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15 July 2025, Volume 22 Issue 7 Previous Issue   

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Research Progress in Integration Sites for Cellular and Gene Therapy Products QI Yujie, WANG Xin, ZHANG Jiahui, MA Enlong, GENG Xingchao 2025, 22(7): 721-727.  DOI: 10.19803/j.1672-8629.20250151 Abstract ( 19 )   PDF (1294KB) ( 39 )   Objective To elaborate the insertional integration mechanisms of retroviral and recombinant adeno-associated viral (rAAV) vectors, and review assessment Methods of integrated toxicity and analytic approaches to integration sites in order to call attention to the safety of cellular and gene therapy (CGT) products. Methods CNKI, PubMed and other databases were searched for literature related to integration sites of different vector types in general and toxicity mechanisms and investigational Methods in particular. Results Retroviral vectors were characterized by high-frequency random integration. The integrated toxicity was assessed using in vitro immortalization assay (IVIM), modified IVIM, or the transcript detection method. rAAV vectors were capable of low-frequency targeted integration, and the integrated toxicity was assessed using a neonatal mouse model of methylmalonic acidemia, where circulating cell-free nucleic acid was a more suitable characterization specimen. Besides, advantages and limitations of analytic techniques for integration sites, including WGS, LM-PCR, LAM-PCR, nr LAM-PCR, MGS-PCR, ITR-seq and AAV-seq, were compared. Conclusion Viral vectors are the primary gene delivery tool for the making of CGT products. The analysis of integration sites of vectors is crucial for ensuring product safety and preventing adverse drug reactions. References | Related Articles | Metrics

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Quality Control and Test Methods of Human Induced Pluripotent Stem Cells YANG Yifan, YANG Yanwei, ZHANG Di, XIE Yin, ZHANG Yong, CHEN Xulin, GAO Sutao, GENG Xingchao, QU Zhe 2025, 22(7): 728-734.  DOI: 10.19803/j.1672-8629.20250265 Abstract ( 15 )   PDF (1227KB) ( 31 )   Objective To explore the challenges to clinical translation of human induced pluripotent stem cell (hiPSC) therapies and define the quality control requirements in order to provide references to regulation of related products. Methods Based on literature review, the current R&D of hiPSC therapies was outlined and technical hurdles in each stage of production were identified. Quality control standards were summarized out of recent guidelines. Results While hiPSC-based therapies promised wide applications, no clinical-grade product had been approved for marketing. The major obstacles arose from technical challenges encountered in the complicated process of production. Quality control and product characterization were critical to the development and commercialization of these products. Despite the lack of a uniform standard, there was consensus regarding critical quality attributes of hiPSC-derived cell therapies. Conclusion A uniform quality control standard is essential to overcome translational barriers. Keen insights into each element of quality control during the process of production will facilitate the assessment of safety/efficacy of hiPSC-derived products, thus accelerating clinical translation and regulatory approval. References | Related Articles | Metrics

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Research Advances in the Pathogenesis of Cytokine Release Syndrome Induced by CAR-T Cell Therapy REN Yuke, JIANG Hua, LI Lulu, LI Shuangxing, HUO Guitao, YANG Yanwei, ZHANG Di, HUANG Ying, GENG Xingchao, LIN Zhi, QU Zhe 2025, 22(7): 735-741.  DOI: 10.19803/j.1672-8629.20250258 Abstract ( 13 )   PDF (1222KB) ( 37 )   Objective To investigate the mechanisms, grading, and management strategies of cytokine release syndrome (CRS) in chimeric antigen receptor T-cell (CAR-T) therapy in order to enhance the safety and efficacy of CAR-T cell therapy. Methods By reviewing studies currently available, the pathogenesis of CRS was analyzed, involving the key cytokines and signaling pathways before the grading criteria for and clinical approaches to CRS were summarized. Results CRS, a common adverse reaction in CAR-T therapy, involved the activation of cytokines (e.g., IL-6, IL-1, IFN-γ) and signaling pathways (e.g., JAK-STAT, NF-κB). Grading systems that guided clinical interventions were available, but targeted therapies required more optimization. Conclusion A better understanding of CRS mechanisms will facilitate the development of novel targeted drugs while improving the safety/efficacy of CAR-T therapy. References | Related Articles | Metrics

