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Chinese Journal of Pharmacovigilance
15 March 2026, Volume 23 Issue 3

15 March 2026, Volume 23 Issue 3 Previous Issue   
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2026, 23(3): 0-0. 
Abstract ( 43 )   PDF (516KB) ( 59 )  
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Proteomics-Based Analysis of Mechanisma Underlying Celastrol-Induced Fibroblast Transdifferentiation
SUN Yue, ZHANG Yunan, SUN Yuanbo, LI Gaofu, YANG Fang, WANG Ningning, ZHANG Pengfei, GAO Yue, ZHOU Wei
2026, 23(3): 241-249. 
DOI: 10.19803/j.1672-8629.20250638

Abstract ( 17 )   PDF (2077KB) ( 32 )  
Objective To explore the mechanisms of celastrol-induced cardiotoxicity and its potential promotion of fibrosis via proteomic analysis. Methods Primary cardiac fibroblasts were isolated from neonatal mice. The Cell Counting Kit-8 (CCK-8) assay was used to determine the concentration and duration of celastrol treatment. Bright-field microscopy was employed to observe the morphological changes of fibroblasts before and after treatment. Seventy-two hours after treatment with 0.01 μmol·L-1, real-time quantitative PCR (qPCR) was used to measure the expression levels of related pro-fibrotic genes. Enzyme-linked immunosorbent assay (ELISA) was employed to quantify changes in the levels of extracellular matrix (ECM), including tissue inhibitor of metalloproteinases-1 (TIMP-1) and matrix metalloproteinase-2 (MMP-2). Immunofluorescence staining was performed to calculate the expressions of fibrosis-related proteins. Proteomic analysis was used to investigate the potential mechanisms by which celastrol promoted fibrosis. Results 72 hours after treatment with celastrol 0.01μmol·L-1, the morphology of cells in the treatment group changed from spindle-shaped to polygonal or flattened, and the cell volume increased compared with the blank control group. The expression levels of pro-fibrotic genes and proteins were significantly elevated in the celastrol-treated group, along with increased levels of the extracellular matrix proteins TIMP-1 and MMP2. Differential protein enrichment analysis based on proteomics indicated that celastrol affected the expressions of such proteins as fibronectin 1 (Fn1), integrin alpha 11 (Itga11), integrin beta 3 (Itgb3), and transforming growth factor beta 1 induced transcript 1 (Tgfb1i1) in fibroblasts. By activating inflammatory and extracellular matrix-related pathways, celastrol subsequently promoted cardiac fibrosis. Conclusion Short-term administration of celastrol may potentially impact cardiac function, likely by influencing collagen synthesis and disrupting extracellular matrix (ECM) homeostasis, thereby promoting the transformation of cardiac fibroblasts into myofibroblasts and exacerbating the fibrosis process.
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Key Active Components and Potential Mechanisms of Antioxidant Effects of Actinidia arguta
WANG Ruojin, SUN Yang, SUN Qi, GONG Liying, LIU Zhao, ZHAO Nan, YUE Jiayin, LIANG Dejun, MENG Fanhao
2026, 23(3): 250-258. 
DOI: 10.19803/j.1672-8629.20250690

Abstract ( 28 )   PDF (2549KB) ( 34 )  
Objective To investigate the key bioactive components, target proteins, and signaling pathways involved in the antioxidant effects of Actinidia arguta based on network pharmacology and to verify the antioxidant activity of these components via in vitro experiments. Methods A “drug-ingredient-target map” was constructed by searching the HERB and TCMSP databases and screening the active ingredients and corresponding targets of Actinidia arguta. Protein-protein interaction (PPI) network analysis of intersection targets, GO functional enrichment analysis, and KEGG pathway enrichment analysis were conducted after antioxidant-related targets were obtained from disease databases and intersected with component targets. The in vitro antioxidant activity of the key active ingredients was validated via DPPH and ABTS+ radical scavenging experiments. Results By searching the HERB and TCMSP databases, eight active components and 283 corresponding targets were identified. Antioxidant-related targets were obtained from disease databases, and 118 common targets were identified by taking the intersection of these datasets. Protein-protein interaction network analysis revealed such core targets as STAT3, SRC, PARP1, MTOR, and MMP9. GO functional enrichment analysis suggested that these targets were mostly involved in biological processes, cellular components, and molecular functions. KEGG pathway enrichment analysis found that the antioxidation mechanisms might be closely related to such pathways as cancer, chemical carcinogenesis-reactive oxygen species, cellular signal transduction, and lipid and atherosclerosis pathways. Conclusion The in vitro antioxidation experiments have confirmed that all the predicted components are capable of antioxidation, with quercetin, caffeic acid, and 3,4-dihydroxybenzoic acid as the strongest ones. Such key components as 3,4-dihydroxybenzoic acid, actinidine, and caffeic acid have a strong ability to scavenge free radicals. They may exert antioxidant effects through multi-target and multi-pathway mechanisms, which is expected to shed light on the antioxidation mechanism of Actinidia arguta.
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Transdermally Absorbed Components of Kangti Shoushen Formula and Their Mechanisms against Obesity
SUN Jian, YANG Siyu, MIMA Zhuoga, REN Zeng, BIANBA Dunzhu, WANG Yuxin, CHENG Haojie, CI Ren, FAN Xinrong
2026, 23(3): 259-266. 
DOI: 10.19803/j.1672-8629.20250941

