1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Study on the management of granulation during surgery for congenital preauricular fistula infection stage.
Xiang XIAO ; Lixue JIANG ; Li LI ; Chunguang DONG ; Jiahui HAN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2024;38(1):77-82
Objective:To investigate the management of granulation tissue during surgery for infected congenital preauricular fistula and to assess the surgical outcomes. Methods:To summarize the surgical methods and the treatment of granulation methods in 140 cases of congenital preauricular fistula during the period of infection treated in our department from January 2018 to September 2022. The study divided patients into an observation group (79 patients) undergoing fistulectomy without granulation treatment, and a control group (61 patients) where fistulectomy and granulation resection were performed concurrently.. After six months of follow-up, the wound healing, recurrence rates, and the aesthetic assessment of granulation healing were evaluated using the Stony Brook Scar Evaluation Scale(SBSES). Results:The two surgical approaches were applied to a total of 140 patients with infected congenital preauricular fistula. There was no statistical difference in wound healing and recurrence rates between the observation group and the control group. However, the observation group exhibited smaller scars. Conclusion:In cases of infected congenital preauricular fistula, surgical removal without excising granulation tissue is feasible, leading to effective healing and lesser scar formation.
Humans
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Cicatrix
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Wound Healing
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Craniofacial Abnormalities
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Fistula/surgery*
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Treatment Outcome
3.Treatment of Diabetic Retinopathy with Blood Stasis, Collateral Obstruction, and Qi and Yin Deficiency Syndrome with Tongluo Mingmu Capsules: A Randomized, Double-blind, and Multi-center Phase Ⅲ Clinical Trial
Junxia REN ; Yongzheng WANG ; Xiaofei LIU ; Li SUN ; Libo YANG ; Lie WU ; Fengmei LIAN ; Qiping WEI ; Lijuan WEI ; Jingsheng YU ; Jianke HAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):170-178
ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis, collateral obstruction, and Qi and Yin deficiency syndrome. MethodA randomized, double-blind, positive-control, and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis, collateral obstruction, and Qi and Yin deficiency syndrome in four test centers were included (the ratio of the treatment group to the control group was 3∶1). On the basis of standardized hypoglycemic treatment, the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day, while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy, traditional Chinese medicine(TCM) syndrome score, corrected visual acuity, fundus changes, fundus fluorescence angiography, and other curative effect indexes before and after treatment in the two groups. At the same time, general examination, laboratory examination, and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable, with the difference not statistically significant. After 12 weeks of treatment, the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group (61.0%, 189/310) was better than that in the control group (44.1%, 45/102), and the difference was statistically significant (χ2=8.880, P<0.01). The total effective rate of TCM syndromes in the treatment group (88.4%, 259/293) was better than that in the control group (69.9%, 65/93), and the difference was statistically significant (χ2=17.927, P<0.01). The disappearance rate of dry eyes (χ2=8.305), dull complexion (χ2=4.053), lassitude (χ2=10.267), shortness of breath (χ2=8.494), and dry stool (χ2=8.657) in the treatment group was higher than that in the control group, and the difference between the groups was statistically significant (P<0.05, P<0.01). In terms of improving corrected visual acuity (χ2=8.382), fundus changes (χ2=6.026) , the treatment group was significantly better than the control group (P<0.05). During the trial, the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%, respectively. There was no significant difference between the two groups. In addition, there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes, visual acuity, fundus changes, and fundus fluorescein angiography, with great safety. Therefore, it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.
