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.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.
3.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.
4.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.
5.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.
6.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.
7.Relationship of biofilm-forming ability of with swimming motility, twitching motility and virulence gene distribution.
Jian SHUI ; Haichen WANG ; Xiaoyan TAO ; Changhang MIN ; Jun LI ; Mingxiang ZOU
Journal of Zhejiang University. Medical sciences 2021;50(3):345-351
To investigate the relationship of biofilm-forming ability of (PA) with swimming motility, twitching motility and virulence gene distribution. A total of 192 clinical isolates of PA were collected consecutively. Microtiter plate method was used to evaluate the ability to form biofilm. The swimming and twitching motilities were detected by plate method. Polymerase chain reaction (PCR) was used to detect virulence genes. Of the 192 PA clinical isolates, 186 (96.9%) showed biofilm-forming ability. Among them, 36 isolates showed weak biofilm-forming ability, 84 exhibited moderate biofilm-forming ability and 66 showed strong biofilm-forming ability. The diameters of the swimming ring for PA with none biofilm-forming ability, weak biofilm-forming ability, moderate biofilm-forming ability, strong biofilm-forming ability were (9.12±6.76), (18.42±7.51), (19.10±4.77) and respectively. The diameters of the twitching ring for PA in above groups were (8.38±1.50), (17.21±7.42), (18.49±5.62) and respectively. The swimming motility and twitching motility of none biofilm-forming ability group were weaker than biofilm-forming ability groups (all <0.05). Among 192 PA strains, 163 were positive (84.9%), 40 were positive (20.8%), 183 were positive (95.3%), and 189 were positive (98.4%). The positive rate of PA virulence gene , and were different in strains with different biofilm-forming abilities (<0.05). The rate of in the strong biofilm-forming ability group was lower than that in the moderate biofilm-forming ability group (=9.293, <0.01) and the weak biofilm-forming ability group (=9.997, <0.01). The rate of in the strong biofilm-forming ability group was higher than that in the weak biofilm-forming ability group (=10.803, <0.01). Most clinical isolates of PA can form biofilm. Swimming and twitching motilities are related to the formation of biofilm, but not significantly related to strength of biofilm-forming ability. The virulence genes of type Ⅲ secretion system for PA may be related to the biofilm-forming ability.
Biofilms
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Humans
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Swimming
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Virulence/genetics*
8.Integrative Analysis of Genome,3D Genome,and Transcriptome Alterations of Clinical Lung Cancer Samples
Li TINGTING ; Li RUIFENG ; Dong XUAN ; Shi LIN ; Lin MIAO ; Peng TING ; Wu PENGZE ; Liu YUTING ; Li XIAOTING ; He XUHENG ; Han XU ; Kang BIN ; Wang YINAN ; Liu ZHIHENG ; Chen QING ; Shen YUE ; Feng MINGXIANG ; Wang XIANGDONG ; Wu DUOJIAO ; Wang JIAN ; Li CHENG
Genomics, Proteomics & Bioinformatics 2021;19(5):741-753
Genomic studies of cancer cell alterations,such as mutations,copy number variations(CNVs),and translocations,greatly promote our understanding of the genesis and development of cancers.However,the 3D genome architecture of cancers remains less studied due to the complexity of cancer genomes and technical difficulties.To explore the 3D genome structure in clin-ical lung cancer,we performed Hi-C experiments using paired normal and tumor cells harvested from patients with lung cancer,combining with RNA sequenceing analysis.We demonstrated the feasibility of studying 3D genome of clinical lung cancer samples with a small number of cells(1×104),compared the genome architecture between clinical samples and cell lines of lung cancer,and identified conserved and changed spatial chromatin structures between normal and cancer sam-ples.We also showed that Hi-C data can be used to infer CNVs and point mutations in cancer.By integrating those different types of cancer alterations,we showed significant associations between CNVs,3D genome,and gene expression.We propose that 3D genome mediates the effects of cancer genomic alterations on gene expression through altering regulatory chromatin structures.Our study highlights the importance of analyzing 3D genomes of clinical cancer samples in addition to cancer cell lines and provides an integrative genomic analysis pipeline for future larger-scale studies in lung cancer and other cancers.
