and non-lethal urological condition with painful symptoms. The complexity of CP/CPPS’s pathogenesis and lack of efficient etiological diagnosis results in incomplete treatment and recurrent episodes, causing long-term mental and psychological suffering in patients. Recent findings indicate that the autonomic nervous system involves in CP/CPPS, including sensory, sympathetic, parasympathetic, and central nervous systems. Neuro-inflammation and sensitization of sensory nerves lead to persistent inflammation and pain. Sympathetic and parasympathetic alterations affect the cardiovascular and reproductive systems and the development of prostatitis. Central sensitization lowers pain thresholds and increases pelvic pain perception in chronic prostatitis. Therefore, this review summarized the detailed processes and mechanisms of the critical role of the autonomic nervous system in developing CP/CPPS.Furthermore, it describes the neurologically relevant substances and channels or receptors involved in this process, which provides new perspectives for new therapeutic approaches to CP/CPPS.
5.Research progress on enteral nutrition monotherapy and combination therapy in adults with Crohn's disease
Shuang LI ; Fangmei LING ; Junrong LI ; Yidong CHEN ; Mingyang XU ; Liangru ZHU
Chinese Journal of Clinical Nutrition 2022;30(6):340-345
Patients with Crohn's disease (CD) are often complicated with malnutrition and enteral nutrition is the preferred option for nutritional support. Enteral nutrition is the first-line therapy to induce remission of CD in children, but its application in adults has not been well established. In recent years, studies have found that enteral nutrition can not only improve the nutritional status in adult CD patients, but also induce and maintain CD remission through various mechanisms. Given its favorable nutritional efficacy and safety, enteral nutrition has been considered as the basic treatment for adult CD patients and often used in combination with other treatment approaches. However, any combination therapy should be assessed in terms of benefit and risk. This review aims to describe the efficacy and safety of enteral nutrition combined with other treatment approaches in adult CD patients and enumerate common applicable clinical settings, so as to better inform clinical treatment.
6.Investigation on Construction Status of Biomedical Research Ethics Committee Involving Human Beings in Medical Institutions in Guangzhou
Jing XU ; Guanglie HUANG ; Yu LUO ; Siyi LIU ; Yujun DONG ; Junrong LIU
Chinese Medical Ethics 2022;35(11):1196-1201
【Objective:】 To investigate the construction status of biomedical research ethics committee involving human beings in medical institutions in Guangzhou, and to provide the basis for the standardized management of ethics committee. 【Methods:】 The convenience sampling method was conducted to investigate the construction status of biomedical research ethics committee involving human beings in 58 medical institutions in Guangzhou. The SPSS 21.0 statistical software was used to analyze the data, and the chi-square test was used for difference analysis. 【Results:】 58 medical institutions had set up biomedical research ethics committee involving human beings. 50.00% of the ethics committees hired full-time secretaries, 33.96% of the ethics offices were administratively independent, 52.83% of the ethics offices were equipped with full-time staff, 79.17% of the ethics committees submitted paper documents for review, and 48.61% of ethics committees organized training irregularly. Comparison of the management of ethics committees of drug clinical trials and non-drug clinical trials was statistically significant (P<0.05). 【Conclusion:】 The management of ethics committee is generally good, but the standardization construction still needs to be further strengthened. It is recommended to strengthen the discipline construction and informatization construction of ethics committee, standardize the special training of ethics, improve the supervision systems of ethics committee, unify the construction standards of ethics committee, so as to improve the ability of ethics review, and effectively protect the safety, rights and interests of subjects.
7.The role of abnormal composition of innate lymphoid cells in the occurrence and development of inflammatory bowel disease
Mingyang XU ; Fangmei LING ; Junrong LI ; Yidong CHEN ; Liangru ZHU
Chinese Journal of Inflammatory Bowel Diseases 2022;06(3):267-270
Innate lymphoid cells (ILC) are a type of innate immune cells with adaptive immune function, which can secrete a variety of cytokines and regulate immune response. In recent years, more and more studies have confirmed that there are abundant ILC in the lamina propria of the human intestinal mucosa, and are closely related to the occurrence and development of inflammatory bowel disease (IBD) . When intestinal inflammation occurs, the composition of ILC also appears abnormal. This article reviews the role of abnormal composition of ILC in the occurrence and development of IBD from the aspects of composition and function of ILC, the influence of its abnormal composition on IBD and possible mechanisms.
