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15 September 2025, Volume 22 Issue 9 Previous Issue   

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Reproductive Toxicity and Risk Control of Psoralea corylifolia Based on Systems Toxicology ZHANG Wang, WANG Ningning, YANG Fang, GAO Yue, ZHOU Wei 2025, 22(9): 961-966.  DOI: 10.19803/j.1672-8629.20250038 Abstract ( 27 )   PDF (1454KB) ( 53 )   Objective To explore the reproductive toxicity of Psoralea corylifolia and its risk prediction based on systems toxicology in order to provide a reference for its rational applications and risk management of reproductive toxicity. Methods The research on the reproductive toxicity of Psoralea corylifolia in literature was retrieved and summarized, and the risk prediction methods were discussed. Results Traditionally recorded as a “non-toxic” herb, Psoralea corylifolia can help warm the kidney and reinforce yang, and is clinically used for treating such syndromes as kidney yang deficiency and loss of essence consolidation. Along with its wide clinical use, frequent adverse reactions/events have drawn increasing attention to its potential toxicity. So far, studies have focused on hepatotoxicity and nephrotoxicity, which are easier to detect clinically, while research on reproductive toxicity remains limited, with only sporadic evidence suggesting potential risks. Moreover, current approaches to research around Chinese medicine toxicity are often hindered by such issues as the complexity of multicomponent systems, oversimplified linear analyses of effects, and difficulties in extrapolating conclusions to clinical practice, making difficult convincing interpretations of the toxicity of Psoralea corylifolia and related herbs. Conclusion Given these limitations, this study recommends new strategies for investigating the reproductive toxicity of Psoralea corylifolia based on systems toxicology, which are expected to offer insights into reproductive toxicity and provide a methodological reference for toxicity assessment and risk management of other widely used traditional Chinese medicines. References | Related Articles | Metrics

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Metabolism and Safety Evaluation of Mesenchymal Stem Cell-Derived Exosomes in vivo CHANG Mingyang, ZHOU Wei, SUN Yuanbo, WANG Rui, SHEN Pan, NI Zhexin, GAO Yue 2025, 22(9): 967-974.  DOI: 10.19803/j.1672-8629.20250133 Abstract ( 18 )   PDF (1270KB) ( 46 )   Objective To assess the clinical safety and in vivo metabolic characteristics of mesenchymal stem cell-derived exosomes (MSC-Exo) in order to provide a reference for the clinical translation and sound applications of emerging biological therapeutic agents. Methods The Clinical Trials. gov registry was searched to identify all registered clinical trials related to MSC-Exo. Studies involving safety assessments were summarized and analyzed. The potential relationships between variations in protein quality and the stability and safety of MSC-Exo were investigated. Results With the rapid advancement of regenerative medicine, MSC-Exo, as a key component of cell-free therapy systems, promised wide applications in the treatment of a range of diseases. A total of 67 clinical trials around MSC-Exo were retrieved, 44 of which were focused on safety and involved a number of countries and diseases. As the number of passages increased, changes in the protein quality of MSC-Exo were observed, including loss of critical functional proteins, enrichment of potentially risky proteins, and instability in immunomodulatory functions, which might compromise its therapeutic safety and efficacy. Conclusion Given the limited data on the long-term safety and in vivo metabolic mechanisms of MSC-Exo in current research, it is recommended that long-term follow-up studies be conducted among clinical subjects and an integrated quality control and evaluation system be established for MSC-Exo. Furthermore, post-marketing pharmacovigilance should be strengthened to ensure clinical safety. References | Related Articles | Metrics

