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.

As a patented characteristic medicine of Yi ethnic minority， Pingxuan capsules have the effects of nourishing the liver and kidney， pacifying the liver， and subduing Yang. With the main indications of dizziness， headache， palpitations， tinnitus， insomnia， dreaminess， waist and knee soreness caused by liver-kidney deficiency and liver Yang upward disturbance， Pingxuan capsules are widely used in the treatment of posterior circulation ischemic vertigo， vestibular migraine， benign paroxysmal positional vertigo. However， the current knowledge is limited regarding the efficacy， syndrome differentiation， and safety of this medicine. On the basis of summarizing the experience of clinicians and the existing evidence， this study invites clinical experts of traditional Chinese and Western medicine， pharmaceutical experts， and methodological experts from relevant fields across China to conduct evidence-based evaluation of Pingxuan capsules. The evaluation follows the Specifications for the Development of Clinical Expert Consensus on Chinese Patent Medicines issued by the Standardization Office of the China Association of Chinese Medicine， and reaches 5 recommendations and 16 consensus suggestions. The consensus clarifies the clinical applications， efficacy， dose， course of treatment， combination of medicines， precautions， and contraindications of Pingxuan capsules in the treatment of vertigo and explains the safety of clinical application. This consensus is applicable to clinicians （traditional Chinese medicine， Western medicine， and integrated traditional Chinese and Western medicine） and pharmacists in tertiary hospitals， secondary hospitals， and community-level medical and health institutions across China， providing a reference for the rational use of Pingxuan capsules in the treatment of vertigo. It is hoped that the promotion of this consensus can facilitate the rational use of drugs in clinical practice， reduce the risk of drug use， and give full play to the advantages of Pingxuan capsules in the treatment of vertigo diseases. This consensus has been reviewed and published by the China Association of Chinese Medicine， with the number GS/CACM330-2023.

Idiopathic pulmonary fibrosis （IPF） is a chronic interstitial lung disease characterized by dyspnea and progressive deterioration of lung function， which significantly impacts patients' quality of life and imposes a major burden on society. Although modern medicine has increasingly enriched the treatment options for pulmonary fibrosis， unfavorable factors such as high costs and significant side effects contribute to the persistently low survival rate of patients. Studies have shown that the occurrence and development of pulmonary fibrosis are closely related to abnormalities in multiple pathways. Among these， Rho/Rho-associated coiled-coil protein kinase （ROCK） plays a key role in the disease progression of IPF by regulating the cytoskeleton. This pathway not only transmits biochemical molecular signals that promote the progress of fibrosis but also responds to the biomechanical environment， such as the increased lung tissue stiffness caused by the deposition of extracellular matrix （ECM） during the process of pulmonary fibrosis. Therefore， research on this pathway is of great significance for the prevention and treatment of IPF. In recent years， traditional Chinese medicine （TCM） has shown remarkable effects in preventing and treating IPF. Many TCM compounds and active components can reduce the production of α-smooth muscle actin （α-SMA）， CollagenⅠ （ColⅠ）， ColⅢ， and inflammatory factors in lung tissue by regulating the Rho/ROCK signaling pathway. These compounds inhibit the transformation of fibroblasts （FBs） into myofibroblasts （MyoFBs）， intervening in the process of pulmonary fibrosis. Based on this， the article briefly reviews relevant research from recent years， discusses the key role of the Rho/ROCK pathway in pulmonary fibrosis from an interdisciplinary perspective， and summarizes the mechanisms through which TCM regulates Rho/ROCK to prevent and treat IPF， based on resources from PubMed， CNKI， and other databases， in order to provide important references for the broader clinical application of TCM in the prevention and treatment of IPF.

