Objective To explore the efficacy and safety of the combination of chicory extract and febuxostat in treating hyperuricemia in rats, and to give tips about related pharmacovigilance. Methods SD rats were randomly divided into ten groups including the control group, HUA model group, low and high-dose febuxostat groups (0.9 mg·kg^-1 and 1.8 mg·kg^-1), low and high-dose chicory extract groups (2.5 g·kg^-1 and 5 g·kg^-1), low-dose febuxostat+low-dose chicory extract group, low-dose febuxostat + high-dose chicory extract group, high-dose febuxostat + low-dose chicory extract group, and the high-dose febuxostat + high-dose chicory extract group. A hyperuricemia rat model was established via 28 consecutive days of intragastric administration of potassium oxonate (750 mg·kg^-1) and yeast extract (10 g·kg^-1). The levels of serum uric acid (SUA) in each group were dynamically monitored. After the experiment, the serum levels of xanthine oxidase (XOD), related indicators and histopathological conditions of the heart, liver, and kidneys were detected to evaluate the safety of the combination. Considerations for the combined use of chicory extract and febuxostat in reducing uric acid were outlined. Results At each stage of the experiment, the SUA levels of rats in the four combination groups under the hyperuricemia state were significantly reduced. Levels of uric acid were lowered more significantly in each combination group than that in the single-agent groups at the corresponding dose, and more markedly in the febuxostat high-dose + chicory high-dose group at 28 d than in the febuxostat high-dose group and chicory high-dose group (P<0.05). The safety indexes of the heart, liver and kidney and results of histopathological staining pointed to no significant changes in the four combination groups compared with the control group, suggesting that the combination could be safely used for lowering uric acid. The indexes of the heart and kidney injury were more significantly improved in the combination group than in the febuxostat single-dose group (especially the high dose). In addition, the combination of chicory extract with febuxostat in the low-dose group had a better safety profile than the combination in the high-dose group. Conclusion The combination of chicory extract and febuxostat can significantly reduce serum levels of uric acid, with better efficacy and safety than single use. The overall effect is the best in the low-dose febuxostat combined with chicory extract group. It is recommended that clinicians start with the minimum dose, regularly monitor serum uric acid levels and organ functions, and be wary of drug interactions.

Objective To predict the renal injury markers of allopurinol, study the effect of allopurinol combined with traditional Chinese medicine (TCM), and provide a new strategy for pharmacovigilance of allopurinol. Methods The transcriptome data on rat renal tubular cells from the normal group and from the allopurinol-treated group were obtained from the microarray (GSE214358) in the GEO database. R language was used to analyze the differentially expressed genes (DEGs). Enrichment analyses of Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) as well as protein-protein interaction (PPI) network analysis were conducted to screen key DEGs. Databases including miRwalk, TargetScan, starBase and miRDB were searched to predict the target microRNA (microRNA, miRNA) of the key DEGs. Lncbase and starBase were used to predict the long non-coding RNA (Long non-coding RNA, lncRNA) targeted by these miRNA. Cytoscape was used to construct the mRNA-miRNA-lncRNA competing endogenous RNA (competing endogenouse RNA, ceRNA) regulatory network. Additionally, molecular docking was performed to verify the binding properties of allopurinol and its active metabolites to the key DEGs. Results The GSE214358 data chip had a total of 1649 DEGs, mainly involved in such metabolic pathways as valine, leucine and isoleucine degradation and β-alanine metabolism. Via PPI analysis and CytoHubba, 10 key DEGs were obtained. It was found that 7 of the key DEGs were involved in the ceRNA network, namely BCKDHB, ALDH6A1, ACADM, HWGCL, ACAT1, IVD, and OXCT1, targeting 128 miRNA, all of which corresponded to lncRNA OIP5-AS1. Molecular docking verification found that BCKDHB had the best binding characteristics with allopurinol and oxypurinol. The BCKDHB-miR-654-3p/miR-766-5p-OIP5-AS1 axis might be significantly activated in allopurinol-induced renal injury. Conclusion The BCKDHB-miR-654-3p/miR-766-5p-OIP5-AS1 axis may play an important role in allopurinol-induced renal injury. It can potentially serve as an early diagnostic biomarker that gives warnings before prescription or in the early stage of medication, so it offers a new strategy for the safe administration of allopurinol. The rational combination of allopurinol with traditional Chinese medicine can enhance therapeutic effects and reduce toxicity, providing a crucial approach to the rational use of allopurinol.

