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.Advances in detection techniques for congenital blood group chimerism
Shuo ZHANG ; Hongyan YANG ; Yuhan GAO ; Ranran QIN ; Xinrui WANG ; Ke ZHANG ; Yifan LI ; Ruiqin HOU
Chinese Journal of Blood Transfusion 2026;39(3):402-407
Congenital blood group chimerism refers to the coexistence of two or more distinct blood types within an individual, resulting from the presence of hematopoietic cell populations with different genotypes. Consequently, red blood cells in such individuals may express different blood group antigens. Based on the timing and mechanism of formation, blood group chimerism can be classified as either congenital or acquired. Although congenital blood group chimerism is rare and involves complex mechanisms, it holds significant implications in transfusion medicine, transplantation, and obstetrics. This article reviews the formation mechanisms, detection methods, and clinical significance of congenital blood group chimerism in transfusion medicine. Particular emphasis is placed on the principles, advantages, and limitations of various detection techniques. Furthermore, the potential applications of these technologies in clinical diagnosis are discussed, providing a technical foundation for the development of precise transfusion strategies.
6.Potential Mechanism of Zuojinwan in Improving Liver Fibrosis Based on Hepatic Tissue Metabolomics
Yiting JIANG ; Kexin LIU ; Yixi QIAN ; Rui ZHANG ; Feng ZHANG ; Hongyan WU ; Li CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):54-61
ObjectiveThis study aims to elucidate the potential mechanism of Zuojinwan in improving liver fibrosis through hepatic tissue metabolomics analysis. MethodsTwenty-four mice were randomly allocated into normal group, model group , positive drug group (silymarin, 100 mg·kg-1), and Zuojinwan group (Zuojinwan solution, 2.5 g·kg-1), with per group six mice. Liver fibrosis model was induced via intraperitoneal injection of olive oil solution with 10% carbon tetrachloride (CCl4) (0.5 μL·g-1, three times weekly for 8 weeks) in all groups except the normal group. During the final 4 weeks, the silymarin group received silymarin (100 mg·kg-1) by gavage thrice weekly, while the Zuojinwan group was administered Zuojinwan solution (2.5 g·kg-1) under the same regimen. After the last administration, the levels of liver fibrosis indicators and liver injury markers in serum were detected. The pathological morphological changes of the liver tissues were observed. The levels of liver fibrosis markers α-smooth muscle actin (α-SMA) and Collagen Ⅰ(ColⅠ) were detected. Metabolomics was analyzed on mice's liver tissues. The mice's serum was collected for metabolomics analysis. ResultsCompared with the model group, Zuojinwan significantly improved indicators related to liver fibrosis and liver injury. Compared with the normal group, the model group showed significantly elevated levels of fibrosis markers such as laminin (LN), hyaluronic acid (HA), procollagen typeⅢ (PC-Ⅲ), and type Ⅳ Collagen (Ⅳ-C), while liver injury indicators such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), and total bilirubin (TBIL), exhibited a marked upward trend (P<0.05). Compared with the model group, the silymarin group showed a significant decrease in the aforementioned indicators (P<0.05). Notably, compared with the model group, the Zuojinwan group exhibited a significant reduction in all these indicators (P<0.05), with efficacy comparable to that of the silymarin group. Zuojinwan reduced mRNA and protein levels of α-SMA and ColⅠ in the liver tissue. Metabolomics results revealed that compared with the model group, Zuojiinwan significantly reduced levels of glucose metabolism-related metabolites such as D-fructose 1,6-bisphosphate (FBP), nicotinamide adenine dinucleotide phosphate (NADPH), sodium beta-D-fructose 6-phosphate (F6P), dihydroxyacetone phosphate (DHAP), fumaric acid, and D-glucose 6-phosphate (G6P) (P<0.05). Serum enzyme-linked immunosorbent assay (ELISA) was used to detect glucose metabolism indicators and further validate the regulatory effect of Zuojinwan on glucose metabolism. ConclusionThese results suggest that Zuojinwan may improve liver fibrosis by regulating the dysregulated levels of glucose metabolism during the progression of liver fibrosis.
