Objective To summarize recent advances in antiviral drugs for Lassa fever (LF) and provide insights into current therapeutic bottlenecks. Methods Such databases as PubMed, Web of Science and the China National Knowledge Infrastructure (CNKI) were searched for literature about the clinical efficacy of favipiravir, ribavirin, and immunotherapy, as well as the mechanisms of promising small-molecule drugs. Results Favipiravir, ribavirin, and immunotherapy all proved to be effective against LF. Desirable outcomes resulted from ribavirin in combination with either favipiravir or dexamethasone. However, the appropriate dosage of ribavirin and course of treatment remained controversial, and there was too little evidence to recommend ribavirin for routine treatment of LF. Moreover, the cardiac safety of favipiravir needed to be assessed. However, a variety of small-molecule inhibitors promised wide applications. Conclusion Although no specific antiviral drug has been approved globally for the treatment of LASV, significant progress has been made in developing candidate therapeutics that target different stages of the viral life cycle. Combination therapy and multi-target strategies will be priorities of subsequent research.

Objective To analyze the roles of pathological changes in mitochondrial homeostasis during the progression of myocardial infarction (MI), and to summarize the latest research advances in improving MI by traditional Chinese medicine (TCM) via the regulation of mitochondrial homeostasis in order to provide data for prevention and treatment of MI through mitochondrial protective pathways. Methods Recent literature on MI and mitochondrial homeostasis was retrieved before the core pathological roles of mitochondrial homeostatic imbalance in MI were analyzed and advances in experimental studies on the ability of TCM to improve MI by regulating mitochondrial function through multi-target mechanisms were outlined. Results Recent studies suggested that mitochondrial homeostatic imbalance was a major pathological mechanism for MI, which manifested itself in impaired oxidative phosphorylation, ROS burst, Ca²⁺ overload, mitochondrial permeability transition, abnormal mitochondrial dynamics, dysregulated mitophagy, and mitochondria-mediated activation of cell death pathways. By targeting abnormal mitochondrial homeostasis in cardiomyocytes and the consequent imbalance of both mitochondrial network remodeling and the mitochondrial quality control system, TCM formulas, single herbs, and active compounds could exert multilevel, multi-pathway, and multitarget synergistic effects that helped alleviate mitochondrial injury, maintain mitochondrial homeostasis, reduce cardiomyocyte apoptosis, improve myocardial function, and attenuate ventricular remodeling. Conclusion Mitochondrial homeostatic imbalance is pathologically critical to MI progression. TCM has a cardioprotective potential by regulating mitochondrial homeostasis through multicomponent, multitarget actions. This study is expected to provide insights into MI prevention and treatment strategies based on mitochondrial protection.

Objective To investigate the role and mechanism of Shuangshen Ningxin capsules (SSNXAIG) against myocardial infarction (MI) in mice via transcriptomics. Methods MI models were established in male C57BL/6J mice via cardiac compression combined with ligation of the left anterior descending artery (LAD). Mice were randomly divided into the sham group, MI model group, low dose of SSNXAIG (SSNXAIG-L) group, and high dose of SSNXAIG (SSNXAIG-H) group, with 9 in each group. The SSNXAIG-L group was given SSNXAIG suspension (0.125 g·kg^-1·d^-1), the SSNXAIG-H group received SSNXAIG suspension (0.250 g·kg^-1·d^-1), and the sham group and MI group were given double distilled water. Intragastric treatment lasted for 14 days. Cardiac indexes were measured. Cardiac function was assessed with Doppler ultrasound. Myocardial pathology was observed via HE staining while fibrosis was evaluated by Masson's trichrome staining. Differentially expressed genes (DEGs) were screened via RNA-seq, followed by GO annotation and KEGG enrichment analysis. Results Compared with the MI group, cardiac indexes were significantly reduced in the SSNXAIG-H group (P<0.01) while LVEF and LVFS were increased in SSNXAIG-L and SSNXAIG-H groups (P<0.01), and both doses mitigated myocardial injury, inflammatory infiltration and fibrosis. The transcriptome sequencing results showed that there were 2 243 DEGs (1 815 upregulated and 428 downregulated) in Sham and MI groups, 94 DEGs (13 upregulated and 81 downregulated) in MI and SSNXAIG groups, with 87 DEGs tending to be reversed. KEGG pathway analysis revealed that DEGs were primarily enriched in cell cycle, cellular senescence, and the p53 signaling pathway. Conclusion SSNXAIG can significantly reduce myocardial injury, improve cardiac function, and attenuate myocardial fibrosis in MI mice. The underlying mechanism may be associated with the modulation of cell cycle, cellular senescence, and the p53 signaling pathway.