Objective To investigate the bleeding risk associated with the concomitant use of warfarin and traditional Chinese medicine (TCM), and the underlying mechanisms for interactions in order to provide evidence for rational clinical co-administration. Methods Such databases as CNKI, Wanfang and Sinomed were searched for literature published between January 1, 2000 and June 30, 2025 to perform data mining on risk factors for warfarin-induced bleeding and the characteristics of TCM used in combination. Network pharmacology and molecular docking were employed to explore potential pharmacological interactions between warfarin and commonly co-administered TCM. Results Seventy-nine cases of warfarin-related bleeding were retrieved in the analysis. The concurrent use of TCM did not significantly increase the risk of bleeding during the initial phase of warfarin therapy (P>0.05). Data mining revealed frequent co-prescription patterns, particularly the herb pair SALVIA MILTIORRHIZA RADIX (Danshen) and OPHIOPOGONIS RADIX (Maidong), which were traditionally used to nourish yin and promote blood circulation. Pathway enrichment analysis indicated that these herbs and warfarin might work together to modulate key signaling pathways such as the PI3K-Akt pathway, lipid metabolism, and atherosclerosis. Molecular docking results demonstrated strong binding affinities between the active components of these herbs and critical targets including STAT3 and ESR1. Conclusion The study has offered evidence about clinical risks, patterns of medications, and interaction mechanisms that suggests warfarin can be used in combination with TCM under some conditions. However, enhanced pharmaceutical surveillance and more research on risk stratification are warranted to ensure patients' safety.

Objective To predict the common molecular mechanisms underlying both therapeutic efficacy and toxicity of toxic herbs used for relieving cough and asthma, and to interpret the pharmacovigilance of Traditional Chinese Medicine (TCM) connotations of the representative herb CHELIDONII HERBA (BAIQUCAI) based on mechanistic insights. Methods Active components from 17 toxic herbs indicated for cough and asthma were collected, and network pharmacology was employed to identify common targets and signaling pathways associated with both anti-cough/anti-asthma effects and neuro-respiratory toxicity. Subsequently, data mining was conducted to extract 549 historical records and 419 prescriptions related to BAIQUCAI, enabling the reconstruction of traditional knowledge of toxicity identification, patterns of clinical applications, prevention strategies, and detoxification methods involving both traditional Chinese and Western medicines. Results A comprehensive “efficacy-toxicity” shared network was constructed, encompassing 117 bioactive compounds (e.g., quercetin) and 126 core targets, including PPARA, AKT1, and CASP3. Functional enrichment analyses via GO and KEGG revealed significant involvement in critical pathways such as neuroactive ligand-receptor interactions. The TCM pharmacovigilance framework for BAIQUCAI aligned well with the predicted molecular mechanisms, supporting a mechanistic interpretation of clinic usage. Conclusion By integrating TCM pharmacovigilance knowledge with modern systems-level mechanistic insights, the study offers a targeted approach to optimizing the safe and effective use toxic herbs.

Objective To establish a rapid quality evaluation method that can identify key quality markers in multiple batches of GEI HERBA materials by integrating fingerprint analysis and electronic eye intelligent detection technology. Methods Sixteen batches of GEI HERBA from different origins were collected. High-performance liquid chromatography (HPLC) was employed to establish a fingerprint profile, and DPPH free radical scavenging assays were performed to evaluate antioxidant activities. Spectrum-effect relationship analysis was conducted to identify potential quality control markers. Subsequently, electronic eye technology was used to analyze the samples, and Pearson correlation analysis was conducted to assess the relationships between electronic eye parameters and the identified markers. Results A validated HPLC fingerprint method was established at 254 nm, with acceptable repeatability, precision, and stability. Thirteen common peaks were detected, six of which were identified by reference standards: gallic acid, Gemin G, Gemin B, tellimagrandin, Gemin A, and ellagic acid. Similarity indices between batches and the reference fingerprint ranged from 70.9% to 99.0%, indicating notable batch-to-batch variability. The DPPH radical scavenging activity (IC₅₀) of the samples ranged from 42.0 to 113.4μg·mL^-1. Correlation analysis revealed that six chromatographic peaks had significant positive correlations (P<0.05) with antioxidant activity. Peak 11 (Gemin A) ranked first, followed by peak 13 (ellagic acid), peak 6, peak 1 (gallic acid), peak 2, and peak 7. Electronic eye analysis found that peak 13 (ellagic acid) and peak 11 (Gemin A) were significantly positively correlated (P<0.05) with the lightness(L^* value), suggesting that higher L^* values corresponded to higher contents of these two compounds. Conclusion This study has established an HPLC fingerprinting method for GEI HERBA and identified antioxidant-related quality control markers. Additionally, a significant correlation is observed between electronic eye-derived L^* values and the contents of ellagic acid and Gemin A.

