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.

ObjectiveTo analyze the epidemiological characteristics and influencing factors of clustered influenza-like illness (ILI) outbreaks in Yangpu District, Shanghai from 2012 to 2022, and to provide a scientific basis for formulating specific prevention and control measures of influenza in this district. MethodsData on clustered ILI outbreaks from 2012 to 2022 were collected, and the epidemiological pattern of the cluster outbreaks of influenza and its influencing factors of prevalence and duration were explored using statistical methods such as descriptive epidemiology, χ² test and logistic regression analysis. ResultsA total of 60 clustered ILI outbreaks were reported in Yangpu District, Shanghai from 2012 to 2022, with a cumulative number of 543 cases and an annual average incidence rate of 16.96%. The male-to-female ratio was1.06∶1. The largest number of ILI were reported in 2019, mainly from November to January of the next year, with December being the peak of outbreaks. The Streets of Changhai Rd. in Yangpu District had the largest number of reported outbreaks, accounting for 30.00% of the total outbreaks. Influenza cluster outbreaks occurred in schools, with the majority of outbreaks and cases reported in primary schools (accounting for 65.00% and 62.06% of the total, respectively). The outbreaks were mainly caused by influenza B virus, accounting for 50% of the total number of outbreaks. The prevalence rate of influenza cluster outbreaks varied among different schools in terms of their affiliated streets, school attributes and school types, with those in Kongjiang Rd. Subdistrict, private schools, and childcare institutions being relatively high. The duration of outbreaks reported for >2 days was longer than those reported for ≤2 days (OR=8.604, 95%CI: 1.509–49.067). ConclusionThe ILI outbreaks in Yangpu District present a seasonal pattern, with primary schools and Changhai Rd. Street as the targeted places for implementing prevention and control measures. Timely detection and reporting and active disposal can prevent a further spread of the outbreaks.

OBJECTIVE To evaluate the efficacy of sulbactam-durlobactam combined with meropenem in treating carbapenem-resistant Acinetobacter baumannii(CRAB)pulmonary infection.METHODS A total of 16 patients treated at China-Japan Friendship Hospital from Jan.1,2025 to Jun.1,2025 were included.Retrospective analy-sis was conducted on patients'basic situation,preliminary treatment regimens,infection-related diagnoses,etiolo-gy and clinical outcomes.Therapeutic drug monitoring(TDM)for sulbactam was also performed.RESULTS By the end of the treatment course,13 patients achieved etiological eradication of CRAB and clinical improvement,while 1 patient experienced CRAB recurrence within one month.Three patients showed treatment failure.TDM for sulbactam was performed in 13 patients.Except for one slightly lower,all achieved trough plasma concentra-tions above the minimum inhibitory concentration(MIC)(100％T＞MIC,MIC=4 mg/L based on clinical breakpoints).Dosage adjustments based on plasma concentrations were made for 4 patients,with 3 receiving re-duced doses and 1 receiving an increased dose.CONCLUSIONS Sulbactam-durlobactam combined with meropenem demonstrates superior efficacy in treating CRAB compared to other regimens.Under the recommended dosage,all patients can achieve the PK/PD target for sulbactam.

