1.Study on the safety and efficacy of micro-perfusion device for preserving isolated porcine limbs
Pengkai LI ; Zhaodi MI ; Shen LI ; Man YUAN ; Xiwei PENG ; Jia LÜ ; Sice WANG ; Zhibo JIA ; Xiangyu SONG ; Yixuan ZHU ; Chonghui LI ; Moling XIAO ; Wenjing XU ; Jiang PENG
Organ Transplantation 2026;17(3):422-431
Objective To evaluate the safety and efficacy of a self-developed micro-normothermic machine perfusion (NMP) system (micro-perfusion device) for preserving isolated porcine limbs. Methods Five healthy Landrace pigs were selected, and their left and right forelimbs were randomly divided into the NMP group and static cold storage (SCS) group. The NMP group was perfused with the self-developed micro-perfusion device and polymerized hemoglobin perfusate for 32 hours at normothermia, while the SCS group was preserved at 4 ℃. Hemodynamic parameters such as perfusion pressure and flow were monitored. The pH value, partial pressure of oxygen (PO2), lactic acid (Lac), creatine kinase (CK) and lactate dehydrogenase (LDH) in the perfusate were measured. Hematoxylin-eosin staining was used to assess the muscle tissue structure, terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling was employed to evaluate muscle cell apoptosis, and immunohistochemistry staining was applied to detect the expressions of tumor necrosis factor (TNF)-α and interleukin (IL)-6. A mixed-effects model was used to analyze the effects of time and treatment methods on tissue structure, cell apoptosis and inflammatory factors. Results The device could stably maintain a perfusion pressure of (69±15) mmHg and a flow rate of (117±42) mL/min. The pH value and electrolytes of the perfusate were generally stable, with PO2 maintained at a high level. Lac was maintained at 5.38(3.81, 6.45) mmol/L, while CK and LDH increased over time. After 32 hours of perfusion in the NMP group, both the myocyte spacing and apoptosis rate were better than those in the SCS group. Mixed-effects model analysis showed that there were statistically significant differences in the effects of NMP treatment and SCS treatment on myocyte spacing and apoptosis rate per unit time (both P < 0.05). There were no statistically significant differences in TNF-α and IL-6 between the two groups, and mixed-effects model analysis showed no statistically significant differences in the effects of NMP treatment and SCS treatment on TNF-α and IL-6 per unit time (both P > 0.05). Conclusions The micro-perfusion device used in this study may achieve 32-hour normothermic preservation in a porcine limb amputation model, maintain basic metabolism and ionic homeostasis, reduce muscle structural damage and cell apoptosis without inducing additional inflammatory responses. This technology is expected to significantly extend the time window for replantation of amputated limbs in disaster rescue and long-distance transportation, providing an important technical basis for clinical translation and subsequent replantation research.
2.Standardized scheme for deploying and withdrawing surgical module of new-type tent hospital system
Zeng-biao SU ; Bin-hong PEI ; Er-xiang XU ; Hai-ying CHEN ; Jia-na CHEN ; Jin-shen PAN ; Yi-feng HUANG ; Qian XU
Chinese Medical Equipment Journal 2025;46(2):74-79
Objective To explore the scheme for the deployment and withdrawal of the surgical module of the new-type tent hospital system.Methods A set of standardized scheme for deploying and withdrawing the surgical module of the new-type tent hosital system was proposed and implemented in terms of labor division,operation precedure,operation technique and precaution.The operating time,number of operational errors and number of equipment damages were recorded for each of the five deployment and withdrawal operations before and after the program was executed,and the team members'immediate heart rate,percentage of maximum heart rate(MHR)and rating of perceived exercise(RPE)at the end of the operation were recorded after the program was implemented.SPSS 26.0 software was used for statistical analysis.Results The standardized scheme had the deployment time shortened from(85.15±11.430)min to(58.23±8.513)min,withdrawal time decreased from(65.36±9.369)min to(48.92±7.129)min,with the differences being statistically significant(P<0.05);the numbers of operatio-nal errors and equipment damages were both reduced when compared with those before the implementation of the schemce;the immediate heart rate of the team members at the end of the operation ranged from 43 to 157 beats/min,with an average value of 151.1 beats/min,the individual MHR percentages were from 75%to 87%,with an average value of 81.1%,and the RPE scores were from 14 to 17,with an average value of 15.3,which all could be categorized as moderate-operation intensity.Condusion The standardized deployment and withdrawal scheme for the surgical module meets the needs of actual combat and training assessment,and thus is worthy promoting in medical institutions equipped with the surgical module of the new-type tent hosital system.[Chinese Medical Equipment Journal,2025,46(2):74-79]