Objective To study the distribution of scopolamine in Daturae Flos via quantitative analysis combined with ultra-microscopic structural analysis. Methods The plant was divided into seven sections: the whole flower, lower segment, middle segment, upper segment, calyx, ovary and corolla. Scanning electron microscopy (SEM) was employed to observe and analyze the ultra-microscopic structures of the seven parts. Results SEM observation found that the secretory cells of Daturae Flos, such as glandular hairs, stomata and crystals, were concentrated in the ovary and its adjacent parts. The content of scopolamine was the highest in the ovary, followed by the lower segment, whole flower, upper segment, corolla, middle segment and calyx. The content of scopolamine varied across these parts. The corolla and calyx, which accounted for a large proportion of the volume, had lower contents than in the ovary. The large size and fragility of the decoction pieces of Daturae Flos made it difficult to maintain their integrity during transportation and storage. In addition, Daturae Flos was a toxic medicinal material. These properties could impact the clinical efficacy and safety of Daturae Flos. Conclusion This study reveals where the current quality evaluation system for Daturae Flos can be improved, and the research results are of referential value for ensuring the clinical efficacy and safety of medication of this medicinal material.

Objective To establish an ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for quantitative determination of thymosin beta 4 in rat plasma in order to provide a reference for subsequent pharmacokinetic studies. Methods Plasma samples were pretreated using a protein precipitation method. The mobile phase consisted of pure water and acetonitrile (both containing 0.1% formic acid), with a column temperature of 45°C, a flow rate of 0.25 mL·min^-1 and a chromatographic column of ACQUITY UPLC Peptide BEH C₁₈ (2.1 mm×50 mm,1.7μm) under gradient elution. Thymosin beta 4 and the internal standard (lispro insulin) were detected and quantified using the multiple reaction monitoring (MRM) mode, with precursor-to-product ion transitions of m/z 709.9→810.6 for thymosin beta 4 and m/z 1 162→217.1 for the internal standard. Methodvalidation involved assessments of selectivity, the calibration curve and lower limit of quantification (LLOQ), precision and accuracy, extraction recovery, matrix effect, and stability. Results Thymosin beta 4 showed a good linearity in rat plasma within the range of 50 to 5000 ng·mL^-1. The intra- and inter-batch accuracy (RE) for thymosin beta 4 in low-, medium-, and high-concentration quality control (QC) samples ranged from -1.6% to 3.1%, and the precision (RSD) ranged from 5.4% to 9.9%. Extraction recoveries of quality control (QC) samples at low, medium, and high concentrations（120、800、3 800 ng·mL^-1) were between 81.94% and 110.23%, with matrix effects of 100.30%~108.08% (coefficient of variation, CV, within ± 15%). The deviation between the mean measured concentrations and the designated concentrations of quality control samples (120、800、3 800 ng·mL^-1) was within ± 15% after 24 hours of storage at room temperature, three freeze-thaw cycles, or 7 days of storage at -20°C, suggesting the good stability of the samples. Conclusion A simple and efficient UPLC-MS/MS method has been established and validated for quantitative determination of thymosin beta 4 in rat plasma.

