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.Gene Mutation Types and Characteristics of 522 Children with Glucose-6-Phosphate Dehydrogenase Deficiency
Mingxiang ZHOU ; Zhenglian YAO ; Huajuan ZHAO
Journal of Medical Research 2025;54(7):42-46
Objective To study the frequency of gene mutations in 522 children with glucose-6-phosphate dehydrogenase(G6PD)deficiency who were admitted to the Affiliated Hospital of Guizhou Medical University to explore the genetic mutation characteris-tics of them in children in Guizhou region.Methods To select 522 pediatric patients who underwent G6PD genetic testing at the Affilia-ted Hospital of Guizhou Medical University from January 1,2017 to December 30,2023,and the frequency and clinical characteristics of these patients were analyzed.Results Among the 522 patients with gene mutations,male cases accounted for 91.18%,female cases ac-counted for 8.82%,and the average age was(1.66±1.89)years;a total of 18 types of mutations were detected in this study,including 10 G6PD gene mutations and 8 compound gene mutations.The four main genotypes were c.1388 G>A,c.1024 C>T,c.95 A>G and c.1376 G>T,accounting for 29.31%,23.75%,17.63%and 17.06%,respectively;Among the cases,male patients accounted for 91.18%,and all cases of compound mutations were female;The majority were class B variants,and no class A were detected.Conclu-sion Eighteen G6PD gene mutations were detected with G6PD deficiency,and c.1388 G>A,c.1024 C>T,c.95 A>G,c.1376 G>T were the first four types;The majority of patients were male,with a variety of complex mutation types,all of which were found in female patients.Guizhou province is a high-risk area for G6PD deficiency,and G6PD gene testing is beneficial for early diagnosis,prevention of G6PD deficiency and treatment of serious complications such as hemolysis and jaundice caused by G6PD gene deficiency.
3.Gene Mutation Types and Characteristics of 522 Children with Glucose-6-Phosphate Dehydrogenase Deficiency
Mingxiang ZHOU ; Zhenglian YAO ; Huajuan ZHAO
Journal of Medical Research 2025;54(7):42-46
Objective To study the frequency of gene mutations in 522 children with glucose-6-phosphate dehydrogenase(G6PD)deficiency who were admitted to the Affiliated Hospital of Guizhou Medical University to explore the genetic mutation characteris-tics of them in children in Guizhou region.Methods To select 522 pediatric patients who underwent G6PD genetic testing at the Affilia-ted Hospital of Guizhou Medical University from January 1,2017 to December 30,2023,and the frequency and clinical characteristics of these patients were analyzed.Results Among the 522 patients with gene mutations,male cases accounted for 91.18%,female cases ac-counted for 8.82%,and the average age was(1.66±1.89)years;a total of 18 types of mutations were detected in this study,including 10 G6PD gene mutations and 8 compound gene mutations.The four main genotypes were c.1388 G>A,c.1024 C>T,c.95 A>G and c.1376 G>T,accounting for 29.31%,23.75%,17.63%and 17.06%,respectively;Among the cases,male patients accounted for 91.18%,and all cases of compound mutations were female;The majority were class B variants,and no class A were detected.Conclu-sion Eighteen G6PD gene mutations were detected with G6PD deficiency,and c.1388 G>A,c.1024 C>T,c.95 A>G,c.1376 G>T were the first four types;The majority of patients were male,with a variety of complex mutation types,all of which were found in female patients.Guizhou province is a high-risk area for G6PD deficiency,and G6PD gene testing is beneficial for early diagnosis,prevention of G6PD deficiency and treatment of serious complications such as hemolysis and jaundice caused by G6PD gene deficiency.
4.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.
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.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.
7.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.
