1.Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Wenxi PENG ; Meng QIAO ; Lianxin WANG ; Yuanyuan LI ; Xiuhui LI ; Xin CUI ; Zijia CHEN ; Xinyi CHEN ; Yi DENG ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):152-160
The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines (hereinafter referred to as the Guidelines) is first specialized in the field of drug safety for oral Chinese patent medicines (OCPMs) in China. Rooted in China's healthcare context, the Guidelines address the unique usage patterns and risk characteristics of OCPMs, filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines, and to promote the standardized development of pharmacovigilance practices for OCPMs, this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting, the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment, the Guidelines were examined from three dimensions of formulation components, medication behaviors, and population to address complex safety issues arising from medicinal constituents, irrational use, and individual susceptibility. In the area of risk control, the analysis focused on context-based interventions and dynamic closed-loop management strategies, exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore, this paper evaluated the applied value of the Guidelines and identified implementation challenges, such as insufficient capacity at the primary-care level and limited digital infrastructure. In response, the study proposed optimization strategies including establishing a dynamic updating mechanism, strengthening training at the grassroots level, and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders (including manufacturers), pharmaceutical distributors, healthcare institutions, and research organizations, ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.
2.Pharmacodynamic Substances and Mechanisms of Xinglou Chengqi Tang in Treating Post-stroke Complications: A Review
Yujin ZHANG ; Xiangzhuo LIU ; Zhouyang CHEN ; Zihao SONG ; Xinyi LIU ; Yizhi YAN ; Chaoya LI ; Yingyan FANG ; Shasha YANG ; Xueqin CHENG ; Zhou XIE ; Sijie TAN ; Peng ZENG ; Yue ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):327-337
Stroke is the leading cause of death and disability among adults in China, and its common complications include digestive system abnormalities, cognitive impairment, depression, stroke-associated pneumonia, and hemiplegia. The combination of traditional Chinese and Western medicine has great potential in treating post-stroke complications. Xinglou Chengqitang (XLCQT) is a representative prescription of alleviating the disease in the upper part by treating the lower part. It has definite therapeutic effect and high safety. Clinically, XLCQT is often used to treat stroke and its complications. However, the quantity and quality of clinical trials of XLCQT in treating post-stroke complications need to be improved. Additionally, since the basic research is weak, the material basis and multi-target mechanism for the efficacy of this prescription are unknown. This article reviews XLCQT in terms of the pharmacodynamic basis, medicinal properties, safety evaluation, and progress in clinical research and mechanisms in treating post-stroke complications. This article summarizes 22 key active ingredients of XLCQT in treating acute stroke complicated with syndrome of phlegm heat and fu-organ excess. Among these key active ingredients, resveratrol, kaempferol, luteolin, chrysoeriol, apigenin, (+)-catechin, and adenosine have good pharmacokinetic properties and high bioavailability. The mechanisms of XLCQT in treating post-stroke complications are complex, including inflammatory response, brain-gut axis, hypothalamic-pituitary-adrenal (HPA) axis, intestinal flora, neurotrophic factors, autophagy, oxidative stress, and free radical damage. This review helps to deeply understand the pharmacodynamic basis and mechanisms of XLCQT in treating post-stroke complications and provides a theoretical basis for the clinical application of XLCQT against post-stroke complications and the development of drugs.
