1.Optimizing the whole-process quality control system of intravenous drug distribution center based on failure mode and effect analysis
Wei WEI ; Mingxia ZHANG ; Yanping ZHOU ; Lan YAN ; Peng TIAN ; Xia FENG
Journal of Pharmaceutical Practice and Service 2026;44(6):322-328
Objective To explore the application effect of a standardized management method based on failure mode and effect analysis (FMEA) in optimizing the whole-process quality control system of the intravenous admixture service (PIVAS). Methods The quality control management system of the PIVAS was optimized by establishing six quality control groups led by the head nurse, with full participation of pharmacy, nursing, and logistical staff, ensuring comprehensive coverage and traceability of all quality control links. Each group conducted risk priority number (RPN) scoring for potential failure modes in their respective quality control processes, and targeted improvement measures were formulated based on the scoring results. The RPN values of failure modes and quality control-related evaluation indicators before and after implementation were compared to achieve closed-loop management. Results After one year of management, the RPN values of the six major failure modes significantly decreased compared to those before implementation (P<0.05). The compounding error rate dropped to 0.13%, the dispensing error rate decreased to 0.95%, the compounding efficiency increased to 98%, the delivery time was shortened by 0.45 h per batch, the intervention rate for irrational prescriptions rose to 94.87%, satisfaction improved to 96.78%, and the participation rate of quality control personnel reached 95.36% (P<0.05). Conclusion FMEA-based identification of potential failure modes in the whole-process quality control system of the IVAS, combined with risk quantification and targeted interventions, significantly reduced high-risk failure modes, improved compounding accuracy and efficiency, and ensured the safety of clinical intravenous medication and the effectiveness of healthcare quality management.
2.Optimizing the whole-process quality control system of intravenous drug distribution center based on failure mode and effect analysis
Wei WEI ; Mingxia ZHANG ; Yanping ZHOU ; Lan YAN ; Peng TIAN ; Xia FENG
Journal of Pharmaceutical Practice and Service 2026;44(6):322-328
Objective To explore the application effect of a standardized management method based on failure mode and effect analysis (FMEA) in optimizing the whole-process quality control system of the intravenous admixture service (PIVAS). Methods The quality control management system of the PIVAS was optimized by establishing six quality control groups led by the head nurse, with full participation of pharmacy, nursing, and logistical staff, ensuring comprehensive coverage and traceability of all quality control links. Each group conducted risk priority number (RPN) scoring for potential failure modes in their respective quality control processes, and targeted improvement measures were formulated based on the scoring results. The RPN values of failure modes and quality control-related evaluation indicators before and after implementation were compared to achieve closed-loop management. Results After one year of management, the RPN values of the six major failure modes significantly decreased compared to those before implementation (P<0.05). The compounding error rate dropped to 0.13%, the dispensing error rate decreased to 0.95%, the compounding efficiency increased to 98%, the delivery time was shortened by 0.45 h per batch, the intervention rate for irrational prescriptions rose to 94.87%, satisfaction improved to 96.78%, and the participation rate of quality control personnel reached 95.36% (P<0.05). Conclusion FMEA-based identification of potential failure modes in the whole-process quality control system of the IVAS, combined with risk quantification and targeted interventions, significantly reduced high-risk failure modes, improved compounding accuracy and efficiency, and ensured the safety of clinical intravenous medication and the effectiveness of healthcare quality management.
