Objective To establish a standard operating procedure (SOP) for the detection of TCMI allergic-like reactions in order to provide a reference for related testing. Methods By taking TCMI A, the effects of such factors as the gender and age of experimental animals, administration methods (vehicle, dosage, injection speed), laboratory temperatures, and batches of production on allergic-like reactions were investigated. The number of animals with scores of blue staining of ear auricles in each group was used to assess the severity of reactions. The Technical Specifications for Testing Anaphy-lactoid Reactions of Intravenous Traditional Chinese Medicine Injections and the Guidelines 9105: Principles for Bioactivity Testing of Traditional Chinese Medicine were referenced. Results At a laboratory temperature of 23-26°C and by using male juvenile and adult ICR mice as subjects, the test article was prepared immediately before use by mixing with Evans blue, and administered via tail vein injection at a rate of 0.2 mL per 10 seconds. Physiological saline or a 5% glucose solution served as both the vehicle and the negative control. This procedure could be adopted as a standard operating procedure (SOP) for testing TCMI A for allergic-like reactions. Conclusion An internal control standard for testing TCMI allergic-like reactions enables rapid detection of the reactions, which can contribute to quick identification, risk control and clinical safety.

Objective To review recent research on the establishment and evaluation of animal models of sleep disorders and related assessment techniques, and summarize the latest research findings on animal models of high-altitude sleep disorders so as to provide a reference for subsequent studies. Methods Literature on animal models of sleep disorders and animal sleep evaluation techniques was retrieved from such databases as CNKI, PubMed, and Elsevier before being analyzed in terms of animal species, model construction methods and principles employed. Results Rodents, including SD rats, C57BL/6J mice, and KM mice, are commonly selected to establish animal models of sleep disorders that are usually constructed via pharmacological induction, sleep deprivation, and stress stimulation. Each of these models has distinct physiopathological characteristics and provides an important reference. Currently, animal models of highaltitude sleep disorders are primarily established using hypobaric hypoxia exposure, which fails to fully replicate the complex pathological state of these disorders. For different syndrome patterns of sleep disorders, diseasesyndrome combination animal models are typically established using various multifactor composite approaches, with rodents serving as the primary experimental subjects. These models can open new avenues for the construction of highaltitude sleep disorder animal models. The constant development of evaluation techniques for animal models of sleep disorders provides technical support for the analysis of the pathological mechanisms of sleep disorders and the assessment of intervention effects. Conclusion More in-depth research is required on animal models of high-altitude sleep disorders. The availability of animal models and evaluation standards that reflect the clinical reality of high-altitude sleep disorders is essential for advancing the research and development of preventive and therapeutic drugs and for safeguarding the health of populations in high-altitude regions.

Objective To establish and evaluate an animal model of high-altitude daytime dysfunction with the Traditional Chinese Medicine (TCM) syndrome of “phlegm-turbidity obstructing the orifices” in order to provide data for research on the pathological mechanisms and for screening therapeutic drugs for daytime dysfunction in high-altitude environments. Methods In the model screening experiment, C57BL/6J mice were divided into a control group (NC), sleep deprivation intervention groups (SD3-HH0, SD3-HH1, SD3-HH2), hypobaric hypoxia intervention groups (HH3-SD0, HH3-SD1, HH3-SD2), and the HH3-SD3 group, with 12 mice in each group. Optimal modeling conditions were selected by observing body weight changes, blood routine parameters, and histopathological alterations. In the model evaluation experiment, C57BL/6J mice were randomly divided into a control group (NC), a model group (HH3-SD1), a caffeine group (CAF, 15 mg·kg^-1), and an acetazolamide group (ACZ, 100 mg·kg^-1), with 12 mice in each group. The treatment groups received daily intragastric administration that started 2 days before the experiment and continued until the end of the experiment while the model and control groups received an equivalent volume of normal saline. In addition, SD rats (n=4) were used for sleep EEG monitoring via a self-control method. The daytime functional status and TCM syndrome of the model animals were evaluated via sleep-wake EEG monitoring, behavioral tests (grip strength test, Morris water maze), transcriptome sequencing, and ELISA techniques. Results An animal model of high-altitude daytime dysfunction with the syndrome of “phlegm-turbidity obstructing the orifices” was established by exposing rats to hypobaric hypoxia equivalent to 5 500 meters for 72 hours, with rotating sleep deprivation (one full rotation every 42 seconds, in alternating directions) during the final 24 hours. The model animals showed disrupted sleep architecture (decreased total waking hours, increased total sleep time), aggravated fatigue, and impaired learning and memory abilities. Concurrently, pathological changes included blood-brain barrier damage, hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis, enhanced oxidative stress and inflammatory responses, and decreased levels of brain-derived neurotrophic factor (BDNF) and monoamine neurotransmitters. Transcriptome analysis revealed significant enrichment of the circadian rhythm pathway in the hypothalamus and the PI3K-Akt signaling pathway in the hippocampus. Conclusion The established animal model of high-altitude daytime dysfunction can effectively simulate the clinical manifestations and pathological features of the “phlegm-turbidity obstructing the orifices” syndrome under high-altitude conditions. It reveals a good correlation between pathological phenotypes and manifestations of this TCM syndrome, providing a reliable experimental platform for studying the pathological mechanisms of high-altitude daytime dysfunction and for conducting drug screening and efficacy evaluation.