3.Zuogui Wan Improve Ovarian Inflammatory Microenvironment and Stemness of Ovarian Germline Stem Cells in Ovarian Aging via cGAS/STING Signaling Pathway
Yunling ZHENG ; Xinyi PAN ; Zuang LI ; Yixuan WANG ; Junyi AN ; Yuxin ZOU ; Mengting XIAO ; Zheng CHEN ; Ling ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):1-10
ObjectiveTo investigate the mechanism of Zuogui Wan (ZGW) in improving ovarian inflammatory microenvironment and stemness of ovarian germline stem cells (OSCs) for treating ovarian aging via the cyclic guanosine monophosphate/adenosine monophosphate synthase (cGAS)/stimulator of interferon genes (STING) signaling pathway. MethodsForty C57BL/6 female mice were randomly divided into a blank group, a model group, a low-dose ZGW group (2.7 g·kg-1), a high-dose ZGW group (5.4 g·kg-1), and an estradiol valerate group (0.15 mg·kg-1), with 8 mice in each group. Except the blank group, all other groups received a single intraperitoneal injection of cyclophosphamide at 120 mg·kg-1 to establish an ovarian aging mouse model. After successful modeling, each group was continuously administered for 4 weeks, once daily. The physiological status of the mice was observed, and the ovarian index was calculated. The estrus cycle of the mice was monitored. Hematoxylin-eosin (HE) staining was used to observe pathological changes in ovarian tissue. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum sex hormone levels. Serum inflammatory factors interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and mouse interleukin-6 (IL-6) levels were detected using kits. Western blot was used to detect the protein expression of ovarian cGAS, STING, p-STING, TANK-binding kinase 1 (TBK1), p-TBK1, interferon-induced transmembrane protein 3 (Fragilis), and Vasa homolog protein (MVH). Quantitative real-time polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of inflammatory factors in ovarian tissue. Immunofluorescence double labeling was performed to locate OSCs in ovarian tissues, and fluorescence intensities of OSCs markers MVH and octamer binding transcription factor 4 (Oct4) were calculated. ResultsCompared with the blank group, the model group showed reduced body weight, ovarian wet weight, and ovarian index (P<0.01) and a disordered estrus cycle (P<0.01). In addition, the levels of serum follicle-stimulating hormone (FSH), TNF-α, IL-6, and IL-1β were increased (P<0.01), while anti-Müllerian hormone (AMH) and estradiol (E2) levels were decreased (P<0.01). The protein expression of cGAS, p-STING/STING, and p-TBK1/TBK1 in ovarian tissue was increased (P<0.05, P<0.01), while that of OSCs stemness factors MVH and Fragilis was reduced (P<0.01). Immunofluorescence indicated a reduction in MVH and Oct4 expression in OSCs (P<0.01). The mRNA expression of inflammatory factors TNF-α, IL-6, and IL-1β in ovarian tissue was increased (P<0.05, P<0.01). Compared with the model group, the treatment groups exhibited improved body weight, ovarian wet weight, and ovarian index (P<0.05) and a reduced rate of estrus cycle disorder (P<0.05, P<0.01). The levels of serum FSH, TNF-α, IL-6, and IL-1β were decreased (P<0.05, P<0.01), while AMH and E2 levels were increased (P<0.01). The protein expression levels of cGAS, p-STING/STING, and p-TBK1/TBK1 in ovarian tissue were decreased (P<0.05), while the protein expression of MVH and Fragilis was increased (P<0.05), and the fluorescence intensities of MVH and Oct4 were increased (P<0.05, P<0.01). The mRNA expression of inflammatory factors in ovarian tissue was decreased (P<0.05). ConclusionZGW alleviate ovarian inflammatory response, regulate ovarian microenvironment homeostasis, and maintain stemness of OSCs in ovarian aging mice probably by modulating the cGAS-STING signaling pathway, thereby improving ovarian function and delaying ovarian aging.
4.Relationship of screen time and sleep duration with screening myopia among junior and senior high school students
CHEN Xinyi, WANG Yun, ZENG Xia
Chinese Journal of School Health 2026;47(3):430-433
Objective:
To explore the relationship of screen time and sleep duration with screening myopia among junior and senior high school students, so as to provide evidence for the prevention and control of myopia among students.
Methods:
From March to October 2024, 429 junior and senior high school students from a district of Guangzhou were selected using stratified cluster random sampling method. Standardized logarithmic visual acuity chart was used for vision assessment, while Questionnaire for the Physical Health Monitoring System of Students in Guangzhou was employed to collect students screen time and sleep duration. The Chi square test was used to compare differences across different groups, and binary Logistic regression analysis was employed to analyze the association of screen time and sleep duration with screening myopia.
Results:
The overall prevalence of screening myopia was 79.5%, with significant differences across educational stage, sex, screen time and sleep duration groups( χ 2=41.64, 9.75, 23.89 , 8.17, all P <0.05).Binary Logistic regression analysis revealed that, compared to the high screen time & insufficient sleep group, the low screen & sufficient sleep group ( OR=0.25, 95%CI =0.09-0.68), the low screen & insufficient sleep group ( OR= 0.27 , 95%CI =0.13-0.56), and the high screen & sufficient sleep group ( OR=0.26, 95%CI =0.10-0.70) exhibited significantly lower screening myopia risks (all P <0.05). After adjusting for sex and educational stage, low screen time & insufficient sleep was significantly associated with screening myopia ( OR=0.48, 95%CI =0.23-0.98); the multiplicative interaction term was statistically significant ( OR=0.99,95%CI =0.98-1.00)(both P <0.05).
Conclusion
The interaction effect between screen time and sleep duration in relation to screening myopia suggests a need to focus on daily routines and screen use habits among junior and senior high school students for ensuring sufficient sleep and limiting screen exposure.
