1.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
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.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
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.Dynamic distribution and clearance of 99mTc-DTPA in brain extracellular space
Jing ZOU ; Tianzi GAO ; Yang WANG ; Mengmeng REN ; Dongyang LIU ; Ren LONG ; Yumeng CHENG ; Meng LIU ; Zhengren XU ; Zhaoheng XIE ; Pengyu LV ; Lan YUAN ; Hongbin HAN
Journal of Peking University(Health Sciences) 2025;57(3):562-568
Objective:To explore the distribution and clearance of 99mTc labeled diethylenetriamine pentaacetic acid(99mTc-DTPA)in different brain regions of adult rats after administration through brain extracellular space(ECS)pathway.Methods:After the injection of a volume of 2 μL and radioactive activity of about 3.7 MBq(100 μCi)of 99mTc-DTPA into the caudate nucleus and thalamus of SD rats through stereotactic positioning of rat brain,the single photon emission computed tomography/computed tomography(SPECT/CT)for small animals was used for imaging at different time points,and the dyna-mic distribution and clearance of the tracer in the whole body were observed continuously.The SD rats were injected with 99mTc-DTPA into thalamus and caudate nucleus respectively for biological distribution in vivo.They were put to death 4 h later.Their blood and urine were collected.The brain,cerebellum,heart,liver,spleen,lung,and kidney were taken and weighed by γ counter to measure its radioactivity.Results:SPECT/CT imaging results showed that after 99mTc-DTPA was administered through brain ECS,the radioactivity was concentrated in the brain,kidney and bladder.The tracer administered to the left caudate nucleus was preferentially drained to the right cerebellum,while the tracer administered to the right caudate nucleus was preferentially drained to the left cerebellum.There was a phenomenon of"con-tralateral cerebellar dominant drainage"in the caudate nucleus.The thalamic area preferentially drained to the ipsilateral cerebellum after administration.Four hours after administration via ECS,high radioac-tive uptake appeared in urine,cerebellum and brain,followed by blood and kidney.The radioactive up-take values of heart,liver,spleen and lung were low,which were mainly excreted through urinary sys-tem.Conclusion:Intracerebral ECS administration is a promising method of administration,but there are significant differences in distribution and clearance in different brain regions.This study further ex-pands the content and significance of"ECS regions",and also provides an important theoretical founda-tion for the treatment of encephalopathy and the research of new drugs through brain ECS in the future.
6.Correlation between serum cartilage intermediate layer protein 1 expression and myocardial fibrosis in patients with diabetes mellitus
Chan ZHAO ; Mengmeng ZHANG ; Rui WANG ; Fanshuo KONG ; Yiwen YANG
Journal of China Medical University 2025;54(9):791-795,801
Objective To investigate the relationship between the expression of serum cartilage intermediate layer protein 1(Cilp1)and myocardial fibrosis(MF)in patients with type 2 diabetes mellitus(T2DM).Methods A total of 106 patients with T2DM(T2DM group)who were admitted to The First Hospital of Qinhuangdao were selected for this study,and 110 healthy individuals were entered into the control group.The serum Cilp1 and MF indexes[procollagen type Ⅲ-N-terminal peptide(P Ⅲ NP),galactose lectin-3(Gal-3),hyaluronic acid(HA),type Ⅲ procollagen(PCⅢ)]were detected and compared between the two groups.According to the degree of MF,there were 31,25,23,and 27 patients with stage 0,1,2,and 3 disease,respectively.The levels of serum Cilp1 and serum Cal-3,P Ⅲ NP,PC Ⅲ,HA were compared between patients of different stages.The Spearman method was applied to analyze the correlation between serum Cilp1 and MF staging,while the Pearson method was applied to analyze the correlation between serum Cilp1 and Gal-3,P Ⅲ NP,PC Ⅲ,HA.We also performed a multivariate logistic regression analysis of the influencing factors of MF 2 to 3 in patients with T2DM,and a receiver operating characteristic(ROC)curve analysis was applied to evaluate the diagnostic efficacy of serum Cilp1 level for MF 2 to 3 in patients with T2DM.Results The serum Cilp1 level in the T2DM group was higher than that in the control group(t=21.758,P<0.05).Furthermore,the serum levels of Gal-3,P Ⅲ NP,PC Ⅲ,and HA in the T2DM group were higher than those in the control group(t=16.536-27.385,all P<0.05),and the serum Cilp1 level in patients with T2DM positively correlated with MF staging,Gal-3,PⅢ NP,PC Ⅲ,and HA(r=0.724,0.555,0.501,0.588,0.655,all P<0.05).The expression level of serum Cilp1 was found to be an influencing factor of MF 2 to 3 in patients with T2DM(P<0.05).Furthermore,the ROC curve analysis showed that the area under the curve of serum Cilp1 for diagnosing MF stage 2 to 3 in patients with T2DM was 0.914.Conclusion Serum Cilp1 levels are elevated in patients with T2DM,and Cilp1 level closely relates to the formation of MF.This information can assist in clinical judgment of the degree of MF in patients with T2DM.