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Research Advancements in Applications of Single-Cell Transcriptome Sequencing Technology in Mechanism Elucidation of Pharmacodynamics and Toxicity of Traditional Chinese Medicine NI Haoyu, ZHOU Lei, WANG Ningning, YANG Xingxin, ZHOU Wei, SHEN Pan, GAO Yue 2025, 22(9): 975-982.  DOI: 10.19803/j.1672-8629.20250374 Abstract ( 11 )   PDF (1746KB) ( 51 )   Objective To explore the applicability of single-cell RNA sequencing (scRNA-seq) technology in TCM research given the current challenges to precise characterization of the therapeutic efficacy and toxicological profiles of Traditional Chinese Medicine (TCM). Methods Recent research advances in utilizing scRNA-seq to investigate the efficacy and toxicity mechanisms of TCM were reviewed in general and related disease treatments and toxicity in particular. The functional positioning and key findings of scRNA-seq in various studies were also analyzed. Results A standardized research paradigm known as "component analysis-cellular localization-target screening-mechanism validation" was established to explore the efficacy and toxicity of TCM using scRNA-seq that could overcome the limitations of traditional organ-level observations and reveal the microscopic essence of TCM’s pharmacological and toxicological actions by enabling precise identification of cellular subpopulation-specific responses and dynamic gene expression changes. Based on these insights, we proposed a single-cell network pharmacological or toxicological strategy for systematic elucidation of mechanisms. Conclusion scRNA-seq has emerged as a pivotal methodology for deciphering what is underlying the pharmacology and toxicology of TCM. Research strategies in TCM using this technology can provide novel perspectives and references for advancing the modernization of TCM. References | Related Articles | Metrics

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Hygroscopic Chemical Reference Substance of Mecobalamin LIU Yi, WANG Tiange, GUO Xianhui, CHEN Hua, NING Xiao, CAO Jin 2025, 22(9): 983-985.  DOI: 10.19803/j.1672-8629.20240450 Abstract ( 12 )   PDF (1251KB) ( 38 )   Objective To identify the reference substance of mecobalamin and to explore the factors that affect its contents. Methods The reference substance was determined using HPLC, water titration, GC and high-resolution mass spectrometry. The dynamic vapor sorption (DVS) method was adopted to study hygroscopicity. Results The structure of the reference substance was confirmed while the adsorbed moisture content was analyzed as expected. In terms of hygroscopicity, the adsorbed moisture content was adjusted to 8%,which could ensure stable weighing when the ambient humidity ranged from RH 40% to RH 50%. Conclusion The changes in the hygroscopicity of the reference substance caused by alterations in the processing technology deserve attention. Studies on packaging, storage conditions and environments can help users better understand the characteristics of and considerations for mecobalamin. References | Related Articles | Metrics

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Preventive Effect of Qingjie Fanggan Granules on Mice with Human Coronavirus 229E-Induced Dampness-Heat Epidemic Toxin Attacking Lung HAN Man, XU Jing, ZHAO Ronghua, GENG Zihan, NIAN Xia, FENG Xiaolan, LIU Shuai, SONG Yanping 2025, 22(9): 986-993.  DOI: 10.19803/j.1672-8629.20250183 Abstract ( 8 )   PDF (2374KB) ( 36 )   Objective To observe the effect of preventive administration of Qingjie Fanggan Granules on this disease-model combination, and explore its possible role in COVID-19 by establishing a mouse model of human coronavirus 229E infection with dampness-heat pestilential toxin attacking the lung, which simulates the TCM syndromes of COVID-19 infection. Methods Sixty BALB/C mice were randomly divided into normal control group, dampness-toxin control group, dampness-heat control group, virus control group, and high/low dose groups of Qingjie Fanggan Granules (8.2/4.1 g·kg-1·d-1). The syndrome-combined model of human coronavirus 229E was established by modeling mice with a damp-heat environment and intranasal infection of 229E. The administration groups were given the drug starting from when the mice were placed in the damp-heat environment until before 229E virus infection. Mice were sacrificed 1 day after 229E virus infection, and lungs and spleens were harvested. Calculate lung and spleen indices, lung inhibition rate. Detect viral load in lung tissues by RT-PCR, observe pathological changes of lung and spleen. Detect levels of inflammatory factors IL-6, TNF-α, IL-1β and IL-8 in lung tissues by ELISA. Detect expressions of P-p38 and p38 proteins in p38 MAPK signaling pathway of lung tissues by Western Blot. Results Compared with the dampness-toxin control group, Qingjie Fanggan Granules significantly reduced the lung index (P<0.01) and increased the spleen index (P<0.05) in mice with damp-heat pestilential toxin attacking the lung infected by human coronavirus 229E. The lung index inhibition rates of high and low-dose groups were 61.73% and 71.15% respectively. It could significantly reduce the viral load in lung tissues (P<0.01), alleviate lung tissue lesions (P<0.01 or P<0.05), improve splenic tissue pathological changes, and significantly decrease the levels of IL-6, TNF-α, IL-1β and IL-8 in lung tissues (P<0.01 or P<0.05), as well as the expression of P-p38 protein in the MAPK pathway (P<0.05). Conclusion Preventive administration of Qingjie Fanggan Granules can alleviate lung inflammation caused by HCoV-229E infection, and its mechanism may be related to the inhibition of p38 protein phosphorylation and the MAPK signaling pathway. References | Related Articles | Metrics

