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.Investigation and control of 2 cases of hospital-acquired Enterococcus faecium infection in a neonatal intensive care unit
Chaomin GUO ; Mingmei DU ; Huan LI ; Hongwu YAO ; Yunxi LIU ; Kun YE ; Xiaoming ZHANG
Chinese Journal of Nosocomiology 2025;35(16):2427-2431
OBJECTIVE To investigate a suspected hospital-acquired infection cluster of Enterococcus faecium(Efm)in a neonatal intensive care unit(NICU)of the First Medical Center of Chinese PLA General Hospital,identify the source of infection and transmission routes,and provide a reference for precise prevention and control of hospital-acquired infections.METHODS Epidemiological investigations and environmental microbiological sam-pling were conducted for two neonates with Efm bloodstream infections in the NICU in Jul.2024 to detect Efm in the ward environment.Whole-genome average nucleotide identity(ANI)and multilocus sequence typing(MLST)were used to analyze the homology,drug resistance,and virulence factors of Efm isolates from patients and envi-ronments.Targeted intervention measures were proposed.RESULTS Two cases of Efm bloodstream infection were detected.A total of 37 environmental specimens were collected,and 2 were cultured Efm(the wipe dispenser o-pening and incubator handle of the patients).The drug susceptibility testing results of 2 environmental specimens were consistent with those of the two patient specimens.Genomic analysis confirmed high homology(ANI>99.99%)among the four Efm isolates.After implementing a series of measures including centralized isolation,strict hand hygiene,thorough environmental cleaning and disinfection,strict disinfection and management of inva-sive devices,enhanced grouping of medical staff for diagnosis and treatment,the incident was effectively con-trolled.CONCLUSIONS This incident can be determined as cluster of hospital-acquired infection with Enterococcus faecium in the neonatal intensive care unit.The wet wipes are the source or transmission medium of contamina-tion.Inadequate disinfection of items and the environment,and insufficient hand hygiene of medical staff are the main reasons for this infection outbreak.Early identification of abnormal cluster of infection,investigation of the source of infection and transmission routes and timely implementation of targeted measures are the keys for preventing infection outbreaks.
3.Characteristics and prevention and control strategies of combat trauma related infections:an open-source literature databases
Guoxing HUANG ; Jingyuan MA ; Hongwu YAO ; Jinlong WANG ; Di WU ; Meng WANG ; Xinlou LI
Chinese Journal of Nosocomiology 2025;35(16):2529-2534
OBJECTIVE By conducting evidence evaluation research on literatures,this study aims to reveal the o-verall characteristics and research hotspots in the field of combat trauma-related infections,ultimately providing data support for the prevention and control of such infections.METHODS Relevant research in this field was sys-tematically collected from open-source databases to construct a dataset.The overall characteristics,research hotspots,prevention and control strategies,and future challenges of trauma-related infections were summarized and analyzed.RESULTS From 2004 to 2024,184 papers were published.The United States contributed the most publications,with Uniformed Services University of the Health Sciences being the most productive research insti-tution and Professor Clinton K.Murray as the author with the highest number of publications.The top five key-words with the highest frequency were combat related injury,infection,Acinetobacter baumannii,epidemiology and management.Among the publicly published literature data on war trauma-related infections,blast injuries ac-counted for the largest proportion,mainly multi-site injuries,with limb injuries being the most common.Bacteri-al infections were more common than fungal infections,with gram-negative bacteria being predominant and A.baumannii being the most common.Besides early wound management and the use of antibacterial drugs,in-creased attention should be paid to infection prevention and control in austere environments and the development of novel countermeasures.These advancements are critical to address projected changes in combat trauma,inclu-ding increasingly complex injuries and substantially elevated risks of infection and antimicrobial resistance.CONCLUSION This study systematically presents research hotspots,developmental trends,and prospects in com-bat trauma-related infections through evidence evaluation study,providing novel perspectives for researchers and facilitating further development in this field.
4.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.
5.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.
6.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.
