1.Investigation of the quality standard of pharmaceutical excipient sucrose palmitate
Lijuan SHEN ; Lingli QIAN ; Guoping JIANG ; Yanyue YE ; Liwei GONG ; Cui CHENG ; Mingyan CHEN
Drug Standards of China 2025;26(5):521-526
Objective:To revise and enlarge the specification of pharmaceutical excipient sucrose palmitate.Methods:Reference to JP2018,USP-NF 2023,EP1 1.0,Chinese Pharmacopoeia 2020 edition of the four general rules and the first supplement of sucrose stearate pharmacopoeia standards and other relevant requirements for standard research.Results:According to the quality of the product and the actual application in the formulation,the quality standards for the pharmaceutical excipient sucrose palmitate will be studied.At present,the quality standard of sucrose palmitate for pharmaceutical excipients has been disclosed.Conclusion:The established stand-ard will provide the quality guarantee for the application of sucrose palmitate in medicines.
2.Dynamic colonization of Enterobacteriaceae in the gastrointestinal tract of tumor pa-tients and bloodstream infections caused by carbapenem-resistant Enterobacteriaceae
Cheng GUOPING ; Wang DENGKIU ; Wang QINGFENG
Chinese Journal of Clinical Oncology 2025;52(1):12-15
Objective:To actively screen the dynamic colonization of Enterobacteriaceae in the gastrointestinal tract of tumor patients and explore the homology between carbapenem-resistant Enterobacteriaceae(CRE)colonized in the gastrointestinal tracts of these patients and the bacteria causing bloodstream infections,to provide meaningful reference data for diagnosis and treatment by clinicians.Methods:A total of 32 strains of gram-negative bacilli were isolated from 353 intestinal specimens of tumor patients at The First Affiliated Hospital of Henan University of Science and Technology from December 2021 to November 2022.The bacterial identification instruments VITEK 2 Com-pact,a carbapenemase detection kit using colloidal gold immunochromatography,and polymerase chain reaction(PCR)were used to de-tectdrug resistance genes and phenotypes.Pulsed-field gel electrophoresis(PFGE)was used to analyze and compare the homology between CRE strains in the intestinal tract of patients and pathogenic microorganisms causing bloodstream infections.Results:Among the 32 strains of Gram-negative bacilli screened from the gastrointestinal tract of cancer patients,6 strains(1.6%,6/353)were carbapenem-resistant Kleb-siella pneumoniae(CRKp).All six CRKp strains harbored blaKPC gene.The proportion of CRE is 3.3%(12/353).Bloodstream infection oc-curred in 2 patients with intestinal colonization of Klebsiella pneumoniae,which was caused by the same CRKp strain as intestinal coloniza-tion.Conclusions:The proportion of CRE intestinal colonization in tumor patients was not high;however,under certain circumstances,CRE colonized in the intestines of tumor patients can cause ectopic infections else where in the body,including the bloodstream,which should be closely monitored.The findings indicate the importance of increased attention to critically ill patients who have undergone multiple hospital-izations with long hospitalization times,as well as early screening for intestine-colonizing microorganisms and rational regulation of the anti-biotic usage.
3.Preliminary establishment of reference intervals for 12 cytokines in adult plasma by multiplex bead-based flow fluorescent immunoassay
Xinyu WANG ; Xing CHENG ; Lu ZHENG ; Yue ZHANG ; Yuting MA ; Guoping NIU ; Feng GU ; Yongqiang CHEN
Chinese Journal of Immunology 2025;41(5):1202-1207
Objective:To establish the reference interval of 12 types of cytokines(IL-1β,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17,IFN-γ,IFN-α,TNF-α)in adult plasma based on multiple microsphere flow immunofluorescence(MBFFI).Methods:A total of 140 healthy adult patients who were examined at Xuzhou Central Hospital between January 2022 and December 2023 were included in the study.Plasma cytokine levels were detected and reference intervals were established by the flow cytometer and the assay kits produced by Qingdao Raisecare Biotechnology Co.,Ltd and Jiangsu BioPredia Biotechnology Co.,Ltd.Results:All of the cytokines exhibited a non-normal distribution,and there was a discrepancy in the 95%reference interval between the two re-agents.The reference intervals for the 12 cytokine kits produced by Qingdao Raisecare Biotechnology Co.,Ltd.were as follows:IFN-α:<4.91 pg/ml,IL-12 p70:<1.95 pg/ml,IL-5:<12.72 pg/ml,IL-8:<60.68 pg/ml,IL-1β:<27.67 pg/ml,IL-2:<5.01 pg/ml,IL-4:<1.22 pg/ml,IL-6:<6.11 pg/ml,TNF-α:<2.92 pg/ml,IL-17:<10.27 pg/ml,IL-10:<6.88 pg/ml,IFN-γ:<17.68 pg/ml.The reference intervals of the 12 cytokines produced by Jiangsu BioPredia Biotechnology Co.,Ltd.were as follows:IFN-α:<4.05 pg/ml,IL-12 p70:<7.33 pg/ml,IL-5:<7.80 pg/ml,IL-8:<13.24 pg/ml,IL-1β:<19.24 pg/ml,IL-2:<2.42 pg/ml,IL-4:<0.99 pg/ml,IL-6:<2.10 pg/ml,TNF-α:<0.87 pg/ml,IL-17:<1.42 pg/ml,IL-10:<1.10 pg/ml,IFN-γ:<1.34 pg/ml.Conclusion:In this study,the ref-erence range of two reagents for the detection of 12 kinds of cytokines in plasma of healthy adults is established by MBFFI,which pro-vides a valuable reference for the diagnosis and treatment of clinical-related diseases.
