1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
		                        		
		                        			
		                        			OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
		                        		
		                        		
		                        		
		                        	
2.Collection, storage and utilization of lung transplant tissue samples
Yixing LI ; Xue SHI ; Hongyi WANG ; Runyi TAO ; Ye SUN ; Ailing SU ; Liyan TONG ; Jinteng FENG ; Yanpeng ZHANG ; Shuo LI ; Yawen WANG ; Guangjian ZHANG
Organ Transplantation 2025;16(1):147-155
		                        		
		                        			
		                        			After continuous development and improvement, lung transplantation has become the preferred means to treat a variety of benign end-stage lung diseases. However, the field of lung transplantation still faces many challenges, including shortage of donor resources, preservation and maintenance of donor lungs, and postoperative complications. Lung tissue samples removed after lung transplantation are excellent clinical resources for the study of benign end-stage lung disease and perioperative complications of lung transplantation. However, at present, the collection, storage and utilization of tissue samples after lung transplantation are limited to a single study, and unified technical specifications have not been formed. Based on the construction plan of the biobank for lung transplantation in the First Affiliated Hospital of Xi'an Jiaotong University, this study reviewed the practical experience in the collection, storage and utilization of lung transplant tissue samples in the aspects of ethical review, staffing, collection process, storage method, quality control and efficient utilization, in order to provide references for lung transplant related research.
		                        		
		                        		
		                        		
		                        	
3.Function Positioning and Implementation Path of Internal Control in Public Hospitals from the Perspective of Finan-cial and Accounting Supervision
Hua FU ; Xiaozhe DAI ; Daxi ZHENG ; Yi WANG ; Dengjiao DONG ; Liyan WANG ; Changrong ZHOU ; Haifen SUN ; Jinxiu SHI
Chinese Health Economics 2024;43(1):82-85,88
		                        		
		                        			
		                        			With the reform of the medical and health system entering a critical period,public hospitals have also exposed new risks and challenges in economic operation.As an important means of hospital standardized management,internal control can better prevent and resolve the risk of hospital economic operation and ensure the sustainable operation of the hospital.By interpreting the requirements of current national policies on hospital internal control,it analyzes the functional positioning of financial and accounting supervision in hospital internal control,shares the internal control implementation path of sample hospitals from the perspective of financial and accounting supervision,and puts forward suggestions on strengthening internal control construction of public hospitals in the new era,in order to lay a good foundation for the high-quality development of hospitals.
		                        		
		                        		
		                        		
		                        	
4.Humanistic Care for the Prevention of Perioperative Hypothermia in the Elderly
Na LI ; Liyan ZHAO ; Lina WU ; Xiongtao LIU ; Ru GU ; Wei PENG ; Xiali SHI ; Dan LEI ; Jing ZHANG ; Weiling LUO
Chinese Medical Ethics 2024;35(3):350-352
		                        		
		                        			
		                        			The intervention and prevention of perioperative hypothermia is not only reflected in the technical level, but also reveals the important role of humanistic care in the whole intervention work. If perioperative patients have hypothermia, it is likely to cause a series of complications such as postoperative shivering, which seriously threatens the life safety of patients. Prevention and intervention was based on a comprehensive understanding of the causes and hazards of hypothermia, especially the impact on the lives of the elderly. Effective supervision was implemented in the whole process of operation, such as dynamic monitoring of vital signs including body temperature, followed by room temperature regulation, body temperature protection and preoperative and postoperative psychological nursing. At this time, the sense of responsibility, good humanistic care of medical staff are of positive significance to effectively prevent and reduce the probability of perioperative hypothermia and accelerate the postoperative rehabilitation of patients.
		                        		
