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Chinese Journal of Pharmacovigilance
15 February 2026, Volume 23 Issue 2

15 February 2026, Volume 23 Issue 2 Previous Issue   
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Methodological Validation of RQ-TRAP for Telomerase Activity Detection and Its Applications in Human Mesenchymal Stem Cells
ZHANG Zhen, YU Xie'an, XU Chunqi, CHEN Ning, QIN Meirong, WANG Ping
2026, 23(2): 121-126. 
DOI: 10.19803/j.1672-8629.20250916

Abstract ( 4 )   PDF (1403KB) ( 1 )  
Objective To validate the methodological performance of the real-time quantitative telomeric repeat amplification protocol (RQ-TRAP), including the specificity, accuracy, precision, linearity, amplification efficiency, and lower limit of quantification, and detect telomerase activity in human mesenchymal stem cells (hMSCs) using this method in order to assess the proliferative potential, senescence process, and potential tumorigenic risk of hMSCs. Methods Telomerase activity in hMSCs was detected using the RQ-TRAP method. hMSCs derived from human umbilical cords were cultured in MEM-α medium. Samples were prepared via cell lysis and extraction, and absolute quantification was performed on a real-time polymerase chain reaction system using TRAP reaction buffer. Methodological validation was conducted using TSR8 control templates to evaluate the specificity, accuracy (recovery rate), intermediate precision (RSD), linearity (R2 and amplification efficiency), and LLOQ (confidence interval of recovery). For hMSCs assessment, telomerase activity was calculated based on standard curve fitting and Ct values. Results Methodological validation results indicated a good specificity with no interference from heat-inactivated cell matrices. The 95% confidence interval (CI) for accuracy recovery ranged from 91.37% to 111.0% (meeting the standard of 75%-125%). The intermediate precision (RSD) was less than 25% for all samples. Linearity assessment showed an R2>0.99 with an amplification efficiency of 104.1% (within the 90%-110% range). The LLOQ was determined to be 0.2 TPG Units (recovery CI: 70%-130%). The telomerase activity in hMSCs was measured at 1.432 TPG per 10 000 cells and the amplification efficiency of the standard curve in this assay was 102.6%. Conclusion The RQ-TRAP method has proved to be reliable and sensitive, which can be used for quantitative detection of telomerase activity in hMSCs and for effective assessment of cell senescence and tumorigenic risks. This method fills the gap in standardized testing for hMSCs and supports safe applications of regenerative medicine.
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Study on the Effect of Ginseng Radix et Rhizoma Rubra and Polygonum Multiflorum Radix Preparata Medicinal Pair on Delaying the Aging Process and Related Pathological Changes in SAMP8 Mice
LIU Jingjing, XU Beilei, WANG Qi, LIU Jing
2026, 23(2): 127-133. 
DOI: 10.19803/j.1672-8629.20250554

Abstract ( 2 )   PDF (2413KB) ( 1 )  
Objective To investigate the effects of Ginseng Radix et Rhizoma Rubra and Polygonum Multiflorum Radix preparata medicinal pair (RSSW) formula on delaying aging and related pathological changes in senescence-accelerated prone 8 (SAMP8) mice. Methods Six-month-old SAMP8 mice and normal aging control mice (senescence accelerated mouse/resistant 1, SAMR1) were used. Mice were divided into five groups including the SAMR1 control group, the SAMP8 model group, the SAMP8 + RSSW low-dose group (117 mg·kg-1, L-Dose), the SAMP8+RSSW high-dose group (234 mg·kg-1, H-Dose), and the donepezil group (1.3 mg·kg-1). Each group consisted of 12 animals. RSSW was administered orally for 60 consecutive days. Aging scores were recorded while balance and motor abilities were evaluated using the novel object recognition and the rotarod tests. Hematoxylin and eosin (H&E) staining was performed to analyze the morphological changes in organ tissues. Enzyme-linked immunosorbent assay (ELISA) was used to measure Aβ deposition in the cerebrospinal fluid and hippocampus. RT-qPCR and Western blot analyses quantified p21, p53 mRNA and protein expressions in cortical tissues. Body weight and visceral parameters were recorded, including antioxidant capacity (superoxide dismutase [SOD] activity, glutathione [GSH], and malondialdehyde [MDA] contents) and anti-inflammatory markers (IL-1β, IL-6, and TNF-α levels) in the heart, liver, lung, and kidney of mice. Immune indexes were detected using flow cytometry. Results Compared with control mice, recognition indexes and motor ability were significantly reduced in SAMP8 mice but the administration of RSSW improved memory and motor performance. RSSW effectively reversed the damage to hippocampal tissues, reduced Aβ deposition in cerebrospinal fluid, decreased p21 and p53 mRNA and protein expressions, protected against organ damage, ameliorated atrophy of immune organs and brains, enhanced antioxidant and anti-inflammatory capacity in the heart, liver, lung and kidney, and lowered the CD4+/CD8+ ratio in the spleen, thereby improving immune function and delaying aging. Conclusion RSSW can improve cognitive impairment and delay pathological changes associated with aging.
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Similarity Evaluation of Critical Quality Attributes of Insulin Aspart Biosimilars
DING Xiaoli, SUN Yue, YAO Shangchen, LI Jing
2026, 23(2): 134-140. 
DOI: 10.19803/j.1672-8629.20250851