Objective To identify the chemical constituents and blood-entering components of Qishen Yiqi dropping pills (QSYQ) using UHPLC-MS/MS, and to investigate its mechanism of action against myocardial ischemia-reperfusion injury (MIRI). Methods Chromatographic separation was performed on an ACQUITY UPLC HSS T3 column under gradient elution with a mobile phase consisting of 0.1% formic acid in water (A) and 0.1% formic acid in acetonitrile (B). Data acquisition was conducted in both positive and negative ionization modes using a UPLC I-Class system coupled with a Synapt G2-Si Q-TOF mass spectrometer. Data processing was performed using the Unifi software's natural product workflow. A theoretical mass spectrometry database of 6400 natural products was used for identification of chemical constituents and blood-entering components. Potential targets of the identified blood-entering components and MIRI-related targets were retrieved from databases. Protein-protein interaction (PPI) networks were constructed to identify core targets of QSYQ against MIRI, followed by Gene Ontology (GO) enrichment analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analysis. Results A total of 194 compounds were identified in QSYQ, while another 24 compounds were identified in the plasma of rats administered with QSYQ. The prototype components absorbed into the bloodstream included saponins and diterpenoid quinones. Network pharmacology analysis suggested that QSYQ exerted anti-MIRI effects by acting on key pathways such as the PI3K-AKT and HIF-1 signaling pathways. Conclusion The results of this study indicate that the prototype components absorbed into the bloodstream are likely the effective constituents of QSYQ. This research provides a reference for investigation into the pharmacodynamic material basis and pharmacological mechanisms of QSYQ.

Objective To review the evolution of the Provisions for Adverse Drug Reaction Reporting and Monitoring and analyze the significant revisions and considerations in order to provide references for revisions. Methods The background and highlights of revisions and the role played by Provisions for the Monitoring of Adverse Drug Reaction (trial) in 1999 and the two revisions in 2004 and 2011 in enhancing the monitoring of adverse drug reactions were reviewed. The priorities of the current revision were analyzed, and the considerations were outlined from a technical perspective. Results The revisions of the provisions fully reflected the current needs of regulation, aligned with the reality in monitoring and evaluation of ADR, and served as a strong force behind related monitoring. The central purpose of this revision was to meet the requirement that “the state establish a pharmacovigilance system” stipulated in the “Drug Administration Law”. Importance was attached to the compatibility between related regulations and guidelines, and efforts were made to ensure inheritance and innovation of the provisions. Revisions involved delimiting the range of reporting, optimizing the requirements for reporting, highlighting risk control, and strengthening supervision and management. Conclusion The revisions of the provisions have a long way to go, but are of great significance for pharmacovigilance in China for some time to come, and will usher China's pharmacovigilance into a new stage of development.

Objective To interpret the revised guidelines for applications of safety tests for injections in the Chinese Pharmacopoeia 2025 edition (Volume IV) in order to provide a reference for related applications. Methods The revisions in guidelines 9301 between the 2020 and 2025 editions of the Chinese Pharmacopoeia were compared and contrasted before the amendments were interpreted based on relevant literature at home and abroad. Results This revision focused on alignment with international practices. The principles about safety tests were specified, items for safety testing such as pyrogen testing and abnormal toxicity testing were revised, and details on experiments were elaborated. Raw materials, excipients, and packaging materials that came into direct contact with drugs were described together. Conclusion The revised guidelines have been made compatible with the formation of standards for medical products administration in other countries, and can contribute to standardization and guidance, which is of vital importance for quality control of injections.

Objective To summarize the standards and requirements for defining the intended use, dose-response relationships, and animal testing studies during the registration submission of holmium laser devices in order to provide guidance for applicants. Methods Related guidelines and requirements by the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) were analyzed in depth before the priorities of regulation were identified. Results A well-grounded framework was established for describing the intended use. The targets, methods and requirements for data analysis related to studies on dose-response relationships were elucidated. The types, objectives, and key considerations during animal testing were summarized. These outcomes could help enhance the quality of materials for submission and the efficiency of review. Conclusion Registration submissions for holmium laser devices have to be steered by clinical needs, backed up by data, and constrained by hierarchical, quantitative, and standardized requirements. Applicants should take into account the differences in required materials between the FDA and NMPA while focusing on core regulatory requirements to provide compelling evidence for product safety and effectiveness so as to be quickly approved for marketing.

