Objective To explore the underlying architecture of the U.S. FDA's new unified Adverse Event Management System (AEMS) and to analyze its approaches to data governance and risk management so as to offer insights for China's AI+drug regulation framework and improve post-marketing risk perception capabilities. Methods We traced the FDA's evolution from a collection of fragmented, standalone databases to the integrated AEMS platform and identified both the strengths and weaknesses of its design in terms of cross-modal data integration, ontology mapping, and the use of AI algorithms. Results Our analysis found that the cloud-native AEMS eliminated information silos, supported dynamic data updates through APIs, and used natural language processing (NLP) models to streamline data preprocessing. These capabilities could improve signal detection and shorten early-warning cycles. However, the system's high level of transparency could give rise to a transparency paradox, which might potentially trigger unnecessary public alarm resulting from exposing industry to the dual pressures of compliance burdens and information overload. Conclusion It is recommended that China develop a unified pharma-covigilance database covering drugs, cosmetics, and medical devices while strengthening interdisciplinary collaboration and human-machine collaborative tiered review to encourage domestic enterprises to build forward-looking, proactive risk management systems.

Objective To summarize the types and new applications of mainstream Common Data Models (CDMs) in the medical field, analyze their applicability in public health and epidemiological surveillance, drug research and clinical trials, and quality and performance management of health care. Methods The leading characteristics, technical architecture, and applications of ten mainstream CDMs were introduced. In combination with typical cases of research at home and abroad, the current applications of CDMs in the medical field, main challenges and developments were analyzed. Results CDMs could effectively support semantic interoperability of multi-source heterogeneous medical data by unifying the data structure and terminology system, so they were highly applicable to cross-border and real-world research, epidemiological surveillance, and response to public health emergencies. The distributed analysis framework based on CDMs could ensure large-scale and collaborative use of data while protecting patients' privacy, which significantly reduced the threshold for multi-center research. However, such issues as the strongly unstructured clinical data in Chinese, low efficiency of distributed analysis, heterogeneity of international data standards, and the imperfect domestic integration system still restrict their large-scale implementation in China. Conclusion CDMs can break down medical data silos and provide core technical support for generating high-quality real-world evidence. It is recommended that such technologies as large language models and lightweight federated learning be combined to enhance automated mapping and distributed analysis, promote multi-standard interoperability and construction of the industrial ecosystem, and accelerate their extensive applications in medical research and management.

Objective To investigate the way cell therapy products are currently regulated globally and to offer evidence-based recommendations for optimizing China's post-marketing long-term safety surveillance framework. Methods Related literature about and guidelines for the regulation of cell therapy products in the United States, the European Union, Japan, South Korea, and China were summarized. Based on the realities in China, feasible optimization strategies for long-term safety surveillance of cell therapy products were proposed. Results As of March 2026, eight chimeric antigen receptor T-cell (CAR-T) therapies and one stem cell product had been approved for marketing in China, compared with 49 cell and gene therapy products by the U.S. FDA and 28 cell therapy products by the European Medicines Agency (EMA). A comparative analysis of the current regulatory frameworks revealed that the United States, the European Union, Japan, and the Republic of Korea had all established specialized regulatory bodies and risk-based management systems, characterized by well-defined regulatory mechanisms and detailed guidelines. China had implemented a “dual-track” regulatory model. Conclusion We recommend a four-pronged strategic framework for optimizing China's post-marketing long-term safety surveillance system by updating the top legislation and establishing a risk-stratified monitoring system, reinforcing the dual-track responsibilities of marketing authorization holders (MAHs) and medical institutions, boosting an AI-empowered precision pharmacovigilance paradigm, and enhancing ethical governance frameworks for long-term follow-up informed consent and patient privacy protection. China needs to consolidate its long-term safety surveillance infrastructure for cell therapy products.