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Pharmacodynamic Evaluation of CAR-T Cell Products Based on Deep Learning Convolutional Neural Network Recognition REN Yuke, QU Zhe, LAI Zixuan, ZHANG Di, ZHAO Yongtian, YANG Yanwei, LI Shuangxing, HUO Guitao, ZHOU Xiaobing, LIN Zhi, GENG Xingchao 2025, 22(7): 742-748.  DOI: 10.19803/j.1672-8629.20250257 Abstract ( 10 )   PDF (2157KB) ( 34 )   Objective To establish an auxiliary diagnostic model for mouse liver lymphoma using deep learning (DL) technology in order to improve the accuracy and consistency of pathological diagnosis and facilitate the research and development of cell therapy products. Methods A total of 102 hepatic lymphoma tissues and 41 normal liver tissues were collected from mice used in chimeric antigen receptor (CAR) T-cell therapeutic and toxicological studies. After the tissues were scanned into digital slides, semi-automated data annotation was performed. To enhance the accuracy of annotation, all data underwent preprocessing (tissue extraction and artifact removal) and was randomly divided into training, validation, and test sets at a ratio of 8∶1∶1. Five convolutional neural networks-FCN, LR-ASPP, DeepLabv3+, U-Net, and DenseNet-were applied to identify tumor and non-tumor regions. The tumor prediction images based on slice images were compared, and the performance of the constructed algorithm models was evaluated using precision, recall, and the F1-score. Results The precision, recall, and F1-score of the DenseNet, DeepLabv3+, and FCN algorithms were all close to or exceeded 95%. Among them, the DenseNet algorithm model performed best in the test set, with an overall precision of 0.989 4, a recall of 0.990 6, and an F1- score of 0.990 0. Conclusion The DenseNet algorithm model established in this study has a good prospect of application in auxiliary diagnosis of mouse liver lymphoma, which can effectively improve the accuracy and consistency of assessment of tumor occurrence in studies on the efficacy and toxicology of CAR-T cell therapy products. References | Related Articles | Metrics

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Related Substances in Efavirenz Tablets Based on HPLC-TRIPLE QUAD-MS/MS Technology LIU Yi, WU Jingfang, QIN Lin, CHEN Junmiao, ZHANG Juan, CHEN Hua, NING Xiao, CAO Jin 2025, 22(7): 749-754.  DOI: 10.19803/j.1672-8629.20250061 Abstract ( 13 )   PDF (1469KB) ( 42 )   Objective To establish an HPLC-TRIPLE QUAD-MS/MS method for determination of related substances in efavirenz tablets and to deduce their mass spectrometry fragmentation pathways. Methods The separation was carried out on a C18 column (4.6 mm×100 mm, 3 μm). The mobile phase was 0.1% formic acid (containing 2 mmol·L-1 ammonium formate)-methanol (gradient elution). An ion source ESI was used and quantification was in a positive ion mode in a multi-reaction monitoring mode (MRM). Results The mass spectra of efavirenz and four of its impurities were analyzed before the fragmentation pathways were deduced. The determination method was validified methodologically. Impurities A, B, and C had good linear relationships within the range of 1-500 ng·mL-1, while impurity D had a good linear relationship within the range of 5-500 ng·mL-1. The limits of quantification ranged from 1.0 to 5.0 ng·mL-1, while the average recovery ranged from 89.5% to 95.3%. Conclusion The established HPLC-TRIPLE QUAD-MS/MS method has a strong specificity, high sensitivity, and good accuracy. It is suitable for simultaneous quantitative determination of related substances in efavirenz tablets. References | Related Articles | Metrics

