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.Traditional Chinese Medicine Syndrome Element, Evolutionary Patterns of Patients with Hepatitis B Virus-Related Acute on Chronic Liver Failure at Different Stages: A Multi-Center Clinical Study
Simiao YU ; Kewei SUN ; Zhengang ZHANG ; Hanmin LI ; Xiuhui LI ; Hongzhi YANG ; Qin LI ; Lin WANG ; Xiaozhou ZHOU ; Dewen MAO ; Jianchun GUO ; Yunhui ZHUO ; Xianbo WANG ; Xin DENG ; Jiefei WANG ; Wukui CAO ; Shuqin ZHANG ; Mingxiang ZHANG ; Jun LI ; Man GONG ; Chao ZHOU
Journal of Traditional Chinese Medicine 2024;65(12):1262-1268
ObjectiveTo explore the syndrome elements and evolving patterns of patients with hepatitis B virus-related acute on chronic liver failure (HBV-ACLF) at different stages. MethodsClinical information of 1,058 hospitalized HBV-ACLF patients, including 618 in the early stage, 355 in the middle stage, and 85 in the late stage, were collected from 18 clinical centers across 12 regions nationwide from January 1, 2012 to February 28, 2015. The “Hepatitis B-related Chronic and Acute Liver Failure Chinese Medicine Clinical Questionnaire” were designed to investigate the basic information of the patients, like the four diagnostic information (including symptoms, tongue, pulse) of traditional Chinese medicine (TCM), and to count the frequency of the appearance of the four diagnostic information. Factor analysis and cluster analysis were employed to determine and statistically analyze the syndrome elements and patterns of HBV-ACLF patients at different stages. ResultsThere were 76 four diagnostic information from 1058 HBV-ACLF patients, and 53 four diagnostic information with a frequency of occurrence ≥ 5% were used as factor analysis entries, including 36 symptom information, 12 tongue information, and 5 pulse information. Four types of TCM patterns were identified in HBV-ACLF, which were liver-gallbladder damp-heat pattern, qi deficiency and blood stasis pattern, liver-kidney yin deficiency pattern, and spleen-kidney yang-deficiency pattern. In the early stage, heat (39.4%, 359/912) and dampness (27.5%, 251/912) were most common, and the pattern of the disease was dominated by liver-gallbladder damp-heat pattern (74.6%, 461/618); in the middle stage, dampness (30.2%, 187/619) and blood stasis (20.7%, 128/619) were most common, and the patterns of the disease were dominated by liver-gallbladder damp-heat pattern (53.2%, 189/355), and qi deficiency and blood stasis pattern (27.6%, 98/355); and in the late stage, the pattern of the disease was dominated by qi deficiency (26.3%, 40/152) and yin deficiency (20.4%, 31/152), and the patterns were dominated by qi deficiency and blood stasis pattern (36.5%, 31/85), and liver-gallbladder damp-heat pattern (25.9%, 22/85). ConclusionThere are significant differences in the distribution of syndrome elements and patterns at different stages of HBV-ACLF, presenting an overall trend of evolving patterns as "from excess to deficiency, transforming from excess to deficiency", which is damp-heat → blood stasis → qi-blood yin-yang deficiency.
3.A Preliminary Study on the Use of Fumigating and Washing Decoctions in Medical Records Integration of Palace in Qing Dynasty
Yi TANG ; Mingxiang LI ; Weiyi WANG
Journal of Zhejiang Chinese Medical University 2024;48(3):350-357
[Objective]To explore the specificity and effectiveness of Medical Records Integration of Palace in Qing Dynasty for the treatment of diseases,and to provide a reference for the modern clinical external therapy.[Methods]Taking 117 fumigating and washing decoctions in Medical Records Integration of Palace in Qing Dynasty as the research object,using Excel software,the formulas,dosage,medicinal properties,and efficacy of Qinggong fumigating and washing decoctions were organized and counted.Combining with the relevant medical cases and the commentaries in the book,the use of the fumigating and washing decoctions in the Qing Palace was systematically organized.[Results]The 117 fumigating and washing decoctions in Medical Records Integration of Palace in Qing Dynasty show many features such as there are many kinds of formula,the quality of the formula is refined;the effect is strength and special focus,formula with modification according to symptoms,flexible usage of medicine,treatment first,independent use of the amount of medicine,good use of the wind-extinguishing medicinal,filling in the poisonous features when needed.It also has other advantages such as a wide range of audiences,a unique approach,sophisticated instruments,and a meticulous process of preparation of the liquid.[Conclusion]The use of the fumigating and washing decoctions in Medical Records Integration of Palace in Qing Dynasty has palace characteristics and advantages,exploring its use can gain unique insights and revelations,which helps to carry forward the characteristics of court medication and promotes the development of external therapeutic methods of traditional Chinese medicine as high research value.
