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.Research progress on molecular mechanism of neuroprotective effects of acetazolamide under acute hypoxic exposure
Qi FU ; Yu WANG ; Ruili GUAN ; Yuankang ZOU ; Kejun DU
Journal of Environmental and Occupational Medicine 2026;43(5):656-662
Acute hypoxic exposure can induce functional brain impairment, driven by molecular mechanisms including mitochondrial dysfunction, intracellular calcium overload, glial cell activation and inflammatory responses, blood-brain barrier disruption, and alterated cerebral blood flow. Acetazolamide, a broad-spectrum carbonic anhydrase inhibitor, is a standard clinical treatment and remains the only medication approved by the Food and Drug Administration for the prevention and treatment of acute mountain sickness. Substantial evidence confirms that under acute hypoxic exposure, acetazolamide exerts multi-level neuroprotective effects on brain tissue by inhibiting carbonic anhydrase VB and other isoforms. These protective mechanisms involve preserving mitochondrial integrity, regulating calcium homeostasis and pH balance, modulating glial cell activity to mitigate neuroinflammation, maintaining blood-brain barrier structure integrity, and improving cerebral perfusion through cerebrovascular regulation. This article reviewed the molecular pathological mechanisms of hypoxia-induced nervous system damage, summarized the pharmacological properties and neuroprotective effects of acetazolamide, and provided a theoretical basis for therapeutic interventions against high-altitude hypoxic neural injury.
6.Research progress on molecular mechanism of neuroprotective effects of acetazolamide under acute hypoxic exposure
Qi FU ; Yu WANG ; Ruili GUAN ; Yuankang ZOU ; Kejun DU
Journal of Environmental and Occupational Medicine 2026;43(5):656-662
Acute hypoxic exposure can induce functional brain impairment, driven by molecular mechanisms including mitochondrial dysfunction, intracellular calcium overload, glial cell activation and inflammatory responses, blood-brain barrier disruption, and alterated cerebral blood flow. Acetazolamide, a broad-spectrum carbonic anhydrase inhibitor, is a standard clinical treatment and remains the only medication approved by the Food and Drug Administration for the prevention and treatment of acute mountain sickness. Substantial evidence confirms that under acute hypoxic exposure, acetazolamide exerts multi-level neuroprotective effects on brain tissue by inhibiting carbonic anhydrase VB and other isoforms. These protective mechanisms involve preserving mitochondrial integrity, regulating calcium homeostasis and pH balance, modulating glial cell activity to mitigate neuroinflammation, maintaining blood-brain barrier structure integrity, and improving cerebral perfusion through cerebrovascular regulation. This article reviewed the molecular pathological mechanisms of hypoxia-induced nervous system damage, summarized the pharmacological properties and neuroprotective effects of acetazolamide, and provided a theoretical basis for therapeutic interventions against high-altitude hypoxic neural injury.
7.Baloxavir marboxil in the treatment of influenza:a re-assessment of sys-tematic review
Ruili WANG ; Xingru TAO ; Lili HAI
Chinese Journal of Infection Control 2025;24(7):912-922
Objective To re-assess the Meta-analyses/network Meta-analyses on baloxavir marboxil in the treat-ment of influenza,and provide evidence-based reference for clinical use of baloxavir marboxil.Methods Meta-ana-lyses/network Meta-analyses on baloxavir marboxil in the treatment of influenza were retrieved from PubMed,Em-base,Cochrane Library,China National Knowledge Infrastructure(CNKI),Wanfang,and VIP databases,with re-trieval time from the inception of each database to December 11,2023.Literatures were screened according to the inclusion and exclusion criteria.Information of included literatures was extracted,and the methodological quality,reporting quality and evidence quality of the included literatures were assessed by assessment of multiple systematic reviews 2(AMSTAR-2)scale,preferred reporting items for systematic reviews and Meta-analyses(PRISMA)statement,as well as grading of recommendations,assessment,development,and evaluation(GRADE)system,respectively.Results A total of 7 Meta-analyses/network Meta-analyses were included.The results showed that in terms of alleviation time of influenza symptoms,the efficacy of baloxavir marboxil was not inferior to oseltamivir,peramivir,and zanamivir.In terms of the decrease in influenza virus titer 48 hours after medication,baloxavir mar-boxil was superior to oseltamivir and zanamivir.In terms of safety,baloxavir marboxil had a lower risk of drug-re-lated adverse events than oseltamivir,and was comparable to peramivir and zanamivir.The overall assessment result of methodological quality of AMSTAR-2 scale was relatively low,with 2 literatures being classified as low-level and 5 as extremely low-level.PRISMA scores ranged 15.5-22.The quality of overall report was moderate.Two lite-ratures were scored>21,and the reports were relatively complete.There were 5 literatures with scores ranging 15-21,and the reports had certain deficiencies.The GRADE evidence quality grading results showed that among the in-cluded 199 outcome indicators,4 indicators were high-level evidence,49 were moderate-level evidence,118 indica-tors were low-level evidence,and 28 indicators were extremely low-level evidence.Conclusion Baloxavir marboxil is comparable to neuraminidase inhibitors in the alleviation time of influenza symptoms,superior to oseltamivir and zanamisvir in decreasing virus titer,and has a lower risk of adverse drug events(especially nausea)than oseltamivir.