3.Predictive efficacy of Delta radiomics for the pathological complete remission of pancrea-tic cancer after total neoadjuvant therapy
Jiangkun JIA ; Miao YU ; Meng JIA ; Quan SHEN ; Jian XU ; Qiang FU ; Huanzhou XUE
Chinese Journal of Digestive Surgery 2025;24(5):642-649
Objective:To investigate the predictive efficacy of Delta radiomics for the patholo-gical complete remission (pCR) of pancreatic cancer after total neoadjuvant therapy (TNT).Methods:The retrospective cohort study was conducted. The clinicopathological data of 263 patients with pancreatic cancer who were admitted to Henan Provincial People′s Hospital (Zhengzhou University People's Hspital) from January 2019 to September 2024 were collected. There were 166 males and 97 females, aged (56±12)years. All patients underwent TNT. The 263 patients were randomly divided into a training set of 184 cases and a test set of 79 cases using a 7∶3 random seed count. The training set was used to construct the prediction model, and the test set was used to validate the performance of the prediction model. Observation indicators: (1) postoperative and follow-up condi-tions; (2) imaging feature selection and model construction; (3) evaluation of predictive efficacy of different radiomic models. Comparison of measurement data with normal distribution between groups was conducted using the t test. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. The Kaplan-Meier method was used to calculate the survival rate and draw survival curve. The Log-rank test was used for survival analysis. The perfor-mance of the prediction model for pCR after TNT was evaluated using the receiver operator charac-teristic (ROC) curve, precision-recall (P-R) curve and Bootstrap method, along with the calculation of area under the curve (AUC), precision rate, recall rate, F1-score. Results:(1) Postoperative and follow-up conditions. All 263 patients underwent surgery after TNT, with pathological examination revealing 124 cases of pCR (86 cases in the training set, 38 cases in the test set) and 139 cases of non-pCR (98 cases in the training set, 41 cases in the test set), respectively. All 263 patients were followed up for 6(range, 3-12) months after surgery, of which 15 cases (4 cases of pCR and 11 cases of non-pCR) were lost to follow-up or died due to non-tumor reasons within 6 months after surgery. The postoperative 6-month recurrence-free survival rate of 124 pCR patients and 139 non-pCR patients were 80% and 50%, respectively, showing a significant difference between the two groups of patients ( χ2=22.84, P<0.05). (2) Imaging feature selection and model construction. Construction of the traditional radiology model: based on the response evaluation criteria in solid tumors 1.1, the Logistic regression model was constructed using the relative shrinkage (D%) as a predictive variable. The AUC of traditional radiology model was 0.72 [95% confidence interval ( CI) as 0.63?0.81] in the training set and 0.75 (95% CI as 0.66?0.84) in the test set, respectively. Construction of the Delta radiomics model: 10 non-zero coefficient features were selected. The Delta radiomics models were constructed by using the regularized Logistic regression, random forest, gradient boosting machine, and support vector machine algorithms through using selected features as input variables. (3) Evaluation of predictive efficacy of different radiomic models. The AUC of Delta radiomics model constructed by regularized Logistic regression algorithm in the test set for predicting pCR in pancreatic cancer after TNT was 0.90, higher than that of the random forest algorithm, gradient boosting machine algorithm, support vector machine algorithm (AUC as 0.81, 0.81, 0.83), and higher than that of the traditional radiology model (AUC as 0.72). Results of Bootstrap method revealed significant differences in the predictive efficacy of Delta radiomics model constructed by regularized Logistic regression algorithm compared to the Delta radiomics model constructed by random forest algorithm, gradient boosting machine algorithm, support vector machine algorithm and the tradi-tional radiology model (95% CI as 0.03?0.16, 0.03?0.16, 0.03?0.13, 0.08?0.29, P<0.05). The regularized Logistic regression algorithm within the Delta radiomics model demonstrated the best overall performance among the above models evaluated. Conclusion:Compared to the traditional radiology model, the Delta radiomics model offers superior efficacy in predicting pCR of pancreatic cancer after TNT, in which the regularized Logistic regression algorithm demonstrates the best overall performance metrics.
