1.Implementation exploration and ethical concerns of decentralized drug clinical trials in the oncology field
Hongwu LIAO ; Haihong ZHANG ; Jie LI
Chinese Medical Ethics 2026;39(5):588-593
The advancement of artificial intelligence and big data has accelerated the exploration of decentralized clinical trials (DCTs), and their future complementary relationship with traditional clinical trial models represents an inevitable trend. Given the greater complexity of preliminary research and protocol design in oncology drug clinical trials, the implementation of “decentralization” requires all stakeholders to clarify the responsibilities and authorities, enhance communication and collaboration, conduct comprehensive training, and progressively promote the integration and sharing of medical resources, thereby facilitating the establishment of a new quality and risk management framework. Concurrently, institutional review board should focus on reviewing and evaluating the scientificity, feasibility, and research risk controllability of DCT project protocol designs. It should also prioritize the implementation of informed consent norms, the management of safety event reporting and continuing review, and the protection of participants’ personal information and privacy. By adopting corresponding ethical review procedures, it emphasizes improving the risk identification and addressing capabilities of institutional review board members regarding the review projects, guiding researchers to adhere to DCT regulations. This aims to genuinely implement the “value-oriented, patient-centered” philosophy, thereby promoting the standardized and efficient conduct of DCTs.
2.Epidemiological characteristics of hospital-associated infections in a three-A hospital COVID-19 epidemic from 2018 to 2023
Qiong WANG ; Aiwu LUO ; Hongwu YAO ; Huihui DING ; Hanqiang CUI ; Qing WANG ; Huie LI
Chinese Journal of Nosocomiology 2025;35(10):1530-1535
OBJECTIVE To analyze the epidemiological characteristics of hospital-associated infections(HAIs)in a large scale three-A hospital and assess the occurrence and development trends of HAIs before and after COVID-19 epidemic and during different stages of prevention and control strategies so as to provide scientific bases for HAIs management.METHODS The surveillance data were collected from the patients who were hospitalized in a large scale three-A hospital by nosocomial infection real-time surveillance system from Jan.2018 to Dec.2023.The prevalence trend,infection sites and distribution of pathogens were analyzed.The study period was divided into the pre-epidemic stage and the epidemic stage,the epidemic stage was divided into the strict infection prevention and control phase and the loose infection prevention and control phase.The epidemiological characteristics of HAIs were observed and compared.RESULTS From 2018 to 2023,the prevalence rate of HAIs was decreased from 3.39%to 2.21%,and there was significant difference in the prevalence rate of the infections among the years(x2=105.00,P<0.001).During the six years,the prevalence rate of HAIs was highest in the internal medicine wards of critical care medicine department(54.91%),and the gram-negative bacteria(56.61%)were dominant among the pathogens.Lower respiratory tract(41.85%),bloodstream(20.93%)and urinary tract(20.50%)ranked the top 3 infection sites;the lower respiratory tract infection ranked the first place before the COVID-19 epidemic and the different stages of epidemic.The overall prevalence rate of HAIs was 3.26%during the epidemic period,remarkably lower than 3.91%before the COVID-19 epidemic(P<0.001);the overall prevalence rate of HAIs was 2.21%in the loose prevention and control phase of 2023,remarkably lower than 3.78%in the strict prevention and control phase(P<0.001).CONCLUSIONS The prevalence of HAIs generally shows a downward trend during the six years.The lower respiratory tract is the major infection site,and the gram-negative bacteria are dominant among the pathogens,especially Klebsiella pneumoniae.The prevention and control strategies for the COVID-19 epidemic may facilitate the reduction of incidence of HAIs,and the prevalence rate is remarkably reduced even in the loose prevention and control phase.It is necessary for the hospital to take targeted prevention and control measures based on the departments,carry out rigid surveillance of the major infection sites and patho-gens,and conduct multidisciplinary coordinated prevention and control so as to control the HAIs.