		                        		
		                        		
		                        	
5.Predictive value of new thrombotic risk assessment model for venous thromboembolism in patients with malignant tumors
Honghong LI ; Na YU ; Minghao SHI ; Ying SUN ; Yao LI ; Zhongjun SHEN ; Xiaoyi LIU ; Liyan ZHAO
Journal of Jilin University(Medicine Edition) 2024;50(5):1390-1399
		                        		
		                        			
		                        			Objective:To construct a new thrombus risk assessment model and evaluate its predictive ability for venous thromboembolism(VTE)in the patients with malignant tumors,and to provide the basis for the early predition of the malignant tumor patients with high risk for VTE.Methods:A total of 128 untreated malignant tumor patients were included,of which 40 were diagnosed with VTE within 2 months of malignant tumor diagnosis and categorized as VTE group.A total of 88 patients who did not develop VTE were categorized as non-VTE group.The clinical risk factors and laboratory indicators of the patients in two groups were compared and analyzed;the types of thrombotic events of the patients were analyzed;the diagnostic values of thrombin-antithrombin-complex(TAT),α2-plasmin inhibitor-plasmin complex(PIC),D-dimer(D-dimer),and fibrin degradation products(FDP)in malignant tumors complicated by VTE were assessed using receiver operating characteristic(ROC)curve analysis;Multivariate Logistic regression analysis was used to analyze the correlations of the clinical risk factors and biomarkers with the malignant tumors complicated with VTE.A new thrombus risk assessment model was constructed,consisting of TAT≥0.70 μg·L-1,poor differentiation,and cardiovascular risk factors.The predictive probability of the model for malignant tumors complicated by VTE was evaluated based on the significance,goodness of fit,calibration curve,and C value of the model.The clinical application value of the new thrombus risk assessment model,COMPASS-CAT risk score(CRS),and Khorana risk score(KRS)in assessing malignant tumor patients complicated by VTE was compared using the C value and decision curve analysis(DCA).Results:The plasma levels of TAT(P<0.001),PIC(P<0.001),D-dimer(P<0.05),and FDP(P<0.01)of the patients in VTE group were higher than those in non-VTE group.Compared with the patients without cardiovascular risk factors,poor differentiation,and lymphatic metastasis,the malignant tumor patients with cardiovascular risk factors(P<0.001),poor differentiation(P<0.001),and lymphatic metastasis(P<0.05)were more likely to develop VTE.Most VTE events(65%)were isolated deep vein thromboembolism(DVT).The ROC curve analysis showed that the area under the curve(AUC),sensitivity,and specificity of TAT and PIC were higher than those of D-dimer and FDP.TAT≥0.70 μg·L-1(P<0.05),poor differentiation(P<0.01),and cardiovascular risk factors(P<0.01)were the independent risk factors for VTE in the malignant tumor patients.A new thrombus risk assessment model consisting of TAT≥0.70 μg·L-1,poor differentiation,and cardiovascular risk factors was constructed.The new risk assessment model had a high goodness of fit(P=0.805)and good predictive ability during internal validation(x2=75.266,P<0.001).The ROC curve analysis results showed that the C values for the new thrombus risk prediction model,CRS,and KRS were 0.908,0.676,and 0.541,respectively.The DCA curve analysis results showed that the new thrombus risk assessment model had a higher net benefit rate compared with CRS and KRS.Conclusion:TAT and PIC have greater diagnostic efficiency than D-dimer in the early prediction of the malignant tumor patients with high-risk VTE.For the patients included in this study,the new thrombus risk assessment model,constructed from TAT≥0.70 μg·L-1,poor differentiation,and cardiovascular risk factors,has superior diagnostic efficiency and clinical predictive value compared with CRS and KRS.
		                        		