8.Establishment of a phase Ⅱ remote home-based cardiac rehabilitation program for patients with coronary heart disease after percutaneous coronary intervention based on social cognitive theory
Ling DAI ; Jianwei ZHOU ; Mingxiang ZHENG ; Lanfang PENG
Journal of Clinical Medicine in Practice 2024;28(22):110-114
Objective To establish a phase Ⅱ remote home-based cardiac rehabilitation (HBCR) program for patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI) based on social cognitive theory (SCT). Methods A preliminary draft of the phase Ⅱ HBCR program for CHD patients after PCI based on SCT was developed through evidence-based literature review and group discussion, and the final version was formed through Delphi expert consultation. Results A total of 18 experts participated in three rounds of expert consultation. The expert authority coefficients for the three rounds were 0.86, 0.87 and 0.87 respectively, and the Kendall's W coefficients were 0.211, 0.242 and 0.271 respectively, with significant differences (
9.Influence of interleukin-2 receptor antagonists on the morbidity and prognosis of new-onset diabetes after liver transplantation
Jing LIANG ; Mengjuan XUE ; Xianying CHEN ; Xiaowu HUANG ; Qiman SUN ; Ting WANG ; Jian GAO ; Jian ZHOU ; Jia FAN ; Mingxiang YU
Chinese Journal of Endocrinology and Metabolism 2018;34(2):121-128
Objective To explore the influence of interleukin-2 receptor antagonists(IL-2Ra) on the morbidity and prognosis of new onset diabetes after transplantation(NODAT)in liver transplant recipients. Methods Pre-and post-operative clinical data of 879 nondiabetic patients who underwent a liver transplantation between April 2001 and December 2016 were retrospectively studied. All the enrolled patients were divided into IL-2Ra and non-IL-2Ra groups according to the use of IL-2Ra. Transient-NODAT(T-NODAT)and Persistent-NODAT(P-NODAT)were defined according to whether NODAT would be existed continuously. The impacts of IL-2Ra on the cumulative incidence as well as the risk of NODAT and T-NODAT were analyzed through comparison between patients who used IL-2Ra or not. And influence of IL-2Ra on the long-term survival of NODAT patients was further analyzed. Results Among 879 patients,177(32.24%)from the IL-2Ra group(n=549)developed NODAT and 29.38%(n=52)of the NODAT reversed,while 131(39.70%)from the non-IL-2Ra group(n=330)developed NODAT and 26.72%(n=35)of the NODAT reversed. After adjusting for 18 possible confounding factors,the IL-2Ra group had significantly decreased cumulative incidence of NODAT over the non-IL-2Ra group(adjusted P=0.028). COX regression analyses showed that IL-2Ra was a protective factor against NODAT development(HR 0.774;95% CI 0.616-0.973; P=0.028), while the use of IL-2Ra and the reverse of NODAT did not significantly related. In addition, long-term survival of the NODAT patients were far better in the IL-2Ra group(adjusted P=0.001). Conclusion IL-2Ra significantly reduces the risk of NODAT in liver transplant recipients and is beneficial to the long-term survival of NODAT patients.
10. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin in Asian adult patients with chronic HCV genotype 1b infection and compensated cirrhosis
Lai WEI ; Guiqiang WANG ; Kopecky-Bromberg SARAH ; Jun CHENG ; Qing XIE ; Maorong WANG ; Min XU ; Zhongping DUAN ; Jinlin HOU ; Mingxiang ZHANG ; Yuexin ZHANG ; Hong TANG ; Wei ZHAO ; Shumei LIN ; Zhansheng JIA ; Junqi NIU ; Zhiliang GAO ; Hong YUAN ; Minghua LIN ; Xinmin ZHOU ; Yan LUO ; Fredrick LINDA ; Mobashery NILOUFAR ; Ye WANG ; Jidong JIA
Chinese Journal of Hepatology 2018;26(5):353-358
Objective:
To evaluate the efficacy and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) 25/150/100 mg once daily and dasabuvir (DSV) 250 mg twice daily combined with ribavirin in adult patients of Mainland China with chronic HCV genotype 1b infection and compensated cirrhosis.
Methods:
An open-label, multicenter, phase 3 clinical trial study was conducted in mainland China, Taiwan, and South Korea. Adult patients with compensated cirrhosis (Metavir score =F4) who were newly diagnosed and treated for hepatitis C virus genotype 1b infection with ombitasvir/paritaprevir/ritonavir and dasabuvir combined with ribavirin for 12 weeks were included. Assessed SVR rate of patients obtained at 12 and 24 weeks after drug withdrawal. Efficacy and safety were evaluated in patients who received at least one time study drugs.
Results:
A total of 63 patients from mainland China were enrolled, 62 of whom (98.4%) had a baseline Child-Pugh score of 5 points. The overall rate of SVR12 and SVR24 in patients was 100% (95% CI: 94.3% to 100.0%). Most of the adverse events that occurred were mild. The incidence of common (≥10%) adverse events and laboratory abnormalities included elevated total bilirubin (36.5%), weakness (19.0%), elevated unconjugated bilirubin (19.0%) and conjugated bilirubin (17.5%), and anemia (14.3%). Three cases (4.8%) of patients experienced Grade ≥ 3 adverse events that were considered by the investigators to be unrelated to the study drug. None patients had adverse events leading to premature drug withdrawal.
Conclusion
Mainland Chinese patients with chronic HCV genotype 1b infection and compensated cirrhosis who were treated with OBV/PTV/r plus DSV combined with RBV for 12 weeks achieved 100 % SVR at 12 and 24 weeks after drug withdrawal. Tolerability and safety were good, and majority of adverse events were mild.


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