Objective To address the safety concerns about mineral drugs (Cinnabar and Realgar) in Angong Niuhuang Wan (AGNHW) and about the uncertain efficacy of artificial substitutes, and to explore its quality and safety evaluation system in terms of “component interactions within the compound micro-environment”. Methods Recent studies on interactions between “mineral components (toxicity/efficacy)” and “plant/animal components (detoxification/assistance)” in AGNHW were reviewed in general and multidimensional detoxification mechanisms, morphological toxicology, and bioequivalence evaluation in particular. Results There was evidence that AGNHW was not merely a simple mixture of ingredients, but instead a precise “toxicity-regulating system”. Plant and animal components proactively intervened in the in vivo processes of heavy metals via chemical chelation (such as peptides from Bubali Cornu), physiological transport regulation (such as upregulation of P-gp efflux by berberine), and pathological anti-inflammation (such as the antioxidant effect of muscone) so that “toxicity was mitigated while efficacy was retained.” However, current quality control standards failed to cover these critical indicators of “detoxification interactions”. The lack of trace synergistic components in artificial substitutes might compromise this endogenous protective mechanism. Conclusion Research on AGNHW should shift from “quantification of chemical components” to “correlations between interactive mechanisms”. It is recommended that an integrated evaluation system based on “the ability of heavy metals to regulate morphology” and “biological activity fingerprints” be established, and that multi-omics and artificial intelligence be used to elucidate the material basis of the “efficacy-toxicity balance” so as to provide a reference for precise clinical applications of classic formulas.

Objective To investigate the neuroprotective mechanism through which Angong Niuhuang Wan mitigates oxidative stress in rats with ischemic and hemorrhagic stroke. Methods Molecular docking and molecular dynamics simulations were used to analyze the interactions between key active components of Angong Niuhuang Wan and the brain-derived neurotrophic factor (BDNF) and the nerve growth factor (NGF). Rat models of cerebral ischemia and cerebral hemorrhage were established before the animals were randomly divided into sham-operated, model, low-dose Angong Niuhuang Wan (257 mg·kg^-1), and high-dose Angong Niuhuang Wan (514 mg·kg^-1) groups. Malondialdehyde (MDA) and glutathione peroxidase (GSH-Px) levels in brain tissues were measured using biochemical assays. Protein expression levels of BDNF and NGF were detected by Western blot. Results Molecular docking results showed that the core components of Angong Niuhuang Wan-berberine and baicalin-had good binding activity with BDNF and NGF, respectively, with binding energies below -5.0 kcal·mol^-1. Molecular dynamics simulations confirmed stable binding activity between berberine and BDNF, and between baicalin and NGF. Animal experiments suggested that in the low-dose Angong Niuhuang Wan groups, MDA levels were significantly reduced (P<0.05) GSH-Px contents increased (P<0.05) while protein expressions of BDNF and NGF were significantly up-regulated (P<0.05) in brain tissues of rats compared with the model group. Conclusion Angong Niuhuang Wan may exert neuroprotective effects in ischemic and hemorrhagic stroke models by reducing oxidative stress and upregulating the BDNF/NGF pathway.

