ObjectiveTo investigate whether anti-programmed death-1 （PD-1） monoclonal antibody can enhance the efficacy and safety of argon-helium cryoablation combined with targeted therapy in patients with unresectable hepatocellular carcinoma （uHCC） aged 60 years or older. MethodsA retrospective analysis was performed for the clinical data of 124 patients with advanced uHCC aged 60 years or older who were treated at The Fifth Medical Center of Chinese PLA General Hospital from January 2013 to September 2024. After propensity score matching， 57 patients received cryoablation combined with targeted therapy （double combination group）， while 57 received cryoablation combined with targeted therapy and anti-PD-1 monoclonal antibody （triple combination group）. The indicators for efficacy assessment included objective response rate （ORR）， disease control rate （DCR）， progression-free survival （PFS）， overall survival （OS）， and the incidence rate of adverse events. The Mann-Whitney U test was used for comparison of continuous data between two groups， and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups. The Kaplan-Meier method was used to plot survival curves， and the Log-rank test was used for comparison between groups. A Cox proportional-hazards regression model analysis was used to investigate the influencing factors for survival prognosis. ResultsThe triple combination group had a significantly higher ORR than the double combination group （59.6% vs 29.8%， χ²=9.083， P=0.003）， while there was no significant difference in DCR between the two groups （87.7% vs 77.2%， χ²=1.516， P=0.218）， and compared with the double combination group， the triple combination group had significantly longer median PFS （9.1 months vs 4.8 months， χ²=7.813， P=0.005） and median OS （26.1 months vs 13.6 months， χ²=14.199， P<0.001）. The multivariate Cox proportional-hazards regression model analysis showed that triple combination treatment was an independent influencing factor for PFS （hazard ratio ［HR］=0.52， 95% confidence interval ［CI］： 0.35 — 0.78， P=0.001） and OS （HR=0.32， 95%CI： 0.20 — 0.51， P<0.001）. There was no significant difference in the incidence rate of adverse events between the two groups （P>0.05）. ConclusionTriple combination treatment with argon-helium cryoablation， targeted therapy， and anti-PD-1 monoclonal antibody can significantly improve survival benefits in uHCC patients aged 60 years or older， with a controllable safety profile.

Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective To investigate the efficacy and influencing factors of programmed death-1(PD-1)inhibitors in neoadjuvant chemotherapy for triple-negative breast cancer(TNBC).Methods A total of 86 patients with TNBC who received neoadjuvant therapy in The Fifth Medical Center,PLA General Hospital between Jan.1,2018,and Jan.1,2024 and met the inclusion criteria were enrolled,and their clinicopathological data were collected.Based on the neoadjuvant treatment regimens,40 patients who received TP+PD-1 inhibitor(paclitaxel+carboplatin+pembrolizumab)were assigned to TP+PD-1 inhibitor group,and 46 patients who received TP(paclitaxel+carboplatin)were assigned to TP group.The efficacy and incidence of adverse events were compared between the 2 groups after 6 cycles of neoadjuvant therapy.According to the efficacy of neoadjuvant therapy,the patients were further categorized into pathological complete response(pCR)group and non-pCR group.Multivariate logistic stepwise regression analysis was performed to identify independent factors influencing neoadjuvant treatment efficacy.Patients were followed up until Dec.31,2024,and survival analysis was conducted using Kaplan-Meier method.Results There was no significant difference in the objective response rates between the TP+PD-1 inhibitor group and TP group after neoadjuvant therapy(95.0%[38/40]vs 91.3%[42/46],P=0.351].However,the pCR rate was significantly higher in the TP+PD-1 inhibitor group compared with the TP group(65.0%[26/40]vs 43.5%[20/46],P=0.047).There were no significant differences between the 2 groups in terms of disease-free survival,overall survival,or incidence of adverse events(all P＞0.05).Multivariate logistic stepwise regression analysis revealed that the expression of Ki-67 and treatment regimen were influencing factors of pCR after neoadjuvant therapy(odds ratio[OR]=3.382,95%confidence interval[95%CI]1.290-8.868,P=0.013;OR=2.524,95%CI 1.013-6.285,P=0.047).One case of distant metastasis and death occurred in the pCR group,while 8 cases of distant metastasis and 4 deaths occurred in the non-pCR group.The disease-free survival was significantly longer in the pCR group than in the non-pCR group(P=0.031),while the overall survival was similar between the 2 groups(P=0.087).Conclusion Compared with the 6-cycle TP regimen,the 6-cycle TP combined with PD-1 inhibitor regimen can improve the pCR rate in the neoadjuvant treatment of TNBC,with manageable adverse events,suggesting it may serve as a preferred option for TNBC neoadjuvant therapy.Ki-67 expression may serve as a predictive biomarker for achieving pCR.TNBC patients who achieved pCR have better disease-free survival than those who did not.