4.Genetic re-analysis of a Chinese pedigree affected with Hypertrophic cardiomyopathy due to a heterozygous truncating variant of ALPK3 gene and literature review.
Chenliang HONG ; Xianhong DING ; Yang LU ; Jia ZHU ; Jinwei WANG ; Mengyi XU ; Shuaishuai CHEN ; Bo SHEN ; Weili GE
Chinese Journal of Medical Genetics 2025;42(11):1337-1346
OBJECTIVE:
To explore the clinical and genetic characteristics of a Chinese pedigree affected with Hypertrophic cardiomyopathy (HCM) due to a truncating variant of ALPK3 gene.
METHODS:
A 44-year-old male admitted to Taizhou Hospital of Zhejiang Province on December 29, 2018 was selected as the study subject. Whole-exome sequencing (WES) was carried out, and candidate variant was interpreted by following the guidelines from the American College of Medical Genetics and Genomics (ACMG). For ALPK3 was considered an autosomal recessive gene, the WES results was considered insufficient to explain his phenotype. In April 2023, the proband's WES data were re-analyzed using updated annotation pipelines, and peripheral blood samples were collected from his first-degree relatives (mother and brother) for Sanger sequencing validation. Conservation analysis and protein structural modeling were performed to assess the impact of the variant. Clinical evaluation and genetic counseling were provided to the proband's family members. Relevant literature on ALPK3tv-induced HCM patients were searched in Wanfang Data Knowledge Service Platform, CNKI, and PubMed database using "ALPK3" and "hypertrophic cardiomyopathy" as keywords. Clinical characteristics of HCM patients with heterozygous ALPK3tv variants were summarized and compared with the clinical characteristics of HCM patients with positive sarcomere-associated gene variants (SARC+). This study was approved by the Medical Ethics Committee of Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University (Ethics No.: K20230314).
RESULTS:
The proband was a 44-year-old male who was transferred to our institution on December 29, 2018 due to "chest tightness and pain for 6 months, exacerbated for 2 days". Emergency coronary angiography was performed, which led to a preliminary diagnosis of "acute coronary syndrome", and the patient was admitted to the Cardiology Department for treatment. Based on electrocardiogram and echocardiogram findings, the diagnosis was revised as HCM. The patient's condition has stabilized post-coronary angiography, and he was discharged with improved condition. On January 2019, WES was conducted to determine the etiology of the proband's HCM. WES results identified a novel heterozygous c.2156dupC (p.Pro720ThrfsTer53) truncating variant in the ALPK3 gene. At that time, the inheritance pattern could not explain the phenotype. In 2022, a literature indicated that heterozygous ALPK3tv could lead to autosomal dominant HCM. Consequently, in April 2023, the proband's whole-exome data were re-annotated, revealing changes in the transcript and protein versions, with the updated site annotated as ALPK3 (NM_020778.5): c.1550dupC (p.Pro518ThrfsTer53). Sanger sequencing confirmed that the proband's mother and brother also carried this variant. The mother exhibited obstructive HCM, while the brother showed no related phenotype. Bioinformatics analysis demonstrated conservation of this site across multiple species, and the variant has resulted in the loss of a protein domain. Based on ACMG guidelines, the variant was classified as likely pathogenic. Literature review and Bayesian calculation further elevated the pathogenicity rating, indicating that this variant was the cause of HCM in the patient. Literature study revealed distinctions between HCM caused by this variant type and SARC+ HCM. The age of onset among heterozygous ALPK3tv patients was delayed by approximately 10 years compared to SARC+ patients. Both forms of HCM exhibited a male predominance, which was particularly marked in individuals with ALPK3tv. Electrocardiographic left ventricular hypertrophy was more prevalent in heterozygous ALPK3tv patients than in SARC+ patients. The incidence of apical or concentric hypertrophy patterns was higher in heterozygous ALPK3tv patients compared to asymmetric septal hypertrophy, which predominated in SARC+ patients. ALPK3tv patients exhibited lower penetrance and later onset compared to SARC+ patients. A positive correlation between left ventricular wall thickness and age was noted in female patients only.