Abstract ( 26 )   PDF (2136KB) ( 29 )  
Objective To study the potential transdermal active components and underlying mechanisms of Kangti Shoushen Formula (KTSF) in the treatment of obesity. Methods The transdermal components of KTSF after experimental permeation were analyzed using HPLC-Q-TOF-MS/MS. Potential targets of KTSF and obesity-related targets were obtained from the PharmMapper and GeneCards databases while the intersecting targets were identified with Venny. The STRING database and Cytoscape software were used to construct and analyze protein-protein interaction (PPI) networks and screen core targets. Finally, enrichment analysis was conducted using Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG). Results A total of 21 transdermal components of KTSF were detected. In total, 509 putative KTSF targets and 1,549 obesity-associated targets were identified, yielding 176 overlapping targets. Subsequently, 65 core targets were prioritized. GO and KEGG enrichment analyses suggested that the anti-obesity effects of KTSF might be mediated by multiple components, including L-norleucine, valine, and ferulic acid, which acted on key targets such as AKT1, TNF, PPARγ, and ESR1, thereby modulating pathways related to HIF-1, reactive oxygen species (ROS), and thyroid hormone receptor (THR) signaling. Conclusion KTSF may deliver therapeutic effect against obesity by maintaining glucose and lipid metabolic homeostasis, alleviating inflammatory responses and oxidative stress, and participating in appetite suppression. This study reveals the therapeutic advantages of this Tibetan herbal compound in terms of its “multi-component, multi-target, multi-pathway” characteristics, providing a reference for rational clinical applications of KTSF.
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HPLC Determination of Changes in Contents of Index Components in Genkwa Flos-Glycyrrhizae Radix et Rhizoma Herb Pair Decocted at Different Temperatures
WANG Minshu, LANG Yingqi, WU Meiling, LU Xinyue, BAI Dong, YANG Yuqin
2026, 23(3): 267-272. 
DOI: 10.19803/j.1672-8629.20250757

Abstract ( 18 )   PDF (2143KB) ( 26 )  
Objective To investigate the significance of hot filtration in component detection of licorice-containing traditional Chinese medicine preparations by taking the herb pair of Genkwa Flos and Radix et Rhizoma Glycyrrhizae as an example in order to elucidate the supramolecular interactions between these herbs and provide chemical-level evidence for the “eighteen incompatible medicaments” theory in traditional Chinese medicine. Methods The experimental approach involved multiple analytical techniques. High-Performance liquid chromatography (HPLC) was employed to quantitatively analyze the content variations of marker components in decoctions prepared at different herb ratios and at two temperatures (85℃ and 35℃). Scanning electron microscopy (SEM) was used to examine the morphological characteristics and structural changes induced by temperature variations in the co-decoction solutions. Comparative HPLC analyses were conducted between single-herb decoctions and combined decoctions to evaluate the impact of self-assembly formation on the dissolution behavior of the marker components. The standard curve method was applied for precise quantification of all target compounds under different preparation conditions. Results The investigation revealed significant temperature-dependent phenomena. The physical state of the Genkwa Flos-Radix et Rhizoma Glycyrrhizae decoction was thermally responsive in that a solution state was maintained at 85℃, but turned into a semi-gel state at 35℃ and room temperature, and no complete gelation was formed that would enable tube inversion. HPLC analysis demonstrated substantially higher recovery rates for all three marker components (Yuanhuacine, Yuanhuadine, and Genkwanin) in decoctions filtered at 85℃ compared to those processed at 35℃. SEM observations provided visual evidence of temperature-mediated nanostructural evolution, revealing well-defined nanoparticles approximately 400 nm in diameter at 85℃ that progressively aggregated into larger structures around 2 μm when the temperature decreased to 35℃. Comparative analysis established that the self-assembly formation in combined decoctions significantly enhanced the dissolution efficiency of the marker components compared to single-herb preparations. Quantitative determination yielded specific content values: 0.012 0±0.000 1 to 0.045 1±0.001 4 μg for Yuanhuacine, 0.008 2±0.000 06 to 0.028 3±0.000 9 μg for Yuanhuadine, and 0.119 9±0.000 7 to 0.255 0±0.003 9 μg for genkwanin at different preparation ratios. Conclusion This research provides insights into the temperature-responsive self-assembly behavior in incompatible herb pairs via integrated component quantification and morphological characterization. The findings clearly demonstrate that the decoction process facilitates the initial formation of supramolecular nanostructures, while subsequent cooling drives the progressive growth and aggregation of these nanoparticles. This study is expected to advance the theoretical framework of traditional Chinese medicine by establishing a supramolecular foundation for comprehending herbal compatibility and decoction processes.
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Aromatic Substances of Perillae Folium Volatile Oil Based on GC-MS and E-Nose Technology
ZHANG Meiqi, QIAN Qi, XIE Zeyang, NIU Liying, WANG Xinguo
2026, 23(3): 273-279. 
DOI: 10.19803/j.1672-8629.20250423