BACKGROUND:Exosomes have been confirmed to be closely related to cartilage degeneration in osteoarthritis.However,the role and mechanism of exosome-derived genes in cartilage degeneration of osteoarthritis have not been fully elucidated.OBJECTIVE:Bioinformatics analyses were used to screen the genes related to cartilage degeneration in the synovial exosomes of patients with osteoarthritis,and to determine their biological functions and signaling pathways in order to provide new therapeutic targets for delaying cartilage degeneration in osteoarthritis.METHODS:Firstly,osteoarthritis-related exosome dataset GSE185059 and cartilage degeneration dataset GSE114007 were downloaded from Gene Expression Omnibus(GEO)database to screen exosome-derived cartilage degeneration related genes.GO functional and KEGG pathway enrichment analyses were performed based on the screened exosome-derived cartilage degeneration related genes.Protein-protein interaction network was drawn and Ingenuity Pathway Analysis(IPA)was conducted to screen and obtain key exosome-derived cartilage degeneration-related genes.Finally,qRT-PCR was used to verify the expression of key genes in osteoarthritis cartilage tissue and interleukin-1β stimulated chondrocyte models.RESULTS AND CONCLUSION:(1)There were 831 differentially expressed genes in the GSE185059 dataset and 5 323 differentially expressed genes in the GSE114007 dataset.A total of 94 exosome-derived cartilage degeneration related genes were screened after the intersection of these differentially expressed genes,of which 51 genes were down-regulated and 43 genes were up-regulated.(2)GO functional enrichment analysis showed that the up-regulated genes were mainly involved in the positive regulation of cell-cell adhesion,the positive regulation of T cell activation,and chronic inflammatory response,while the down-regulated genes were mainly involved in biological processes such as cell aggregation,cartilage differentiation and development,and skeletal system morphogenesis.(3)KEGG pathway enrichment analysis showed that exosome-derived cartilage degeneration-related genes were mainly involved in tryptophan enrichment metabolism,vitamin B6 metabolism,and leukocyte transendothelial migration.(4)The constructed protein-protein interaction network confirmed the existence of multiple interaction relationships among exosome-derived cartilage degeneration-related genes.Combined with five algorithms in CytoHubba software,four key exosome-derived cartilage degeneration-related genes were further screened,namely THY1,CYP1A1,NFKB2,and COL6A3.(5)The results of qRT-PCR showed that compared with normal cartilage,the expressions of THY1 and COL6A3 in osteoarthritic cartilage were increased,while the expression of CYP1A1 and NFKB2 was decreased.Similarly,compared with the unstimulated group,the expression of THY1 and COL6A3 in the interleukin-1β induced chondrocytes was upregulated,while the expression of CYP1A1 and NFKB2 was downregulated.(6)These results indicate that THY1,CYP1A1,NFKB2,and COL6A3 are genes related to cartilage degeneration in the exosomes of synovial fluid of patients with osteoarthritis,and may participate in the pathogenesis of osteoarthritis by regulating biological processes such as protein tyrosine kinase activity and lipid metabolism,as well as nuclear factor-κB signaling pathway and focal adhesion signaling pathway.However,the specific regulatory roles and molecular mechanisms of these key genes in cartilage degeneration need to be further verified by experiments.

Gyrovirus galga1(GyVg1)and gyrovirus homsa1(GyH1)are two newly discovered cir-coviruses that can cause symptoms related to transmissible viral proventriculitis of chickens.These viruses have been reported in various regions worldwide.This research aims to establish a duplex real-time PCR assay capable of identifying and detecting GyVg1 and GyH1.Specific primers and probes were designed based on the conserved regions of GyVg1 and GyH1 respectively using all genome sequence data currently available in GenBank.After optimizing reaction conditions,the du-plex real-time PCR detection method was established and further validated by comparing it with a conventional PCR assay and sequencing results from an analysis of 256 clinical samples collected in 2023 across eight regions of Nanning,Guangxi.The results showed that GyVg1 and GyH1 could be identified in 1 h by the duplex real-time PCR assay and two pairs of primer probes can amplify effectively but there is no any cross reaction with other pathogens.Besides,the detection limit was determined to be 7.5 copies/μL.The correlation coefficient of standard curves exceeded 0.99,and CV for intra-and inter-assay was less than 0.45％.Based on clinical performance,when the quanti-ty of template was greater than or equal to 100 copies,the agreements between the duplex real-time PCR assay and the conventional PCR assay were 94.3％(GyVg1)and 100％(GyH1).In con-clusion,the newly developed duplex real-time PCR assays exhibited good specificity,sensitivity and repeatability,which could contribute to the rapid detection and differentiation of GyVg1 and GyH1.