Objective To investigate the preventive hypolipidemic effects and metabolic regulatory mechanisms of Hongqu Dilong tablets so as to provide a reference for subsequent research on the mechanism of action of such drugs and their safe clinical use. Methods A high-fat diet (HFD)-induced C57BL/6N mouse model was established. Mice, male or female, were orally administered Hongqu Dilong tablets (0.208 mg·g⁻¹) daily for 4 weeks. Body weight, serum levels of ALT, AST, blood lipids, glucose, and liver histopathology were assessed. Serum metabolomics was employed to explore metabolic alterations and potential mechanisms. Results Compared with the HFD model group, mice treated with Hongqu Dilong tablets had their body weight significantly reduced and liver function (ALT and AST) improved. The treatment markedly reversed HFD-induced elevations in serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) while significantly reducing blood glucose levels in male mice. Histopathological examination (H&E and oil red O staining) revealed that the tablets alleviated hepatic lipid accumulation and mitigated HFD-induced structural abnormalities, including disorganized hepatocyte arrangement and expanded intercellular spaces. Metabolomic analysis suggested that the preventive hypolipidemic effects were mediated by regulating lipid metabolism and sphingolipid signaling pathways, along with modulations in amino acid and protein metabolism. Conclusion Hongqu Dilong tablets can effectively counteract HFD-induced increases in body weight, dyslipidemia, and hepatic lipid deposition in mice of both sexes. The mechanism may involve regulation of a metabolic network related to lipid metabolism.

Objective To compare the contents of eight saponins in different parts of Paris polyphylla var. yunnanensis, and provide data for subsequent development and applications of medicinal resources. Methods HPLC was used to simultaneously determine the contents of eight saponins, including saponins polyphyllinⅦ, D, H,Ⅵ, Ⅱ, dioscin, gracillin, and polyphyllinⅠ, in the rhizomes, fibrous roots, stems, leaves, and sepals of the plant. The chromatographic column was YMC Pack ODS-A C₁₈ (250 mm × 4.6 mm, 5 μm), and the mobile phase was composed of acetonitrile (A)-water (B) under gradient elution (0-50 min, 30%→50% A; 50-65 min, 50% A). The detection wavelength was 203 nm, the flow rate was 1 mL·min^-1, and the column temperature was 30℃. Results Each part of the plant contained a certain amount of saponins, but there were significant differences. The fibrous root contained more of polyphyllin Ⅶ than the rhizomes, but contained no polyphyllinⅠ. The content of total saponins in the stems was lower while that of polyphyllin Ⅶ was higher. There was significant difference in the contents of total saponins and individual saponins between leaves and sepals of different batches. For example, some batches contained higher levels of polyphyllinⅦ, H, or Ⅱ. There was a correlation between the contents of saponins in leaves and sepals. In the same batch of samples, the components whose contents were higher in leaves also had higher contents in sepals, but the total content in sepals was lower than in leaves. Conclusion There are significant differences in saponin contents between non-medicinal parts and rhizomes, but both contain some saponins. Non-medicinal parts can be used to extract saponins or explore their medicinal value.

Objective To describe the formulation process and checklist items of the Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE), and to advance our understanding and applications of the RIMES-SE checklist tool. Methods The background of updating the reporting standards for pharmaceutical risk minimization evaluation studies was summarized. Following a translation integrity procedure involving forward and backward translation steps, the translation of the RIMES-SE checklist was completed. An illustrative interpretation using the effective evaluation research of valproate risk minimization measures implemented in Europe was attempted. Results The RIMES-SE checklist was organized into two dimensions—risk minimization interventions and implementation strategies—comprising a total of 27 items. The reporting of the valproate risk minimization program was clear in structure and methodologically sound. However, the principles about implementation science, explicit definitions and threshold setting for effectiveness of risk minimization measures, and clarity regarding the extent to which interventions were delivered as intended to all participants needed to be improved. Conclusion With the progressive adoption of RIMES-SE by pharmacovigilance authorities worldwide, this reporting standard will provide an important framework to guide more rigorous and standardized pharmaceutical risk minimization evaluation studies in China.