Objective To analyze the safety risk of Tongbianling capsules, and to provide a reference for clinical rational drug use. Methods Adverse reaction reports in 2004-2023 involving the basic information, systems and organs, clinical manifestations, times of occurrence and outcomes of adverse drug reactions of Tongbianling capsules were retrieved from the National Adverse Drug Reaction Monitoring System Database and from CNKI、VIP before being analyzed. The way safety information in the package insert of this drug was revised was recommended. Results A total of 2 389 cases of adverse reactions/events of Tongbianling capsules were reported to the National Adverse Drug Reaction Monitoring System database, 33 of which (1.38%) were serious. Data and literature on adverse reaction monitoring suggested that the adverse reactions of Tongbianling capsules involved multiple systems and organs, including abdominal pain, diarrhea, nausea, abdominal distension, abdominal discomfort, vomiting, dry mouth, rash, itching and dizziness. There were several case reports of melanosis coli caused by long-term use of this drug. On October 10, 2024, the National Medical Products Administration（NMPA）of China issued a notice on the revision of the drug instructions for Tongbianling capsules. Conclusion Healthcare providers and patients alike should be aware of the safety profile of Tongbianling capsules and ensure their rational use. Medication should be discontinued once constipation is relieved or diarrhea occurs, and long-term administration has to be avoided. Marketing authorization holders (MAHs) should promote the safe and rational use of Tongbianling via related health education and pharmacovigilance.

Objective To explore the key genes and immune infiltration mechanisms of severe influenza and predicts related drugs using bioinformatics. Methods Differential expression genes (DEGs) of severe influenza were screened from the GSE101702 dataset. Following GO and KEGG enrichment analyses, the key genes were identified using LASSO, SVM-RFE, and random forest algorithms. The correlations of these genes with immune infiltration and diagnostic value were evaluated. Finally, potential drugs were predicted via the Coremine Medical and DSigDB databases. Results A total of 82 DEGs were identified from the GSE101702 dataset, including 68 up-regulated and 14 down-regulated ones. Three key genes (IL18R1, CSF1R, and MPO) were selected, with IL18R1 and MPO up- regulated and CSF1R down-regulated. ROC curve analysis confirmed their diagnostic value. Immune cell infiltration analysis revealed significant suppression of multiple immune cells and functions (B cells, CD8⁺T cells, natural killer cells, and HLA) in the severe influenza group compared to the healthy control group. The key genes showed significant correlations with a range of immune infiltrates. Drug prediction suggested that ginseng, salvia miltiorrhiza and retinoic acid were closely related to the key genes, often corresponding to such effects traditional Chinese medicine as “nourishing healthy qi and removing blood stasis”. Conclusion This study has identified DEGs and key genes associated with severe influenza, elucidated the immune infiltration mechanisms, and predicted potential therapeutic drugs, thus providing insights into the underlying mechanisms, clinical prediction, and treatment of severe influenza.

Objective To explore the underlying therapeutic mechanisms of the traditional Chinese medicine (TCM) formula-Guominjian combined with Yupingfengsan-in treating asthma complicated with atopic dermatitis using network pharmacology and molecular docking techniques. Methods Potential active ingredients and their corresponding targets in this TCM formula were identified using the TCMSP database. Disease-related targets were retrieved from the GeneCards and OMIM database. The intersection of these targets was determined using Venn diagram analysis. A protein-protein interaction (PPI) network was constructed with the STRING database, and enrichment analysis of Gene Ontology (GO) functions and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways was conducted using the Metascape platform. Molecular docking was employed to verify the binding affinity between the core targets and active ingredients. Results PPI network analysis revealed that such targets as IL6、STAT3、TNF、SRC and AKT1 were central to the therapeutic action. The TNF and IL-17 signaling pathways might play pivotal roles in the treatment of asthma complicated with atopic dermatitis. Molecular docking results indicated that the core therapeutic targets exhibited strong binding affinity with such active ingredients as quercetin, kaempferol, and isorhamnetin. Conclusion Guominjian combined with Yupingfengsan may combat asthma combined with atopic dermatitis by modulating multiple signaling pathways, such as those involving TNF and IL-17, via its action on core targets. This study provides data for subsequent experimental research and clinical applications.