CONCLUSION
In this pedigree, the proband has presented with HCM, characterized by echocardiographic evidence of apical left ventricular hypertrophy without significant outflow tract obstruction or extracardiac phenotypes. Although his mother and brother had carried the same heterozygous ALPK3 (NM_020778.5) c.1550dupC (p.Pro518ThrfsTer53), the mother exhibited severe obstructive HCM, while the brother was asymptomatic, suggesting incomplete or age-dependent penetrance within the family. This study has enriched the evidence for the pathogenicity of ALPK3tv among Chinese HCM pedigrees and underscored the importance of periodic literature reviews and genetic re-analysis for unresolved genetic testing results.
Humans
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Male
;
Pedigree
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Adult
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Cardiomyopathy, Hypertrophic/genetics*
;
Heterozygote
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Asian People/genetics*
;
Exome Sequencing
;
Mutation
;
China
;
Female
;
East Asian People
5.Experimental study on alternative method of local lymph node assay using bromodeoxyuridine with flow cytometry(LLNA:BrdU-FCM)for skin sensitization evaluation of cosmetics
Xiao-jun LYU ; Ju ZHANG ; Sen WU ; Xiao-ling XU ; Meng-ting SHI ; Jin-jing XU ; Wang-ping PAN ; Jia-te SHEN ; Kai-yong HE
Chinese Pharmacological Bulletin 2025;41(4):793-799
Aim To establish and evaluate an alternative meth-od for detecting skin sensitization of cosmetics based on local lymph node assay using bromodeoxyuridine(BrdU)with flow cytometry(FCM).Methods(1)25%hexyl cinnamic alde-hyde(HCA)was chosen as a positive control with an acetone:olive oil(4∶1,V/V,AOO)mixture as a vehicle control for the experiment.The dorsal sides of both ears of mice were treated with test solutions on day 1,day 2,and day 3.Brdu solution was injected inter-peritoneally on day 5.On day 6,the bilateral ears and mandibular lymph nodes were excised,and the number of Brdu positive cells was measured by flow cytometry.The stim-ulation index(SI)was calculated to identify whether it was ≥3,in order to establish the method of LLNA:Brdu-FCM.(2)BrdU-FCM test was conducted using a blind method with the fif-teen reference substances listed in OECD TG429 whose skin sensitization potentials were known.The test substances were dissolved in AOO,N,N-dimethylformamide(DMF)or dimeth-yl sulfoxide(DMSO)at three different concentrations.Tests were performed the same as above.SI and EC2.7 were calculat-ed to evaluate whether the test substance was categorized as a skin sensitizer.The reliability and accuracy of the method were validated by comparing the classification of test substances with that in OECD TG429.Results The SI for 25%HCA was 3.9,showing positive in the skin sensitization test.It demonstrated that the LLNA:Brdu-FCM test method was properly implemen-ted.Nine test substances(2,4-dinitrochlorobenzene,4-pheny-lenediamine,cobalt chloride,2-mercaptobenzothiazole,hexyl-cinnamaldehyde,eugenol,phenyl benzoate,cinnamic alcohol,imidazolidinyl urea)were positive,and six test substances(methyl methacrylate,chlorobenzene,isopropanol,lactic acid,methyl salicylate,salicylic acid)were negative.The method was evaluated with sensitivity of 90%,specificity of 100%,positive prediction rate of 100%,negative prediction rate of 83%,false positive rate of 0%,false negative rate of 17%and accuracy of 93%.The LLNA:BrdU-FCM assay could correctly categorize the test substances that were skin sensitizers or non-sensitizers.Conclusion The LLNA:BrdU-FCM assay appears to be a relia-ble predictor of skin sensitization protential of chemicals,and it is expected to an alternative method for identifying skin sensitization as a supplementary in safety evaluation of cosmetic ingredient.