Abstract ( 9 )   PDF (2271KB) ( 25 )  
Objective To study the differences in the composition and aroma of an volatile oil from Perillae Folium grown in different regions so as to find out about the aromatic substances of such oil. Methods Gas chromatography-mass spectrometry (GC-MS) and E-nose technology were used to conduct multivariate statistical analysis of the composition and aroma of a volatile oil from Perillae Folium grown in different areas in order to find the differences in composition and aroma. The aromatic substances of this volatile oil were screened out via correlation analysis. Results A total of 48 volatile components were identified by GC-MS, represented by terpenes and their oxides, alcohols and ketones. The E-nose could distinguish samples of volatile oils from Perillae Folium grown in Guangxi, Hebei and Anhui provinces. Based on Pearson correlation analysis, 19 aromatic substances were identified, including linalool, perillaldehyde, caryo-phyllene oxide, and egomaketone. Conclusion GC-MS and E-nose combined with multivariate statistical analysis can effectively distinguish the volatile oil of Perillae Folium from different regions, reveal the differences in composition and aroma, and determine the aromatic substances. This study is expected to provide a reference for quality evaluation of Perillae Folium.
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Exposure Levels of Heavy Metals in Artemisia argyi and Risk Assessment
FEI Yiqin, XIAO Ling, LYU Pan, WANG Bo, NIE Jing
2026, 23(3): 280-284. 
DOI: 10.19803/j.1672-8629.20250555

Abstract ( 12 )   PDF (1328KB) ( 25 )  
Objective To conduct a comprehensive risk assessment of ten heavy metal contaminants in 26 batches of Artemisia argyi in order to establish a reference framework for precise evaluation of associated health risks. Methods The concentrations of Pb, Cd, As, Hg, Cu, Al, Mn, Ni, Cr, and Zn in Artemisia argyi samples were quantified using inductively coupled plasma mass spectrometry (ICP-MS). The health risks of heavy metal contamination were analyzed using three methods: oral intake risk assessment, non-carcinogenic risk assessment and carcinogenic risk assessment. Results The mean elemental concentrations were the highest with Al, followed by Mn, Zn, Cu, Ni, Pb, Cr, Cd, As and Hg. The levels of Pb, Cd, As, Hg, and Cu in each batch were below the established safety thresholds for medicinal plants and decoction pieces. Oral intake risk assessment indicated that the estimated daily intake (EDI) of heavy metals from Artemisia argyi consumption remained within provisional tolerable daily intake (PTDI) limits, suggesting a negligible risk. For non-carcinogenic risks, the hazard index (HI) across samples was<1, indicating a negligible overall risk, with Mn posing the highest non-carcinogenic risk, followed by As and Cd. Carcinogenic risk evaluation identified Cd and As as contributors to measurable carcinogenic potential and worthy of attention, whereas Pb posed a minimal carcinogenic risk. Conclusion The risk assessment method established in this study integrates multi-dimensional risk indicators, enabling precise identification and quantification of key determinants of safety risks of Artemisia argyi. This study is expected to provide a reference for the sustainable development of the Artemisia argyi industry.
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Construction of an Indicator System for Evaluating Safety of Pediatric Medication
LUO Qiang, DENG Bin, XIONG Huiyu, WANG Chunting, HUANG Yan, LIU Zuoren
2026, 23(3): 285-289. 
DOI: 10.19803/j.1672-8629.20250768