Objective To analyze the current regulation of post-approval changes to pharmaceutical products both at home and abroad so as to provide references for the research on and regulation of post-approval changes in China. Methods The systems for post-approval changes to drugs in the United States, Europe, and China and the provisions of ICH Q12 were compared and analyzed. Domestic regulatory requirements and industrial practices were taken into consideration. Results China's framework for regulation of post-approval changes was basically full-fledged. However，due to the complexity of variations, multiple regulatory bodies in China, and disparities in the development of the pharmaceutical industry between provinces, there was still room for improvement in this field. Conclusion Regulators of drugs and manufacturers should collaborate closely to keep upgrading the management system for post-marketing changes by strengthening the lifecycle mana-gement of drugs, adopting the same standards, and enhancing the management capabilities of marketing authorization holders.

Objective To analyze the data from China's Adverse Drug Reaction (ADR) monitoring, explore developments, and propose strategies for building a more efficient and precise pharmacovigilance system. Methods The data from the 2020-2024 annual reports released by the National Adverse Drug Reaction Monitoring Center of China was reviewed and analyzed. Results Substantial progress was made in China's ADR monitoring, such as the huge increases in the number of reports and continuous optimization of the monitoring network. However, challenges persisted, including inadequate participation of reporting entities (especially MAH), insufficient risk monitoring for key populations (e.g., children and the elderly), incomplete safety assessments of high-risk drugs (e.g., novel antitumor agents and biologics), and slow progress in information technology and intelligent capabilities. Conclusion To address these challenges and enhance drug safety surveillance, it is recommended that the regulatory framework for ADR monitoring be updated, responsibilities and abilities for reporting be upgraded in such key entities as MAH, medication safety for vulnerable groups (children/elderly) be prioritized, lifecycle supervision and signal detection for high-risk drugs be enhanced, IT and AI technologies be integrated in monitoring, and literacy about rational medication and awareness of pharmacovigilance be improved.

Objective To construct a well-designed and efficient intelligent digital management platform for emergency medical supplies to bolster this support system. Methods Based on literature retrieval and investigation into the mechanisms for emergency medical supplies and resource scheduling both at home and abroad, the classification of emergency medical supplies and demands of platform construction were analyzed. Results An intelligent digital management platform for emergency medical supplies was constructed that integrated a collaborative “cloud-edge-device” framework. The platform was backed up by five core technologies: a dynamic modeling engine, information reasoning and intelligent judgment, visual interaction, remote positioning, and big-data-driven optimal path planning so that a closed-loop process was made possible that involved reserve of supplies, prediction of demands, intelligent scheduling, oversight of transportation, quality tracing, and emergency decision-making. Conclusion The reserve and efficient management of emergency medical supplies are critical to responding to emergencies and reducing casualties. The intelligent digital platform constructed in this study integrates mechanisms, technologies and processes, thus providing a replicable and scalable paradigm for ensuring medical supplies during emergencies in China. More research is needed on validation of its robustness and scalability under multi-hazard coupling scenarios.

Objective To find out about the implementation of the Post-Approval Studies (PAS) and Section 522 Postmarket Surveillance Studies programs, and to provide insights into the regulatory framework of China's counterparts. Methods A cross-sectional analysis was conducted. Data from the FDA’s official PAS and 522 study databases was analyzed. The basic characteristics, study designs, programs completed, and applications of findings were compared between the two systems. The findings were then analyzed in light of the current regulatory landscape in China. Results A total of 970 PAS (1991-2025) and 409 522 Studies (2001-2025) were included. The PAS primarily targeted Class Ⅲ high-risk devices approved via the Premarket Approval (PMA) pathway (93.3%). The study designs were predominantly prospective cohorts (65.05%), demonstrating a relatively high rate of completion (57.73%). In contrast, the 522 studies involved Class Ⅱ devices cleared via the 510(k) pathway (92.9%). Their design was primarily cross-sectional (21.03%), with a low rate of completion (12.47%). Findings from both programs were effectively used for label updates and regulatory decision-making, yet challenges like high costs, delayed reactions, and insufficient transparency of data persisted. Conclusion It is recommended that China, within its existing regulatory framework, continue to refine and elaborate its mandatory postmarket study regulations based on practical oversight experience in order to facilitate execution control and the transformation of research findings.

