1.Reliability and Validity Evaluation of TCM Identification Scale of Five Human Qualities in Elderly People
Manman LU ; Rui YU ; Baozhao JU ; Feng GU ; Huan ZHANG ; Zengjin JIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):153-160
ObjectiveBased on the Huangdi Neijing,a traditional Chinese medicine(TCM)identification scale of five human qualities was constructed and applied in elderly people to evaluate its reliability and validity. MethodsBased on the original text of the Huangdi Neijing and a review of relevant ancient and modern literature, an identification scale of five human qualities was developed through Delphi expert interviews. Offline surveys were conducted to evaluate the feasibility,reliability,and validity of its application in elderly people,and the scale was evaluated and revised. ResultsThe scale of five human qualities is divided into five subscales:wood,fire,earth,metal,and water. Each subscale is divided into four dimensions:morphological structure,psychological characteristics,tolerance,and physiological characteristics,with a total of 75 items. The survey results in elderly people show that:(1) The recovery rate and completion rate are 100%,and the average filling time is 23.3 min. 85.5% of the samples are completed within the preset time. (2) Reliability analysis results:The homogeneity reliability of each subscale,Chronbach's α,ranges from 0.702 to 0.793. The scores of each subscale in the split-half reliability range from 0.758 to 0.841, indicating that the internal consistency of the scale is good. (3) Validity analysis results. Content validity:During the development stage of the scale,the item pool,dimensions,and structure of the scale are designed reasonably, and the content is complete. The evaluation of content validity shows that the item-level content validity index (I-CVI) ranges from 0.83 to 1.00, and the scale-level content validity index for universal agreement (S-CVI/UA) is 0.92,indicating good content validity of the scale. Construct validity extracts 22 common factors based on an eigenvalue of 1,with a contribution rate of 62.333% to the overall system. The number of common factors in the five subscales is 4,5,4,5,and 4,respectively,with contribution rates of 52.64%,53.376%,51.445%,51.359%,and 50.714%,respectively,indicating the required structure for physical fitness measurement in elderly people. ConclusionThe scale constructed in this study has high reliability and validity,and it is suitable for evaluating the physical condition of elderly people in TCM.
2.Analysis on the current situation of clinical trials registration of Chinese materia medica in China
Jing HUANG ; Bin FENG ; Shuibing LIU ; Hongxu YANG ; Huan ZHANG ; Lifei CHENG ; Yihuan LIU ; Weigang WANG ; Jia JU
International Journal of Traditional Chinese Medicine 2025;47(10):1454-1460
Objective:To analyze the current status of clinical trials of Chinese materia medica for the purpose of registration in China; To provide reference for the research and development of new TCM drugs.Methods:Clinical trials of Chinese materia medica/natural medicine registered in Drug Clinical Trial Registration and Information Disclosure Platform were retrieved from inception to December 31, 2024. Excel 2019 software was used to input and analyze the data such as the number of registered clinical trials, date of first publication, study status, field of indication, trial phases, sponsors, group leader, and design types.Results:A total of 1 137 Chinese materia medica clinical trials had been registered, accounting for 4.12% of the total number registered on the platform. Phase Ⅱ clinical trials accounted for the highest proportion (58.8%), and 99.7% of clinical trials conducted domestically. The sponsors were predominantly domestically pharmaceutical enterprises. These 1 137 clinical trials of Chinese materia medica clinical trials involved 752 drug categories, 28 dosage forms, and 796 varieties (the same class of drugs had different drug dosage forms), with capsules being the most common. The indications primarily focused on respiratory, digestive, cardio-cerebrovascular, neuropsychiatric, gynecological diseases. The group leader of clinical trials was distributed in 28 provinces, among which the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine as the group leader, undertook the most clinical trials of TCM. 89.9% of the clinical trials adopted the randomized controlled trial design, and only 31.9% of the clinical trials purchased insurance for the subjects.Conclusion:The research and development of new TCM drugs has entered a phase of vigorous development. Further efforts are still needed in establishing systematic guidelines for Chinese materia medica clinical trials, accelerating the internationalization of TCM, exploring innovative dosage forms and indications, and strengthening the protection of participants' rights.