		                        		
		                        		
		                        	
6.Development and Analysis of the Standard for Drug Use Monitoring and Evaluation
Jingjing ZHANG ; Liyan MIAO ; Jiancun ZHEN ; Jianguo ZHU ; Jun ZHANG ; Luwen SHI ; Ting XU ; Shiting LIU ; Bin WU
Herald of Medicine 2024;43(8):1212-1216
		                        		
		                        			
		                        			Drug use monitoring and evaluation play a key role in promoting drugs to return to clinical value,optimizing the basic medicine system,and improving the drug supply guarantee system.In order to promote the implementation of drug use monitoring and evaluation in medical institutions,the Pharmaceutical Affairs Committee of the Chinese Hospital Association led the efforts of organizing relevant domestic experts to follow the group standard development process.It successfully formulated the group standard of Drug Use Monitoring and Evaluation through the steps of problem sorting,framework construction,evidence collection,draft writing,opinion consultation,and standard formation.This article introduces the standard formulation process in detail,and explains and analyzes the content of the standard,aiming to help readers better understand the connotation of drug use monitoring and evaluation,and provide practical guidance.
		                        		
		                        		
		                        		
		                        	
7.Effectiveness of early warning management of nosocomial infection based on neural network model and decision tree model
Xiaojuan LIU ; Liyan JIAO ; Xiaoxue SHI ; Yuping CHEN
Journal of Public Health and Preventive Medicine 2023;34(5):87-90
		                        		
		                        			
		                        			Objective  To predict the effectiveness of nosocomial infection management and effectively control the risk of nosocomial infection.  Methods  In this study, with the population of ICU patients in a Grade A hospital , 345 ICU patients seen from June 2020 to June 2021 were included in the analysis to collect the infection data in the hospital. Based on the use of the decision tree model to analyze the influencing factors of nosocomial infection, the neural network model was also used to predict the risk of developing nosocomial infection.  Results  The decision tree model showed that advanced age (age> 80 years) influenced the root node. Type 2 diabetes, gender by male, and BMI level were child nodes, which had different synergistic effects on the occurrence of nosocomial infection. At the same time, random forest (RF), support vector machine (SVM), logical regression (LR) and K nearest neighbor (KNN) algorithms were used to construct a neural network prediction model of nosocomial infection risk, suggesting that the condition, sex and body size of basic diseases are related to the occurrence of nosocomial infection. The combined use of the above model in parallel can effectively increase the specificity and reduce the missed diagnosis.  Conclusion  The neural network model joint decision tree model in parallel and joint early warning of nosocomial infection risk have excellent effect, and can effectively provide information support for the prevention, management and disposal of nosocomial infection.
		                        		
		                        		
		                        		
		                        	
8.Establishment of HPLC fingerprints for Ardisia crenata,Sophora tonkinensis and their couplet medicines and content determination of 5 chemical components
Yun CHEN ; Hui SHI ; Tingting FENG ; Liyan ZHANG ; Xiu DONG ; Jinhe ZHANG ; Bei HUANG ; Ying ZHOU
China Pharmacy 2023;34(16):1949-1954
		                        		
		                        			
		                        			OBJECTIVE To establish the fingerprints of Ardisia crenata, Sophora tonkinensis and their couplet medicines, and to determine the contents of five components in them. METHODS Using water as solvent, single lyophilized powder of A. crenata and S. tonkinensis and combined lyophilized powder of their couplet medicines were prepared by combining lyophilization technology. The fingerprints of three lyophilized powder samples were established by using high-performance liquid chromatography (HPLC), and the contents of 5 kinds of components such as gallic acid were determined simultaneously. RESULTS There were 5, 10 and 14 common peaks in the fingerprints for single lyophilized powder of A. crenata and S. tonkinensis and combined lyophilized powder of their couplet medicines; the similarities of them with the control fingerprints were all greater than 0.90. For combined lyophilized powder of couplet medicines, peak 3 Δ 基金项目 国家重点研发计划项目(No.2018YFC1708100);贵 州省科技计划项目(No.黔科合基础-ZK〔2022〕一般483,No.黔科合成 was identified as gallic acid, peak 4 as matrine, peak 6 as 果〔2021〕一般137);贵州省教育厅高等学校科学研究项目(青年项目) oxymatrine, peak 8 as bergenin, and peak 14 as trifolirhizin. In single lyophilized powder of A. crenata, the average contents of gallic acid and bergenin were 0.499 3 and 4.962 6 mg/g, respectively. In single lyophilized powder of S.tonkinensis, the average contents of matrine, oxymatrine and trifolirhizin were 3.046 0, 2.336 6 and 0.278 6 mg/g, respectively. In combined lyophilized powder of couplet medicines, the average contents of gallic acid, matrine, oxymatrine, bergenin and trifolirhizin were 0.560 6, 2.548 7, 1.382 2, 5.960 7 and 0.279 1 mg/g, respectively. The transfer rates were 8.87%-513.19%. CONCLUSIONS The established fingerprint and content determination methods are stable and feasible, and can be used for the quality control of A. crenata and S. tonkinensis and their couplet medicines. The average contents of matrine and oxymatrine in combined lyophilized powder of A. crenata-S. tonkinensis couplet medicines are decreased.
		                        		
