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.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.
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.Research Progress of Stem Cells Transplantation in Treatment of Cognitive Impairment After Stroke
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(1):41-49
Stroke is a common acute cerebrovascular disease. Post-stroke cognitive impairment (PSCI) is one of the most common complications of stroke, which seriously affects the quality of life and physical health of patients. As a cutting-edge medical therapy, stem cells transplantation has great potential in the treatment of PSCI by reducing inflammation, promoting axon regeneration and immune regulation, and has become the focus of current research. However, the relationship between stem cells transplantation and PSCI has not been systematically summarized. Therefore, this paper will briefly summarize the biological functions of different types of stem cells, systematically comb out and summarize the mechanisms of stem cells transplantation in PSCI regulation and its applications in PSCI treatment, providing a deeper understanding and strategy for clinical PSCI management.
5.Research progress on the molecular mechanism and therapeutic targets of ferroptosis in acute kidney injury
Yang ZHANG ; Fanyi HE ; Kongchun SUN ; Rui YANG ; Xuezhi YU ; Ling ZHANG ; Ruixiang CHEN ; Baochun SHEN
Organ Transplantation 2025;16(2):315-321
Acute kidney injury (AKI) is one of the most common and severe nephropathy syndromes in clinical practice and also one of the most common serious complications after organ transplantation, with high incidence and fatality. Iron is an essential trace element in the body. Ferroptosis is a form of programmed cell death induced by the accumulation of iron-mediated lipid peroxidation, and its occurrence is closely related to iron metabolism, lipid metabolism, amino acid metabolism and multiple signaling pathways. Recent studies have shown that ferroptosis plays a key role in the occurrence and development of AKI and provides therapeutic targets for AKI. This article summarizes the regulatory mechanism of ferroptosis and its role in AKI, as well as the compounds that play an important role in the prevention and treatment of AKI by inhibiting ferroptosis, providing new ideas for the future treatment and research of AKI.
6.The application strategies of non-uniform sampling in the structure elucidation of small molecule compounds—an instantiation using fuziline
Li-li ZHANG ; Ke ZHANG ; Jie LIU ; Chun-wang MENG ; Rui FENG ; Liang XIONG
Acta Pharmaceutica Sinica 2025;60(1):218-224
Two-dimensional nuclear magnetic resonance (2D NMR) is a widely used technique for structural analysis of small molecular compounds. It can obtain information about the hydrogen-hydrogen correlation, hydrogen-carbon single bond correlation, hydrogen-carbon remote correlation, and hydrogen-hydrogen spatial arrangement of compounds. Thus, 2D NMR has an irreplaceable role in the structure elucidation of small molecular products. However, the sample amount of trace components in phytochemical research is very low, and the traditional sampling method (uniform sampling) has problems of poor spectral quality and too long measure time. Increasing the number of scans results in several hours of the acquisition time for a single two-dimensional spectrum, which in turn causes strain on the NMR machine. The non-uniform sampling (NUS) technique can shorten the acquisition time to a large extent and not affect the quality of 2D NMR data, which greatly improves the efficiency of 2D NMR acquisition. In this paper, fuziline, a small molecular compound in the lateral roots of
7.The effect of rutaecarpine on improving fatty liver and osteoporosis in MAFLD mice
Yu-hao ZHANG ; Yi-ning LI ; Xin-hai JIANG ; Wei-zhi WANG ; Shun-wang LI ; Ren SHENG ; Li-juan LEI ; Yu-yan ZHANG ; Jing-rui WANG ; Xin-wei WEI ; Yan-ni XU ; Yan LIN ; Lin TANG ; Shu-yi SI
Acta Pharmaceutica Sinica 2025;60(1):141-149
Metabolic-associated fatty liver disease (MAFLD) and osteoporosis (OP) are two very common metabolic diseases. A growing body of experimental evidence supports a pathophysiological link between MAFLD and OP. MAFLD is often associated with the development of OP. Rutaecarpine (RUT) is one of the main active components of Chinese medicine Euodiae Fructus. Our previous studies have demonstrated that RUT has lipid-lowering, anti-inflammatory and anti-atherosclerotic effects, and can improve the OP of rats. However, whether RUT can improve both fatty liver and OP symptoms of MAFLD mice at the same time remains to be investigated. In this study, we used C57BL/6 mice fed a high-fat diet (HFD) for 4 months to construct a MAFLD model, and gave the mice a low dose (5 mg·kg-1) and a high dose (15 mg·kg-1) of RUT by gavage for 4 weeks. The effects of RUT on liver steatosis and bone metabolism were then evaluated at the end of the experiment [this experiment was approved by the Experimental Animal Ethics Committee of Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences (approval number: IMB-20190124D303)]. The results showed that RUT treatment significantly reduced hepatic steatosis and lipid accumulation, and significantly reduced bone loss and promoted bone formation. In summary, this study shows that RUT has an effect of improving fatty liver and OP in MAFLD mice.