Objective To investigate the clinical outcomes of and management strategies for secondary T-cell lymphomas after chimeric antigen receptor T (CAR-T) cell therapy. Methods Such databases as Medline, Embase and the Cochrane Library were searched for literature that was published as of September 1, 2025 to analyze cases of secondary T-cell lymphomas following CAR-T cell therapy in general and the related pathogenesis, diagnostic and therapeutic approaches in particular. Results Seventeen cases of secondary T-cell lymphomas after CAR-T cell therapy were identified, with 11 cases being CAR positive T-cell lymphomas and 6 cases being CAR negative ones. There were 8 cases of secondary T-cell lymphomas after cilta-cel, including 7 cases of CAR positive T-cell lymphomas. There were 2 cases of CAR negative T-cell lymphomas after tisa-cel. There were 4 cases of CAR-T cell lymphomas after axi-cel. Among the three cases treated with CAR-T cell therapy for clinical research, there were two cases of CAR positive T-cell lymphomas. The incidence of secondary T-cell lymphomas after CAR-T cell therapy was below 1%. Molecular abnormalities with loss-of-function changes in TET2 (Ten–Eleven Translocation 2) were frequent in T-cell lymphomas, and were detected in 7 cases. CAR molecules could serve as persistent signals that directly promoted the proliferation and survival of malignant precursor T-cell clones. A few cases of aggressive T-cell lymphomas responded to multi-drug chemotherapy while indolent cases generally responded well to immunosuppressive treatments such as glucocorticoids or cyclosporine A. CAR T-cell lymphomas needed to be differentiated from CAR T-cell expansion. Diagnosis was made using PET-CT and biopsy. Multimodal analysis could help distinguish malignant T cells from healthy T cells, identify highly expressed targets, and verify them through flow cytometry along with other cytokines and receptors that promoted cell survival. Subsequently, suitable drugs could be selected based on in vitro drug screening and efficacy evaluation using biochemical markers and imaging. Conclusion The proportion of secondary T-cell lymphomas is the highest after cilta-cel. The risk of secondary T-cell lymphomas after CAR-T cell therapy remains unclear, so data on more rigorous large-sample case-control studies is needed. CAR T-cell lymphomas not only affect lymph nodes, but also tend to invade extralymphatic sites, particularly in the skin and gastrointestinal system. Lifelong follow-up is necessary, and early detection, early diagnosis, and early treatment are recommended. Combination therapies, immunosuppression, and targeted therapy, followed by hematopoietic stem cell transplantation after remission, may be effective.

Objective To analyze the incidence of new adverse drug reactions (ADR) induced by Chinese patent medicines among 1 939 elderly patients in Weifang, and to identify contributors to ADR in the elderly so as to provide references for monitoring of the safety of Chinese patent medicines. Methods A total of 13 553 ADR reports submitted to the spontaneous reporting system of the Weifang Adverse Drug Reaction Monitoring Center between January 1 2019 and January 1, 2025 were collected. Patients ages 60 and older were selected as the subjects. Among them, 1 939 cases (14.31%) of new ADR were identified and analyzed in terms of gender, age, drug category, routes of administration, affected systems-organs, and major clinical manifestations. Results The incidence of new ADR was higher in elderly females than in elderly males, with the majority of cases in the group ages 60 to 75. However, severe ADR were more prevalent in males. Among the reported cases, 1 212 (62.51%) ADR occurred on the first day of medication. The most common route of administration was oral (89.79%), followed by intravenous infusion (8.30%). The top five categories of Chinese patent medicines by function were blood-regulating agents, tonifying agents, collateral-dredging and pain-relieving agents, dampness-eliminating agents, and joint-relieving and collateral-dredging agents. The most commonly affected systems were the digestive system (57.26%) and the central and peripheral nervous systems (11.92%). Conclusion Chinese patent medicines should be used more rationally in the elderly in clinical practice. It is recommended that medical institutions enhance targeted ADR monitoring based on different age groups and varieties of Chinese patent medicines to ensure safe and rational clinical use.