Abstract ( 44 )   PDF (1461KB) ( 65 )  
Objective To construct an indicator system for evaluating the safety of pediatric medication in order to contribute to children’s health. Methods A tentative framework was established via literature review and brainstorming. The Delphi method was used to analyze, screen, and refine the indicators. The Analytic Hierarchy Process (AHP) was applied to determine the weight of each indicator before the indicator system for evaluation of safety of pediatric medication was established. Results The final system comprised 3 first-level indicators, 10 second-level indicators, and 37 third-level indicators, with corresponding weights assigned to each indicator. Conclusion The significant weight of “inherent medication risks” underscores that the risk to pediatric medication lies in the drug itself. It is recommended that risks be managed throughout medication, pre-market research upgraded, and post-market surveillance enhanced. The constructed indicator system is well-grounded and can serve as a reference for evaluating the safety of pediatric medication.
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Global Trends and China’s Practices Related to Medical Device Vigilance Systems
SONG Yana, ZHAO Yan, LI Dong, ZHAO Yifei, ZHENG Lijia, ZHI Rui, DENG Gang
2026, 23(3): 290-295. 
DOI: 10.19803/j.1672-8629.20250930

Abstract ( 30 )   PDF (1237KB) ( 46 )  
Objective To analyze the developments of the medical device vigilance system so as to provide a reference and guidance for the establishment of such a system in China. Methods The developments of the medical device industry, post-market supervision of medical devices in developed countries, and the evolution of pharmacovigilance in China were traced. On this basis, the need to establish a vigilance system of medical devices in China was elaborated in combination with the progress in our pilot programs concerning adverse event monitoring and vigilance in medical device. Results and Conclusion Medical device vigilance is critical to risk management throughout the lifecycle of medical devices. Amid such vigilance, efforts should be made to accelerate the transition from oversight of adverse events to medical device vigilance, establish a new framework for related vigilance, and enforce proactive risk monitoring, precise analysis, and effective management of medical device products, which will boost product innovation and industrial upgrading.
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Mechanisms of Post-Marketing Adverse Reactions of Chikungunya Vaccines
LIU Mengxin, CHEN Zhihai
2026, 23(3): 296-301. 
DOI: 10.19803/j.1672-8629.20250767

Abstract ( 18 )   PDF (1304KB) ( 32 )  
Objective To explore the post-marketing adverse reactions of two Chikungunya vaccines-the live attenuated vaccine IXCHIQ and the virus-like particle vaccine VIMKUNYA-and related mechanisms in order to contribute to the development and applications of Chikungunya vaccines in the future. Methods Such databases as PubMed, ScienceDirect and CNKI were searched for information on the marketing and adverse reactions of Chikungunya vaccines before the adverse reactions and related mechanisms were compared and analyzed. Results The post-marketing adverse reactions of the live attenuated vaccine IXCHIQ included fever, joint pain, headache and myalgia, and pain at the site of injection, which were related to such mechanisms as exposures to antigens, high expressions of Mxra8 receptor, and increased inflammatory mediators. Dozens of serious adverse events were reported that involved the cardiovascular and nervous systems, and were believed to be linked to direct infections, immune mediation, and amplification of NLRP3 inflammasomes. VIMKUNYA, a virus-like particle vaccine, was put on markets not long ago, so there were relatively few reports of adverse reactions, including fever, syncope, fatigue, headache, myalgia and joint pain. Conclusion The clinical use of the live attenuated vaccine IXCHIQ requires vigilance about serious adverse reactions. The data on safety of the virus-like particle vaccine VIMKUNYA needs to be monitored all the time.
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Safety Risk of Azithromycin in Minors
QIN Bo, LI Gen, DU Yu, GAO Shan, LAN Shan, PENG Dan, JIANG Yongxian
2026, 23(3): 302-306. 
DOI: 10.19803/j.1672-8629.20250550

Abstract ( 43 )   PDF (1293KB) ( 64 )  
Objective To investigate the incidence and characteristics of adverse drug reactions (ADR) of azithromycin (AZM) in minors in order to provide data on safety of medications. Methods Reports of ADR caused by AZM in Sichuan Province that were published between January 2010 and March 2024 were retrieved. Key information, including patient demographics, medication-specific details (such as dosage, administration routes, and courses of treatment), manifestations of ADR, clinical outcomes, and other related parameters, was analyzed to delineate the patterns of AZM-associated ADR. Results A total of 5,143 ADR cases were collected, with no significant gender difference observed. Inappropriate dosage was found in 981 cases (19.07%), with 126 serious reports (38 new serious reports). Most of the ADR occurred within 3 days of administration (4,875, 94.79%). These ADR involved multiple systems-organs, the top three of which were gastrointestinal system disorders, skin/subcutaneous tissue reactions, and general disorders/reactions at the sites of administration. Severe ADR mostly manifested themselves as gast-rointestinal symptoms. Favorable clinical outcomes were observed in 98.83% of these cases, with complete recovery or significant improvement. Conclusion ADR caused by azithromycin among minors often involve multiple systems, but are mostly tolerable. Rational dosing, individualized medications, and close monitoring for early detection/intervention are recommended.
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Serious Adverse Reactions and Risks Caused by Camrelizumab for Injection
JIANG Yanlin, DENG Jungang, CHEN Wei, ZHANG Jingjing, FANG Chunxia, QIN Zhongyu, PENG Yingzhi, GUO Bing, LIAO Rujia
2026, 23(3): 307-311. 
DOI: 10.19803/j.1672-8629.20250439

