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.Dynamic gait parameters reveal long-term compensatory characteristics in knee joint function recovery following anterior cruciate ligament reconstruction: A retrospective cohort study.
Qitai LIN ; Zehao LI ; Meiming LI ; Yongsheng MA ; Wenming YANG ; Yugang XING ; Yang LIU ; Ruifeng LIANG ; Yixuan ZHANG ; Ruipeng ZHAO ; Wangping DUAN ; Pengcui LI ; Xiaochun WEI
Chinese Medical Journal 2025;138(22):3016-3018
3.Expert consensus on digital restoration of complete dentures.
Yue FENG ; Zhihong FENG ; Jing LI ; Jihua CHEN ; Haiyang YU ; Xinquan JIANG ; Yongsheng ZHOU ; Yumei ZHANG ; Cui HUANG ; Baiping FU ; Yan WANG ; Hui CHENG ; Jianfeng MA ; Qingsong JIANG ; Hongbing LIAO ; Chufan MA ; Weicai LIU ; Guofeng WU ; Sheng YANG ; Zhe WU ; Shizhu BAI ; Ming FANG ; Yan DONG ; Jiang WU ; Lin NIU ; Ling ZHANG ; Fu WANG ; Lina NIU
International Journal of Oral Science 2025;17(1):58-58
Digital technologies have become an integral part of complete denture restoration. With advancement in computer-aided design and computer-aided manufacturing (CAD/CAM), tools such as intraoral scanning, facial scanning, 3D printing, and numerical control machining are reshaping the workflow of complete denture restoration. Unlike conventional methods that rely heavily on clinical experience and manual techniques, digital technologies offer greater precision, predictability, and efficacy. They also streamline the process by reducing the number of patient visits and improving overall comfort. Despite these improvements, the clinical application of digital complete denture restoration still faces challenges that require further standardization. The major issues include appropriate case selection, establishing consistent digital workflows, and evaluating long-term outcomes. To address these challenges and provide clinical guidance for practitioners, this expert consensus outlines the principles, advantages, and limitations of digital complete denture technology. The aim of this review was to offer practical recommendations on indications, clinical procedures and precautions, evaluation metrics, and outcome assessment to support digital restoration of complete denture in clinical practice.
Humans
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Denture, Complete
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Computer-Aided Design
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Denture Design/methods*
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Consensus
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Printing, Three-Dimensional
4.Design and synthesis of novel saponin-triazole derivatives in the regulation of adipogenesis.
Yongsheng FANG ; Zhiyun ZHU ; Chun XIE ; Dazhen XIA ; Huimin ZHAO ; Zihui WANG ; Qian LU ; Caimei ZHANG ; Wenyong XIONG ; Xiaodong YANG
Chinese Journal of Natural Medicines (English Ed.) 2025;23(8):920-931
Saponins associated with Panax notoginseng (P. notoginseng) demonstrate significant therapeutic efficacy across multiple diseases. However, certain high-yield saponins face limited clinical applications due to their reduced pharmacological efficacy. This study synthesized and evaluated 36 saponin-1,2,3-triazole derivatives of ginsenosides Rg1/Rb1 and notoginsenoside R1 for anti-adipogenesis activity in vitro. The research revealed that the ginsenosides Rg1-1,2,3-triazole derivative a17 demonstrates superior adipogenesis inhibitory effects. Structure-activity relationships (SARs) analysis indicates that incorporating an amidyl-substituted 1,2,3-triazole into the saponin side chain via Click reaction enhances anti-adipogenesis activity. Additionally, several other derivatives exhibit general adipogenesis inhibition. Compound a17 demonstrated enhanced potency compared to the parent ginsenoside Rg1. Mechanistic investigations revealed that a17 exhibits dose-dependent inhibition of adipogenesis in vitro, accompanied by decreased expression of preadipocytes. Peroxisome proliferator-activated receptor γ (PPARγ), fatty acid synthase (FAS), and fatty acid binding protein 4 (FABP4) adipogenesis regulators. These findings establish the ginsenoside Rg1-1,2,3-triazole derivative a17 as a promising adipocyte differentiation inhibitor and potential therapeutic agent for obesity and associated metabolic disorders. This research provides a foundation for developing effective therapeutic approaches for various metabolic syndromes.
Adipogenesis/drug effects*
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Triazoles/chemical synthesis*
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Ginsenosides/chemical synthesis*
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Saponins/chemical synthesis*
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Animals
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Mice
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Structure-Activity Relationship
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PPAR gamma/genetics*
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3T3-L1 Cells
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Adipocytes/metabolism*
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Panax notoginseng/chemistry*
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Drug Design
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Molecular Structure
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Humans
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Cell Differentiation/drug effects*
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Fatty Acid-Binding Proteins/genetics*
5.Influencing factors and coping strategies for mental health promotion activities among junior and senior high schools from the perspective of teachers
LIU Xiaoquan, LI Peiyao, WANG Xingyu, YANG Jianing, TONG Yongsheng
Chinese Journal of School Health 2025;46(12):1731-1735
Objective:
To explore the facilitating and hindering factors of mental health promotion activities in junior and senior high schools from teachers perspectives, as well as coping strategies, so as to provide evidence for implementing teacher led mental health promotion programs.
Methods:
From September 2023 to September 2024, by using purposive sampling method, 5 junior high schools, 5 regular high schools, 2 vocational high schools in four provinces and municipalities (Tianjin, Shanxi, Shandong, and Jiangxi) were selected. A total of 92 teachers (78 homeroom teachers and 14 full time or part time psychological counselors) were interviewed using semi structured focus group discussions (one session per school, totaling 12 sessions). Thematic analysis was applied to code and analyze the interview transcripts.