3.Preparation of monoclonal antibodies against human leukocyte immunoglobulin like receptor B2 and preliminary identification of their activity in vitro
Chinese Journal of Biologicals 2025;38(05):549-556
Objective To prepare monoclonal antibodies against human leukocyte immunoglobulin like receptor subfamilyB2(LILRB2) by hybridoma technique and preliminarily identify their activity in vitro, so as to provide a new strategy for targeting“cold”tumor therapy.MethodsThe extracellular region of human LILRB2 protein was expressed, purified by affinity chro-matography, and then used to immunize BALB/c mice to prepare anti-LILRB2 monoclonal antibodies with high specificityand affinity. The variable regions of light chain and heavy chain of mouse monoclonal antibodies were inserted into an expres-sion vector containing human constant regions by DNA recombination technique to produce chimeric antibodies, and theactivity in vitro was identified by ELISA, flow cytometry and bio-layer interferometry(BLI).ResultsSeven anti-LILRB2monoclonal antibodies with high purity were successfully prepared by hybridoma technique, all of which could recognizeLILRB2 protein with high specificity. Among them, 11C6-8, 43H7-2 and 53A6-11 had superior performance, with the EC_(50)values of 0. 272 3, 0. 431 8 and 0. 344 0 μg/mL, respectively. The chimeric antibodies obtained by humanized modificationexhibited higher binding ability to LILRB2 and effectively blocked the binding of LILRB2 to its ligand, human leukocyteantigen-G(HLA-G), among which the IC_(50)values of 11C6-8 and 53A6-11 were 0. 429 2 and 0. 283 6 μg/mL.ConclusionThe specific monoclonal antibodies against LILRB2 were successfully prepared, and expected to be developed into new anti-tumor immune antibody drugs, which provides a new idea for the development of therapy strategy targeting tumors.
4.Research progress of anti-inflammation therapy and immunotherapy for acute pancreatitis
Chinese Journal of Clinical Medicine 2025;32(1):120-124
At present, the incidence and mortality rate of severe acute pancreatitis is 15%-20% and about 20%, respectively, which can lead to local and systemic complications of patients and huge medical costs. The occurrence of acute pancreatitis is closely related to inflammatory response. This article reviews the progress of anti-inflammation therapy and immunotherapy of acute pancreatitis, aiming to provide reference for treatment in patients with acute pancreatitis.
5.GJB4 Gene Expression in Relation to Clinical and Pathological Features of Pancreatic Cancer Patients
Runlin FENG ; Zongqi DENG ; Mengyao WU ; Yunna WANG ; Yu WANG ; Guilan LIU ; Yanping TAO
Journal of Kunming Medical University 2025;46(1):78-86
Objective To investigate the expression of GJB4 gene in pancreatic cancer tissue and its correlation with clinicopathology.Methods The expression levels of GJB4 mRNA in pancreatic cancer and adjacent cancer tissues were analyzed using bioinformatics to analyze the Cancer Genome Atlas(TCGA)and Genotype-Tissue Expression(GTEx)RNA sequencing datasets.A total of 120 pancreatic cancer samples and 40 adjacent cancer samples from the Pathology Department of The Second Affiliated Hospital of Kunming Medical University from January 2019 to December 2023 were collected and sorted.Immunohistochemistry staining method was used to detect the expression difference of GJB4 protein between the two groups.RT-qPCR method was used to detect the expression levels of GJB4 in four pancreatic cancer cell lines.Univariate and multivariate Cox regression and Kaplan-Meier curves were used to analyze the clinical pathological data of GJB4 and pancreatic cancer patients.DAVID functional annotation bioinformatics and GSEA enrichment analysis were used to explore the relevant pathways of GJB4 in pancreatic cancer.Results The expression level of GJB4 mRNA in pancreatic cancer was higher than that in adjacent tissues,and the high expression of GJB4 was significantly associated with poor prognosis of patients(P<0.05).Immunohistochemical analysis showed that GJB4 protein was brown-yellow granular in pancreatic cancer tissues,mainly expressed in cytoplasm and cell membrane,and GJB4 protein expression was up-regulated in pancreatic cancer(P<0.05).The RT-qPCR test results showed that out of 4 pancreatic cancer cell lines,3 of them had upregulated expression(P<0.05).COX regression analysis showed that GJB4 gene was an independent risk factor in the prognosis of pancreatic cancer patients.The results of GO enrichment analysis showed that GJB4 was related to the transmembrane transport,ion channel,signal release and membrane potential regulation of pancreatic cancer.GSEA analysis showed that GJB4 was enriched in the Wnt/β-catenin signaling pathway.Conclusion In pancreatic cancer,the high expression level of GJB4 is closely related to the clinicopathological features of the patients,which may predict the poor prognosis of the patients.GJB4 may be involved in regulating the Wnt/β-catenin signaling pathway of pancreatic cancer,and is expected to be one of the potential biomarkers of pancreatic cancer prognosis.
