1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
2.Construction of a Regional Clinical Research Data Integration Platform Based on Standardization Theory
Xuequn HUANG ; Zhaoxia CHEN ; Tiantian QU ; Enlu SHEN ; Yiran MIAO ; Chenxi LI ; Shiyang MA ; Biyun QIAN ; Zhangsh-Eng YU ; Tienan FENG
Journal of Medical Informatics 2024;45(5):89-95
Purpose/Significance To solve the problem that regional clinical research data are difficult to integrate efficiently,and to promote"Chinese evidence"and"Chinese protocol"in the global clinical research community.Method/Process Based on the standard-ization theory,the data standardization system is proposed,and the construction and application methods of the regional clinical research data platform are explored with the integration of multi-center clinical research data as the starting point.Result/Conclusion The theo-retical framework of the regional clinical research data platform has been preliminarily established,and the clinical research capabilities of tertiary hospitals in Shanghai have been significantly improved.
3.Neuroprotective effects of Shaoyao Gancao decoction against excitatory damage in PC12 cells based on the Src-NR2-nNOS pathway
Xiaxu Fan ; Hongyan Ma ; Tiantian Zhou ; Min Fu ; Zhiyuan Qiao ; Yingtong Feng ; Zhen Wang ; Yiwei Shen ; Jingxia Wang
Journal of Traditional Chinese Medical Sciences 2024;11(3):293-302
Objective:
To explore the neuroprotective effects of the Shaoyao Gancao decoction (SGD) against excitatory damage in PC12 cells and the role of the Src-NR2-nNOS pathway mediation by SGD in regulating γ-aminobutyric acid (GABA)-glutamate (Glu) homeostasis.
Methods:
N-Methyl-d-aspartic acid (NMDA) was used to establish a PC12 cell excitability injury model. To investigate the neuroprotective effect of SGD, a cell counting kit-8 (CCK-8) assay was used to determine PC12 cell viability, Annexin V/Propidium Iodide (Annexin V/PI) double staining was used to determine PC12 cell apoptosis, and Ca2+ concentration was observed using laser confocal microscopy. GABA receptor agonists and antagonists were used to analyze the neuroprotective interactions between γ-aminobutyric acid (GABA) and NMDA receptors. Additionally, molecular biology techniques were used to determine mRNA and protein expression in the Src-NR2-nNOS pathway. We analyzed the correlations between the regulatory sites of GABA and NMDA interactions, excitatory neurotoxicity, and brain damage at the molecular level.
Results:
NMDA excitotoxic injury manifested as a significant decrease in cell activity, increased apoptosis and caspase-3 protein expression, and a significant increase in intracellular Ca2+ concentration. Administration of SGD, a GABAA receptor agonist (muscimol), or a GABAB receptor agonist (baclofen) decreased intracellular Ca2+ concentrations, attenuated apoptosis, and reversed NMDA-induced upregulation of caspase-3, Src, NMDAR2A, NMDAR2B, and nNOS. Unexpectedly, a GABAA receptor antagonist (bicuculline) and a GABAB receptor antagonist (saclofen) failed to significantly increase excitatory neurotoxicity.
Conclusions
Taken together, these results not only provide an experimental basis for SGD administration in the clinical treatment of central nervous system injury diseases, but also suggest that the Src-NR2A-nNOS pathway may be a valuable target in excitotoxicity treatment.