4.Antimicrobial resistance surveillance in the bacterial strains isolated from pediatric intensive care units in China:results from 2020 to 2022
Jing LIU ; Huiyuan YAN ; Gangfeng YAN ; Guoping LU ; Pan FU ; Chuanqing WANG ; Danqun JIN ; Wenjia TONG ; Chenyu ZHANG ; Jianli CHEN ; Yi LIN ; Jia LEI ; Yibing CHENG ; Qunqun ZHANG ; Kaijie GAO ; Yuanyuan CHEN ; Shufang XIAO ; Juan HE ; Li JIANG ; Huimin XU ; Yuxia LI ; Hanghai DING ; Hehe CHEN ; Yao ZHENG ; Qunying CHEN ; Ying WANG ; Hong REN ; Chenmei ZHANG ; Zhenjie CHEN ; Mingming ZHOU ; Yucai ZHANG ; Yiping ZHOU ; Zhenjiang BAI ; Saihu HUANG ; Lili HUANG ; Weiguo YANG ; Weike MA ; Qing MENG ; Pengwei ZHU ; Yong LI ; Yan XU ; Yi WANG ; Yanqiang DU ; Huijun CAI ; Bizhen ZHU ; Huixuan SHI ; Shaoxian HONG ; Yukun HUANG ; Meilian HUANG
Chinese Journal of Infection and Chemotherapy 2025;25(3):303-311
Objective This study aimed to investigate the antimicrobial resistance profiles of bacterial strains isolated from pediatric intensive care units(PICU)in China for better antimicrobial therapy.Methods Clinical isolates were collected from 17 institutions,including tertiary care children's hospitals and pediatric department of tertiary general hospitals in China from January 1,2020 to December 31,2022.Antimicrobial susceptibility testing was carried out according to a unified protocol using Kirby-Bauer method or automated systems.Results were interpreted according to the breakpoints released by the Clinical and Laboratory Standards Institute(CLSI)in 2020.Results A total of 10 688 isolates were collected,including gram-positive organisms(39.2%)and gram-negative organisms(60.8%).The top three organisms were S.aureus(13.6%,1 453/10 688),A.baumannii(10.0%,1 067/10 688),and coagulase-negative Staphylococcus(9.9%,1 058/10 688).Multi-drug resistant organisms(MDROs)were very common in children.The prevalence of methicillin-resistant Staphylococcus aureus(MRSA),carbapenem-resistant Enterobacterales(CRE),carbapenem-resistant E.coli,carbapenem-resistant K.pneumoniae(CRKP),carbapenem-resistant A.baumannii(CRAB),and carbapenem-resistant P.aeruginosa(CRPA)was 41.1%,19.4%,8.8%,30.9%,67.4%,and 28.8%,respectively.Overall,more than 50%of Enterobacteriales isolates were resistant to cephalosporins,while nearly 25%of Enterobacteriales isolates were resistant to carbapenems.MDROs were highly resistant to commonly used antibiotics.More than 80%of CRE and CRAB strains were resistant to all beta-lactam antibiotics.CRE and CRAB showed low resistance rates to tigecycline and polymyxin.CRPA showed lower resistance rates to piperacillin,beta-lactamase inhibitor combinations than the resistance rates to third and fourth generation cephalosporins.All of the Staphylococcus and Enterococcus isolates were susceptible to vancomycin and tigecycline.None of PRSP strains isolated from meningitis and nonmeningitis samples were resistant to rifampicin,vancomycin,or linezolid.The prevalence of β-lactamase-negative ampicillin-resistant(BLNAR)strains was 43.3%in Haemophilus influenzae.Conclusions MDROs were prevalent in PICU.It is necessary to establish an effective multidisciplinary team(MDT)to control the antimicrobial resistance.
