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 and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
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 and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
5.The regulatory role of microRNA in the progression from metabolic dysfunction-associated fatty liver disease to hepatocellular carcinoma
Jiali XIE ; Yaonan LIU ; Rui ZHAO
Journal of Clinical Hepatology 2026;42(4):943-949
Metabolic dysfunction-associated fatty liver disease (MAFLD) is the main cause of chronic liver disease around the world and can eventually lead to hepatocellular carcinoma. This article describes the evolution of the definition of MAFLD, the epidemiological burden of MAFLD, and the biosynthesis and biological functions of microRNA (miRNA), as well as the important role of various types of miRNA in the progression of MAFLD by regulating the processes such as lipid metabolism, inflammation and liver fibrosis, oxidative stress, endoplasmic reticulum stress, and glycolysis. This article also evaluates the application prospect of miRNA as diagnostic biomarkers and therapeutic targets. It is pointed out that although existing studies have shown that miRNA plays an important role in the progression of MAFLD, there are still challenges in clinical translation, and large-scale studies should be conducted in the future to clarify the practical value of miRNA in MAFLD diagnosis and treatment, thereby providing new ways for precision medicine.
6.PCBP1-mediated regulation of iron homeostasis suppresses ferroptosis against cadmium-induced neurotoxicity in mouse neuroblastoma cells
Sheng JIE ; Rui TIAN ; Yuchen QU ; Li TIAN ; Jia XIE ; Mengyan CHEN ; Mindi HE ; Zhengping YU ; Huifeng PI ; Ping DENG
Journal of Army Medical University 2025;47(19):2315-2326
Objective To investigate the role of poly(rC)-binding protein 1(PCBP1)in cadmium(Cd)-induced ferroptosis in mouse neuroblastoma Neuro-2a(N2A)cells.Methods N2A cells were exposed to a concentration gradient of CdCl?(0,1,2,4 μmol/L)for 72 h.Cell viability was assessed by trypan blue staining.Western blotting was employed to detect the expression of ferroptosis-related proteins(GPX4,HMOX1,ACSL4)and PCBP1.Intracellular Fe2? level and lipid peroxidation were detected using FerroOrange and BODIPY581/591 C11 probes,respectively.Ferrostatin-1(Fer-1),a ferroptosis inhibitor,was applied to confirm the critical role of ferroptosis in Cd-induced cytotoxicity.Molecular docking was performed to elucidate the interaction between PCBP1 and ferritin,as well as the binding sites of Cd2?.PCBP1 overexpression plasmid was further constructed for functional validation.Results Cd exposure suppressed cell viability in N2A cells in a dose-dependent manner(P<0.01),significantly down-regulated GPX4 expression(P<0.05),up-regulated HMOX1 expression(P<0.01),and induced Fe2? overload and lipid peroxidation(P<0.01).Molecular docking revealed that Cd2? directly bound to the KH2 domain of PCBP1 and then co-localized on the outer surface of ferritin heavy chain.Overexpression of PCBP1 markedly reversed Cd-induced Fe2? accumulation,GPX4 down-regulation,lipid peroxidation,and cell death.Conclusion Cd exposure disrupts PCBP1-mediated iron homeostasis via transcriptional suppression and competitive displacement of metal ions,and then synergistically drives Fe2? overload-triggered ferroptosis cascades,ultimately leading to neurotoxicity.Targeting PCBP1-mediated iron homeostasis can effectively mitigate Cd-induced neurotoxicity,and may serve as a novel therapeutic strategy.