4.Pregnancy distress and related factors in late trimester pregnant women
Hengxu WANG ; Chaofeng LI ; Mingxiang ZHENG ; Tian YUAN ; Lijun LI ; Lihua LIU
Chinese Mental Health Journal 2024;38(5):407-412
Objective:To investigate the current situation of pregnancy distress and related factors in the third trimester of pregnancy,and explore its association with self-compassion and emotional inhibition.Methods:A total of 214 women in the third trimester of pregnancy were selected and measured the pregnancy pain,self-compassion and emotional depression levels of pregnant women in the third trimester with the Tilburg Pregnancy Pain Scale(TPDS),Self-Compassion Scale(SCS),and Emotional Suppression Scale(EIS).Results:The average score of pregnancy distress of 214 pregnant women in the third trimester was(26.7±4.9),with a medium level of pregnan-cy distress.Multiple linear regression analysis showed that the total scores of pregnancy distress in the third trimes-ter of pregnancy were negatively associated with the accompanying situation of the lover(β=-0.15,P<0.05),the number of accompanying prenatal examinations(β=-0.24,P<0.05)and the total scores of self-compassion(β=-0.12,P<0.05),while positively correlated with gestational age(β=0.14,P<0.05),complications(β=0.15,P<0.05),and the total score of emotional suppression(β=0.17,P<0.05).Conclusion:Pregnancy distress is common in pregnant women in the third trimester,which may be related to gestational age and complications,companionship of loved ones,number of accompanying prenatal examinations,self-compassion level and emotional inhibition.
5.Related factors of emotional inhibition in women undergoing in vitro fertilization-embryo transfer
Mingxiang ZHENG ; Li LI ; Xihong LI ; Chaofeng LI ; Hengxu WANG ; Yan OUYANG ; Jianwei ZHOU
Chinese Mental Health Journal 2024;38(11):961-966
Objective:To understand the status and related factors of emotional inhibition among women re-ceiving in vitro fertilization-embryo transfer(IVF-ET).Methods:A total of 791 women receiving IVF-ET from a specialized hospital in Changsha were selected,and surveyed with the General Questionnaire,Emotional Inhibition Scale(EIS),Locke-Wollance Marital Adjustment Questionnaire,Self-Compassion Scale and Medical Coping Mode Questionnaire.Results:The average score of EIS in women receiving IVF-ET was(28.0±6.4).Multiple linear re-gression analysis showed that the EIS scores in women receiving IVF-ET were negatively associated with infertility factors(β=-9.23,-4.56,-2.86),personality type(β=-1.11),and marital adjustment,confrontation and self-compassion scores(β=-0.03,-0.13,-0.05),and positively associated with residence and surrender di-mension scores(β=0.82,0.20).Conclusion:It suggests that women receiving IVF-ET have a certain degree of e-motional inhibition,which is related to infertility factors,residence,personality type,self-compassion,marital adjust-ment,confrontation,and surrender.
6.Changing distribution and resistance profiles of common pathogens isolated from urine in the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Yanming LI ; Mingxiang ZOU ; Wen'en LIU ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2024;24(3):287-299
Objective To investigate the distribution and antimicrobial resistance profiles of the common pathogens isolated from urine from 2015 to 2021 in the CHINET Antimicrobial Resistance Surveillance Program.Methods The bacterial strains were isolated from urine and identified routinely in 51 hospitals across China in the CHINET Antimicrobial Resistance Surveillance Program from 2015 to 2021.Antimicrobial susceptibility was determined by Kirby-Bauer method,automatic microbiological analysis system and E-test according to the unified protocol.Results A total of 261 893 nonduplicate strains were isolated from urine specimen from 2015 to 2021,of which gram-positive bacteria accounted for 23.8%(62 219/261 893),and gram-negative bacteria 76.2%(199 674/261 893).The most common species were E.coli(46.7%),E.faecium(10.4%),K.pneumoniae(9.8%),E.faecalis(8.7%),P.mirabilis(3.5%),P.aeruginosa(3.4%),SS.agalactiae(2.6%),and E.cloacae(2.1%).The strains were more frequently isolated from inpatients versus outpatients and emergency patients,from females versus males,and from adults versus children.The prevalence of ESBLs-producing strains in E.coli,K.pneumoniae and P.mirabilis was 53.2%,52.8%and 37.0%,respectively.The prevalence of carbapenem-resistant strains in E.coli,K.pneumoniae,P.aeruginosa and A.baumannii was 1.7%,18.5%,16.4%,and 40.3%,respectively.Lower than 10%of the E.faecalis isolates were resistant to ampicillin,nitrofurantoin,linezolid,vancomycin,teicoplanin and fosfomycin.More than 90%of the E.faecium isolates were ressitant to ampicillin,levofloxacin and erythromycin.The percentage of strains resistant to vancomycin,linezolid or teicoplanin was<2%.The E.coli,K.pneumoniae,P.aeruginosa and A.baumannii strains isolated from ICU inpatients showed significantly higher resistance rates than the corresponding strains isolated from outpatients and non-ICU inpatients.Conclusions E.coli,Enterococcus and K.pneumoniae are the most common pathogens in urinary tract infection.The bacterial species and antimicrobial resistance of urinary isolates vary with different populations.More attention should be paid to antimicrobial resistance surveillance and reduce the irrational use of antimicrobial agents.
