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.

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.

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.

Objective To investigate the expression of carcinoembryonic antigen-related cell adhesion molecule 6 (CEACAM6) in esophageal squamous cell carcinoma (ESCC) and analyze its correlation with immune cell infiltration and patient prognosis. Methods Three ESCC datasets (GSE161533, GSE26886, and GSE23400) from the GEO database were analyzed to identify differentially expressed genes. CEACAM6 was identified as a key gene through survival analysis. Its expression, prognostic value, and relationship with immune cell infiltration were further explored using databases, such as TIMER. Tissue samples were collected from 162 patients with ESCC. Immunohistochemistry was performed to detect the expression of CEACAM6, immune cell markers (CD4, CD8, CD20, and CD56), and immune checkpoint molecules (HHLA2 and CD40LG). Correlations between CEACAM6 expression and clinicopathological features, immune cell infiltration, and immune checkpoints were analyzed. Results Bioinformatic analysis and clinical sample validation confirmed that CEACAM6 expression was significantly upregulated in ESCC tissues compared with adjacent nontumor tissues (P<0.05). High CEACAM6 expression was closely associated with advanced clinical stage (AJCC Ⅲ-Ⅳ), high T stage (T3-T4), lymph node metastasis, nonulcerative type, and poor prognosis. Furthermore, CEACAM6 expression levels were positively correlated with the infiltration density of CD8⁺ T cells, CD4⁺ T cells, and CD20⁺ B cells within the tumor microenvironment and with the expression of the immune checkpoint molecules HHLA2 and CD40LG (all P<0.05). Conclusion CEACAM6 serves as an independent poor prognostic factor for ESCC. Its high expression is implicated in the modulation of the tumor immune microenvironment by correlating with specific immune cell infiltration and immune checkpoint molecules, suggesting its potential as a novel prognostic biomarker and immunotherapeutic target for ESCC.

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*

Objective:To analyze the prevalence of human respiratory syncytial virus（RSV）and the evolutionary characteristics of the adhesion glycoprotein（G）gene in Xi'an from 2023 to 2024.Methods:Respiratory specimens were collected from patients with acute respiratory infections in Xi'an between October 2023 to October 2024. RSV nucleic acid screening was performed using real-time fluorescence quantitative PCR；full-length G gene sequencing was conducted on nucleic acid-positive specimens. Genotyping characterization of the obtained sequences was performed using Nextclade v3.10.0 software.Results:A total of 2 548 respiratory tract infection samples were collected，with 104 cases（4.08%，104/2 548）testing positive for RSV. The highest RSV positivity rate was observed in children aged ≤1 year（12.24%，18/147），and significant difference in positivity rates were found among age groups（χ 2=37.868， P<0.001）. Since October 2023，RSV has seen an epidemic peak during January to February 2024，and gradually declined thereafter，with no positive cases from May to September 2024. Among the 43 RSV-positive samples，12 strains were identified as subtype A（all genotype A.D.3），and 31 strains were subtype B（14 genotype B.D.4.1.1 and 17 genotype B.D.E.1）. Conclusion:From October 2023 to October 2024，RSV had an epidemic peak in January and February in Xi＇an，with subtype B being the predominant circulating type.

Objective:To determine the clinical issues in the Clinical practice guidelines for postoperative pain management in adults (2024 edition). Methods:A preliminary list of clinical issues for the guidelines was developed through literature review, clinical surveys, and expert interviews. This was followed by two rounds of Delphi questionnaire surveys, with quality control and statistical analysis conducted using expert positive coefficient, mean item scores, full score ratio, coefficient of variation, Cronbach′s α coefficient, and expert authority level to finalize the list of clinical issues.Results:The experts participating in the Delphi questionnaire surveys had multidisciplinary collaborative backgrounds and regional representativeness, with a high level of authority. The overall positive coefficient of expert participation in the surveys was 78.9%. Through two rounds of the Delphi method and based on the screening criteria of a mean score ≥3.5, coefficient of variation ≤30%, and full score ratio ≥30%, 17 clinical issues were ultimately included following an expert consensus meeting.Conclusions:Through the Delphi method and rigorous quality control, the clinical issues in the Clinical practice guidelines for postoperative pain management in adults (2024 edition) are determined, laying a foundation for the subsequent development of the guidelines.

Objective To explore the necessity,significance,and implementation forms of integrating tumor health sci-ence popularization education and communication practice into clinical undergraduate oncology teaching.Methods Science pop-ularization education was conducted among clinical undergraduate oncology students at Guangzhou Medical University who partici-pated in science communication activities.Before and after the activities,online questionnaires were distributed via Wenjuanxing.Student questionnaires were collected within the deadline,while two different versions of questionnaires were randomly distributed to 30 parents and 20 faculty members involved in oncology teaching to assess their views and attitudes toward the necessity of pub-lic cancer prevention science communication,as well as the integration of science popularization education and communication practice into oncology teaching,and to evaluate its educational significance.Results The analysis of the questionnaires showed that nearly all or the vast majority of students,parents,and teachers highly recognized the necessity of public cancer prevention science education and awareness-raising,as well as the importance of medical students disseminating tumor health knowledge.They also strongly supported the inclusion of science popularization education in oncology teaching.Most students felt that their knowledge level improved significantly after the education sessions.Conclusion The integration of tumor science popularization education and communication practice into oncology teaching is highly necessary and meaningful.It significantly enhances students' health science literacy,sense of mission,and responsibility.It is recommended to incorporate such content into oncolo-gy teaching.

The incidence rate of coronary atherosclerotic heart disease(commonly referred to as coronary heart disease)remains high in China.In clinical practice,drug therapy,percutaneous coronary intervention(PCI),and coronary artery bypass grafting(CABG)are commonly employed.For patients with multi-vessel coronary artery stenosis,minimally invasive interventional therapy is often the preferred option.However,for those with multi-vessel disease complicated by comorbidities,CABG is generally recommended.Despite its advantages,PCI carries risks such as vascular restenosis,thrombosis,and other adverse events.Consequently,hybrid coronary revascularization(HCR)has emerged as an alternative approach.This paper provides an overview of coronary heart disease and re-views the advantages,applications,and patient selection criteria for HCR.