9. A phase II, single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of sofosbuvir combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection
Yinghui GAO ; Guangming LI ; Qinglong JIN ; Yingren ZHAO ; Zhansheng JIA ; Xiaorong MAO ; Yongfeng YANG ; Jia SHANG ; Gongchen WANG ; Wen XIE ; Shanming WU ; Mingxiang ZHANG ; Jinlin HOU ; Dongliang LI ; Yuemin NAN ; Yujuan GUAN ; Chunxia ZHU ; Yangzhou YUAN ; Lai WEI
Chinese Journal of Hepatology 2019;27(5):352-357
Objective:
To evaluate the efficacy and safety of sofosbuvir (Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection.
Methods:
Treatment-naïve or treatment experienced genotype 2 chronic hepatitis C patients from sixteen research centers of China were screened. All subjects received once-daily dose of sofosbuvir (400 mg) combined with ribavirin (body weight < 75 kg, 1 000 mg/day, 400 mg in the morning and 600 mg in the evening; body weight > 75 kg, 1 200 mg/d, 600 mg in the morning and 600 mg in the evening) for 12 weeks. Patients were followed-up for a period of 12 weeks after discontinuation of treatment. Continuous variables were expressed as mean ± standard deviation. The proportion of subjects with virologic response at different follow-up time points and 95% confidence intervals were estimated by maximum likelihood ratio and Clopper-Pearson interval.
Results:
132 cases with genotype 2 chronic hepatitis C virus infection from sixteen research centers of China were included, 12 cases of whom were associated with cirrhosis, and the remaining 120 cases were not associated with cirrhosis. One hundred and thirty-one cases completed the study, and one patient lost to follow-up at week 4 after the end of treatment. The sustained virological response rate was 96.2% (95% confidence interval: 92.37% - 99.16%) after 12 weeks of drug withdrawal. Virological relapse occurred in four cases. Of the 132 subjects enrolled in the study, 119 (90.2%) reported 617 adverse events during treatment, of which 359 (76.5%) were TEAE related to sofosbuvir and/or ribavirin. There were nine TEAEs of grade 3 and above, and six cases (4.5%) of them had six severe adverse events. Only one serious adverse event was associated with sofosbuvir and ribavirin (unstable angina pectoris). There were no adverse events leading to drug discontinuation or death.
Conclusion
Sofosbuvir combined with ribavirin has a high SVR rate in the treatment of genotype 2 chronic hepatitis C virus infection, and most of the adverse events occurred were mild with acceptable safety profile.
10. Combined anluohuaxianwan and entecavir treatment significantly improve the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection
Liang MIAO ; Wanna YANG ; Xiaoqin DONG ; Zhanqing ZHANG ; Shibin XIE ; Dazhi ZHANG ; Xuqing ZHANG ; Jun CHENG ; Guo ZHANG ; Weifeng ZHAO ; Qing XIE ; Yingxia LIU ; Anlin MA ; Jun LI ; Jia SHANG ; Lang BAI ; Lihua CAO ; Zhiqiang ZOU ; Jiabin LI ; Fudong LYU ; Hui LIU ; Zhijin WANG ; Mingxiang ZHANG ; Liming CHEN ; Weifeng LIANG ; Hui GAO ; Hui ZHUANG ; Hong ZHAO ; Guiqiang WANG
Chinese Journal of Hepatology 2019;27(7):521-526
Objective:
To explore the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection who received entecavir alone or in combination with anluohuaxianwan for 78 weeks.
Methods:
Patients with chronic HBV infection were randomly treated with entecavir alone or in combination with anluohuaxian for 78 weeks. Ishak fibrosis score was used for blind interpretation of liver biopsy specimens. The improvement in liver fibrosis condition before and after the treatment was compared. Student's t test and non-parametric test (Mann-Whitney U-Test and Kruskal-Wallis test) were used to analyze the measurement data. The categorical variables were analyzed by Chi-square test method and Spearman’s rank correlation coefficient was used to test bivariate associations.
Results:
Liver fibrosis improvement rate after 78 weeks of treatment was 36.53% (80/219) and the progression rate was 23.29% (51/219). The improvement of liver fibrosis was associated to the degree of baseline fibrosis and treatment methods (


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