Objective To determine the levels of heavy metals and harmful elements in imported Korean red ginseng, American ginseng, and licorice, and to assess their potential health risks using a probabilistic risk assessment approach. Methods A total of 416 batches of Korean red ginseng, 93 batches of American ginseng, and 102 batches of licorice were collected. The concentrations of lead (Pb), cadmium (Cd), arsenic (As), and mercury (Hg) were determined using inductively coupled plasma mass spectrometry (ICP-MS). A Monte Carlo simulation model was constructed to estimate population exposure levels (chronic daily intake, CDI). The non-carcinogenic risk (hazard index, HI) and carcinogenic risk (total carcinogenic risk, TCR) were subsequently assessed, with particular attention to risk characteristics under high-exposure scenarios. Results The concentrations of Pb, Cd, As, and Hg in all these samples were below the maximum limits specified in the Chinese Pharmacopoeia (2025 edition), although differences were observed between the three herbal materials. The mean concentrations of Pb and As were relatively higher in licorice. Probabilistic risk assessment indicated that the HI remained below the safety threshold of 1 even at the P₉₉ percentile for all the three herbal medicines. The calculated TCR were also below 10^-4, suggesting an overall acceptable risk level. However, variations in the contribution of individual elements to the overall risk were observed among the herbs, with arsenic in licorice contributing relatively more to the risk among high-exposure populations. Conclusion Heavy metal contamination in imported Korean red ginseng, American ginseng, and licorice is generally low and within acceptable safety limits. Nevertheless, variations exist among these herbal materials in terms of high-exposure risk and element-specific contributions. Probabilistic risk assessment can reveal characteristics of risk distribution beyond traditional limit-based evaluations, providing useful evidence for identifying potentially higher-risk herbal materials and supporting differentiated quality control strategies for imported medicinal herbs.

Objective To explore the protective effect and underlying mechanism of Twenty-One-Ingredient Shenqi pills (SQW) against renal injury in diabetic kidney disease (DKD) rats based on the advanced glycation end products (AGEs)/receptor for advanced glycation end products (RAGE) signaling pathway. Methods A DKD rat model was established by feeding high-glucose and high-fat diet for 6 consecutive weeks combined with intraperitoneal injection of streptozotocin (STZ). Rats were randomly divided into a normal group, model group, SQW group, irbesartan (EBST) group, and SQW combined with EBST (SQW+EBST) group, with 8 rats in each group. Except the normal group and model group, all these groups were given intragastric perfusion of SQW (6.3 g·kg^-1·d^-1), irbesartan (15.75 mg·kg^-1·d^-1), and SQW (6.3 g·kg^-1·d^-1) combined with irbesartan (15.75 mg·kg^-1·d^-1), respectively. The normal group and model group were given an equal volume of distilled water by gavage once a day for 12 consecutive weeks. The general conditions of rats during the experiment were observed and recorded, fasting blood glucose (FBG) was detected, and urine was collected with metabolic cages to determine 24-hour urinary total protein (24h-UTP) levels. After anesthesia, blood was collected from the abdominal aorta to separate serum, and renal tissues were harvested and weighed to calculate renal indexes. The serum levels of blood urea nitrogen (BUN), serum creatinine (SCr), interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) were detected. The contents of malondialdehyde (MDA) and superoxide dismutase (SOD) in renal tissues were determined. HE staining and Masson staining were used to observe the pathomorphological changes of renal tissues in each group. The mRNA expression level of RAGE in renal tissues was detected by qRT-PCR, and the protein expression levels of AGEs and RAGE were determined by Western Blot. Results Compared with the normal group, rats in the model group presented with poor mental state, sluggish response, reduced activity, emaciation, withered and yellow hair, and significantly increased daily water intake, food intake and urine output. In the model group, the levels of FBG, renal indexes, BUN, SCr, 24h-UTP, MDA, IL-6, TNF-α, as well as the mRNA and protein expression of AGEs and RAGE in renal tissues were significantly increased to varying extents (P<0.01 or P<0.001), while body weight and SOD levels were significantly decreased (P<0.001). Pathologically, the glomerular volume was increased, basement membrane thickened, and mesangial proliferation and glomerular collagen hyperplasia occurred in the model group. Compared with the model group, the levels of FBG, renal indexes, BUN, SCr, 24h-UTP, MDA, IL-6, TNF-α, and the mRNA and protein expression levels of AGEs and RAGE in the SQW group, EBST group and SQW+EBST group were significantly decreased (P<0.05, P<0.01 or P<0.001), body weight and SOD levels were significantly increased (P<0.05, P<0.01 or P<0.001), and the renal pathological damage was alleviated correspondingly after 12 weeks of continuous intragastric administration. These improvements were the most pronounced in the SQW+EBST group, which was superior to SQW alone and EBST alone. Conclusion Twenty-One-Ingredient Shenqi pills can effectively protect the kidney and delay the progression of DKD by inhibiting the activation of the AGEs/RAGE signaling pathway, suppressing oxidative stress and inflammatory response, mitigating renal pathological damage and improving proteinuria. Moreover, the combined use of traditional Chinese medicine and Western medicine is superior to single drug use.