Abstract ( 23 )   PDF (1360KB) ( 41 )  
Objective To retrospectively analyze real-world data on adverse drug reactions (ADR) associated with camrelizumab, characterize the profile, and identify contributors in order to provide evidence for rational drug use. Methods Reports about adverse reactions from hospitalized cancer patients treated with camrelizumab for injection between May 2021 and March 2025 in Guangxi Zhuang Autonomous Region were retrieved from the China Hospital Pharmacovigilance System. The demographics of patients, medications, and severity of ADR were statistically analyzed. Results Among the 481 camrelizumab-treated patients, Serious ADR accounted for over half of the reported cases. ADR were much more prevalent in males than in females. The proportion of middle-aged and elderly patients was relatively large. Primary malignancies were predominantly esophageal cancer, hepatocellular carcinoma and lung cancer. ADR primarily involved the hematopoietic/lymphatic systems, with such major manifestations as myelosuppression syndrome, reactive cutaneous capillary endothelial proliferation, and hepatotoxicity. Univariate analysis disclosed significant differences in age and treatments. Multivariate logistic regression confirmed age and combination therapy as independent risk factors for serious ADR. One-way ANOVA pointed to significantly higher proportions of serious ADR in patients with esophageal cancer, hepatocellular carcinoma, and nasopharyngeal carcinoma. Conclusion Clinical use of camrelizumab requires heightened vigilance regarding the patients’ age, treatment regimens (particularly combination chemotherapy), and specific tumor types (esophageal, hepatic, nasopharyngeal). Drugs should be monitored when necessary to ensure the safety of medication.
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Analysis of 209 Cases of Adverse Reactions to Haemocoagulase Agkistrodon
HUANG Li, ZHANG Liaoyun, FU Min, LI Gen, DU Yu, GAO Shan, LAN Shan, PENG Dan, JIANG Yongxian
2026, 23(3): 312-317. 
DOI: 10.19803/j.1672-8629.20260024

Abstract ( 18 )   PDF (1296KB) ( 33 )  
Objective To analyze the characteristics and related risk factors of adverse drug reactions (ADR) associated with Haemocoagulase Agkistrodon for injection, and to provide evidence for safe clinical use. Methods ADR reports submitted between January 1, 2011 and December 31, 2024, from a certain province, involving Haemocoagulase Agkistrodon as the suspected drug, were collected. Data on patients’ demographics, medication use, ADR occurrence, and clinical outcomes were extracted and analyzed to characterize the features of these ADR. Results Among the 209 ADR reports, the occurrence of serious ADR showed no statistically significant association with off-label use (P>0.05). However, statistically significant differences were observed with respect to age, concomitant medication use, indication for administration, and route of administration (P<0.05). Most ADR occurred within 30 minutes after administration (56.93%), and serious ADR were predominantly concentrated within this period (77.42%), exhibiting characteristics of immediate hypersensitivity reactions, primarily manifesting as anaphylactic shock. ADR involved multiple organ systems, mainly affecting the skin and subcutaneous tissue as well as the gastrointestinal system. A total of 99.04% of the ADR either resolved or showed improvement. Conclusion Adverse reactions associated with Haemocoagulase Agkistrodon for Injection exhibit distinct immediate-onset characteristics and are related to the route of administration. Clinical medication should focus on rigorous monitoring within 30 minutes following administration. Preparedness for emergency rescue measures in response to hypersensitivity reactions is essential.
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Cases of Colitis Caused by Immune Checkpoint Inhibitors
WANG Yuting, ZHU Fangyi, LYU Xinge, PAN Chen, WU Yi, CUI Xiangli
2026, 23(3): 318-322. 
DOI: 10.19803/j.1672-8629.20250529