8.Butyrate-based ionic liquid for improved oral bioavailability and synergistic anti-colorectal cancer activity of glycyrol.
Ziyu WANG ; Xingyue SHI ; Yikang SHU ; Ran GAO ; Ting SUN ; Mingyue WU ; Mingxin DONG ; Weiguo WU ; Ruili MA ; Daoquan TANG ; Min YE ; Shuai JI
Journal of Pharmaceutical Analysis 2025;15(11):101359-101359
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9.Induction of apoptosis in hepatocellular carcinoma cells by polyphyllin 9 through regulating the Fas/FasL sig-naling pathway and the inhibitory effect on the growth of transplanted tumor in nude mice
Minna YAO ; Wei ZHANG ; Kai GAO ; Ruili LI ; Ying YIN ; Chao GUO ; Yunyang LU ; Haifeng TANG ; Jingwen WANG
China Pharmacy 2025;36(18):2238-2243
OBJECTIVE To investigate the induction of apoptosis in hepatocellular carcinoma cells by polyphyllin 9 (PP9) through the regulation of the Fas/Fas ligand (FasL) signaling pathway, and its inhibitory effect on the growth of transplanted tumor in nude mice. METHODS Based on the screening of cell lines and intervention conditions, HepG2 cells were selected as the experimental subject to investigate the effects of 2 μmol/L and 4 μmol/L PP9 treatment on cell colony formation activity, apoptosis rate, as well as the protein expressions of Fas, FasL, cleaved caspase-8 and cleaved caspase-3. Additionally, Fas inhibitor KR- 33493 was introduced to investigate the underlying mechanism of PP9’s anti-hepatocellular carcinoma activity. Using HepG2 cell tumor-bearing nude mice model as the object, and 5-fluorouracil (20 mg/kg) as the positive control, the effects of 10 mg/kg PP9 on tumor volume, tumor mass, and the protein expressions of the nuclear proliferation-associated antigen Ki-67 and cleaved caspase-3 in tumor-bearing nude mice were investigated. RESULTS Compared with the control group, 2, 4 μmol/L PP9 significantly decreased the number of clones and the clone formation rate of cells, but significantly increased the apoptosis rate, the protein expressions of Fas, FasL, cleaved caspase-8 and cleaved caspase-3 (P<0.05 or P<0.01). However, the combination of Fas inhibitor KR-33493 could significantly reverse the effect of PP9 on the up-regulation of proteins related to the Fas/FasL signaling pathway (P<0.01). Compared with the control group, the tumor volume (on day 27), mass and protein expression of Ki- 67 in nude mice of the PP9 group were significantly decreased, while the protein expression of cleaved caspase-3 was significantly increased (P<0.01). CONCLUSIONS PP9 can induce apoptosis of HepG2 cells by activating the Fas/FasL signaling pathway. Meanwhile, PP9 can also effectively inhibit the growth of transplanted tumors in nude mice.
10.Imperatives, practical challenges, and strategic pathways for high-quality cultivation of doctoral candidates for professional degree of acupuncture-moxibustion and tuina in the new era.
Dingming ZHI ; Tie LI ; Xin XIANG ; Jiajia WANG ; Ruili LI
Chinese Acupuncture & Moxibustion 2025;45(12):1833-1838
High-quality development has emerged as a central theme in the cultivation of doctoral candidates for the professional degree of acupuncture-moxibustion and tuina in the new era. Focusing on the core mission and contemporary demands, and through literature analysis and research interviews, the current situation for training acupuncture-moxibustion and tuina personnel was introduced. In order to break through the four practical challenges in the high-quality training of doctoral candidates for professional degree (including homogenization of training mechanism, optimization of training mode, limited integration of training resources and lack of evaluation of training quality), it needs to explore the strategy pathways from 4 aspects, (1) adhering to the goal orientation, following the specific rules of talent training and innovating talent training system; (2) optimizing the training process by building a "medicine-teaching-research-practice" integrative training model so as to meet the needs of talent training; (3) strengthening the development of practice bases, and organizing collaborative supervisory teams to provide favorable training conditions; (4) consolidating quality-guarantee mechanism by integrating dissertation with ascertainment of practical achievements, and implementing scientific assessment and evaluation.
Humans
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Moxibustion
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Acupuncture/standards*
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Acupuncture Therapy
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Education, Graduate

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