5.Monitoring and management of adverse reactions to pegylated interferon alpha-2b for treatment of chronic hepatitis B
Xinyi LI ; Weijiang YE ; Danlei CHEN ; Jiawei ZHANG
Journal of Clinical Hepatology 2026;42(2):414-419
Pegylated interferon α-2b (PEG-IFN-α-2b) is currently a first-line drug for the treatment of chronic hepatitis B virus infection and is widely used in clinical practice. This drug has multiple effects of inhibiting viral replication, regulating immunity, and improving liver function, and some patients can achieve clinical cure. However, it often causes various adverse reactions during treatment, which are important factors for compromising treatment compliance and efficacy. This article systematically reviews the adverse reactions and their mechanisms during PEG-IFN-α-2b therapy for chronic hepatitis B, including influenza-like symptoms, peripheral blood cytopenia, thyroid dysfunction, and neuropsychiatric symptoms, and it also summarizes the monitoring and management strategies for these adverse reactions, in order to provide evidence-based guidance for clinical decision-making and emphasize the importance of individualized treatment.
6.Erchentang Ameliorates SiO2-induced Lung Injury by Regulating Oxidative Stress and Metabolic Disorders via Nrf2/HO-1 Signaling Pathway
Jun LU ; Xinyi ZHU ; Ziyi LIU ; Jixia HU ; Jialu CHEN ; Rong XIAO ; Zhibin WANG ; Chang LIU ; Fangguo LU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):32-42
ObjectiveTo observe the protective effect of Erchentang (ECT) on SiO2-induced lung injury in rats and to explore its underlying mechanism. MethodsA rat model of lung injury was established by a single intratracheal instillation of 50 mg·mL-1 SiO2 suspension. Thirty male Sprague-Dawley (SD) rats were randomly assigned to five groups: control, model, low and high-dose (4.5 g·kg-1·d-1 and 9 g·kg-1·d-1, respectively) ECT, and dexamethasone (0.2 mg·kg-1·d-1). All the groups were treated for 4 consecutive weeks. Histopathological alterations in the lung tissue were examined by hematoxylin and eosin (HE) staining. The levels of malondialdehyde (MDA), superoxide dismutase (SOD), and glutathione peroxidase (GSH-Px) in the lung tissue were measured through biochemical assays. The expression of key molecules in the nuclear factor erythroid 2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) pathway was determined by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR), Western blot, and immunofluorescence assay. The primary active components of ECT were identified by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), and their binding affinity to Nrf2/HO-1 was assessed by molecular docking. Untargeted metabolomics of the lung tissue was performed based on UPLC-quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS), and correlation analysis was performed to identify differential metabolites and parameters closely associated with the Nrf2/HO-1 pathway. ResultsCompared with the control group, the model group exhibited a reduction in body weight gain, an increase in lung index, increased MDA content, weakened SOD and GSH-Px activities in the lung tissue, down-regulated mRNA and protein levels of Nrf2 and protein levels of HO-1 and GPX4, and an up-regulated protein level of Keap1 (P<0.05, P<0.01). Treatment with ECT attenuated the SiO2-induced decline in body weight (P<0.05), alleviated inflammatory cell infiltration and silicotic nodule formation in alveoli, and reduced the MDA content and enhanced the SOD and GSH-Px activities in the lung tissue (P<0.05, P<0.01). UPLC-MS/MS and molecular docking revealed that core components of ECT, such as hesperidin and glycyrrhizic acid, displayed strong binding affinity to Nrf2/HO-1. Molecular biological experiments demonstrated that ECT promoted nuclear translocation of Nrf2, up-regulated the mRNA and protein levels of HO-1 and GPX4, and down-regulated Keap1 expression (P<0.05, P<0.01). Metabolomic analysis indicated that ECT reversed the SiO2-induced aberrant expression of metabolites, including linoleic acid and glutamine (P<0.05, P<0.01). Correlation analysis showed that Nrf2 and HO-1 were positively correlated with SOD and GSH-Px (P<0.05, P<0.01), but negatively correlated with glutamine and serine (P<0.05, P<0.01). ConclusionECT may activate the Nrf2/HO-1 pathway through its core active components, thereby regulating oxidative stress and metabolic disorders to ameliorate SiO2-induced lung injury in rats. This study provides experimental evidence for ECT in the prevention and treatment of occupational lung injury.