Objective To analyze the adverse drug reactions (ADR) among and medications for hospitalized pediatric patients so as to provide references for rational drug use. Methods A retrospective analysis was conducted of ADR reports involving inpatients treated at a tertiary children's hospital between April 1, 2024 and March 31, 2025. The association between medications and ADR was studied, and the severity of ADR was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results Among the 213 patients involved, 110 were male and 103 were female. There were 10 cases (4.70%) aged 1 or younger, 36 cases (16.90%) ages 1 to 3, 68 cases (31.92%) ages 4 to 6, 91 cases (42.72%) ages 7 to 12 and 8 cases (3.76%) aged 12 to 17. The most common type of drug involved was anti-infective drugs, the dominating route of administration was intravenous injection (79.73%), and the most vulnerable organ was the skin and its accessories (59.73%), with rash as the primary clinical manifestation. Severe adverse reactions occurred in 45 cases (21.13%), and the top three drugs involved were cefotaxime sodium for injection (5 cases), erythromycin lactobionate for injection (4 cases), and chloral hydrate enema solution (3 cases). One case of new drug adverse reactions was reported. Conclusion ADR among pediatric patients are mostly adverse reactions that are caused by anti-infective drugs and manifest as skin damage. Severe allergic reactions caused by non-anti-infective drugs (such as chloral hydrate and turmeric oil) in children deserve more attention. Self-medication by parents is an important risk factor for ADR in children. Clinicians should try to ensure safe medications among children under 12.

Objective To mine signals of adverse drug reactions induced by elagolix and provide references for safe and rational use of drugs in patients with endometriosis. Methods Data on all the adverse drug events (ADEs) of elagolix was retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System database from July 23, 2018 to September 30, 2024, and reports in which elagolix was listed as the “primary suspect” (PS) were obtained. Data was analyzed using the reporting odds ratio (ROR)method, proportional reporting ratio (PRR) method, Bayesian Confidence Propagation Neural Network (BCPNN) method, and the Multiple Gamma-Poisson Shrinkage Estimation (MGPS) method. Results A total of 10 005 reports of ADEs related to elagolix were identified, involving 3 775 patients, 27 System Organ Classes (SOCs) and 145 preferred terms (PTs). Positive SOCs that met all the four algorithms were surgical and treatment procedures, the reproductive system, breast diseases, psychiatric disorders, and vascular and lymphatic diseases. The most frequent PTs were hot flashes, ache, and nausea headache. New ADEs that were never mentioned in drug inserts were discovered, such as alopecia, food craving, umbilical haemorrhage. Conclusion When elagolix is used to treat endometriosis, clinicians need to be alert to adverse events in patients, identify risks as early as possible, and ensure the rational use of drugs in clinical practice.

Objective To study one case of lactic acidosis caused by Enterococcus faecium infection following treatment with linezolid. Methods One patient with renal insufficiency developed lactic acidosis after treatment with linezolid. Clinical pharmacists gave the clinicians advice on the treatment regimen via therapeutic drug monitoring(TDM) and based on the pharmacokinetics of linezolid as well as literature review. Results Lactic acidosis was believed to have been caused by linezolid,so a new treatment was adopted. The patient was cured of the infection, adverse reactions resolved, and the patient was discharged. Conclusion The use of linezolid in patients with renal insufficiency should start with an individualized dose, which is then dynamically adjusted according to TDM. Clinicians need to be alert to linezolid-induced lactic acidosis. Both non-specific clinical manifestations and levels of lactate have to be monitored.

Objective To study limb weakness caused by abiraterone-induced hypokalemia so as to provide references for safe use of abiraterone. Methods One case of limb weakness due to abiraterone-induced hypokalemia in a 74-year-old male patient with prostate cancer was analyzed. Related literature was retrieved to explore the mechanism of action, incidence and precautions related to abiraterone-induced hypokalemia. Results The clinical pharmacist took into consideration the history of disease and medications and concluded that the patient's limb weakness might be related to hypokalemia caused by abiraterone. After symptomatic treatment and optimization of treatment plans, the patient's blood potassium level returned to normal, and the symptoms of muscle weakness improved. Conclusion Clinicians should remind patients to take prednisone regularly while they take abiraterone, and monitor the blood potassium levels regularly (at least once a month) so as to detect and manage related adverse reactions quickly and ensure the safety of patients.

Objective To analyze the clinical characteristics and potential mechanisms of heart failure caused by osimertinib mesylate tablets (osimertinib) in order to provide a reference for safe use of osimertinib and for clinical management. Methods The clinical data of a 59-year-old patient with lung adenocarcinoma who developed heart failure after taking osimertinib was analyzed. Combined with related literature, the Naranjo's score was used to find out about the drugs that might have caused heart failure, causes of occurrence, and measures for prevention and treatment. Results It was very likely that osimertinib caused heart failure in this patient. After discontinuation of osimertinib and management of heart failure, the patient's cardiac function significantly improved. Conclusion Despite the scarcity of cases of heart failure caused by osimertinib, clinicians should be aware that osimertinib can cause heart failure a few days to several months after administration.