6.Distribution and resistance profiles of bacterial strains isolated from cerebrospinal fluid in hospitals across China:results from the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Juan MA ; Lixia ZHANG ; Yang YANG ; Fupin HU ; Demei ZHU ; Han SHEN ; Wanqing ZHOU ; Wenen LIU ; Yanming LI ; Yi XIE ; Mei KANG ; Dawen GUO ; Jinying ZHAO ; Zhidong HU ; Jin LI ; Shanmei WANG ; Yafei CHU ; Yunsong YU ; Jie LIN ; Yingchun XU ; Xiaojiang ZHANG ; Jihong LI ; Bin SHAN ; Yan DU ; Ping JI ; Fengbo ZHANG ; Chao ZHUO ; Danhong SU ; Lianhua WEI ; Fengmei ZOU ; Xiaobo MA ; Yanping ZHENG ; Yuanhong XU ; Ying HUANG ; Yunzhuo CHU ; Sufei TIAN ; Hua YU ; Xiangning HUANG ; Sufang GUO ; Xuesong XU ; Chao YAN ; Fangfang HU ; Yan JIN ; Chunhong SHAO ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Fang DONG ; Zhiyong LÜ ; Lei ZHU ; Jinhua MENG ; Shuping ZHOU ; Yan ZHOU ; Chuanqing WANG ; Pan FU ; Yunjian HU ; Xiaoman AI ; Ziyong SUN ; Zhongju CHEN ; Hong ZHANG ; Chun WANG ; Yuxing NI ; Jingyong SUN ; Kaizhen WEN ; Yirong ZHANG ; Ruyi GUO ; Yan ZHU ; Jinju DUAN ; Jianbang KANG ; Xuefei HU ; Shifu WANG ; Yunsheng CHEN ; Qing MENG ; Yong ZHAO ; Ping GONG ; Ruizhong WANG ; Hua FANG ; Jilu SHEN ; Jiangshan LIU ; Hongqin GU ; Jiao FENG ; Shunhong XUE ; Bixia YU ; Wen HE ; Lin JIANG ; Longfeng LIAO ; Chunlei YUE ; Wenhui HUANG
Chinese Journal of Infection and Chemotherapy 2025;25(3):279-289
Objective To investigate the distribution and antimicrobial resistance profiles of common pathogens isolated from cerebrospinal fluid(CSF)in CHINET program from 2015 to 2021.Methods The bacterial strains isolated from CSF were identified in accordance with clinical microbiology practice standards.Antimicrobial susceptibility test was conducted using Kirby-Bauer method and automated systems per the unified CHINET protocol.Results A total of 14 014 bacterial strains were isolated from CSF samples from 2015 to 2021,including the strains isolated from inpatients(95.3%)and from outpatient and emergency care patients(4.7%).Overall,19.6%of the isolates were from children and 80.4%were from adults.Gram-positive and Gram-negative bacteria accounted for 68.0%and 32.0%,respectively.Coagulase negative Staphylococcus accounted for 73.0%of the total Gram-positive bacterial isolates.The prevalence of MRSA was 38.2%in children and 45.6%in adults.The prevalence of MRCNS was 67.6%in adults and 69.5%in children.A small number of vancomycin-resistant Enterococcus faecium(2.2%)and linezolid-resistant Enterococcus faecalis(3.1%)were isolated from adult patients.The resistance rates of Escherichia coli and Klebsiella pneumoniae to ceftriaxone were 52.2%and 76.4%in children,70.5%and 63.5%in adults.The prevalence of carbapenem-resistant E.coli and K.pneumoniae(CRKP)was 1.3%and 47.7%in children,6.4%and 47.9%in adults.The prevalence of carbapenem-resistant Acinetobacter baumannii(CRAB)and Pseudomonas aeruginosa(CRPA)was 74.0%and 37.1%in children,81.7%and 39.9%in adults.Conclusions The data derived from antimicrobial resistance surveillance are crucial for clinicians to make evidence-based decisions regarding antibiotic therapy.Attention should be paid to the Gram-negative bacteria,especially CRKP and CRAB in central nervous system(CNS)infections.Ongoing antimicrobial resistance surveillance is helpful for optimizing antibiotic use in CNS infections.
