The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.

The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.

ObjectiveTo explore the possible mechanism of action of Lifei Xiaoji Pill （理肺消积丸， LXP） in the treatment of non small cell lung cancer based on the Warburg effect and the USP47/BACH1 pathway. MethodsFifty C57BL/6 mice were randomly divided into five groups， model group， LXP group， inhibitor group， LXP + inhibitor group， and cisplatin group， with 10 mice in each group. A lung cancer mouse model was established by subcutaneously injecting Lewis cells. On the next day， the model group mice were given 0.2 ml of saline by gavage daily， the LXP group given 240 mg/（kg·d） of LXP solution once a day by gavage， the inhibitor group intraperitoneally injected with P22077 at a dose of 10 mg/（kg·d） every day， the LXP + inhibitor group given both LXP by gavage and P22077 by intraperitoneal injection once a day， and the cisplatin group received 0.5 mg/（kg·d） cisplatin intraperitoneally every other day. All treatments lasted for 14 days. On the day after the last dose， tumor weight and volume were measured， tumor histopathology was examined by HE staining， apoptosis in tumor tissues was detected by TUNEL staining， and proliferation cell nuclear antigen （PCNA） protein levels were detected by immunohistochemistry. Warburg effect indicators， including glucose concentration， lactate content， and adenosine triphosphate （ATP） production in tumor tissues， were measured. Western Blot and qRT-PCR were used to detect the protein and mRNA expression levels of USP47， BACH1， hexokinase 2 （HK2）， and glyceraldehyde 3-phosphate dehydrogenase （GAPDH）. ResultsCompared with the model group， all drug intervention groups showed reduced tumor weight and volume， improved tumor pathology， decreased PCNA positive rate， increased apoptosis rate， and reduced expression levels of USP47， BACH1， and HK2 proteins and mRNA （P＜0.05 or P＜0.01）. Except for lactate content in the cisplatin group， the glucose concentration in tumor tissues of other drug intervention groups increased， while lactate content and ATP production decreased （P＜0.05 or P＜0.01）. Compared with the LXP group， the LXP + inhibitor group showed more significant improvements in these indicators （P＜0.05 or P＜0.01）. Compared with the cisplatin group， the LXP + inhibitor group had lower mRNA expression of HK2 and GAPDH， and lower protein levels of USP47 and HK2 （P＜0.05 or P＜0.01）. Compared with the inhibitor group， the cisplatin group had higher HK2 protein levels， while the LXP + inhibitor group showed lower mRNA expression of BACH1， HK2， and GAPDH （P＜0.05 or P＜0.01）. ConclusionLXP significantly inhibits tumor growth in lung cancer mice， and its mechanism of action may be related to inhibiting the Warburg effect via the USP47/BACH1 pathway.

Objective Building a TCM health management and clinical research integration platform for knee osteoarthritis,promoting the integration of traditional Chinese medicine with internet and mobile health technology,driving the digitalization of TCM-enabled knee osteoarthritis health management strategies,and providing a convenient digital platform for the efficient conduct of TCM clinical research on knee osteoarthritis.Methods Using a combination of literature review and market research,a preliminary framework for the platform's functions and services was established.Then,17 patients with knee osteoarthritis were interviewed through a convenient sampling method to identify their needs and preferences,and design the platform's functional modules and service flow.In the development and testing phase,a multidisciplinary team consisting of professional development engineers,data scientists,and clinical experts conducted multiple rounds of discussions to ensure the scientificity,feasibility,and convenience of the platform's function and service development.Results The integrated platform of traditional Chinese medicine health management and clinical research for knee osteoarthritis is built.The traditional Chinese medicine health management module includes features of health education,evaluation and exercise training,etc.The scientific research module includes patient self-report outcome data collection and remote quality control,etc.,which can provide the whole process service integrating health management and remote intelligent clinical trial.Conclusion Building an integrated platform of TCM health management and clinical research will provide more convenient and effective health management solutions for patients with knee osteoarthritis.

Objective:To evaluate the role of myosin heavy chain 9(MYH9) in gut-vascular barrier damage in septic mice.Methods:Eighty SPF C57BL/6J male mice, aged 6-8 weeks, weighing 20-25 g, were divided into 4 groups( n=20 each) by the random number table method: sham operation group(Sham group), sham operation + MYH9 inhibitor blebbistatin group(Sham+ Ble group), cecal ligation and perforation(CLP) group, and CLP+ blebbistatin group(CLP+ Ble group). A mouse sepsis model was established using CLP in anesthetized animals. Blebbistatin solution 5 mg/kg was intraperitoneally injected at 1 h before CLP in Sham+ Ble and CLP+ Ble groups, while the equal volume of phosphate buffer was given instead in Sham and CLP groups. Fourteen mice were randomly selected from each group to observe the survival at 24 h after CLP. Blood samples were taken by apical puncture at 24 h after surgery in the remaining 6 mice in each group for determination of the plasma concentrations of tumor necrosis factor-α(TNF-α), interleukin-1β(IL-1β) and interleukin-6(IL-6)(using enzyme-linked immunosorbent assay), expression of plasma membrane vesicle-associated protein(PLVAP) in intestinal microvascular endothelial cells(using immunofluorescence), and expression of MYH9, PLVAP, vascular endothelial calreticulin(VE-cadherin) and β-catenin protein and mRNA(by Western bot or fluorescent quantitative real-time polymerase chain reaction) and for examination of the pathological changes of intestinal tissues. Intestinal damage was assessed and scored according to Chiu. Results:Compared with Sham group, the expression of MYH9 protein and mRNA was significantly down-regulated in Sham+ Ble group, and the survival rate was significantly decreased at 24 h after surgery, Chiu′s scores in intestinal tissues were increased, the plasma concentrations of TNF-α, IL-1β and IL-6 were increased, the expression of PLVAP in intestinal microvascular endothelial cells was up-regulated, the expression of MYH9 and PLVAP protein and mRNA in intestinal tissues was up-regulated, and the expression of VE-cadherin and β-catenin protein and mRNA was down-regulated in CLP group( P<0.05). Compared with CLP group, the survival rate was significantly increased at 24 h after surgery, Chiu′s scores in intestinal tissues were decreased, the plasma concentrations of TNF-α, IL-1β and IL-6 were decreased, the expression of PLVAP in intestinal microvascular endothelial cells was down-regulated, the expression of MYH9 and PLVAP protein and mRNA in intestinal tissues was down-regulated, and the expression of VE-cadherin and β-catenin protein and mRNA was up-regulated in CLP+ Ble group( P<0.05). Conclusions:MYH9 is involved in gut-vascular barrier damage in septic mice.