Objective To explore the mechanism by which total flavonoids of Artemisia scoparia (TFA) ameliorate acute lung injury (ALI) in mice by regulating the signaling pathway of nuclear factor erythroid 2-related factor 2 (Nrf2)/heme oxygenase 1 (HO-1). Methods A total of 90 ICR mice were randomly divided into a control group, model group, dexamethasone group (2.5 mg·kg^-1), TFA low dose, medium dose, and high dose groups (100, 200, 400 mg·kg^-1), with 15 mice in each group. The administration groups were orally administered with corresponding drugs once a day for 5 days. An ALI model was induced by nasal instillation of lipopolysaccharide (LPS) in these groups except the control group. Samples were collected 16 hours after LPS administration, and the lung weight wet/dry ratio was determined for mice in each group. The pathological changes of lung tissues were examined by HE staining. The protein content in BALF was measured using the BCA method. The levels of superoxide dismutase (SOD), catalase (CAT), myeloperoxidase (MPO), malondialdehyde (MDA) and glutathione (GSH) in lung tissues were detected using colorimetry. The mRNA expressions of Kelch-like ECH-associated protein 1(Keap-1), Nrf2, HO-1, quinone oxidoreductase 1 (NQO1) in lung tissues were detected by RT-qPCR. The protein expressions of Keap-1, Nrf2 and HO-1 in lung tissues were determined by Western blotting. Results Compared with the model group, the lung wet/dry weight ratio was significantly decreased in the TFA group (P<0.05, P<0.01), pathological injury of lung tissues was significantly improved, and the concentrations of ICAM-1, TNF-α and protein in BALF were significantly deduced (P<0.01). The content of GSH and the activities of SOD and CAT in lung tissues were significantly increased (P<0.05, P<0.01), while the content of MDA and the activities of MPO were markedly decreased (P<0.05). The expression of Keap-1 mRNA and protein in lung tissues was significantly decreased (P<0.05), while the expressions of Nrf2 and HO-1 mRNA and protein were significantly increased (P<0.05, P<0.01). Conclusion TFA may alleviate inflammatory responses and enhance antioxidant capacity by regulating the Nrf2/HO-1 signaling pathway, thereby improving ALI.

Objective To establish a chemical method for covalently binding proteins and evaluate the skin sensitization of five topical chemical materials. Methods The chemical method using covalent binding proteins (direct peptide reaction test or kinetic direct peptide reaction test) was employed to conduct skin sensitization tests on five commonly used topical chemical raw materials including minoxidil, loxoprofen sodium, prilocaine, lidocaine and flurbiprofen in pharmaceuticals. According to OECD TG442C, two substances were selected to validate the direct peptide reaction test (DPRA) and kinetic direct peptide reaction test (kDPRA) in our laboratory. These five raw materials were incubated with cysteine peptide and lysine peptide mimicking skin proteins respectively, and the peptide content was determined using high-performance liquid chromatography. Skin sensitization was evaluated based on the percentage of peptide consumption. Three of these raw materials (co-eluted with lysine peptide) were incubated with the cysteine peptide solution for different lengths of time before the fluorescence intensity was measured using an enzyme-labeled instrument to classify their sensitization based on the reaction kinetic constant. Results The pass rate was 100% based on laboratory verification, suggesting that the experimental system was stable and reliable. The consumption rates of loxoprofen sodium and flurbiprofen peptide were both below 6.38%, while sensitization was negative. Lidocaine and piperacaine were non-reactive and negative in sensitization, compared with lgk_max <-2.0 for minoxidil, indicating it was a moderate or weak sensitizing agent. Conclusion The combined chemical method of DPRA and kDPRA is complementary and user-friendly. It can be used as a new method for preliminary evaluation of skin sensitization of topical chemical raw materials.