7.Effects and mechanisms of combined exposure to noise and microwave on hippocampal structure and function in mice
Chunxue LU ; Lei SHI ; Yue WANG ; Yanhui HAO ; Xuelong ZHAO ; Yang LI ; Hongyan ZUO ; Liqian ZHU
Journal of Environmental and Occupational Medicine 2026;43(4):419-426
Background Co-exposure to noise and microwave radiation occurs frequently. The central nervous system has been identified as a sensitive target organ for both noise and microwave exposure individually, and the underlying mechanisms remain poorly understood. The specific biological effects resulting from co-exposure to these two factors have yet to be fully elucidated. Objective To clarify the effects of co-exposure to noise and microwave on neurobehavior and hippocampal tissue structure, and to explore the underlying mechanism through the assessment of serum cytokines. Methods C57BL/6N mice were selected and randomly assigned to a blank control group, a noise group, a microwave group, and a combined noise & microwave exposure group. To establish the exposure models, the noise group was subjected to broadband noise at 100 dB for 2 h, while the microwave group received radiation at a central frequency of 9.375 GHz with an average power density of 12 mW·cm−2 and a specific absorption rate of 2.58 W·kg−1 for 15 min. Open field and tail suspension tests assessed anxiety-like emotional behaviour; novel object recognition and Y-maze tests evaluated cognitive function. Histological changes in hippocampal tissue were examined using haematoxylin and eosin (HE) staining, and Nissl staining under light microscopy. Serum cytokine levels were measured using radioimmunoassay and enzyme-linked immunosorbent assay (ELISA). Results After 3 d of exposure, the noise, microwave, and combined exposure groups showed significant reductions in exploration frequency, duration, and distance within the central zone of the open field test compared to the control group (P < 0.01); the combined exposure group exhibited increased ratios of peripheral-to-central exploration time and distance (P < 0.05). After 7 d of exposure, compared with the control group, the noise group maintained a decrease in central zone exploration time (P < 0.01), while the combined exposure group showed persistent decline across all central zone metrics (P < 0.05) and elevated peripheral-to-central ratios (P < 0.05); compared to the microwave group, the combined exposure group showed significant less time in the central zone (P < 0.05) and higher peripheral-to-central ratios (P < 0.05). Regarding behaviour and cognition, compared with the control group, the combined exposure group showed increased immobility time in the tail suspension test after 3 d of exposure (P < 0.01). At this interval, all exposure groups demonstrated reduced frequency and duration of novel object recognition (P < 0.05), with the combined exposure group showing a marked decrease in novel arm exploration time (P < 0.01). After 7 d of exposure, compared with the control group, the noise group showed reduced novel object recognition frequency (P < 0.05), and both the noise and microwave groups exhibited decreased novel arm exploration time (P < 0.05). Pathological alterations including an increased number of hyperchromatic nuclei and depleted Nissl bodies were observed in the CA3 and DG regions across all exposure groups with the most severe lesions observed in the combined exposure group. Serum levels of central nervous system-specific protein β (S-100β), glial fibrillary acidic protein (GFAP), and corticosterone (CORT) were significantly elevated in all exposure groups compared with the control group (P < 0.05). Aquaporin-4 (AQP4) levels increased in the combined exposure group (P < 0.05), while CXC chemokine ligand 10 (CXCL10) levels rose in both the noise and combined groups compared with the control group (P < 0.05). Specifically, S-100β and CXCL10 levels in the combined exposure group were higher than those in the microwave group (P < 0.05); moreover, levels of S-100β, GFAP, CORT, AQP4, and CXCL10 in the combined exposure group were significantly higher than those in the noise group (P < 0.05). Conclusion Combined exposure to noise and microwave radiation induces pathological changes in the hippocampus of mice, increases levels of serum stress hormones and neuro-specific biomarkers. These impairments are more severe than those observed following single-factor exposure. The underlaying mechanism may be related to systemic stress response, neuronal damage, astrocyte activation, and changes in blood-brain barrier permeability, leading to emotional behavioral abnormalities and cognitive decline.