3.Progress of research on extensively drug-resistant Acinetobacter baumannii
Xiaoli LIU ; Hongwu YAO ; Mi LI ; Shan LI ; Yunxi LIU
Chinese Journal of Nosocomiology 2025;35(13):2050-2056
Acinetobacter baumannii is an opportunistic pathogen and a major pathogen causing hospital-associat-ed infection worldwide.In recent years,the prevalence rate of extensively drug-resistant A.baumannii(XDR-AB)infection shows an upward trend worldwide,and A.baumannii has become one of the major pathogens cau-sing the hospital-associated infection,which posing a tremendous threat to worldwide public health safety.The critically ill patients with low immune function are the major population for the XDR-AB infection,and the preva-lence of XDR-AB is closely associated with the abuse of antibiotics,invasive medical procedures and long-term via-bility in hospital environment.The XDR-AB strains have produced extensive resistance to the commonly used anti-biotics,which makes the treatment be less effective and brings great challenge to the clinical treatment.The bio-logical characteristics,drug resistance mechanisms of A.baumannii strains and the progress of research on cur-rent prevalence trend of XDR-AB strains are comprehensively evaluated in the article,close attention are paid to the current treatment methods of XDR-AB,and the prevention and control strategies for XDR-AB infections are put forward so as to provide guidance for prevention of the XDR-AB infection and prevalence and look forward to the future research directions.
4.Effect of single or combined transcranial direct current stimulation and functional electrical stimulation on grip strength and brain activation in young healthy individuals:a functional near-infrared spectroscopy-based study
Yingya WANG ; Taibiao LI ; Ahong SU ; Youyi LIN ; Xianhong ZHOU ; Lu TIAN ; Hongwu XIE
Chinese Journal of Rehabilitation Theory and Practice 2025;31(10):1134-1142
Objective To compare the effect of transcranial direct current stimulation(tDCS),functional electrical stimulation(FES)of the forearm flexors,and their combined intervention on grip strength and cerebral cortical activation in healthy young adults.Methods From December,2024 to March,2025,twelve healthy right-handed young volunteers aged 20 to 23 years were recruited from the Fifth Hospital of Xiamen.They were randomly assigned to receive tDCS alone(tDCS group),FES alone(FES group),or simultaneous tDCS-FES(Sim group)in a crossover design.For tDCS,synchronous bihemispheric stimulation of the primary motor cortex(M1)was applied(anode on the left/cathode on the right).FES was delivered to the right flexor carpi radialis and flexor digitorum superficialis muscles.Isometric maximal grip strength was measured before and after each intervention,and functional near-infrared spectroscopy(fNIRS)was used to synchronously monitor oxyhemoglobin(HbO2)during grip strength tasks.Results A case dropped down.The effect of time on grip strength was significant(F=3.964,P=0.048);Post-hoc tests revealed that grip strength significantly increased after intervention in both FES group and Sim group(P<0.05).The effect of groups was significant on HbO2 of the left prefrontal cortex(PFC)and left premotor and supplemen-tary motor cortex(PMC)(F>3.613,P<0.05);Post-hoc tests revealed that the HbO2 of the left PFC and left pri-mary sensory cortex was higher in FES group than in Sim group,while the HbO2 of the left PMC and right PMC was higher in tDCS group than in Sim group(all P<0.05).Correlation analysis indicated that the grip strength was positively correlated with the HbO2 of the bilateral M1 only in Sim group(r>0.694,P<0.05).Conclusion For healthy young adults,tDCS alone mainly activates motor-related brain regions such as PFC and PMC,while FES alone directly enhances peripheral muscle force output and activates the left PFC to participate in mo-tor regulation.The combined intervention achieves the maximum gain in grip strength through a brain-limb inte-grated regulation mechanism,which may be associated with optimization of neural resource and M1 activity.