4.Regulation of Immune Balance by Traditional Chinese Medicine in Treatment of Cough Variant Asthma: A Review
Han YANG ; Yonghuang YAN ; Wenting ZHANG ; Peixuan ZHU ; Fang YAN ; Yujie WU ; Shiqing QIAO ; Tieshan WANG ; Zeqi SU ; Ting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):206-212
Cough variant asthma (CVA) is a chronic respiratory disease with cough as its main symptom. The occurrence of CVA is closely related to non-specific airway inflammation, and its pathogenesis involves environmental, genetic, immune, and other factors. In recent years, the advantages of traditional Chinese medicine (TCM) in the treatment of CVA have attracted the attention of experts and scholars in China and abroad, especially its prominent role in regulating immune balance, relieving cough symptoms in CVA patients, and reducing recurrence. T Helper cells 1 (Th1), T helper cells 2 (Th2), T helper cells 17 (Th17), and regulatory T cells (Treg) are derived from CD4+ T cells. Immune imbalance of Th1/Th2 and Th17/Treg is a new hotspot in the pathogenesis of CVA and a potential key target in the treatment of CVA by TCM. Th cell subsets are in dynamic balance under physiological conditions, maintaining respiratory immune homeostasis in which pro-inflammatory cytokines and anti-inflammatory cytokines are balanced. Immature helper T cells (Th0) can be differentiated into Th1, Th2, Th17, Treg, and other cell subsets due to cytokine types in the microenvironment in the stage of CVA maturation. The proliferation of Th2 cells leads to eosinophilic airway inflammation. Excessive differentiation of Th17 cells induces neutrophil airway inflammation. Th1/Th2 and Th17/Treg cells are mutually restricted in number and function, and the immune imbalance of Th1/Th2 and Th17/Treg is easy to aggravate the generation of inflammatory response. Restoring immune balance is particularly important for the airway anti-inflammatory therapy of CVA. In this paper, the imbalance of Th1/Th2 and Th17/Treg and the pathogenesis of CVA were systematically expounded. Meanwhile, the latest research on the regulation of immune imbalance by TCM compound, single TCM, and its effective ingredients in the treatment of CVA was reviewed. It provides ideas and references for revealing the scientific connotation of TCM regulating immune balance therapy of CVA, as well as the development of clinical treatment and basic research of CVA.
5.Drug resistance and molecular typing characteristics of Klebsiella pneumoniae in meat food and diarrhea samples in a local area
Fengxia QUE ; Jiachun YUAN ; Dongfang HAN ; Chunfu LIU ; Canlei SONG ; Yulong YE
Shanghai Journal of Preventive Medicine 2024;36(5):448-452
ObjectiveTo determine the drug sensitivity and molecular typing characteristics of Klebsiella pneumoniae isolated from meat and diarrhea samples in a local area. MethodsSeventy-one strains of K.pneumoniae were isolated from 118 meat food (chicken and pork) randomly sampled in the markets in Jinshan District, Shanghai, 2020‒2021, and 1 499 diarrhea samples from outpatient diarrhoea patients in hospitals in the same district. Then drug susceptibility testing was conducted by micro-broth dilution method, and sequence identity was determined by pulsed field gel electrophoresis(PFGE). ResultsThe overall detection rate of K.pneumoniae in meat was 11.86% (14/118), with detection rate 20.93% (9/43) in chicken and 6.67% (5/75) in pork. The difference in detection between meats was statistically significant (χ2=5.317,P<0.05). The detection rate of K.pneumoniae in diarrhea samples was 3.80% (57/1 499). Furthermore, the isolated strains showed the highest resistance to ampicillin at 76.06%. The multi-drug resistant strains included 5 of human origin (8.77%) and 2 of foodborne origin (14.28%). Additionally, 1 foodborne imipenem-resistant strain was detected. A total of 71 strains of K.pneumoniae were found to have 70 banding types, with similarity ranging from 39.4% to 100%, suggesting genetic diversity. ConclusionK.pneumoniae isolated from foodborne and diarrhea samples showed multi-drug resistance in Jinshan District, . with scattered PFGE banding patterns. It is recommended to strengthen the monitoring of this pathogen in the population and animal food, and be alert to the emerging multi-drug resistant strains and risk of food chain transmission.