Abstract ( 2 )   PDF (1605KB) ( 1 )  
Objective To evaluate the similarity in critical quality attributes and stability profiles between the insulin aspart biosimilar candidate and the reference product in order to offer technical guidance for enterprises and provide data for review and approval by regulators. Methods Based on the risk classification principles for critical quality attributes, multidimensional analytical methods were applied to evaluate the candidate biosimilar and the reference product in terms of structural characterization, purity and impurities, biological activity and stability. Results The candidate biosimilar was highly similar to the reference product in critical quality attributes and stability profiles. Conclusion The study of quality similarities underlies the evaluation of overall similarities of biosimilars and the extrapolation of indications. Similarity evaluation can yield scientific evidence to support subsequent non-clinical and clinical studies and facilitate the development and approval of domestic biosimilars of the same variety.
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Effects of Tongxinshu Capsules on Inflammatory Microenvironments and Myocardial Cell Apoptosis in Hearts of Rats with Myocardial Infarction
LI Na, YAO Kuiwu
2026, 23(2): 141-146. 
DOI: 10.19803/j.1672-8629.20250535

Abstract ( 2 )   PDF (1900KB) ( 1 )  
Objective To explore the role of Tongxinshu capsules, a traditional Chinese patent medicine, in mitigating heart inflammation and apoptosis in rats with myocardial infarction. Methods A myocardial infarction model was established in rats with left anterior descending artery ligation. Fifty rats were divided into five groups: the normal group (Normal), sham operation group (Sham), model group (Model), Tongxinshu group (TXSC), and positive control Western medicine group (Positive), with 10 rats in each. The number of NLRP3 inflammasomes in the heart was measured by immunohistochemistry, and the levels of inflammatory factors in the serum were determined. The indicators of total bile acids in the serum and cardiac tissue of rats with myocardial infarction were observed. The degree of myocardial cell apoptosis was determined by TUNEL staining, and the levels of apoptosis related proteins, Bax, and Bcl-2 were detected by Western blot. Results Tongxinshu capsules could reduce NLRP3 in the heart tissue of myocardial infarction rats(P<0.01), decrease serum levels of IL-1β (P<0.01) and TNF-α (P<0.05), and increase the thymus body mass index (P<0.05). They could also significantly reduce levels of total bile acids in both serum and cardiac tissue (P<0.05). Conclusion Tongxinshu capsules can reduce inflammatory infiltration in the heart and serum, thereby improving the immune environment of the body after myocardial infarction. Reducing bile acids can help alleviate lipid toxicity and ameliorate inflammatory infiltration. This drug has a significant antiapoptotic effect on the myocardium after myocardial infarction by mitigating myocardial apoptosis and decreasing the ratio of Bax/Bcl-2 proteins.
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Toxicity of 90-Day Repeated Ingastric Administration of Cetilistat Impurity A in Rats
DU Jiancai, YAO Fangfang, LIU Ruoxun, ZHAO Yun, LI Guochao, QIU Deyang, LI Bin, YAO Jingchun
2026, 23(2): 147-154. 
DOI: 10.19803/j.1672-8629.20250632