7.Antibiotic resistance and epidemiological characteristics of polymyxin-resistant Klebsiella pneumoniae
Lihua CHEN ; Mengqian DENG ; Jiali WANG ; Tianrui WU ; Shenghong ZHOU ; Ruyin YANG ; Di ZHANG ; Mingxiang ZOU
Journal of Central South University(Medical Sciences) 2024;49(5):737-747
Objective:The emergence of polymyxin-resistant Klebsiella pneumoniae(KPN)in clinical settings necessitates an analysis of its antibiotic resistance characteristics,epidemiological features,and risk factors for its development.This study aims to provide insights for the prevention and control of polymyxin-resistant KPN infections. Methods:Thirty clinical isolates of polymyxin-resistant KPN were collected from the Third Xiangya Hospital of Central South University.Their antibiotic resistance profiles were analyzed.The presence of carbapenemase KPC,OXA-48,VIM,IMP,and NDM was detected using colloidal gold immunochromatography.Hypervirulent KPN was initially screened using the string test.Biofilm formation capacity was assessed using crystal violet staining.Combination drug susceptibility tests(polymyxin B with meropenem,tigecycline,cefoperazone/sulbactam)were conducted using the checkerboard method.Polymyxin-related resistance genes were detected by PCR.Multi-locus sequence typing(MLST)was performed for genotyping and phylogenetic tree construction.The study also involved collecting data from carbapenem-resistant(CR)-KPN polymyxin-resistant strains(23 strains,experimental group)and CR-KPN polymyxin-sensitive strains(57 strains,control group)to analyze potential risk factors for polymyxin-resistant KPN infection through univariate analysis and multivariate Logistic regression.The induction of resistance by continuous exposure to polymyxin B and colistin E was also tested. Results:Among the 30 polymyxin-resistant KPN isolates,28 were CR-KPN,all producing KPC enzyme.Four isolates were positive in the string test.Most isolates showed strong biofilm formation capabilities.Combination therapy showed additive or synergistic effects.All isolates carried the pmrA and phoP genes,while no mcr-1 or mcr-2 genes were detected.MLST results indicated that ST11 was the predominant type.The phylogenetic tree suggested that polymyxin-resistant KPN had not caused a hospital outbreak in the institution.The use of two or more different classes of antibiotics and the use of polymyxin were identified as independent risk factors for the development of polymyxin-resistant strains.Continuous use of polymyxin induced drug resistance. Conclusion:Polymyxin-resistant KPN is resistant to nearly all commonly used antibiotics,making polymyxin-based combination therapy a viable option.No plasmid-mediated polymyxin-resistant KPN has been isolated in the hospital.Polymyxin can induce resistance in KPN,highlighting the need for rational antibiotic use in clinical settings to delay the emergence of resistance.