7.Exploring the Potential Targets of Traditional Chinese Medicine for Lung Cancer Treatment Based on Intestinal Flora
Xinyi LYU ; Simin CHEN ; Yanan WANG
Journal of Zhejiang Chinese Medical University 2025;49(5):617-621
[Objective]To explore the potential therapeutic targets of traditional Chinese medicine(TCM)in the treatment of lung cancer,based on the differences in gut microbiota,for providing new ideas for the TCM diagnosis and treatment of lung cancer.[Methods]Beginning with the TCM theories"Interior-exterior relationship between the lung and the large intestine"and"Simultaneous treatment of lung and intestine",integrating clinical research and empirical evidence,this study aims to clarify the feasibility of treating lung cancer by targeting gut microbiota and to summarize key gut microbiota targets in TCM for lung cancer treatment.[Results]Ancient Chinese medical literature and modern medical research provide a reliable theoretical basis for treating lung cancer based on intestinal microbiota.Empirical clinical prescriptions can regulate the composition and metabolism of gut microbiota.Some of the Chinese medicines in these prescriptions can specifically increase the abundance of key bacteria such as Lactobacillus,Faecalibacterium,and Bifidobacterium,thereby playing a positive role in the treatment of lung cancer.[Conclusion]There is a potential correlation between key gut microbiota in lung cancer patients and Chinese medicine,and regulating gut microbiota may be a target for TCM treatment of lung cancer.In depth exploration of the specific correlation between Chinese medicine and key bacteria,targeting the regulation of gut microbiota to formulate prescriptions,may become a new approach for TCM treatment of lung cancer.
8.Quantitative analysis of the distance between articular disc and condyle in patients with temporomandibular disorders
Lei SUN ; Shifeng DAI ; Yuhua CHEN ; Xinyi XU ; Kele JIANG ; Xiaowen LI ; Chengjing LI ; Tingting WU
Journal of Shanghai Jiaotong University(Medical Science) 2025;45(6):684-692
Objective·To evaluate the relationships between disc-condyle distance and anterior disc displacement,as well as between disc-condyle distance and disc morphology,in patients with temporomandibular disorders(TMD)using magnetic resonance imaging(MRI)of the temporomandibular joint(TMJ).Methods·From September 2023 to March 2024,90 patients(180 TMJs)who visited the TMJ clinic of Department of Stomatology,The Second Affiliated Hospital of Anhui Medical University,with clinical symptoms of TMD and were diagnosed via MRI with either anterior disc displacement or no significant displacement,were included.Clinical data were collected,and MRI images were used to measure the angle of disc displacement,disc-condyle distance,disc length,and thickness.The degree of disc deformation was assessed.The relationships between clinical symptoms and anterior disc displacement,between anterior disc displacement and both disc morphology and disc-condyle distance,and between disc-condyle distance and disc morphology were analyzed.Results·Among the 90 patients,there were 16 males and 74 females,with a mean age of(28.1±14.5)years.Among the 180 TMJs,175 had clinical symptoms and 5 were asymptomatic.There were 40 joints with no displacement,78 with reducible anterior disc displacement,and 62 with irreducible anterior disc displacement.In the joints with irreducible anterior disc displacement,the proportion of those with two or more symptoms was slightly higher at 62.9%,but the difference was not statistically significant compared with the joints with no displacement or reducible anterior disc displacement.MRI assessment revealed that in the joints with irreducible anterior disc displacement,the proportion of disc deformation type Ⅲ or higher was significantly higher compared with the non-displaced joints(P<0.001).The disc length was significantly shorter(P<0.001),and the intermediate zone thickness was significantly greater(P<0.001)compared with the non-displaced joints.The disc displacement angles at centric closure and maximum opening were also significantly larger(P<0.001).The disc-condyle distance was 3.10(2.70,3.70)mm for non-displaced joints,3.40(3.00,4.00)mm for joints with reducible anterior disc displacement,and 6.60(4.78,7.90)mm for joints with irreducible anterior disc displacement,with significant differences(P<0.001).The disc-condyle distance was 3.10(2.80,3.60)mm for type Ⅰ discs,3.70(3.10,4.60)mm for type Ⅱ discs,5.10(4.00,7.30)mm for type Ⅲ discs,and 6.80(4.98,8.20)mm for type Ⅳ/Ⅴ discs,with significant differences(P<0.001).The disc-condyle distance was negatively correlated with disc length(rs=-0.469,P<0.001),positively correlated with intermediate zone thickness(rs=0.319,P<0.001),and positively correlated with disc displacement angle at centric closure(rs=0.626,P<0.001).Conclusion·With increasing severity of disc deformation,intermediate zone thickness,and disc displacement angle at centric closure,as well as decreasing disc length,the disc-condyle distance increases.The disc-condyle distance is an important indicator for MRI assessment of pathological changes in TMD.