Objective To investigate the protective effect of Gaoyuan Changweian formula (GYW) against intestinal injury induced by hypobaric hypoxia in mice. Methods C57BL/6J mice were divided into the following groups (n=8 each): a normal control (NC) group, a hypobaric hypoxia model (MOD) group, a positive control (compound glutamine, 0.8 g·kg^-1·d^-1) group, and GYW-treated groups at low (7.3 g·kg^-1·d^-1), medium (14.6 g·kg^-1·d^-1), and high (29.2 g·kg^-1·d^-1) doses. Each of these groups received oral administration for 14 consecutive days except the NC and MOD groups that were given an equal volume of distilled water. A model for hypobaric hypoxia-induced intestinal stress injury was established by exposing mice to conditions simulating 7 000 m altitude in a hypobaric oxygen chamber for 3 days. Serum levels of intestinal injury markers, D-lactate (D-LA) and diamine oxidase (DAO), were measured by enzyme-linked immunosorbent assay (ELISA). The levels of inflammatory cytokines (IL-1β, TNF-α, IL-6) and oxidative stress markers (4-HNE, MDA, SOD, GSH) in intestinal tissues were also detected by ELISA. Intestinal tissue damage was observed via hematoxylin and eosin (HE) staining and electron microscopy. The expression of intestinal tight junction proteins (ZO-1, occludin) was analyzed by Western blotting. Fresh fecal samples were collected, and gut microbiota composition was assessed by 16S rRNA gene sequencing. Results GYW intervention alleviated the decrease in body weight of mice with intestinal injury (P<0.05), significantly lowered the levels of injury markers D-LA and DAO (P<0.000 1), inhibited the inflammatory response (P<0.05) and oxidative stress (P<0.05), and upregulated the expressions of the tight junction proteins ZO-1 and occludin (P<0.01). Furthermore, GYW treatment regulated the brain-gut axis by suppressing the secretion of 5-HT and SP (P<0.05), mitigated damage to intestinal epithelial cells, modulated gut microbiota balance, and increased the relative abundance of probiotics. Conclusion Gaoyuan Changweian formula exerts a protective effect against intestinal injury caused by high-altitude hypoxia in mice. The underlying mechanism may be associated with the regulation of gut microbiota balance, inhibition of the inflammatory response, and antagonism of oxidative stress.