Abstract ( 21 )   PDF (1256KB) ( 38 )  
Objective To analyze cases of colitis induced by immune checkpoint inhibitors (ICIs) reported in literature in order to provide a reference for the clinical identification, diagnosis and management of such immune-related adverse events. Methods Databases including CNKI, VIP, Wanfang, PubMed, Web of Science, Embase and Cochrane Library were searched for related articles published as of June 2025. Reports of colitis caused by ICIs were screened, and patients’ demographics, tumor type, treatment regimens, onset time, severity, therapeutic strategies and outcomes were analyzed statistically. Results Ninety-eight articles involving 148 patients were included. The majority of the patients were male (72.97%), and the median age was 60. Lung cancer (41.21%) and melanoma (30.41%) were the most common primary tumors. PD-1 inhibitors were used in 81.76 % of the regimens. The median onset time from initiation of ICIs was 20.50 days. Severe colitis (grade 3-4) occurred in 72.97% of the cases. Corticosteroids were the major regimens (58.78%), and infliximab used in 14.86% of the cases. Most of the patients improved (69.59%), but 6.08% died. Conclusion Once severe colitis occurs after the use of ICIs, clinicians need to be alert for the possibility of immune-mediated colitis, especially diarrhea. A combination of glucocorticoid pulse therapy can yield good results.
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Adverse Reactions and Risk Factors of Voriconazole for Injection
LI Yujie, MA Jiantong, ZHANG Wenjing, GUO Hao
2026, 23(3): 323-327. 
DOI: 10.19803/j.1672-8629.20250827

Abstract ( 23 )   PDF (1310KB) ( 36 )  
Objective To analyze the adverse reactions and potential risk factors of voriconazole for injection so as to provide a reference for proper clinical applications. Methods The medical records of patients treated with voriconazole for injection in Inner Mongolia Autonomous Region People’s Hospital in 2020-2024 were collected. The patients with adverse reactions related to voriconazole for injection were assigned to the study group while those without served as the control group at a ratio of 1∶4 based on propensity score matching. Univariate and multivariate logistic regression analyses were conducted to identify risk factors for adverse reactions related to voriconazole for injection. Results A total of 665 patients treated with voriconazole for injection were included, 44 of whom had 68 related adverse reactions, so the overall incidence was 6.62%. The adverse reactions primarily involved the nervous system (35.29%) and blood system (33.82%). Multivariate logistic regression analysis indicated that diabetes [P=0.004, OR=3.250, 95%CI(1.448-7.297)], previous surgery [P=0.038, OR=2.167, 95%CI(1.042-4.507)], history of allergy [P=0.033, OR=2.729, 95%CI(1.083-6.873)], history of blood transfusion [P=0.040, OR=2.241, 95%CI(1.038-4.835)] and duration of medication (ranging from 14 d or less to 21 d) [P=0.011, OR=8.365, 95%CI(1.626-43.041)] might be independent risk factors for adverse reactions related to voriconazole for injection. Conclusion In the clinical application of voriconazole for injection, the patients’ diabetes, previous surgery, history of allergy, history of blood transfusion and medication duration should be taken into consideration while adverse reactions involving the nervous system and blood system deserve more attention. Pharmacovigilance should be implemented when necessary to detect and deal with adverse drug reactions immediately and ensure the safety of medication.
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Medications for Hemodialysis Catheter-Related Bloodstream Infections
ZHANG Wei, LU Lianhe, ZHANG Ruihua, TAN Yanan, LI Fenghong, TIAN Guobao, LI Jun, DONG Jianping, CHEN Zhihai
2026, 23(3): 328-333. 
DOI: 10.19803/j.1672-8629.20250793

Abstract ( 11 )   PDF (1352KB) ( 29 )  
Objective To analyze the distribution of pathogens, drug resistance, and clinical drug use associated with catheter-related bloodstream infections (CRBSI) among patients undergoing maintenance hemodialysis (MHD) and non-MHD pain in order to provide a reference for rational use of antibiotics in clinical practice. Methods A retrospective analysis was conducted of the clinical data, pathogens, results of drug sensitivity tests, and antibiotic use of CRBSI patients admitted to Beijing Haidian Hospital in 2023-2024. These patients were divided into MHD and non-MHD groups, and differences between the two groups were studied. Results A total of 44 CRBSI patients were enrolled, including 25 in the MHD group and 19 in the non-MHD group. Patients in the MHD group were younger and the percentage of malignancy was lower than in the non-MHD group. Tunneled central venous catheters (TCVCs) were dominating in the MHD group while non-tunneled central venous catheters (NTCVCs) were more common in the non-MHD group, and the differences between the two groups were statistically significant (P<0.01). A total of 52 pathogen strains were isolated, with Gram-positive bacteria as the dominating pathogens (28, 53.85%), followed by Gram-negative bacteria (19, 36.54%) and fungi (5, 9.62%). There was no statistically significant difference in the distribution of pathogens between the two groups (P=0.225). The most common pathogens were Staphylococcus aureus (7, 24.14%) in the MHD group and Staphylococcus epidermidis in the non-MHD group (5, 21.74%), respectively. The proportion of methicillin-resistant staphylococcus was similar across the two groups (P=0.157). Multidrug-resistant Gram-negative bacteria were prevalent in the non-MHD group. As for antimicrobial therapy, monotherapy was mostly used in the MHD group, whereas combination and broad-spectrum antimicrobial regimens were more commonly used in the non-MHD group. Conclusion The spectrum of pathogens and drug resistance related to CRBSI in non-MHD patients are more complicated, aggravated by multidrug-resistant Gram-negative bacteria. In clinical practice, differentiated empirical antibiotic regimens should be formulated based on patient populations.
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One Case of EDTA-Dependent Pseudothrombocytopenia Induced by Paclitaxel Liposome for Injection
JI Liu, HAO Min, WU Wenhui
2026, 23(3): 334-336. 
DOI: 10.19803/j.1672-8629.20250148