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Toxicity Caused by 28 Days of Repeated Intravenous Injection of Forsythoside Aglycone in Rats QIU Deyang, TAN Yujun, WANG Dali, LI Guochao, YAO Fangfang, ZHAO Yun, DU Jiancai, LI Bin, YAO Jingchun 2025, 22(9): 994-1002.  DOI: 10.19803/j.1672-8629.20250017 Abstract ( 10 )   PDF (1706KB) ( 34 )   Objective To observe the possible toxic reactions and reversibility in SD rats after 28 consecutive days of repeated intravenous injection of forsythoside aglycone, and to provide a reference for its clinical applications. Methods One hundred and fifty SPF-grade rats (half male and half female) were randomly divided into 5 groups according to body weight: the solvent control group, hydrocortisone positive control group (30 mg·kg-1·d-1), and low, medium and high dose forsythoside aglycone groups (4、12、40 mg·kg-1·d-1), with 30 rats in each group. The rats were given respective drugs twice a day, in the morning and afternoon and for 28 consecutive days, followed by a 28-day recovery period. During the experiment, the condition of the rats was observed, and the body weight, food intake, hematology, blood biochemistry, ophthalmology, results of urine analysis, organ weight and coefficient, and data on histopathological examination were recorded. Results After 28 days of continuous administration, the hydrocortisone positive control group was abnormal in body weight, blood biochemistry, hematology and urine tests. Histopathological examination revealed atrophy of the thymus and increased phagocytosis of lymphocytes in the cortex, with starry-sky macrophages. At the end of recovery, no abnormal results were observed in body weight, blood biochemistry, hematology or urine tests in the hydrocortisone positive control group. Histopathological examination showed that the thymus returned to normal, suggesting that the lesion was reversible. After 28 days of continuous intravenous injection of forsythoside aglycone and 28-day recovery, the rats were in stable condition, and no abnormal changes related to forsythoside aglycone were observed in body weight, food intake, urine routine indexes, hematology, coagulation indicators, serum biochemistry, serum electrolytes or results of histopathological examination. Conclusion Under the conditions of this experiment, no abnormalities related to the toxicity of forsythoside aglycone are found. Twenty-eight days of intravenous injection of forsythoside aglycone have no obvious toxicity on SD rats. References | Related Articles | Metrics

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Technical Highlights of Safety Monitoring Plans during Drug Clinical Trials SU Xian, LIU Wendong, HU Yangping, WANG Xiaohan, WANG Haixue 2025, 22(9): 1003-1007.  DOI: 10.19803/j.1672-8629.20250270 Abstract ( 42 )   PDF (1254KB) ( 78 )   Objective To define the highlights of safety surveillance plans (SSP) and address key challenges to implementation of these plans. Methods The global SSP frameworks were traced, compared and contrasted. The shared issues and challenges facing implementation were identified before essential technical elements of these plans were summarized. Results A framework composed of key elements of SSP was recommended that involved such dimensions as risk identification, signal monitoring/assessment, and measures for risk minimization. Critical challenges were unveiled that included dynamic updating of plans and cross-disciplinary collaboration. Conclusion Applicants are to keep updating SSP based on advances in R&D and on the latest information about safety and validity, stick to pharmacovigilance, work towards minimization of risks and be active in communicating with regulators or agencies concerned in order to ensure the safety of subjects. References | Related Articles | Metrics