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Quantitative Characterization and Chemometric Discrimination of 24 Coumarin Constituents in Peucedanum Medicinal Materials LI Yaolei, JIN Hongyu, CHENG Xianlong, WEI Feng 2025, 22(7): 755-762.  DOI: 10.19803/j.1672-8629.20250213 Abstract ( 10 )   PDF (1261KB) ( 37 )   Objective To establish a multi-component simultaneous quantitative analytical method for 24 coumarin constituents in Peucedanum medicinal materials, elucidate the differences in chemical properties and species-specific markers between Peucedanum praeruptorum Dunn (Qianhu) and Peucedanum decursivum (Miq.) Maxim. (Zihua Qianhu) in order to provide a reference for varietal identification and for evaluation of geographical authenticity. Methods Using UPLC-MS/MS technology, a multi-component quantitative analytical method was established, which was validated in terms of linearity, sensitivity, precision, stability, matrix effects, and recovery rates. Chemometric techniques, including principal component analysis (PCA), partial least squares-discriminant analysis (PLS-DA), and hierarchical clustering analysis (HCA), were applied to profile the chemical patterns of multi-batch samples from Peucedanum praeruptorum Dunn and Peucedanum decursivum (Miq.) Maxim. Results The analytical method for 24 coumarins in the genus Peucedanum established based on the UPLC-MS/MS method passed the methodological validation, and all the investigated items met the analytical requirements. The analysis of contents of the components in Peucedanum praeruptorum Dunn and Peucedanum decursivum (Miq.) Maxim. showed that there were significant species-specific and chemical characteristic differences in the distribution of coumarin components between these two plants. The contents of such compounds as nodakenin (10-30 times) and 7-hydroxycoumarin (2-10 times) in Peucedanum praeruptorum Dunn were much lower than those of Peucedanum decursivum (Miq.) Maxim. PCA, PLS-DA, and HCA indicated that the 24 coumarin components were distinctly separated in the chemical space between Peucedanum praeruptorum Dunn and Peucedanum decursivum (Miq.) Maxim. The core markers of Peucedanum praeruptorum Dunn were praeruptorin A and praeruptorin B in linear furanocoumarins, while Peucedanum decursivum (Miq.) Maxim. was rich in isodecursinol and hydroxylated derivatives, such as 7-hydroxycoumarin, in angular pyranocoumarins. Conclusion The UPLC-MS/MS method devised in this study has proved to be highly efficient and precise. Along with chemometric models, this method can shed light on the species-specific distribution profiles of coumarins in Peucedanum medicinal materials. This approach offers a multi-index collaborative control strategy as well as data-driven means for the varietal authentication, quality standardization, and regulatory supervision of traditional Chinese medicines. References | Related Articles | Metrics

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Regulation of hERG Channels by Hypaconitine and Its Cardiotoxicity DENG Baoyi, LI Yanning, ZHOU Liu, ZHANG Guozhuang, CAO Chunyu, LI Chun, ZHAO Chunhui, YANG Yifei, LIU Ting, ZHANG Haijing 2025, 22(7): 763-770.  DOI: 10.19803/j.1672-8629.20250140 Abstract ( 18 )   PDF (3197KB) ( 33 )   Objective To investigate the effects of hypaconitine on cardiac conduction function and hERG channels, and to elucidate the potential mechanisms underlying cardiotoxicity. Methods Langendorff isolated heart perfusion combined with electrical mapping technology was used to assess changes in cardiac conduction function. Whole-cell patch-clamp techniques were employed to evaluate the effects of hypaconitine on hERG channel currents in hERG-HEK293 cells. Western blot analysis was performed to examine the expression levels of the proteins. Results Electrical mapping experiments revealed that hypaconitine exhibited significant dose-dependent cardiotoxicity. Concentrations above 25 nmol·L-1 disrupted cardiac conduction function, characterized by altered conduction direction, increased heart rate, prolonged conduction time, and reduced conduction velocity. At concentrations of 100 to 150 nmol·L-1,ventricular fibrillation could be induced. Moreover, a 15-min perfusion with 25 nmol·L-1 hypaconitine prolonged the QTc interval. Patch-clamp experiments showed that the half-maximal inhibitory concentration (IC50) of hypaconitine on hERG channels was 34.34 μmol·L-1. Western blot analysis demonstrated that 200 μmol·L-1 hypaconitine significantly decreased the expressions of mature hERG protein (relative molecular mass: 155 000) and inhibited the phosphorylation of PKA. Conclusion The effect of hypaconitine on hERG channels is not the leading contributor to cardiac conduction dysfunction in guinea pigs. References | Related Articles | Metrics