Objective To analyze the characteristics of new and serious adverse drug reactions (ADR) associated with antineoplastic agents, and to provide a reference for safe medication. Methods A total of 470 reports of new and serious ADR associated with antineoplastic agents were collected from a hospital in 2022-2024. The types of reports, causality assessments, gender of patients, age, primary diseases, routes of administration, time to ADR onset, outcomes, suspected drugs, and clinical manifestations were statistically analyzed. Results Among the 470 cases, 173 (36.81%) were new ADR, including 132 new and mild ADR and 41 that were both new and serious. There were 297 (63.19%) cases of serious ADR. The incidence of ADR was slightly higher in males than in females, with gender distribution varying across age-groups. The highest incidence occurred in the group ages 51 to 70. Intravenous infusion was the most common route of administration (587 instances, 82.10%). There were 245 reported cases of ADR (52.13%) that had occurred within one day of drug administration, and a total of 440 cases of ADR (93.62%) improved and completely recovered. A total of 715 suspected drugs involving 63 varieties were reported, including 144 (20.14%) novel antineoplastic drugs of 30 varieties, and 571 (79.86%) traditional antineoplastic drugs of 33 varieties. Platinum-based agents were the most frequently involved (213, 37.3%). The most commonly affected organs and systems by new ADR were systemic disorders and conditions at administration sites, with chest tightness being the predominant clinical manifestation (34 instances). For serious ADR, the most frequently affected systems were blood and lymphatic system disorders, with neutropenia as the main clinical presentation (122 instances). Conclusion New and serious ADR are associated with patients’ gender, age, underlying diseases, routes of administration, and suspected medications. Close monitoring is recommended for patients prone to such ADR in clinical practice.

Objective To analyze the current incidence of and risk factors for drug-induced liver injury (DILI), and to investigate the differences in risk factor profiles between non-ATB-DILI and ATB-DILI. Methods A retrospective study was conducted to collect medical records of patients diagnosed with drug-induced liver injury (DILI) in 2024 at the Third People's Hospital of Kunming. Patients in the DILI group (n=400) were assigned to the case group while those in the abnormal liver biochemistry group (n=500) served as controls. A multivariate logistic regression model was used to identify potential risk factors associated with DILI. Based on the suspected causative agents, DILI cases were subsequently classified into non-ATB-DILI and ATB-DILI subgroups that were then compared with the overall abnormal liver biochemistry group as well as their corresponding subgroups (non-ATB abnormal liver biochemistry and ATB abnormal liver biochemistry) in order to explore differences in risk factor profiles between the two types of DILI. Results Among the suspected drugs causing DILI, anti-tuberculosis agents accounted for the highest proportion (64.54%), followed by anti-infective agents (23.52%) and traditional Chinese medicines/dietary supplements (TCM/DS) (4.12%). DILI and its subgroups (non-ATB-DILI and ATB-DILI) were mostly hepatocellular in type, with most cases classified as mild (Grade 1). Multivariate logistic regression analysis indicated that female sex, liver disease, HIV infection, and coagulation dysfunction might be potential risk factors for DILI, with notable differences between non-ATB-DILI and ATB-DILI. For non-ATB-DILI, risk factors included female sex, liver disease, HIV infection, and coagulation dysfunction, whereas for ATB-DILI, only coagulation dysfunction was identified as a risk factor. In addition, patients with coagulation dysfunction were more vulnerable to non-ATB-DILI (OR=2.595>1.847). Conclusion Female sex, liver disease, HIV infection, and coagulation dysfunction are identified as potential risk factors for DILI. Differences in risk factor profiles between non-ATB-DILI and ATB-DILI are of statistically significant. Therefore, differentiated risk assessment and monitoring strategies should be implemented in clinical practice according to the types of patients in order to enable early identification and precise interventions among high-risk populations, thereby reducing the risk of DILI.