Objective To establish the bacterial endotoxin limit and test method for the insoluble drug—borneol—and to validate the method. Methods The bacterial endotoxin limit for borneol was determined according to the Chinese Pharmacopoeia (2025 Edition). Borneol was dissolved in anhydrous ethanol and diluted with water for the bacterial endotoxin test (BET water). Interference and bacterial endotoxin recovery tests were performed using the gel method and kinetic turbidimetric assay. Results No interference was observed with either method when the sample dissolved in anhydrous ethanol was diluted at a dilution factor of 40 or more with BET water, and the results of each test met the related requirements. Conclusion The established method is applicable to testing of bacterial endotoxins in borneol, which can contribute to the improvement of quality standards for borneol as a traditional Chinese medicine. This study is expected to provide a reference for related tests.

Objective To explore the applications of large language models (LLMs) in data cleaning for individual case safety reports (ICSRs). Methods A technical framework was developed by integrating the characteristics of data cleaning. This framework was built on a standardized knowledge base, employed a rule engine as a pre-filtering mechanism, used retrieval-augmented generation (RAG) for candidate recall, leveraged an LLM for semantic reasoning and re-ranking, and established a closed-loop system through manual review and log-based feedback. Recommendations regarding implementation were accessible for such scenarios as giving tips for reporting by grassroots institutions, reviews by regulators, term extraction from ADR narrative descriptions, and continuous iteration and optimization of models. Results The constructed framework proved that LLMs could technologically improve both the standardization of data and cleaning efficiency of ICSRs. Conclusion LLMs can be embedded as an auxiliary data cleaning tool within explainable, traceable, and auditable processes of oversight. However, due to their inherent limitations, they should not replace professional human review. During actual use, their value in enhancing data cleaning and reducing manual workload should be progressively validated through phased and pilot programs, evaluation of benchmark datasets , and compliance-driven cleaning.

Objective To analyze the core framework and practical requirements of documents concerning the medical device vigilance system so as to provide a reference for medical device vigilance. Methods Based on the recently released “Good Vigilance Practice for Medical Devices (trial)” and its supporting documents, the drafting background, core objectives, framework, and specific requirements of this series of documents were analyzed in general and their implications for the construction of China's medical device vigilance system in particular. Results and Conclusion The “Good Vigilance Practice for Medical Devices” and its supporting documents reflect the core concept about risk management throughout the lifecycle of medical devices in China's medical device vigilance. Their issuance means that China has established the initial framework of the medical device vigilance system, which provides clear institutional documents for the implementation of medical device vigilance in China. This is of great significance for improving China's medical device vigilance system and facilitating related work.

Objective To establish a nomogram model to identify independent factors associated with serum VPA concentrations that exceed the safety threshold so as to provide a reference for safe clinical use of VPA. Methods The patients were divided into two groups based on serum VPA concentration: a therapeutic range group (50-100 μg·mL^-1) and a group exceeding the safety threshold (>100 μg·mL^-1). R4.3.0 software was used to establish a nomogram model. The receiver operating characteristic (ROC) curve was used to evaluate the discriminative ability of the model while the Hosmer-Lemeshow goodness-of-fit test was used to assess the accuracy of prediction. Results A total of 813 patients were enrolled, including 699 in the VPA therapeutic range group and 114 in the group exceeding the safety threshold. Lasso regression identified four top predictors: gender, body weight, body mass index, and administration routes. Binary logistic regression analysis found that body weight (OR=0.985) and administration routes (OR=5.880) were independent risk and protective factors, respectively, for maintaining serum VPA concentrations within the therapeutic range. The nomogram model was moderately accurate for predicting patients exceeding the safety threshold, with an ROC AUC of 0.705 (95%CI: 0.654-0.757), a sensitivity of 78.95%, and a specificity of 55.94%. The Hosmer-Lemeshow test indicated good model fit (χ²=14.144, P=0.078). Decision curve analysis showed that the nomogram model provided a good net benefit in predicting whether serum VPA concentrations were within the therapeutic range across a range of high-risk threshold probabilities. Conclusion Body weight and administration routes are independent risk factors associated with serum VPA concentrations exceeding the safety threshold. The nomogram model can effectively estimate the risk of elevated serum VPA concentrations.