7.Changing antibiotic resistance profiles of the bacterial strains isolated from geriatric patients in hospitals across China:data from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Xiaoman AI ; Yunjian HU ; Chunyue GE ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Hui LI ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2025;25(3):290-302
Objective To investigate the antimicrobial resistance of clinical isolates from elderly patients(≥65 years)in major medical institutions across China.Methods Bacterial strains were isolated from elderly patients in 52 hospitals participating in the CHINET Antimicrobial Resistance Surveillance Program during the period from 2015 to 2021.Antimicrobial susceptibility test was carried out by disk diffusion method and automated systems according to the same CHINET protocol.The data were interpreted in accordance with the breakpoints recommended by the Clinical and Laboratory Standards Institute(CLSI)in 2021.Results A total of 514 715 nonduplicate clinical isolates were collected from elderly patients in 52 hospitals from January 1,2015 to December 31,2021.The number of isolates accounted for 34.3%of the total number of clinical isolates from all patients.Overall,21.8%of the 514 715 strains were gram-positive bacteria,and 78.2%were gram-negative bacteria.Majority(90.9%)of the strains were isolated from inpatients.About 42.9%of the strains were isolated from respiratory specimens,and 22.9%were isolated from urine.More than half(60.7%)of the strains were isolated from male patients,and 39.3%isolated from females.About 51.1%of the strains were isolated from patients aged 65-<75 years.The prevalence of methicillin-resistant strains(MRSA)was 38.8%in 32 190 strains of Staphylococcus aureus.No vancomycin-or linezolid-resistant strains were found.The resistance rate of E.faecalis to most antibiotics was significantly lower than that of Enterococcus faecium,but a few vancomycin-resistant strains(0.2%,1.5%)and linezolid-resistant strains(3.4%,0.3%)were found in E.faecalis and E.faecium.The prevalence of penicillin-susceptible S.pneumoniae(PSSP),penicillin-intermediate S.pneumoniae(PISP),and penicillin-resistant S.pneumoniae(PRSP)was 94.3%,4.0%,and 1.7%in nonmeningitis S.pneumoniae isolates.The resistance rates of Klebsiella spp.(Klebsiella pneumoniae 93.2%)to imipenem and meropenem were 20.9%and 22.3%,respectively.Other Enterobacterales species were highly sensitive to carbapenem antibiotics.Only 1.7%-7.8%of other Enterobacterales strains were resistant to carbapenems.The resistance rates of Acinetobacter spp.(Acinetobacter baumannii 90.6%)to imipenem and meropenem were 68.4%and 70.6%respectively,while 28.5%and 24.3%of P.aeruginosa strains were resistant to imipenem and meropenem,respectively.Conclusions The number of clinical isolates from elderly patients is increasing year by year,especially in the 65-<75 age group.Respiratory tract isolates were more prevalent in male elderly patients,and urinary tract isolates were more prevalent in female elderly patients.Klebsiella isolates were increasingly resistant to multiple antimicrobial agents,especially carbapenems.Antimicrobial resistance surveillance is helpful for accurate empirical antimicrobial therapy in elderly patients.
8.Predictive efficacy of Delta radiomics for the pathological complete remission of pancrea-tic cancer after total neoadjuvant therapy
Jiangkun JIA ; Miao YU ; Meng JIA ; Quan SHEN ; Jian XU ; Qiang FU ; Huanzhou XUE
Chinese Journal of Digestive Surgery 2025;24(5):642-649
Objective:To investigate the predictive efficacy of Delta radiomics for the patholo-gical complete remission (pCR) of pancreatic cancer after total neoadjuvant therapy (TNT).Methods:The retrospective cohort study was conducted. The clinicopathological data of 263 patients with pancreatic cancer who were admitted to Henan Provincial People′s Hospital (Zhengzhou University People's Hspital) from January 2019 to September 2024 were collected. There were 166 males and 97 females, aged (56±12)years. All patients underwent TNT. The 263 patients were randomly divided into a training set of 184 cases and a test set of 79 cases using a 7∶3 random seed count. The training set was used to construct the prediction model, and the test set was used to validate the performance of the prediction model. Observation indicators: (1) postoperative and follow-up condi-tions; (2) imaging feature selection and model construction; (3) evaluation of predictive efficacy of different radiomic models. Comparison of measurement data with normal distribution between groups was conducted using the t test. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. The Kaplan-Meier method was used to calculate the survival rate and draw survival curve. The Log-rank test was used for survival analysis. The perfor-mance of the prediction model for pCR after TNT was evaluated using the receiver operator charac-teristic (ROC) curve, precision-recall (P-R) curve and Bootstrap method, along with the calculation of area under the curve (AUC), precision rate, recall rate, F1-score. Results:(1) Postoperative and follow-up conditions. All 263 patients underwent surgery after TNT, with pathological examination revealing 124 cases of pCR (86 cases in the training set, 38 cases in the test set) and 139 cases of non-pCR (98 cases in the training set, 41 cases in the test set), respectively. All 263 patients were followed up for 6(range, 3-12) months after surgery, of which 15 cases (4 cases of pCR and 11 cases of non-pCR) were lost to follow-up or died due to non-tumor reasons within 6 months after surgery. The postoperative 6-month recurrence-free survival rate of 124 pCR patients and 139 non-pCR patients were 80% and 50%, respectively, showing a significant difference between the two groups of patients ( χ2=22.84, P<0.05). (2) Imaging feature selection and model construction. Construction of the traditional radiology model: based on the response evaluation criteria in solid tumors 1.1, the Logistic regression model was constructed using the relative shrinkage (D%) as a predictive variable. The AUC of traditional radiology model was 0.72 [95% confidence interval ( CI) as 0.63?0.81] in the training set and 0.75 (95% CI as 0.66?0.84) in the test set, respectively. Construction of the Delta radiomics model: 10 non-zero coefficient features were selected. The Delta radiomics models were constructed by using the regularized Logistic regression, random forest, gradient boosting machine, and support vector machine algorithms through using selected features as input variables. (3) Evaluation of predictive efficacy of different radiomic models. The AUC of Delta radiomics model constructed by regularized Logistic regression algorithm in the test set for predicting pCR in pancreatic cancer after TNT was 0.90, higher than that of the random forest algorithm, gradient boosting machine algorithm, support vector machine algorithm (AUC as 0.81, 0.81, 0.83), and higher than that of the traditional radiology model (AUC as 0.72). Results of Bootstrap method revealed significant differences in the predictive efficacy of Delta radiomics model constructed by regularized Logistic regression algorithm compared to the Delta radiomics model constructed by random forest algorithm, gradient boosting machine algorithm, support vector machine algorithm and the tradi-tional radiology model (95% CI as 0.03?0.16, 0.03?0.16, 0.03?0.13, 0.08?0.29, P<0.05). The regularized Logistic regression algorithm within the Delta radiomics model demonstrated the best overall performance among the above models evaluated. Conclusion:Compared to the traditional radiology model, the Delta radiomics model offers superior efficacy in predicting pCR of pancreatic cancer after TNT, in which the regularized Logistic regression algorithm demonstrates the best overall performance metrics.
9.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
10.Changing antimicrobial resistance profiles of Burkholderia cepacia in hospitals across China:results from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Chunyue GE ; Yunjian HU ; Xiaoman AI ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Hui LI ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2025;25(5):557-562
Objective To examine the changing prevalence and antimicrobial resistance profiles of Burkholderia cepacia in 52 hospitals across China from 2015 to 2021.Methods A total of 9 261 strains of B.cepacia were collected from 52 hospitals between January 1,2015 and December 31,2021.Antimicrobial susceptibility of the strains was tested using Kirby-Bauer method or automated antimicrobial susceptibility testing systems according to a unified protocol.The results were interpreted according to the breakpoints released in the Clinical & Laboratory Standards Institute(CLSI)guidelines(2023 edition).Results A total of 9 261 strains of B.cepacia were isolated from all age groups,especially elderly patients.The proportion was 11.1%(1 032 strains)in children,significantly lower than the proportion in adults.About half(46.5%,4 310/9 261)of the strains were isolated from patients at least 60 years old and 42.3%(3 919/9 261)of the strains were isolated from young adults.Most isolates(71.1%)were isolated from sputum and respiratory secretions,followed by urine(10.7%)and blood samples(8.1%).B.cepacia isolates were highly susceptible to the five antimicrobial agents recommended in the CLSI M100 document(33rd edition,2023).B.cepacia isolates showed relatively higher resistance rates to meropenem and levofloxacin.However,the resistance rates to ceftazidime,trimethoprim-sulfamethoxazole,and minocycline remained below 8.1%.The percentage of B.cepacia strains resistant to levofloxacin was the highest compared to other antibiotics in any of the three age groups(from 12.4%in the patients<18 years old to 20.6%in the patients aged 60 years or older).Conclusions B.cepacia is one of the clinically important non-fermenting gram-negative bacteria.Accurate and timely reporting of antimicrobial susceptibility test results and ongoing antimicrobial resistance surveillance are helpful for rational prescription of antimicrobial agents and proper prevention and control of nosocomial infections.

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