5.Multicenter survey on the current status of pediatric life support training
Xin QIAN ; Xiaodi CAI ; Quan WANG ; Meifang LIN ; Qian WANG ; Tingting XUE ; Biru LI ; Quelan HUANG ; Yi WANG ; Yunxia HONG ; Zhixu CHEN ; Guoping LU ; Ye CHENG ; Hongyang HU
Chinese Pediatric Emergency Medicine 2025;32(11):827-831
Objective:To investigate the current status and challenges of pediatric life support training in China and provide references for improving training quality.Methods:A cross-sectional study was conducted to collect data from pediatric life support training centers across the country,covering basic institutional information,training capacity and training faculty,training program funding,as well as existing challenges and issues.The domestic registry of training centers in 2023 was obtained through the American Heart Association's online platform.After contacting and verifying each center,an online questionnaire was distributed,and the aggregated data were statistically analyzed.Results:A total of 42 institutions participated in the survey,including 19 children's hospitals,14 general hospitals,6 maternal and child health hospitals,2 women and children’s hospitals,and 1 training institution.The distribution of training centers showed a concentration in coastal areas,with the top three provinces/municipalities being Guangdong(7/42,16.7%),Zhejiang(6/42,14.3%),and Shanghai(4/42,9.5%).As of December 31 2023,the 42 institutions had an annual basic life support(BLS)training volume of 8 587 individuals,the median was 120 (100,200),and an annual pediatric advanced life support(PALS)training volume of 2 448 individuals,the median was 30 (20,50).Among the 42 institutions,there were 598 BLS instructors and 306 PALS instructors.Among the surveyed institutions,24(24/42,57.1%)reported BLS instructor teams comprising fewer than 10 members,and 33(33/42,78.6%)reported PALS instructor teams comprising fewer than 10.Only 7 centers(7/42,16.7%)reported having dedicated funding support.The top three challenges were:training sessions occupying instructors’personal time(27/42,64.3%),low instructor compensation(16/42,38.1%),and issues with the data submission system(16/42,38.1%).Conclusion:Pediatric life support training centers in China are primarily children’s hospitals,with a geographical concentration in coastal areas,which is also reflected in the distribution of training scale and instructor resources.Most centers have relatively small training scales and limited instructor capacity,with many instructors conducting training during their personal time.These issues may hinder the implementation and effectiveness of training programs.
6.Catheter-directed thrombolysis for acute entire lower extremity deep venous thrombosis: a comparative study of calf deep vein and contralateral femoral venous access
Jian WANG ; Cheng QIAN ; Guoqing NI ; Maofeng GONG ; Liang LIU ; Peng PENG ; Libing GAO ; Jianping GU ; Guoping CHEN
Chinese Journal of Radiology 2025;59(5):577-585
Objective:To compare the clinical efficacy of catheter-directed thrombolysis (CDT) via the contralateral femoral vein approach (CFVA-CDT) and the calf deep vein approach (CVA-CDT) in the treatment of acute mixed-type lower extremity deep vein thrombosis (DVT).Methods:Patients treated with CFVA-CDT and CVA-CDT for acute mixed-type DVT were retrospectively collected from January 2018 to December 2021, totaling 49 and 32 patients, respectively. The relevant technical indicators, thrombolysis rates in the iliac-femoral vein segment and femoral-popliteal vein segment, clinical efficacy, and the incidence of lower extremity deep vein patency, venous valve insufficiency, and post-thrombotic syndrome (PTS), as well as the severity of chronic venous disease in the affected limb (VCSS score) during a 2-year follow-up period were retrospectively compared between the two venous access CDT groups. The t-test was used for comparing quantitative data, while the chi-square test or Fisher′s exact test was used for categorical data.Results:During CFVA-CDT procedure, 6-8 F vascular sheaths were used, and balloon dilation of 2~6 mm was more frequently employed (65.31%, 32/49) to expand venous stenosis/occlusion segments before successful sheath placement compared to the CVA-CDT group (37.50%, 12/32), and the difference was statistically significant ( P=0.014). In the CVA-CDT group, 31.25% (10/32) of patients had a maximum sheath size of 6 F, while