Objective To establish a population pharmacokinetic (PPK) model of olanzapine in patients with schizophrenia so as to identify key covariates influencing its pharmacokinetic characteristics and to provide evidence for individualized dosing. Methods A total of 221 measurements of olanzapine plasma concentrations from 31 patients were included in the final analysis. A nonlinear mixed-effects model was developed in Phoenix NLME (version 8.7; Certara USA, Princeton, NJ) using first-order conditional estimation with extended least squares. A one-compartment model with first-order absorption and elimination without an absorption lag time was selected as the structural model. Covariates were screened through a stepwise forward inclusion followed by backward elimination approach. Internal validation was performed using goodness-of-fit plots, prediction-corrected visual predictive checks (pcVPC), and nonparametric bootstrapping. Results The typical values of apparent clearance (CL/F) and apparent volume of distribution (V/F) of the population were estimated by the final model at 28.95 L·h^-1 and 248.76 L, respectively. Covariate analysis identified total bilirubin as a statistically significant positive factor influencing the absorption rate constant (K_a). Gender, age, body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine did not make much difference, which might be attributed to the limited sample size. Internal validation confirmed satisfactory predictive performance and stability of the final model. Conclusion Total bilirubin levels may influence the absorption of olanzapine and should be taken into consideration when individualized dosing regimens are formulated for patients with schizophrenia.

Objective To analyze the patterns and characteristics of adverse drug reactions (ADRs) associated with iodixanol injection, and to provide evidence for safe clinical use. Methods ADR reports submitted between January 1, 2020 and June 30, 2025 that involved iodixanol injection as the suspected drug were collected. Data on patients' gender, age, severity of ADRs, system organ classes (SOCs), routes of administration, and clinical outcomes was analyzed. Results Among the 1358 reports of ADRs, 743 (54.71%) involved males and 615 (45.29%) involved females, so the male-to-female ratio was 1.21∶1. Although the recorded ADRs were primarily expected reactions, severe ADRs made up 56.77% (771 cases). SOCs involved were mostly the skin and subcutaneous tissues (1 938 times, 89.81%). Intravenous injection was identified as the most common route of administration (765 cases, 56.33%). Most of the ADRs had an onset within 24 hours of administration, especially within 6-24 hour (319 cases, 41.37%). Furthermore, there was statistically significant difference in the proportion of severe and mild ADRs between different dosage groups (P=0.027). Conclusion ADRs induced by iodixanol injection are predominantly expected reactions and generally have favorable clinical outcomes. However, the proportion of severe ADRs remains high, which is a health concern. It is recommended that middle-aged and elderly patients as well as those with multiple underlying diseases be given special care.

Objective To analyze the regularity and characteristics of adverse drug reactions (ADRs) caused by escitalopram oxalate tablets in order to provide a reference for clinical medication. Methods Reports of ADRs caused by escitalopram oxalate tablets collected by an ADR database in 2010-2025 were retrieved before the basic data of patients, system and organs involved, clinical manifestations and risk factors for severe ADRs were analyzed. Results A total of 1 115 ADR reports were collected, 83 of which involved (7.44%) new and mild ADRs, and 232 (20.81%) involved severe ones. The ratio of males to females was 1∶1.75. Patients aged 45 to 64 accounted for 39.46%, compared with 5.11% among those under 18. The dosage was usually 10 mg per day (45.29%), and dosages exceeding 20 mg per day accounted for 3.14%. Most of these ADRs occurred within one week of treatment, accounting for 53.19%. The symptoms were mostly gastrointestinal damage, damage to central and peripheral nervous systems, damage to the hepatobiliary system, and mental disorders, manifested as nausea, constipation, dizziness, abnormal liver function, drowsiness, palpitations, rash, fatigue, and leukopenia. Most of the patients improved (55.25%) or recovered (36.95%) after treatment. The combined drugs included lorazepam tablets, buspirone hydrochloride tablets, olanzapine tablets, tandospirone citrate capsules, and other psychotropic drugs. Conclusion ADRs caused by escitalopram oxalate tablets involve multiple systems and organs. Leukopenia and neutropenia are new ADR signals with more reported cases. Patients' gender, age, and concomitant medication are risk factors for severe ADRs. Clinicians should devote more effort to monitoring and effective management of new ADR signals.

