The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.

The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.

ObjectiveTo analyze the research hotspots and development trends in the field of spinal cord stimulation (SCS) for spinal cord injury (SCI). MethodsLiterature about SCS for SCI was retrieve from the Web of Science (WOS) Core Collection database, with a time range from January, 1999 to July, 2025. VOSviewer 1.6.20 and CiteSpace 6.4.R2 were used to analyze the annual publication volume, countries, authors, institutions, journals and keywords. ResultsA total of 636 literatures were included. From 1999 to 2025, the overall publication trend in this field showed an upward trajectory, with recent years fluctuating but tending to stabilize. The country with the most publications was the United States (429 papers), followed by Russia (98 papers) and China (70 papers). The institution with the highest number of publications was the University of California, Los Angeles (76 papers), the author with the most publications was V. Reggie Edgerton (70 papers), and the journal with the most publications was Journal of Clinical Medicine (31 papers). The most frequently cited study focused on exploring the combination of epidural spinal cord stimulation with task-specific training to restore motor function in patients with complete SCI. Keyword analysis showed that the research hotspots in this field were mainly focused on neuroregulation mechanisms, recovery of motor and autonomic nervous dysfunction, artificial intelligence, closed-loop stimulation and brain-computer interface technology innovations. In recent years, the research focus gradually shifted from basic mechanisms to personalized and precise multifunctional rehabilitation strategies. ConclusionThe field of SCS for SCI has undergone phases of basic mechanism exploration and clinical application expansion. Current research hotspots and future trends focus primarily on the development of new stimulation paradigms and combined innovative technologies.

Metabolic dysfunction-associated fatty liver disease （MAFLD） is a chronic metabolic liver disorder with complex etiologies. Different clinical phenotypes of MAFLD （such as obesity， hyperlipidemia， type 2 diabetes mellitus， the postmenopausal state， and chronic hepatitis B） have different mechanisms of action in the development and progression of MAFLD， leading to high heterogeneity in its clinical progression and prognosis. This article systematically reviews the pathogeneses and clinical features of the above five clinical phenotypes of MAFLD and elaborates on the corresponding individualized diagnosis and treatment regimens integrating traditional Chinese medicine and Western medicine， in order to provide a reference for clinical practice and improve clinical diagnosis and treatment.

Objective To investigate the relationship of serum programmed cell death 4(PDCD4)and a disintegrin and metalloprotease 10(ADAM10)levels with short-term prognosis in elderly patients with large artery atherosclerosis(LAA)-related acute cerebral infarction(AIS).Methods A total of 122 elderly patients with LAA-related AIS admitted in Nanyang Second People's Hos-pital during April 2022 and April 2024 were retrospectively enrolled and served as observation group.According to their neurological function,they were categorized into mild,moderate and se-vere subgroups(29,68 and 25 cases,respectively),and based on their prognosis,they were as-signed into good and poor prognosis subgroups(72 and 50 cases,respectively).Another 125 indi-viduals taking physical examination in above hospital during the same period were included as the control group.ELISA was applied to detect serum PDCD4 and ADAM10 levels.Multivariate logis-tic regression analysis was employed to investigate the relationship of above two indicators with short-term prognosis of LAA-related AIS patients.ROC curves were plotted to analyze the predic-tive value of the indicators for short-term prognosis of the patients.Results The serum PDCD4 and ADAM10 levels were significantly higher in the observation group than the control group(P＜0.01),in the moderate and severe subgroups than the mild subgroups(P＜0.05),and in the severe than the moderate subgroups(P＜0.05).Larger proportions of severe neurologic deficit and hypertension,and higher Hcy level were observed in the poor than the good prognosis sub-groups(P＜0.01).PDCD4 and ADAM10 were correlated with poor short-term prognosis in pa-tients with LAA-related AIS(OR=2.759,95％CI:1.479-5.146,P=0.001;OR=2.818,95％CI:1.559-5.093,P=0.001).The AUC value of PDCD4 and ADAM10 alone and their combination in predicting poor short-term prognosis was 0.840,0.864,and 0.935,respectively,and the combina-tion showed better predictive performance than alone(Z=2.687,2.008,P＜0.05).Conclusion Serum PDCD4 and ADAM10 levels are higher in patients with LAA-related AIS.Their combina-tion showed good predictive efficacy for poor short-term prognosis of these patients.

Objective To retrieve and evaluate the evidence related to surgical instrument management,and to integrate the evidence to provide an evidence-based basis for clinical surgical instrument management practice.Methods Evidence on surgical instrument management,including guidelines,expert consensuses,and clinical decision-making,was systematically searched from domestic and international databases and related websites.The search timeframe was from database construction to 4 November 2024.Literature was screened and evaluated,and the evidence was integrated by 2 researchers.Results A total of 16 papers were included,including 2 systematic evaluations,1 class experimental study,2 clinical decisions,4 expert consensuses,5 guidelines,and 2 evidence summaries,resulting in a total of 33 pieces of evidence in 5 areas,including requirements for surgical instrument management,general principles of surgical instrument handling,logistics and supply chain management of surgical instruments,surgical instrument pre-treatment and cleaning,disinfection,and sterilisation processes,and personnel training.Conclusion This study summarises the best available evidence on the management of surgical instruments in hospitals and provides an evidence-based basis for healthcare professionals to manage surgical instruments,thereby improving the quality and efficiency of surgical instrument disposal.