3.Analysis on the current status and characteristic of clinical trials for oral diseases in China
Jia JU ; Yihuan LIU ; Hongxu YANG ; Shuibing LIU ; Huan ZHANG ; Zhiqiang SHI ; Yuanming SUN ; Bin FENG
Chinese Journal of Stomatology 2025;60(4):394-402
Objective:To understand the current status and characteristics of clinical trials for oral diseases in China, for the purpose of providing a reference for the research and development of oral diseases in China.Methods:Retrieving the information on clinical trials related to oral diseases registered on the "Platforms for drug clinical trial registration and information" of the National Medical Products Administration from the date of the database establishment to December 31, 2024. The number of clinical trials, type of drugs, trial phases, indication, trial scope, design types were statistically analyzed.Results:As of December 31, 2024, a total of 578 drug clinical trials for oral disease were registered, accounting for 2.1% (578/27 905) of the clinical trials disclosed on the platform during the same period. Bioequivalence clinical trials accounted for the highest proportion [73.9% (427/578)], followed by Phase Ⅰ [9.0% (52/578)], Phase Ⅱ [8.0% (46/578)], and Phase Ⅲ [4.5% (26/578)]. The 578 clinical trials involved 149 types of trial drugs, mainly chemical drugs, among which 127 were developed by domestic pharmaceutical enterprises and 27 by international pharmaceutical enterprises (the five investigational drugs have undergone clinical trials by both domestic and international pharmaceutical companies). The project leader units of the 578 drug clinical trials were distributed in 27 provinces, autonomous regions, municipalities, and Hong Kong Special Administrative Region. Excluding 427 bioequivalence clinical trials, the project leader units of 151 new drug clinical trials showed a significant aggregation phenomenon, and only three specialized oral hospitals have served as project leader units for drug clinical trials.Conclusions:The number of drug clinical trials for oral disease in China has generally shown an increasing trend, but there are still problems such as small number of clinical trials, low proportion of investment in new drug development and international multicenter trials, concentrated indications of clinical trials and insufficient clinical trial experience in specialized oral medical institutions. Enhancing the enthusiasm and innovation capabilities of domestic pharmaceutical enterprises in the research and development of oral diseases drugs, exploring the advantages of traditional Chinese medicine/natural medicine resources for oral diseases, and establishing a clinical research system in specialized oral medical institutions are of great significance for the development of oral drugs.
4.Development status and thinking of drug clinical trials in northwest China: taking Shaanxi Province as an example
Jia JU ; Qi ZHANG ; Bin FENG ; Hongxu YANG ; Shuibing LIU ; Huan ZHANG ; Yihuan LIU ; Tian ZHANG ; Zhongying MA
Chinese Journal of Medical Science Research Management 2025;38(2):150-155
Objective:To review drug clinical trial development in Shaanxi province and to understand the effectiveness of the implementation of a record system in promoting drug clinical trial development.Methods:Based on the data of drug clinical trials in Shaanxi province released on the official website of the National Medical Products Administration, this study made a statistical analysis of the number of drug clinical trial institutions, regional distribution, registered majors and principal investigators, and the development of drug clinical trial projects.Results:After implementing drug clinical trial institution registration, the drug clinical trial institutions in Shaanxi Province developed rapidly, increasing from 20 in the qualification period to 46, with a growth rate of 130%. A total of 113 specialties were recorded, of which the highest number of professional records were for endocrinology and oncology. 46 institutions recorded 1, 094 principal investigators and participated in 3803 drug clinical trial projects. However, only 8 institutions had undertaken drug clinical trial projects as group leaders.Conclusions:The number of drug clinical trial institutions in Shaanxi province increased significantly, reflecting a good overall development status. However, issues still exist, such as unbalanced development of clinical trial resources within the region, insufficient researchers with the ability to conduct clinical trials, relatively concentrated drug clinical trial projects, and lack of experience in undertaking clinical trials as a group leader.