8.Application of telemedicine, wearables and artificial intelligence in pulmonary rehabilitation for chronic obstructive pulmonary disease from 2011 to 2025: a bibliometric analysis
Jinmeng LI ; Junna LIU ; Qiang CHEN ; Hongyan BI
Chinese Journal of Rehabilitation Theory and Practice 2026;32(7):829-840
ObjectiveTo systematically sort out literatures regarding telemedicine, wearable devices and artificial intelligence in pulmonary rehabilitation for chronic obstructive pulmonary disease (COPD) from 2011 to 2025, to identify the research status, hotspots and development trends. MethodsOriginal articles and reviews published from January 1, 2011 to December 31, 2025 were retrieved from Web of Science Core Collection and Scopus. Bibliometric analyses were performed via VOSviewer, CiteSpace and Scimago Graphica, including annual publication volume, collaboration networks of countries, institutions and authors, co-citation of journals and references, and keyword co-occurrence, clustering and bursting. ResultsA total of 917 literatures were included. The annual number of publications showed a sustained upward trend. The United States and the United Kingdom took the leading position in publication output and academic influence. The University of Toronto was the most productive institution, and Anne E. Holland was the most prolific author. European Respiratory Journal and American Journal of Respiratory and Critical Care Medicine were high-impact journals. COPD, pulmonary rehabilitation, telerehabilitation and telemedicine were high-frequency core keywords. Machine learning, interstitial lung disease, virtual reality and digital health were the bursting keywords in recent years. ConclusionThe researches on digital pulmonary rehabilitation for COPD are increasing continuously in the past 15 years. The research focus has shifted from hospital-based standardized rehabilitation to community home digital rehabilitation centered on patient self-management. Future studies will focus on the deep integration of multiple digital technologies and extension of rehabilitation protocols to other chronic respiratory diseases.
9.Diagnostic value of cytokines combined with Model for End-Stage Liver Disease score in predicting hepatic encephalopathy in end-stage liver disease
Jinyu XIANG ; Lixian CHANG ; Yingyuan ZHANG ; Huan MU ; Wenyan LI ; Hongyan WEI ; Chunyun LIU ; Li LIU
Journal of Clinical Hepatology 2026;42(7):1638-1647
ObjectiveTo construct and validate a predictive model for hepatic encephalopathy (HE) in patients with end-stage liver disease (ESLD) by combining key indicators such as cytokines and Model for End-Stage Liver Disease (MELD) score, and to provide evidence-based support for the early identification of high-risk populations and the optimization of intervention strategies in clinical practice. MethodsA retrospective analysis was performed for 2 167 patients with ESLD who were admitted to The Third People’s Hospital of Kunming from January 2022 to December 2024, the patients were divided into a training set with 1 517 patients and a validation set with 650 patients at a ratio of 7∶3 using the stratified random sampling method. A univariate analysis and a least absolute shrinkage and selection operator (LASSO) regression analysis were performed for the training set to identify potential influencing variables, and then a binary Logistic regression model was constructed to investigate the independent influencing factors for HE in ESLD patients. A nomogram prediction model was established based on this regression model, and the Hosmer-Lemeshow goodness-of-fit test was performed. The receiver operating characteristic (ROC) curve, calibration curves, decision curve analysis, and clinical impact curve were used to comprehensively evaluate the degree of fit, accuracy, consistency, and clinical practicability of the predictive model derived from the training set. The Mann-Whitney U test was used for comparison of non-normally distributed quantitative data between two groups. The chi-square test or Fisher exact test was used for comparison of categorical data between two groups. ResultsThe univariate analysis showed that there were significant differences between the study group and the control group in age, sex, blood ammonia, lymphocytes, hemoglobin, platelet