1.Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products
Mengxia ZHAO ; Lina SUN ; Dan XU ; Wen CHAI ; Xuekong JIANG ; Zhihai MAO ; Shengliang HE
China Pharmacy 2024;35(7):783-786
		                        		
		                        			
		                        			In July 2023, the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products (hereinafter referred to as the Measures). This article interprets the main content of the Measures, and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter, and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time, and build a national drug standard data-sharing platform based on the basic framework of user interface layer, computing processing layer, and data storage layer. Digital drug standards will be free, and access and download services for the public will be provided.
		                        		
		                        		
		                        		
		                        	
2.The influence of specialized nurses′ assistance mode on the maintenance ability of PICC catheter in nursing hospital from the perspective of combination of medical care and nursing care
Dan LI ; Chunyan CHAI ; Xuefang YANG ; Min WANG ; Jing GUO ; Bin GU
Chinese Journal of Practical Nursing 2024;40(2):142-148
		                        		
		                        			
		                        			Objective:To evaluate the effect of nursing specialist nurses′ assistance on the ability of nursing home nurses to maintain venous catheter under the vision of combination of medical care and nursing care, providing reference for carrying out specialized nursing assistance work in grassroots hospitals.Methods:This study was an experimental study. According to Miller′s pyramid theory, a model of specialist nurse assistance was established with specialized technology as the core. From January to December 2021, three nursing hospitals in Suzhou were assisted. Convenience sampling method was used to investigate the ability of intravenous catheter maintenance, the incidence of central venous catheter maintenance defects, the incidence of central venous catheter complications and unplanned extubation, and the satisfaction of doctors and patients before and after help.Results:Totally 86 nurses were included, aged (33.17 ± 2.31) years old. After the help, the theoretical and operational skill scores of nurses in the nursing home were (89.77 ± 2.11) and (92.75 ± 1.62) points, respectively, which were significantly higher than those before the help (60.84 ± 2.71) and (79.81 ± 1.68) points, and the differences were statistically significant ( t=-84.96, -52.12, both P<0.05). Among the maintenance defects of central venous catheter in nursing homes, incomplete labeling, film wrapping, blood seepage, catheter discounting, non-standard film fixing, and incomplete information of extended care were 9.95% (21/211), 8.53% (18/211), 2.84% (6/211), 6.16% (13/211), 4.74% (10/211), 2.37% (5/211) after help, all lower than 50.57% (89/176), 43.18% (76/176), 14.20% (25/176), 25.57% (45/176), 18.18% (32/176), 11.93% (21/176) before help. The differences were statistically significant ( χ2 values were 14.00 to 77.81, all P<0.05). The incidence of medical adhesive related skin injury, catheter obstruction complications and unplanned extubation were 4.44% (4/90), 3.33% (3/90) and 2.22% (2/90), respectively, which were lower than 20.51% (16/78), 15.38% (12/78) and 11.54% (9/78) before help. The differences were statistically significant ( χ2=8.81, 6.06, 4.50, all P<0.05). Doctors′ satisfaction with nurses and patients′ satisfaction with nursing work were 96.43%(27/28) and 93.75%(45/48), respectively, both higher than 71.43%(20/28) and 72.73%(32/44) before help, and the differences were statistically significant respectively ( χ2=4.77, 5.97, both P<0.05). Conclusions:From the perspective of combination of medical care and nursing care, the maintenance and assistance of intravenous catheters by the team of intravenous therapy nurses in nursing hospitals can effectively reduce the incidence of central venous catheter complications and unplanned extubation, improve the maintenance ability of intravenous catheters of nurses in nursing hospitals, and help to improve the quality of nursing care in nursing hospitals.
		                        		
		                        		
		                        		
		                        	
3.Application value of intravoxel incoherent motion and dynamic contrast-enhanced MRI in prognostic staging evaluation of early-stage rectal adenocarcinoma
Yaxin CHAI ; Yongchao NIU ; Dan SONG
Journal of Practical Radiology 2024;40(8):1291-1295
		                        		