Objective To investigate the differences in hepatotoxicity between diverse prepared samples of Paris polyphylla in a zebrafish system and confirm the role of PolyphyllinⅠ(PPⅠ) in the overall hepatotoxicity of the herb so as to provide data for elucidating the toxic material basis of PPⅠ and its safe applications. Methods Methanol was used to extract Paris polyphylla medicinal materials while crude total saponins were obtained via n-Butanol extraction. More separation by column chromatography yielded the Paris extract without PolyphyllinⅠ(PE-PPⅠ). On this basis, a zebrafish model was used to evaluate the toxicity of different samples, involving the determination of lethal concentration 10% (LC₁₀), observation of histopathological sections of livers, Nile Red staining, acridine orange staining, and fluorescence morphological analysis of livers. Meanwhile, the serum levels of triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) were detected. Real-time quantitative PCR (RT-qPCR) was used to measure the mRNA expression levels of such genes as apoa2, cyp7a1, cyp27a1, hmgcs1, fabp4 and cd36. Results At specific mass concentrations, the methanol extract (ME), n-Butanol extract (NBE), and PE-PPⅠ of Paris polyphylla all induced liver injury in zebrafish, but there were significant differences in toxicity and pathology. In the high- and low-dose NBE groups, toxicity was relatively strong, characterized by extensive liver tissue damage that was accompanied by obvious hepatocyte apoptosis, compensatory enlargement of the liver size, and significant lipid metabolism disorders. In the ME group, focal hepatocyte damage with moderate lipid accumulation was observed. In the PE-PPⅠ group, only mild liver lesions occurred. RT-qPCR results indicated that the expression levels of core genes related to lipoprotein metabolism were significantly upregulated, the rate-limiting enzyme genes for bile acid synthesis were inhibited, the regulatory genes for cholesterol synthesis were upregulated, and that the key factors for fat transport trended upward. Conclusion PolyphyllinⅠ is one of the key active components responsible for the hepatotoxicity of Paris polyphylla, which may interfere with lipid metabolism pathways, leading to liver lipid accumulation, hepatocyte apoptosis, and structural damage to liver tissues.

Objective To elucidate the underlying mechanisms of periplocin-induced hepatotoxicity using a zebrafish model, combined with cytochrome P450 (CYP) inhibitor interventions and transcriptomics. Methods Zebrafish larvae at 4 days post-fertilization (4 dpf) were used as the experimental model. Hepatotoxicity was evaluated by analyzing liver phenotypes in transgenic zebrafish and performing hematoxylin-eosin (H&E) staining following combined exposure to periplocin and CYP inhibitors. Subsequently, transcriptome sequencing and real-time quantitative PCR (RT-qPCR) were employed to uncover and validate the molecular mechanisms. Results Periplocin exposure caused a dose-dependent decrease in liver fluorescence intensity and induced pathological damage, including hepatocyte vacuolization and disordered arrangement. Notably, co-treatment with CYP inhibitors exacerbated these toxic effects, suggesting that the hepatotoxicity of periplocin was closely associated with its metabolic clearance. Transcriptomic analysis revealed significant alterations in the hepatic gene transcription profile, characterized primarily by the suppression of pathways related to CYP-mediated xenobiotic metabolism, lipid metabolism, and bile acid synthesis. RT-qPCR confirmed the significant downregulation of the key transcription factor hnf4a and its downstream phaseⅠmetabolic enzymes (cyp3a65, cyp2p6), phaseⅡmetabolic enzyme (gstp1), as well as the lipid metabolism regulator pparab and the bile acid regulator cyp8b1 (P<0.05). Conclusion Periplocin can induce severe liver injury by suppressing the expression of the upstream core transcription factor-hepatocyte nuclear factor 4α (HNF4α). This suppression triggers a transcriptional inhibition cascade affecting downstream CYP detoxification systems and the PPARα lipid metabolism pathway, leading to disrupted hepatic homeostasis, diminished detoxification capacity, and metabolic disorders.

