1.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
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.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
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.
3.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
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.
4.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
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.
5.Effect of Lifei Xiaoji Pill (理肺消积丸) on the Warburg Effect and USP47/BACH1 Pathway in Tumor Tissues of Lung Cancer Model Mice
Suxiao LIU ; Ruili ZHAO ; Yu GU ; Jinbeng DING ; Yuebing CHEN ; Suxiang FENG ; Suyun LI ; Ya LI
Journal of Traditional Chinese Medicine 2025;66(11):1157-1164
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.
6.Expression Levels of BRD9 mRNA and HNRNPA2B1 mRNA in Bone Marrow Tissue of Multiple Myeloma Patients and Their Correlation with Survival Prognosis
Ruili YUAN ; Hao MENG ; Ni LIU ; Juan LIU
Journal of Modern Laboratory Medicine 2025;40(2):30-35
Objective To analyze the bromodomain-containing protein 9(BRD9)and heterogeneous nuclear ribonucleoprotein A2/B1(HNRNPA2B1)in the bromine domain of multiple myeloma(MM)and explore their correlation with the survival prognosis of MM patients.Methods A total of 102 MM patients who received treatment in the First Affiliated Hospital of Xi'an Jiaotong University from May 2017 to May 2020 were selected as the MM group,while 60 patients who were confirmed to have no bone marrow dysfunction through bone marrow puncture were selected as the control group.Real time fluorescence quantitative PCR(qRT-PCR)was applied to detect the expression of BRD9 mRNA and HNRNPA2B1 mRNA in bone marrow tissue.Pearson correlation analysis was applied to analyze the relationship between BRD9 mRNA and HNRNPA2B1 mRNA.Kaplan-Meier curve and COX regression analysis were used to investigate the relationship between BRD9 mRNA and HNRNPA2B1 mRNA expression and the survival prognosis of MM patients.Results The relative expression levels of BRD9 mRNA(3.14±0.66)and HNRNPA2B1 mRNA(2.93±0.57)in the bone marrow tissue of the MM group were higher than those in the control group(0.84±0.22,0.92±0.36),and the differences were statistically significant(t=26.124,24.567,all P<0.001).Pearson correlation analysis showed a positive correlation between BRD9 mRNA and HNRNPA2B1 mRNA expression in the bone marrow tissue of MM group(r=0.761,P<0.001).The relative expression levels of BRD9 mRNA(3.90±0.69)and HNRNPA2B1 mRNA(4.13±0.64)in the bone marrow tissue of the MM group with ISS stage III were higher than those in international staging system(ISS)stages I,II(2.70±0.60,3.15±0.65;2.23±0.51,2.95±0.56),and the differences were statistically significant(t=7.399,4.272;13.255,7.551,all P<0.05).The 3-year overall survival rates of the BRD9 mRNA high expression and low expression groups were 60.00%(30/50)and 82.69%(43/52),respectively,the overall 3-year survival rates of HNRNPA2B1 mRNA high and low expression groups were 57.14%(28/49)and 84.91%(45/53),respectively,with statistically significant differences between the groups(Log Rank χ2=7.572,9.686,P=0.006,0.002).ISS stage III,high expression of BRD9 mRNA,and high expression of HNRNPA2B1 mRNA were risk factors affecting the poor survival prognosis of MM patients(all P<0.001).Conclusion The expression of BRD9 and HNRNPA2B1 are elevated in MM patients,both of them are risk factors for poor prognosis in MM patients.
7.Expert recommendations on the development content and functional specifications for the public vaccination service platform
Qi ZHU ; Qianli MA ; Ruili XIE ; Lijun LIU ; Lei LI ; Lin CHEN ; Yong HUANG ; Ronghai TAN ; Xiaoru CAI ; Jianfeng HE ; Wenzhou YU
Chinese Journal of Preventive Medicine 2025;59(9):1448-1453
To satisfy the growing healthcare demands of the public, it is essential to develop a public service platform for vaccination. This initiative aligns with national policies, optimizes resource allocation, innovates service models, enhances service efficiency, and reduces service costs. Drawing on relevant national policies and regulatory requirements, as well as the notable achievements and practical experiences gained through the exploration and innovation of vaccination service models across various regions, this paper proposes expert recommendations. It defines the essential components and functional specifications for public service platforms, focusing on public needs such as electronic vaccination record management, appointment management, the promotion of electronic vaccination certificates, vaccination certificate verification for school enrollment, vaccination site navigation, and science communication and public engagement. The recommendations aim to serve as a reference for the development of vaccination public service platforms nationwide.
8.CT and MRI manifestations of gastritis cystica profunda
Qian YANG ; Jing YUAN ; Ruili MAO ; Zhiying XUE ; Peng ZHONG ; Weiguo ZHANG ; Chunhua LIU
Chinese Journal of Medical Imaging Technology 2025;41(2):277-280
Objective To observe CT and MRI manifestations of gastritis cystica profunda(GCP).Methods Seventeen patients with GCP confirmed by operation or biopsy pathology were enrolled,and lesions'CT and MRI manifestations were observed.Results Among 17 cases,16 cases(16/17,94.12%)were found with single lesion and 1(1/17,5.88%)with diffuse multiple lesions.The lesion located in the fundus of stomach in 5 cases(5/17,29.41%),in the body of stomach in 4 cases(4/17,23.53%),in the cardia and antrum of stomach each in 3 cases(3/17,17.65%)and in the pylorus in 1 case(1/17,5.88%),while 1 case(1/17,5.88%)was found with diffused multiple lesions within stomach.Non-enhance CT showed local thickening of gastric wall in 10 cases(10/17,58.82%),all were isodensities,and the mucosa uniformly enhanced in contrast enhance CT(CECT).Predominately cystic lesion in 5 cases(5/17,29.41%)presented as submucosal cystic protrusions,and grew into the stomach cavity with circular or oblong low density in non-enhanced CT,while sandwich enhancement of mucosa was observed in CECT.Among these 5 cases(5/17,29.41%),MRI showed lesion confined to the submucosa with low signal on T1WI and high signal on T2WI,while diffusion weighted imaging showed unrestricted diffusion,and the enhancement pattern was consistent with that of CT in 2 cases.In other 2 cases(2/17,11.77%)with cystic-solid lesion,non-enhanced CT showed soft tissue density,while CECT showed lump-like stratified enhancement.Conclusion CT and MRI manifestations of GCP had certain characteristics.
