AIM:To optimize the clinical dosage and administration regimen of a novel long-acting injectable aripiprazole microsphere(LZMT05)using plasma concentration data from two clinical trials.METHODS:Plasma concentrations were collected from 196 schizophrenia patients administered LZMT05,and a population pharmacokinetic(Pop-PK)model was developed.The therapeutic window was defined as the steady-state trough-to-peak concentration range(94.0-534 ng/mL)of oral ar-ipiprazole.Multiple clinical scenarios were simulat-ed to identify the optimal regimen.RESULTS:A one-compartment model with dual first-order ab-sorption and first-order elimination characterized LZMT05 pharmacokinetics.Covariates like sex and CYP2D6 genotype were integrated into the final model.Simulations demonstrated that switching from 10 mg oral aripiprazole to 350 mg LZMT05 ev-ery 4 weeks sustained concentrations within the therapeutic window with minimal peak-to-trough fluctuations.CONCLUSION:The PopPK-guided opti-mized LZMT05 regimen maintained drug exposure within the therapeutic window,suggesting favor-able efficacy and safety.

Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.

With the rapid increase in the ownership of MRI equipment in China,quality control,particularly in clinical usage aspects,has become critically important.For clinical quality control of MRI systems,it is essential to establish comprehensive workflow principles encompassing multiple elements such as personnel,equipment,standards,tools and methodologies.To advance the standardization and widespread adoption of clinical quality control for MRI equipment,efforts must focus on strengthening regulatory frameworks,advancing phantom research,development and enhancing professional expertise.Concurrently,continuous improvements in training programs and supervision mechanisms are necessary to ensure the effective implementation of MRI clinical quality control practices.Furthermore,in the era of digital healthcare,clinical quality assurance for MRI equipment is evolving toward automation and intelligent solutions,providing higher-quality and more efficient assurance for clinical applications.

Purpose To measure the spatial resolution in MRI quality control testing automatically based on the American College of Radiology(ACR)phantom using the support vector machine(SVM)method,and the feasibility,accuracy and measurement speed of this method are explored.Materials and Methods Quality control tests were performed using eight MRI devices at Beijing Friendship Hospital of Capital Medical University.A retrospective study was conducted on 71 MRI quality control test images collected based on ACR phantoms between 2017 and 2019.The images were preprocessed by binarization,extraction region of interest and so on.An SVM-based classification model was constructed for analyzing the spatial resolution of dot arrays in row and column directions.The dataset was randomly split into a training set and a test set.The generalization performance of the classification model in this study was evaluated through accuracy,precision,recall and F1 score on the test set.Comparing the results of spatial resolution measurements obtained by both manual and automatic method,we demonstrated the feasibility and accuracy of the method.Additionally,the time taken for the automatic spatial resolution measurement was recorded.Results In this study,the proposed method of automatically measuring the spatial resolution of ACR phantom test images using SVM was feasible,high accuracy and short time.In classification performance test,the accuracy of the spatial resolution of the row directional latices was 95%,the precision was 100%.The accuracy of the spatial resolution of the column directional latices was 97%,the precision was 100%.Among the test cases,the results of automatic measurements matched those of manual measurements in 13 out of 14 cases.On average,automatic spatial resolution measurement took 0.158 seconds per case.Conclusion This study achieves automatic measurement of spatial resolution in MRI quality control based on the ACR phantom using SVM method.The method demonstrates high accuracy and fast measurement speeds,holding significant implications for future rapid MRI quality control stability testing.

Purpose To explore an automatic detection method for quality control performance indicators of radio frequency coils based on American College of Radiology(ACR)phantom,and verify its accuracy stability and computational efficiency.Materials and Methods A retrospective study was conducted on 50 quality control images collected based on ACR phantom in Beijing Friendship Hospital,Capital Medical University from May 2017 to July 2019.The measurement and calculation methods of signal noise ratio(SNR),percent image uniformity(PIU)and percent signal ghosting(PSG)were used to automatically calculate the above indicators using a self-designed program in Python.A simple linear regression analysis on the automatically calculated SNR,PSG and PIU values compared to the manually measured results was performed,and Bland-Altman analysis was used to calculate the percentage difference to evaluate the consistency and bias between the performance indicators calculated by the two methods.The time consumption of two detection methods was compared to verify their computational complexity and efficiency.Results There was a strong correlation between the performance indicators SNR,PSG and PIU of radio frequency coils measured and calculated automatically and manually(r=0.991 4,0.992 8 and 0.909 8,all P<0.0001).The Bland-Altman results showed that most of the data fall within the 95%confidence interval and were evenly distributed.In terms of computational complexity and efficiency,compared to the complex manual delineation and calculation of 2-3 minutes per case,automatic detection could simultaneously obtain SNR,PSG and PIU values in less than 1 second.Conclusion The automatic and manual measurement methods have good consistency,and the automatic detection method is easy to operate,which is helpful for the daily quality control work and performance monitoring of radio frequency coils.

