1.Key Points for Quality Management in Phase Ⅰ Clinical Trials of Anti-Tumor Drugs
Li GONG ; Bin LIAO ; Jie SHEN ; Juan ZHAO ; Yi GONG ; Xiaoxiao LU ; Huiyao YANG ; Sha LI ; Yongsheng LI
Cancer Research on Prevention and Treatment 2025;52(5):347-354
		                        		
		                        			
		                        			Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.
		                        		
		                        		
		                        		
		                        	
2.Problems and Reflections on Salary System of Public Hospitals in China from the Policy Perspective
Cui LIAO ; Gelin ZHENG ; Yongsheng YANG
Chinese Health Economics 2024;43(9):18-22
		                        		
		                        			
		                        			Objective:It sorts out the relevant policies of China's public hospital salary system reform,summarizes the short-comings of public hospital salary policy in the process of formulation,and provides references for the subsequent adjustment and opti-mization of salary system.Methods:Based on Policy Modeling Consistency(PMC)index model,public hospital salary policies were collected and preprocessed,high-frequency words were extracted by text mining method,and an evaluation index system of sal-ary policies of public hospitals was constructed.By calculating the score of PMC index and first-level variables,the common prob-lems of various policies are analyzed,and specific suggestions were put forward.Results:The average PMC index of 12 public hos-pital compensation policies was 6.00,the overall quality of the policies was good,but there was still much room for improvement.The main common problems are the lack of internal and external linkage,the neglect of the incentive function of non-economic com-pensation and the unreasonable compensation structure.Conclusion:From the perspective of policy,the reform of public hospital salary system is a systematic project.It is suggested to take holistic thinking as the guide in the follow-up policy making process,en-hance the internal and extemal coordination of the policy,attach importance to the incentive role of non-economic compensation and optimize the salary structure,so as to promote the steady operation of the salary system reform of public hospitals.
		                        		
		                        		
		                        		
		                        	
3.The application effect of sacubitril valsartan in patients with chronic heart failure
Shaochun ZHONG ; Yongsheng LIAO ; Qinglu ZHANG
China Modern Doctor 2024;62(4):77-80
		                        		
		                        			
		                        			Objective To explore the application effect of sacubitril valsartan in patients with chronic heart failure(CHF).Methods A total of 66 CHF patients admitted to Xinyu Yuanhe Hospital from September 2021 to September 2022 were selected and divided into control group and study group according to random number table method,with 33 cases in each group.The control group was treated with benazepril + spironolactone + metoprolol,and the study group was treated with sacubitril valsartan + spironolactone + metoprolol.The clinical efficacy,ventricular remodeling,cardiac function,serum factor levels and adverse reactions were compared between two groups.Results The total effective rate in study group was significantly higher than that in control group(χ2=5.974,P=0.015).After treatment,left ventricular mass index,myocardial wall stress,left ventricular posterior wall thickness,left ventricular ejection fraction,N-terminal pro-brain natriuretic peptide(NT-proBNP),angiotensin Ⅱ and aldosterone in study group were significantly lower than those in control group,and left ventricular remodelling index,stroke volume and left ventricular end-diastolic volume were significantly higher than those in control group(P<0.05).There was no significant difference in adverse reactions between two groups(P>0.05).Conclusion The treatment effect of sacubitril valsartan in CHF patients is significant,which can effectively improve cardiac function indicators,reverse ventricular remodeling,reduce serum NT-proBNP level,and have fewer adverse reactions.
		                        		
		                        		
		                        		
		                        	
4.Problems and Reflections on Salary System of Public Hospitals in China from the Policy Perspective
Cui LIAO ; Gelin ZHENG ; Yongsheng YANG
Chinese Health Economics 2024;43(9):18-22
		                        		
		                        			
		                        			Objective:It sorts out the relevant policies of China's public hospital salary system reform,summarizes the short-comings of public hospital salary policy in the process of formulation,and provides references for the subsequent adjustment and opti-mization of salary system.Methods:Based on Policy Modeling Consistency(PMC)index model,public hospital salary policies were collected and preprocessed,high-frequency words were extracted by text mining method,and an evaluation index system of sal-ary policies of public hospitals was constructed.By calculating the score of PMC index and first-level variables,the common prob-lems of various policies are analyzed,and specific suggestions were put forward.Results:The average PMC index of 12 public hos-pital compensation policies was 6.00,the overall quality of the policies was good,but there was still much room for improvement.The main common problems are the lack of internal and external linkage,the neglect of the incentive function of non-economic com-pensation and the unreasonable compensation structure.Conclusion:From the perspective of policy,the reform of public hospital salary system is a systematic project.It is suggested to take holistic thinking as the guide in the follow-up policy making process,en-hance the internal and extemal coordination of the policy,attach importance to the incentive role of non-economic compensation and optimize the salary structure,so as to promote the steady operation of the salary system reform of public hospitals.
		                        		