OBJECTIVE To establish a risk prediction model for antibiotic-associated diarrhea(AAD)in intensive care unit(ICU)patients receiving mechanical ventilation so as to provide bases for early identification of high-risk population and formulation of corresponding individualized prevention strategies.METHODS A total of 1016 pa-tients who received mechanical ventilation and were treated with antibiotics in the ICU of The First Medical Center of Chinese PLA General Hospital from Jan.1,2020 to Jun.30,2022 were retrospectively enrolled in the study and were divided into the AAD group with 200 cases and the non-AA group according to the diagnostic criteria for AAD.Multivariate logistic regression analysis was performed for risk factors for AAD in the ICU patients receiv-ing mechanical ventilation,and the nomogram prediction model was established with R software.The performance of the model was evaluated by means of receiver operating characteristic(ROC)curves and calibration curves.RESULTS Among the 1016 patients who underwent mechanical ventilation,200 had AAD,and the incidence rate of AAD was 19.69％.Multivariate logistic regression analysis showed that hemoglobulin[OR=0.990,95％CI(0.983 to 0.997)],C-reactive protein[OR=1.046,95％CI(1.009 to 1.085)],serum phosphorus[OR=0.498,95％CI(0.328 to 0.755)],serum lipase[OR=1.001,95％CI(1.000 to 1.002)],ceftriaxo ne sodium[OR=2.331,95％CI(1.253 to 4.334)],linezolid[OR=2.387,95％CI(1.329 to 4.289)],fluconazole[OR=2.083,95％CI(1.238 to 3.505)]and sedatives[OR=0.307,95％CI(0.160 to 0.590)]were the risk factors for the AAD in the ICU patients receiving mechanical ventilation.The area under ROC curve(AUC)of the predic-tion model established based on the risk factors was 0.705 for the training set,0.751 for the validation set.Hos-mer-Lemeshow test indicated that the predicated probability of the model was consistent with the actual risk for the occurrence(x2=6.057,5.304,P=0.641,0.725).CONCLUSION The nomogram model that is established based on the above influencing factors can quantitatively predict the risk for AAD in the ICU patients undergo-ing mechanical ventilation,and it has certain clinical predictive efficiency.

Objective To analyze the reasons and influencing factors of ambiguous medical records,and propose targe-ted intervention strategies.Methods The medical records discharged from the Department of Otolaryngology,Head and Neck Surgery of a large Class Ⅲ hospital in Xi'an from January 2023 to December 2023 were retrospectively collected,and the medical records groups and ambiguous medical records were screened through the DRG information platform.The clinical features,defect causes and risk factors of ambiguous cases were analyzed statistically.Results There were 4 124 discharged cases in the year,of which 77 were ambiguous cases,accounting for 1.87％.Compared with the non-ambiguous group,more patients in the ambig-uous group adopted a self-funded approach,experienced a transfer and a longer hospital stay.The proportion of surgery and trau-ma in ambiguous group was higher,but the proportion of tumor patients was lower.Due to DRG grouping rules,64 cases(83.1％)were divided into ambiguous groups,which was the primary direct cause.Binary Logistic regression indicated that self-paid medical treatment(OR=2.2),transfer(OR=4.8),hospitalization ≥7 days(OR=3.1),trauma(OR=15.0),and total cost＞20 000 yuan(OR=1.7)were the risk factors for ambiguous disease cases(P＜0.05),while tumor disease was the pro-tective factor(OR=0.6,P＜0.05).Conclusion The emergence of ambiguous medical records involves many aspects such as clinical diagnosis and treatment,hospital management,health policy and so on,which has an important impact on hospital per-formance and medical insurance fund.Only by strengthening the level of hospital management,improving the quality of informa-tion system,and promoting the coordination and communication between doctors,management and patients,can we effectively re-duce the occurrence of ambiguous medical records.