7.Exploring Vascular Recruitment in Tracheobronchial Adenoid Cystic Carcinoma from Perspective of Abnormal Collateral
Jun TENG ; Lei LI ; Junyan XIA ; Yi LUO ; Qinyan HONG ; Shuiping CHEN ; Hongwu WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):260-269
Tracheobronchial adenoid cystic carcinoma (TACC) is a low-grade malignant tumor originating from the airway mucosa. Despite its slow progression,it is characterized by high invasiveness,frequent recurrence,and a strong tendency for metastasis. Preclinical studies have shown that vascular-targeted therapy holds significant potential. However,an effective systemic treatment for TACC has not been established yet. This study explored TACC from the perspective of "Feiji" in traditional Chinese medicine (TCM) as the starting point. It deeply investigated the mechanisms of abnormal collaterals and tumor vascular recruitment and further elaborated on the theoretical connection between abnormal collaterals and tumor vascular recruitment. Firstly,collateral hyperactivity led to disordered and erratic pulmonary collaterals. Their abnormal structures were similar to the disorderly and tortuous nature of tumor (pseudo)angiogenesis. This resulted in imbalances in the functions of circulation,perfusion,and reverse injection of the pulmonary collaterals,and then led to unrestrained collateral dysfunction and the accumulation of pathogenic factors. Secondly,the remodeling of the extracellular matrix (ECM) and epithelial-mesenchymal transition (EMT) in TACC were critical processes in vascular co-option (VCO),representing the micro-level manifestation of the displacement of nutrient and defense. During this process,ECM remodeling made TACC cells more likely to hijack normal blood vessels,creating a complex vascular microenvironment conducive to tumor growth. In terms of treatment,this study proposed a TCM strategy of "regulating collaterals to expel pathogenic factors and nourishing collaterals to strengthen the healthy Qi",and listed potential TCM. These were intended to regulate the Qi and blood in the collaterals,repair the functions of abnormal collaterals,and intervene in the vascular recruitment process of TACC. Future research should focus on improving the TCM clinical syndrome characteristics of TACC. Through modern molecular biology techniques,it is necessary to deeply analyze the micro-level pattern of vascular recruitment in TACC. This would enrich the understanding of the profound connection between abnormal collaterals and tumor vascular recruitment,providing empirical evidence for TCM-targeted therapies for vascular recruitment in TACC.
8.Clinical Observation on 60 Cases of Knee Osteoarthritis Treated with Heat-Sensitive Moxibustion
Lu TIAN ; Hongwu XIE ; Meihua LIU ; Jing ZHANG ; Shaozhong XU ; Changjun LI ; Zhixiong KOU
Journal of Traditional Chinese Medicine 2025;66(5):492-500
ObjectiveTo explore the central neuroregulation mechanism of heat-sensitive moxibustion for knee osteoarthritis on pain relief. MethodsThirty patients who did not have experience of Deqi (得气) during heat-sensitive moxibustion treatment were assigned to the "non-Deqi group", while another 30 patients who had experience of Deqi were assigned to the "Deqi group". Both groups received moxibustion at the left Heding (EX-LE2) acupoint. In the Deqi group, after the patients experienced sensation of Deqi at the acupoint, moxibustion was applied at approximately 3 cm from the skin for 10 minutes; in the non-Deqi group, moxibustion was also applied at approximately 3 cm from the skin for 10 minutes. Both groups received treatment once daily for 10 consecutive days. Knee joint pain was assessed before and after treatment using the visual analog scale (VAS). Resting-state functional magnetic resonance imaging (rs-fMRI) scans were performed on all participants before the first treatment session and after the final session on the 10th day. The fractional amplitude of low-frequency fluctuations (fALFF) maps before and after treatment were processed using the SPM12 module by MATLAB. ResultsAfter treatment, VAS scores in both groups were significantly lower than before treatment (P<0.05 or P<0.01), with the Deqi group showing significantly lower VAS scores than the non-Deqi group (P<0.01). Compared to