1.Guidelines of ethics review for clinical application of medical technology
Jiyin ZHOU ; Mingjie ZI ; Qi LU ; Hui JIANG
Chinese Medical Ethics 2025;38(1):15-22
Access to the clinical application of medical technology is one of the core institutional contents of medical quality management, involving medical quality assurance, the achievement of patient safety goals, and medical service satisfaction. Medical technology is only permitted for clinical use after its safety and effectiveness have been verified through clinical research, as well as evaluated and reviewed by the medical technology clinical application management committee and ethics committee of this medical and health institution. Based on the relevant laws, regulations, and ethical principles, combined with the experience of ethical review in the clinical application of medical technology from some medical and health institutions, a thematic discussion was held to formulate ethical review guidelines for the clinical application of medical technology for references. These guidelines elaborated on the management system for access to the clinical application of medical technology in medical and health institutions, the system of ethics committees and the requirements of review norms, technical plans and their review points, key points for the implementation of informed consent, technical teams and conditions, and other aspects.
2.Exploration on the relation between tumors and anaphylactic reaction from the perspective of traditional Chinese medicine constitution
Yuhan ZONG ; Huaiyu WANG ; Mengru ZHOU ; Haoyue JIANG ; Luyao JIN ; Xihuan ZHU ; Ji WANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(2):240-245
The etiology of tumors is complex and influenced by multiple factors, including the host and environmental conditions. Allergy is primarily driven by the immune response of helper T cell 2 (Th2). Research has shown that the Th2 immune response is closely related to tumors, which is specifically manifested through Th2 antibodies, allergy-related effector cells and mediators within the tumors, as well as tumor immune-related functions. This internal interaction mechanism will increase the complexity and challenges associated with the clinical diagnosis and treatment of tumors and allergy. The formation of allergic constitution is shaped by both congenital and acquired factors, and its physical state is closely linked to the occurrence and progression of allergic diseases. Therefore, this paper aims to explore the relationship between tumors and allergic reactions from the perspective of traditional Chinese medicine (TCM) constitution theory. Based on the four basic principles of the TCM constitution, including endowment inheritance theory, environment constraint theory, body-spirit composition theory, and life process theory, this exploration will focus on four aspects: genetic factors and internal disease causes, inflammatory environments and functional regulation, psychological disorders and emotional pathogenesis, as well as age structure and disease risk. Furthermore, from the perspective of constitution-disease relation of chronic disease prevention, this paper will discuss the significant importance of adjusting allergic constitution to improve both subjective symptoms and objective indicators of allergic reactions in tumor patients.
3.Intervention of Traditional Chinese Medicine in NLRP3 Signaling Pathway for Prevention and Treatment of Alzheimer's Disease: A Review
Xinyu JIANG ; Yanyan ZHOU ; Qi WANG ; Quan LI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(8):290-298
Alzheimer's disease (AD) is a neurodegenerative disease often characterized by cognitive impairment in clinical practice. The main pathogenesis includes β amyloid protein (Aβ) excessive deposition, neuroinflammatory response, Tau protein hyperphosphorylation, and other factors, and currently only a few chemical drugs have been approved for clinical treatment of AD. The mechanism of action is relatively single, so it is imperative to find new treatment strategies. Traditional Chinese medicine theory believes that the loss of nourishment in the brain and marrow, as well as the loss of vital energy, is the internal mechanisms underlying the occurrence and development of AD, which runs through the entire treatment process. The pathogenesis of AD is closely related to the inflammasome signaling pathway of nucleotide binding oligomerization domain-like receptor protein 3 (NLRP3). Activating the NLRP3 signaling pathway increases neuroinflammatory response, intervenes in microglial polarization, and regulates Aβ sedimentation, cellular autophagy, brain homeostasis, etc. This article takes the NLRP3 signaling pathway as the starting point to sort out and summarize the upstream and downstream targets under the AD mechanism in the past five years, as well as the research on the NLRP3 signal pathway targets with the participation of the relevant traditional Chinese medicine compounds, such as Danggui Shaoyaosan, modified Shuyu Wan, Qingxin Kaiqiao prescription, Kaixin San, Jiedu Yizhi prescription, and modified Buwang San, traditional Chinese medicine monomer extracts, such as silibinin, Lycium barbarum polysaccharides, liquiritigenin, salidroside, baicalin, cinnamaldehyde, betaine, acacetin, and Hericium erinaceus, and acupuncture and moxibustion. It also reviews the latest achievements in the prevention and treatment of AD. This study provides ideas and directions for in-depth research on the prevention and treatment of cognitive dysfunction related diseases with traditional Chinese medicine.
