1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
3.Expert Consensus on Clinical Application of Pingxuan Capsules
Yuer HU ; Yanming XIE ; Yaming LIN ; Yuanqi ZHAO ; Yihuai ZOU ; Mingquan LI ; Xiaoming SHEN ; Wei PENG ; Changkuan FU ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):201-210
As a patented characteristic medicine of Yi ethnic minority, Pingxuan capsules have the effects of nourishing the liver and kidney, pacifying the liver, and subduing Yang. With the main indications of dizziness, headache, palpitations, tinnitus, insomnia, dreaminess, waist and knee soreness caused by liver-kidney deficiency and liver Yang upward disturbance, Pingxuan capsules are widely used in the treatment of posterior circulation ischemic vertigo, vestibular migraine, benign paroxysmal positional vertigo. However, the current knowledge is limited regarding the efficacy, syndrome differentiation, and safety of this medicine. On the basis of summarizing the experience of clinicians and the existing evidence, this study invites clinical experts of traditional Chinese and Western medicine, pharmaceutical experts, and methodological experts from relevant fields across China to conduct evidence-based evaluation of Pingxuan capsules. The evaluation follows the Specifications for the Development of Clinical Expert Consensus on Chinese Patent Medicines issued by the Standardization Office of the China Association of Chinese Medicine, and reaches 5 recommendations and 16 consensus suggestions. The consensus clarifies the clinical applications, efficacy, dose, course of treatment, combination of medicines, precautions, and contraindications of Pingxuan capsules in the treatment of vertigo and explains the safety of clinical application. This consensus is applicable to clinicians (traditional Chinese medicine, Western medicine, and integrated traditional Chinese and Western medicine) and pharmacists in tertiary hospitals, secondary hospitals, and community-level medical and health institutions across China, providing a reference for the rational use of Pingxuan capsules in the treatment of vertigo. It is hoped that the promotion of this consensus can facilitate the rational use of drugs in clinical practice, reduce the risk of drug use, and give full play to the advantages of Pingxuan capsules in the treatment of vertigo diseases. This consensus has been reviewed and published by the China Association of Chinese Medicine, with the number GS/CACM330-2023.
4.Study on the inhibition mechanism of melatonin for neuroglioma cell proliferation based on whole transcriptome sequencing
Li XU ; Xiu-jiao CHEN ; Wei-nan ZHENG ; Xin-ling MAO ; Li-bin LIN ; Qun XIE ; Qing-dong JIN
Chinese Pharmacological Bulletin 2025;41(1):163-170
Aim To detect the non-coding RNA(ncRNA)expression profile of neuroglioma cells via whole transcriptome sequencing,establish the ceRNA network and reveal the molecular mechanism of ncRNA participating in the inhibition of neuroglioma cell prolif-eration by melatonin.Methods Neuroglioma cells were intervened with by 0,2,4,6 and 8 mmol·L-1 melatonin for 24,48 and 72 h,and the inhibitory effect of melatonin on cell proliferation was detected via CCK-8;after the intervention of 0 and 4 mmol·L-1 melatonin to U251 cells for 24 h,differentially ex-pressed miRNA(DEmiRNA),lncRNA(DElncRNA)and mRNA(DEmRNA)were detected through whole transcriptome sequencing,along with GO and KEGG enrichment analysis of DEmRNA;the ceRNA network was constructed,and the key gene expression of ceR-NA was verified through qRT-PCR.Results Melato-nin exerts a time-dose-dependent inhibitory effect on the proliferation of neuroglioma cells;a total of 5049 DEmRNA,635 DElncRNA and 146 DEmiRNA in 0 and 4 mmol·L-1 melatonin groups were screened out via whole transcriptome sequencing;DEmRNAs were mainly enriched in cancer-related signaling pathways,such as ferroptosis,mTOR signaling pathway,FoxO signaling pathway and cell cycle;the ceRNA network included 4 lncRNAs,3 miRNAs and 48 mRNAs.As verified through real-time PCR,the expressions of hsa-miR-129-5p,hsa-miR-362-5p,LINC00707 and SLC16A1-AS1 of U251 cells were consistent with the sequencing results,and the gene expression of U87 cells was basically consistent with the sequencing re-sults.Conclusions Melatonin affects cancer-related signaling pathways through the differential expression of ncRNA so as to inhibit the proliferation of U251 cells;the ceRNA network composed of LINC00707,SLC16A1-AS1,hsa-miR-129-5p and hsa-miR-362-5p may take a part in the molecular mechanism of melato-nin in inhibiting neuroglioma cell proliferation.