count, prothrombin time, fibrinogen, international normalized ratio, total bilirubin, aspartate aminotransferase, total protein, albumin, prealbumin, alkaline phosphatase, cholinesterase, total bile acid, triglyceride, total cholesterol, high-density lipoprotein, low-density lipoprotein, blood glucose, CD3+ T cells, CD4+ T cells, CD8+ T cells, high-sensitivity C-reactive protein, carcinoembryonic antigen, triiodothyronine, thyroxine, free triiodothyronine, free thyroxine, interleukin-1β, interleukin-5, interleukin-6, interleukin-8, interleukin-12p70, interleukin-17, interferon-γ, and MELD score (all P<0.05). The LASSO regression analysis identified nine variables of age, blood ammonia, albumin, prealbumin, cholinesterase, total cholesterol, thyroxine, interleukin-17, and MELD score, and the binary Logistic regression analysis showed that blood ammonia, interleukin-17, and MELD score were independent risk factors for HE in ESLD patients, while age and thyroxine were independent protective factors (all P<0.05). A nomogram model was constructed based on these five variables. The Hosmer-Lemeshow goodness-of-fit test in the training set showed a good degree of fit (P=0.207), with a McFadden’s pseudo-R2 of 0.184, suggesting that the model had acceptable explanatory power; the Hosmer-Lemeshow goodness-of-fit test in the internal validation set further confirmed the calibration stability of the model (P=0.067), suggesting that the model had a good degree of fit in independent data. The model had an area under the ROC curve of 0.784 in the validation set, with a sensitivity of 0.710 and a specificity of 0.752. The mean absolute error of the calibration curve was 0.067, and decision curve analysis and clinical impact curve showed that the nomogram model had positive net benefit and good clinical practicability. ConclusionThe nomogram model constructed based on age, blood ammonia, thyroxine, interleukin-17, and MELD score for predicting HE in patients with ESLD has a good degree of fit, high accuracy and consistency, and excellent clinical practicability.
10.Safety analysis of Yttrium-90 resin microsphere selective internal radiation therapy on malignant liver tumors
Jia CAI ; Shiwei TANG ; Rongli LI ; Mingxin KONG ; Hongyan DING ; Xiaofeng YUAN ; Yuying HU ; Ruimei LIU ; Xiaoyan ZHU ; Wenjun LI ; Haibin ZHANG ; Guanwu WANG
Chinese Journal of Clinical Medicine 2025;32(1):24-29
Objective To explore the safety of Yttrium-90 resin microsphere selective internal radiation therapy (90Y-SIRT) on malignant liver tumors. Methods A retrospective analysis was conducted on 64 patients with malignant liver tumors who underwent 90Y-SIRT from February 2023 to November 2024 at Weifang People’s Hospital. The clinical characteristics of the patients and the occurrence of adverse reactions after treatment were analyzed to assess the safety of 90Y-SIRT. Results Among the 64 patients, there were 52 males (81.25%) and 12 females (18.75%); the average age was (56.29±11.08) years. Seven patients (10.94%) had tumors with maximum diameter of less than 5 cm, 38 patients (59.38%) had tumors with maximum diameter of 5-10 cm, and 19 patients (29.68%) had tumors with maximum diameter of greater than 10 cm. There were 47 cases (73.44%) of solitary lesions and 17 cases (26.56%) of multiple lesions; 53 cases (82.81%) were primary liver cancers and 11 cases (17.19%) were metastatic liver cancers. Of the 64 patients, 63 successfully completed the Technetium-99m macroaggregated albumin (99mTc-MAA) perfusion test and received the 90Y-SIRT; one patient received 90Y-SIRT after the second 99mTc-MAA perfusion test due to a work error. The most common adverse reactions included grade 1 alanine aminotransferase (ALT) elevation in 26 cases (40.62%) and grade 2 in 2 cases (9.37%), grade 1 aspartate aminotransferase (AST) elevation in 27 cases (42.18%) and grade 2 in 7 cases (10.93%); grade 1 nausea in 17 cases (26.56%) and grade 2 in 6 cases (9.37%); grade 1 abdominal pain in 12 cases (18.75%), grade 2 in 5 cases (7.81%), and grade 3 in 1 case (1.56%); grade 1 vomiting in 11 cases (17.18%), grade 2 in 5 cases (7.81%), and grade 3 in 1 case (1.56%). Conclusion The adverse reactions of 90Y-SIRT for treating malignant liver tumors are mild, indicating good safety.

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