4.Effect of macrophages polarization on proliferation,migration and osteogenic differentiation of periodontal ligament stem cells
Kepeng LI ; Zhenguo SHEN ; Xiangdong LIU ; Tiantian CHENG ; Yuanyin WANG
Acta Universitatis Medicinalis Anhui 2024;59(8):1392-1398
Objective To explore the effects of different phenotypes macrophages(Mφs)on the proliferation,mi-gration and osteogenic differentiation of periodontal ligament stem cells(PDLSCs).Methods PDLSCs were isola-ted and cultured by tissue block method.Tohoku Hospital Pediatrics-1(THP-1)cell line was stimulated to activate into unpolarized Mφs(M0),then induced to polarize into type Ⅰ Mφs(M1)and type Ⅱ Mφs(M2).Quantitative real-time PCR(qPCR)detected the inflammatory factors tumor necrosis factor α(TNF-α),interleukin(IL)-1 β,IL-6,IL-10 and transforming growth factor-β(TGF-β)mRNA expression level.After collecting culture superna-tants with different phenotypes,PDLSCs were stimulated,native control(NC)group did not receive the culture su-pernatant of Mφs.The effects of PDLSCs proliferation were assessed via Methylthiazolyldiphenyl-tetrazolium bro-mide(MTT)assay,while scratch assays were employed to evaluate their migration.Western blot was utilized to analyze the protein expression of Runt-related transcription factor 2(RUNX2)and alkaline phosphatase(ALP).Additionally,Alizarin Red staining was performed to investigate the deposition of calcified nodules in PDLSCs.Re-sults qPCR showed the relative expression of TNF-α,IL-1 β and IL-6 in M1 Mφs were higher than those in M0 and M2 Mφs(P<0.05),and the relative expression of IL-10 and TGF-β in M2 Mφs were higher than those in M0 and M1 Mφs(P<0.05);Western blot showed the expression of RUNX2 and ALP proteins in PDLSCs in M0 and M2 groups was higher than those in the NC group(P<0.05),Alizarin Red staining showed increased calcified nodule deposition in PDLSCs in M0,M1 and M2 groups compared to the NC group;MTT assay showed the prolifer-ation of PDLSCs in the M0 and M1 groups was suppressed compared to the NC group(P<0.05);and scratch ex-periment showed the migratory capacity of PDLSCs in the M1 and M2 groups was stronger than that in the NC group.Conclusion M0 and M1 Mφs inhibit PDLSCs proliferation,M1 and M2 Mφs promote PDLSCs migration,and all types of Mφs promote osteogenic differentiation of PDLSCs.
5.Construction of a Theoretical Framework for the Performance Assessment of Basic Medical Insurance Designated Medical Institutions Based on the Objectives of Medical Insurance Policy
Qian WANG ; Ruiming DAI ; Lin KE ; Ling CAO ; Wei ZHANG ; Mengjiao SHEN ; Tiantian ZHANG
Chinese Hospital Management 2024;44(1):78-82
It collected relative policy documents systematically and analyzed the development process and policy objective evolution of Chinese basic medical insurance system.Based on this,it determined the performance assessment objectives of the designated medical institutions of basic medical insurance and constructed the assessment framework guided by the goal realization.Then,from the perspective of contract management and performance management,it determined the assessment elements of contract enforcement assessment system of designated medical institutions and the logical relationship between the elements,and to construct a conceptual model,which provides a reference for guiding the research of the contract enforcement assessment of the designated medical institutions of basic medical insurance.
6.Consideration of countermeasures to promote family doctor contracting rate and first-return-visit rate in primary care institutions
Fei SHENG ; Ping LU ; Liqing ZHOU ; Bihua CHEN ; Chuntao YI ; Jiangen CHEN ; Fulai SHEN ; Tiantian DENG ; Dongjian XU ; Liling MAO
Chinese Journal of General Practitioners 2024;23(2):180-184
Based on the analysis of the existing problems and implementation dilemmas in family doctor contracting and first-return-visits faced by primary medical institutions in China, the authors propose countermeasures to provide reference for managers of primary health care institutions.
7.Practice and thinking of building active learning general practice team based on learning health system
Fei SHENG ; Tiantian DENG ; Dongjian XU ; Liling MAO ; Jing PU ; Yu LIU ; Ping YU ; Weifang LIU ; Fulai SHEN ; Puyang ZHENG
Chinese Journal of General Practitioners 2024;23(4):399-405
By sorting out the differences and connections between family doctor teams and specialized disease teams, role competency and mutual collaboration, and introducing the learning health system (LHS) mechanism, a comprehensive operating system for community general practice learning organizations based on LHS was constructed, focusing on five single disease types. The system includes a combination of general and specialized medicine that links three levels of medical institutions, thereby opening up the business cooperation process between professionals in different institutions, and establishing a sustainable collaboration mechanism. This allows medical institutions at three levels to continuously tap the potential of their disciplines, achieve their own ability growth and feel higher work value, and also bring better health solutions to residents, guided by the common goal of "health centered, patient centered".