		                        			
		                        			Objective To explore the application value and diagnostic efficiency of dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI)and intravoxel incoherent motion(IVIM)in prognostic staging of early-stage rectal adenocarcinoma.Methods Eighty-one patients with early-stage rectal adenocarcinoma confirmed by surgery were retrospectively selected.They were examined by high-resolution MRI,IVIM and DCE-DWI before operation.According to prognostic staging criteria,they were divided into stageⅠ and stage Ⅱ A groups.The quantitative parameters of DCE-MRI and IVIM were obtained by GenIQ or MITK software respectively.The differences of parameter values between the two groups were compared by independent sample t-test or Mann-Whitney U test,and the diagnostic efficiency was analyzed.Results The values of rate constant(Kep),volume transfer constant(Ktrans)and pseudo diffusion coefficient(D*)in stage Ⅰ group were lower than stage Ⅱ A group(P<0.05).The f value in stage Ⅰ group was higher than stage Ⅱ A group(P<0.05).D*and Kep values were included in the binary logistic regression equation.The receiver operating characteristic(ROC)curves of D*,Kep values and their joint prediction probability values were obtained,and the area under the curve(AUC)were 0.791,0.770 and 0.852 respectively.The sensitivities were 90.91%,66.67%and 81.82%respectively.The specificities were 66.67%,83.33%and 79.17%respectively.Conclusion D*and Kep values have the potential to be imaging indicators of prognostic staging of early-stage rectal adenocarcinoma,and to guide the selection of clinical treatment schemes.
		                        		
		                        		
		                        		
		                        	
4.The Value of REG3α,sST2,and TNFR1 in Risk Stratification and Prognostic Evaluation of Acute Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation in Children
Yu-Jie CHAI ; Na-Dan LU ; Ping LI ; Shu-Fang SU ; Hui-Xia WEI ; Yan XU ; Dao WANG
Journal of Experimental Hematology 2024;32(5):1566-1570
		                        		
		                        			
		                        			Objective:To explore the value of REG3α,sST2 and TNFR1 in peripheral blood for risk stratification and prognostic evaluation of acute graft-versus-host disease(aGVHD)after allogeneic hematopoietic stem cell transplantation(allo-HSCT)in children.Methods:From January 2020 to March 2022,70 children with aGVHD after allo-HSCT in the First Affiliated Hospital of Zhengzhou University were selected as the research objects,of which 50 cases were mild aGVHD(grade Ⅰ-Ⅱ)and 20 cases were severe aGVHD(grade Ⅲ-Ⅳ).30 healthy children who underwent physical examinations in our hospital during the same period were selected as the control group.Luminex platform was used to detect the protein expression levels of REG3α,sST2 and TNFR1 during aGVHD occurrence,and the differences between the three groups were analyzed by one-way ANOVA.According to the outcome of aGVHD treatment within 28 days,the patients were divided into a good prognosis group of 58 cases and a poor prognosis group of 12 cases.The ROC curve was used to analyze the value of REG3α,sST2 and TNFR1 in predicting the prognosis of children with aGVHD.Results:The peripheral blood levels of REG3α,sST2 and TNFR1 in the mild aGVHD and severe aGVHD groups were significantly higher than those in the control group(P<0.05),and those in the severe aGVHD group were significantly higher than those in the mild aGVHD group(P<0.05).Compared with the good prognosis group,the peripheral blood levels of REG3α,sST2 and TNFR1 in the poor prognosis group were significantly higher(t=9.27,3.33,2.97;P<0.01).ROC curve analysis showed that the area under the curve(AUC),sensitivity and specificity of the combined detection of REG3α,sST2 and TNFR1 in predicting the prognosis of children with aGVHD were higher than those of the above indicators detected alone or in pairs.Conclusion:The expression levels of REG3α,sST2 and TNFR1 were related to the severity of aGVHD.The combination of REG3α,sST2 and TNFR1 has a high clinical value in predicting the prognosis of children with aGVHD,which is expected to provide a reliable reference for clinical evaluation of the prognosis of children with aGVHD.
		                        		
		                        		
		                        		
		                        	
5.Characteristics of early cognitive development in children with Williams syndrome:a prospective cohort study
Dan YAO ; Fang-Fang LI ; Ji-Yang SHEN ; Wei-Jun CHEN ; Chai JI
Chinese Journal of Contemporary Pediatrics 2024;26(10):1053-1057
		                        		