5.Effect of single or combined transcranial direct current stimulation and functional electrical stimulation on grip strength and brain activation in young healthy individuals:a functional near-infrared spectroscopy-based study
Yingya WANG ; Taibiao LI ; Ahong SU ; Youyi LIN ; Xianhong ZHOU ; Lu TIAN ; Hongwu XIE
Chinese Journal of Rehabilitation Theory and Practice 2025;31(10):1134-1142
Objective To compare the effect of transcranial direct current stimulation(tDCS),functional electrical stimulation(FES)of the forearm flexors,and their combined intervention on grip strength and cerebral cortical activation in healthy young adults.Methods From December,2024 to March,2025,twelve healthy right-handed young volunteers aged 20 to 23 years were recruited from the Fifth Hospital of Xiamen.They were randomly assigned to receive tDCS alone(tDCS group),FES alone(FES group),or simultaneous tDCS-FES(Sim group)in a crossover design.For tDCS,synchronous bihemispheric stimulation of the primary motor cortex(M1)was applied(anode on the left/cathode on the right).FES was delivered to the right flexor carpi radialis and flexor digitorum superficialis muscles.Isometric maximal grip strength was measured before and after each intervention,and functional near-infrared spectroscopy(fNIRS)was used to synchronously monitor oxyhemoglobin(HbO2)during grip strength tasks.Results A case dropped down.The effect of time on grip strength was significant(F=3.964,P=0.048);Post-hoc tests revealed that grip strength significantly increased after intervention in both FES group and Sim group(P<0.05).The effect of groups was significant on HbO2 of the left prefrontal cortex(PFC)and left premotor and supplemen-tary motor cortex(PMC)(F>3.613,P<0.05);Post-hoc tests revealed that the HbO2 of the left PFC and left pri-mary sensory cortex was higher in FES group than in Sim group,while the HbO2 of the left PMC and right PMC was higher in tDCS group than in Sim group(all P<0.05).Correlation analysis indicated that the grip strength was positively correlated with the HbO2 of the bilateral M1 only in Sim group(r>0.694,P<0.05).Conclusion For healthy young adults,tDCS alone mainly activates motor-related brain regions such as PFC and PMC,while FES alone directly enhances peripheral muscle force output and activates the left PFC to participate in mo-tor regulation.The combined intervention achieves the maximum gain in grip strength through a brain-limb inte-grated regulation mechanism,which may be associated with optimization of neural resource and M1 activity.
6.Retrospective Analysis on Clinical Efficacy of Xiazhu Sanjie Prescription in the Treatment of Pulmonary Nodules
Qinyan HONG ; Xinyi ZHANG ; Andong LI ; Mingsheng LYU ; Lei LI ; Hongwu WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(10):148-153
Objective To retrospectively analyze the clinical efficacy of Xiazhu Sanjie Prescription in treating pulmonary nodules.Methods A retrospective study was conducted on 58 patients of pulmonary nodules with spleen deficiency and excessive dampness syndrome who received Xiazhu Sanjie Prescription for 3 months or more at Dongzhimen Hospital,Beijing University of Chinese Medicine,from January 2021 to September 2024 were set as the observation group.Another 58 patients of pulmonary nodules with spleen deficiency excessive dampness syndrome who did not receive TCM intervention during the same period were selected as the control group.Basic information,TCM syndromes,and the diameters of pulmonary nodules on chest HRCT at the first and last visit were collected.Changes in nodule diameter,TCM syndrome scores,and TCM syndrome efficacy were compared between the two groups.Results Compared with the control group,the nodule diameter in the observation group significantly decreased(P<0.05),and the proportion of nodule disappearance or reduction was significantly higher than the control group(P<0.05).The TCM syndrome scores for symptoms such as excessive phlegm,fatigue,loss of appetite,pale complexion,irregular bowel movements,chest tightness,shortness of breath,heaviness of the head and limbs,and abdominal distention showed significant improvement in the observation group both compared to pre-treatment and the control group(P<0.05).The total effective rate of TCM syndromes in the observation group was 93.10%(54/58),while the control group was 17.24%(10/58).The observation group was significantly better than the control group(P<0.05).Conclusion Xiazhu Sanjie Prescription can reduce the diameter of pulmonary nodules to some extent and improve TCM syndromes in patients with pulmonary nodules.