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Monitoring of Adverse Drug Reactions Caused by Hospital Preparations and Evaluation Systems JIANG Xiaofeng, YANG Shuting, BAI Liqin, QI Jun, HE Jianxiong, CHEN Wenge, LIANG Zuhong, LI Yu, YU Xiaoxia 2025, 22(9): 1008-1011.  DOI: 10.19803/j.1672-8629.20250218 Abstract ( 35 )   PDF (1226KB) ( 56 )   Objective To construct an intelligent adverse drug reaction (ADR) monitoring system for hospital-made preparations in order to prevent underreporting, data fragmentation, and delayed risk signals. Methods Based on Java 2 Platform and Enterprise Edition (J2EE), a multi-layer and distributed architecture system was designed to integrate the Hospital Information System (HIS) with the China Hospital Pharmacovigilance System (CHPS), making possible real-time synchronization and intelligent analysis of multi-source heterogeneous data. Its performance was evaluated through empirical studies conducted at two healthcare institutions in Yunnan and Guangdong. Results Among the 3,680 cases who had used blood-activating and stasis-resolving preparations, the identified incidence rate of ADR was 0.54 per thousand. In the 7,950 cases administered with heat-clearing and detoxifying preparations, one case of ADR was identified via active monitoring. Conclusion This system can quickly identify ADR risk signals associated with hospital preparations, but its performance needs to be verified by large-scale empirical studies. References | Related Articles | Metrics

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Clinical Features and Integrated Care Pathway for Second Primary Malignancies after CAR-T Cell Therapy ZHANG Hao, WU Xueting, HE Shujiao, WANG Yiran 2025, 22(9): 1012-1017.  DOI: 10.19803/j.1672-8629.20250457 Abstract ( 80 )   PDF (779KB) ( 85 )   Objective To investigate related second primary malignancies (SPMs) and comprehensive management practices following Chimeric antigen receptor T (CAR-T) cell therapy. Methods The epidemiology and mechanism of SPM after CAR-T cell therapy were reviewed, and the whole process management strategy for SPMs after CAR-T cell therapy was discussed. Results The risk of SPMs associated with CAR-T cell therapy was found to range from 3% to 8%. Risk factors for SPMs after CAR-T cell therapy included hematological precursor lesions such as clonal hematopoiesis of uncertain significance, excessive inflammatory responses triggered by CAR-T cell therapy, and the carcinogenic potential of multiple lines of treatment. Clinical pharmacists could effectively reduce the risk via compr-ehensive management based on three-level prevention. Conclusion The clinical benefits of CAR-T cell therapy for primary tumors outweigh the potential risks associated with SPMs. It is essential for clinical pharmacists to intervene in the entire process of CAR-T cell therapy and collaboratively construct a three-level prevention system with healthcare providers that involves providing pharmaceutical services for the identification, analysis, reporting, and follow-up of SPMs and incorporating comprehensive management of CAR-T cell therapy into a data-driven continuous quality improvement approach, which is of clinical importance for the safe and effective administration of CAR-T cell therapy. References | Related Articles | Metrics

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887 Reports of Adverse Drug Reactions Induced by Intravenous Drip of Antibacterial Drugs CAI Jie, HAN Chenyuan, JIANG Junwei 2025, 22(9): 1018-1023.  DOI: 10.19803/j.1672-8629.20241044 Abstract ( 35 )   PDF (1284KB) ( 63 )   Objective To analyze the patterns and clinical characteristics of adverse drug reactions (ADR) induced by intravenous drip of antibacterial drugs so as to provide references for safe clinical medications. Methods Reports of ADR induced by antibacterials for intravenous drip submitted by our hospital to the National Adverse Drug Reaction Monitoring Center in 2016-2024 were collected and analyzed in terms of patients' gender and age, primary diseases, types of drugs involved in ADR, time of onset, systems and organs involved, clinical manifestations, outcomes and distribution of ADR. Results Among the 887 cases of ADR, 257 were new and mild ADR, 32 were new and severe ones, and 57 were severe ones. Among the patients involved in these ADR, 52.31% were male and 47.69% were female. The percentage of patients ages 60 and older was the highest (40.47%). Totally 40 types of antibiotics of 15 classes were involved, and the top three categories were cephalosporins (28.97%), quinolones (25.59%) and β-lactamase inhibitor combinations (20.52%) respectively. The top three drugs were ceftriaxone (17.59%), piperacillin-tazobactam (15.67%) and levofloxacin (14.54%). ADR mostly occurred within 30 minutes of administration (42.05%), and involved the skin and its accessories (62.31%), the nervous system (9.20%) and digestive system (9.02%). Most of these ADR were cured or improved after symptomatic treatment. Conclusion The clinical manifestations of adverse reactions caused by antibacterial drugs for intravenous drip are diverse, and what deserves more attention is severe ADR, including anaphylactic shock, allergy-like reactions, epileptic seizures, thrombocytopenia, coagulation disorders and abnormal liver function. New ADR are difficult to predict. Clinicians should devote more effort to monitoring of ADR, especially those among special populations and due to high-risk drugs so as to reduce the incidence of ADR and ensure safe medications. References | Related Articles | Metrics

