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.Comparison of healthcare-asociated infection surveilance standards between China and WHO and inspirations
Yuzheng ZHANG ; Hongliang DONG ; Wensen CHEN ; Xiaodong GAO ; Fu QIAO ; Juyuan LIU ; Hongwu YAO ; Mingmei DU
Chinese Journal of Nosocomiology 2025;35(12):1877-1881
OBJECTIVE Healthcare-associated infection(HAI)surveillance is a crucial tool for healthcare manage-ment and public health prevention,the World Health Organization(WHO)released simplified technical guidelines of HAI surveillance to enhance the HAI surveillance in areas with limited medical resources.This study explores the applicability and implementation pathways of the WHO's simplified standards for HAI surveillance in China.METHODS This study used text analysis and qualitative interviews to compare the differences of HAI sur-veillance criteria between China and WHO.Interviews were conducted with professionals of infection prevention and control(IPC)to explore the opportunities and challenges of implementing WHO simplified standards in China.RESULTS Twenty-two IPC professionals with long-term experiences participated in the interviews.Main themes derived from the interview were:WHO simplified standards could enhance the sensitivity of HAI surveil-lance,this approach provided insights for a risk early warning surveillance and improved surveillance in primary healthcare institutions.It also increased the international comparability of Chinese HAI surveillance results.How-ever,the implementation of the WHO simplified standards required further pilot validation,higher levels of infor-matic surveillance and clinical diagnostic capabilities.CONCLUSION This study explores the feasibility and accept-ability of the WHO's simplified HAI surveillance in China,provides references for the transformation of China's HAI surveillance models and systems.
3.Current status of advanced study personnel engaging in hospital-acquired infection control in a three-A hospital
Xing DONG ; Yunxi LIU ; Mingmei DU ; Yanling BAI ; Congjiao ZHAN ; Xiaona ZHANG ; Yun GE ; Zhen ZHANG ; Haixia SUN ; Rong XU ; Junlong YANG ; Xingxing ZHAO ; Hongwu YAO
Chinese Journal of Nosocomiology 2025;35(14):2214-2218
OBJECTIVE To investigate and analyze the current situation and problems of the advanced personnel en-gaging in the hospital-acquired infection control during their training period and explore the existing countermeas-ures and future development.METHODS The literatures regarding to the advanced study in China were retrieved from databases,the subjects of the literatures covered infection control-related advanced study practice,discipline construction,position competence,talent cultivation,scientific research innovation,professional title evaluation,laws,regulations and development plans.From Aug.2024 to Nov.2024,a questionnaire survey and face-to-face interviews were conducted among 36 advanced study personnel from 9 provinces of China who engaged in hos-pital-acquired infection control in the First Medical Center of Chinese PLA General Hospital.Eventually,36 ques-tionnaires were retrieved,all of which were valid with a questionnaire recovery rate of 100.00%.RESULTS Among the 36 advanced study personnel of hospital-acquired infection control,58.33%were medium-grade professional ti-tle;preventive medicine(41.67%),clinical medicine(25.00%)and nursing(16.67%)ranked the top 3 majors.The personnel engaged in the infection control for more than 6 years,and the duration of the advanced study was generally 3 or 6 months.In reality,the personnel faced the choices in terms of the purposes of further education,learning approaches and learning contents.The advanced study personnel also encountered the problems of challenges from promotion,improvement of position competency,integration with clinical training,supervision and practice,as well as physiological,psychological and family pressure.CONCLUSION Aiming at the problems that the advanced study personnel are generally concerned about,such as how to scientifically and effectively carry out hospital-acquired infection control advanced study and preset and solve the problems that may encounter,it is necessary to formulate targeted training programmes so as to provide bases and enlightenment for establishment of a long-term mechanism for advanced study of infection control in China.
4.Comparison of healthcare-asociated infection surveilance standards between China and WHO and inspirations
Yuzheng ZHANG ; Hongliang DONG ; Wensen CHEN ; Xiaodong GAO ; Fu QIAO ; Juyuan LIU ; Hongwu YAO ; Mingmei DU
Chinese Journal of Nosocomiology 2025;35(12):1877-1881
OBJECTIVE Healthcare-associated infection(HAI)surveillance is a crucial tool for healthcare manage-ment and public health prevention,the World Health Organization(WHO)released simplified technical guidelines of HAI surveillance to enhance the HAI surveillance in areas with limited medical resources.This study explores the applicability and implementation pathways of the WHO's simplified standards for HAI surveillance in China.METHODS This study used text analysis and qualitative interviews to compare the differences of HAI sur-veillance criteria between China and WHO.Interviews were conducted with professionals of infection prevention and control(IPC)to explore the opportunities and challenges of implementing WHO simplified standards in China.RESULTS Twenty-two IPC professionals with long-term experiences participated in the interviews.Main themes derived from the interview were:WHO simplified standards could enhance the sensitivity of HAI surveil-lance,this approach provided insights for a risk early warning surveillance and improved surveillance in primary healthcare institutions.It also increased the international comparability of Chinese HAI surveillance results.How-ever,the implementation of the WHO simplified standards required further pilot validation,higher levels of infor-matic surveillance and clinical diagnostic capabilities.CONCLUSION This study explores the feasibility and accept-ability of the WHO's simplified HAI surveillance in China,provides references for the transformation of China's HAI surveillance models and systems.
5.Current status of advanced study personnel engaging in hospital-acquired infection control in a three-A hospital
Xing DONG ; Yunxi LIU ; Mingmei DU ; Yanling BAI ; Congjiao ZHAN ; Xiaona ZHANG ; Yun GE ; Zhen ZHANG ; Haixia SUN ; Rong XU ; Junlong YANG ; Xingxing ZHAO ; Hongwu YAO
Chinese Journal of Nosocomiology 2025;35(14):2214-2218
OBJECTIVE To investigate and analyze the current situation and problems of the advanced personnel en-gaging in the hospital-acquired infection control during their training period and explore the existing countermeas-ures and future development.METHODS The literatures regarding to the advanced study in China were retrieved from databases,the subjects of the literatures covered infection control-related advanced study practice,discipline construction,position competence,talent cultivation,scientific research innovation,professional title evaluation,laws,regulations and development plans.From Aug.2024 to Nov.2024,a questionnaire survey and face-to-face interviews were conducted among 36 advanced study personnel from 9 provinces of China who engaged in hos-pital-acquired infection control in the First Medical Center of Chinese PLA General Hospital.Eventually,36 ques-tionnaires were retrieved,all of which were valid with a questionnaire recovery rate of 100.00%.RESULTS Among the 36 advanced study personnel of hospital-acquired infection control,58.33%were medium-grade professional ti-tle;preventive medicine(41.67%),clinical medicine(25.00%)and nursing(16.67%)ranked the top 3 majors.The personnel engaged in the infection control for more than 6 years,and the duration of the advanced study was generally 3 or 6 months.In reality,the personnel faced the choices in terms of the purposes of further education,learning approaches and learning contents.The advanced study personnel also encountered the problems of challenges from promotion,improvement of position competency,integration with clinical training,supervision and practice,as well as physiological,psychological and family pressure.CONCLUSION Aiming at the problems that the advanced study personnel are generally concerned about,such as how to scientifically and effectively carry out hospital-acquired infection control advanced study and preset and solve the problems that may encounter,it is necessary to formulate targeted training programmes so as to provide bases and enlightenment for establishment of a long-term mechanism for advanced study of infection control in China.
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.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.
8.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.
9.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.
10.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.

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