the remainder used 4 or 5 F sheaths. Among them, 34.38% (11/32) of patients required re-puncture of the popliteal or femoral vein for larger sheaths (≥8 F) for thrombus aspiration and subsequent endovascular treatment during or after thrombolysis. The effective thrombolysis rates (≥50%) in the iliac-femoral vein segment were not significantly different between the two groups ( P=0.778). The effective thrombolysis rate of the femoral-popliteal venous segment is related to the presence or absence of popliteal vein opacification on lower extremity venous antegrade venography. There was no significant difference between the groups when the popliteal vein was visualized ( P=1.000). While the popliteal vein was not visualized, the CVA-CDT group (75.0%, 15/20) was significantly better than the CFVA-CDT group (34.38%, 11/32), and the difference was statistically significant ( P=0.004). There was no significant difference in clinical efficacy between the two groups ( P=0.819). During follow-up, the femoral-popliteal vein patency rate in the CVA-CDT group (87.50%, 28/32) was significantly higher than in the CFVA-CDT group (44.90%, 22/49), the difference was statistically significant ( P<0.001). Conclusions:Successful CFVA-CDT requires the assistance of more ancillary devices, while the use of larger sheaths is more limited in CVA-CDT due to the smaller caliber of the calf deep veins. The presence or absence of popliteal vein opacification on lower extremity venous antegrade venography may influence the effective thrombolysis of the femoral-popliteal venous segment thrombus in patients with acute mixed deep vein thrombosis (DVT) treated with CFVA-CDT and CVA-CDT. Compared to CFVA-CDT, CVA-CDT can improve the patency rate of the femoral-popliteal venous segment.
7.Multicenter survey on the current status of pediatric life support training
Xin QIAN ; Xiaodi CAI ; Quan WANG ; Meifang LIN ; Qian WANG ; Tingting XUE ; Biru LI ; Quelan HUANG ; Yi WANG ; Yunxia HONG ; Zhixu CHEN ; Guoping LU ; Ye CHENG ; Hongyang HU
Chinese Pediatric Emergency Medicine 2025;32(11):827-831
Objective:To investigate the current status and challenges of pediatric life support training in China and provide references for improving training quality.Methods:A cross-sectional study was conducted to collect data from pediatric life support training centers across the country,covering basic institutional information,training capacity and training faculty,training program funding,as well as existing challenges and issues.The domestic registry of training centers in 2023 was obtained through the American Heart Association's online platform.After contacting and verifying each center,an online questionnaire was distributed,and the aggregated data were statistically analyzed.Results:A total of 42 institutions participated in the survey,including 19 children's hospitals,14 general hospitals,6 maternal and child health hospitals,2 women and children’s hospitals,and 1 training institution.The distribution of training centers showed a concentration in coastal areas,with the top three provinces/municipalities being Guangdong(7/42,16.7%),Zhejiang(6/42,14.3%),and Shanghai(4/42,9.5%).As of December 31 2023,the 42 institutions had an annual basic life support(BLS)training volume of 8 587 individuals,the median was 120 (100,200),and an annual pediatric advanced life support(PALS)training volume of 2 448 individuals,the median was 30 (20,50).Among the 42 institutions,there were 598 BLS instructors and 306 PALS instructors.Among the surveyed institutions,24(24/42,57.1%)reported BLS instructor teams comprising fewer than 10 members,and 33(33/42,78.6%)reported PALS instructor teams comprising fewer than 10.Only 7 centers(7/42,16.7%)reported having dedicated funding support.The top three challenges were:training sessions occupying instructors’personal time(27/42,64.3%),low instructor compensation(16/42,38.1%),and issues with the data submission system(16/42,38.1%).Conclusion:Pediatric life support training centers in China are primarily children’s hospitals,with a geographical concentration in coastal areas,which is also reflected in the distribution of training scale and instructor resources.Most centers have relatively small training scales and limited instructor capacity,with many instructors conducting training during their personal time.These issues may hinder the implementation and effectiveness of training programs.