Objective To analyze one case of drug-induced hypersensitivity syndrome caused by sulfasalazine in order to provide a reference for clinical use. Methods One case of drug hypersensitivity syndrome caused by sulfasalazine enteric-coated tablets in a patient with colitis was analyzed to explore the possible mechanisms, clinical manifestations and preventive measures related to drug hypersensitivity syndrome. Results After being treated with sulfasalazine enteric-coated tablets for 1 month, the patient presented with liver function damage, scattered rashes all over the body, multiple lymphadenopathy, and significantly elevated atypical lymphocytes in peripheral blood, which was considered to be drug-induced hypersensitivity syndrome caused by sulfasalazine enteric-coated tablets and the conclusion was “probable”. The patient was in better condition after treatment with glucocorticoids, TNF-α inhibitors, liver protection, and anti-allergy. Conclusion Drug hypersensitivity syndrome is a rare adverse reaction of sulfasalazine with a long incubation period and various clinical manifestations. In case of abnormal liver function, rash, lymphadenopathy and abnormal results of hematological examination, clinicians should be highly vigilant against drug hypersensitivity syndrome when sulfasalazine is used.

Objective To analyze one case of toxic epidermal necrolysis (TEN) caused by moxifloxacin hydrochloride and sodium chloride injection in order to provide a reference for rational drug use in clinic. Methods One case of TEN caused by moxifloxacin hydrochloride and sodium chloride injection in an adult patient with lung squamous cell carcinoma was analyzed, the sensitizing drug was identified, and the causes and risk factors were analyzed. Results According to clinical symptoms and medication of the patient, moxifloxacin hydrochloride and sodium chloride injection was identified as the sensitizing drug of TEN via the Algorithm of Drug Causality for Epidermal Necrolysis (ALDEN) standards. Effective treatment was offered and the patient was gradually improved. The pathogenesis of TEN linked to moxifloxacin hydrochloride and sodium chloride injection remained unclear, and risk factors were hypoproteinemia and hypersensitivity reactions to β-lactam antibiotics. Conclusion Clinicians who prescribe moxifloxacin hydrochloride and sodium chloride injection should be alert to the risk of TEN, monitor adverse reactions, especially among patients with a history of allergy, and ensure safety in clinical practice.

Objective To explore the multi-target and multi-channel effects of Xinkeshu in the treatment of cardiovascular diseases in order to provide a reference for subsequent development of new cardiovascular drugs. Methods Based on related literature published over the past five years, the pharmacological effects, mechanism of action and clinical applications of Xinkeshu were summarized. The role of Xinkeshu in improving cardiac function and relieving anxiety/ depression was analyzed before its safety was evaluated. Results Studies showed that Xinkeshu had multi-target and multi-channel pharmacological effects. This drug could significantly improve the cardiac function of patients, relieve palpitations, chest tightness and angina pectoris while mitigating anxiety/depression. It was highly safe in that no obvious adverse reactions were found. Conclusion As a Chinese patent medicine that can help promote blood circulation, remove blood stasis, strengthen qi and relieve pain, Xinkeshu is effective and safe in treating palpitation, chest tightness, angina pectoris, hypertension, hyperlipidemia and arrhythmia caused by qi stagnation and blood stasis.

Objective To explore the safety of long-term oral nucleos(t)ide analogues (NAs) in treating chronic hepatitis B (CHB) and to provide references for clinical practice. Methods By analyzing drug inserts, results of clinical trials, data on post-marketing surveillance and real-world cohort data, the risks of nephrotoxicity, bone toxicity, and dyslipidemia were compared between entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF) and tenofovir amibufenamide (TMF). Results NAs were generally safe, but chronic use might lead to decreased renal function, hypophosphatemia and dyslipidemia. TAF and TMF caused significantly lower nephrotoxicity and bone toxicity than TDF, but were associated with a higher risk of hyperlipidemia. Conclusion NAs should be selected based on differences between individual patients. TAF/TMF is the first option for patients with renal insufficiency or at high risk of bone metabolism. For patients with cardiovascular risks or dyslipidemia, TAF/TMF should be used with caution.