8.Epidemiological distribution and genetic characterization of the colistin resistance gene mcr-1 in avian-origin enteroaggregative Escherichia coli
LIU Mingxiang ; ZHANG Jing ; WANG Shan
China Tropical Medicine 2024;24(11):1363-
Objective To understand the contamination status and distribution of Escherichia coli in frozen raw poultry meat in Hongkou District, Shanghai,from February to November 2023, as well as the genetic characterization of colistin resistance gene mcr-1. Methods A total of 100 samples of different kinds of raw poultry meat, such as chicken, duck, and pigeon, were randomly collected from four types of venues including farmers' markets, stores, restaurants, and online stores in Hongkou District of Shanghai from February to November 2023. These samples were used for the isolation and culture of diarrheagenic Escherichia coli. Micro broth dilution method was used to conduct the drug susceptibility experiments, and real-time fluorescence quantitative PCR was adopted to detect mcr-1 resistance genes. Whole-genome sequencing was carried out to explore the resistance genes, plasmid type, and multilocus sequence typing (MLST) of mcr-1 positive strains. Phylogenetic trees of the core genome of the strain and MCR-1 protein were constructed based on single-copy genes and the maximum likelihood method, respectively. The data was analyzed by IBM SPSS Statistics 25.0 software. Results Among 100 raw poultry meat samples, diarrheagenic Escherichia coli was detected in 29 samples, and all of them were identified as enteroaggregative Escherichia coli (EAEC), with an overall detection rate of 29.0% (29/100). The highest detection rate was observed in restaurants (53.3%, 8/15). Among them, two strains (6.9%, 2/29) of chicken-origin EAEC carried mcr-1 resistance genes, both of which were multidrug-resistant strains producing extended-spectrum beta-lactamases (ESBLs), with 100.0% resistance to ciprofloxacin, nalidixic acid, ampicillin, cefotaxime, cefazolin, tetracycline, gentamicin, and polymyxin. Additionally, they carried various resistance genes including blaCTX-M-55, blaCTX-M-14, blaTEM-1, qnrS1, tet(A), tet(M), sul1, sul2, fosA3, aadA2, aac(3)-IVa, aac(3)-IId, aph(4)-Ia, mph(A) and mrx. MLST analysis showed that the ST types of two positive strains belonged to ST69 and ST156, respectively, with plasmids carrying mcr-1 of InCHI2 type. Core group genome analysis of the two avian-derived E.coli strains found high similarity to human-derived E.coli_042 (GCA_000027125) and E.coli_SE11 (GCA_000010385). The MCR-1 protein showed high phylogenetic similarity to avian-origin MCR-1 proteins reported from other countries. Conclusions The contamination of raw poultry meat with EAEC in Hongkou District is serious, with most of the isolated strains exhibiting multidrug resistance. The molecular surveillance of antibiotic resistance genes with public health significance such as mcr-1 should be continuously carried out in frozen raw poultry to control the development of resistance.
9.Establishment and verification of the tightness inspection method of blood products
Xiaojie ZHAO ; Yali WANG ; Yunfei ZHAO ; Qiming ZHANG ; Mingxiang SONG ; Lingli GUO ; Zi DOU ; Jipeng ZHANG ; Xiao LIU
Chinese Journal of Blood Transfusion 2022;35(1):89-92
【Objective】 To establish and verify the vacuum decay method for the tightness inspection of blood products. 【Methods】 The method for inspecting the tightness of blood product was established, and the detection limit, linearity, range, accuracy, precision and durability were verified according to the requirements of methodological verification.The validated method was used to check the tightness of blood product packaging. 【Results】 The detection limit of this method was 2.5 μm, linear correlation coefficient was r=1, the differential pressure of positive sample was within the allowable range of accuracy, and the durability met the requirements.The RSD of results of 6 repeatability tests and 12 intermediate precision tests were both less than 10%, and all validation items met the verification standards. 【Conclusion】 Vacuum decay method can be used to check the tightness of blood products.
10.Application value of neuroendoscopic Endoport technique in resection of intracranial lesions involving the interventricular foramen
Donghao SONG ; Ling XU ; Mingguo XIE ; Ke WANG ; Mingxiang XIE ; Pei WANG ; Shunwu XIAO
Chinese Journal of Neuromedicine 2022;21(1):63-67
Objective:To explore the application value of neuroendoscopic Endoport technique in resection of intracranial lesions involving the interventricular foramen.Methods:A retrospective analysis was performed; 21 patients with intracranial lesions involving the interventricular foramina accepted treatment by neuroendoscopic Endoport technique in our hospital from January 2018 to August 2020 were chosen. The surgical results and prognoses at follow-up were discussed.Results:In these 21 patients, total removal of the lesions was achieved in 19 patients, and subtotal removal in 2 patients; perioperative complications included 1 patient with postoperative hemorrhage and 1 patient with intracranial infection. During the follow-up of 3-30 months, except for 1 patient lost of follow-up, Karnofsky performance scale scores at the last follow-up were 85.5±3.5, and no signs of tumor recurrence were found during the imaging follow-up.Conclusion:Neuroendoscopic Endoport technique can help to safely and effectively remove intracranial lesions involving the interventricular foramen, and the patients enjoy good prognosis.


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