before treatment, the Deqi group exhibited significant activation in the prefrontal cortex (t = 6.28), white matter (t = 6.36), and left temporal lobe (t = 9.33), while significant inhibition was observed in the occipital lobe (t = -9.86) and right cerebrum (t = -4.54, P<0.01); in the non-Deqi group, significant changes after treatment were observed in the left occipital lobe (t = -6.42), left medial frontal gyrus (t = -4.35), left middle frontal gyrus (t = -4.74), right superior frontal gyrus (t = -4.82), right superior temporal gyrus (t = -6.61), and right cerebellar posterior lobe (t = -8.64), all of which were in inhibited states (P<0.01). Compared to the non-Deqi group, the Deqi group exhibited significant activation after treatment in the external nucleus (t = 5.77), white matter (t = 3.58), right cerebrum (t = 5.84), left cerebellum (t = 5.35), and left cerebrum (t = 4.32), while significant inhibition was observed in the prefrontal cortex (t = -4.16), occipital lobe (t = -4.87), and precentral gyrus (t = -4.46, P<0.01). ConclusionsHeat-sensitive moxibustion provides better analgesic effects for knee osteoarthritis under state of Deqi. Its central neuroregulation mechanism may be related to the involvement of the frontal lobe, temporal lobe, occipital lobe, external nucleus, white matter, right cerebrum, left cerebellum, left cerebrum, and precentral gyrus in modulating pain signals.
9.Endovascular recanalization for symptomatic non-acute internal carotid artery occlusion:analysis of its short-term efficacy
Junlei CUI ; Xinyu XIE ; Dayong DU ; Yanwei HOU ; Wenlong ZHANG ; Bo LI ; Hongwu ZHANG ; Heliang ZHANG ; Zaiyu GUO
Journal of Interventional Radiology 2025;34(10):1105-1109
Objective To discuss the short-term efficacy of endovascular recanalization for symptomatic non-acute internal carotid artery occlusion.Methods A total of 90 patients with symptomatic non-acute internal carotid artery occlusion,who were admitted to the Department of Neurology of Tianjin Municipal Teda Hospital of China from August 2017 to December 2021,were selected as the research objects.The patients were divided into study group(n=45)and control group(n=45).Percutaneous endovascular recanalization of internal carotid artery occlusion was performed for the patients of the study group,and standardized antiplatelet aggregation and anti-lipid therapy(including oral aspirin,clopidogrel bisulphate and atorvastatin)was adopted for the patients of the control group.The symptom recurrence rate at one year after treatment in both groups was analyzed.Results Of the 45 patients in the control group,4 were lost in touch,and 41 completed the one-year follow-up.Of the 45 patients in the study group,2 patients had failure of surgery,one patient had lost contact visit,and 42 completed the one-year follow-up.Postoperative intracranial hemorrhage occurred in 2 patients.After one year of follow-up,in the control group 26 patients(63.41%)developed recurrence of symptoms,presenting as transient ischemic attack(TIA,n=13,31.7%)and cerebral infarction(n=13,31.7%),and in the study group 8 patients(4.76%)developed recurrence of symptoms,presenting as TIA(n=6,14.3%)and cerebral infarction(n=2,4.8%);the incidence of cerebral infarction in the study group was strikingly lower than that in the control group,and the difference between the two groups was statistically significant(P<0.05).In the patients with grade Ⅲ compensation,the recurrence rate of symptoms was remarkably decreased after endovascular recanalization of internal carotid artery occlusion,and the difference between the two groups was statistically significant(P<0.05).However,in the patients with grade Ⅰ or grade Ⅱ compensation,although the recurrence rate of symptoms was decreased after endovascular recanalization of internal carotid artery occlusion,the difference between the two groups was not statistically significant(P>0.05).Conclusion For the treatment of patients with symptomatic non-acute internal carotid artery occlusion,percutaneous endovascular recanalization of internal carotid artery occlusion is clinically safe,it can significantly decrease the recurrence rate of symptoms.
10.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.

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