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.

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.

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.

ObjectiveTo provide technical support for the molecular surveillance of pathogenic bacteria strains carrying mobile colistin resistance-1 （mcr⁃1） gene isolate from inlet of wastewater treatment plants （WWTP）. MethodsThe Enterobacteriaceae strains carrying mcr⁃1 resistance gene isolate from inlet of WWTP during April 1 to June 30， 2023 in Shanghai were cultured on blood-rich and SS culture medium and were identified using a mass spectrometry analyzer. The mcr⁃1 gene and copy number were detected by real-time fluorescence quantitative PCR. Drug susceptibility test was performed by microbroth dilution method. The copy numbers of Escherichia coli carrying mcr⁃1 gene isolated from wastewater and human fecel were statistically analyzed by SPSS 25.0. ResultsA total of 14 strains carrying the mcr⁃1 gene were isolated from 49 WWTP samples， and the positive isolation rate was 28.6%， including 12 non-diarrheal E. coli strains and 2 Klebsiella pneumoniae strains. The drug susceptibility results showed that all 14 strains were multi-drug resistant bacteria. They were all sensitive to imipenem and tigecycline， but were ampicillin- and cefazolin-resistant. There was no significant difference in the copy number between human-sourced diarrheal E. coli and wastewater-sourced non-diarrheal E. coli （t=0.647， P>0.05）. ConclusionThe isolation and identification of strains carrying the mcr⁃1 gene from inlet of WWTP samples were firstly established in Shanghai. The multi-drug resistance among the isolated strains is severe. To effectively prevent and control the spread of colistin-resistant bacteria， more attention should be paid to the surveillance of mcr⁃1 gene.

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.

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.

【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.

【Objective】 To establish gas chromatography for the determination of tributyl phosphate(TBP) residues in human prothrombin complex and then verify it. 【Methods】 Acid modified polyethylene glycol(PEG)(20M) capillary column was used with n-hexane as solvent. The chromatographic parameters were as follows: gasification chamber temperature at 220 ℃, column temperature at 155 ℃, detector temperature at 220 ℃, column flow rate at 2.0 mL/min, carrier gas as N2, detector as FID, and collection time for 10min. The accuracy, repeatability, linearity, specificity, intermediate precision, detection limit, quantitative limit, range and durability were verified. 【Results】 The verification results showed that the method had good specificity. The linear regression correlation coefficient of standard curve was 0.999 90. The recovery rate were 98.4%, 97.5% and 95.7% when the concentration at 50%, 100%(30μg/mL) and 150%, respectively, with an average recovery of 97.2% and a relative deviation of 2.15%. When the concentration was 100%, the repeatability was 2.08%, and the relative deviation of intermediate precision was 1.63%. The detection limit was 0.255 μg/mL, and the quantitative limit was 0.511 μg/mL. After changing capillary chromatographic columns with different batch numbers but the same types and manufacturer, the applicability test of the system met the requirements, and the method had good durability. 【Conclusion】 This method can be used for the determination of TBP residues of human prothrombin complex in laboratory.

Thyroid hormones(TH), one of the human′s essential hormones, play a crucial role in the cardiovascular system.Studies have shown that hypothermia, blood dilution, vascular endothelial injury, ischemia-reperfusion, and inflammatory factor release during cardiopulmonary bypass may cause thyroid dysfunction, leading to the euthyroid sick syndrome(ESS). There is a close correlation between ESS and postoperative low cardiac output and elevated systemic vascular resistance, which seriously affects the prognosis of pediatric patients.Studies have shown that perioperative supplementation of thyroid hormones can reduce ESS levels, especially among pediatric patients and those children with complex congenital heart disease have apparent clinical advantages.However, the results from different clinical studies varied, and currently, thyroid hormone replacement therapy is under debate.This review examines the available literature on the clinical effects of thyroid hormone on the cardiovascular system and the relationship between ESS and cardiopulmonary bypass.The clinical evidence of the treatment of ESS is gathered and discussed with an intent to find a gap for further research.

Objective To investigate the predictive value of HIT-antibodies(HIT-Ab) detection for new thrombus in suspected Heparin-Induced thrombocytopenia (HIT). Methods Retrospective cohort study. 472 suspected HIT patients were collected from July 2016 to November 2018, and all subjects under-went a 4Ts score and were sent for HIT-Ab tests. According to the results of HIT-Ab, there were four groups:412 cases of negative HIT-Ab (0-0.9 U/ml), 45 cases of weak-positive HIT-Ab (1.0-4.9 U/ml), 12 cases of moderate-positive HIT-Ab (5.0-15.9 U/ml), and 3 cases of strong-positive HIT-Ab (≥16.0 U/ml) respective-ly. Ultrasound or CT examination was used to confirm new thrombosis as a standard to evaluate the value of HIT-Ab for predicting new thrombus. The diagnostic efficacy of HIT-Ab for HIT was evaluated in clinically confirmed HIT. Results The incidence rates of new thrombus in each group were: 15.8％ in Negative HIT-Ab group (62/412), 48.9％in Weak-positiveHIT-Ab group (22/45), 75.0％in Moderate-positive HIT-Ab group (9/12), and100％in Strong-positive HIT-Ab group (3/3)(P<0.00). When HIT-Ab≥1.0 U/ml, the speci-ficity for diagnosing new thrombus was 93.0％, the sensitivity was 34.2％, the negative predictive value (NPV) was 84.2％, and the positive predictive value (PPV) was 56.5％. The diagnostic rates of HIT in each group were:negative 0％(0/412), weak-positive 62.2％(28/45), moderate-positive (12/12) and strong-positive (3/3) were 100％. When HIT-Ab≥ 1.0 U/ml, the specificity for HIT diagnosis was 96.0％, the sensitivity was 100％, NPV was 100％, and PPV was 71.5％. Conclusions In suspected HIT patients, the incidence of new thrombosis increases with the elevated HIT-Ab level. HIT-Ab detection can be used as a crucial tool for new thrombosis prediction and HIT diagnosis in suspected HIT patients. Clinicians can develop treatment strategies based on HIT-Ab levels.