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222 Adverse Reaction Reports of Factor Xa Inhibitors ZHENG Jinfeng, WU Jiani, LIN Jingyu, YANG Xueqing 2025, 22(9): 1024-1028.  DOI: 10.19803/j.1672-8629.20250163 Abstract ( 21 )   PDF (1340KB) ( 60 )   Objective To analyze the reports of adverse drug reactions (ADR) caused by factor Xa inhibitors in Beijing, find out about the characteristics of ADR associated with these drugs, and provide references for rational clinical use. Methods ADR reports of factor Xa inhibitors (rivaroxaban, edoxaban and apixaban) collected by Beijing Center for ADR Monitoring from January 2019 to June 2024 were retrieved. The gender and age of patients, organs and systems involved, clinical manifestations, management and outcomes of ADR, and severe cases of the ADR were statistically analyzed. Results A total of 199 ADR reports concerning rivaroxaban and 23 concerning edoxaban were collected, with no ADR reports related to apixaban. The male-to-female ratio was 1.05∶1 for rivaroxaban and 1∶1 for edoxaban based on these ADR. The age of these patients averaged over 70 years. The proportion of severe ADR was 6.14% for rivaroxaban, compared with 16.00% for edoxaban. The ADR of rivaroxaban involved blood vessels, bleeding and coagulation disorders, gastrointestinal disorders and urinary disorders, with bleeding-related adverse reactions accounting for 58.77% of the cases. The ADR of edoxaban included gastrointestinal disorders, blood vessel disorders, bleeding and coagulation disorders and respiratory system disorders, with bleeding-related adverse reactions making up 76.00% of the reported cases. Conclusion Bleeding is the most significant ADR caused by factor Xa inhibitors. Patients at high risk of bleeding should be closely monitored. Meanwhile, ADR not explicitly stated in drug inserts require more attention and research. References | Related Articles | Metrics

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211 Reports of Adverse Drug Reactions Induced by New Antineoplastic Drugs XIE Jiali, XUN Yan, TAO Yunsong, ZHANG Shengpeng 2025, 22(9): 1029-1033.  DOI: 10.19803/j.1672-8629.20241003 Abstract ( 29 )   PDF (1247KB) ( 51 )   Objective To analyze reports of adverse drug reactions (ADR) caused by new antineoplastic drugs in a hospital in order to provide a reference for safe clinical use of drugs. Methods ADR reports related to new antineoplastic drugs submitted by a hospital between January 1, 2022 and October 31, 2024 were retrieved. The demographic data of patients, categories of drugs, affected systems and organs, clinical manifestations and off-label drug use were analyzed. Results Among the patients involved in the 211 ADR reports, the male-to-female ratio was 1.03∶1, and those over 60 years old accounted for 70.62%. There were 106 reports of mild cases (50.24%) and 105 reports of severe ones (49.76%). The blood system and hematopoietic system were the most frequently involved, accounting for 61.14% (129 cases). There were 18 ADR reports related to off-label drug use, including 13 severe cases (72.22%). Conclusion The proportion of reports of severe cases among ADR reports caused by new antineoplastic drugs is relatively high, pointing to the need for early clinical identification and intervention. It is imperative for medical institutions to enhance the regulation of off-label drug use in order to ensure patients’ safety. References | Related Articles | Metrics

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Mining and Analysis of Adverse Drug Event Signals of Romosozumab Based on FAERS Database WANG Yi, REN Weilian, DU Haitao, WANG Ping 2025, 22(9): 1034-1039.  DOI: 10.19803/j.1672-8629.20240521 Abstract ( 15 )   PDF (1383KB) ( 40 )   Objective To investigate romosozumab-related adverse drug events (ADE) in the real world based on the FDA Adverse Event Reporting System (FAERS) in order to contribute to management of safety of clinical drugs. Methods The FAERS database was searched for romosozumab-related articles that were published between April 1, 2019 and January 31, 2024. Romosozumab-related ADE were identified and evaluated using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Results A total of 8 432 351 reports of ADE were retrieved, 7 477 of which identified romosozumab as the “primary suspect”. Romosozumab was associated with 195 ADE across 16 system organ classes (SOCs), involving injuries and poisoning, general disorders, musculoskeletal and connective tissue disorders, and cardiac disorders. Common ADE included fractures, abnormal bone density, injection site reactions, arthralgia, limb pain and cardiac events. Additionally, some ADE that were not mentioned in the instruction manual, such as vertebral compression fractures, radial fractures, elevated parathyroid hormone and renal dysfunction, showed significant signals. Serious events associated with Romosozumab included hospitalization and death. Conclusion This study has confirmed common ADE associated with romosozumab and identified potential safety risks in actual clinical practices. Physicians and pharmacists should be alert to ADE signals not mentioned in the instructions, such as new fractures or bone density abnormalities, and take precautions. References | Related Articles | Metrics