		                        			
		                        			Objective To investigate the early cognitive development characteristics of children with Williams syndrome(WS)at different age stages.Methods From September 2018 to June 2023,106 children diagnosed with WS at the Department of Pediatric Health Care,Children's Hospital,Zhejiang University School of Medicine,aged 1 to<5 years,were prospectively enrolled.All children underwent Gesell developmental diagnostic assessments to analyze the cognitive development characteristics of WS children across different age groups.Results The average age of the 106 WS children was(3.1±1.2)years;58 were male,and 48 were female.There were no significant differences in developmental levels between males and females in the five domains of gross motor skills,fine motor skills,language,personal-social skills,and adaptive behavior(P>0.05).The incidence rates of mild,moderate,severe,and profound developmental disabilities among children of different age groups showed no significant differences(P>0.05).Comparisons of developmental levels in gross motor skills,language,personal-social skills,and adaptive behavior among different age groups were also not statistically significant(P>0.05).With the increase of age,the developmental level of fine motor skills showed a decreasing trend(P<0.05).There were no significant differences in verbal IQ and non-verbal IQ within each age group of WS children(P>0.05).Conclusions The overall developmental level of WS children stabilizes with age,and their early language abilities do not significantly exceed their non-verbal abilities.
		                        		
		                        		
		                        		
		                        	
6.Mechanism of ginsenoside Rg1 inhibiting the proliferation and metastasis of tongue squamous cell carcinoma
Xue LI ; Sha-Fei ZHAI ; Xin-Yang MA ; Dan-Yang WANG ; Juan CHAI ; Fang ZHOU ; Jia ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(13):1888-1892
		                        		
		                        			
		                        			Objective To investigate the inhibitory effect of Ginsenosides Rg1(GS-Rg1)on the proliferation and metastasis of tongue squamous cell carcinoma(TSCC),and its related mechanisms of action.Methods TSCC cells were treated with GS-Rg1 at concentrations of 1.25,2.5,5.0 and 10.0 μmol·L-1 for 48 hours.The proliferation ability of cells at different concentrations was measured by cell counting kit-8(CCK-8)experiment,and the IC5ovalue of GS-Rg1 at CAL-27 for 48 hours was calculated.TSCC cells CAL-27 were divided into control group and GS-Rg1 group.The control group and GS-Rg1 group were treated with 0.9%NaCl and IC50concentration of GS-Rg1 for 48 hours,respectively.The cell cycle distribution of each group was detected by flow cytometry,and the cell metastasis ability of each group was detected by Transwell experiment.Construct TOP/FOP Flash plasmid,transfect control group and GS-Rg1 group,and detect the effect of GS-Rg1 effect on wnt/β-catenin signaling pathway activity in TSCC cell CAL-27 using luciferase assay.Using wnt/β-catenin pathway inhibitor XAV939 treated GS-Rg1 group cells(XAV939+GS-Rg1 group),and wnt/β-catenin pathway activator HLY78 was used to treat GS-Rg1 group cells(HLY78+GS-Rg1 group)and detect changes of wnt/β-catenin signaling pathway activity,the cell proliferation ability,cell cycle distribution,and metastasis ability in XAV939+GS-Rg1 group,HLY78+GS-Rg1 group and GS-Rg1 group.The expression of wnt/β-catenin signaling pathway related proteins β-catenin,and its downstream cell cycle related proteins cellular myelocytomatosis oncogene(cMYC),Cyclin dependent kinase 4(CDK4),andcyclinD1,as well as metastasis related proteins E-cadherin,N-cadherin and matrix metalloproteinase 2(MMP-2)were detected by Western blotting in each group of cells.Results GS-Rg1 significantly inhibited the proliferation ability of TSCC cells CAL-27(P<0.05),and the IC50value of GS-Rg1 on CAL-27 was(5.46±1.58)μmol·L-1.The ratio of GO/G1 phase cells in the control group and GS-Rg1 group were(60.65±2.16)%and(71.20±2.38)%,respectively;the number of cell transmembrane penetration were 87.33±7.51 and 50.67±3.21,respectively;the luciferase activity were 1.00±0.02 and 0.35±0.06,respectively.Compared with the control group,the GS-Rg1 group showed cell cycle arrest in GO/G1 phase,decreased cell metastasis ability,and the activity of wnt/β-catenin signaling pathway decreased(P<0.05,P<0.01).Compared with the GS-Rg1 group,the activity of the wnt/β-catenin signaling pathway was decreased,cell proliferation ability and metastasis ability was decreased(P<0.05),while the number of GO/G1 phase cells was increased(P<0.05),the expression of β-catenin,cMYC,CDK4,cyclinD1,E-cadherin and MMP-2 proteins were decreased(P<0.05),while the expression of N-cadherin protein increased in XAV939+GS-Rg1 group cells.However,the result were opposite in the HLY78+GS-Rg1 group of cells.Conclusion GS-Rg1 downregulates wnt/β-catenin signaling pathway inhibits the proliferation and metastasis ability of TSCC cells.
		                        		