4.Research progress on the regulation of intestinal flora and effect on intestinal absorption and transport by TCM components
Jun JIANG ; Li CHEN ; Zhong LI ; Jin’ge LIU ; Tian QI ; Tingting ZHOU
Journal of Pharmaceutical Practice and Service 2024;42(3):89-93
The domestic and international research progress on the regulation of gut microbiota by Traditional Chinese Medicine (TCM) ingredients and their impact on intestinal absorption and transportation were summarized, which provided assistance for subsequent clinical rational drug use targeting gut microbiota. Literature on the relationship between gut microbiota and intestinal absorption and transportation in recent years were reviewed and analyzed, and the mechanism of TCM ingredients regulating gut microbiota on drug absorption and transportation was elucidated. Research has found that TCM ingredients alter gut microbiota, thereby affecting intestinal barrier function and absorption of transport proteins, which is of great significance for rational clinical medication.
5.The relationship between activities of daily living and mental health in community elderly people and the mediating role of sleep quality
Heng-Yi ZHOU ; Jing LI ; Dan-Hua DAI ; Yang LI ; Bin ZHANG ; Rong DU ; Rui-Long WU ; Jia-Yan JIANG ; Yuan-Man WEI ; Jing-Rong GAO ; Qi ZHAO
Fudan University Journal of Medical Sciences 2024;51(2):143-150
Objective To explore the relationship and internal path between activities of daily living(ADL),sleep quality and mental health of community elderly people in Shanghai.Methods A questionnaire survey was conducted among community residents aged 60 years and older seeing doctors in community health care center of five streets in Shanghai during Sept to Dec,2021 using convenience sampling.Activities of Daily Living(ADL),Pittsburgh Sleep Quality Index(PSQI)and 10-item Kessler Psychological Distress Scale(K10)were adopted in the survey.Single factor analysis,correlation analysis and multiple linear regression were used to analyze the data.The effect relationship between the variables was tested using Bootstrap's mediated effects test.Results A total of 1 864 participants were included in the study.The average score was 15.53±4.47 for ADL,5.60±3.71 for PSQI and 15.50±6.28 for K10.The rate of ADL impairment,poor sleep quality,poor and very poor mental health of the elderly were 23.6%,27.3%,11.9%and 4.9%,respectively.ADL and sleep quality were all positively correlated with mental health(r=0.321,P<0.001;r=0.466,P<0.001);ADL was positively correlated with sleep quality(r=0.294,P<0.001).Multiple linear results of factors influencing mental health showed that ADL(β= 0.457,95%CI:0.341-0.573),sleep quality(β =0.667,95%CI:0.598-0.737)and mental health were positively correlated(P<0.001).Sleep quality partially mediated the relationship between ADL and mental health(95%CI:0.078-0.124)with an effect size of 33.0%.Conclusion Sleep quality is a mediator between ADL and mental health among community elderly people.Improving ADL and sleep quality may improve mental health in the population.
6.Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults (version 2024)
Qingde WANG ; Yuan HE ; Bohua CHEN ; Tongwei CHU ; Jinpeng DU ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Hua GUO ; Yong HAI ; Lijun HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Hong XIA ; Guoyong YIN ; Jinglong YAN ; Wen YUAN ; Zhaoming YE ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Yingjie ZHOU ; Zhongmin ZHANG ; Wei MEI ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2024;40(2):97-106
Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.