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Allergic Reactions and Treatment Involving Sodium Dimercaptopropane Sulfate Injection during Copper Chelation for Wilson’s Disease YU Yong, MA Shouliang, SHENG Yuqin 2025, 22(7): 771-775.  DOI: 10.19803/j.1672-8629.20240969 Abstract ( 8 )   PDF (1387KB) ( 56 )   Objective To explore the clinical characteristics and management Methods of allergic reactions that occur during copper chelation with sodium dimercaptopropane sulfonate (DMPS) in patients with Wilson’s disease (WD). Methods The clinical data of WD patients who received DMPS treatment at the Brain Disease Center of the First Affiliated Hospital of Anhui University of Chinese Medicine between January 1, 2023 and June 30, 2024 was retrospectively analyzed. Patients with allergic reactions were identified from electronic medical records. Information on demography, drug allergy history, types and clinical manifestations of allergic reactions, and management strategies were collected. Allergic reactions were graded according to the Immediate Drug Reaction Grading Scale of the United States Drug Allergy Registry (USDAR). Results A total of 1 810 patients were included. The incidence of allergic reactions was 24.09% (436 cases), among which grade 1 accounted for 46.56%, grade 2 52.29%, and grade 3 1.15%. The clinical manifestations were primarily rash, skin itching and fever. The allergic symptoms of most of the patients were relieved 2 to 4 days after anti-allergic treatment. Conclusion The incidence of allergic reactions is relatively high in patients during copper chelation with DMPS. To improve the safety and effectiveness of this treatment regimen, it is critical to monitor the occurrence of allergic reactions in clinical practice and manage them without delay. References | Related Articles | Metrics

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Considerations for Revision of Safety Information in the Post-Marketing Instructions of Chemical Drugs WANG Chunting, CHEN Yafei 2025, 22(7): 776-779.  DOI: 10.19803/j.1672-8629.20250211 Abstract ( 51 )   PDF (574KB) ( 83 )   Objective To lay out the considerations for post-marketing revision of safety information in the instructions of chemical drugs, and provide a reference for drug marketing authorization holders and regulatory agencies. Methods Based on experiences related to revision of safety information in package inserts for chemical drugs, the priorities for collecting and analyzing safety information in package inserts were described, and the key points for writing the revised information related to warnings, adverse reactions, contraindications and precautions were summarized. Results and Conclusion Safety information needs to be revised all the time to dynamically reflect the risk-benefit balance of chemical drugs. Regulatory agencies should specify the working procedures and key points of the post-marketing revision of package inserts for chemical drugs while marketing authorization holders should promptly and proactively fulfill their responsibility of revising the safety information in drug instructions after marketing to ensure the safety of drugs. References | Related Articles | Metrics

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Considerations for Establishing National Sentinel Hospitals for Medical Device Adverse Event Monitoring LI Dong, SONG Yana, WANG Ligang, BIAN Rongrong, ZHAO Yan 2025, 22(7): 780-785.  DOI: 10.19803/j.1672-8629.20250281 Abstract ( 18 )   PDF (1174KB) ( 35 )   Objective To explore the functions and ways of establishing sentinel hospitals for medical device adverse event surveillance, and to establish a scientific, efficient, and sustainable operational model for sentinel hospitals in order to provide data for enhancing China's surveillance system for medical devices. Methods By reviewing domestic and foreign literature, this article analyzed the status quo of spontaneous adverse event reporting in China and elucidated the role and value of sentinel hospitals by drawing on the experience of the FDA's MedSun program. Results and Conclusion National sentinel hospitals should be established to improve the quality of reporting, upgrade risk identification, and enhance active surveillance so as to provide data for medical device vigilance in China. References | Related Articles | Metrics

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Safety Risks of Human Rabies Immunoglobulin ZHU Huijuan, REN Jingtian 2025, 22(7): 786-789.  DOI: 10.19803/j.1672-8629.20250128 Abstract ( 12 )   PDF (1116KB) ( 29 )   Objective To analyze the safety risks of human rabies immunoglobulin so as to provide a reference for rational clinical use of drugs. Methods Data on adverse reactions caused by human rabies immunoglobulin was retrieved from China’s Adverse Drug Reaction Monitoring Database (collected from inception to February 13, 2023) and FAERS database (collected from inception to December 31, 2024). Domestic literature published from inception to December 31, 2024 and foreign literature published between 2019 and 2024 on cases of adverse drug reactions caused by human rabies immunoglobulin were also retrieved from related databases. Package inserts of the drug were also analyzed. Results Adverse drug reactions of human rabies immunoglobulin involved multiple systems or organs. The clinical manifestations included dizziness, pyrexia, nausea, chest discomfort, rash, hypodynamia, pruritus and anaphylactic shock. The package inserts of human rabies immunoglobulin were upgraded as required by the National Medical Products Administration (NMPA) on October 20, 2023. Conclusion Medical institutions should be alert to such serious risks as anaphylactic shock and thromboembolism associated with this drug. Close observation is essential during medication. In case of allergic reactions or other serious adverse reactions, the drug must be discontinued immediately and quick treatment should be provided. References | Related Articles | Metrics