8.Summary of the best evidence for pain management in emergency adult patients with trauma
Tiantian ZHOU ; Ping HUANG ; Xiaojing WANG ; Ying XIA ; Tianshu MEI ; Ping SHEN ; Jun WANG
Chinese Journal of Emergency Medicine 2023;32(12):1699-1704
Objective:To retrieve,evaluate and integrate the best evidence of pain management in emergency adult patients with trauma,and to provide references for clinical nursing practice.Methods:The best evidence of pain management in emergency adult patients with trauma were systematically searched in domestic and international databases.The retrieval period is from the establishment of databases to December,2022.There were 2 researchers evaluating the quality of the literature and extracting the data.Results:Total of 16 articles were selected,including 5 top clinical decisions,6 guidelines,3 expert consensuses,2 systematic review. 36 pieces of best evidence were formed from 6 aspects,including pain management principles, pain assessment methods, pain medication principles, pharmacological interventions, non pharmacological interventions and dynamic monitoring of pain management.Conclusions:Medical staff can formulate corresponding nursing measures in clinical applications based on the actual situation of trauma patients, and use scientific methods to solve the pain problem of emergency adult trauma patients and improve their quality of life.
9.Latent profile analysis of multiple symptom distress in children and adolescents with cancer and its effect on their physical activity
Yanyan LIU ; Tiantian YANG ; Nanping SHEN ; Mengxue HE ; Hongyan ZHANG
Journal of Shanghai Jiaotong University(Medical Science) 2023;43(11):1408-1416
Objective·To describe the level of multiple symptom distress and physical activity in children and adolescents with cancer,analyze symptom distress profiles,and explicit the relationship between latent profiles and physical activity.Methods·From November 2021 to March 2023,the convenient sample method was used to recruit children and adolescents with cancer aged 10-18 years old,who had been treated for more than 1 month in the Departments of Hematology/Oncology,Shanghai Children's Medical Center and Xin Hua Hospital,Shanghai Jiao Tong University School of Medicine.The questionnaires,including General Information Questionnaire,Memorial Symptom Assessment Scale 10-18(MSAS 10-18)and Modified Chinese Version of Children's Leisure Time Activities Study Survey(CLASS-C),were used.Latent profile analysis was used to identify whether the level of multiple symptom distress in children and adolescents with cancer was population heterogeneity and its explicit characteristics.Whether there were differences in physical activity levels among different profiles of symptom distress was also analyzed.Results· A total of 165 valid questionnaires were collected,with an effective response rate of 91.7%.The symptom distress scores of the top five occurrence rates of symptoms in children and adolescents with cancer were lack of energy with a median of 1(1,2)point,nausea 1(1,2)point,lack of appetite 2(2,3)points,sweat 1(1,2)point,and pain 1(1,2)point.The physical activity level of the patients was mainly light,with a median of 2 530.00(1 577.50,3 721.00)min/week,and moderate to vigorous physical activity was relatively lower[70.00(10.00,197.50)min/week].The patients with cancer could be divided into two latent profiles:"high fatigue-high nausea-high hair loss-high sleepy"and"high fatigue-low nausea-low vomiting-low sleepy",which were named as high symptom distress(n=47,30.6%)and low symptom distress(n=l 18,69.4%)separately.Multivariate Logistic regression analysis showed that patients with acute lymphoblastic leukemia were more likely to be classified as high symptom distress group,and outpatients in the latest hospital visit were more likely to classified as low symptom distress group(both P<0.05).In addition,patients with high symptom distress had a higher level of light physical activity(P<0.05),and had a lower level of moderate to vigorous physical activity,but the difference was not statistically significant.Conclusion·There is population heterogeneity in the multiple symptom distress in children and adolescents with cancer.Disease type(acute leukemia)and the way of the latest hospital visit(through outpatient department)are the predictors of symptoms profiles of patients with cancer.Patients who experience high symptom distress have higher level of light physical activity,and perhaps lower level of moderate to vigorous physical activity.
10.Discussions on risk-based quality management of investigator initiated trials
Wenwen LYU ; Tingting HU ; Jiayuan JIANG ; Weituo ZHANG ; Tiantian QU ; Enlu SHEN ; Jiacheng DUAN ; Tienan FENG ; Biyun QIAN
Chinese Journal of Hospital Administration 2022;38(7):525-529
Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.


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