5.Guidelines for the Digital Ancient Books of TCM Indexing
Weina ZHANG ; Bing LI ; Bin LI ; Jing XIE ; Yan DONG ; Wei LONG ; Chuchu ZHANG ; Tong WEI ; Sihong LIU ; Yang WU ; Hongtao LI ; Lin TONG ; Guangkun CHEN ; Fei DONG ; Rui WANG ; He LU ; Meng LI ; Jingpeng DENG ; Tengfei WANG ; Xiaoying LI ; Di ZHANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(3):1-11
Guidelines for Digital Ancient Books of TCM Indexing(T/CIATCM 119-2024)is based on the theoretical knowledge,disciplinary methods,and practical applications of TCM classical cataloging.Taking digital ancient books of TCM as the object,it systematically reveals the content of TCM knowledge,which is an essential indexing processing standard for building an intelligent retrieval system for TCM ancient books,and can provide support for the deep development and innovative utilization of TCM knowledge.It can not only promote the co-construction and sharing of ancient book resources in the TCM industry,but also promote the standardization construction and application of TCM information.This standard specifies the principles,methods,and examples of free indexing of digital ancient books of TCM based on their original content.It is applicable to the indexing and processing of digital ancient books of TCM for TCM professional libraries and related institutions,and to the data processing and construction of various types of TCM ancient book databases.
6.Current status and influencing factors of decision anxiety in guardians of children with acute appendicitis under ERAT background
Dan WEI ; Yali LI ; Tingting HE ; Xiaomin XIE ; Lei WANG ; Jiawei FENG ; Yan LIN ; Xun JIANG ; Bei FENG
Chinese Journal of Practical Nursing 2025;41(27):2134-2139
Objective:To investigate the current status and influencing factors of decision anxiety in guardians of children with acute appendicitis under Endoscopic retrograde appendicitis therapy (ERAT) background, and to provide reference for the development of targeted intervention programs for decision anxiety.Methods:Convenient sampling method was used to select 254 guardians of children with acute appendicitis treated in the Department of Pediatrics, Second Affiliated Hospital of PLA Air Force Medical University from February 2023 to April 2024. A cross-sectional survey was conducted using the General Data Questionnaire, the State-Trait Anxiety Inventory Form Y-State anxiety subscale and the Preparation for Decision Making Scale. Multiple linear regression was used to analyze the influencing factors in guardians of children with acute appendicitis.Results:Among the guardians of 254 children with acute appendicitis, 156 were males and 98 were females, aged (37.44 ± 3.63) years old. The decision anxiety score of guardians of children with acute appendicitis was (52.49 ± 6.54). The results of multiple linear regression showed that age of children, gender of guardian, education level of guardian, per capita monthly income of family, decision making tendency and decision preparation were the main influencing factors of decision anxiety in guardians of children with acute appendicitis ( t values were -7.07-3.58, all P<0.05), which could explain 64.4% of the total variation. Conclusions:The decision anxiety in guardians of children with acute appendicitis is at a high level. Medical staff should provide targeted decision guidance, improve decision assistance programs and provide more effective decision support for guardians of children with acute appendicitis.
7.Guidelines for the Digital Ancient Books of TCM Indexing
Weina ZHANG ; Bing LI ; Bin LI ; Jing XIE ; Yan DONG ; Wei LONG ; Chuchu ZHANG ; Tong WEI ; Sihong LIU ; Yang WU ; Hongtao LI ; Lin TONG ; Guangkun CHEN ; Fei DONG ; Rui WANG ; He LU ; Meng LI ; Jingpeng DENG ; Tengfei WANG ; Xiaoying LI ; Di ZHANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(3):1-11
Guidelines for Digital Ancient Books of TCM Indexing(T/CIATCM 119-2024)is based on the theoretical knowledge,disciplinary methods,and practical applications of TCM classical cataloging.Taking digital ancient books of TCM as the object,it systematically reveals the content of TCM knowledge,which is an essential indexing processing standard for building an intelligent retrieval system for TCM ancient books,and can provide support for the deep development and innovative utilization of TCM knowledge.It can not only promote the co-construction and sharing of ancient book resources in the TCM industry,but also promote the standardization construction and application of TCM information.This standard specifies the principles,methods,and examples of free indexing of digital ancient books of TCM based on their original content.It is applicable to the indexing and processing of digital ancient books of TCM for TCM professional libraries and related institutions,and to the data processing and construction of various types of TCM ancient book databases.