		                        		
		                        		
		                        	
7.Expert consensus on late stage of critical care management.
Bo TANG ; Wen Jin CHEN ; Li Dan JIANG ; Shi Hong ZHU ; Bin SONG ; Yan Gong CHAO ; Tian Jiao SONG ; Wei HE ; Yang LIU ; Hong Min ZHANG ; Wen Zhao CHAI ; Man hong YIN ; Ran ZHU ; Li Xia LIU ; Jun WU ; Xin DING ; Xiu Ling SHANG ; Jun DUAN ; Qiang Hong XU ; Heng ZHANG ; Xiao Meng WANG ; Qi Bing HUANG ; Rui Chen GONG ; Zun Zhu LI ; Mei Shan LU ; Xiao Ting WANG
Chinese Journal of Internal Medicine 2023;62(5):480-493
		                        		
		                        			
		                        			We wished to establish an expert consensus on late stage of critical care (CC) management. The panel comprised 13 experts in CC medicine. Each statement was assessed based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) principle. Then, the Delphi method was adopted by 17 experts to reassess the following 28 statements. (1) ESCAPE has evolved from a strategy of delirium management to a strategy of late stage of CC management. (2) The new version of ESCAPE is a strategy for optimizing treatment and comprehensive care of critically ill patients (CIPs) after the rescue period, including early mobilization, early rehabilitation, nutritional support, sleep management, mental assessment, cognitive-function training, emotional support, and optimizing sedation and analgesia. (3) Disease assessment to determine the starting point of early mobilization, early rehabilitation, and early enteral nutrition. (4) Early mobilization has synergistic effects upon the recovery of organ function. (5) Early functional exercise and rehabilitation are important means to promote CIP recovery, and gives them a sense of future prospects. (6) Timely start of enteral nutrition is conducive to early mobilization and early rehabilitation. (7) The spontaneous breathing test should be started as soon as possible, and a weaning plan should be selected step-by-step. (8) The waking process of CIPs should be realized in a planned and purposeful way. (9) Establishment of a sleep-wake rhythm is the key to sleep management in post-CC management. (10) The spontaneous awakening trial, spontaneous breathing trial, and sleep management should be carried out together. (11) The depth of sedation should be adjusted dynamically in the late stage of CC period. (12) Standardized sedation assessment is the premise of rational sedation. (13) Appropriate sedative drugs should be selected according to the objectives of sedation and drug characteristics. (14) A goal-directed minimization strategy for sedation should be implemented. (15) The principle of analgesia must be mastered first. (16) Subjective assessment is preferred for analgesia assessment. (17) Opioid-based analgesic strategies should be selected step-by-step according to the characteristics of different drugs. (18) There must be rational use of non-opioid analgesics and non-drug-based analgesic measures. (19) Pay attention to evaluation of the psychological status of CIPs. (20) Cognitive function in CIPs cannot be ignored. (21) Delirium management should be based on non-drug-based measures and rational use of drugs. (22) Reset treatment can be considered for severe delirium. (23) Psychological assessment should be conducted as early as possible to screen-out high-risk groups with post-traumatic stress disorder. (24) Emotional support, flexible visiting, and environment management are important components of humanistic management in the intensive care unit (ICU). (25) Emotional support from medical teams and families should be promoted through"ICU diaries"and other forms. (26) Environmental management should be carried out by enriching environmental content, limiting environmental interference, and optimizing the environmental atmosphere. (27) Reasonable promotion of flexible visitation should be done on the basis of prevention of nosocomial infection. (28) ESCAPE is an excellent project for late stage of CC management.
		                        		
		                        		
		                        		
		                        			Humans
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		                        			Consensus
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		                        			Critical Care/methods*
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		                        			Intensive Care Units
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		                        			Pain/drug therapy*
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		                        			Analgesics/therapeutic use*
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		                        			Delirium/therapy*
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		                        			Critical Illness
		                        			
		                        		
		                        	
8.A concise review of diagnosis and evaluation of interstitial lung abnormalities.
Chinese Journal of Industrial Hygiene and Occupational Diseases 2023;41(5):396-400
		                        		
		                        			
		                        			Interstitial lung abnormalities (ILAs) refer to the subtle or mild signs of ILAs pulmonary parenchyma on chest HRCT scans, which are not yet sufficient to diagnose a certain interstitial lung disease, may be potentially compatible an early stage of the diseases. The signs of ILAs usually includes ground-glass opacities, reticular abnormakicies, honeycombing, traction bronchiectasis or non-emphysematous cysts. This article reviews the research progreses in the definition and classification, risk factors, prognosis, comorbidities and management of ILAs in combination with domestic and foreign literatures.
		                        		
