The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

Objective:To report the nationwide surveillance results of pathogenic profiles and antimicrobial resistance patterns of Gram-positive bloodstream infections in China in 2023.Methods:The clinical isolates of Gram-posttive bacteria from blood cultures were collected in member hospitals of National Bloodstream Infection Bacterial Resistant Investigation Collaborative System（BRICS）during January to December 2023. Antimicrobial susceptibility testing was performed using the dilution method recommended by the Clinical and Laboratory Standards Institute（CLSI）. Statistical analyses were conducted using WHONET 5.6 and SPSS 25.0 software.Results:A total of 4 385 Gram-positive bacterial isolates were obtained from 60 participating center. The top five pathogens were Staphylococcus aureus（ n=1 544，35.2%），coagulase-negative Staphylococci（ n=1 441，32.9%）， Enterococcus faecium（ n=574，13.1%）， Enterococcus faecalis（ n=385，8.8%），and α-hemolytic Streptococci（ n=187，4.3%）. The prevalence of methicillin-resistant Staphylococcus aureus（MRSA）and methicillin-resistant coagulase-negative Staphylococci（MRCNS）was 26.2%（405/1 544）and 69.8%（1 006/1 441），respectively. Notably，all Staphylococci remained susceptible to glycopeptide or daptomycin. Staphylococcus aureus demonstrated excellent susceptibility（>97.0%）to cephalobiol，rifampicin，trimethoprim-sulfamethoxazole，linezolid，minocycline，tigecycline，and eravacycline. No Enterococcus exhibiting resistance to linezolid were detected. Glycopeptide resistance was uncommon but more frequent in Enterococcus faecium（resistance to vancomycin and teicoplanin：both 1.7%）compared to Enterococcus faecalis（both 0.3%）. The detection rates of MRSA and MRCNS exhibited significant regional variations across the country（ χ2=17.674 and 148.650，respectively，both P<0.001）. No vancomycin-resistant Enterococci were detected in central China. Institutional comparison demonstrated higher prevalence of MRSA（ χ2=14.111， P<0.001）and MRCNS（ χ2=4.828， P=0.028）in provincial hospitals than that in municipal hospitals. Socioeconomic analysis identified elevated detection rates of both MRSA（ χ2=18.986， P<0.001）and MRCNS（ χ2=4.477， P=0.034）in less developed regions（per capita GDP

Objective:To report the results of bacterial resistant investigation collaborative system（BRICS）on the distribution and antimicrobial resistance profile of clinical Gram-negative bacteria isolates from bloodstream infections in China in 2023，and provide reference for clinical tretment of bloodstream infections and prevention and control of bacterial resistance.Methods:The clinical isolates of Gram-negative bacteria from blood cultures in member hospitals of BRICS were collected during January 2023 to December 2023. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical and Laboratory Standards Institute（CLSI）. WHONET 5.6 and SPSS 25.0 were used to analyze the data.Results:During the study period，11 492 strains of Gram-negative bacteria were collected from 60 hospitals，of which 10 098（87.9%）were Enterobacterales and 1 394（12.1%）were non-fermentative bacteria. The top 5 bacterial species were Escherichia coli（50.0%）， Klebsiella pneumoniae（26.1%）， Pseudomonas aeruginosa（5.1%）， Acinetobacter baumannii complex（5.0%）and Enterobacter cloacae complex（4.1%）. The ESBL-producing rates in Escherichia coli， Klebsiella pneumoniae and Proteus mirablilis were 46.8%（2 685/5 741），18.3%（549/2 999）and 44.0%（77/175），respectively. The prevalence of carbapenem-resistant Escherichia coli（CREC）and carbapenem-resistant Klebsiella pneumoniae（CRKP）were 1.3%（76/5 741）and 15.0%（450/2 999）；32.9%（25/76）and 78.0%（351/450）of CREC and CRKP were sensitive to ceftazidime/avibactam combination，respectively. 94.7%（72/76）and 90.2%（406/450）of CREC and CRKP were sensitive to aztreonam/avibactam combination. Furthermore，57.9%（44/76）and 79.1%（356/450）were sensitive to imipenem/relebactam combination. The prevalence of carbapenem-resistant Acinetobacter baumannii（CRAB）complex was 64.6%（370/573），while more than 80.0% of CRAB complex was sensitive to tigecycline，eravacycline and polymyxin B. The prevalence of carbapenem-resistant Pseudomonas aeruginosa（CRPA）was 17.0%（99/581）. There were differences in the composition ratio of Gram-negative bacteria in bloodstream infections and the prevalence of important Gram-negative bacteria resistance among different regions in China，with statistically significant differences in the prevalence of CREC，CRKP，CRPA and CRAB complex（ χ2=10.6，28.6，10.8 and 19.3， P<0.05）. The prevalence of ESBL-producing Escherichia coli， CREC，CRAB complex and CRKP were higher in provincial hospitals than those in municipal hospitals（ χ2=12.5，9.8，12.7 and 57.8，all P<0.01）. Conclusions:Gram-negative bacteria are the main pathogens causing bloodstream infections in China，and Escherichia coli is ranked in the top，while the trend of Klebsiella pneumoniae increases continuously with time. CRKP infection shows a slow upward trend，CREC infecton maintains a low prevalence level，and CRAB complex infection continues to exhibit a high prevalence rate. The composition and resistance patterns of pathogens causing bloodstream infections vary to some extent across different regions and levels of hospitals in China.