Objective To investigate the clinical characteristics of conjunctival congestion caused by hemocoagulase agkistrodon for injection in patients with perioperative bleeding so as to provide a reference for safe clinical medication. Methods Two cases of conjunctival congestion that occurred after the postoperative use of hemocoagulase agkistrodon for injection for hemostasis were analyzed. Related literature was reviewed. Results Two pediatric patients experienced conjunctival congestion immediately after using hemocoagulase agkistrodon for injection. There was a significant temporal correlation. According to the Naranjo's Adverse Drug Reaction Probability Scale, the causality was assessed as possible. After quick symptomatic treatment, the patients recovered. Conclusion The risk of anaphylactic shock caused by hemagglutinin is unpredictable, which deserves the attention of medical staffs. Before prescribing the drug in high-risk populations, clinicians should take safety into consideration and take precautions.

Objective To find out about myocarditis induced by gefitinib in order provide a reference for clinical safe medication. Methods The diagnostic and therapeutic process of a patient with myocarditis induced by gefitinib was reviewed. Related literature was retrieved to explore the mechanism of and management strategies for gefitinib-induced myocarditis. Results After more than three months of treatment with gefitinib, the patient developed chest tightness, dyspnea, and hemoptysis. Gefitinib-induced myocarditis was suspected. The drug was immediately withdrawn before symptomatic treatments including fluid resuscitation, diuresis, and myocardial nutritional support were offered. The patient's symptoms subsequently improved. Conclusion Adverse reactions such as myocarditis should be monitored during the use of gefitinib. Enhanced surveillance, early identification, and prompt interventions are required.

Objective To analyze a case of acute severe liver injury caused by acyclovir (ACV) chewable tablets in order to provide a reference for rational clinical use of this drug. Methods One case of acute severe liver injury induced by ACV chewable tablets in an adult patient was analyzed before the causality between acyclovir exposure and liver injury was assessed based on the clinical course, laboratory findings and temporal association with drug administration. The potential mechanism of drug-induced liver injury related to acyclovir was explored via literature review. Results Prior to hospitalization, the patient was treated with ACV chewable tablets alone. Based on clinical manifestations, laboratory tests, and the temporal correlations with medication, it was determined that the acute severe liver injury in this patient was likely caused by acyclovir chewable tablets. After acyclovir chewable tablets were discontinued and liver-protecting therapy was initiated, the liver function of this patient improved significantly. Conclusion The underlying mechanism of acyclovir-induced hepatotoxicity remains elusive. When acyclovir is used clinically, the risk of drug-induced liver injury needs to be taken into consideration while adverse reactions should be monitored to make medication safer.

Objective To investigate one case of chorea induced by digoxin toxicity in order to provide a reference for safe and rational medication. Methods A patient with stage 5 chronic kidney disease undergoing long-term haemodialysis developed chorea following digoxin administration for recurrent heart failure after coronary stent implantation. Related literature was collected and the association between chorea and digoxin as well as its potential mechanisms were studied. Results The plasma concentration of digoxin was found to be 4.1 ng·mL^-1. Based on the Naranjo's Causality Index, digoxin-induced chorea was considered probable. Discontinuation of digoxin and administration of diazepam for sedation resulted in the absence of subsequent adverse reactions. Conclusion Risk factors for digoxin-induced chorea primarily stem from digoxin accumulation and toxicity. Early detection of digoxin toxicity is crucial in clinical practice. Particular attention should be paid to dosage adjustment and regular monitoring of serum concentrations in patients with renal impairment, those concurrently taking drugs interacting with digoxin, and special populations to ensure safe and rational clinical use.

Objective To explore the risk of rhabdomyolysis induced by piperacillin sodium and tazobactam sodium for injection and provide a reference for clinical safe medications. Methods One case of rhabdomyolysis caused by piperacillin sodium and tazobactam sodium for injection used to combat infection in a patient with infection complicated with diabetic ketoacidosis (DKA) was analyzed. The clinical manifestations, possible mechanisms, and prevention of adverse drug reactions (ADRs) were explored based on literature. Results Rhabdomyolysis was believed to be linked to piperacillin tazobactam. After discontinuation of the drug, the levels of MYO and CK decreased significantly, and muscle pain disappeared. Conclusion Clinicians should be vigilant about the potential risk of rhabdomyolysis induced by piperacillin sodium and tazobactam sodium for injection. Early detection and prompt interventions are critical to mitigating severe neurological complications.