7.Bibliometric and Visual Analysis of Forensic Research on Body Fluid Identification
Bao-Yan XIE ; Ruo-Cheng XIA ; Ting-Ting JIANG ; Rui-Yang TAO ; Cheng-Tao LI
Journal of Forensic Medicine 2025;41(3):217-227
Objective To analyze the literature in the field of body fluid identification collected in the Web of Science Core Collection(WoSCC)database from 2000 to 2023,and explore the research sta-tus,hotspots and development trends in this field.Methods The CiteSpace software was utilized to conduct a visual analysis of the literature in the field of body fluid identification included in the WoSCC database from 2000 to 2023.Meanwhile,a bibliometric analysis of the annual publication vol-ume,journal distribution,national contribution,research institutions,author collaboration,and keywords of the literature was conducted.Results A total of 715 papers on forensic body fluid identification were included,and the annual publication volume showed a continuous and stable growth.Among the 55 countries(regions)that published papers,the United States ranked first with 174 papers,followed by China with 107 papers.In terms of journal distribution,Forensic Science International:Genetics had the largest number of papers,which accounted for 20%of the total papers.In terms of author collaboration,a total of 2 079 authors participated in body fluid identification research,and the author collaboration network showed a clearly clustered distribution.The keywords analysis revealed that re-search hotspots focused on traditional methods,specific RNA molecular markers,DNA methylation,spectroscopy,and the application of microbiomics.Conclusion Research in the field of forensic body fluid identification is thriving,and research institutions and teams should strengthen their collaboration.Establishing unified result interpretation standards and systems and exploring the multiple biomarkers combined application methods will be the research hotspots and important directions for future research in this field.
8.Bioinformatics analysis of breast cancer specific expression gene based on the single-cell level
Yang WANG ; Guoxuan GAO ; Rui XIE ; Zhicheng GE
International Journal of Surgery 2025;52(6):375-379
Objective:To analyze the transcriptomic features of breast cancer and its lymph node metastasis using single-cell RNA sequencing, to identify potential biomarkers for breast cancer.Methods:The GSE180286 single-cell RNA sequencing dataset was used to examine the transcriptomic characteristics of breast cancer and its lymph node metastasis. Following quality control, dimensionality reduction, clustering, and cell annotation of single-cell data, genes associated with breast cancer were identified. Dotplot, FeaturePlot, and other analytical methods were applied to investigate the expression profiles of target genes ( ALOX15B, FAAH, HDGF, KLF5, TLE3, TNS1) across different cell types and to assess their activity in immune and metabolic pathways. Statistical analysis was performed using the bilateral Student′s t-test. Results:ALOX15B, FAAH, HDGF, KLF5, TLE3, and TNS1 were differentially expressed across various cell types in breast cancer. ALOX15B was specifically expressed in macrophages and involved in immune responses, particularly with high activity in complement and inflammatory response pathways. HDGF was primarily expressed in epithelial cells and closely associated with breast cancer proliferation, migration, and angiogenesis. FAAH, KLF5, TLE3, and TNS1 were also closely related to the onset and progression of breast cancer. Co-expression analysis revealed relationships between these genes and breast cancer regulatory genes such as BRCA1 and BRCA2. Conclusions:This study identified 6 breast cancer-specific expressed potential biomarkers, and revealed their expression characteristics in different cell types and their differential activity in immune-metabolism-related pathways. These findings provide potential targets for understanding the molecular mechanisms of breast cancer and developing new therapeutic strategies.