Objective:To propose suggestions for the revision of quality standard of steviol glycosides through research on its major manufacturer's products.Methods:The inspection items in the current quality standards were inspected,with domestic and international quality standard of steviol glycosides.Results:Specific rotation was from-33.39° to-39.50°,pH was from 5.3 to 6.7,impurity absorbency was lower than 0.096 0,while the contents of weight loss on drying were lower than 5.0％,residue on ignition were lower than 0.043％,methanol residual were lower than 0.01％,ethanol residual were lower than 0.06％,residue on arsenic were lower than 0.000 054％,lead wasn't detected.The content of rebaudioside A and 13 kinds of steviol glycosides were 8.23％-68.48％and 85.78％-96.13％.Conclusion:The main components of the commercial steviol glycosides products were rebaudioside A and stevioside,with low safety risk of elemental impurities and solvent residues.It provided suggestions for the revision of quality standard of steviol glycosides in the Chinese Pharmacopoeia.

Gyrovirus galga1(GyVg1)and gyrovirus homsa1(GyH1)are two newly discovered cir-coviruses that can cause symptoms related to transmissible viral proventriculitis of chickens.These viruses have been reported in various regions worldwide.This research aims to establish a duplex real-time PCR assay capable of identifying and detecting GyVg1 and GyH1.Specific primers and probes were designed based on the conserved regions of GyVg1 and GyH1 respectively using all genome sequence data currently available in GenBank.After optimizing reaction conditions,the du-plex real-time PCR detection method was established and further validated by comparing it with a conventional PCR assay and sequencing results from an analysis of 256 clinical samples collected in 2023 across eight regions of Nanning,Guangxi.The results showed that GyVg1 and GyH1 could be identified in 1 h by the duplex real-time PCR assay and two pairs of primer probes can amplify effectively but there is no any cross reaction with other pathogens.Besides,the detection limit was determined to be 7.5 copies/μL.The correlation coefficient of standard curves exceeded 0.99,and CV for intra-and inter-assay was less than 0.45％.Based on clinical performance,when the quanti-ty of template was greater than or equal to 100 copies,the agreements between the duplex real-time PCR assay and the conventional PCR assay were 94.3％(GyVg1)and 100％(GyH1).In con-clusion,the newly developed duplex real-time PCR assays exhibited good specificity,sensitivity and repeatability,which could contribute to the rapid detection and differentiation of GyVg1 and GyH1.

Objective:To investigate the life expectancy of antiretroviral treatment (ART) HIV-infected patients and its trends in Taizhou City, Zhejiang Province from 2014 to 2023.Methods:The data were obtained from the China Information System for Disease Control and Prevention , and the study subjects were HIV-infected patients received ART in Taizhou City. An abbreviated life expectancy table was prepared based on Chiang's method to analyze the differences in life expectancy of HIV-infected patients receiving ART in Taizhou City with different characteristics in 2023 and to compare the trends in life expectancy of patients with different CD4 +T lymphocytes (CD4) counts at the time of initiation of ART from 2014 to 2023. Results:A total of 4 825 patients were enrolled in this study, with a cumulative follow-up of 276 648.56 person-years, and a case-fatality rate of 18.07 (95% CI: 16.48-19.65) /1 000 person-years. In 2023, male patients had lower life expectancy than females in all age groups, and those who were married had higher life expectancy than those who were unmarried and those who were divorced or widowed; patients who had been transmitted heterosexually had lower life expectancy than those who had been transmitted through homosexual transmission. Patients with different CD4 counts at the time of initiating ART had different life expectancies in all age groups. The life expectancy of patients with CD4 counts ≥350 cells/μl when initiating the treatment was higher than that of patients with CD4 counts <200 cells/μl in all age groups. The life expectancy of HIV-infected patients on ART at age 20 and 50 increased from 39.0 years and 19.1 years in 2014 to 46.0 years and 24.1 years in 2023, respectively, with an average annual percentage change of 2.43% (95% CI: 0.81%-4.07%) and 3.34% (95% CI: 1.17%-5.56%). The change in life expectancy was similar for patients with CD4 counts ≥350 cells/μl and 200-349 cells/μl at the time of initiating treatment in 2016-2023, and was higher than that for patients with CD4 counts <200 cells/μl. The rate of increase in life expectancy for patients at age 50 was higher than that at age 20 for all CD4 counts. Conclusions:The rising trend of life expectancy among HIV-infected patients on ART in Taizhou City is obvious. But the disparity between patients with different characteristics is obvious, especially among patients with baseline CD4 counts <200 cells/μl, suggesting the importance of expanded testing, early diagnosis and timely initiation of ART to improve the life expectancy of HIV-infected patients.