5.Construction method and application of a cloud-based platform for full process closed-loop quality control management of healthcare-associated infection based on multi-source data fusion
Lihua HUANG ; Jiao LIU ; Zetao PAN ; Haozhi ZHU ; Xueer PENG ; Xu JU ; Huan LI
Chinese Journal of Infection Control 2025;24(10):1478-1486
Objective To construct a cloud-based platform for healthcare-associated infection(HAI)management based on multi-source data fusion and data visualization,and evaluate its application effectiveness.Methods A ter-tiary first-class cancer hospital was selected as the research object.Aligned with graded hospital accreditation stan-dards and based on grid-based management and responsibility zone mode,a platform was constructed in 2023 with low-code technology,multi-source data fusion,and visualization function.The self-comparison method was adopted to compare occurrence of HAI before and after the operation of the platform.A questionnaire survey was adopted to assess the experience and workload reduction feelings of full-time and part-time infection surveillance and control profe-ssionals using the platform.Results 81.56%of the surveyed respondents believed that the platform could re-duce the workload of infection surveillance and control.Compared with before the trial operation,the hospital achieved an annual reduction of 11 200 yuan in paper costs,with associated labor savings of approximately 4 482.5 hours.The incidence of HAI cases in the whole hospital decreased from 0.67%to 0.45%.The pathogen detection rate before therapeutic use of antimicrobial agents increased from 51.26%to 71.54%.Differences were both statis-tically significant(both P<0.05).The detection number and proportion of carbapenem-resistant Pseudomonas aeruginosa(CRPA)and extended-spectrum β-lactamase-producing Klebsiella pneumoniae(ESBL-KP)in HAI cases decreased(54.55%vs 36.47%and 51.14%vs 32.50%,respectively,both P<0.05).Conclusion The construc-tion and application of smart HAI management cloud-based platform can reduce cost,improve management quality,and provide a theoretical basis and technical paradigm for the construction of smart HAI management system.
6.Electroacupuncture Alleviates Hepatic Lipid Accumulation and Intestinal Mucosal Injury in Hyperlipidemia Model Rats
Huan WU ; Zhaoqing ZHANG ; Shiru JU
Acta Medicinae Universitatis Scientiae et Technologiae Huazhong 2025;54(2):166-171
Objective To investigate the effect of electrotherapy on liver and intestinal mucosal injury in hyperlipidemia rats.Methods Wistar rats were divided into control group,model group and electroacupuncture group,with 6 rats in each group.Both the model group and the electroacupuncture group were fed with high-fat diet,and the electroacupuncture group re-ceived electroacupuncture intervention.After treatment,HE staining was used to detect the pathological changes of liver and ile-al mucosa.The contents of TC,TG,LDL-C and HDL-C in serum of rats were detected by biochemical method.AB-PAS staining was used to detect ileum mucosa in rats.The protein expressions of FXR,FGF19,ZO-1,occludin and JAM-C in rat ileum were detected by Western blotting.Results Compared with the control group,the body weight was significantly increased in the model group(P<0.05),and the liver and ileum tissues were seriously damaged.The levels of TC,TG and LDL-C in serum and the expression of JAM-C protein in ileum were increased(P<0.01).HDL-C level in serum,FXR,FGF19,ZO-1 and occludin in ileum tissue were decreased(P<0.01).Compared with model group,the weight gain of rats in electroacupuncture group was significantly reduced(P<0.01),and the pathological injury of liver and ileum tissue was alleviated.The levels of TC,TG and LDL-C in serum and the expression of JAM-C protein in ileum were decreased(P<0.01).HDL-C level in serum as well as FXR,FGF19,ZO-1 and occludin levels in ileum tissue were increased(P<0.01).Conclusion Electroacupuncture stimulation can improve the damage of intestinal barrier by activating FXR/FGF19 pathway in rats,play a protective role in liver,and inhibit dyslipidemia.