6.A mixed method study on the relationship between health promotion behavior and health locus of control among patients living with pulmonary tuberculosis
Dongfang HAN ; Tian TIAN ; Chang GAO ; Jingjun ZHANG ; Xiaomei LI
Chinese Journal of Nursing 2024;59(9):1029-1036
Objective To explore the health promotion behaviors among patients with pulmonary tuberculosis(TB),and to analyze its relationship with health locus of control,in order to provide scientific references for improving TB patients'health-promotion behaviors in clinical nursing care.Methods The interpretive sequence mixed method design was utilized.A convenient sampling was used to enroll 300 TB patients from 2 TB specialized tertiary hospitals in Xi'an as research subjects from January to April 2023.General information questionnaire,Health promoting lifestyle profile-Ⅱ,and Multidimensional health locus of control scale were used to collect data,and single-factor analysis and multiple linear regression analysis were conducted.Purposeful sampling was used to select 11 TB patients for a semi-structured interview,and the Colaizzi 7-step method was used to extract themes.Results In the quantitative study,the total score of health promoting behaviors in 294 TB patients was(110.26±15.74).Patients'intemal health locus of control,chance health locus of control,and occupational status significantly influenced their health-promotion behaviors(P<0.05).In the qualitative study,4 themes were extracted,including awakening self-awareness of health,the desire to establish a normal life,the distress of multiple uncertainties,and the immediate effect of authoritative guidance.The qualitative and quantitative studies complemented each other and further verified the relationship between health promotion behaviors and health locus of control of TB patients.Conclusion The level of health-promotion behaviors in TB patients needs to be further improved.Nurses need to take systematic health education as an opportunity by the catalytic effect of individual health awareness,to improve their internal locus of control,reduce their opportunity control tendency due to multiple uncertainties,with the ultimate purpose of helping TB patients form and maintain health promotion behaviors.
7.Impacts of galangin on immune inflammatory response in preeclampsia rats by regulating IL-6/STAT3 signaling pathway
Dongfang LIU ; Yi WANG ; Senji HAN ; Chong SUN ; Ningning SUN ; Tianshu LONG
Chinese Journal of Immunology 2024;40(12):2513-2517,2524
Objective:To investigate the impacts of galangin(Gal)on the immune inflammatory response in preeclampsia(PE)rats by regulating the IL-6/signal transducer and activator of transcription 3(STAT3)signaling pathway.Methods:Pregnant rats were injected subcutaneously with L-arginine methyl ester(L-NAME 125 mg/kg)to establish a PE model.After successful modeling,they were randomly grouped into Model group,low,medium and high doses Gal groups(10,30,and 60 mg/kg)and activator group(60 mg/kg Gal+0.05 mg/kg IL-6/STAT3 pathway activator rIL-6).Twelve pregnant rats of the same period were randomly selected as the control group,and each group was given corresponding drugs by gavage and intraperitoneal injection,once a day for a continuous week.The levels of mean caudal artery pressure(MAP)and 24-hour urinary protein and blood urea nitrogen(BUN)in rats during the third trimester of pregnancy were measured using a blood pressure tester and a fully automated biochemical analyzer;the number and weight of the average offspring of pregnant mice in each group were calculated,and the pregnancy outcome was analyzed;HE staining was applied to observe the pathological damage of rat placenta;ELISA was applied to detect the levels of IL-6,IL-1β and TNF-α in the placenta of rats in each group;the proportion of T lymphocytes in rat peripheral blood was detected by flow cytometry;Western blot was applied to detect the expression of IL-6/STAT3 pathway protein in rat placenta.Results:Compared with control group,the lev-els of MAP,24-hour urinary protein,BUN,IL-6,IL-1β,TNF-α,the CD8+T cells,and the expression levels of IL-6 and p-STAT3/STAT3 proteins in Model group were obviously increased,the placenta tissue was severely damaged,the mean offspring number and mean offspring weight,the proportions of CD3+T,CD4+T,and CD4+/CD8+T cells were decreased(P<0.05);compared with Model group,the levels of MAP,24-hour urinary protein,BUN,IL-6,IL-1β,TNF-α,the CD8+T cells,and the expression levels of IL-6 and p-STAT3/STAT3 proteins in Gal low,medium and high doses groups were obviously decreased,the damage to placental tissue was reduced,the mean offspring number and mean offspring weight,the proportions of CD3+T,CD4+T,and CD4+/CD8+T cells were in-creased(P<0.05);compared with Gal high-dose group,the levels of MAP,24-hour urinary protein,BUN,IL-6,IL-1β,TNF-α,the CD8+T cells,and the expression levels of IL-6 and p-STAT3/STAT3 proteins in activator group were obviously increased,the placenta tissue was aggravated,the mean offspring number and mean offspring weight,the proportions of CD3+T,CD4+T and CD4+/CD8+T cells were decreased(P<0.05).Conclusion:Gal may play a role in alleviating PE symptoms and improving pregnancy outcomes by inhibit-ing the IL-6/STAT3 pathway,inhibiting inflammatory reactions,and regulating cellular immunity.