9.Exosomes derived from bone marrow mesenchymal stem cells of young rats to reverse senescence in aged rat bone marrow mesenchymal stem cells
Xiongjinfu ZHANG ; Yida CHEN ; Xinyi CHENG ; Daihui LIU ; Qin SHI
Chinese Journal of Tissue Engineering Research 2025;29(36):7709-7718
BACKGROUND:Bone marrow mesenchymal stem cells are the main effector cells for bone formation.With the increase of age,the regenerative ability of bone marrow mesenchymal stem cells is weakened and the differentiation function is impaired,leading to poor osteoporosis.Therefore,restoring the regenerative capacity and cellular function of aged bone marrow mesenchymal stem cells is essential for the effective treatment of osteoporosis.OBJECTIVE:To investigate the effects of passage 3 and passage 11 bone marrow mesenchymal stem cells-derived exosomes of young rats on the aging of bone marrow mesenchymal stem cells derived from elderly rats.METHODS:Bone marrow mesenchymal stem cells from 6-8-week-old female SD rats were isolated and cultured,and passaged to the passages 3 and 11,respectively.Then,exosomes from passages 3 and 11 bone marrow mesenchymal stem cells were extracted.Bone marrow mesenchymal stem cells from 18-month-old female SD rats were isolated and cultured,passaged to passage 3,and divided into 3 groups.The control group was routinely cultured,and the other two groups were intervened with exosomes from passages 3 and 11 bone marrow mesenchymal stem cells.After 48 hours of exosome intervention,the expression of β-galactosidase in the nucleus was detected by β-galactosidase staining kit.The expression of aging-related genes was detected by qRT-PCR.The expression differences of miRNA in exosomes from passages 3 and 11 bone marrow mesenchymal stem cells were compared by Small RNA sequencing.RESULTS AND CONCLUSION:(1)Compared with the control group and passage 11 bone marrow mesenchymal stem cell-derived exosomes group,theβ-galactosidase activity of bone marrow mesenchymal stem cells of aged rats was significantly lower in the passage 3 bone marrow mesenchymal stem cell-derived exosomes group.(2)Compared with the control group,the expression of aging-related genes p21 and p16 was significantly reduced in the passage 3 bone marrow mesenchymal stem cell-derived exosome group(P<0.05),while there was no significant difference in the expression of aging-related genes p21 and p16 in the passage 11 bone marrow mesenchymal stem cell-derived exosome group.(3)Sequencing results showed that there was a significant difference in the expression of miRNAs in the two exosomes,among which the miRNAs with the most significant expression differences were let-7c-5p,let-7b-5p,miR-320-3p,and miR-26a-5p.KEGG analysis results showed that significantly different miRNA enrichment pathways include mTOR,AMPK and other aging-related signaling pathways.The above results indicate that passage 3 bone marrow mesenchymal stem cell-derived exosomes have the ability to reverse the aging of bone marrow mesenchymal stem cells in aged rats.
10.Clinical effects of the digital guided porcelain veneer restoration of anterior teeth
Xinyi SHI ; Xiaodong CHEN ; Xiuling LUAN
Journal of Practical Stomatology 2025;41(2):162-167
Objective:To explore the short-term clinical effects of digitally guided anterior teeth porcelain veneer restoration.Methods:17 patients with 80 teeth treated by digitally guided anterior teeth porcelain veneer restoration were included and divided into minimally invasive group(A,9 cases with 40 teeth)and the invasive group(B,8 cases with 40 teeth).The accuracy of tooth preparation guides was evaluated by Bland-Altman analysis,the clinical effects at 1 week and 3,6 and 12 months and the plaque in-dex at 12 months after operation were compared between the two groups.Results:The mean error of tooth preparation by the guide plate is(0.089±0.029)mm,and the mean differences in cervical and middle were smaller than that in incisal area.There were sta-tistically significant differences between the two groups in the follow-up clinical effect scores of color matching,gingival health and postoperative sensitivity(P<0.05).The plaque index at 12 months after surgery was 0.67±0.41 in the minimally invasive group and 0.88±0.47 in the invasive group(P=0.026).Conclusion:The digitally guided porcelain veneer restoration realizes the visualiza-tion of tooth preparation and has good short-term clinical effects.


Result Analysis
Print
Save
E-mail