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An Automatic Generation Platform for Adverse Drug Reaction Reports from Literature Sources Based on the Generative Artificial Intelligence Large Language Model LIU Qin, ZHANG Jiayi, WU Xuan, SOANES Nigel 2025, 22(9): 1040-1044.  DOI: 10.19803/j.1672-8629.20250291 Abstract ( 118 )   PDF (1394KB) ( 73 )   Objective To leverage generative artificial intelligence to explore how to automate the generation of adverse drug reaction (ADR) reports from medical literature in order to enhance the efficiency and accuracy of the report processing workflow. Methods Based on the mature basic large language model in this industry, table parsing, OCR recognition and other advanced technologies, and using the annotated data training set (6 925 pieces) retrieved from about 700 published articles in Chinese downloaded from CNKI and WanFang Database, related training was carried out under an ADR report generation-specific scenario. A model was established that could understand academic publications and automatically generate individual case safety reports (ICSRs). This platform was optimized through multiple rounds of algorithmic iterations and assisted by manual review. The research results were evaluated by comparing the values of three AI algorithm performance indicators (recall rate, precision, F1 value) and the report processing time. Results After four rounds of algorithm iterations, the recall rate, precision and F1 value of this generative AI model for ADR reports reached 97.1%, 90.1% and 93.5% respectively, all meeting the project’s acceptance standards. The processing time for ICSRs was reduced from 80 minutes taken by conventional manual methods to 45 minutes, which was boosted by 77.8%. Conclusion Generative artificial intelligence offers new tools for the intelligent identification and efficient generation of ADR reports sourced from literature and plays a significant role in driving the automation and intelligent transformation of pharmacovigilance. However, this platform has such limitations as the complexity of formatting and abnormal data. Constant optimization of datasets and algorithms is required, along with strict adherence to ethical and regulatory requirements to ensure data compliance. References | Related Articles | Metrics

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Two Cases of Thrombosis Caused by Ethinylestradiol and Cyproterone Acetate Tablets during Thrombocytopenia in Patients with Acute Myeloid Leukemia LI Shuyue, QIU Huiying, WU Jiaqi, GAO Junwei 2025, 22(9): 1045-1048.  DOI: 10.19803/j.1672-8629.20240892 Abstract ( 14 )   PDF (1209KB) ( 56 )   Objective To explore the risk of thrombosis in female patients with acute myeloid leukemia (AML) who use combined oral contraceptives (COCs) during thrombocytopenia so as to provide a reference for safe use of COCs in such patients. Methods The clinical data of two AML patients who developed thrombosis after taking ethinylestradiol and cyproterone acetate tablets during thrombocytopenia was analyzed and the risk factors and monitoring measures for thrombosis in AML patients taking COCs were discussed. Results Thrombosis was correlated with COCs in both patients. After quick diagnosis and treatment, the prognosis was good. AML patients were often considered high-risk for bleeding due to low platelet counts, but they were also at high risk for thrombosis such as blood stasis and endothelial damage. When COCs were used, the risk of cerebral venous sinus thrombosis and deep vein thrombosis increased significantly. Conclusion Clinical pharmacists should be alert to the risk of thrombosis in AML patients using COCs. Coagulation indicators and symptoms of patients should be monitored to detect thrombosis early and reduce the risk. References | Related Articles | Metrics