		                        		
		                        		
		                        			Humans
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		                        			Lung/diagnostic imaging*
		                        			;
		                        		
		                        			Tomography, X-Ray Computed
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		                        			Lung Diseases, Interstitial/diagnosis*
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		                        			Prognosis
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		                        			Diagnosis, Differential
		                        			
		                        		
		                        	
9.Exploration and thinking of standardized residency training education for the residents in the intensive care unit of neurosurgery department
Weina CHAI ; Dan XU ; Xiaochuan SUN
Chinese Journal of Medical Education Research 2023;22(7):1038-1041
		                        		
		                        			
		                        			Critical neurosurgery is one of the difficulties and key points in the standardized residency training of neurosurgery. Through the systematic and standardized training of the residents of the Intensive Care Unit of Neurosurgery Department in The First Affiliated Hospital of Chongqing Medical University, consisting of first aid skills training, multi-modal case analysis with complementary theory and practice, expansion of neuroimaging and electrophysiological knowledge, specialized knowledge training in surgical operation and perioperative management, and regular case discussion, their clinical thinking becomes more mature, the time to master the management methods of neurosurgical intensive care patients is significantly shortened, the initiative to participate in clinical practice is also significantly increased, and the perioperative management methods of neurosurgical patients are more deeply understood. These trainings have effectively improved the teaching effect of neurosurgery intensive care unit.
		                        		
		                        		
		                        		
		                        	
10.Diagnosis model of the white matter injury of premature infants based on ultrasonography radiomics
Ting ZHU ; Wei JIANG ; Shuang ZHANG ; Dan CHAI ; Jiaoyu MAO ; Zhen LEI ; Yuya WEI
Chinese Journal of Ultrasonography 2023;32(4):324-331
		                        		
		                        			
		                        			Objective:To investigate the value of the ultrasonography in the diagnosis of the white matter injury of premature infants based on gray-scale ultrasonography radiomics.Methods:A total of 256 premature infants in Huazhong University of Science and Technology Union Shenzhen Hospital and Shenzhen Hospital of Southern Medical University from August 2018 to April 2022 were analyzed retrospectively. The computer-generated random numbers were assigned to the training set and the verification set according to 6∶4 ratio. On the basis of standardized collection of craniocerebral ultrasound images, the radiomics features were extracted from imaging by Pyradiomics 3.0.1 software package, the Mann-Whitney U test and the least absolute shrinkage and selection operator (LASSO) and stepwise regression were used to select the optimal features. Then the Logistic regression was used to build radiomics model. According to MRI, ROC curve was utilized to evaluate the performance of the model. The craniocerebral ultrasound images in the validation set were independently diagnosed by a senior physician and a junior physician, and then the above two physicians diagnosed again with the help of the radiomics, and the diagnostic abilities of this model were compared with those of the junior and senior physicians with and without radiomics assist. Results:A total of 5 optimal features were selected to develop radiomics model. The sensitivity, specificity, accuracy and the area under the ROC curve (AUC) in the training and validation sets were 0.861, 0.775, 0.799, 0.818; 0.929, 0.824, 0.853, 0.876, respectively. The sensitivity, specificity, accuracy and AUC in the senior sonographer, the junior sonographer, and both of them with radiomics assist for the dagnosis in the validation set were 0.929, 0.892, 0.902, 0.910; 0.714, 0.743, 0.735, 0.729; 0.929, 0.919, 0.922, 0.924; 0.857, 0.824, 0.833, 0.841, respectively. Performance of radiomics model reached the level of the senior sonographer (AUC: 0.876 vs 0.910, P=0.284), which was significantly better than the performance of the junior sonographer(AUC: 0.876 vs 0.729, P=0.001). Performance of the junior sonographer with radiomics assist was significantly better than the performance of the junior sonographer(AUC: 0.841 vs 0.729, P=0.003). Performance of the senior sonographer with radiomics assist was comparable to that of the senior sonographer(AUC: 0.924 vs 0.910, P=0.156). Conclusions:The ultrasound diagnosis method based on radiomics technology shows good diagnostic performance for the white matter injury of premature infants. It is helpful to improve the diagnostic ability of junior sonographer. It is expected to assist the sonographers in diagnosis and provide objective, consistent and accurate results for clinical practice.
		                        		
		                        		
		                        		
		                        	
            
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