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Mining of Real-World ADR Signals Related to Cefradine for Injection in 268 Cases LI Qiurong, FU Miaoqing, ZHOU Baishui, LI Cui, XIAO Xiaotong, YU Yuping, DENG Lu 2025, 22(7): 790-793.  DOI: 10.19803/j.1672-8629.20240887 Abstract ( 25 )   PDF (1192KB) ( 49 )   Objective To analyze the adverse drug reaction (ADR) signals of cefradine for injection so as to provide a clinical reference for safe medication. Methods The ROR and BCPNN Methods were employed to mine and analyze signals in cefradine-related ICSRs collected between 2017 and 2023 by safety databases based on real-world data from medical institutions. Results A total of 268 cases were included, and a total of 15 overlapping signals were detected by both ROR and BCPNN Methods. Among them, there were 7 safety signals identified as expected ADR that were specified in package inserts, namely haematuria, injection-site pain, hypersensitivity, vomiting, nausea, abdominal discomfort and abdominal pain. Meanwhile there were 8 unexpected safety signals identified, including temperature intolerance, tachypnoea, chills, pallor, hypoaesthesia, swelling, dizziness and flushing. Conclusion When cefradine for injection is clinically used, dosage regimens should be determined based on the patient’s conditions. Special care has to be given to those patients who are male, or under 18 or taking a combination of drugs. Changes in urinary routine indexes and renal function should be monitored to prevent such ADR as haematuria. In addition, clinicians should provide pharmaceutical care and remain alert to unexpected potential risks in order to ensure the safety of patients. References | Related Articles | Metrics

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48 Cases of Hematological Adverse Reactions Associated with Piperacillin Sodium and Tazobactam Sodium CHEN Yaozhe, ZHAN Yunli, SONG Xingdong, ZHU Manyu, OU Xuemei, LI Chuyun 2025, 22(7): 794-798.  DOI: 10.19803/j.1672-8629.20240988 Abstract ( 16 )   PDF (1179KB) ( 44 )   Objective To investigate the adverse drug reactions (ADR) of piperacillin sodium and tazobactam sodium in the hematological system in order to provide a reference for rational medications. Methods Reports about hematological ADR caused by piperacillin sodium and tazobactam sodium submitted by a hospital in 2019-2023 were analyzed. Results Forty-eight related reports were collected, involving 36 males and 12 females with a mean age of (59.67±18.74) years. The hematological ADR were primarily manifested as thrombocytopenia (22 cases) and leukopenia (17 cases). The mean platelet count was (43.05±18.57)×109·L-1 for thrombocytopenia while the mean count of white blood cells was (1.71±0.83)×109·L-1 for leukopenia. The time to onset of ADR was (5.59±3.74) days and (21.14±6.04) days, respectively, with statistically significant differences (P<0.001). The symptoms included simultaneous reductions in white blood cells and platelets or in white blood cells, platelets and hemoglobin, and leukocytosis, thrombocytosis, and decreased hemoglobin levels. Clinically, most of the patients were asymptomatic, but a few had a fever. Following symptomatic treatment, 46 cases improved while 2 cases died. These ADR were mostly classified as grade III (25 cases). Among the patients with leukopenia, five were reexposed to piperacillin sodium and tazobactam sodium, and leukopenia recurred in one case. Conclusion The primary manifestations of hematological ADR induced by piperacillin sodium and tazobactam sodium include leukopenia and thrombocytopenia, which are clinically often asymptomatic or may present only with fever. Prompt discontinuation of medication and symptomatic treatment can lead to a favorable prognosis. References | Related Articles | Metrics