Objective To elucidate the detoxifying and efficacy-enhancing effects of berberine (BBR), the principal active constituent of Coptidis Rhizoma, on hepatotoxicity induced by Evodiae fructus (EF) and its therapeutic efficacy against inflammatory bowel disease (IBD). Methods The hepatotoxicity of EF was evaluated in terms of zebrafish mortality, liver fluorescence areas, hepatocyte apoptosis, biochemical indices (ALT and AST), and hepatic histopathology. The antagonistic effect of BBR against EF-induced hepatotoxicity was also explored. In a TNBS-induced zebrafish IBD model, the synergistic effect of BBR on EF treatment of IBD was evaluated based on such crucial indicators as intestinal endocytic function, macrophage abundance, neutrophil infiltration, and goblet cell mucus secretion. Network pharmacology analysis was conducted to identify the shared targets and signaling pathways between EF, BBR, and IBD. Subsequently, the expressions of core genes were validated using quantitative real-time PCR (qRT-PCR). Results A high-dose of EF induced significant hepatotoxicity in zebrafish, manifested as liver enlargement, an increase in apoptosis, and elevated levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) while berberine (BBR) markedly alleviated these toxic effects. In the IBD model, EF improved the intestinal endocytic function, reduced the infiltration of neutrophils and macrophages, and promoted the mucus secretion of goblet cells. Notably, the co-administration of BBR and EF led to significant improvements in these parameters, indicating a pronounced synergistic effect. Network pharmacology analysis identified the PI3K-Akt, TNF, and VEGF signaling pathways as potential key pathways, with core targets including SRC, MAPK14, ptgs2a, CDK4, CDK2, and KIT. The results of quantitative reverse transcription polymerase chain reaction (qRT-PCR) were highly consistent with the prediction that EF could significantly downregulate inflammation-related genes such as IL-1β, ptgs2a, MAPK14, SRC, and CDK4 while upregulating CDK2. BBR added to the downregulation of these inflammatory targets. Conclusion BBR can effectively attenuate the hepatotoxicity induced by EF while enhancing its therapeutic efficacy in IBD, possibly by inhibiting the TNF, VEGF, and PI3K-Akt signaling pathways and by synergistically downregulating such key targets as SRC, MAPK14, IL-1β, ptgs2a, and CDK4, thereby alleviating inflammation and boosting the repair of the intestinal mucosa. The study is expected to provide experimental evidence for safe applications of toxic medicines derived from EF and offers a new interpretation of the classical herbal pair Coptidis Rhizoma-EF.

Objective To quickly identify the main chemical components of Guipi Anmian decoction and those absorbed into the bloodstream and brain based on ultra-high performance liquid chromatography-quadrupole-orbitrap mass spectrometry (UPLC-Q Exactive Orbitrap HRMS) technology. Methods The herbs were decocted in water before Amomum villosum was added and Panax ginseng decocted separately. The filtered residue was extracted with 50% ethanol using ultrasonication. The filtrates were combined to prepare the extract of Guipi Anmian decoction. Eight SPF male SD rats were randomly divided into the control group and administration group, with four rats in each. The rats in the administration group were given the extract of Guipi Anmian decoction by gavage (the crude drug concentration was 15 g·kg^-1), while those in the control group received an equal dose of normal saline. Blood and brain tissue samples were collected after drug administration. Chromatographic separation was performed on a Waters ACQUITY UPLC BEH Shield RP C₁₈ column (2.1 mm×100 mm, 1.7 μm). The mobile phase composed of acetonitrile (A) and water containing 0.1% formic acid aqueous solution (B) was used under gradient elution. As mass spectrometry, a full-scan mode with positive/negative ion switching and data-dependent secondary mass spectrometry scanning (Full MS/dd MS²) was adopted to acquire data so that precise primary information on mass spectrometry and abundant secondary fragmental data on mass spectrometry were collected. Combined with the reference standard retention times, PubChem database entries, and related literature, the main components in the extract and the prototype components in the plasma or brain were identified. Results A total of 158 chemical constituents were identified from GuipiAnmian decoction, including 55 terpenes, 34 flavonoids, 15 tannins, 19 phenylpropanoids, 8 alkaloids, 5 phenolic acids, 5 amino-acids, 4 nucleotides and 13 other compounds. Twenty-five of the prototype constituents were detected in the plasma and 29 in the brain. Conclusion A method for rapid multicomponent identification of GuipiAnmian decoction in vitro and in vivo has been established in this study, which is expected to contribute to research on effective substances and quality control.