7.Correlation between serum cartilage intermediate layer protein 1 expression and myocardial fibrosis in patients with diabetes mellitus
Chan ZHAO ; Mengmeng ZHANG ; Rui WANG ; Fanshuo KONG ; Yiwen YANG
Journal of China Medical University 2025;54(9):791-795,801
Objective To investigate the relationship between the expression of serum cartilage intermediate layer protein 1(Cilp1)and myocardial fibrosis(MF)in patients with type 2 diabetes mellitus(T2DM).Methods A total of 106 patients with T2DM(T2DM group)who were admitted to The First Hospital of Qinhuangdao were selected for this study,and 110 healthy individuals were entered into the control group.The serum Cilp1 and MF indexes[procollagen type Ⅲ-N-terminal peptide(P Ⅲ NP),galactose lectin-3(Gal-3),hyaluronic acid(HA),type Ⅲ procollagen(PCⅢ)]were detected and compared between the two groups.According to the degree of MF,there were 31,25,23,and 27 patients with stage 0,1,2,and 3 disease,respectively.The levels of serum Cilp1 and serum Cal-3,P Ⅲ NP,PC Ⅲ,HA were compared between patients of different stages.The Spearman method was applied to analyze the correlation between serum Cilp1 and MF staging,while the Pearson method was applied to analyze the correlation between serum Cilp1 and Gal-3,P Ⅲ NP,PC Ⅲ,HA.We also performed a multivariate logistic regression analysis of the influencing factors of MF 2 to 3 in patients with T2DM,and a receiver operating characteristic(ROC)curve analysis was applied to evaluate the diagnostic efficacy of serum Cilp1 level for MF 2 to 3 in patients with T2DM.Results The serum Cilp1 level in the T2DM group was higher than that in the control group(t=21.758,P<0.05).Furthermore,the serum levels of Gal-3,P Ⅲ NP,PC Ⅲ,and HA in the T2DM group were higher than those in the control group(t=16.536-27.385,all P<0.05),and the serum Cilp1 level in patients with T2DM positively correlated with MF staging,Gal-3,PⅢ NP,PC Ⅲ,and HA(r=0.724,0.555,0.501,0.588,0.655,all P<0.05).The expression level of serum Cilp1 was found to be an influencing factor of MF 2 to 3 in patients with T2DM(P<0.05).Furthermore,the ROC curve analysis showed that the area under the curve of serum Cilp1 for diagnosing MF stage 2 to 3 in patients with T2DM was 0.914.Conclusion Serum Cilp1 levels are elevated in patients with T2DM,and Cilp1 level closely relates to the formation of MF.This information can assist in clinical judgment of the degree of MF in patients with T2DM.