Objective:To determine the epidemic characteristics of polymyxin resistance ( mcr) genes of Enterobacteriales colonized in patients admitted to hospitals in Zhejiang, Henan, Gansu and Shandong provinces in China in 2023. Methods:A comprehensive collection of 667 fecal specimens from patients admitted to five medical facilities across the provinces of Zhejiang, Henan, Gansu, and Shandong in 2023 was collected. Epidemiological characteristics of Enterobacteriales bacteria positive for the mcr gene were examined, employing techniques such as microbial culturing, using agarose gel electrophoresis, PCR, whole-genome sequencing, bioinformatics analysis, and the induction of antimicrobial resistance. Statistical analysis was subsequently applied to the gathered data. Results:Among 667 fecal samples from admitted patients, five samples were positive for mcr gene, with a carrier rate of 0.75%(5/667), and from two of the samples, two different strains carrying the mcr gene were isolated, respectively. A total of seven strains of Enterobacteriales carrying the mcr gene were detected, of which four strains carried mcr-1 gene and three strains carried mcr-9 gene. The positive isolates included three strains of Escherichia coli, one strain of Citrobacter braakii, Citrobacter freundii, one strain of Klebsiella pneumoniae, and one strain of Enterobacter hormaechei. The seven mcr positive strains were isolated from two distinct geographical locations within China, with four from Zhejiang Province and three from Henan Province. After whole-genome sequencing, it was found that the 16S rRNA sequences of the three strains of mcr-1 positive Escherichia coli had high homology. The three isolates of mcr-9 positive strains preserved a significant degree of homology within the mcr-9 and wbuC regions. Following polymyxin exposure, there was a marked difference in the growth kinetics of the ZJ-307, HN-11-1, and HN-135 strains post-induction compared to their pre-induction growth rates, and their motility capacity was reduced. Conclusions:The prevalence of Enterobacteriales harboring the mcr gene is minimal among hospitalized patients. However, it is noteworthy that these genes are prone to horizontal transfer. They can move into drug-resistant strains, which may have elevate minimum inhibitory concentration(MIC). Resistance to polymyxin can alter the bacterial growth rate and motility, potentially impacting the MIC of other antibiotics, thereby complicating clinical management. Consequently, it is imperative to focus on the proactive screening of susceptible populations to prevent the further dissemination of plasmid-mediated polymyxin resistance among clinically significant gram-negative bacterial pathogens.