Objective Analyze the chemical constituents of Rhei Radix et Rhizoma and its processed products (Raw Rhubarb Rhizome, Stew-Baked Rhubarb Rhizome, Wine-Processed Rhubarb Rhizome, Charred Rhubarb Rhizome), and initially explore the variations of content among different processed products. Methods Based on ultra-performance liquid chromatography-quadrupole-exactive orbitrap mass spectrometry (UHPLC-Q Exactive Orbitrap MS), A Hypersil GOLD aQ column (100 mm×2.1 mm, 1.9 μm) was used with mobile phases of 0.1% formic acid in acetonitrile (A) and water (B) at a 0.3 mL·min^-1 flow rate, in positive-negative ionmode. Identifica-tion and analysis of chemical constituents and relative content in Rhei Radix et Rhizoma and its processed products using self-built compound library, reference standards, and literature. Results A total of 63 chemical constituents were identified: 15 anthraquinones, 4 anthones, 13 flavonoids, 5 sugars, and 26 others. Raw Rhubarb Rhizome contains 61 constituents, Stew-Baked Rhubarb Rhizome 44, Wine-Processed Rhubarb Rhizome 54, and Charred Rhubarb Rhizome 36, with 23 constituents common to all forms. Among the shared constituents, the compounds exhibited regular differences in across the different processed products. Conclusion sProcessing Rhei Radix et Rhizoma converts bound anthraquinones into free ones, reducing its laxative effect and boosting blood-activating and hemostatic properties. Various methods affect its constituents differently; wine processing aids in extracting and preserving stable glycosides but destroys unstable ones.

Objective To screen the conditions for establishment of models representing different pathological stages of 1-methyl-3-nitro-1-nitrosoguanidine (MNNG)-induced chronic atrophic gastritis (CAG). Methods The cell counting kit-8 (CCK-8) assay was used to screen the concentration and time at which MNNG acted on the human gastric mucosal epithelial cell line (GES-1 cells). Mitochondrial membrane potential changes were detected via JC-1 staining to assess the severity of mitochondrial damage. Commercial assay kits were employed to measure levels of malondialdehyde (MDA), superoxide dismutase (SOD) and lactate dehydrogenase (LDH), which reflected oxidative stress and cell apoptosis, respectively. qRT-PCR was performed to detect the mRNA expression levels of gastric mucins (SOX2, MUC5AC), intestinal metaplasia markers (MUC2, KLF4, CDX2) and proinflammatory cytokines (TNF-α, IL-6, IL-8). Western blot was used to determine the protein expression of CDX2 while ELISA was applied to detect the secretory level of TNF-α. In addition, vitacoenzyme(WMS), a positive control drug, was used for interventions to evaluate the efficiency of the cell model. Results Eight hours of treatment of GES-1 cells with 20 μmol·L^-1 MNNG induced signs of early CAG, manifested as increased LDH release, upregulated CDX2 expressions and elevated TNF-α levels. After 24 h of treatment, the cells exhibited the incomplete type of intestinal metaplasia, including mitochondrial damage, aggravated oxidative stress, increased cell apoptosis, downregulated expressions of gastric mucins, and upregulated expressions of intestinal metaplasia markers and proinflammatory cytokines. However, WMS significantly reversed the above abnormalities, indicating the applicability of the cell model. Conclusion Eight hours of treatment of GES-1 cells with 20 μmol·L^-1 MNNG can help establish a CAG cell model, and 24 hours of treatment can lead to a model of CAG with the incomplete type of intestinal metaplasia. This cell model can well simulate the clinical pathology of the disease, thereby contributing to the mechanism research of CAG and the toxicological evaluation of MNNG.