Objective To explore CT manifestations of perivascular epithelioid cell tumor(PEComa)of liver and kidney.Methods Totally 18 hepatic PEComa and 5 renal PEComa confirmed by surgical pathology were retrospectively enrolled,and the preoperative CT manifestations were explored.Results Single lesion of liver or kidney was found in all 23 cases,and the main CT manifestations included low or slightly low density lesion(23/23,100％),with irregular morphology(16/23,69.57％),clear boundaries(17/23,73.91％),non-envelope(21/23,91.30％)and enhancement after administration of contrast agents(21/23,91.30％).Among 18 cases of liver PEComa,most lesions(13/18,72.22％)presented as uniform density,while some(5/18,27.88％)presented as non-uniform density lesions often contained with fat components(5/5,100％)and thickened blood vessels(4/5,80.00％)but rare hemorrhagic necrosis(1/5,20.00％)nor calcification(0/5,0).Fast in and fast out of contrast agents were observed in 16(16/18,88.89％)lesions.Uneven density and internal fat components were found in all 5(5/5,100％)renal PEComa,which rarely with hemorrhagic necrosis(1/5,20.00％),blood vessels orientation(1/5,20.00％)and calcification(0/5,0).After enhancement,fast in and fast out,progressive enhancement and non-enhancement was observed in 2(2/5,40.00％),1(1/5,20.00％)and 2(2/5,40.00％)cases,respectively.Conclusion CT manifestations of PEComa in liver and kidney had certain characteristics.

Fetal malformation of cortical development(MCD)is a group of structural neurological disorders caused by abnormalities in development of cortical layer during embryogenesis,characterized by significant heterogeneity and diversity,which may lead to adverse clinical outcomes such as epilepsy and intellectual disabilities.The progresses in prenatal evaluation on fetal MCD were reviewed in this article.

Objective To observe the association of the changes in monocyte to high density lipo-protein cholesterol ratio(MHR)and thromboxane B2(TXB2)with risk of left atrial appendage thrombus(LAAT)in elderly patients with atrial fibrillation(AF).Methods A retrospective study was conducted on 152 elderly AF patients admitted in our hospital from May 2022 to May 2024.According to the results of transesophageal echocardiography,they were divided into thrombus group(46 cases)and non-thrombus group(106 cases).Blood MHR and TXB2 levels were measured and calculated,and the predictive efficacy of MHR and TXB2 levels for the risk of LAAT was analyzed.Results The thrombus group had older age,larger left atrial diameter(LAD),higher monocyte count,and larger proportion of persistent AF(P＜0.01),while lower LVEF and HDL-C levels when compared with the non-thrombus group(P＜0.05,P＜0.01).The MHR and TXB2 level were significantly higher in the thrombus group than those in non-thrombus group(P＜0.01).Multivariate logistic regression analysis indicated that age(OR=1.244,95％CI:1.022-1.466,P=0.028),persistent AF(OR=29.290,95％CI:4.573-187.610,P=0.000),LAD(OR=1.502,95％CI:1.203-1.876,P=0.000),MHR(OR=1.115,95％CI:1.055-1.178,P=0.000)and TXB2(OR=1.064,95％CI:1.031-1.097,P=0.000)were risk fac-tors for LAAT in elderly AF patients,and LVEF(OR=0.813,95％CI:0.707-0.935,P=0.004)was a protective factor.ROC curve analysis suggested that the AUC value of MHR and TXB2 in evaluating the risk of LAAT in elderly AF patients was 0.767 and 0.829,respectively.Conclusion MHR and TXB2 are abnormally elevated in elderly AF patients with LAAT.They are risk factors affecting the occurrence of LAAT,and have certain predictive value for the risk of LAAT.

Objective This study aimed to investigate the antimicrobial resistance profiles of bacterial strains isolated from pediatric intensive care units(PICU)in China for better antimicrobial therapy.Methods Clinical isolates were collected from 17 institutions,including tertiary care children's hospitals and pediatric department of tertiary general hospitals in China from January 1,2020 to December 31,2022.Antimicrobial susceptibility testing was carried out according to a unified protocol using Kirby-Bauer method or automated systems.Results were interpreted according to the breakpoints released by the Clinical and Laboratory Standards Institute(CLSI)in 2020.Results A total of 10 688 isolates were collected,including gram-positive organisms(39.2％)and gram-negative organisms(60.8％).The top three organisms were S.aureus(13.6％,1 453/10 688),A.baumannii(10.0％,1 067/10 688),and coagulase-negative Staphylococcus(9.9％,1 058/10 688).Multi-drug resistant organisms(MDROs)were very common in children.The prevalence of methicillin-resistant Staphylococcus aureus(MRSA),carbapenem-resistant Enterobacterales(CRE),carbapenem-resistant E.coli,carbapenem-resistant K.pneumoniae(CRKP),carbapenem-resistant A.baumannii(CRAB),and carbapenem-resistant P.aeruginosa(CRPA)was 41.1％,19.4％,8.8％,30.9％,67.4％,and 28.8％,respectively.Overall,more than 50％of Enterobacteriales isolates were resistant to cephalosporins,while nearly 25％of Enterobacteriales isolates were resistant to carbapenems.MDROs were highly resistant to commonly used antibiotics.More than 80％of CRE and CRAB strains were resistant to all beta-lactam antibiotics.CRE and CRAB showed low resistance rates to tigecycline and polymyxin.CRPA showed lower resistance rates to piperacillin,beta-lactamase inhibitor combinations than the resistance rates to third and fourth generation cephalosporins.All of the Staphylococcus and Enterococcus isolates were susceptible to vancomycin and tigecycline.None of PRSP strains isolated from meningitis and nonmeningitis samples were resistant to rifampicin,vancomycin,or linezolid.The prevalence of β-lactamase-negative ampicillin-resistant(BLNAR)strains was 43.3％in Haemophilus influenzae.Conclusions MDROs were prevalent in PICU.It is necessary to establish an effective multidisciplinary team(MDT)to control the antimicrobial resistance.