Breast cancer remains one of the frequently diagnosed malignant tumors among Chinese women,with hereditary cases accounting for 5%-10%of all diagnoses,where BRCA1/2 gene mutations serve as the primary genetic predisposition factors.Although targeted therapies like poly(ADP-ribose)polymerase(PARP)inhibitors have significantly improved prognoses for patients with BRCA-mutated breast cancer in recent years,critical clinical challenges persist,including the standardization of genetic testing protocols,optimization of precision treatment approaches,and refinement of long-term management strategies.In response to these challenges,our expert panel has conducted a comprehensive update to the 2018 Edition of this consensus by integrating the latest global evidence-based medical research with China's unique clinical practice characteristics.This 2025 Edition provides systematic evaluations and recommendations on five key aspects:indications for BRCA1/2 gene testing,testing methodologies,result interpretation,treatment strategies,and risk management.The main updates include:① Increasing the relationship between BRCA1/2 gene mutations and programmed death ligand-1(PD-L1)expression,as well as related content on BRCAness types;② Standardizing the application of genetic testing,such as increasing the significance,timing,and sample selection of clinical testing,and optimizing the BRCA testing population;③ Updating treatment strategies,such as non-drug treatment of BRCA1/2 gene mutation,treatment of triple negative breast cancer(TNBC)patients with BRCA1/2 gene mutation,treatment decisions of hormone receptor(HR)+/human epidermal growth factor receptor 2(HER2)-breast cancer patients with BRCA1/2 gene mutation,clinical use of PARP inhibitors and adverse reaction management;④ Addion of relevant content on long-term risk management,such as covering follow-up management,indications for preventive surgery,quality control and requirements for new genetic testing,updating genetic testing processes,report content and interpretation.This consensus aimed to establish standardized diagnostic and therapeutic frameworks for clinicians,advance precision medicine in BRCA-mutated breast cancer,and ultimately improve patient survival outcomes.As new evidence emerges,continuous updates will be implemented to incorporate the latest research findings.This consensus has been registered on the Practice guideline REgistration for transPAREncy(PREPARE)platform(registration number:PREPARE-2025CN1085).

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.

Breast cancer remains one of the frequently diagnosed malignant tumors among Chinese women,with hereditary cases accounting for 5%-10%of all diagnoses,where BRCA1/2 gene mutations serve as the primary genetic predisposition factors.Although targeted therapies like poly(ADP-ribose)polymerase(PARP)inhibitors have significantly improved prognoses for patients with BRCA-mutated breast cancer in recent years,critical clinical challenges persist,including the standardization of genetic testing protocols,optimization of precision treatment approaches,and refinement of long-term management strategies.In response to these challenges,our expert panel has conducted a comprehensive update to the 2018 Edition of this consensus by integrating the latest global evidence-based medical research with China's unique clinical practice characteristics.This 2025 Edition provides systematic evaluations and recommendations on five key aspects:indications for BRCA1/2 gene testing,testing methodologies,result interpretation,treatment strategies,and risk management.The main updates include:① Increasing the relationship between BRCA1/2 gene mutations and programmed death ligand-1(PD-L1)expression,as well as related content on BRCAness types;② Standardizing the application of genetic testing,such as increasing the significance,timing,and sample selection of clinical testing,and optimizing the BRCA testing population;③ Updating treatment strategies,such as non-drug treatment of BRCA1/2 gene mutation,treatment of triple negative breast cancer(TNBC)patients with BRCA1/2 gene mutation,treatment decisions of hormone receptor(HR)+/human epidermal growth factor receptor 2(HER2)-breast cancer patients with BRCA1/2 gene mutation,clinical use of PARP inhibitors and adverse reaction management;④ Addion of relevant content on long-term risk management,such as covering follow-up management,indications for preventive surgery,quality control and requirements for new genetic testing,updating genetic testing processes,report content and interpretation.This consensus aimed to establish standardized diagnostic and therapeutic frameworks for clinicians,advance precision medicine in BRCA-mutated breast cancer,and ultimately improve patient survival outcomes.As new evidence emerges,continuous updates will be implemented to incorporate the latest research findings.This consensus has been registered on the Practice guideline REgistration for transPAREncy(PREPARE)platform(registration number:PREPARE-2025CN1085).

Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.