OBJECTIVE To clarify the roles and functions of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs， and to provide theoretical and practical support for their transformation from traditional drug managers to multi-dimensional roles in clinical research. METHODS Combined with relevant regulations such as the Good Clinical Practice （GCP） （2020 Edition）， and based on the clinical practice experience of the Phase Ⅰ Clinical Ward in our hospital， this study systematically sorted out full-time pharmacists’ roles and functions in early-phase clinical trials of antineoplastic drugs， and explored the core challenges and optimization pathways for role transformation and capacity-building of domestic full-time clinical trial pharmacists. RESULTS & CONCLUSIONS Full-time pharmacists assumed multiple roles in early-phase clinical trials of antineoplastic drugs， including providing pharmaceutical support for protocol design， implementing whole-process standardized management of clinical trial drugs， ensuring medication safety for clinical trial subjects/participants， conducting quality control throughout the clinical trial process， and serving as a bridge for interdisciplinary collaboration and communication. Currently， there are challenges in this field in China， such as unclear roles， an imperfect capacity building system， and insufficient regulatory support. This paper proposes that by establishing a standardized role framework， clarifying the core responsibilities and authorities of full-time pharmacists， and leveraging cutting-edge technologies to provide comprehensive support for their roles， so as to fully harness their pharmaceutical expertise and contribute to the standardization and efficiency of the antineoplastic new drug development process.

ObjectiveTo construct an automatic measurement model for palmar tilt and radial inclination suitable for traditional Chinese medicine （TCM） clinical scenarios， and to validate its accuracy and efficiency in TCM manipulative reduction settings. MethodsData on anteroposterior （AP） and lateral X-rays of distal radius fractures were collected from patients admitted to 18 TCM/ integrated TCM and western medicine hospitals in Jiangsu province between September 1st， 2023， and September 1st， 2024， via the Jiangsu Diagnosis and Treatment Big Data Platform for TCM Dominant Diseases. A medical image segmentation framework based on multi-scale feature fusion and edge-awareness was employed， combined with anatomical knowledge specific to TCM orthopedics， to optimize the feature extraction strategy of an artificial intelligence （AI） model. This framework enabled automatic segmentation of fracture regions and measurement of distal radius palmar tilt and radial inclination. The accuracy of the AI model in measuring radial inclination and volar tilt was validated， and the measurement time and average time gain rate of the AI model were compared to those of manual measurement. ResultsA total of 15,444 AP and lateral X-ray images of distal radius fractures were collected， and were divided into a training set （11,144 images， 5066 AP and 6078 lateral）， a validation set （3700 images， 1840 AP and 1860 lateral）， and an independent test set （600 images， 300 AP and 300 lateral） after preprocessing. In the measurement of 300 AP X-rays in the independent test set for radial inclination， when the degree error between AI measurement and manual measurement was ＜3° and ＜5°， AI measurement accuracy was 83% and 93%， respectively. In 300 lateral X-rays in the test set for palmar tilt， when AI measurements had an error of ＜3° and ＜5° compared to manual measurements， corresponding accuracy rate was 78% and 90%， respectively. For 50 X-ray images， AI measurement time was （1.37±0.05） min for radial inclination while manual measurement time was （22.57±2.52） min （P＜0.001）； in terms of palmar tilt， the AI measurement time was （1.33±0.14） min， shorter than （23.70±2.80） min for manual measurement time （P＜0.001）. Average time gain rates for manual and AI measurements were 93.93% and 94.39% respectively. ConclusionAn automatic measurement model for palmar tilt and radial inclination in distal radius fractures has been established， enabling more accurate and efficient assessment as well as providing a tool to support the quantitative evaluation of the efficacy of TCM manipulative reduction and large-sample clinical research.

Cold ischemia-reperfusion injury (CIRI) is a major contributor to delayed graft function and long-term graft failure after kidney transplantation.Its pathogenesis involves multiple mechanisms, including energy metabolism disorders, oxidative stress and sterile inflammatory responses.Increasing evidence indicates that immune cells play a central regulatory role in the initiation and progression of CIRI.Damage-associated molecular patterns released during cold ischemia and reperfusion activate innate immunity, leading to the rapid recruitment of neutrophils, macrophages, dendritic cells and amplification of inflammatory cascades.Subsequently, adaptive immune cells, including T cells and B cells, are activated and further contribute to sustained inflammation, disruption of immune tolerance and graft injury.Through cytokine signaling, chemokine-mediated recruitment and antigen presentation, different immune cell subsets form a complex interactive network that ultimately determines the severity and outcome of CIRI.This review summarizes the roles and mechanisms of innate and adaptive immune cells in renal allograft CIRI, highlights their interconnections, and discusses emerging immune cell-targeted therapeutic strategies, aiming to provide a theoretical basis for improving clinical outcomes in kidney transplantation.

Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.

Radiogenomics, an extension of radiomics, explores the relationship between imaging features and underlying gene expression patterns. This field is instrumental in providing reliable imaging surrogates, thus potentially representing an alternative to genetic testing. The rapidly growing area of radiogenomics that utilizes ultrasound (US) imaging seeks to elucidate the connections between US image characteristics and genomic data. In this review, the authors outline the radiogenomics workflow and summarize the applications of US-based radiogenomics. These include the prediction of gene variations, molecular subtypes, and other biological characteristics, as well as the exploration of the relationships between US phenotypes and cancer gene profiles. Although the field faces various challenges, US-based radiogenomics offers promising prospects and avenues for future research.

Objective To explore the characteristics and influencing factors of complicated intra-abdominal infection in ICU patients after abdominal surgery.Methods A retrospective study was performed on ICU patients(n=92,observation group)developing complicated intra-abdominal infection after abdominal surgery versus patients(n=104,control group)without complicated intra-abdominal infection after abdominal surgery in our hospital from January 2020 to December 2023.The characteristics of patients who developed complicated intra-abdominal infections were analyzed and the relevant influencing factors were identified using multivariate Logistic regression analysis.Results A total of 124 strains of pathogenic bacteria were isolated and identified in 92 infected patients,with 64.52％(80/124)of Gram-negative strains comprising mainly 29.03％(36/124)of Escherichia coli,25.81％(32/124)of Gram-positive strains comprising mainly 12.90％(16/124)of Enterococcus faecalis,and 9.68％(12/124)of fungi comprising mainly 6.45％(8/124)of Candida albicans.Multivariate Logistic regression results showed that preoperative underlying disease,surgical methods,duration of surgery,invasive procedures,antibiotic use,and length of ICU stay,enteral nutrition were the influencing factors of complicated intra-abdominal infection in ICU patients after abdominal surgery(P＜0.0 5).Conclusion Patients with complicated intra-abdominal infection are infected with a variety of pathogenic bacteria,predominantly Gram-negative.The patient's preoperative underlying disease,surgical approach,duration of surgery,invasive procedures,use of antibiotics,length of ICU stay,and early enteral nutrition all affect the risk of complicated intra-abdominal infection in ICU patients after abdominal surgery.

Background and purpose:Accurate preoperative differentiation between vagal nerve cervical schwannomas(SCCS)and sympathetic chain cervical schwannomas(SCCS)in the neck is crucial because of their different postoperative complication.This study aimed to construct and validate a Diagnosis Score and vascular displacement nomogram for the preoperative differentiation of VNCS from SCCS in the neck.Methods:This cross-sectional study retrospectively analyzed patients with pathologically confirmed VNCS and SCCS at Fudan University Shanghai Cancer Center from January 2017 to April 2022.This study was approved by the medical ethics committee of Fudan University Shanghai Cancer Center(approval number:1612167-18).Inclusion criteria:① histopathological diagnosis of VNCS or SCCS through biopsy or surgical resection;② patients with complete clinic data;③availability of preoperative contrast-enhanced computed tomography(CT)or magnetic resonance imaging(MRI)examinations.Patients were excluded for:① contrast agent contraindications;② poor image quality;③ severe artifacts;④ non-standard scanning protocols.The cohort was randomly divided into training and validation sets in a 7∶3 ratio.Two radiologists(one resident and one attending physician)independently evaluated tumor characteristics(location,size and vascular displacement patterns)on preoperative imaging.Independent predictors were selected using LASSO regression analysis to construct a diagnostic scoring system and nomogram,with model performance evaluated by the receiver operating characteristic(ROC)curve.Results:A total of 110 patients were enrolled,with 77 cases allocated to the training set and 33 cases to the validation set.The age range was 24-78 years,and the mean age was(51.22±12.36)years.There were no statistically significant differences in baseline characteristics including age,gender,tumor location and size between the two patient groups(P＞0.05).ICA/ECA splaying was significantly associated with SCCS(P＜0.001),while the ICA/IJV splaying was significantly associated with VNCS(P＜0.001).Lateral and posterior ICA displacement were significantly associated with SCCS(P＜0.001),and medial and anterior ICA displacement were significantly associated with VNCS(P＜0.001).Five features including tumor size,ICA displacement direction,IJV displacement direction,ICA/ECA splaying and ICA/IJV splaying were used to establish the Diagnosis Score and nomogram.The nomogram combined imaging features showed favorable preference value for differentiating VNCS from SCCS,with area under curve(AUC)values of 0.953(95%CI:0.912-0.994)and 0.939(95%CI:0.885-0.993)for the training and validation cohorts,respectively.Conclusion:The Diagnosis Score and vascular displacement nomogram showed favorable predictive efficacy for differentiating VNCS from SCCS in the neck,and might be useful for clinical decision-making.