7.Construction and application of an intelligent system for recognition,pre-vention,and control of infectious diseases and multidrug-resistant orga-nism infections
Chenguang LI ; Zetao PAN ; Haozhi ZHU ; Xu JU ; Zhonglian HE ; Chaofeng LI ; Huan LI
Chinese Journal of Infection Control 2025;24(4):499-505
Objective To construct an intelligent recognition,prevention,and control system for infectious disea-ses and multidrug-resistant organism infections,aiming at improving the efficacy of full-process management,and to evaluate its application effects.Methods Based on personalized logic parsing rules that accurately reflect the infec-tion status and transmission risks in real-time,an intelligent recognition,prevention,and control system with func-tions of automatic recognition,dynamic labeling,real-time sharing,early warning,and visual guidance was estab-lished.Patients undergoing invasive diagnostic and therapeutic procedures in two departments of a tertiary first-class hospital from October 2023 to May 2024 were selected as the research subjects.The differences in recognition,pre-vention,and control efficacy before and after the application of the system were compared using a self-controlled method,with traditional manual management as the control group and intelligent system management as the experi-mental group.Results A total of 2 146 patients were included in the analysis.The recognition,prevention,and control rate and the accuracy rate of recognizing infected individuals using the intelligent system were enhanced sig-nificantly compared with those using manual mode(improved from 5.3%and 72.4%to 100%,respectively),with statistical significance(both P<0.001).The median early warning time for infection information reached 85.20 days,with 100%early warning achieved.The average time spent by medical staff on infection information recogni-tion and management was reduced by 4.71 hours per day.Conclusion The intelligent system constructed in this study significantly improves the effectiveness of full-process management in recognition,prevention,and control of infectious diseases and multidrug-resistant organism infection,effectively reduces the risk of cross-infection,and en-hances the efficiency of diagnostic and therapeutic services.
8.Analysis on the current status and characteristic of clinical trials for oral diseases in China
Jia JU ; Yihuan LIU ; Hongxu YANG ; Shuibing LIU ; Huan ZHANG ; Zhiqiang SHI ; Yuanming SUN ; Bin FENG
Chinese Journal of Stomatology 2025;60(4):394-402
Objective:To understand the current status and characteristics of clinical trials for oral diseases in China, for the purpose of providing a reference for the research and development of oral diseases in China.Methods:Retrieving the information on clinical trials related to oral diseases registered on the "Platforms for drug clinical trial registration and information" of the National Medical Products Administration from the date of the database establishment to December 31, 2024. The number of clinical trials, type of drugs, trial phases, indication, trial scope, design types were statistically analyzed.Results:As of December 31, 2024, a total of 578 drug clinical trials for oral disease were registered, accounting for 2.1% (578/27 905) of the clinical trials disclosed on the platform during the same period. Bioequivalence clinical trials accounted for the highest proportion [73.9% (427/578)], followed by Phase Ⅰ [9.0% (52/578)], Phase Ⅱ [8.0% (46/578)], and Phase Ⅲ [4.5% (26/578)]. The 578 clinical trials involved 149 types of trial drugs, mainly chemical drugs, among which 127 were developed by domestic pharmaceutical enterprises and 27 by international pharmaceutical enterprises (the five investigational drugs have undergone clinical trials by both domestic and international pharmaceutical companies). The project leader units of the 578 drug clinical trials were distributed in 27 provinces, autonomous regions, municipalities, and Hong Kong Special Administrative Region. Excluding 427 bioequivalence clinical trials, the project leader units of 151 new drug clinical trials showed a significant aggregation phenomenon, and only three specialized oral hospitals have served as project leader units for drug clinical trials.Conclusions:The number of drug clinical trials for oral disease in China has generally shown an increasing trend, but there are still problems such as small number of clinical trials, low proportion of investment in new drug development and international multicenter trials, concentrated indications of clinical trials and insufficient clinical trial experience in specialized oral medical institutions. Enhancing the enthusiasm and innovation capabilities of domestic pharmaceutical enterprises in the research and development of oral diseases drugs, exploring the advantages of traditional Chinese medicine/natural medicine resources for oral diseases, and establishing a clinical research system in specialized oral medical institutions are of great significance for the development of oral drugs.