Abstract ( 17 )   PDF (1125KB) ( 32 )  
Objective To investigate the ways in which EDTA-dependent pseudothrombocytopenia (EDTA-PTCP) is identified and differentiated during chemotherapy in order to provide a reference for quick clinical diagnosis. Methods The clinical data of one breast cancer patient who experienced a significant decrease in platelet count after treatment with liposomal paclitaxel was analyzed. By reviewing the patient’s medical history, medications, and laboratory test results, the association between EDTA-PTCP and liposomal paclitaxel was studied, and recommendations for re-testing with alternative anticoagulants were proposed. Results The pharmacist assessed the likelihood of EDTA-PTCP associated with paclitaxel liposome. After replacement of the anticoagulant and retesting, the patient’s platelet count returned to normal. The patient’s subsequent chemotherapy plan was not affected, and the condition was stable. Conclusion In case of thrombocytopenia during chemotherapy, the possibility of EDTA-PTCP should be considered. Peripheral blood smears or retesting with a different anticoagulant should be adopted to confirm the diagnosis.
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One Case of Disulfiram-Like Reactions Caused by Cefoperazone Sodium and Sulbactam Sodium for Injection Combined with Deslanoside Injection
WANG Lei, ZHANG Lichao, QIAN Fengdan
2026, 23(3): 337-339. 
DOI: 10.19803/j.1672-8629.20250154

Abstract ( 25 )   PDF (1241KB) ( 38 )  
Objective To investigate the safety of drugs with similar structure to disulfiram and combined with drugs containing ethanol as excipients. Methods One case of disulfiram-like reactions after using cefoperazone sodium and sulbactam sodium for injection combined with deslanoside injection was analyzed before the disulfiram-like reactions were explored based on literature at home and abroad. Results The patient was given intravenous drips of deslanoside injection, cefoperazone sodium and sulbactam sodium for injection. After 12 minutes, the patient began to show a mild increase of heart rate, chills, facial flushing, sweating and other symptoms. After withdrawal of medication and symptomatic treatment, these symptoms were alleviated. Conclusion The combination of ethanol-containing excipients and cephalosporin antibiotics may lead to disulfiram-like reactions that, in severe cases, can cause disturbance of consciousness, fainting, shock and death. Clinicians should be cautious in using excipients containing ethanol in high-risk groups, make careful assessments before medication and monitor patients in order to prevent serious disulfiram-like reactions.
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One Case of Anaphylactic Shock Caused by Purified Protein Derivative of Tuberculin
LI Jiaxi, LEI Xiaotian, ZHAO Ke, NIU Li, SUN Yang, ZHONG Huaile, GUO Hao
2026, 23(3): 340-342. 
DOI: 10.19803/j.1672-8629.20250185

Abstract ( 15 )   PDF (1187KB) ( 31 )  
Objective To investigate the characteristics and mechanisms of anaphylactic shock caused by a purified protein derivative of tuberculin (TB-PPD) in order to ensure the safety of medication. Methods The clinical data of a 10-year-old patient was studied, who had experienced anaphylactic shock following an intradermal injection of TB-PPD during a tuberculin skin test. The underlying mechanisms were analyzed based on related literature. Results According to correlation analysis, it was concluded that the allergic shock experienced by the patient was likely caused by TB-PPD. After anti-allergic and symptomatic treatment, the patient recovered. Conclusion Anaphylactic shock has rapid onset and may be life-threatening, which is a rare but severe adverse reaction linked to TB-PPD. Close monitoring of patients is essential during treatment to prevent this adverse reaction.
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One Case of Thyroid and Cardiac Damage Caused by Tislelizumab Injection
ZHANG Jing, YANG Bo, YANG Shuai, MAO Meijuan, YAO Jingyue, GUO Qing
2026, 23(3): 343-345. 
DOI: 10.19803/j.1672-8629.20250295