Objective To investigate the distribution and antimicrobial resistance profiles of clinically isolated Haemophilus influenzae and Moraxella catarrhalis in hospitals across China from 2015 to 2021,and provide evidence for rational use of antimicrobial agents.Methods Data of H.influenzae and M.catarrhalis strains isolated from 2015 to 2021 in CHINET program were collected for analysis,and antimicrobial susceptibility testing was performed by disc diffusion method or automated systems according to the uniform protocol of CHINET.The results were interpreted according to the CLSI breakpoints in 2022.Beta-lactamases was detected by using nitrocefin disk.Results From 2015 to 2021,a total of 43 642 strains of Haemophilus species were isolated,accounting for 2.91％of the total clinical isolates and 4.07％of Gram-negative bacteria in CHINET program.Among the 40 437 strains of H.influenzae,66.89％were isolated from children and 33.11％were isolated from adults.More than 90％of the H.influenzae strains were isolated from respiratory tract specimens.The prevalence of β-lactamase was 53.79％in H.influenzae strains.The H.influenzae strains isolated from children showed higher resistance rate than the strains isolated from adults.Overall,779 strains of H.influenzae did not produce β-lactamase but were resistant to ampicillin(BLNAR).Beta-lactamase-producing strains showed significantly higher resistance rates to these antimicrobial agents than the β-lactamase-nonproducing strains.Of the 16 191 M.catarrhalis strains,80.06％were isolated from children and 19.94％isolated from adults.M.catarrhalis strains were mostly susceptible to both amoxicillin-clavulanic acid and cefuroxime,evidenced by resistance rate lower than 2.0％.Conclusions The emergence of antibiotic-resistant H.influenzae due to β-lactamase production poses a challenge for clinical anti-infective treatment.Therefore,it is very important to implement antibiotic resistance surveillance for H.influenzae and guide rational antibiotic use.All local clinical microbiology laboratories should actively improve antibiotic susceptibility testing and strengthen antibiotic resistance surveillance for H.influenzae.