		                        		
		                        		
		                        	
5.Problems and Reflections on Salary System of Public Hospitals in China from the Policy Perspective
Cui LIAO ; Gelin ZHENG ; Yongsheng YANG
Chinese Health Economics 2024;43(9):18-22
		                        		
		                        			
		                        			Objective:It sorts out the relevant policies of China's public hospital salary system reform,summarizes the short-comings of public hospital salary policy in the process of formulation,and provides references for the subsequent adjustment and opti-mization of salary system.Methods:Based on Policy Modeling Consistency(PMC)index model,public hospital salary policies were collected and preprocessed,high-frequency words were extracted by text mining method,and an evaluation index system of sal-ary policies of public hospitals was constructed.By calculating the score of PMC index and first-level variables,the common prob-lems of various policies are analyzed,and specific suggestions were put forward.Results:The average PMC index of 12 public hos-pital compensation policies was 6.00,the overall quality of the policies was good,but there was still much room for improvement.The main common problems are the lack of internal and external linkage,the neglect of the incentive function of non-economic com-pensation and the unreasonable compensation structure.Conclusion:From the perspective of policy,the reform of public hospital salary system is a systematic project.It is suggested to take holistic thinking as the guide in the follow-up policy making process,en-hance the internal and extemal coordination of the policy,attach importance to the incentive role of non-economic compensation and optimize the salary structure,so as to promote the steady operation of the salary system reform of public hospitals.
		                        		
		                        		
		                        		
		                        	
6.Problems and Reflections on Salary System of Public Hospitals in China from the Policy Perspective
Cui LIAO ; Gelin ZHENG ; Yongsheng YANG
Chinese Health Economics 2024;43(9):18-22
		                        		
		                        			
		                        			Objective:It sorts out the relevant policies of China's public hospital salary system reform,summarizes the short-comings of public hospital salary policy in the process of formulation,and provides references for the subsequent adjustment and opti-mization of salary system.Methods:Based on Policy Modeling Consistency(PMC)index model,public hospital salary policies were collected and preprocessed,high-frequency words were extracted by text mining method,and an evaluation index system of sal-ary policies of public hospitals was constructed.By calculating the score of PMC index and first-level variables,the common prob-lems of various policies are analyzed,and specific suggestions were put forward.Results:The average PMC index of 12 public hos-pital compensation policies was 6.00,the overall quality of the policies was good,but there was still much room for improvement.The main common problems are the lack of internal and external linkage,the neglect of the incentive function of non-economic com-pensation and the unreasonable compensation structure.Conclusion:From the perspective of policy,the reform of public hospital salary system is a systematic project.It is suggested to take holistic thinking as the guide in the follow-up policy making process,en-hance the internal and extemal coordination of the policy,attach importance to the incentive role of non-economic compensation and optimize the salary structure,so as to promote the steady operation of the salary system reform of public hospitals.
		                        		
		                        		
		                        		
		                        	
7.Problems and Reflections on Salary System of Public Hospitals in China from the Policy Perspective
Cui LIAO ; Gelin ZHENG ; Yongsheng YANG
Chinese Health Economics 2024;43(9):18-22
		                        		
		                        			
		                        			Objective:It sorts out the relevant policies of China's public hospital salary system reform,summarizes the short-comings of public hospital salary policy in the process of formulation,and provides references for the subsequent adjustment and opti-mization of salary system.Methods:Based on Policy Modeling Consistency(PMC)index model,public hospital salary policies were collected and preprocessed,high-frequency words were extracted by text mining method,and an evaluation index system of sal-ary policies of public hospitals was constructed.By calculating the score of PMC index and first-level variables,the common prob-lems of various policies are analyzed,and specific suggestions were put forward.Results:The average PMC index of 12 public hos-pital compensation policies was 6.00,the overall quality of the policies was good,but there was still much room for improvement.The main common problems are the lack of internal and external linkage,the neglect of the incentive function of non-economic com-pensation and the unreasonable compensation structure.Conclusion:From the perspective of policy,the reform of public hospital salary system is a systematic project.It is suggested to take holistic thinking as the guide in the follow-up policy making process,en-hance the internal and extemal coordination of the policy,attach importance to the incentive role of non-economic compensation and optimize the salary structure,so as to promote the steady operation of the salary system reform of public hospitals.
		                        		