The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.

Objective:To investigate the effects of learning flow experience on system thinking in medical students under the mixed mode.Methods:Medical students who completed Medical Statistics of the 2022-2023 academic year were enrolled.Then learning attitudes,learning flow experience,and system thinking were investigated using SATS-36 Scale,Adolescent Learning Flow Experience Questionnaire,and Systems Thinking Scale.Linear correlation analysis explored relationships among these variables.Multiple linear regression and restricted cubic spline(RCS)model analyzed linear/non-linear relationships between learning flow experience and system thinking after adjusting for gender,major,and learning attitude.Results:Among the 349 medical students surveyed,the mean score for learning attitudes was(4.31±0.59)and for learning flow experience was(3.33±0.65),both indicating a moderate to high level.The mean score for systems thinking was(59.01±13.57),indicating a moderate level.Positive correlations were found among learning flow experience,learning attitudes,and system thinking.Significant gender and major differences were observed in learning flow experience.After controlling for gender,major,and learning attitudes,multiple linear regression analysis revealed a significant linear trend between learning flow experience and system thinking(P＜0.01).RCS model analysis indicated a significant J-shaped nonlinear relationship between learning folw experience and system thinking(P for non-linearity＜0.01).Using the median score of 3.16 as the inflection point,when the learning flow experience score was＜3.16,it had no significant effect on medical students'system thinking(P=0.51).When the score was≥3.16,system thinking increased significantly with increasing learning flow experience(Beta per SD=0.56,95%CI:0.44-0.68,P＜0.01).Conclusions:The learning flow experience of medical students under the mixed mode can promote their system thinking.When the flow experience score is≥3.16,higher levels of learning flow experience are associated with increased systems thinking.Different dimensions of learning flow experience exhibit varying strengths of correlation with systems thinking.

OBJECTIVE To establish a risk prediction model for antibiotic-associated diarrhea(AAD)in intensive care unit(ICU)patients receiving mechanical ventilation so as to provide bases for early identification of high-risk population and formulation of corresponding individualized prevention strategies.METHODS A total of 1016 pa-tients who received mechanical ventilation and were treated with antibiotics in the ICU of The First Medical Center of Chinese PLA General Hospital from Jan.1,2020 to Jun.30,2022 were retrospectively enrolled in the study and were divided into the AAD group with 200 cases and the non-AA group according to the diagnostic criteria for AAD.Multivariate logistic regression analysis was performed for risk factors for AAD in the ICU patients receiv-ing mechanical ventilation,and the nomogram prediction model was established with R software.The performance of the model was evaluated by means of receiver operating characteristic(ROC)curves and calibration curves.RESULTS Among the 1016 patients who underwent mechanical ventilation,200 had AAD,and the incidence rate of AAD was 19.69％.Multivariate logistic regression analysis showed that hemoglobulin[OR=0.990,95％CI(0.983 to 0.997)],C-reactive protein[OR=1.046,95％CI(1.009 to 1.085)],serum phosphorus[OR=0.498,95％CI(0.328 to 0.755)],serum lipase[OR=1.001,95％CI(1.000 to 1.002)],ceftriaxo ne sodium[OR=2.331,95％CI(1.253 to 4.334)],linezolid[OR=2.387,95％CI(1.329 to 4.289)],fluconazole[OR=2.083,95％CI(1.238 to 3.505)]and sedatives[OR=0.307,95％CI(0.160 to 0.590)]were the risk factors for the AAD in the ICU patients receiving mechanical ventilation.The area under ROC curve(AUC)of the predic-tion model established based on the risk factors was 0.705 for the training set,0.751 for the validation set.Hos-mer-Lemeshow test indicated that the predicated probability of the model was consistent with the actual risk for the occurrence(x2=6.057,5.304,P=0.641,0.725).CONCLUSION The nomogram model that is established based on the above influencing factors can quantitatively predict the risk for AAD in the ICU patients undergo-ing mechanical ventilation,and it has certain clinical predictive efficiency.