8.Effects of Hofmeister series ions on encapsulation efficiencies of three components in inclusion complex of volatile oils from Wenjing Decoction
Wen SHEN ; Zhuo-yuan LI ; Lin TAO ; Wei XIE ; Run SHI ; Yu-han CUI ; Wen LI ; Jun-song LI
Chinese Traditional Patent Medicine 2025;47(11):3571-3580
AIM To explore the effects of Hofmeister series ions on encapsulation efficiencies of cinnamaldehyde,paeonol,and ligustilide in inclusion complex of volatile oils from Wenjing Decoction.METHODS The volatile oils were extracted,after which the β-cyclodextrin inclusion complex was prepared,the thermal stability was evaluated,and encapsulation efficiencies and inclusion complex constants of various volatile components in Na2SO4,NaH2PO4,NaCl,NaI,NaSCN solutions were determined.RESULTS The β-cyclodextrin inclusion complex demonstrated good thermal stability within 10 d.After the addtion of Hofmeister series ions,various volatile components displayed increased encapsulation efficiencies and inclusion complex constants,and concentration-dependent manner was observable in the latter.CONCLUSION Hofmeister series ions can affect the binding affinities of volatile components and β-cyclodextrin in volatile oils from Wenjing Decoction,thus regulate their encapsulation efficiencies.
9.Distribution and resistance profiles of bacterial strains isolated from cerebrospinal fluid in hospitals across China:results from the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Juan MA ; Lixia ZHANG ; Yang YANG ; Fupin HU ; Demei ZHU ; Han SHEN ; Wanqing ZHOU ; Wenen LIU ; Yanming LI ; Yi XIE ; Mei KANG ; Dawen GUO ; Jinying ZHAO ; Zhidong HU ; Jin LI ; Shanmei WANG ; Yafei CHU ; Yunsong YU ; Jie LIN ; Yingchun XU ; Xiaojiang ZHANG ; Jihong LI ; Bin SHAN ; Yan DU ; Ping JI ; Fengbo ZHANG ; Chao ZHUO ; Danhong SU ; Lianhua WEI ; Fengmei ZOU ; Xiaobo MA ; Yanping ZHENG ; Yuanhong XU ; Ying HUANG ; Yunzhuo CHU ; Sufei TIAN ; Hua YU ; Xiangning HUANG ; Sufang GUO ; Xuesong XU ; Chao YAN ; Fangfang HU ; Yan JIN ; Chunhong SHAO ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Fang DONG ; Zhiyong LÜ ; Lei ZHU ; Jinhua MENG ; Shuping ZHOU ; Yan ZHOU ; Chuanqing WANG ; Pan FU ; Yunjian HU ; Xiaoman AI ; Ziyong SUN ; Zhongju CHEN ; Hong ZHANG ; Chun WANG ; Yuxing NI ; Jingyong SUN ; Kaizhen WEN ; Yirong ZHANG ; Ruyi GUO ; Yan ZHU ; Jinju DUAN ; Jianbang KANG ; Xuefei HU ; Shifu WANG ; Yunsheng CHEN ; Qing MENG ; Yong ZHAO ; Ping GONG ; Ruizhong WANG ; Hua FANG ; Jilu SHEN ; Jiangshan LIU ; Hongqin GU ; Jiao FENG ; Shunhong XUE ; Bixia YU ; Wen HE ; Lin JIANG ; Longfeng LIAO ; Chunlei YUE ; Wenhui HUANG
Chinese Journal of Infection and Chemotherapy 2025;25(3):279-289
Objective To investigate the distribution and antimicrobial resistance profiles of common pathogens isolated from cerebrospinal fluid(CSF)in CHINET program from 2015 to 2021.Methods The bacterial strains isolated from CSF were identified in accordance with clinical microbiology practice standards.Antimicrobial susceptibility test was conducted using Kirby-Bauer method and automated systems per the unified CHINET protocol.Results A total of 14 014 bacterial strains were isolated from CSF samples from 2015 to 2021,including the strains isolated from inpatients(95.3%)and from outpatient and emergency care patients(4.7%).Overall,19.6%of the isolates were from children and 80.4%were from adults.Gram-positive and Gram-negative bacteria accounted for 68.0%and 32.0%,respectively.Coagulase negative Staphylococcus accounted for 73.0%of the total Gram-positive bacterial isolates.The prevalence of MRSA was 38.2%in children and 45.6%in adults.The prevalence of MRCNS was 67.6%in adults and 69.5%in children.A small number of vancomycin-resistant Enterococcus faecium(2.2%)and linezolid-resistant Enterococcus faecalis(3.1%)were isolated from adult patients.The resistance rates of Escherichia coli and Klebsiella pneumoniae to ceftriaxone were 52.2%and 76.4%in children,70.5%and 63.5%in adults.The prevalence of carbapenem-resistant E.coli and K.pneumoniae(CRKP)was 1.3%and 47.7%in children,6.4%and 47.9%in adults.The prevalence of carbapenem-resistant Acinetobacter baumannii(CRAB)and Pseudomonas aeruginosa(CRPA)was 74.0%and 37.1%in children,81.7%and 39.9%in adults.Conclusions The data derived from antimicrobial resistance surveillance are crucial for clinicians to make evidence-based decisions regarding antibiotic therapy.Attention should be paid to the Gram-negative bacteria,especially CRKP and CRAB in central nervous system(CNS)infections.Ongoing antimicrobial resistance surveillance is helpful for optimizing antibiotic use in CNS infections.