Results:
The implementation of mental health promotion activities in middle schools was influenced by three levels: teachers, schools and society. Specifically, teachers exhibited a high support low capability phenomenon (81 participants supported conducting such activities, but 71 felt lacking in professional capacity); activity effectiveness and support systems were imbalanced (42 mentioned significant effects, while 78 reported insufficient support); there was a mismatch between student demand and activity content (9 mentioned students had psychological needs, but 11 indicated existing activities failed to meet these needs); administrative support and sustainability showed disparities (14 believed sufficient administrative support existed, while 37 noted sustainability issues); parental awareness and participation remained inadequate (11 highlighted parents need for mental health knowledge, and 37 perceived insufficient understanding of psychological issues among parents). Effective strategies included enhancing teachers effectiveness, providing essential skill training, focusing on the needs of teenagers,enhancing program sustainability, and eliminating misconceptions about mental health among parents.
Conclusion
Mental health promotion activities in junior and senior high schools should focus on enhancing teachers skills, improving activity sustainability, reducing stigma among parents, and establishing a collaborative network for school based mental health promotion.
6.Mechanism of Medicated Serum of Buyang Huanwutang in Inhibiting Endothelial-to-mesenchymal Transition of Human Pulmonary Artery Endothelial Cells Based on Wnt1/β-catenin Signaling Pathway
Qifen YANG ; Jinglian QU ; Huiliang ZHAO ; Yongsheng GUO ; Long CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):49-58
ObjectiveTo investigate the role of the Wnt1/β-catenin signaling pathway in the intervention of medicated serum of Buyang Huanwutang (BYHWT) in endothelial-to-mesenchymal transition (EndMT) of human pulmonary artery endothelial cells (HPAECs) as well as its related mechanisms. MethodMedicated serum of BYHWT was prepared by gavage to New Zealand rabbits with a dosage of 53.36 g·kg-1·d-1 after decocting the medicine as usual. In addition, the same volume of normal saline was used to prepare blank serum. The HPAECs were cultured in vitro, and then induced by the transforming growth factor-β1 (TGF-β1) to establish the EndMT model. Five groups were established: blank group (10% blank serum), model group (TGF-β1+10% blank serum), low-dose BYHWT group (TGF-β1+2.5% medicated serum+7.5% blank serum), medium-dose BYHWT group (TGF-β1+5% medicated serum+5% blank serum) and high-dose BYHWT group (TGF-β1+10% medicated serum). Through Western blot, the expressions of Wnt1, β-catenin, and glycogen synthase kinase-3β (GSK-3β) were detected. In order to further clarify the mechanism of the Wnt1/β-catenin signaling pathway in the intervention of the medicated serum of BYHWT in inhibiting EndMT, the overexpression of β-catenin was confirmed by polymerase chain reaction after plasmid of overexpression β-catenin was constructed and transfected into the HPAECs. The HPAECs were intervened by 10% medicated serum with the optimal effect in previous studies. Then, they were divided into another five groups: the blank group (10% blank serum), the model group (TGF-β1+10% blank serum), the BYHWT group (TGF-β1+10% medicated serum), the BYHWT+overexpression plasmid control group (TGF-β1+10% medicated serum+blank plasmid) and the BYHWT+β-catenin overexpression plasmid group (TGF-β1+10% medicated serum+β-catenin). Apart from that, cell proliferation ability was detected by the methyl thiazolyl tetrazolium (MTT) method and cell migration ability by scratch assay and Transwell assay together. Immunofluorescence was adopted to detect the expressions of platelet endothelial cell adhesion molecule (PECAM-1/CD31), vascular endothelial cadherin (VE-cadherin), fibroblast-specific protein 1 (FSP1), and α-smooth muscle actin (α-SMA). ResultIn comparison to the blank group, the expressions of Wnt1 and β-catenin were significantly increased (P<0.01) while the expression of GSK-3β significantly decreased (P<0.01) in the model group. In comparison to the model group, the expressions of Wnt1 and β-catenin were significantly decreased (P<0.01) while the expression of GSK-3β was significantly increased (P<0.01) in the high-dose BYHWT group. The expression of β-catenin was significantly decreased (P<0.01) while the expression of GSK-3β was significantly increased (P<0.01) in the medium-dose BYHWT group. There was no significant difference in these indexes of the low-dose BYHWT group. In comparison to the blank group, proliferation and migration abilities were remarkably increased (P<0.01) and the immunofluorescence intensities of CD31 and VE-cadherin were decreased, while those of FSP1 and α-SMA were increased in the model group. In comparison to the model group, proliferation and migration abilities were significantly decreased (P<0.01) and the immunofluorescence intensities of CD31 and VE-cadherin were increased, while those of FSP1 and α-SMA diminished in the BYHWT group. Beyond that, the change trend of those indexes in the BYHWT+β-catenin overexpression plasmid group was consistent with that in the model group. In comparison to the BYHWT+overexpression plasmid control group, proliferation and migration abilities were significantly increased (P<0.01) and the immunofluorescence intensities of CD31 and VE-cadherin were decreased, while those of FSP1 and α-SMA were increased in the BYHWT+β-catenin overexpression plasmid group. ConclusionMedicated serum of BYHWT can inhibit EndMT of HPAECs by the Wnt1/β-catenin signaling pathway.
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.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.


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