Objective To evaluate the safety of Bushen Bitong Wan and provide a reference for the dosage design of safe clinical medications via acute and long-term toxicity tests in SD rats. Methods In the acute toxicity test, SD rats were administered with tolerated doses up to 12.0 g·kg^-1 by gavage twice daily. The rats were closely observed for toxic reactions. In the long-term toxicity test, 160 SD rats were divided into high-dose (6.0 g·kg^-1), medium-dose (3.0 g·kg^-1), low-dose (1.5 g·kg^-1) groups and a control group, with 40 rats in each. The rats were given the drug for 26 weeks, followed by 4 weeks of recovery. The test indicators involved body weight, feed consumption, hematological parameters, serum biochemistry, blood coagulation, urine parameters, and histopathological examination. Results In the acute toxicity test, the maximum tolerated dose of Bushen Bitong Wan in SD rats exceeded 12.0 g·kg^-1, equivalent to 94.38 times the intended clinical dose, but no obvious toxic or side effects were observed. In the long-term toxicity test, SD rats were given the extract powder of Bushen Bitong Wan by gavage for 26 weeks. The non-toxic response dose was 6.0 g (crude drug)·kg^-1, which was 47.19 times the intended clinical dose. Conclusion Under the conditions used in this test, Bushen Bitong Wan produces no obvious toxicity in the tested animals. Long-term oral administration is safe within the intended clinical dosage range and courses of treatment.

Objective To explore strategies for pharmacovigilance in medical institutions in order to provide a reference for related pharmacovigilance systems. Methods By analyzing the current practices and priorities related to pharmacovigilance in medical institutions, the challenges to construction of systems, risk identification, and processes of management were investigated while schemes for optimization were devised based on concepts of risk control. Results Strategies for optimization were proposed, and a closed-loop management model was established using a “monitoring-assessment-intervention-feedback” framework. Conclusion This study is expected to improve the ability of medical institutions to monitor, identify, assess drug risks, and provide feedback.

Objective To analyze the way ancient and modern proved prescriptions for oral gangrene are used in order to provide data for clinical medication and development of new drugs. Methods Prescriptions, ancient or modern, for the treatment of gangrene were collected before drug frequency, association rules, and compatibility of combination prescriptions were analyzed using the Traditional Chinese Medicine Inheritance Platform System (TCMICS) 3.0. The pharmacodynamic effects of potential prescriptions were predicted based on the TCMATCOV platform. Results A total of 389 ancient proved prescriptions were obtained, involving 450 types of traditional Chinese medicinal materials, and 167 pairs of high-frequency drug combinations, compared with 132, 221 and 242 respectively for modern proved cases. The percentage of common drug pairs was 7% (28), such as Glycyrrhizae Radix et Rhizoma-Angelicae Sinensis Radix and Angelicae Sinensis Radix-Astragali Radix. Five types of core prescriptions were obtained from the ancient proved prescriptions and modern proved cases. The results of the TCMATCOV platform analysis showed that drug combinations of the ancient proved recipes and modern proved cases had high scores. Based on comparisons, drug combination (Olibanum, Angelicae Sinensis Radix, Myrrh, Glycyrrhizae Radix et Rhizoma, Lonicerae Japonicae Flos, Angelicae Dahuricae Radix) from ancient proved prescriptions proved to be the best target of development. Conclusion By taking gangrene as an example, the “literature prescriptions-medical record practices-network prediction” method has been established, which can provide references for the prevention and treatment of clinically dominant diseases and the screening of candidate prescriptions of traditional Chinese medicine.

Objective To assess the clinical efficacy and safety of Western medicine combined with Traditional Chinese Medicine (TCM) in the treatment of adult brucellosis. Methods Such databases as CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, and Embase were searched for randomized controlled trials (RCTs) related to the combined treatment of adult brucellosis with TCM and Western medicine that were published from inception to August 2025. Meta-analysis was conducted using Cochrane ROB 2.0 tool and RevMan 5.4.1 software. Results Eleven RCTs involving 1 561 patients were enrolled. Meta-analysis found that compared with Western medicine alone, the combined therapy significantly improved the clinical effective rate (RR=1.14, 95% CI[1.06, 1.22], P=0.000 3) across different courses of treatment (subgroup analysis: <6 weeks and ≥6 weeks). After combined treatment, serum levels of C-reactive protein (CRP) (SMD= -2.13, 95% CI [-2.87, -1.38], P<0.000 01), interleukin-6 (IL-6) (MD= -7.45, 95% CI [-13.81, -1.09], P=0.02), immunoglobulin G (IgG) (MD= -3.01, 95% CI [-3.33, -2.70], P<0.000 01), and immunoglobulin M (IgM) (MD= -0.31, 95% CI[-0.39, -0.24], P<0.000 01) in the experimental group were significantly lower than in the control group, with statistically significant differences. Safety analysis indicated no statistically significant difference in the incidence of adverse reactions between the two groups (OR=0.66, 95% CI [0.39, 1.14], P=0.14). Conclusion The combination of Western medicine and TCM can significantly enhance the clinical effectiveness in adult patients with brucellosis and shows notable advantages in reducing inflammatory responses and modulating immune function.

