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 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 investigate the risk factors for mortality and bleeding complications in extracorporeal membrane oxygenation(ECMO)treated patients and to evaluate the impact of thrombocytopenia severity on the prognosis of ECMO therapy.Methods A total of 153 patients who received ECMO treatment at Peking University Third Hospital between January 2013 and September 2024 were en-rolled in this study.The patients were divided into death group(n=97)and recovery group(n=56)based on their final outcomes.Additionally,the patients were categorized into bleeding group(n=104)and non-bleeding group(n=49)based on the occurrence of bleeding complications during ECMO.Clinical baseline characteristics and extreme laboratory values during ECMO were compared be-tween groups.Logistic regression was used to analyze the risk factors for mortality and bleeding.The patients were further divided,based on the initial platelet(PLT)values on the day of catheter placement and the lowest platelet count during ECMO,into normal group(PLT≥ 100× 109/L),moderate reduction group[PLT=(50～99)× 109/L],and severe reduction group(PLT＜50× 109/L).Kaplan-Meier analysis was used to compare survival rates among these groups.The patients in the moderate and severe reduction groups were further divided into a platelet transfusion group and a non-transfusion group,and the outcomes and complication rates were com-pared.Results The recovery group had a higher proportion of myocarditis,higher minimum values of PLT,Hb,and Fib,and higher initial PLT values,while the maximum values of lactic dehydrogenase(LDH),total bilirubin(T-Bil),prothrombin time(PT),and procalcitonin(PCT)were lower(all P＜0.05)with significant differences.Logistic regression showed that age and maximum PCT were independent risk factors for mortality(OR=1.025 and 1.015 respectively,all P＜0.05).The bleeding group had longer ECMO dura-tions,more plasma transfusions,lower minimum Hb values,and higher maximum values of WBC,neutrophils(Neu),and APTT(all P＜0.05)with statistical differences.The minimum PLT value,maximum WBC value,and maximum APTT value were independent risk factors for bleeding complications(OR=0.986,1.062,and 1.004 respectively,all P＜0.05).Kaplan-Meier analysis showed that the patients in the severe reduction group had lower survival rates,regardless of whether the grouping was based on initial or minimum platelet counts(all P＜0.05).Platelet transfusion improved the mortality in the severe reduction group(P＜0.05)but had no effect on the moderate reduction group.Conclusion Age and peak value of PCT are the risk factors for mortality in ECMO patients,while mini-mum PLT count,peak value of WBC and APTT are the risk factors for bleeding complications.Early intervention for infection and in-flammation during ECMO may improve the outcome of patients.Severe thrombocytopenia during ECMO therapy increased the risk of mortality,and targeted platelet transfusion may improve the survival of these patients.

Objective:To investigate the distribution of iodine in drinking water in Inner Mongolia Autonomous Region, and provide a basis for delineation of different types of water iodine areas and the adoption of targeted prevention and control measures, as well as scientific adjustment of intervention strategies.Methods:Using cross-sectional survey method, from June to December in 2017, a survey on the distribution of water iodine was conducted in the entire autonomous region on a township (street, Sumu, abbreviated as township) basis in accordance with the requirements of the "National Survey Plan for Iodine Content in Drinking Water". For townships with water iodine level greater than 10 μg/L found in the survey, the survey was conducted on an administrative village (community, Gacha, abbreviated as administrative village) basis. The water iodine of regions with water iodine level greater than 100 μg/L found in the survey were reviewed in 2018 - 2019. Arsenic-cerium catalytic spectrophotometry was used to test water iodine.Results:A total of 1 009 townships of 103 counties (cities, districts) were surveyed on a township by township basis, with a median water iodine of 6.7 μg/L. Among them, there were 707 townships with water iodine < 10 μg/L, accounting for 70.1%. There were 251 townships with water iodine of 10 - < 40 μg/L, accounting for 24.9%. There were 44 townships with water iodine of 40 - 100 μg/L, accounting for 4.4%. There were 7 townships with water iodine > 100 μg/L, accounting for 0.7%. A total of 3 326 administrative village of 298 townships were surveyed based on administrative villages, among which, 791 villages had water iodine < 10 μg/L, accounting for 23.8%. There were 2 031 villages with water iodine of 10 - < 40 μg/L, accounting for 61.1%. There were 468 villages with water iodine of 40 - 100 μg/L, accounting for 14.1%. There were 36 administrative villages with water iodine > 100 μg/L, accounting for 1.1%. After review, 96 administrative villages in 12 townships of 4 league cities had water iodine > 100 μg/L.Conclusions:Most areas in Inner Mongolia Autonomous Region are iodine deficiency areas, and there are localized areas with high iodine levels due to water sources. Different iodine supplementation or iodine reduction measures should be taken for areas with different water iodine levels.

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 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 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.