8.Factors influencing influenza vaccination coverage among kindergarten and primary school children in Zhejiang Province, 2023
Minchao LI ; Jing TAO ; Rui ZHANG ; Yumeng WU ; Zhaokai HE ; Chen WU
Shanghai Journal of Preventive Medicine 2025;37(1):23-28
ObjectiveTo investigate the influenza vaccination coverage among kindergarten and primary school children in Zhejiang Province in 2023 and analyze the influencing factors, and to provide the basis for improving the effect of influenza vaccination in children. MethodsA multi-stage random cluster sampling method was used to select 3 681 parents of children from 10 primary schools and kindergartens based on economic level and geographical distribution in Zhejiang Province, who participated in an online questionnaire survey, including basic information about the children and their parents, parents’ knowledge about influenza, and their willingness to vaccination. ResultsAmong the 3 681 parents surveyed, 33.82% (1 245/3 681) reported that their children received influenza vaccination in 2023. Multivariate logistic regression analysis showed that factors contributing to children’s influenza vaccination included both parents [adjusted OR (95%CI): 1.56 (1.32‒1.84)] and children [6.04 (5.04‒7.27)] having a history of influenza vaccination, parents’ conviction the influenza vaccine could protect children from severe diseases [1.43 (1.19‒1.74)], and the willingness of most parents would let their children get vaccinated [1.40 (1.13‒1.74)]. In contrast, vaccine hesitancy among parents [0.55 (0.43‒0.69)] and the belief that influenza is just a common cold [0.80 (0.65‒1.00)] were hindering factors. ConclusionThe influenza vaccination coverage among children is insufficient. Both the vaccination history of parents and children, as well as parents’ correct understanding of influenza and the effectiveness of influenza vaccine, significantly influence the influenza vaccination status in children. Efforts to address vaccine hesitancy and misconceptions about influenza are essential to improve vaccination rates.
9.Effects of parthenolide on systemic inflammation and intestinal injury in rats with acute pancreatitis
Yanan ZHAO ; Rui ZHANG ; Shuling WANG ; Chunchun YANG ; Yang WANG ; Mingyue YANG
China Pharmacy 2025;36(6):704-709
OBJECTIVE To investigate the effects of parthenolide (PLT) on systemic inflammation and intestinal injury in rats with acute pancreatitis (AP) by regulating the Kelch-like epichlorohydrin-associated protein 1 (Keap1)/nuclear factor-erythroid-2 related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) signaling pathway. METHODS AP rat model was established by injecting 3.5% sodium taurine cholate solution (1 mL/kg) into the biliary pancreatic duct, and modeled rats were divided into AP group, PLT (300 µg/kg) group, dexamethasone (2 mg/kg) group, inhibitor (11 mg/kg Nrf2 inhibitor ML385) group, and PLT+inhibitor group (300 µg/kg PLT+11 mg/kg ML385), with 10 rats in each group. Another 10 rats were taken as a sham operation group. Each group was given relevant medicine or normal saline via tail vein/intraperitoneal injection once. After 24 h, serum lipase and amylase levels, the levels of oxidative stress index [superoxide dismutase (SOD) and malondialdehyde (MDA)] and inflammatory factors [interleukin-1β (IL-1β), IL-6 and tumor necrosis factor-α (TNF-α)] were detected. The histopathological changes in colon mucosa and pancreas were observed, and Chiu and Schmidt scores were performed. The cell apoptosis in colon mucosa and the protein expressions of Keap1, Nrf2 and HO-1 were detected. RESULTS Compared with the sham operation group, there was obvious inflammatory cell infiltration in colon mucosa and pancreatic tissue, cell shedding or tissue necrosis and severe bleeding; serum levels of lipase, amylase, MDA, IL-1β, IL-6 and TNF-α, Chiu and Schmidt scores, apoptotic rate and protein expression of Keap1 in colonic mucosa were significantly increased or up-regulated, while SOD level and protein expressions of Nrf2 20230993) and HO-1 were decreased or down-regulated significantly (P<0.05). Compared with the AP group, the above indexes in the PLT group and dexamethasone group were significantly improved, while those in the inhibitor group further deteriorated (P<0.05). Inhibitor could significantly reverse the improvement effect of PLT on the above indexes in AP rats (P< 0.05). CONCLUSIONS PLT inhibits inflammation and oxidative stress in AP rats, alleviates intestinal damage, and its mechanism may be related to inhibiting protein expression of Keap1 and activating Nrf2/HO-1 signaling pathway.