8.Effect of Astrocyte-neuron Coupling Imbalance in Development of Alzheimer's Disease and Intervention Mechanism of Kidney-tonifying and Marrow-filling TCM Prescriptions
Guanghui HAN ; Shenghua KANG ; Hongni YU ; Mengjie SUN ; Dongyue LI ; Rui MA ; Weizhe ZHEN ; Tao MA
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(8):1-9
Astrocytes are important nerve cells in the central nervous system (CNS), which mainly play a key role in nutrition and support. Astrocytes and neurons undergo close energy coupling and substance coupling, which are closely related and interact with each other. In recent years, many studies have shown that the astrocyte-neuron coupling imbalance plays a central role in the occurrence and progression of Alzheimer's disease (AD) and serves as an important therapeutic target receiving increasing attention. According to traditional Chinese medicine (TCM) theory, the main pathogenesis of AD is kidney deficiency and marrow inadequacy, and in clinical medication, kidney-tonifying and marrow-filling TCM prescriptions are often employed with satisfactory results achieved. As reported, many kidney-tonifying and marrow-filling prescriptions exhibit regulatory and protective effects on the imbalance of astrocyte-neuron coupling, suggesting that the effect of kidney-tonifying and marrow-filling prescriptions in treating AD may have some internal relationship with its regulation of the imbalance of astrocyte-neuron coupling. This article reviewed the underlying internal relationship between the imbalance of astrocyte-neuron coupling and the pathogenesis of kidney deficiency and marrow inadequacy in AD and the research progress in the intervention mechanism of TCM for tonifying the kidney and filling the marrow.
9.Mechanism of Dihuang Yinzi in Improving Astrocyte Injury and Glycolysis in AD Mice via PI3K/Akt Pathway
Hongni YU ; Mengjie SUN ; Fengli WANG ; Shenghua KANG ; Guanghui HAN ; Dongyue LI ; Weizhe ZHEN ; Tao MA
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(8):10-18
ObjectiveTo explore the mechanism of Dihuang Yinzi in improving astrocyte injury and glycolysis in Alzheimer's disease (AD) mice via regulating the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway, thereby improving the cognitive function of AD mice. MethodForty male APP/PS1 transgenic mice aged four months were randomly divided into a model group and a model + Dihuang Yinzi (0.25 g·kg-1) group, with 20 mice in each group. Forty C57BL/6J mice with the same background and same age were randomly divided into a control group and a control + Dihuang Yinzi (0.25 g·kg-1) group, with 20 mice in each group. The mice in the control + Dihuang Yinzi group and the model + Dihuang Yinzi group were administered with Dihuang Yinzi by gavage, and those in the control group and the model group received an equal volume of sterilized normal saline, once a day for 150 days. Morris water maze test was performed to test the ability of navigation and space exploration of mice. The protein expression of p-PI3K, PI3K, p-Akt, Akt, phosphofructokinase-1 (PFK-1), and aldehyde dehydrogenase 3 family member B2 (ALDH3B2) in mouse brain tissues was measured by Western blot. An immunofluorescence assay was performed to detect astrocyte morphology and the expression level of ALDH3B2. ResultAs compared with the control group, the model group showed prolonged escape latency during the 2nd to 5th days of the location-based navigation (P<0.05, P<0.01), reduced number of times crossing the target area of the platform, shortened residence time in the target quadrant (P<0.05, P<0.01), prolonged residence time in the opposite quadrant (P<0.05), increased surface area of the cell body and total length of cell protrusions of astrocytes (P<0.05, P<0.01), and down-regulated protein expression of p-PI3K, p-Akt, ALDH3B2, and PFK-1 (P<0.01), while the above experimental indexes were not significantly different in the control + Dihuang Yinzi group. Compared with the model group, the model + Dihuang Yinzi group showed shortened escape latency of APP/PS1 mice during the 2nd to 5th days of the location-based navigation (P<0.05, P<0.01), increased number of times crossing the platform, prolonged target quadrant residence time (P<0.05, P<0.01), shortened residence time in the opposite quadrant (P<0.05), reduced surface area of the cell body and total length of cell protrusions of astrocytes (P<0.05), and up-regulated protein expression of p-PI3K, p-Akt, ALDH3B2, and PFK-1 (P<0.01). ConclusionDihuang Yinzi can improve the learning and memory ability of AD mice by activating the PI3K/Akt signaling pathway and up-regulating the protein expression of PFK-1 and ALDH3B2 to protect against astrocyte injury in brain tissues and improve glycolysis.