Objective To construct an intelligent model for prediction of severe adverse drug reactions (ADR) based on spontaneous ADR reporting data in order to enhance the efficiency of pharmacovigilance, identify high-risk adverse reactions earlier, and optimize the allocation of healthcare resources. Methods A retrospective analysis was conducted of 4 144 spontaneous ADR reports. The DeepSeek large language model (LLM) was applied to standardize diagnostic information and names of drugs. Twenty-four clinical features were selected to process data on age, time variables, and unordered categories with feature engineering. Ten machine learning algorithms, including Bernoulli Naive Bayes (BNB) and Random Forest (RF), were compared. Besides, the effectiveness of such sampling techniques as SMOTE, ADASYN, and TomekLinks in addressing data imbalance (10.4% severe ADR) was evaluated. Model performance was evaluated with the area under the precision-recall curve (AUPRC) as primary metrics, and the area under the curve (AUC) and true positive rate (TPR) as secondary metrics. Feature contributions were analyzed by using SHAP values. Results The combination of BNB and TomekLinks delivered the best performance. In internal validation, AUC=0.921, AUPRC=0.757, and TPR=0.626 were achieved, compared with AUPRC=0.711 and AUC=0.901 in external validation, suggesting good generalization ability. SHAP analysis revealed that hospitalizations or prolonged hospital stay, age, and immune abnormalities or infections indicated significant positive influence, while insignificant impact on preexisting diseases, damage to the gastrointestinal system and the skin and its accessories, and recovery/improvement were indicators of negative influence. Conclusion Undersampling techniques, particularly TomekLinks, outperform oversampling methods for high-dimensional sparse features. The BNB algorithm, a classic classification method based on Bayes' theorem, continues to excel in classification efficiency among various algorithms. Limitations include potential bias from single-center data and insufficient sample size for severe ADR. A more accurate early warning system should be established by integrating multi-center data, taking molecular features of drugs into consideration and leveraging natural language processing technologies.

Objective To investigate the causal relationship between GLP-1RA medications and pancreatic-related adverse event (AE) using Mendelian randomization (MR) before mining AE signals for causal AE using the FDA Adverse Event Reporting System (FAERS) database from 1 Jan, 2018 to 30 Sep, 2024. Methods The inverse variance weighting method was used as the primary analysis method for MR. Chi-square test and three disproportionality analysis methods were combined to mine AE signals. Results GLP-1RA medications were found to have causal associations with acute pancreatitis (OR=1.003, 95%CI:1.002–1.004, P＜0.000 1) and chronic pancreatitis (OR=1.434, 95%CI:1.231–1.670, P＜0.000 1). No causal associations were found with pancreatic cancer (ORBI-DDBJ=1.444, 95%CI:0.818–1.222, P=2.549; ORMRC-IEU=0.856, 95%CI: 0.294–2.497, P=0.776 5). In the FAERS database, 11 261 704 AE reports were obtained from five clinically commonly used GLP-1RA medications, and 10 types of AE signals related to pancreatitis were identified. Stratified analysis revealed that AE signals primarily involved groups ages 45 to 64 and ages 65 and older, with similar types of AE across these age groups. For dulaglutide, exenatide and liraglutide, the types of signal AE were the same in both male and female stratum. Conclusion GLP-1RA medications can increase the risk of pancreatitis rather than pancreatic cancer. Signal mining of the FAERS data reveals the characteristics of pancreatitis-related AE associated with different GLP-1RA medications.