OBJECTIVE: To observe the effects of thumbtack-needle embedding therapy of auricular acupuncture on gastrointestinal function and intestinal microflora in the patients with gastric cancer after operation, and to explore its mechanism. METHODS: A total of 80 patients with gastric cancer after radical operation were randomly divided into an observation group (40 cases, 3 cases discontinued) and a control group (40 cases, 3 cases discontinued). The patients of both groups received the perioperative care for accelerating recovery. Additionally, in the observation group, the thumbtack-needle embedding therapy of auricular acupuncture was delivered at the auricular points of unilateral side, including Wei (CO₄), Pi (CO₁₃), Dachang (CO₇), Xiaochang (CO₆), Yuanzhong (AT_2,3,4i), Erzhong (HX₁), Sanjiao (CO₁₇) and Jiaowozhong (TF₃), and the needles were embedded and retained for 72 h. The postoperative recovery time of gastrointestinal function (the postoperative bowel sound recovery time, the first exhaust time, the first defecation time), the postoperative hospital stay and pain visual analogue scale (VAS) score were observed in the two groups. Before operation and on day 5 after operation, the serum gastrin level was detected in the two groups. The third-generation 16S rRNA sequencing technology was used to detect the composition and relative abundance of intestinal flora in the two groups before and after operation. RESULTS: Compared with the control group, the postoperative bowel sound recovery time, the first exhaust time and the first defecation time were shortened in the observation group (P<0.05). In the observation group, the VAS scores at 24 h, 48 h, and 72 h after surgery were lower than those of the control group, respectively (P<0.05). There was no significant differences in postoperative hospital stay and serum gastrin level between the two groups (P>0.05). The alpha diversity analysis showed that the differences in Shannon index, Simpson index, Pielou_J index and Pd_fath index were not significant statistically after intervention between the two groups (P>0.05). After intervention, the community structure of the fecal sample was similar at each taxonomic level between the two groups, and although the proportion between species was various, the difference was not significant (P>0.05). After intervention, there were 55 species with the differences between the two groups, 17 species of them presented significant difference in relative abundance in the observation group and 38 species in the control group. Regarding the level of genus, the levels of Klebsiell and Enterobacter increased (P<0.05) and the level of Streptococcus decreased (P<0.05) in the observation group. The main microbial groups that played an important role were Coprobacillaceae, Sutterellaceae and Yersiniaceae in the observation group. KEGG function prediction indicated that the function of intestinal microflora was mainly associated with the cofactor and vitamin metabolism, carbohydrate metabolism, and amino acid metabolism. CONCLUSION The thumbtack-needle embedding therapy of auricular acupuncture improves the postoperative gastrointestinal function of the patients with gastric cancer probably through regulating the structure and relative abundance of intestinal microflora and affecting the energy metabolism.
Humans ; Male ; Female ; Middle Aged ; Acupuncture, Ear/instrumentation* ; Gastrointestinal Microbiome ; Aged ; Stomach Neoplasms/therapy* ; Adult ; Acupuncture Points ; Gastrointestinal Tract/microbiology* ; Intestines/physiopathology* ; Postoperative Period ; Acupuncture Therapy

The inhibition of cyclin-dependent kinases (CDKs) is considered a promising strategy for cancer treatment due to their role in cell cycle regulation. However, CDK inhibitors with no selectivity among CDK families have not been approved. A CDK inhibitor with high selectivity for CDK4/6 exhibited significant treatment effects on breast cancer and has become a heavy bomb on the market. Subsequently, resistance gradually decreased the efficacy of selective CDK4/6 inhibitors in breast cancer treatment. In this review, we first introduce the development of selective CDK4/6 inhibitors and then explain the role of CDK2 activation in inducing resistance to CDK4/6 inhibitors. Moreover, we focused on the development of CDK2/4/6 inhibitors and selective CDK2 inhibitors, which will aid in the discovery of novel CDK inhibitors targeting the cell cycle in the future.
Humans ; Cell Cycle/drug effects* ; Protein Kinase Inhibitors/chemistry* ; Cyclin-Dependent Kinases/metabolism* ; Neoplasms/genetics* ; Antineoplastic Agents/pharmacology* ; Animals ; Breast Neoplasms/enzymology* ; Cyclin-Dependent Kinase 4/metabolism*

Hepatitis B virus (HBV) infection represents a significant global health challenge. Current therapeutic options, such as interferon and nucleoside analogues (NAs), are limited by issues including long-term medication toxicity, the virus's propensity to develop drug resistance, and the inability to eradicate covalently closed circular DNA (cccDNA). Core protein allosteric modulators (CpAMs), as an emerging class of anti-HBV drugs, target HBcAg to interfere with capsid assembly. This not only blocks viral nucleocapsid formation and inhibits viral replication but also indirectly destabilizes the cccDNA pool, while exhibiting a relatively high genetic barrier to resistance. This article systematically evaluates HBV drug resistance to CpAMs and proposes anti-resistance strategies, including the combination of nucleoside analogues with CpAMs, enhancing protein-drug interactions, targeting HBcAg degradation, designing multi-target inhibitors, and employing combination therapy. Looking ahead, the integration of structural biology, computational chemistry, and immunotherapy will offer innovative approaches for developing novel, highly effective, and low-resistance inhibitors, thereby advancing the functional cure of hepatitis B.