8.Progress in practice of infectious disease epidemiology in China
Weizhong YANG ; Luzhao FENG ; Zhongjie LI ; Yu LI ; Qiangru HUANG ; Xuancheng HU ; Zeni WU ; Xiaodan FAN ; Ting ZHANG ; Qing WANG ; Yanxia SUN ; Jianxing YU ; Enmin DING ; Mengmeng JIA
Chinese Journal of Epidemiology 2025;46(7):1276-1282
With the change of infectious disease incidence pattern and the development of related technologies, progresses have been made in the research of infectious disease epidemiology. In recent years, due to the change in the requirements of infectious disease prevention and control, the research focus has expanded from common infectious diseases to diseases which have been eliminated or might be eliminated, as well as emerging and re-emerging infectious diseases. Infectious disease data has been characterized by multiple sources and modalities. Along with the rapid development of pathogen detection methods, infectious disease surveillance has shifted from a single disease-targted one to a comprehensive one. Moreover, novel technologies such as multi-omics and artificial intelligence have been applied in infectious disease epidemiology research. The international cooperation in this field has become increasingly crucial, and the revision of the International Health Regulations and the negotiation of pandemic agreement will have a profound impact. In the future, infectious disease epidemiology research will develop with more powerful tools to improve its capabilities.
9.Research on arrhythmia classification algorithm based on adaptive multi-feature fusion network.
Mengmeng HUANG ; Mingfeng JIANG ; Yang LI ; Xiaoyu HE ; Zefeng WANG ; Yongquan WU ; Wei KE
Journal of Biomedical Engineering 2025;42(1):49-56
Deep learning method can be used to automatically analyze electrocardiogram (ECG) data and rapidly implement arrhythmia classification, which provides significant clinical value for the early screening of arrhythmias. How to select arrhythmia features effectively under limited abnormal sample supervision is an urgent issue to address. This paper proposed an arrhythmia classification algorithm based on an adaptive multi-feature fusion network. The algorithm extracted RR interval features from ECG signals, employed one-dimensional convolutional neural network (1D-CNN) to extract time-domain deep features, employed Mel frequency cepstral coefficients (MFCC) and two-dimensional convolutional neural network (2D-CNN) to extract frequency-domain deep features. The features were fused using adaptive weighting strategy for arrhythmia classification. The paper used the arrhythmia database jointly developed by the Massachusetts Institute of Technology and Beth Israel Hospital (MIT-BIH) and evaluated the algorithm under the inter-patient paradigm. Experimental results demonstrated that the proposed algorithm achieved an average precision of 75.2%, an average recall of 70.1% and an average F 1-score of 71.3%, demonstrating high classification accuracy and being able to provide algorithmic support for arrhythmia classification in wearable devices.
Humans
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Arrhythmias, Cardiac/diagnosis*
;
Algorithms
;
Electrocardiography/methods*
;
Neural Networks, Computer
;
Signal Processing, Computer-Assisted
;
Deep Learning
;
Classification Algorithms
10.Deciphering the Role of Shank3 in Dendritic Morphology and Synaptic Function Across Postnatal Developmental Stages in the Shank3B KO Mouse.
Jing YANG ; Guaiguai MA ; Xiaohui DU ; Jinyi XIE ; Mengmeng WANG ; Wenting WANG ; Baolin GUO ; Shengxi WU
Neuroscience Bulletin 2025;41(4):583-599
Autism Spectrum Disorder (ASD) is marked by early-onset neurodevelopmental anomalies, yet the temporal dynamics of genetic contributions to these processes remain insufficiently understood. This study aimed to elucidate the role of the Shank3 gene, known to be associated with monogenic causes of autism, in early developmental processes to inform the timing and mechanisms for potential interventions for ASD. Utilizing the Shank3B knockout (KO) mouse model, we examined Shank3 expression and its impact on neuronal maturation through Golgi staining for dendritic morphology and electrophysiological recordings to measure synaptic function in the anterior cingulate cortex (ACC) across different postnatal stages. Our longitudinal analysis revealed that, while Shank3B KO mice displayed normal neuronal morphology at one week postnatal, significant impairments in dendritic growth and synaptic activity emerged by two to three weeks. These findings highlight the critical developmental window during which Shank3 is essential for neuronal and synaptic maturation in the ACC.
Animals
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Nerve Tissue Proteins/metabolism*
;
Mice, Knockout
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Dendrites/metabolism*
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Mice
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Synapses/metabolism*
;
Gyrus Cinguli/metabolism*
;
Male
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Mice, Inbred C57BL
;
Autism Spectrum Disorder/genetics*
;
Microfilament Proteins

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