Objective To analyze one case of acne caused by aripiprazole in order to provide a reference for safe and rational medications. Methods A personalized treatment plan and tips about medication were provided for a patient with acne caused by aripiprazole. The clinical manifestations, mechanism of occurrence, adverse outcomes and priorities of treatment of acne were analyzed based on literature. Results This case was a patient with mood disorder. After treatment with aripiprazole, the patient’s mood improved significantly, but acne appeared. The adverse reactions caused by aripiprazole were determined through causal relationships. By adjusting the personalized medication plan, the patient’s condition became stable and the symptoms of acne improved. Conclusion The adverse drug reactions of acne caused by aripiprazole can lead to a patient’s feelings of physical inferiority and social barriers, thereby reducing medication compliance. During medication, the patient ought to be given better pharmaceutical care. Symptoms of acne can be eliminated or mitigated by adjusting the treatment regimen.

Objective To analyze the clinical characteristics and pathogenesis of obinutuzumab injection induced acute severe thrombocytopenia based on real cases in order to improve clinical vigilance on a rare adverse reaction induced by obinutuzumab. Methods The clinical medication for and changes in blood platelets count of a 61-year-old male patient with follicular lymphoma who suffered from acute severe thrombocytopenia caused by the combination of obinutuzumab and chemotherapy were analyzed, and related literature was consulted. Results Acute severe thrombocytopenia occurred following chemotherapy with the G-CHOP regimen (obinutuzumab, cyclophosphamide, pirarubicin, vindesine and prednisone). After causality assessment, obinutuzumab was discontinued. The patient immediately received combined treatment with intravenous immunoglobulins, thrombopoietin, and romiplostim. Subsequently, the platelets count returned to normal. The above adverse reactions did not occur when rituximab replaced obinutuzumab. Conclusion When a patient uses obinutuzumab for the first time, clinicians should care about platelets count and watch for bleeding symptoms. Before bone marrow suppression and in its absence, obinutuzumab-induced acute thrombocytopenia should be taken into consideration in case of acute thrombocytopenia. Pharmacovigilance and risk management are required.

Objective To study one case of drug hypersensitivity syndrome caused by allopurinol sustained-release capsules so as to provide a reference for safe clinical medications. Methods The diagnosis and treatment process of an adult patient who developed drug hypersensitivity syndrome and acute exacerbation of chronic renal failure one month after using allopurinol sustained-release capsules was analyzed. Based on related literature, the characteristics of the case and the mechanisms of the drug for adverse reactions were analyzed before treatment for this patient was traced. Results Following a causality assessment, the drug hypersensitivity syndrome was attributed to allopurinol. The patient's condition was stabilized after discontinuation of medication and symptomatic treatment. Conclusion Patients with chronic renal failure who use allopurinol sustained-release capsules may develop drug hypersensitivity syndrome, potentially leading to acute deterioration of renal function. Therefore, enhanced monitoring of adverse reactions is required during treatment. HLA-B*5801 genetic testing may help reduce the risk of adverse reactions.

Objective To analyze one case of paroxysmal tremor associated with roxadustat capsules in order to provide data for clinical safety. Methods The clinical data of an elderly patient with stage 5 chronic kidney disease (CKD5) was studied, who developed paroxysmal tremor during roxadustat therapy for renal anemia. Literature was reviewed to find out about the incidence, potential mechanisms, and management strategies of tremor induced by roxadustat. Results The patient presented with recurrent tremor following standard-dose roxadustat administration, which was resolved completely after drug discontinuation. Based on causality assessment, the tremor was likely attributed to roxadustat capsule administration. Conclusion Clinicians should remain alert to tremor-related adverse drug reactions in elderly patients receiving roxadustat for renal anemia. Early detection and prompt interventions are critical to mitigating severe neurological complications.

Objective To analyze one case of immune-related cystitis induced by immune checkpoint inhibitors (ICIs) and provide references for clinical medications. Methods One case of immune-related cystitis caused by sintilimab was discussed, and related literature was reviewed to summarize its clinical characteristics and treatments. Results The association between sintilimab and immune-related cystitis was close. After quick symptomatic treatment, the patient was discharged after the symptoms improved. Conclusion There are currently no definitive diagnostic criteria for immune-related cystitis, which is a rare immune-related adverse event (irAEs). Immune-related cystitis is likely if a patient has used ICIs, presents with urinary irritation symptoms, and shows no response to anti-infective treatment.