10.Mechanism of Dihuang Yinzi in Improving Energy Metabolism Disorder and Autophagy Injury of Astrocytes in Brain of AD Mice
Mengjie SUN ; Hongni YU ; Guanghui HAN ; Fengli WANG ; Shenghua KANG ; Dongyue LI ; Tao MA
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(8):19-26
ObjectiveTo explore the mechanism of Dihuang Yinzi (DHYZ)in improving astrocyte injury in the brain and regulating energy metabolism and autophagy disorder in Alzheimer's disease (AD) model mice. MethodForty male APP/PS1 transgenic mice aged four months were randomly divided into a model group and a model + DHYZ group (2.5 g·kg-1), with 20 mice in each group. Forty C57BL/6J mice with the same background and same age were randomly divided into a control group and a control + DHYZ group (2.5 g·kg-1), with 20 mice in each group. The mice in the control group and the model group were administered with an equal volume of sterilized normal saline by gavage, once a day for 150 days. Novel object recognition test and step-down test were performed to evaluate the learning and memory ability of mice. The expression of glial fibrillary acidic protein (GFAP) in astrocytes was detected by immunofluorescence and Western blot. High-performance liquid chromatography (HPLC) was used to detect adenosine triphosphate (ATP), adenosine diphosphate (ADP), and adenosine monophosphate (AMP) in brain tissues of mice, and the data obtained were used to calculate energy charge (EC) levels. The phosphorylation levels of liver kinase B1 (LKB1), adenosine 5′-monophosphate (AMP)-activated protein kinase (AMPK), UNC-51-like kinase 1 (ULK1), and mammalian target of rapamycin (mTOR) and the expression levels of autophagy-related proteins Beclin-1, microtuble-associated protein 1 light chain 3 (LC3)-Ⅱ/LC3-Ⅰ, and p62 in mouse brain were measured by Western blot. ResultCompared with the control group, the model group showed decreased novel object recognition index, shortened retention latency, increased error times in the step-down test, up-regulated protein expression of GFAP, decreased content of ATP, ADP, and EC in brain tissues, elevated AMP , increased levels of p-AMPK, p-LKB1, and p-mTOR, and protein expression of p62 , and down-regulated p-ULK1 level and protein expression of Beclin-1 and LC3-Ⅱ/LC3-Ⅰ(P<0.01), while the above experimental indexes were not significantly different in the control + DHYZ group. Compared with the model group, the model + DHYZ group showed increased novel object recognition index(P<0.05), prolonged retention latency(P<0.01), decreased error times(P<0.01) in the step-down test, reduced protein expression of GFAP(P<0.05), increased content of ATP, ADP, and EC in brain tissues (P<0.05, P<0.01), decreased AMP content(P<0.05), reduced p-AMPK, p-LKB1, and p-mTOR levels and protein expression of p62, and up-regulated p-ULK1 level and protein expression of Beclin-1 and LC3-Ⅱ/LC3-Ⅰ(P<0.01). ConclusionBy protecting astrocytes, DHYZ can improve energy metabolism and autophagy disorder in AD mice to improve the learning and memory ability of model mice.


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