7.Construction and validation of a machine learning-based risk prediction model for delayed onset of lactogenesis in prenatally overweight women
Aoxue LI ; Qinyan GU ; Zhouli GUI ; Hongwu LIAO ; Wenying TANG ; Ye YANG
Chinese Journal of Modern Nursing 2025;31(19):2609-2616
Objective:To explore risk factors for delayed onset of lactogenesis in prenatally overweight women and construct risk prediction models based on machine learning for early identification of high-risk individuals.Methods:Convenience sampling was adopted to select 338 prenatally overweight women who delivered in the Obstetrics Departments of four ClassⅢ Grade A hospitals in Hengyang City from October 2023 to June 2024 for the study. Delivery women were randomly divided into training set and test set in the ratio of 7∶3. The survey was conducted with the General Information Questionnaire, Breastfeeding Self-efficacy Scale Short Form, Edinburgh Postnatal Depression Scale, LATCH Scale and Pittsburgh Sleep Quality Index. One-way analysis and LASSO regression were used to screen predictors using delayed onset of lactogenesis as the outcome variable. Risk prediction models were constructed based on three machine learning algorithms of Logistic regression, support vector, and random forest, respectively. The models were tuned by ten-fold cross-validation to filter out the best models.Results:Delayed onset of lactogenesis occurred in 140 of 338 prenatally overweight women, an incidence of 41.4%. Among the three predictive model performances, the random forest model had the highest area under the receiver operating characteristic curve, accuracy, precision, recall, and F1 value. The importance of each predictor was ranked according to the fandom forest algorithm, and in descending order of importance, they were breastfeeding 1 h after the birth of the newborn, number of previous deliveries, age, feeding mode 3 d postpartum, pregnancy complications, mode of delivery, number of breastfeeding 24 h postpartum, and monthly household income.Conclusions:Risk prediction models for delayed onset of lactogenesis in prenatally overweight women are constructed based on three machine learning algorithms, aiming to help provide a scientific basis for clinical healthcare professionals to take relevant decisions.
8.Study on the Correlation between Tongue Features and Laboratory Indexes in Type 2 Diabetes Patients with Coronary Heart Disease
Naijin ZHANG ; Yin YUAN ; Huixia REN ; Mi ZHOU ; Ying LIU ; Shujiao YUE ; Yonghui LI ; Huaien BU ; Yuanyuan GUAN ; Hongwu WANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(6):1734-1741
Objective To explore the correlation between tongue features of type 2 diabetes patients with coronary heart disease and glycosylated hemoglobin,liver function,blood lipids,C-reactive protein,so as to provide reference for related research.Methods Using the TFDA-1 tongue imaging device to collect patients'tongue images,experts will interpret the tongue images and extract objective parameters of the tongue images through the intelligent auxiliary diagnosis system of traditional Chinese medicine tongue diagnosis;Record patient laboratory indicators and use SPSS statistical software to analyze the correlation between tongue image distribution characteristics,tongue image parameter characteristics,and laboratory indicators using Spearman method.Results 702 patients with type 2 diabetes and coronary heart disease were included.In terms of glycated hemoglobin indicators,bruising parameters are positively correlated with HbA1c,while tongue tip RGB values are negatively correlated with HbA1c.In terms of liver function indicators,tongue edge redness,tongue tip and tongue texture R value are positively correlated with ALT and AST;Red tongue tip,tooth marks on the tongue,etc.are positively correlated with ALT;Fat tongue is positively correlated with AST.In terms of blood lipid indicators,parameters such as tooth mark tongue and tooth mark are positively correlated with TG;The parameters of white coating and tongue coating area are positively correlated with LDL-C;Thin coating is positively correlated with HDL-C,while thick coating is negatively correlated with HDL-C;Red tongue is negatively correlated with TCHO.In terms of C-reactive protein,red tongue,tip red,and edge red are positively correlated with CRP;The GB value of tongue root and tongue substance is negatively correlated with CRP.Conclusion Type 2 diabetes patients with coronary heart disease have tongue picture distribution,tongue shape parameters,tongue color parameters,coating color parameters and HbA1c,ALT,AST,TCHO,TG,HDL-C,LDL-C,CRP indicators in varying degrees of correlation.The combination of patients'tongue picture and laboratory indicators is helpful to clarify the diagnosis and prognosis of type 2 diabetes with coronary heart disease.