Objective To review the recent advances in research on the role of traditional Chinese medicine (TCM) in regulating DNA methylation over the past three years so as to provide evidence for the elucidation of the mechanisms, rational clinical applications and pharmacovigilance related to TCM. Methods Such databases as CNKI, PubMed and Web of Science were searched. Literature about DNA methylation regulated by TCM monomers, effective parts/extracts, single herbs, compound preparations and property-meridian theories was summarized and analyzed. Results DNA methylation was an important epigenetic modification, the abnormality of which was closely related to such diseases as tumors, atherosclerosis, liver fibrosis, nephropathy, osteoporosis and aging. TCM exerted multi-target and multi-channel regulatory effects primarily by modulating DNA methyltransferases, demethylases and methylation levels of key gene promoters. Conclusion The regulation of DNA methylation by TCM is highly consistent with the holistic concept, nature-taste-meridian tropism and compatibility theory of TCM, which is why this sphere is promising. The development of pharmacovigilance and precise medication of TCM based on DNA methylation can contribute to the modernization and high-quality development of TCM.

Objective To elucidate the regulatory network linking microglial autophagy to NLRP3 inflammation so as to provide a reference for targeted interventions in Parkinson's disease. Methods The pathological mechanisms of Parkinson's disease, activation pathways of the NLRP3 inflammasome, and regulatory mechanisms of cellular autophagy were explored based on literature review. The underlying mechanisms linking microglia-mediated inflammatory responses to autophagy dysfunction were identified and their roles in the onset and progression of Parkinson's disease as well as the current research were summarized. Results Parkinson's disease is a neurodegenerative disorder characterized by the loss of dopaminergic neurons and the abnormal aggregation of α-synuclein. Overexpression of the NLRP3 inflammasome and defects in microglial autophagy are deeply involved in its pathological progression. Currently, there is a lack of systematic integration of the mechanisms of their mutual regulation. Conclusion Excessive activation of the NLRP3 inflammasome and defects in microglial autophagy synergistically exacerbate dopaminergic neuron damage and the pathological spread of α-synuclein, thereby accelerating disease progression. Conversely, activating microglial autophagy can inhibit NLRP3 inflammasome activation and exert neuroprotective effects. The dynamic interactions between these two processes regulate the course of Parkinson's disease, and targeted intervention in this regulatory axis may provide new insights into the clinical prevention and treatment of the disease. The combined formulations of small-molecule NLRP3 inhibitors, natural autophagy modulators, brain-targeted nanodrugs, and cell-specific prodrugs may promise a new sphere of research for the development of novel Parkinson's disease therapeutics.

Objective To identify high-risk drugs that can induce cognitive impairment, summarize their pathological mechanisms and clinical manifestations, and compare mainstream scales for the anticholinergic burden and inappropriate medication screening in elders so as to provide references for clinical screening of risks of medication. Methods Related guidelines, controlled clinical trials, and retrospective studies on drug-induced cognitive impairment published globally were retrieved. The mechanisms by which anticholinergic agents, sedative-hypnotics, anesthetics, and other medicines impaired cognitive function were summarized. The applicability, strengths and weaknesses of assessment tools, including the Anticholinergic Cognitive Burden (ACB) scale, the Beers Criteria, the STOPP/START criteria, and the Mini-Mental State Examination (MMSE), were compared. Results Anticholinergic agents were most likely to trigger cognitive impairment while polypharmacy could cause cumulative anticholinergic effects. Polypharmacy and patients' age were key contributors to cognitive impairment. The ACB scale was more correlated with clinical outcomes than other tools. Conclusion A range of commonly-used drugs can induce cognitive impairment, and elderly patients with polypharmacy are the most vulnerable. Clinicians are advised to adopt the ACB scale to quantify the anticholinergic burden, combine it with the Beers Criteria and STOPP/START to screen a variety of high-risk drugs, and intervene quickly to reduce the risks of drug-induced cognitive impairment.