Abstract ( 12 )   PDF (1231KB) ( 29 )  
Objective To investigate such serious adverse reactions as thyroid and cardiac damage induced by tislelizumab in order to provide a reference for safe medications. Methods One case of thyroid and cardiac damage in a patient with cholangiocarcinoma liver metastasis after 10 cycles of treatment with tislelizumab injection in combination with gemcitabine and capecitabine was discussed. The clinical features and treatment of adverse reactions based on related literature were reviewed. Results Based on the patient’s medical history, medication history, drug prescriptions and literature, this event was assessed as an immune-related adverse reaction caused by tislelizumab, manifested as a series of severe adverse reactions, such as hypothyroidism, cardiac damage, heart failure, and ventricular fibrillation. After anti-inflammatory, anti-heart failure and anti-arrhythmia treatments and thyroid hormone supplementation, the patient’s thyroid function and cardiac function improved significantly. Conclusion Clinicians should be alert to the potential risk of thyroid and myocardial damage induced by tislelizumab so as to prevent deadly serious adverse reactions and ensure the safety of medication.
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One Case of Thrombotic Thrombocytopenic Purpura Caused by Tirofiban Hydrochloride and Sodium Chloride Injection
CAO Yang, FU Xiaoxiu, MA Lin
2026, 23(3): 346-348. 
DOI: 10.19803/j.1672-8629.20250297

Abstract ( 17 )   PDF (1174KB) ( 31 )  
Objective To investigate one case of tirofiban-induced thrombotic thrombocytopenic purpura (TTP) so as to provide a reference for safe medication. Methods One case of tirofiban-induced TTP was analyzed in terms of clinical manifestations, mechanisms and treatment strategies based on literature. Results Six days into tirofiban administration, the patient developed severe thrombocytopenia, bleeding, limb weakness, slowed response and microangiopathic hemolytic anemia (MAHA). In combination with bone marrow aspiration findings, these symptoms pointed to tirofiban-induced TTP. Platelet counts returned to normal eight days after drug discontinuation and symptomatic treatment. Conclusion Tirofiban may induce the risk of TTP. Platelet counts should be closely monitored when tirofiban is administered. Once TTP is suspected, the risk should be assessed or the activity of ADAMTS13 is tested for early identification and management.
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Research Progress in Target Exploration of CAR-T Therapy for Anaplastic Thyroid Cancer
LIU Yanlin, BAI Huaixi, LI Zhigang, DAI Xiaoyan, WANG Juan
2026, 23(3): 349-354. 
DOI: 10.19803/j.1672-8629.20250551

Abstract ( 13 )   PDF (1297KB) ( 30 )  
Objective To explore the advances in targets and applications of chimeric antigen receptor T-cell (CAR-T) therapy in the treatment of anaplastic thyroid cancer (ATC). Methods Recent literature on studies on CAR-T therapy in anaplastic thyroid cancer (ATC) was retrieved to summarize the principal therapeutic targets, such as ICAM-1, TSHR, CSPG4, B7-H3, and ROR1, and their underlying mechanisms of action, and to identify major problems encountered in clinical applications. Results CAR-T cells exerted antitumor activity by targeting multiple ATC-associated antigens. However, their therapeutic efficacy was still limited by such factors as tumor heterogeneity, immunosuppressive tumor microenvironments, and potential safety concerns. Conclusion Insights into ATC-associated antigens and optimization of CAR design, in combination with integrated therapeutic strategies, may enhance the efficacy of CAR-T therapy and offer clues to precision immunotherapy in ATC.
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Pharmacovigilance for Radioprotective Drugs
LONG Huan, WANG Kaixin, YANG Yueqi, AN Minghui, LIANG Yuwei, LIU Hongran, GAO Xu, ZHANG Li, DING Jiaxin, GONG Jian
2026, 23(3): 355-360. 
DOI: 10.19803/j.1672-8629.20250771

Abstract ( 16 )   PDF (1321KB) ( 36 )  
Objective To analyze the challenges facing pharmacovigilance related to radioprotective drugs and propose optimization strategies so as to promote safe and rational clinical use of drugs. Methods Through literature review, radioprotective drugs and the identified representative agents were categorized. Major problems with pharmacovigilance were summarized while corresponding countermeasures were proposed. Results Radioprotective drugs were classified into three major categories: radioprotective agents, radiation mitigators, and radiotherapeutic agents. Five major challenges were identified: inadequate regulatory frameworks, insufficient research on pharmacology and toxicology, the lack of real-world data, difficulties in detecting adverse reactions, and imperfect data collection and sharing mechanisms. Conclusion A multidimensional approach is required to enhance the pharmacovigilance system for radioprotective drugs by strengthening regulatory frameworks, broadening nonclinical and clinical research, establishing real-world data platforms, developing intelligent risk identification tools, and promoting data sharing and international collaboration to ensure medication safety and efficacy.
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