Objective To understand the changing composition and antibiotic resistance of bacterial species in the clinical isolates from outpatient and emergency department(hereinafter referred to as outpatients)and inpatient children over time in various hospitals,and to provide laboratory evidence for rational antibiotic use.Methods The data on clinically isolated pathogenic bacteria and antimicrobial susceptibility of isolates from outpatients and inpatient children in the CHINET program from 2015 to 2021 were collected and analyzed.Results A total of 278 471 isolates were isolated from pediatric patients in the CHINET program from 2015 to 2021.About 17.1％of the strains were isolated from outpatients,primarily group A β-hemolytic Streptococcus,Escherichia coli,and Staphylococcus aureus.Most of the strains(82.9％)were isolated from inpatients,mainly SS.aureus,E.coli,and H.influenzae.The prevalence of methicillin-resistant S.aureus(MRSA)in outpatients(24.5％)was lower than that in inpatient children(31.5％).The MRSA isolates from outpatients showed lower resistance rates to the antibiotics tested than the strains isolated from inpatient children.The prevalence of vancomycin-resistant Enterococcus faecalis or E.faecium and penicillin-resistant S.pneumoniae was low in either outpatients or inpatient children.S.pneumoniae,β-hemolytic Streptococcus and S.viridans showed high resistance rates to erythromycin.The prevalence of erythromycin-resistant group A β-hemolytic Streptococcus was higher in outpatients than that in inpatient children.The prevalence of β-lactamase-producing H.influenzae showed an overall upward trend in children,but lower in outpatients(45.1％)than in inpatient children(59.4％).The prevalence of carbapenem-resistant Klebsiella pneumoniae(CRKpn),carbapenem-resistant Pseudomonas aeruginosa(CRPae)and carbapenem-resistant Acinetobacter baumannii(CRAba)was 14％,11.7％,47.8％in outpatients,but 24.2％,20.6％,and 52.8％in inpatient children,respectively.The prevalence of multidrug-resistant E.coli,K.pneumoniae,Proteus mirabilis,P.aeruginosa and A.baumannii strains was lower in outpatients than in inpatient children.The prevalence of fluoroquinolone-resistant E.coli,ESBLs-producing K.pneumoniae,ESBLs-producing P.mirabilis,carbapenem-resistant E.coli(CREco),CRKpn,and CRPae was lower in children in outpatients than in inpatient children,but the prevalence of CRAba in 2021 was higher than in inpatient children.Conclusions The distribution of clinical isolates from children is different between outpatients and inpatients.The prevalence of MRSA,ESBL,and CRO was higher in inpatient children than in outpatients.Antibiotics should be used rationally in clinical practice based on etiological diagnosis and antimicrobial susceptibility test results.Ongoing antimicrobial resistance surveillance and prevention and control of hospital infections are crucial to curbing bacterial resistance.

Objective To investigate the changing antibiotic resistance profiles of E.coli isolated from patients in the 52 hospitals participating in the CHINET program from 2015 to 2021.Methods Antimicrobial susceptibility was tested for clinical isolates of E.coli according to the unified protocol of CHINET program.WHONET 5.6 and SPSS 20.0 software were used for data analysis.Results Atotal of 289 760 nonduplicate clinical strains ofE.coli were isolated from 2015 to 2021,mainly from urine samples(44.7±3.2)％.The proportion of E.coli strains isolated from urine samples was higher in females than in males(59.0％vs 29.5％).The proportion of E.coli strains isolated from respiratory tract and cerebrospinal fluid samples was significantly higher in children than in adults(16.7％vs 7.8％,0.8％vs 0.1％,both P＜0.05).The isolates from internal medicine department accounted for the largest proportion(28.9±2.8)％with an increasing trend over years.Overall,the prevalence of ESBLs-producing E.coli and carbapenem resistant E.coli(CREco)was 55.9％and 1.8％,respectively during the 7-year period.The prevalence of ESBLs-producing E.coli was the highest in tertiary hospitals each year from 2015 to 2021 compared to secondary hospitals.The prevalence of CREco was higher in children's hospitals compared to secondary and tertiary hospitals each year from 2015 to 2021.The prevalence of ESBLs-producing E.coli in tertiary hospitals and children's hospitals and the prevalence of CREco in children's hospitals showed a decreasing trend over the 7-year period.The prevalence of CREco in secondary and tertiary hospitals increased slowly.Antibiotic resistance rates changed slowly from 2015 to 2021.Carbapenem drugs(imipenem,meropenem)were the most active drugs amongβ-lactams against E.coli(resistance rate≤2.1％).The resistance rates of E.coli to β-lactam/β-lactam inhibitor combinations(piperacillin-tazobactam,cefoperazone-sulbactam),aminoglycosides(amikacin),nitrofurantoin and fosfomycin(for urinary isolates only)were all less than 10％.The resistance rate of E.coli strains to antibiotics varied with the level of hospitals and the departments where the strains were isolated,especially for cefazolin and ciprofloxacin,to which the resistance rate of E.coli strains from children in non-ICU departments was significantly lower than that of the strains isolated from other departments(P＜0.05).The E.coli isolates from ICU showed higher resistance rate to most antimicrobial agents tested(excluding tigecycline)than the strains isolated from other departments.The E.coli strains isolated from tertiary hospitals showed higher resistance rates to the antimicrobial agents tested(excluding tigecycline,polymyxin B,cefepime and carbapenems)than the strains from secondary hospitals and children's hospitals.Conclusions E.coli is an important pathogen causing clinical infection.More than half of the clinical isolates produced ESBL.The prevalence of CREco is increasing in secondary and tertiary hospitals over the 7-year period even though the overall prevalence is still low.This is an issue of concern.