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One Case of Rhabdomyolysis in Patients with Chronic Kidney Disease Caused by Benzafibrate Tablets LI Dan, YANG Xiongwen, CHEN Danjun, FU Chengxiao, YANG Bo 2025, 22(9): 1049-1050.  DOI: 10.19803/j.1672-8629.20240764 Abstract ( 18 )   PDF (1191KB) ( 45 )   Objective To analyze the risk of benzafibrate-associated rhabdomyolysis in patients with chronic kidney disease (CKD) so as to provide a reference for safe clinical use. Methods One case of CKD who developed rhabdomyolysis following bezafibrate administration was analyzed while related literature published over the past five years was reviewed to find out more about the clinical characteristics and outcomes in this population. Results Bezafibrate was possibly a risk factor for rhabdomyolysis in CKD patients, but the prognosis was good after symptomatic and supportive treatment. Conclusion Patients with end-stage renal disease are at higher risk of bdomyolysis caused by benzabate and the prognosis is undesirable. Serum drug concentrations have to be monitored and the dosage adjusted when needed. References | Related Articles | Metrics

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One Case of Severe Anaphylactic Shock Caused by Hemocoagulase Agkistrodon for Injection QIAN Fengdan, ZHANG Lichao, GONG Yifei 2025, 22(9): 1051-1053.  DOI: 10.19803/j.1672-8629.20240860 Abstract ( 16 )   PDF (1145KB) ( 45 )   Objective To investigate the characteristics of severe anaphylactic shock caused by hemocoagulase agkistrodon for injection in a patient with perioperative bleeding so as to provide a reference for safe clinical medication. Methods One case of severe anaphylactic shock that occurred after the use of hemocoagulase agkisttodon for injection for hemostasis in a breast cancer patient postoperatively was analyzed. Related literature was reviewed. Results The patient experienced severe anaphylactic shock immediately after using the hemocoagulase agkisttodon for injection. There was a significant temporal correlation. After quick symptomatic treatment, the patients recovered. Literature suggested that anaphylactic shock usually occurred within 30 minutes of using hemocoagulase agkistrodon. Patients with or without a history of allergies were at risk of anaphylactic shock. Conclusion The risk of anaphylactic shock caused by hemagglutinin is unpredictable, which deserves attention. Assessment of safety and precautions against adverse reactions should precede the use of this drug in high-risk populations. References | Related Articles | Metrics

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One Case of Severe Allergic Reactions Caused by Hydrotalcite Chewable Tablets SHAO Yifan, CHENG Qiucen, ZHAI Huiqi, WU Wei, CHU Qingmin 2025, 22(9): 1054-1056.  DOI: 10.19803/j.1672-8629.20240940 Abstract ( 28 )   PDF (1171KB) ( 51 )   Objective To explore serious allergic reactions caused by hydrotalcite chewable tablets so as to provide a reference for clinical practice. Methods One case was analyzed in which hydrotalcite chewable tablets were used after surgery to prevent severe allergic reactions caused by digestive tract injury. The mechanism of occurrence, clinical manifestations, and treatment of sub-adverse reactions were investigated based on literature. Results Correlation analysis found that there was a close relationship between the time this adverse reaction occurred and the time of medication. The adverse reaction was classified as a grade II severe allergic reaction. This patient’s symptoms improved after treatment with anti-allergy drugs, blood pressure elevation and rehydration. Conclusion Clinicians should be alert to severe allergic reactions caused by hydrotalcite chewable tablets. The related mechanism remains elusive and more studies are needed. References | Related Articles | Metrics

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One Case of Pustular Psoriasis Caused by Duvalumab Injection WEI Ying, LI Wenfeng, ZHANG Yufei, HOU Xin, YANG Yanwei, FAN Yongli 2025, 22(9): 1057-1060.  DOI: 10.19803/j.1672-8629.20241018 Abstract ( 17 )   PDF (1214KB) ( 47 )   Objective To analyze the clinical characteristics and mechanisms of pustular psoriasis caused by duvalumab injection so as to provide a reference for rational use of duvalumab injection. Methods One case of pustular psoriasis (PP) that was considered to have been caused by duvalumab was analyzed. Related literature was reviewed while the process of diagnosis and treatment, possible mechanisms, clinical manifestations and treatment regimens were summarized. Results Correlation analysis suggested that the immune-related adverse reactions of the skin in this patient were likely induced by durvalumab injection. After effective treatment with guselkumab and discontinuation of durvalumab injection, the patient’s symptoms of PP were relieved. Conclusion Durvalumab may induce PP via activation of the IL-36/IL-17 inflammatory axis. Clinicians should be alert to such immune-related adverse events (irAEs) to ensure early detection and quick interventions. References | Related Articles | Metrics