7.Value of explainable artificial intelligence ultrasound characteristic risk model in predicting cervical lymph node metastasis of papillary thyroid carcinoma
Aqian CHEN ; Ru CAO ; Na LI ; Xin YUAN ; Lirong WANG ; Jue JIANG ; Qi ZHOU ; Juan WANG
Chinese Journal of Ultrasonography 2024;33(1):14-20
Objective:To construct an explainable artificial intelligence(AI) model of risk characteristics of papillary thyroid carcinoma(PTC), and to explore its value of it combined with clinical features in predicting cervical lymph node metastasis(CLNM) in PTC patients.Methods:From January 2021 to September 2022, 422 patients(422 nodules) with pathologically confirmed PTC underwent thyroidectomy and neck lymph node dissection in the Second Affiliated Hospital of Xi′an Jiaotong University were retrospectively collected, the patients were randomly divided into training set and test set according to the ratio of 7∶3. Ultrasonographic features highly correlated with PTC risk characteristics were extracted by traditional machine learning method, and an intelligent prediction model with optimal probability of risk characteristics was established. Then, a risk model for predicting CLNM of PTC patients was constructed in combination with clinical features. The diagnostic effectiveness of the model was evaluated by drawing a ROC curve and calculating the area under curve (AUC).Results:In the AI explaineable model of PTC risk characteristics in the test set, the intelligent diagnosis model of calcification based on logistic regression classification showed the highest diagnostic efficiency, with an AUC of 0.87 ( P<0.05). Compared with the probability model of risk characteristic of PTC alone, the comprehensive model combined with clinical characteristics showed higher diagnostic efficiency in predicting CLNM of PTC patients, with AUC of 0.97, diagnostic critical value of 0.15, corresponding accuracy, sensitivity and specificity of 92.65%, 92.76% and 92.54%, respectively (all P<0.05). Conclusions:The explaineble risk characteristics of PTC AI model combined with clinical features can effectively predict the cervical lymph node metastasis of PTC, and then provide effective information for clinical decision-making of PTC patients.
8.A new variant of respiratory syncytial virus glycoprotein gene and clinical features of infected children
Mingli JIANG ; Fengjie WANG ; Zhenzhi HAN ; Yanpeng XU ; Yu SUN ; Runan ZHU ; Dongmei CHEN ; Qi GUO ; Yutong ZHOU ; Linqing ZHAO
Chinese Journal of Microbiology and Immunology 2024;44(2):120-127
Objective:To analyze the epidemiological features of respiratory syncytial virus (RSV) infection in Beijing, and monitor the sequence variations in RSV glycoprotein (G) gene and clinical features of infected children.Methods:Respiratory tract specimens were collected from children with acute respiratory infection in the Children′s Hospital Affiliated to Capital Institute of Pediatrics from January 1, 2023 to December 31, 2023. RSV-positive specimens screened by multiple nucleic acid testing were subjected to PCR to amplify the full-length RSV G gene. A phylogenetic tree was constructed after gene sequencing to analyze RSV subtypes and trace G gene variants. Clinical data were retrieved from the medical record system to analyze the clinical features of children with RSV infection in Beijing.Results:A total of 5 489 respiratory specimens were collected from 3 046 male patients and 2 443 female patients. The average age of the patients was 4.36 years. A total of 589 RSV-positive specimens (10.7%, 589/5 489) were detected with 349 from male patients and 240 from female patients. The average age of children with RSV infection was (2.51±2.78) years and the median age was 0.48 years. RSV had been circulating among children in Beijing since March 2023 with two epidemic peaks in May (24.6%, 122/496) and December (18.2%, 126/693). The predominant subtype of RSV in the first half of 2023 was subtype A, but it was replaced by subtype B from November 2023. Phylogenetic analysis revealed a novel G gene of RSV subtype B (RSV-B-BA9-954bp) with a length of 954 bp, which belonged to a new cluster in the phylogenetic tree. The percentage of patients admitted to the Intensive Care Unit (ICU) was higher in children with new variant of RSV subtype B infection than in those with common RSV subtype B infection [44.1% (15/34) vs 25.2% (31/123), χ 2=4.600, P=0.032], while the counts of white blood cells and the levels of C-reactive protein were lower in the children with new variant infection ( P<0.05). Conclusions:RSV has been prevalent among children in Beijing since March 2023 with two epidemic peaks. The predominant A subtype is gradually replaced by to B subtype. A new variant of RSV B G gene (RSV-B-BA9-954bp) is detected among the children.
9.Burden of acute gastrointestinal illness caused by non-typhoidal Salmonella and Vibrio parahaemolyticus in Zhejiang Province
CHEN Jiang ; QI Xiaojuan ; CHEN Lili ; LU Qinbao ; WANG Jikai ; ZHOU Biao
Journal of Preventive Medicine 2024;36(9):755-759
Objective:
To analyze the disease burden of acute gastrointestinal illness (AGI) caused by non-typhoidal Salmonella and Vibrio Parahaemolyticus in Zhejiang Province, so as to provide the reference for the prevention and control of foodborne diseases.