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Mining of Risk Signals Adverse Events Related to Drug-Induced Salivary Gland Calculus Based on FAERS Database CAO Kai, QIAN Peipei, GAO Xin, YANG Futian, ZHAO Liang, XU Bingxin, ZHANG Xianjun 2025, 22(7): 799-804.  DOI: 10.19803/j.1672-8629.20240508 Abstract ( 24 )   PDF (1292KB) ( 44 )   Objective To conduct a disproportionality analysis of drug-induced salivary gland calculus by using the individual case safety reports in the FDA Adverse Event Reporting System (FAERS) in order to provide a reference for prevention of this disease. Methods Data on individual case safety reports collected between the fourth quarter of 2012 and the second quarter of 2023 in the FAERS was retrieved. The reporting odds ratio (ROR) method and Medicines and Healthcare Products Regulatory Agency (MHRA) method were used for detection of signals of adverse drug reactions related to salivary gland calculus. Results A total of 211 reports related to salivary gland calculus were retrieved, involving 135 primary suspected or secondary suspected drugs. Using the ROR method and MHRA method, signals of disproportionate reporting (SDR) were detected in 14 drugs, which were calcium, macitentan, metoprolol, levothyroxine, adalimumab, golimumab, tocilizumab, zoledronic acid, denosumab, topiramate, olanzapine, quetiapine, sodium oxybate and meclizine (sorted by the ATC code). Conclusion There are 14 types of drugs with SDR related to salivary gland calculus detected in this study. Clinicians should be aware of the potential risks of salivary gland calculus when prescribing drugs mentioned above. Active monitoring and appropriate precautions are required. References | Related Articles | Metrics

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Pharmaceutical Care to a Geriatric Syndrome Patient with Heart Failure Combined with Uremia LI Ying, HUANG Lishuang, ZHANG Jingjing, ZHU Yuanchao, SHEN Ji, YANG Jun 2025, 22(7): 805-808.  DOI: 10.19803/j.1672-8629.20240898 Abstract ( 30 )   PDF (1155KB) ( 37 )   Objective To explore the role of clinical pharmacists in the geriatric treatment team based on pharmaceutical services to a geriatric syndrome patient with heart failure combined with uremia. Methods A clinical pharmacist participated in the whole process of diagnosis and treatment of this patient. This pharmacist observed pharmacokinetic-pharmacodynamic changes in this patient, recommended an individualized medication plan according to the Results of comprehensive assessment, and improved pharmaceutical care. Results Adjustment of medication based on the patient’s condition reduced adverse reactions and optimized the treatment regimen for a patient with geriatric syndromes. Giving tips about medication improved the patient’s compliance. Conclusion Clinical pharmacists can give full play to their expertise by recommending individualized medications, detecting adverse reactions quickly, preventing drug interactions and analyzing the process of medication. They can play an important role in ensuring the safety of medication and improving the compliance of elderly patients. References | Related Articles | Metrics

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One Case of Delayed Hypersensitivity Reactions Caused by Cefotaxime Sodium and Sulbactam Sodium for Injection LIN Lu, ZHAO Anzhi, CHEN Jinhui, LI Zhongwen, HUANG Guohua, ZHONG Shilong 2025, 22(7): 809-811.  DOI: 10.19803/j.1672-8629.20240761 Abstract ( 14 )   PDF (1085KB) ( 37 )   Objective To analyze the clinical characteristics of delayed hypersensitivity reactions induced by cefotaxime sodium and sulbactam sodium and to devise diagnostic approaches and therapeutic strategies in order to provide evidence-based references for safe clinical medications. Methods One clinical case that presented with delayed hypersensitivity reactions following cefotaxime sodium and sulbactam sodium for injection administration was analyzed before management protocols were formulated based on literature and evidence. Results A patient with intermittent dry cough was diagnosed with a pulmonary space-occupying lesion comorbid with type 2 diabetes mellitus. After six days of combined therapy with cefotaxime sodium and sulbactam sodium, the patient developed pruritic erythematous rashes on bilateral lower extremities and across facial regions. The temporal correlation between drug administration and symptom onset, coupled with the characteristic manifestation pattern consistent with established adverse drug reaction profiles, strongly suggested delayed hypersensitivity reactions attributed to cefotaxime sodium and sulbactam sodium. Immediate discontinuation of the suspected agent combined with antihistamine therapy resulted in complete resolution of cutaneous manifestations and stabilization of vital signs. Conclusion Clinicians should remain vigilant against the risk of delayed hypersensitivity reactions associated with cefotaxime sodium and sulbactam sodium. These reactions exhibit distinct latency periods that may complicate causal attribution, potentially leading to misdiagnosis. Enhanced clinical monitoring, comprehensive causality assessment, prompt withdrawal of suspected agents and coupled with antihistamine therapy when necessary are crucial to optimizing patient outcomes. References | Related Articles | Metrics