9.Construction method and application of a cloud-based platform for full process closed-loop quality control management of healthcare-associated infection based on multi-source data fusion
Lihua HUANG ; Jiao LIU ; Zetao PAN ; Haozhi ZHU ; Xueer PENG ; Xu JU ; Huan LI
Chinese Journal of Infection Control 2025;24(10):1478-1486
Objective To construct a cloud-based platform for healthcare-associated infection(HAI)management based on multi-source data fusion and data visualization,and evaluate its application effectiveness.Methods A ter-tiary first-class cancer hospital was selected as the research object.Aligned with graded hospital accreditation stan-dards and based on grid-based management and responsibility zone mode,a platform was constructed in 2023 with low-code technology,multi-source data fusion,and visualization function.The self-comparison method was adopted to compare occurrence of HAI before and after the operation of the platform.A questionnaire survey was adopted to assess the experience and workload reduction feelings of full-time and part-time infection surveillance and control profe-ssionals using the platform.Results 81.56%of the surveyed respondents believed that the platform could re-duce the workload of infection surveillance and control.Compared with before the trial operation,the hospital achieved an annual reduction of 11 200 yuan in paper costs,with associated labor savings of approximately 4 482.5 hours.The incidence of HAI cases in the whole hospital decreased from 0.67%to 0.45%.The pathogen detection rate before therapeutic use of antimicrobial agents increased from 51.26%to 71.54%.Differences were both statis-tically significant(both P<0.05).The detection number and proportion of carbapenem-resistant Pseudomonas aeruginosa(CRPA)and extended-spectrum β-lactamase-producing Klebsiella pneumoniae(ESBL-KP)in HAI cases decreased(54.55%vs 36.47%and 51.14%vs 32.50%,respectively,both P<0.05).Conclusion The construc-tion and application of smart HAI management cloud-based platform can reduce cost,improve management quality,and provide a theoretical basis and technical paradigm for the construction of smart HAI management system.
10.Electroacupuncture Alleviates Hepatic Lipid Accumulation and Intestinal Mucosal Injury in Hyperlipidemia Model Rats
Huan WU ; Zhaoqing ZHANG ; Shiru JU
Acta Medicinae Universitatis Scientiae et Technologiae Huazhong 2025;54(2):166-171
Objective To investigate the effect of electrotherapy on liver and intestinal mucosal injury in hyperlipidemia rats.Methods Wistar rats were divided into control group,model group and electroacupuncture group,with 6 rats in each group.Both the model group and the electroacupuncture group were fed with high-fat diet,and the electroacupuncture group re-ceived electroacupuncture intervention.After treatment,HE staining was used to detect the pathological changes of liver and ile-al mucosa.The contents of TC,TG,LDL-C and HDL-C in serum of rats were detected by biochemical method.AB-PAS staining was used to detect ileum mucosa in rats.The protein expressions of FXR,FGF19,ZO-1,occludin and JAM-C in rat ileum were detected by Western blotting.Results Compared with the control group,the body weight was significantly increased in the model group(P<0.05),and the liver and ileum tissues were seriously damaged.The levels of TC,TG and LDL-C in serum and the expression of JAM-C protein in ileum were increased(P<0.01).HDL-C level in serum,FXR,FGF19,ZO-1 and occludin in ileum tissue were decreased(P<0.01).Compared with model group,the weight gain of rats in electroacupuncture group was significantly reduced(P<0.01),and the pathological injury of liver and ileum tissue was alleviated.The levels of TC,TG and LDL-C in serum and the expression of JAM-C protein in ileum were decreased(P<0.01).HDL-C level in serum as well as FXR,FGF19,ZO-1 and occludin levels in ileum tissue were increased(P<0.01).Conclusion Electroacupuncture stimulation can improve the damage of intestinal barrier by activating FXR/FGF19 pathway in rats,play a protective role in liver,and inhibit dyslipidemia.

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