		                        		
		                        		
		                        	
9.Expression and Role of Integrin β-like 1 in Hepatocellular Carcinoma
Liyan LIN ; Jianping LU ; Weifeng ZHU ; Shi HE ; Fengying PENG ; Gang CHEN
Cancer Research on Prevention and Treatment 2022;49(12):1232-1239
		                        		
		                        			
		                        			Objective To investigate the expression of ITGBL1 in hepatocellular carcinoma (HCC) and its role in promoting the proliferation, migration, and invasion of HCC cell lines. Methods RT-qPCR and immunohistochemistry were used in investigating ITGBL1 expression in 12 pairs of fresh HCC and adjacent normal liver tissue samples and 160 paraffin HCC specimens. The relationships of ITGBL1 expression level with clinicopathological parameters and prognosis were analyzed. HUH7 cell line with the stable overexpression of ITGBL1 and LM3 cell line with stable downregulated expression of ITGBL1 were constructed. The effects of ITGBL1 on the proliferation, migration, and invasion of HCC cells were examined by CCK8 assay, wound-healing assay, and Transwell invasion assay. Results The expression levels of ITGBL1 gene and protein in tumor tissues were higher than those in surrounding liver tissues. The high expression of ITGBL1 was correlated with serum AFP level, tumor capsular invasion, vascular invasion, tumor differentiation, and clinical stage (
		                        		
		                        	
10.Interpretation for Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China
Zaiwei SONG ; Shuang LIU ; Rongsheng ZHAO ; Suodi ZHAI ; Xianglin ZHANG ; Youping LI ; Guanhua DU ; Yuankai SHI ; Liyan MIAO ; Lingli ZHANG ; Hongmei JING
China Pharmacy 2022;33(16):2032-2039
		                        		
		                        			
		                        			Evidence-based Practice Guideline of Medication Therapy of High-dose Methotrexate in China was published in the British Journal of Clinical Pharmacology in February 2022. The guideline followed the latest definition of clinical practice guideline and the methodology specification for the guideline development of WHO. The Grading of Recommendations Assessment , Development,and Evaluation (GRADE)approach was applied to rate the quality of evidence and determine the strength of recommendations. Finally ,this guideline presents 28 recommendations covering the whole process of clinical medication of high-dose methotrexate ,involving evaluation prior to administration (liver and renal function ,pleural effusion and ascites , comedication,genetic testing ),pre-treatment and routine dosing regimen (pretreatment of hydration and alkalization ,urine alkalization,routine dosing regimen ),therapeutic drug monitoring (necessity,method,timing,target concentration ),leucovorin rescue(rescue timing ,rescue regimen ,rescue dose optimization ),and management of toxicities (liver and kidney function monitoring,supportive treatment ,blood purification treatment ). This article aims to summarize and interpret the recommendations of this guideline ,so as to promote the better promotion and implementation of this guideline and provide comprehensive technical support and suggestions for whole-course individualized administration of high-dose methotrexate in China.
		                        		
		                        		
		                        		
		                        	
            

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