9.Expression Levels of BRD9 mRNA and HNRNPA2B1 mRNA in Bone Marrow Tissue of Multiple Myeloma Patients and Their Correlation with Survival Prognosis
Ruili YUAN ; Hao MENG ; Ni LIU ; Juan LIU
Journal of Modern Laboratory Medicine 2025;40(2):30-35
Objective To analyze the bromodomain-containing protein 9(BRD9)and heterogeneous nuclear ribonucleoprotein A2/B1(HNRNPA2B1)in the bromine domain of multiple myeloma(MM)and explore their correlation with the survival prognosis of MM patients.Methods A total of 102 MM patients who received treatment in the First Affiliated Hospital of Xi'an Jiaotong University from May 2017 to May 2020 were selected as the MM group,while 60 patients who were confirmed to have no bone marrow dysfunction through bone marrow puncture were selected as the control group.Real time fluorescence quantitative PCR(qRT-PCR)was applied to detect the expression of BRD9 mRNA and HNRNPA2B1 mRNA in bone marrow tissue.Pearson correlation analysis was applied to analyze the relationship between BRD9 mRNA and HNRNPA2B1 mRNA.Kaplan-Meier curve and COX regression analysis were used to investigate the relationship between BRD9 mRNA and HNRNPA2B1 mRNA expression and the survival prognosis of MM patients.Results The relative expression levels of BRD9 mRNA(3.14±0.66)and HNRNPA2B1 mRNA(2.93±0.57)in the bone marrow tissue of the MM group were higher than those in the control group(0.84±0.22,0.92±0.36),and the differences were statistically significant(t=26.124,24.567,all P<0.001).Pearson correlation analysis showed a positive correlation between BRD9 mRNA and HNRNPA2B1 mRNA expression in the bone marrow tissue of MM group(r=0.761,P<0.001).The relative expression levels of BRD9 mRNA(3.90±0.69)and HNRNPA2B1 mRNA(4.13±0.64)in the bone marrow tissue of the MM group with ISS stage III were higher than those in international staging system(ISS)stages I,II(2.70±0.60,3.15±0.65;2.23±0.51,2.95±0.56),and the differences were statistically significant(t=7.399,4.272;13.255,7.551,all P<0.05).The 3-year overall survival rates of the BRD9 mRNA high expression and low expression groups were 60.00%(30/50)and 82.69%(43/52),respectively,the overall 3-year survival rates of HNRNPA2B1 mRNA high and low expression groups were 57.14%(28/49)and 84.91%(45/53),respectively,with statistically significant differences between the groups(Log Rank χ2=7.572,9.686,P=0.006,0.002).ISS stage III,high expression of BRD9 mRNA,and high expression of HNRNPA2B1 mRNA were risk factors affecting the poor survival prognosis of MM patients(all P<0.001).Conclusion The expression of BRD9 and HNRNPA2B1 are elevated in MM patients,both of them are risk factors for poor prognosis in MM patients.
10.CT and MRI manifestations of gastritis cystica profunda
Qian YANG ; Jing YUAN ; Ruili MAO ; Zhiying XUE ; Peng ZHONG ; Weiguo ZHANG ; Chunhua LIU
Chinese Journal of Medical Imaging Technology 2025;41(2):277-280
Objective To observe CT and MRI manifestations of gastritis cystica profunda(GCP).Methods Seventeen patients with GCP confirmed by operation or biopsy pathology were enrolled,and lesions'CT and MRI manifestations were observed.Results Among 17 cases,16 cases(16/17,94.12%)were found with single lesion and 1(1/17,5.88%)with diffuse multiple lesions.The lesion located in the fundus of stomach in 5 cases(5/17,29.41%),in the body of stomach in 4 cases(4/17,23.53%),in the cardia and antrum of stomach each in 3 cases(3/17,17.65%)and in the pylorus in 1 case(1/17,5.88%),while 1 case(1/17,5.88%)was found with diffused multiple lesions within stomach.Non-enhance CT showed local thickening of gastric wall in 10 cases(10/17,58.82%),all were isodensities,and the mucosa uniformly enhanced in contrast enhance CT(CECT).Predominately cystic lesion in 5 cases(5/17,29.41%)presented as submucosal cystic protrusions,and grew into the stomach cavity with circular or oblong low density in non-enhanced CT,while sandwich enhancement of mucosa was observed in CECT.Among these 5 cases(5/17,29.41%),MRI showed lesion confined to the submucosa with low signal on T1WI and high signal on T2WI,while diffusion weighted imaging showed unrestricted diffusion,and the enhancement pattern was consistent with that of CT in 2 cases.In other 2 cases(2/17,11.77%)with cystic-solid lesion,non-enhanced CT showed soft tissue density,while CECT showed lump-like stratified enhancement.Conclusion CT and MRI manifestations of GCP had certain characteristics.

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