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Research Progress in Metabolomics of Depression and Regulatory Mechanisms of Traditional Chinese Medicine WANG Xuezhen, SUN Yang, SUN Qi, ZHAO Nan, WANG Lin, YUE Jiayin, MENG Fanhao 2025, 22(9): 1061-1067.  DOI: 10.19803/j.1672-8629.20250012 Abstract ( 17 )   PDF (1531KB) ( 36 )   Objective To summarize the research progress in the involvement of metabolites in the pathogenesis of depression and in treatments for depression with traditional Chinese medicine. Methods The way in which differential metabolites changed in patients with depression and the effects of traditional Chinese medicine on metabolites and pathways were explored. Results The differential metabolites in patients with depression were concentrated in such pathways as the metabolism of amino acids, energy, and lipids. Traditional Chinese medicine could combat depression by affecting metabolites and pathways. Conclusion In-depth study of the changes in metabolites and pathways in patients with depression can help explore the potential pathogenesis of depression. Traditional Chinese medicine can serve as antidepressants by bringing about changes in metabolites and pathways. References | Related Articles | Metrics

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Research Progress in Toxicological Effect and Attenuation Mechanisms of KANSUI RADIX GAI Xiaocan, JIN Xin, LIU Shumin 2025, 22(9): 1068-1072.  DOI: 10.19803/j.1672-8629.20240876 Abstract ( 18 )   PDF (1278KB) ( 34 )   Objective To summarize the toxicity, mechanisms for toxicity and detoxification and recent research advancements related to KANSUI RADIX so as to provide a reference for safe applications and development. Methods Based on literature review and data integration, the toxic components, toxicological mechanisms, and detoxification methods of KANSUI RADIX were analyzed. Results KANSUI RADIX was highly toxic to the kidney, liver, gastrointestinal tract, heart and reproductive system. The mechanism of action involved inflammatory response and mitochondrial dysfunction. In addition, the toxicity of KANSUI RADIX could be reduced via processing and compatibility so that its therapeutic effects might be enhanced. Conclusion Significant progress has been made in research on the toxicity of KANSUI RADIX, but more research is needed on the exact mechanisms of toxicity and approaches to detoxification. Future studies should integrate modern toxicological techniques to elucidate the toxicity network of KANSUI RADIX and develop safer and better strategies for detoxification in order to facilitate its safe and rational applications. References | Related Articles | Metrics

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Research Progress in Chemical Composition, Pharmacological Effect, Chinese Materia Medica Processing and Toxicological Properties of BUPLEURI RADIX NIU Yuanfei, LIU Meiting, SHI Yujing, RONG Wenshuang, MA Lina, ZHENG Changhui, FU Yao, WANG Lianmei, CAO Junling 2025, 22(9): 1073-1080.  DOI: 10.19803/j.1672-8629.20240996 Abstract ( 23 )   PDF (1356KB) ( 44 )   Objective To summarize the latest progress in research on the chemical composition, pharmacological effects, Chinese materia medica processing and toxicological properties of BUPLEURI RADIX so as to provide a reference for applications and development of this drug. Methods Based on literature review and data integration, the clinical applications, chemical composition, pharmacological effects, processing methods, and toxicological properties of BUPLEURI RADIX were analyzed. Results Different processing methods yielded varying forms, such as raw BUPLEURI RADIX, vinegar-processed BUPLEURI RADIX, wine-processed BUPLEURI RADIX, turtle blood-processed BUPLEURI RADIX and honey-fried BUPLEURI RADIX, each with distinct therapeutic properties. Raw and vinegar forms were predominantly used in clinical settings. Pharmacological studies demonstrated its antipyretic, analgesic, anti-inflammatory, immunoregulatory, antidepressant, hepatoprotective, and antitumor activities. Despite its clinical efficacy, improper use could lead to pulmonary and hepatic toxicity, necessitating careful dosage and duration management. Conclusion In the future, the changes in the chemical composition structure caused by the processing of BUPLEURI RADIX, a detailed comparison of the pharmacological effects and material basis of various processed decoction pieces, and the toxicological research on processed products of BUPLEURI RADIX will be good options for research. Further research can be conducted on the role of Bupleurum chinense in heart protection, kidney protection, relief of gastric ulcers, anti-allergy treatment, and alleviation of Alzheimer’s disease. References | Related Articles | Metrics