		                        		
		                        		
		                        	
8.Problems and Reflections on Salary System of Public Hospitals in China from the Policy Perspective
Cui LIAO ; Gelin ZHENG ; Yongsheng YANG
Chinese Health Economics 2024;43(9):18-22
		                        		
		                        			
		                        			Objective:It sorts out the relevant policies of China's public hospital salary system reform,summarizes the short-comings of public hospital salary policy in the process of formulation,and provides references for the subsequent adjustment and opti-mization of salary system.Methods:Based on Policy Modeling Consistency(PMC)index model,public hospital salary policies were collected and preprocessed,high-frequency words were extracted by text mining method,and an evaluation index system of sal-ary policies of public hospitals was constructed.By calculating the score of PMC index and first-level variables,the common prob-lems of various policies are analyzed,and specific suggestions were put forward.Results:The average PMC index of 12 public hos-pital compensation policies was 6.00,the overall quality of the policies was good,but there was still much room for improvement.The main common problems are the lack of internal and external linkage,the neglect of the incentive function of non-economic com-pensation and the unreasonable compensation structure.Conclusion:From the perspective of policy,the reform of public hospital salary system is a systematic project.It is suggested to take holistic thinking as the guide in the follow-up policy making process,en-hance the internal and extemal coordination of the policy,attach importance to the incentive role of non-economic compensation and optimize the salary structure,so as to promote the steady operation of the salary system reform of public hospitals.
		                        		
		                        		
		                        		
		                        	
9.Problems and Reflections on Salary System of Public Hospitals in China from the Policy Perspective
Cui LIAO ; Gelin ZHENG ; Yongsheng YANG
Chinese Health Economics 2024;43(9):18-22
		                        		
		                        			
		                        			Objective:It sorts out the relevant policies of China's public hospital salary system reform,summarizes the short-comings of public hospital salary policy in the process of formulation,and provides references for the subsequent adjustment and opti-mization of salary system.Methods:Based on Policy Modeling Consistency(PMC)index model,public hospital salary policies were collected and preprocessed,high-frequency words were extracted by text mining method,and an evaluation index system of sal-ary policies of public hospitals was constructed.By calculating the score of PMC index and first-level variables,the common prob-lems of various policies are analyzed,and specific suggestions were put forward.Results:The average PMC index of 12 public hos-pital compensation policies was 6.00,the overall quality of the policies was good,but there was still much room for improvement.The main common problems are the lack of internal and external linkage,the neglect of the incentive function of non-economic com-pensation and the unreasonable compensation structure.Conclusion:From the perspective of policy,the reform of public hospital salary system is a systematic project.It is suggested to take holistic thinking as the guide in the follow-up policy making process,en-hance the internal and extemal coordination of the policy,attach importance to the incentive role of non-economic compensation and optimize the salary structure,so as to promote the steady operation of the salary system reform of public hospitals.
		                        		
		                        		
		                        		
		                        	
10.The Influence of Double-Headed Screws on Stability of Multi-Rod Structures in Posterior Three-Column Spinal Osteotomy
Yunqian LIAO ; Yu ZHOU ; Zhenglun WANG ; Yongsheng LIU ; Wei LI
Journal of Medical Biomechanics 2024;39(3):407-412
		                        		
		                        			
		                        			Objective To compare the stability of multi-rod structures with double-headed screws and traditional connectors in posterior three-column osteotomy of the spine using finite element analysis.Methods A finite element model of the T3-L4 thoracolumbar spine was constructed based on postoperative computed tomography(CT)data of patients with severe kyphosis.Based on the patient's standard two-rod model(2R),a double-headed screw multi-rod structure model(4R-DHS)and a traditional connector multi-rod structure model(4R-TC)were constructed.The two models were evaluated under 300 N follower load and 7.5 N-m moment load,and the stability,maximum von Mises stresses on the main rods,and stress distributions of the two multi-rod structures were analyzed.Results There was little difference in the stability between the two multi-rod structures.Compared with 4R-TC,4R-DHS showed a decrease in the maximum von Mises stresses on the main rods during all motions(the stress decreased by 7.2%,8.8%,8.7%,18.5%,and 16.9%during flexion,left lateral bending,right lateral bending,left axial rotation,and right axial rotation,respectively)and more uniform stress distribution,except for a slight increase in the maximum von Mises stresses on the main rods during post-extension.Conclusions The double-headed screw multi-rod structure can reduce the maximum stress on the main rod compared with the traditional connector multi-rod structure,and there is no problem with stress concentration on the main rod near the connector,which can more effectively reduce the risk of internal fixation failure.
		                        		
		                        		
		                        		
		                        	
            
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