In order to establish a competitive chemiluminescent enzyme-linked immunoassay for rapid and quantitative detection of Senecavirus A antibodies,the polystyrene plate was coated with inactivated Senecavirus A antigen,and the monoclonal antibodies against Senecavirus A VP2 and VP3 proteins labeled by horseradish peroxidase(HRP)were used as the competitive enzymic anti-bodies of the antibodies in the serum samples.The standard curve of the calibrator prepared by di-lution of positive serum was drawn to achieve quantitative detection.The successfully established SVA competitive CLEIA reported the result within 45 minutes.The maximum dilution of 1∶2 048 for calibrator serum was still detectable with no cross-reaction with the standard positive serum of other five kinds of virus antigens such as foot-and-mouth disease.The coefficient of variation within batches was less than 10％,and the coefficient of variation between batches was less than 15％,which showed good repeatability and stability.The positive and negative coincidence rates were 95.30％and 97.57％,respectively,and the total coincidence rate was 96.88％,showing high consistency.The SVA competitive CLEIA assay established in this study can be used for the rapid quantitative detection of Senecavirus A antibodies,filling the gap in the domestic rapid quantitative detection of SVA antibodies.

Objective:To investigate the clinicopathological characteristics and prognostic influencing factors in young breast cancer patients.Methods:A retrospective case series study was conducted. The clinical data of 408 young patients with breast cancer in the Fifth Medical Center of Chinese PLA General Hospital from January 2005 to December 2020 were retrospectively analyzed. The clinical characteristics and prognostic influencing factors of patients were observed. The Kaplan-Meier method was used to analyze overall survival (OS) and disease-free survival (DFS) of patients. Univariate analysis of prognostic factors was conducted by using the log-rank test, and multivariate analysis was performed by using Cox proportional risk model.Results:The median age [ M ( Q1, Q3)] of 408 young female patients with breast cancer was 36 (33, 39) years; the 5-year OS and 5-year DFS rates were 89.9%, 84.0% of 387 breast cancer patients in early and middle stage (except for stage Ⅳ). There were statistically significant differences in the 5-year OS and 5-year DFS rates (excluding stage Ⅳ of DFS) of patients with different clinical staging and molecular subtypes (all P < 0.05). The differences were statistically significant in the 5-year DFS rate of patients with different pathological types and histological grades (all P < 0.05). There were no statistically significant differences in the 5-year OS and DFS rates between the patients receiving breast-conserving surgery or mastectomy (all P > 0.05). The results of multivariate Cox regression analysis indicated that clinical staging ( HR = 3.121, 95% CI: 2.301-4.233, P < 0.001) and molecular classification ( HR = 1.441, 95% CI: 1.126-1.845, P = 0.004) were independent prognostic factors for OS. Additionally, clinical staging ( HR = 3.001, 95% CI: 2.174-4.141, P < 0.001) was identified as an independent prognostic factor for DFS. Conclusions:The prognosis of young breast cancer patients is closely related to clinical staging and molecular subtype. The later the clinical stage is, the poorer prognosis is. Luminal-type breast cancer has a better prognosis than other subtypes. For early-stage breast cancer patients who meet the criteria for breast-conserving surgery, breast-conserving surgery is the first-choice alternative.