Objective : To explore the relationship between single nucleotide polymorphisms ( SNPs) in D-loop region of mitochondrial DNA ( mtDNA) and mtDNA copy number and the risk of dermatomyositis ( DM) ，and its in- fluencing factors． Methods : 74 patients with DM and 92 healthy controls were included in the study． Genomic DNA was extracted from peripheral blood and the target fragment of mtDNA D-loop region was amplified by PCR technique，and the products were subsequently sequenced．Serum levels of ROS were assessed using a high-sensi- tivity reactive oxygen species detection kit．The expression levels of cytokines，interleukin ( IL) -5，IL-13，inter- feron-γ ( IFN-γ) ，IL-2，IL-6，IL-10，tumor necrosis factor-α ( TNF-α) and IL-4 were measured using Flow Fluo- rescence Immunmicrobeads Assay．Wilcoxon rank-sum test was used to assess the potential correlation between cy- tokines and SNPs associated with DM risk．The relative copy number of mtDNA was measured using quantitative re- al-time polymerase chain reaction ( qPCR) analysis． Results : Two SNPs ( 16304T / C，16519T / C) were found to be associated with the risk of developing DM，and alleles 16304C ( χ2 = 4. 937，P = 0. 026) and 16519C ( χ2 = 4. 405，P = 0. 036) in the mitochondrial D-loop region were confirmed to be associated with DM development risk． The DM risk-associated allele 16304C was significantly associated with lower IL-4 expression ( P = 0. 016) ．The mtDNA copy number was significantly higher in DM patients than in controls ( P ＜0. 001) ． Conclusion Mitochondrial D-loop SNPs can be potential biomarkers for DM risk，and SNPs may be involved in DM by influencing cytokines．DM shows high expression of mtDNA copy number，and the increase in mtDNA copy number may lead to mitochondrial dysfunction，which triggers the pathogenesis of DM．

Objective To conduct a survey on students for their common needs for the course and the support to their research training,to provide reference for course reform and curriculum of ideology and politics.Methods A survey before and after course was conducted in 704 graduates who selected the course of"Experiments of Molecu-lar Biology"from the autumn of 2018 to the spring of 2024.After collecting the survey,they were summarized,counted,and analyzed.Results The students selected this course were mainly research-oriented graduate students.Their professional background was mainly in clinical medicine,and there was a relatively lack of training in tech-nology and laboratory skill in molecular biology experiment.The follow-up survey showed that experimental operation and implementation as well as analysis of experimental results were the two most helpful aspects for students;PCR,RNA extraction and detection,and Western blot were the most useful techniques for student learning and scientific research.Conclusions Through the survey,the professional background of students,dynamic changes in their course selection needs are well acknowledged and so thus able to optimize,provide good reference for teaching and learning in this field,and provide a basis for curriculum reform and construction of ideological and political courses.

Objective:The principal components (PC) of venous-to-arterial carbon dioxide content diference [C(v-a)CO 2] were extraceted in septic shock patients, in orter to compare the contribution of the principal components to C(v-a)CO 2. Methods:Septic shock patients monitored by Swan Ganz floating catheter in the Medical Intensive Care Unit of Peking Union Medical College Hospital were included in the retrospective study. All pairs of arterial and mixed-venous blood gases within 1 h before and after a flood challenge were included in the analyses. The principal component method was used to extract the components of C(v-a)CO 2. Spearman correlation analysis was used to evaluate the correlation between the components and C(v-a)CO 2, and the correlation between the components and cardiac output. The differences of the components beween the 28-day survival group and 28-day death group were analyzed by univariate analysis. Results:A total of 504 pairs of blood gases in 104 septic shock patients were included in the analyses. The median age of patients was 62 years ( IQR, 48 to 71), and 59.6% (62/104) were men. Four principal components were extracted and the components account for 77.7% of variance. PC1 included PaO 2, PvO 2, SaO 2 and SvO 2. PC2 included pHa and pHv. PC3 included Hb and Hct. PC4 included PaCO 2 and PvCO 2. There was a significant difference in PC4 between the two group. PC4 could weakly predict the 28-day death (AUROC 0.634, 95% CI 0.527-0.741, P=0.015). Conclusions:In patients with infectious shock, arteriovenous [C(v-a)CO 2] consists of principal components of four dimensions: oxygenation, pH, Hb, and CO 2 partial pressure difference.Arterial CO 2 partial pressure difference [P(v-a)CO2] weakly predicts 28-d morbidity and mortality.

Ceria nanoparticles(CeO2 NPs)have become popular materials in biomedical and industrial fields due to theirpotential applications in anti-oxidation,cancer therapy,photocatalytic degradation of pollutants,sensors,etc.Many methods,including gas phase,solid phase,liquid phase,and the newly proposed green synthesis method,have been reported for the synthesis of CeO2 NPs.Due to the wide application of CeO2 NPs,concerns about their adverse impacts on human health have been raised.This review covers recent studies on the biomedical applications of CeO2 NPs,including their use in the treatment of various diseases(e.g.,Alzheimer's disease,ischemic stroke,retinal damage,chronic inflammation,and cancer).CeO2 NP toxicity is discussed in terms of the different systems of the human body(e.g.,cytotoxicity,genotoxicity,respiratory toxicity,neurotoxicity,and hepatotoxicity).This comprehensive review covers both fundamental discoveries and exploratory progress in CeO2 NP research that may lead to practical developments in the future.