Objective To analyze reports of adverse reactions of diprophylline injection preparations so as to provide a reference for rational clinical use of the drug. Methods Related reports were retrieved from the National Adverse Drug Reaction Monitoring Database that were collected between January 1, 2004 and September 30, 2023 and from overseas databases that were collected from the inception to January 25, 2026. Related articles were retrieved from literature databases that were published from the inception to October 31, 2025. Risk control measures taken by drug regulatory authorities were summarized. The basic information of cases, organs or systems involved and clinical manifestations of adverse reactions related to diprophylline injection preparations were analyzed. Results Adverse drug reactions of diprophylline injection preparations involved multiple systems or organs. Nausea, vomiting, palpitations, chest discomfort, dyspnoea and pruritus were common manifestations. Diprophylline for injection was involved in a larger proportion of reports about severe adverse reactions than other diprophylline injection preparations. Most of the patients were aged 65 and older. Conclusion Clinicians should be alert to the adverse reactions caused by diprophylline injection preparations, inquire about the allergic history of patients before medication, especially hypersensitivity to dextran-based excipients, monitor the symptoms and signs of severe adverse reactions such as anaphylactic shock so as to offer immediate symptomatic treatment.

Objective To investigate the contributors to the olanzapine concentration/dose (C/D) ratio and weight gain among teen patients by analyzing serum concentrations of olanzapine in order to provide a reference for rational use of olanzapine in teenagers. Methods Serum concentrations and associated clinical results of olanzapine were collected from the therapeutic drug monitoring (TDM) data of 270 inpatients treated with olanzapine at Shenzhen Kangning Hospital between 2020 and 2024. The effects of gender, body mass index (BMI) and comedications on olanzapine concentrations were analyzed while risk factors for weight gain were explored. Results Among the 270 teen patients, the ratio of males to females was 1∶1.57, and the average age was (15.5±1.3) years, the daily dose of olanzapine was 15.0 (5.0, 20.0) mg·d^-1, the serum concentration was 37.8 (23.9, 56.5) ng·mL^-1 and the C/D ratio was 3.33 (2.35, 4.43) ng·mL^-1·mg^-1. The C/D ratio of female patients was higher than that of male patients, with statistically significant differences (P<0.05). The C/D ratio of olanzapine in obese patients (BMI>24.0 kg·m^-2) was lower than that of normal patients (BMI 18.5 to 24.0 kg·m^-2),with statistically significant differences (P<0.05). The C/D ratio of patients treated with olanzapine combined with valproate was lower than that of patients who were not, with statistically significant differences (P<0.05). The C/D ratio of patients treated with olanzapine combined with fluoxetine was higher than that of patients who were not, with statistically significant differences (P<0.05). Wight gain was more prevalent in teenagers than in adults. Logistic regression analysis showed that BMI, C/D ratios and concomitant antidepressants were protective factors for weight gain. Conclusion Gender, BMI, and the combination of valproate and fluoxetine can impact the C/D ratio of olanzapine. In addition, BMI, C/D ratios and the combination of antidepressants are contributors to weight gain.

Objective To explore one case of immune myocarditis complicated with myasthenia gravis caused by pabolizumab Injection so as to provide a reference for rational use of pabolizumab in clinic. Methods The diagnosis and treatment of one patient with autoimmune myocarditis complicated with myasthenia gravis due to lung adenocarcinoma and treated with pabolizumab were analyzed. Related literature was searched for to find out whether ICIs treatment could be restarted and what was the best coping strategy. Results The patient developed immune myocarditis complicated with myasthenia gravis about 6 weeks after pabolizumab was taken. After discontinuation of this drug and symptomatic treatment, cardiac troponin I decreased significantly and the symptoms of ocular myasthenia improved. It was found that immune myocarditis complicated with myasthenia gravis might occur following the use of pabolizumab, making it necessary to stop taking the drug and intervene as soon as possible. Conclusion Pabolizumab may lead to immune myocarditis complicated with myasthenia gravis, which deserves more attention.