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One Case of Oculomotor Paralysis Caused by Sugemalimab Injection TANG Jiong, ZENG Yuqi 2025, 22(7): 812-814.  DOI: 10.19803/j.1672-8629.20240900 Abstract ( 10 )   PDF (1079KB) ( 35 )   Objective To investigate one case of oculomotor paralysis caused by immune checkpoint inhibitor-sugemalimab injection-in order to provide a reference for clinical safety and monitoring of adverse drug reactions. Methods One case of oculomotor paralysis induced by sugemalimab in a female patient with non-small cell lung cancer was analyzed. The correlations between oculomotor paralysis and sugemalimab injection were studied based on a literature review in order to find potential causes. Results Twenty-nine days after the use of pemetrexed disodium and carboplatin combined with sugemalimab injection, the patient developed blurred vision, double vision and photopsia, manifesting as oculomotor paralysis with extraocular muscle paralysis. The sugemalimab injection was discontinued and replaced by methylprednisolone and B-vitamins. Two weeks after treatment, the patient’s symptoms of oculomotor paralysis were relieved. Conclusion Oculomotor paralysis associated with sugemalimab injection can affect the quality of life of patients, which deserves more attention in clinical use. References | Related Articles | Metrics

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One Case of Extremely Severe Thrombocytopenia Caused by Tirofiban Injection WANG Yuan, LI Ruoning, GUO Zhanli, ZHANG Lei, LI Jiayuan, DONG Ying, SUN Jianjun 2025, 22(7): 815-818.  DOI: 10.19803/j.1672-8629.20240793 Abstract ( 15 )   PDF (1118KB) ( 34 )   Objective To investigate the clinical characteristics, management strategies and outcomes of extremely severe thrombocytopenia induced by tirofiban. Methods One case of severe thrombocytopenia induced by tirofiban was analyzed, the correlation between thrombocytopenia and tirofiban was studied, and related literature was retrieved before the mechanisms underlying tirofiban-induced thrombocytopenia were investigated. Results Tirofiban was discontinued immediately after detection of the adverse reaction, followed by quick symptomatic treatment. Subsequent blood routine indices returned to normal, clinical parameters were stabilized, and the patient showed favorable recovery with a good prognosis. Conclusion Cases of extremely severe thrombocytopenia caused by tirofiban are relatively rare. Clinical pharmacists’ analysis of the treatment process can facilitate individualized medications in similar cases. It is recommended that clinicians monitor platelet counts while tirofiban is used and remain vigilant against adverse reactions. References | Related Articles | Metrics

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One Case of Phenytoin Intoxication Caused by Compound Phenytoin Sodium Ephedrine Hydrochloride and Theophylline Tablets LEI Jianlin, WANG Na, WANG Wenzheng, WANG Yan 2025, 22(7): 819-822.  DOI: 10.19803/j.1672-8629.20240626 Abstract ( 11 )   PDF (1081KB) ( 38 )   Objective To provide a reference for pharmacovigilance by analyzing the clinical characteristics and mechanisms of phenytoin sodium poisoning induced by compound phenytoin sodium, ephedrine hydrochloride and theophylline tablets (CPEHTTs) in an asthmatic patient. Methods One case of dizziness and ataxia induced by CPEHTTs in a patient with asthma was analyzed. Case reports of phenytoin sodium poisoning caused by CPEHTTs were retrieved from PubMed, Web of Science, Ovid and CNKI Full-text databases. The mechanism of adverse drug reactions (ADR) was explored. Results According to the correlation evaluation of ADR, the score of the Naranjo's scale and the Results of therapeutic drug monitoring, CPEHTTs were considered to have caused phenytoin sodium poisoning. After discontinuation of the drug and initiation of symptomatic treatment, the patient’s symptoms gradually subsided and recovered. Conclusion CPEHTT may carry the risk of phenytoin sodium poisoning, so they should be used with caution. References | Related Articles | Metrics

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One Case of Acute Generalized Exanthematous Pustulosis Caused by Abrocitinib Tablets LI Min, LI Chunlei, SUN Cuicui, YU Wenwen, SUN Qing, QI Yingmei, LIU Anchang 2025, 22(7): 823-825.  DOI: 10.19803/j.1672-8629.20240992 Abstract ( 12 )   PDF (1119KB) ( 43 )   Objective To analyze one case of acute generalized exanthematous pustulosis (AGEP) caused by abrocitinib tablets in order to provide a reference for rational clinical use and subsequent studies. Methods One rare case of AGEP in a patient with atopic dermatitis (AD) was reported after 3 days of medication with abrocitinib tablets 200 mg po qd, who had taken this drug for 15 days 100 mg qd. Related literature was reviewed. The causes and precautions were investigated. Results AGEP was possibly related to abrocitinib tablets, and such cases were very rare. The symptoms were relieved after effective treatment. Conclusion Clinicians need to be alert to AGEP caused by abrocitinib tablets. Quick detection and treatment are crucial. References | Related Articles | Metrics