8.Preliminary establishment of reference intervals for 12 cytokines in adult plasma by multiplex bead-based flow fluorescent immunoassay
Xinyu WANG ; Xing CHENG ; Lu ZHENG ; Yue ZHANG ; Yuting MA ; Guoping NIU ; Feng GU ; Yongqiang CHEN
Chinese Journal of Immunology 2025;41(5):1202-1207
Objective:To establish the reference interval of 12 types of cytokines(IL-1β,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17,IFN-γ,IFN-α,TNF-α)in adult plasma based on multiple microsphere flow immunofluorescence(MBFFI).Methods:A total of 140 healthy adult patients who were examined at Xuzhou Central Hospital between January 2022 and December 2023 were included in the study.Plasma cytokine levels were detected and reference intervals were established by the flow cytometer and the assay kits produced by Qingdao Raisecare Biotechnology Co.,Ltd and Jiangsu BioPredia Biotechnology Co.,Ltd.Results:All of the cytokines exhibited a non-normal distribution,and there was a discrepancy in the 95%reference interval between the two re-agents.The reference intervals for the 12 cytokine kits produced by Qingdao Raisecare Biotechnology Co.,Ltd.were as follows:IFN-α:<4.91 pg/ml,IL-12 p70:<1.95 pg/ml,IL-5:<12.72 pg/ml,IL-8:<60.68 pg/ml,IL-1β:<27.67 pg/ml,IL-2:<5.01 pg/ml,IL-4:<1.22 pg/ml,IL-6:<6.11 pg/ml,TNF-α:<2.92 pg/ml,IL-17:<10.27 pg/ml,IL-10:<6.88 pg/ml,IFN-γ:<17.68 pg/ml.The reference intervals of the 12 cytokines produced by Jiangsu BioPredia Biotechnology Co.,Ltd.were as follows:IFN-α:<4.05 pg/ml,IL-12 p70:<7.33 pg/ml,IL-5:<7.80 pg/ml,IL-8:<13.24 pg/ml,IL-1β:<19.24 pg/ml,IL-2:<2.42 pg/ml,IL-4:<0.99 pg/ml,IL-6:<2.10 pg/ml,TNF-α:<0.87 pg/ml,IL-17:<1.42 pg/ml,IL-10:<1.10 pg/ml,IFN-γ:<1.34 pg/ml.Conclusion:In this study,the ref-erence range of two reagents for the detection of 12 kinds of cytokines in plasma of healthy adults is established by MBFFI,which pro-vides a valuable reference for the diagnosis and treatment of clinical-related diseases.
9.Education and certification model for radiation dosimetrists in the United States: Implications and reference for China
Wenjie WU ; Junliang XU ; Guoping SHAN ; Binbing WANG ; Feng LU ; Xue BAI ; Xiaolong CHENG ; Dannong RUAN ; Jiping LIU
Chinese Journal of Radiological Medicine and Protection 2025;45(1):69-73
Given the escalating number of cancer patients and the consequent rise in demand for radiation therapy in China, there is an urgent need to establish and improve a talent cultivation system for radiation dosimetrists. The United States, with an early-established cultivation system for radiation dosimetrists, boasts relatively mature and comprehensive systems of academic education and qualification certification. This study summarized and analyzed the educational and certification patterns for radiation dosimetrists in the United States based on public data from relevant institutions, related literature, and interviews with American radiation dosimetrists. Meanwhile, this study delved into and assessed the shortcomings in China′s radiation dosimetry education, examination, certification, and career advancement pathways. Furthermore, this study offered suggestions and recommendations for constructing a novel pattern tailored to the cultivation of radiation dosimetrists in China, in order to facilitate the high-quality development of the medical dosimetry discipline.
10.Research advances in the role of gut microbiota in radiotherapy sensitivity and radiation-induced injury
Xu CHENG ; Moli CHEN ; Guoping ZHAO ; Hongzhi WANG
Chinese Journal of Radiological Medicine and Protection 2025;45(3):243-248
Radiotherapy remains one of the primary therapeutic modalities for various cancers. However, individual heterogeneity exists in treatment outcomes and adverse reactions. In recent years, the interaction between the gut microbiota and radiotherapy has garnered increasing attention. The gut microbiota plays a crucial role in modulating host immune responses, maintaining intestinal barrier integrity, and participating in metabolic processes, thereby influencing both the efficacy and tolerance of radiotherapy. Modulating gut microbiota composition through probiotics, antibiotics, or dietary interventions may reduce the toxic side effects induced by radiotherapy, thereby enhancing therapeutic outcomes. Despite numerous challenges in mechanistic studies and clinical application, current research has shed light on cancer therapies. This review emphasizes the significant role of gut microbiota in radiotherapy, impacting treatment outcomes and patients’ tolerance and quality of life. Future research should further explore the links between microbiota regulation and optimization of radiotherapy outcomes, with the prospect of translating these strategies into clinical practice to provide more personalized treatment options for patients.

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