Objective:To explore the real-life experiences of patients six months after laparoscopic sleeve gastrectomy (LSG), aiming to provide a reference for developing intervention plans.Methods:This was a descriptive phenomenological study. Purposeful sampling and maximum variation sampling were used to select 24 patients who underwent LSG at the Affiliated Hospital of Zunyi Medical University from February to August 2023. Semi-structured in-depth interviews were conducted, and the Colaizzi 7-step analysis method was applied to inductively extract and refine the themes.Results:A total of six main themes and ten sub-themes were identified through analysis. The main themes were: desires to improve postoperative physical symptoms (gastrointestinal symptoms, hair loss, neurological symptoms, and general symptoms) ; perception of subjective emotions (anxiety, regret, fear, and confidence) ; decreased social adaptability (decline in work ability, impaired social skills) ; general low compliance; desire for professional guidance; and postoperative benefit finding.Conclusions:Six months after LSG, patients primarily experienced physical symptom disturbances, poor psychological states, decreased social adaptability, low compliance, and a desire for professional guidance. However, they also recognized various benefits of the surgery. Healthcare providers should strengthen dynamic symptom assessments and management, guide patients psychologically, enhance social support, and actively improve follow-up and continuous care to help patients improve self-coping abilities and weight loss outcomes.

Objective:Investigate the impact of calcification on the long-term outcomes of patients with coronary chronic total occlusion (CTO) after percutaneous coronary intervention (PCI).Methods:A retrospective cohort study was conducted. Patients who underwent PCI and had at least one CTO lesion at Fuwai Hospital between January 2010 and December 2013 were consecutively enrolled. Calcification was evaluated by coronary angiography, and patients were divided into two groups: moderate/severe calcification group and non/mild calcification group. Clinical follow-up was completed up to 5 years. Incidence of PCI-related complications and immediate procedural outcomes were compared between two groups, and the primary endpoint was the target lesion failure (TLF) at 5 years after PCI. Clinical follow-up endpoint events were analyzed using Kaplan-Meier survival analysis with log-rank test, and Cox multivariate regression model was used to evaluate the relationship between calcification and TLF.Results:The study included 2 659 CTO patients with an age of (57.2±10.5) years, of whom 442 (16.6%) were female, and among whom 13.5% (360/2 659) had moderate/severe calcification. Compared with the non/mild calcification group, the moderate/severe calcification group had a higher incidence of PCI-related complications (43.2% (156/361) vs. 32.5% (772/2 374), P<0.001) and procedural failure (34.3% (124/361) vs. 24.3% (577/2 374), P<0.001). Additionally, the moderate/severe calcification group showed a higher risk of the primary endpoint event (TLF) during the 5-year follow-up (19.8% vs. 15.3%, log-rank P=0.028). Higher incidence of cardiac death was observed in moderate/severe calcification group (5.7% vs. 2.7%, log-rank P=0.003). Cox multivariate regression analysis revealed that moderate/severe calcified plaques remained an independent risk factor for 5-year TLF after CTO-PCI ( HR=1.34, 95% CI: 1.01-1.79, P=0.043). Conclusion:Compared with CTO patients with non/mild calcification, those with moderate/severe calcification have higher procedural failure and complication rates, as well as poorer long-term prognosis, mainly due to an increase in cardiac death.