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Research Progress in Biological Activity and Mechanisms of Pachymic Acid LIU Ming, ZHENG Li, ZHANG Weina, SUN Xuelin, TIAN Jinhui, ZHAO Yan 2025, 22(7): 826-830.  DOI: 10.19803/j.1672-8629.20240121 Abstract ( 12 )   PDF (1223KB) ( 29 )   Objective To advance the understanding of pachymic acid in order to explore its potentials and to promote its clinical applications. Methods A systematic literature review was conducted to retrieve studies on pachymic acid. The biological activities and mechanisms of action were summarized while future developments were predicted. Results Pachymic acid could be extracted from various natural sources and demonstrated potentials in the treatment of multiple diseases. It could possibly exert antitumor and anti-ischemic/reperfusion injury effects by modulating the cell cycle, apoptosis-related factors, and several signaling pathways, including NF-κB, Shh/Gli1 and JAK2/STAT3/SOCS3. In addition, pachymic acid garnered attention for its role in inflammation regulation and could potentially impact such conditions as pneumonia, asthma, radiation-induced lung injury, colitis, cystitis, and osteoarthritis. Conclusion Pachymic acid exhibits significant biological activity, revealing its potential applicability in the treatment of various diseases, including tumors, ischemic injury and inflammation. References | Related Articles | Metrics

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Research Progress in Adverse Reactions Caused by Obinutuzumab in the Treatment of Follicular Lymphoma ZHONG Xinru, YANG Deying, GUAN Tangming, CHEN Ju, JIANG Dongbo 2025, 22(7): 831-835.  DOI: 10.19803/j.1672-8629.20250146 Abstract ( 12 )   PDF (1172KB) ( 35 )   Objective To summarize the research progress in adverse reactions associated with obinutuzumab used to treat follicular lymphoma (FL), and provide data for optimizing therapeutic regimens and mitigating the risks of adverse reactions. Methods Based on literature analysis, the structure, properties, types of adverse reactions, real-world data, and mechanisms of obinutuzumab were analyzed. Results As a glycoengineered type II humanized anti-CD20 monoclonal antibody, obinutuzumab demonstrated good efficacy and antitumor activity in B-cell malignancies. However, its clinical use might be associated with such adverse reactions as infusion-related reactions (IRR), increased risk of infection, tumor lysis syndrome (TLS), myelosuppression, hepatitis B virus (HBV) reactivation, and progressive multifocal leukoencephalopathy (PML), involving such factors as activation of the immune system, cytokine release, B-cell depletion, and impaired immune surveillance. Conclusion Obinutuzumab has shown significant efficacy in the treatment of FL. However, its potential adverse reactions deserve attention. Subsequent studies need to find out more about the mechanisms behind these adverse reactions and develop effective prevention and management strategies to optimize treatment regimens and reduce the risk of adverse reactions. References | Related Articles | Metrics

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Research Progress in Correlations between SGLT2 Inhibitors and Malignant Tumors GAO Caiyun, WANG Boyuan, GAO Xiaojie 2025, 22(7): 836-840.  DOI: 10.19803/j.1672-8629.20250082 Abstract ( 12 )   PDF (1106KB) ( 33 )   Objective To explore the correlations between SGLT2i as a new anti-tumor drug for regulating glucose uptake and malignant tumors in order to provide data for tumor research. Methods The latest research findings on the mechanism of SGLT2i in lung cancer, breast cancer, thyroid cancer, colorectal cancer and liver cancer were reviewed. Results SGLT2i could significantly reduce the all-cause mortality of NSCLC patients, effectively inhibit the growth of MCF-7 cells of breast cancer, promote apoptosis of thyroid cancer and colorectal cancer cells, and drastically reduce the risk of non-alcoholic fatty liver disease and liver cancer. Conclusion The combination of SGLT2i as a potential anti-cancer therapy with current standard chemotherapy may offer a new line of thought for research. However, the expressions and specific mechanism of action of SGLT2i in different cancers, the activity of drugs of different subtypes and the efficacy and safety of the combination of drugs require more experimental evidence. References | Related Articles | Metrics