Objective To explore the advantages and limitations of different evaluation methods for medical quality.Methods The rank sum ratio method(RSR),rank sum ratio method after principal component analysis(RSR-after-PCA),and technique for order preference by similarity to ideal solution(TOPSIS)were used to comprehensively evaluate the surgical medical quality in a hospital,respectively.The results of the three evaluation methods were compared.Results The result of Kendall's coefficient of concordance showed high consistency among the three evaluation methods(Kendall's W=0.879,χ2=26.364,P=0.003),although there were significant differences in the evaluation outcomes for some departments.Conclusion Each evaluation method is capable of objectively evaluating the overall situation of a department,but it also has certain limitations and scope of application.The appropriate method should be selected based on the purpose of analysis and data distribution.The evaluation indexes in hospitals are dispersed,but may be correlated to some extent.RSR-after-PCA can overcome these problems and is more suitable for the comprehensive evaluation of multiple indexes in hospitals.

Objective To investigate the status of management of iodinated contrast media(ICM)extravasation in Henan Province,as well as nurses' knowledge and influencing factors,in order to provide a basis for optimizing management strategies.Methods A self-designed questionnaire was applied,employing convenience sampling,to survey nursing administrators and nurses in the radiology departments of 55 tertiary hospitals across 16 regions of Henan Province,from December 2024 to January 2025.Multiple linear regression analysis was conducted to explore the factors influencing nurses' knowledge.Results A total of 55 nursing administrators and 64 nurses participated,with a valid questionnaire response rate of 100％.The survey results reveal that only 5.45％of radiology depart-ments utilized high-pressure central venous catheters,and 32.73％employed vascular visualization techniques.When setting the high-pressure injection speed for ICM,only 54.55％of radiology departments required an assessment of the type and model of intravenous access.Additionally,only 9.09％of radiology departments mandated an observa-tion for 2 to 4 hours following ICM extravasation.Furthermore,only 50.91％of radiology departments had estab-lished an information system for ICM use.The nurses' knowledge score regarding the prevention and management of ICM extravasation was(90.00±17.59),influenced by years of experience in radiology and professional titles(P＜0.05).Conclusion The prevention and management measures for ICM in radiology departments in Henan Province need further improvement.Nursing administrators should optimize management strategies,improve relevant training systems,and continuously enhance nurses' knowledge and practical abilities.

Objective:To investigate the correlation between leucine-rich α2 glycoprotein (LRG) and endoscopic activity in patients with Crohn′s disease (CD), based on the assessment of inflammation in small intestinal lesion by double-balloon enteroscope (DBE).Methods:From 15 August 2022 to 22 August 2023, the clinical data of 139 patients with small bowel CD diagnosed by DBE at the First Affiliated Hospital of Anhui Medical University were prospectively collected, which included fecal calprotectin (FC), C-reactive protein (CRP), white blood cell count, hemoglobin, albumin, Crohn′s disease activity index (CDAI), and simple endoscopic score for Crohn′s disease (SES-CD). According to the SES-CD, endoscopic activity was classified as mucosal healing (0), endoscopic remission (0 to 2), mild activity (3 to 6), moderate activity (7 to 15), and severe activity (≥16). LRG levels were detected in all patients. Spearman rank correlation was used to analyze the correlation between LRG, clinical biochemical parameters and endoscopic scores. Receiver operating characteristic curve (ROC) was performed to determine the optimal cut-off value of LRG for evaluating endoscopic mucosal healing. Mann-Whitney U test, Kruskal-Wallis H test, and Bonferroni corrected test were used for statistical analysis. Results:Among 139 patients with small bowel CD, the LRG level was 17.3 (13.0, 25.2) mg/L, and SES-CD was 5 (1, 9); 32 patients achieved mucosal healing, 50 patients achieved endoscopic remission; 39 patients had mild activity, 40 patients had moderate activity, and 10 patients had severe activity. The SES-CD was negatively correlated with both hemoglobin and albumin ( r=-0.177 (95% confidence interval, 95% CI: -0.334 to -0.011), -0.293 (95% CI: -0.438 to -0.133)), with statistical significance ( P=0.037, <0.001). The SES-CD was positively correlated with CRP, CDAI, LRG and FC ( r=0.344 (95% CI: 0.188 to 0.482), 0.429 (95% CI: 0.282 to 0.556), 0.525 (95% CI: 0.393 to 0.636), 0.661 (95% CI: 0.556 to 0.745)), with statistical significant (all P<0.001). For the 64 small bowel CD patients with CRP in the normal reference value, SES-CD was positively correlated with CDAI, LRG and FC ( r=0.296 (95% CI: 0.054 to 0.505), 0.364 (95% CI: 0.129 to 0.559), 0.547 (95% CI: 0.348 to 0.699)), with statistical significance ( P=0.017, =0.003, <0.001). The LRG level of patients with endoscopic mucosal healing was significantly lower than that of patients with endoscopic remission (11.5 (10.1, 17.2) mg/L vs. 17.3 (13.4, 23.5) mg/L), with statistical significance ( Z=-3.25, P<0.001). ROC analysis showed that the area under the curve (AUC) of LRG in predicting endoscopic mucosal healing was 0.81 (95% CI: 0.73 to 0.89), with an optimal cut-off value of 15.27 mg/L. The sensitivity, specificity, positive predictive value and negative predictive value were 0.757, 0.718, 0.900 and 0.469, respectively. The accuracy of the combination of LRG and FC (AUC was 0.88, 95% CI: 0.82 to 0.94) in predicting endoscopic mucosal healing was higher than that of LRG alone (AUC was 0.81, 95% CI: 0.73 to 0.89), and the difference was statistically significant ( P=0.011). Conclusion:Based on the results of DBE, LRG may be a reliable biomarker for predicting endoscopic remission and mucosal healing in patients with small bowel CD.