10.Study on soluble microneedles loaded with aPexos and EGCG for healing of burn wounds in rats
Along ZHANG ; Wanjing LI ; Hong WANG ; Jiaxin LIU ; Ye CAO ; Rui ZHONG
Chinese Journal of Blood Transfusion 2025;38(3):333-342
[Objective] To use Chitosan Methacryloyl (CSMA) loaded with artificial platelet-derived exosomes (aPexos) as the needle body material, and gelatin and carboxymethyl chitosan (CMCS) loaded with Epigallocatechin gallate(EGCG) as the backing material to prepare microneedles, aims to investigate the therapeutic effect and mechanism of aPexos-EGCG microneedles in the treatment of burn wound healing. [Methods] First, aPexos were extracted using ultrasound and gradient ultracentrifugation. The concentration, morphology, and growth factor content (TGF-β1, PDGF-BB, VEGF) of the exosomes were assessed using NTA, transmission electron microscopy, and ELISA kits. The aPexos and EGCG were then dissolved in the needle body and backing materials, respectively. The aPexos and EGCG were loaded into the needle body and backing layer, respectively. The morphology, mechanical properties, and puncture performance of the microneedles were examined, and the preparation conditions for the microneedles loaded with aPexos-EGCG were optimized. Finally, animal experiments and tissue staining were conducted to assess the efficacy of the aPexos-EGCG microneedles in promoting burn wound healing in rats. [Results] The size distribution of aPexos was mainly in the range of 50-150 nm, with an average diameter of 132.7±3.8 nm and an average concentration of approximately 2.88×1013±3.62×1012 particles/mL. The concentrations of TGF-β1, PDGF-BB, and VEGF were approximately 1 363±135.9 ng/mL, 63.5±14.8 ng/mL, and 1 606.0±77.5 pg/mL, respectively. Mechanical property testing of the microneedles indicated that, compared with the blank microneedles, the drug-loaded microneedles had sufficient piercing ability to penetrate the stratum corneum of the skin. The results of the rat burn wound healing experiment showed that the wound healing rates of the d 3, d 7, aPexos-EGCG microneedle group compared to the control group showed significant differences, with respective values of (47.64±12.5)% vs (18.11±6.40)%, (87.45±5.57)% vs (79.85±5.03)%(P<0.05). Hematoxylin-eosin (HE) staining revealed more intact epidermal layers in the aPexos-EGCG microneedle group. Masson staining showed that the collagen deposition percentage in the aPexos-EGCG microneedle group was higher than in the control group. Immunofluorescence staining results indicated that the aPexos-EGCG microneedle group had a reduced content of M1-type macrophages and an increased content of M2-type macrophages. Additionally, the vascular markers CD31 and α-SMA showed elevated expression in this group, with significant differences compared to the other groups (P<0.05). [Conclusion] The aPexos-EGCG microneedle developed in this study exhibits good mechanical properties, capable of successfully penetrating the skin's stratum corneum and delivering aPexos and EGCG. aPexos promotes wound repair, while EGCG regulates the ratio of M1 and M2 macrophages at the wound site and suppresses the inflammatory response. This microneedle can effectively promote wound healing in rats with burn injuries, offering a novel approach for tissue repair.

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