6.Construction and application of a quality and safety evaluation index system for the daytime chemotherapy
Yanping DENG ; Feng HUANG ; Jian SHI ; Yujiao YU ; Lanlan ZHANG ; Xiaxiang XUE ; Xiaohua WU ; Peicheng LIN ; Yang SUN
Chinese Journal of Hospital Administration 2025;41(8):609-613
Objective:To establish a quality and safety evaluation index system for the daytime chemotherapy in the Day Medical Management Quality Control Center of Fujian Province, providing references for objectively evaluating the quality of day chemotherapy.Methods:From December 2023 to August 2024, this study screened the initial indexes of the quality and safety evaluation index system for daytime chemotherapy through literature search and expert discussions. An index system and its weights were determined by using two rounds of Delphi method and precedence chart method. The quality of daytime chemotherapy services in 8 hospitals was evaluated by using a thousand point scale checklist based on this index system.Results:The expert motivation of both rounds of Delphi method was 100%, and the expert authority coefficient was 0.92. The quality and safety evaluation index system for daytime chemotherapy included 3 first-level indicators, 13 second-level indicators, and 54 third-level indicators; Among them, the weights of the first-level indicator included structure quality, process quality, and result quality were 0.334, 0.556, and 0.110, respectively. The quality and safety scores of daytime chemotherapy in 8 hospitals ranged from 812 to 980 points, with an average of 933 points.Conclusions:The quality and safety evaluation index system for daytime chemotherapy could objectively and comprehensively evaluate the quality and safety of hospital daytime chemotherapy.
7.Modified epitope peptides targeting the porcine PD-1/PD-L1 interaction enhance cellular and humoral immune responses
Feng YUE ; Juanjuan ZHOU ; Yanping ZHU ; Xuehua LI ; Peng LI ; Yuping WU ; Yangzhao ZHU ; Xuannian WANG
Journal of Veterinary Science 2025;26(6):e91-
Objective:
To evaluate the immune function of epitope peptides interacting with porcine PD-1 or PD-L1.
Methods:
We optimized and synthesized peptides (PD-L14QN-GF and PD-L14QN-AF) using the solid-phase method and assessed their effects on peripheral blood mononuclear cell (PBMC) proliferation and PD-1 and cytokine expression after porcine reproductive and respiratory syndrome virus (PRRSV) infection in vitro and on antibody responses to a porcine circovirus type 2 (PCV2) vaccine in vivo.
Results:
The optimized peptides PD-L14QN-GF and PD-L14QN-AF exhibited lower binding free energy and higher stability when interacting with the PD-1 target protein.Under both PRRSV-infected and non-infected conditions in vitro, both peptides enhanced the proliferation of PBMCs, inhibited PRRSV RNA replication, and downregulated PD-1 transcription levels. Additionally, PD-L14QN-GF and PD-L14QN-AF upregulated the mRNA transcription and protein secretion of interleukin (IL)-2, IL-10, and interferon-γ to varying degrees. In vivo experiments demonstrated that PD-L14QN-GF significantly increased the antibody titer and seroconversion rate of the PCV2 vaccine.
Conclusions
and Relevance: PD-L14QN-GF and PD-L14QN-AF induced stronger immune responses than PD-L14. PD-L14QN-GF has potential as an immune-enhancing adjuvant.
8.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.
9.Comparison of CT features between hyperlipidemic acute pancreatitis and acute biliary pancreatitis
Chinese Journal of Clinical Medicine 2025;32(4):642-646
Objective To analyze the difference of CT features between hyperlipidemic acute pancreatitis (HLAP) and acute biliary pancreatitis (ABP). Methods Retrospective analysis was performed on 66 HLAP patients and 96 ABP patients admitted to East Hospital Affiliated to Tongji University from January 2018 to December 2019. The clinical data and CT features of patients between the two groups were compared. Results There were statistically significant differences in the clinical data and CT grades (A-E) between the HLAP group and the ABP group (P<0.01). ABP group showed more swelling and effusion in pancreatic body and tail (58.3%), 16.7% of swelling and effusion in whole pancreas, but rare swelling and effusion located in pancreatic head and neck alone (3.1%). The HLAP group showed more swelling and effusion in whole pancreas (48.5%), 39.4% of swelling and effusion in pancreatic head and neck, but rare swelling and effusion located in pancreatic body and tail alone (12.1%). Conclusions CT features of HLAP are significantly different from the ABP, which may be useful for early precise diagnosis and treatment for HLAP.
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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