9.Effects of "four-steps tendon resetting and collaterals dredging manipulation" on the clinical symptoms and muscle status of calf muscle group of patients with chronic ankle sprain
Qifei WU ; Xiaoning ZHOU ; Rui WANG ; Keru LIN ; Bing WANG ; Fengwei WAN ; Xihuan YAN ; Xiangyuan XIE
International Journal of Traditional Chinese Medicine 2025;47(4):469-475
Objective:To explore the intervention effects of the "four-steps tendon resetting and collaterals dredging manipulation" on the symptoms and muscle status of calf muscle group of patients with chronic ankle sprains.Methods:This study was a prospective self-controlled clinical trial. A total of 39 patients with chronic ankle sprains who sought treatment at the basic units from April to September 2023 and Rehabilitation Medicine Center of Characteristic Medical Center of PLA Rocket Force from February to October 2023 were recruited. The "four-steps tendon resetting and collaterals dredging manipulation" was employed for treatment, with two sessions conducted per patient and one session per week. Pain levels were assessed using the Visual Analog Scale (VAS), ankle joint function was evaluated using the Ankle Osteoarthritis Scale and Function Assessment (AOFAS) score, and MyotonPRO digital palpation instrument was used to measure bilateral triceps and peroneal longus muscles and evaluate muscle status.Results:Compared with before treatment, VAS scores decreased ( t values were 5.85, 5.97, respecively, P<0.001) and AOFAS scores increased ( Z values were -4.59, -4.68, respecively, P<0.001). Before the first treatment and after the second treatment, the damping vibration frequency (Freq) of the affected and healthy triceps and peroneal muscles increased ( t values were -3.09,-2.92,-2.97,-2.28, respecively, P<0.05), the muscle stiffness (Stiff) increased ( t values were -3.12, -2.99, -2.88, -2.15, respecively, P<0.05), and the logarithmic attenuation value (Decr) of the damping vibration of the healthy calf triceps muscle decreased ( t=-2.31, P<0.05); Compared before and after the first treatment, the Decr value ( t=-2.51, P<0.05) and Stiff value ( t=-2.05, P<0.05) of the affected fibular longus muscle increased, while the Ferq, Decr, and Stiff values of the healthy calf triceps muscle increased before and after treatment ( t values were -2.92, -2.13, -2.64, respecively, P<0.05); before and after the second treatment, the Freq values of the triceps and peroneal longus muscles on the affected and healthy sides increased ( t values were -4.28, -2.67, -2.69, -2.38, respecively, P<0.05) and Stiff values increased ( t values were -4.24, -3.43, -3.87, -2.33, respecively, P<0.05); there was no statistical significance in Ferq, Decr, and Stiff values between the affected and healthy sides before and after the first and second treatments ( P>0.05). Conclusion:The "four-steps tendon resetting and collaterals dredging manipulation" can improve the symptoms of chronic ankle sprains and significantly change the muscle condition of the affected and healthy sides of the calf. The mechanism may be related to the neuromuscular control mechanism.
10.Clinical study on Chinese materia medica soaking therapy combined with cervical rotation-traction manipulation in the treatment of cervical spondylotic radiculopathy
Di WANG ; Rui XIE ; Lei SHI ; Long GONG ; Jie LUO ; Peiyu SUN
International Journal of Traditional Chinese Medicine 2025;47(12):1682-1686
Objective:To observe the clinical efficacy of Chinese materia medica soaking therapy combined with cervical rotation-traction manipulation in the treatment of cervical spondylotic radiculopathy (CSR).Methods:A randomized controlled trial was conducted. Totally 84 CSR patients from the Orthopedics Department of Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital from April 2023 to May 2024 were selected as the observation subjects. They were divided into two groups using a random number table method, with 42 patients in each group. The treatment for both groups lasted for 14 d. VAS scale was used to assess pain levels before and after treatment, OASTCSR was used to evaluate cervical function, and NDI was used to assess cervical functional status; adverse reactions during treatment were observed and recorded, and clinical efficacy was evaluated.Results:The total effective rate was 95.24% (40/42) in the treatment group and 80.95% (34/42) in the control group, with statistical significance ( χ2=4.36, P=0.029). After treatment, the VAS score (1.60±1.21 vs. 2.91±1.12, t=-1.89), the OASTCSR score (5.17±2.14 vs. 9.31±3.82, t=-11.57), and the NDI score (9.17±2.13 vs. 13.36±3.45, t=-10.82) in the treatment group were lower than those in the control group ( P<0.001 or P<0.05). During the treatment period, neither group experienced any adverse reactions. Conclusion:The combination of Chinese materia medica soaking therapy and cervical rotation-traction manipulation can significantly improve the clinical symptoms and quality of life of patients with CSR, and its efficacy is superior to the use of cervical rotation-traction manipulation alone.

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