Objective:To evaluate the role of myosin heavy chain 9(MYH9) in gut-vascular barrier damage in septic mice.Methods:Eighty SPF C57BL/6J male mice, aged 6-8 weeks, weighing 20-25 g, were divided into 4 groups( n=20 each) by the random number table method: sham operation group(Sham group), sham operation + MYH9 inhibitor blebbistatin group(Sham+ Ble group), cecal ligation and perforation(CLP) group, and CLP+ blebbistatin group(CLP+ Ble group). A mouse sepsis model was established using CLP in anesthetized animals. Blebbistatin solution 5 mg/kg was intraperitoneally injected at 1 h before CLP in Sham+ Ble and CLP+ Ble groups, while the equal volume of phosphate buffer was given instead in Sham and CLP groups. Fourteen mice were randomly selected from each group to observe the survival at 24 h after CLP. Blood samples were taken by apical puncture at 24 h after surgery in the remaining 6 mice in each group for determination of the plasma concentrations of tumor necrosis factor-α(TNF-α), interleukin-1β(IL-1β) and interleukin-6(IL-6)(using enzyme-linked immunosorbent assay), expression of plasma membrane vesicle-associated protein(PLVAP) in intestinal microvascular endothelial cells(using immunofluorescence), and expression of MYH9, PLVAP, vascular endothelial calreticulin(VE-cadherin) and β-catenin protein and mRNA(by Western bot or fluorescent quantitative real-time polymerase chain reaction) and for examination of the pathological changes of intestinal tissues. Intestinal damage was assessed and scored according to Chiu. Results:Compared with Sham group, the expression of MYH9 protein and mRNA was significantly down-regulated in Sham+ Ble group, and the survival rate was significantly decreased at 24 h after surgery, Chiu′s scores in intestinal tissues were increased, the plasma concentrations of TNF-α, IL-1β and IL-6 were increased, the expression of PLVAP in intestinal microvascular endothelial cells was up-regulated, the expression of MYH9 and PLVAP protein and mRNA in intestinal tissues was up-regulated, and the expression of VE-cadherin and β-catenin protein and mRNA was down-regulated in CLP group( P<0.05). Compared with CLP group, the survival rate was significantly increased at 24 h after surgery, Chiu′s scores in intestinal tissues were decreased, the plasma concentrations of TNF-α, IL-1β and IL-6 were decreased, the expression of PLVAP in intestinal microvascular endothelial cells was down-regulated, the expression of MYH9 and PLVAP protein and mRNA in intestinal tissues was down-regulated, and the expression of VE-cadherin and β-catenin protein and mRNA was up-regulated in CLP+ Ble group( P<0.05). Conclusions:MYH9 is involved in gut-vascular barrier damage in septic mice.

Objective Building a TCM health management and clinical research integration platform for knee osteoarthritis,promoting the integration of traditional Chinese medicine with internet and mobile health technology,driving the digitalization of TCM-enabled knee osteoarthritis health management strategies,and providing a convenient digital platform for the efficient conduct of TCM clinical research on knee osteoarthritis.Methods Using a combination of literature review and market research,a preliminary framework for the platform's functions and services was established.Then,17 patients with knee osteoarthritis were interviewed through a convenient sampling method to identify their needs and preferences,and design the platform's functional modules and service flow.In the development and testing phase,a multidisciplinary team consisting of professional development engineers,data scientists,and clinical experts conducted multiple rounds of discussions to ensure the scientificity,feasibility,and convenience of the platform's function and service development.Results The integrated platform of traditional Chinese medicine health management and clinical research for knee osteoarthritis is built.The traditional Chinese medicine health management module includes features of health education,evaluation and exercise training,etc.The scientific research module includes patient self-report outcome data collection and remote quality control,etc.,which can provide the whole process service integrating health management and remote intelligent clinical trial.Conclusion Building an integrated platform of TCM health management and clinical research will provide more convenient and effective health management solutions for patients with knee osteoarthritis.

Objective:In order to truly realize the deep integration of ideological and political education and professional edu-cation in the course of Animal Immunology and effectively improve the comprehensive quality of students.Methods:The experiment adopts the teaching method of integrating the online and offline hybrid teaching of Animal Immunology into the ideology and politics of the course,studies the course design concept,teaching objectives,teaching design and teaching implementation,and will conduct an evaluation of the teaching effect from the examination results and ideological and political effect.Results:The results show that the teaching model has stimulated students'interest in learning and improved their overall ability.Conclusion:It shows that the teaching effect of this method is good and the basic task of moral education is realized.