9.Epidemiological characteristics of hospital-associated infections in a three-A hospital COVID-19 epidemic from 2018 to 2023
Qiong WANG ; Aiwu LUO ; Hongwu YAO ; Huihui DING ; Hanqiang CUI ; Qing WANG ; Huie LI
Chinese Journal of Nosocomiology 2025;35(10):1530-1535
OBJECTIVE To analyze the epidemiological characteristics of hospital-associated infections(HAIs)in a large scale three-A hospital and assess the occurrence and development trends of HAIs before and after COVID-19 epidemic and during different stages of prevention and control strategies so as to provide scientific bases for HAIs management.METHODS The surveillance data were collected from the patients who were hospitalized in a large scale three-A hospital by nosocomial infection real-time surveillance system from Jan.2018 to Dec.2023.The prevalence trend,infection sites and distribution of pathogens were analyzed.The study period was divided into the pre-epidemic stage and the epidemic stage,the epidemic stage was divided into the strict infection prevention and control phase and the loose infection prevention and control phase.The epidemiological characteristics of HAIs were observed and compared.RESULTS From 2018 to 2023,the prevalence rate of HAIs was decreased from 3.39%to 2.21%,and there was significant difference in the prevalence rate of the infections among the years(x2=105.00,P<0.001).During the six years,the prevalence rate of HAIs was highest in the internal medicine wards of critical care medicine department(54.91%),and the gram-negative bacteria(56.61%)were dominant among the pathogens.Lower respiratory tract(41.85%),bloodstream(20.93%)and urinary tract(20.50%)ranked the top 3 infection sites;the lower respiratory tract infection ranked the first place before the COVID-19 epidemic and the different stages of epidemic.The overall prevalence rate of HAIs was 3.26%during the epidemic period,remarkably lower than 3.91%before the COVID-19 epidemic(P<0.001);the overall prevalence rate of HAIs was 2.21%in the loose prevention and control phase of 2023,remarkably lower than 3.78%in the strict prevention and control phase(P<0.001).CONCLUSIONS The prevalence of HAIs generally shows a downward trend during the six years.The lower respiratory tract is the major infection site,and the gram-negative bacteria are dominant among the pathogens,especially Klebsiella pneumoniae.The prevention and control strategies for the COVID-19 epidemic may facilitate the reduction of incidence of HAIs,and the prevalence rate is remarkably reduced even in the loose prevention and control phase.It is necessary for the hospital to take targeted prevention and control measures based on the departments,carry out rigid surveillance of the major infection sites and patho-gens,and conduct multidisciplinary coordinated prevention and control so as to control the HAIs.
10.Progress of research on extensively drug-resistant Acinetobacter baumannii
Xiaoli LIU ; Hongwu YAO ; Mi LI ; Shan LI ; Yunxi LIU
Chinese Journal of Nosocomiology 2025;35(13):2050-2056
Acinetobacter baumannii is an opportunistic pathogen and a major pathogen causing hospital-associat-ed infection worldwide.In recent years,the prevalence rate of extensively drug-resistant A.baumannii(XDR-AB)infection shows an upward trend worldwide,and A.baumannii has become one of the major pathogens cau-sing the hospital-associated infection,which posing a tremendous threat to worldwide public health safety.The critically ill patients with low immune function are the major population for the XDR-AB infection,and the preva-lence of XDR-AB is closely associated with the abuse of antibiotics,invasive medical procedures and long-term via-bility in hospital environment.The XDR-AB strains have produced extensive resistance to the commonly used anti-biotics,which makes the treatment be less effective and brings great challenge to the clinical treatment.The bio-logical characteristics,drug resistance mechanisms of A.baumannii strains and the progress of research on cur-rent prevalence trend of XDR-AB strains are comprehensively evaluated in the article,close attention are paid to the current treatment methods of XDR-AB,and the prevention and control strategies for XDR-AB infections are put forward so as to provide guidance for prevention of the XDR-AB infection and prevalence and look forward to the future research directions.

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