8.The role of abnormal composition of innate lymphoid cells in the occurrence and development of inflammatory bowel disease
Mingyang XU ; Fangmei LING ; Junrong LI ; Yidong CHEN ; Liangru ZHU
Chinese Journal of Inflammatory Bowel Diseases 2022;06(3):267-270
Innate lymphoid cells (ILC) are a type of innate immune cells with adaptive immune function, which can secrete a variety of cytokines and regulate immune response. In recent years, more and more studies have confirmed that there are abundant ILC in the lamina propria of the human intestinal mucosa, and are closely related to the occurrence and development of inflammatory bowel disease (IBD) . When intestinal inflammation occurs, the composition of ILC also appears abnormal. This article reviews the role of abnormal composition of ILC in the occurrence and development of IBD from the aspects of composition and function of ILC, the influence of its abnormal composition on IBD and possible mechanisms.
9.Comparison of the Contents of 14 Inorganic Elements in Cyperus rotundus from Different Origins Based on Stoichiometry
Na XU ; Shiyu WANG ; Wenbing LI ; Chaomei FU ; Hulan CHEN ; Junrong LU
China Pharmacy 2021;32(3):289-294
OBJECTIVE:To establish the method for the content determination of inorganic elements in Cyperus rotundus ,and to compare the contents of 14 kinds of inorganic elements in C. rotundus from different producing areas ,and to provide theoretical basis for its quality control and high quality resources development . METHODS :The samples were processed by microwave digestion,and ICP-MS method was used to determine the contents of Na ,Mg,K,Ca,Mn,Fe,Ni,Cu,Zn,As,Se,Sr,Cd and Pb. SPSS 23.0 software were used for principal component analysis (PCA)and cluster analysis. RESULTS :The average contents of above 14 kinds of inorganic elements in C. rotundus from different producing areas were 168.62,753.71, 6 938.33,24.31,14.69,197.77,0.60,2.43,26.89,0.21,0.06,5.64,0.05,0.32 mg/kg,respectively. The results of PCA showed that the cumulative variance contribution rate of the first four principal components was 86.203%,which could reflect most of the information of the original data. C. rotundus from Shandong ,Jiangxi,Shanxi,Hubei and Yunnan ranked the top five places in terms of comprehensive score of inorganic element contents. The results of cluster analysis showed that the samples from 9 producing areas were clustered into 5 categories,showing the characteristics of clustering by producing area. From the perspective of inorganic elements ,the quality of C. rotundus from East China ,Central China ,North China and Southwest China was better than that from South China. CONCLUSIONS :Essential trace elements like Na ,Mg,K,Ca,Mn,Fe,Cu,Zn,Sr are rich in C. rotundus,and there are small amounts of Ni ,As,Se,Cd,Pb elements in it. The contents difference of inorganic elements in C. rotundus from different origins may related to the geographical area it belongs to.
10. Anxiety and Depression Related to Inflammatory Bowel Disease and its Intervention
Fangmei LING ; Junrong LI ; Yidong CHEN ; Mingyang XU ; Liangru ZHU
Chinese Journal of Gastroenterology 2021;26(3):176-180
Anxiety and depression are common in patients with inflammatory bowel disease (IBD), especially in patients with complex and active disease. IBD promotes the occurrence of anxiety and depression, while anxiety and depression also affect the progression of IBD. However, the pathogenesis has not been fully clarified, which is related mainly to inflammation, immune activation and brain-gut axis. Clinically, psychological disorders could be screened and identified by quantifiable assessment tools. Appropriate psychotherapy and psychiatric drugs can reduce the level of anxiety and depression and improve the quality of life of patients. This article reviewed the anxiety and depression related to IBD and its intervention.

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