10.Changing antibiotic resistance profiles of the bacterial strains isolated from geriatric patients in hospitals across China:data from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Xiaoman AI ; Yunjian HU ; Chunyue GE ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Hui LI ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2025;25(3):290-302
Objective To investigate the antimicrobial resistance of clinical isolates from elderly patients(≥65 years)in major medical institutions across China.Methods Bacterial strains were isolated from elderly patients in 52 hospitals participating in the CHINET Antimicrobial Resistance Surveillance Program during the period from 2015 to 2021.Antimicrobial susceptibility test was carried out by disk diffusion method and automated systems according to the same CHINET protocol.The data were interpreted in accordance with the breakpoints recommended by the Clinical and Laboratory Standards Institute(CLSI)in 2021.Results A total of 514 715 nonduplicate clinical isolates were collected from elderly patients in 52 hospitals from January 1,2015 to December 31,2021.The number of isolates accounted for 34.3%of the total number of clinical isolates from all patients.Overall,21.8%of the 514 715 strains were gram-positive bacteria,and 78.2%were gram-negative bacteria.Majority(90.9%)of the strains were isolated from inpatients.About 42.9%of the strains were isolated from respiratory specimens,and 22.9%were isolated from urine.More than half(60.7%)of the strains were isolated from male patients,and 39.3%isolated from females.About 51.1%of the strains were isolated from patients aged 65-<75 years.The prevalence of methicillin-resistant strains(MRSA)was 38.8%in 32 190 strains of Staphylococcus aureus.No vancomycin-or linezolid-resistant strains were found.The resistance rate of E.faecalis to most antibiotics was significantly lower than that of Enterococcus faecium,but a few vancomycin-resistant strains(0.2%,1.5%)and linezolid-resistant strains(3.4%,0.3%)were found in E.faecalis and E.faecium.The prevalence of penicillin-susceptible S.pneumoniae(PSSP),penicillin-intermediate S.pneumoniae(PISP),and penicillin-resistant S.pneumoniae(PRSP)was 94.3%,4.0%,and 1.7%in nonmeningitis S.pneumoniae isolates.The resistance rates of Klebsiella spp.(Klebsiella pneumoniae 93.2%)to imipenem and meropenem were 20.9%and 22.3%,respectively.Other Enterobacterales species were highly sensitive to carbapenem antibiotics.Only 1.7%-7.8%of other Enterobacterales strains were resistant to carbapenems.The resistance rates of Acinetobacter spp.(Acinetobacter baumannii 90.6%)to imipenem and meropenem were 68.4%and 70.6%respectively,while 28.5%and 24.3%of P.aeruginosa strains were resistant to imipenem and meropenem,respectively.Conclusions The number of clinical isolates from elderly patients is increasing year by year,especially in the 65-<75 age group.Respiratory tract isolates were more prevalent in male elderly patients,and urinary tract isolates were more prevalent in female elderly patients.Klebsiella isolates were increasingly resistant to multiple antimicrobial agents,especially carbapenems.Antimicrobial resistance surveillance is helpful for accurate empirical antimicrobial therapy in elderly patients.

Result Analysis
Print
Save
E-mail