Objective To establish and compare rat models of psoriasis with blood-heat syndrome and blood-stasis syndrome.Methods The blood-heat syndrome model was induced by compound heat potion decoction and imiquimod.The blood-stasis syndrome model was induced by fatigue,hunger,cold dampness,panic and imiquimod.The groups were evaluated for TCM syndromes,psoriasis lesions,pathological tissue,spleen index,hemorheology and key gene expression levels.Results The blood-heat syndrome model group showed significant differences from the control group in syndrome manifestations,PASI score,Baker score,spleen index and plasma viscosity(P<0.05).The blood-stasis model group showed significant differences from the control group in syndrome manifestations,body weight,PASI score,Baker score,spleen index,whole blood viscosity(60s-1),whole blood viscosity(10s-1)and plasma viscosity(P<0.05).The key gene expression levels were different among all syndrome groups.Conclusion The animal models had the typical features of psoriasis and matched the signs of blood-heat syndrome and blood-stasis syndrome of TCM.The models can provide a basis for explaining the scientific meaning of TCM syndrome differentiation in treating psoriasis.

The wide application of assisted reproductive technology (ART) has brought the hope of fertility to infertile couples worldwide. However, with the gradual popularization of ART, the long-term health status of ART children has attracted extensive attention from society. Adolescence is a critical developmental period for individuals to transition from childhood to adulthood, with significant physical and psychological changes, so the health status of ART offspring during this period has a profound impact on their overall future health. This article reviews the existing studies, focusing on the effects of ART on multiple aspects of adolescent health, especially growth and development, cardiovascular health, endocrine function, fertility, cancer risk, atopic diseases, mental health, epigenetic changes and other aspects. The possible mechanisms leading to these health problems, including genetic factors, environmental exposures, and the long-term effects of early life interventions, were explored. Future research should continue to explore the long-term effects of ART on the health of offspring and further clarify the mechanisms of these effects, so as to provide a scientific basis for the development of effective prevention and intervention measures.

Objective:To propose suggestions for the revision of quality standard of steviol glycosides through research on its major manufacturer's products.Methods:The inspection items in the current quality standards were inspected,with domestic and international quality standard of steviol glycosides.Results:Specific rotation was from-33.39° to-39.50°,pH was from 5.3 to 6.7,impurity absorbency was lower than 0.096 0,while the contents of weight loss on drying were lower than 5.0％,residue on ignition were lower than 0.043％,methanol residual were lower than 0.01％,ethanol residual were lower than 0.06％,residue on arsenic were lower than 0.000 054％,lead wasn't detected.The content of rebaudioside A and 13 kinds of steviol glycosides were 8.23％-68.48％and 85.78％-96.13％.Conclusion:The main components of the commercial steviol glycosides products were rebaudioside A and stevioside,with low safety risk of elemental impurities and solvent residues.It provided suggestions for the revision of quality standard of steviol glycosides in the Chinese Pharmacopoeia.