Objective To investigate a rare adverse reaction caused by zoledronic acid injection and provide a reference for safe and rational drug use in clinical practice. Methods The process of diagnosing and treating one case of agranulocytosis induced by zoledronic acid injection was analyzed. The clinical manifestations, risk factors, and prevention strategies related to this adverse reaction were summarized based on both domestic and foreign literature. Results After the administration of zoledronic acid injection, the patient developed persistent fever accompanied by sore throat. Three days later, a blood routine examination pointed to agranulocytosis. Following treatment with granulocyte colony-stimulating factors, the granulocyte count returned to normal while the associated symptoms, including fever and sore throat, were mitigated. Conclusion When zoledronic acid injection is used clinically, clinicians should be vigilant to the occurrence of agranulocytosis and ensure quick identification and treatment.

Objective To study one case of acute generalized exanthematous pustulosis caused by hydroxychloroquine sulfate tablets in a pregnant woman in order to provide a reference for rational clinical drug use. Methods One case of acute generalized exanthematous pustulosis caused by hydroxychloroquine sulfate tablets in a pregnant woman was analyzed. Based on association evaluation and related literature, the adverse reactions and its pathogenesis were investigated, and a treatment regimen was proposed. Results The association between hydroxychloroquine sulfate tablets and acute generalized exanthematous pustulosis was highly likely. After discontinuation of hydroxychloroquine sulfate tablets and start of corticosteroid therapy, the condition persisted. The clinical pharmacist recommended adding such medications as cyclosporine, which are relatively safe for pregnant women and fetuses, and the patient’s symptoms and indicators improved significantly. Conclusion Acute generalized exanthematous pustulosis is a rare and severe adverse reaction of hydroxychloroquine sulfate tablets. After treatment with methylprednisolone combined with cyclosporine soft capsules, the symptoms of severe drug eruption in patients can be significantly improved, ensuring the safety and effectiveness of drug use for pregnant women and fetuses.

Objective To analyze one case of adverse drug reactions–gastrointestinal bleeding–caused by sunitinib Malate Lepsules, and to provide a reference for safe use of sunitinib in clinical practice. Methods Based on a clinical case of a 62-year-old female patient who developed lower gastrointestinal bleeding after taking sunitinib capsules due to gastrointestinal stromal tumor with liver metastasis, clinical pharmacists consulted related literature and analyzed the causes of bleeding. Results Gastrointestinal bleeding of the patient was determined as a “probable” adverse drug reaction to sunitinib capsules. The mechanism might be that vascular endothelial growth factors were inhibited by sunitinib, leading to the impairment of normal vascular physiological functions and the inhibition of platelet function and fibrin formation. Conclusion Clinicians should remain vigilant on gastrointestinal bleeding caused by sunitinib during medication. When a therapy with this drug is used a second time, the risks and benefits must be weighed, and patients should be monitored to ensure the safety of medication.

Objective To summarize the research progress in therapeutic drug monitoring (TDM) based on liquid chromatography-mass spectrometry (LC-MS) technology in precision medicine so as to provide a reference for clinical precision medicine. Methods By searching China National Knowledge Infrastructure (CNKI), Chinese Medical Journal Network, Wanfang Database, and PubMed for related literature that was published between June 1, 2011 and May 31, 2025, this study summarized the applications of TDM among specific patients and described the prospects of and challenges to TDM based on LC-MS technology. Results TDM and real-time adjustment of doses of drugs could maximize efficacy of drugs and help prevent adverse drug reaction(ADR). LC-MS technology was widely used in the field of TDM due to its high sensitivity, specificity and accuracy. Conclusion TDM is a key clinical tool that can accurately evaluate the clinical efficacy and safety of drugs. TDM based on LC-MS technology can formulate individualized drug delivery schemes for patients and boost advances in clinical precision medicine.