Methods:
The detection rates of non-typhoidal Salmonella and Vibrio parahaemolyticus in 2022 were collected through the Zhejiang Foodborne Disease Outbreak Surveillance System. The number of cases, incidence and hospitalizations of AGI caused by non-typhoidal Salmonella and Vibrio parahaemolyticus were calculated. Disability-adjusted life years (DALY) were used to analyze the disease burden of AGI caused by non-typhoidal Salmonella and Vibrio parahaemolyticus among different age groups.
Results:
The number of AGI cases caused by non-typhoidal Salmonella in Zhejiang Province in 2022 was 889 500 person-times, the incidence rate was 1 352.42/105, the number of hospital visits was 328 900 person-times, the DALY was 972.69 (95%CI: 771.68-1 164.16) person-years, and the DALY rate was 1.48 (95%CI: 1.17-1.77) /105. The incidence rate and DALY rate were highest in the children aged under 5 years, reaching 3 989.51/105 and 13.93 (95%CI: 8.67-18.42) /105, respectively. The number of AGI cases caused by Vibrio parahaemolyticus in Zhejiang Province was 639 400 person-times, the incidence rate of 972.16/105,the number of hospital visits was 166 800 person-times, the DALY was 509.30 (95%CI: 411.75-699.62) person-years, and the DALY rate was 0.78 (95%CI: 0.63-1.06)/105. The incidence rate and DALY rate were highest in the residents aged 45 to <65 years, reaching 1 383.55/105 and 1.27 (95%CI: 1.14-1.96)/105, respectively.
Conclusions
The incidence and DALY of AGI caused by non-typhoidal Salmonella were relatively high in Zhejiang Province. The AGI caused by non-typhoidal Salmonella in the children under 5 years and the AGI caused by Vibrio parahaemolyticus in the residents aged 45 to <65 years need to be monitored with priority.
10.Consensus statement on research and application of Chinese herbal medicine derived extracellular vesicles-like particles (2023 edition).
Qing ZHAO ; Tong WANG ; Hongbin WANG ; Peng CAO ; Chengyu JIANG ; Hongzhi QIAO ; Lihua PENG ; Xingdong LIN ; Yunyao JIANG ; Honglei JIN ; Huantian ZHANG ; Shengpeng WANG ; Yang WANG ; Ying WANG ; Xi CHEN ; Junbing FAN ; Bo LI ; Geng LI ; Bifeng LIU ; Zhiyang LI ; Suhua QI ; Mingzhen ZHANG ; Jianjian ZHENG ; Jiuyao ZHOU ; Lei ZHENG ; Kewei ZHAO
Chinese Herbal Medicines 2024;16(1):3-12
To promote the development of extracellular vesicles of herbal medicine especially the establishment of standardization, led by the National Expert Committee on Research and Application of Chinese Herbal Vesicles, research experts in the field of herbal medicine and extracellular vesicles were invited nationwide with the support of the Expert Committee on Research and Application of Chinese Herbal Vesicles, Professional Committee on Extracellular Vesicle Research and Application, Chinese Society of Research Hospitals and the Guangdong Engineering Research Center of Chinese Herbal Vesicles. Based on the collation of relevant literature, we have adopted the Delphi method, the consensus meeting method combined with the nominal group method to form a discussion draft of "Consensus statement on research and application of Chinese herbal medicine derived extracellular vesicles-like particles (2023)". The first draft was discussed in online and offline meetings on October 12, 14, November 2, 2022 and April and May 2023 on the current status of research, nomenclature, isolation methods, quality standards and research applications of extracellular vesicles of Chinese herbal medicines, and 13 consensus opinions were finally formed. At the Third Academic Conference on Research and Application of Chinese Herbal Vesicles, held on May 26, 2023, Kewei Zhao, convenor of the consensus, presented and read the consensus to the experts of the Expert Committee on Research and Application of Chinese Herbal Vesicles. The consensus highlights the characteristics and advantages of Chinese medicine, inherits the essence, and keeps the righteousness and innovation, aiming to provide a reference for colleagues engaged in research and application of Chinese herbal vesicles at home and abroad, decode the mystery behind Chinese herbal vesicles together, establish a safe, effective and controllable accurate Chinese herbal vesicle prevention and treatment system, and build a bridge for Chinese medicine to the world.


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