Abstract ( 1 )   PDF (2027KB) ( 1 )  
Objective To assess the potential toxicity of 90-day consecutive ingastric administration of cetilistat impurity A in SD rats. Methods A total of 120 SPF-grade SD rats were randomly assigned to four groups: the low-dose, medium-dose, and high-dose(20.0, 80.0, and 320.0 mg·kg-1·d-1) treatment groups and a solvent control group that received 0.5% sodium carboxymethyl cellulose solution. There were 30 rats in each group (half male and half female). The volume of administration was 10 mL·kg-1·d-1, once daily and for 90 days, followed by a 28-day recovery period. During the study, health status of these rats was observed daily, food intake was measured weekly, and body weight was recorded twice. At the end of dosing and recovery periods, indexes related to ophthalmology, urine, hematology, coagulation, serum biochemistry, and electrolytes were detected, along with bone marrow smears and histopathological examination. Results No significant changes in health status, food intake, body weight, ophthalmology, urine, or coagulation parameters were observed in any of the dose groups (P>0.05). Minor changes were observed in neutrophil percentages (NEU%) of alanine aminotransferase, total bilirubin, total protein, and urea (P<0.05), but all the values remained within normal limits. Histopathological examination revealed mild pathological changes in such organs as the heart, kidney, liver, and prostate. However, the incidence and severity of these changes were similar across these groups (P>0.05), suggesting that these alterations were likely spontaneous. Conclusion No significant toxic effects are observed in SD rats administered with cetilistat impurity A ingastricly at doses of 20.0, 80.0, and 320.0 mg·kg-1·d-1 for 90 days.
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Pathogenesis in a Rat Model of Osteosarcopenia Based on Network Pharmacology and Experimental Validation
MA Ningning, ZHU Lin, XIAN Junying, FENG Xue, ZHANG Caijuan, WANG Dunfang, LIU Haifan, LIU Bin, LIU Jianyao, LI Yuehua, YANG Weipeng
2026, 23(2): 155-161. 
DOI: 10.19803/j.1672-8629.20250762

Abstract ( 2 )   PDF (2078KB) ( 1 )  
Objective To explore the molecular mechanisms of osteosarcopenia (OS) based on network pharmacology and animal experiments. Methods Common targets of sarcopenia and osteoporosis were identified from multiple databases. A protein-protein interaction network was constructed to screen for hub genes, followed by GO and KEGG enrichment analyses. An OS rat model was established using a combined approach and randomly divided into a sham operation (Sham) group and an ovariectomy plus dexamethasone (OVX+DXM) group. Rats in the OVX+DXM group received daily intraperitoneal injections of dexamethasone (1 mg·kg-1 for 2 weeks) while the Sham group was administered with an equal volume of normal saline. After model validation by HE staining, micro-CT, and ELISA, target protein expressions were determined by Western blot. Results The core hub genes in OS included INS, IL-6, and IL-1β. GO analysis suggested that OS was associated with such biological processes as muscle cell differentiation, inflammation, and apoptosis. KEGG analysis revealed the involvement of PI3K/AKT, NF-κB, and PPAR signaling pathways. Animal experiments showed that in the OVX+DXM group grip strength was significantly reduced (P<0.01), serum levels of irisin, calcium and alkaline phosphatase decreased (P<0.05), bone microstructure deteriorated on micro-CT, muscle fiber arrangement disorganized, and bone marrow cavities enlarged on HE staining. Western blot analysis demonstrated that the expressions of OPG, PGC-1α, Runx2, and PI3K were significantly downregulated while those of PPARγ, RANKL, and NF-κB were significantly upregulated in femoral tissue (P<0.05). Conclusion PI3K, NF-κB, and PPARγ can participate in the pathogenesis of OS, and the pathological process is likely associated with insufficient bone/muscle anabolism caused by reduced activity of the PI3K/AKT signal pathway, accelerated degradation of bone resorption/muscle proteins due to activation of the NF-κB signal pathway, and bone marrow/muscle adipogenesis induced by increased activation of the PPARγ signal pathway.
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Risk Factors for Liver Injury Induced by Anaplastic Lymphoma Kinase Inhibitors
DENG Qingqing, YAO Qingqing, HU Tao, YANG Jiale, BIAN Yicong, MIAO Liyan
2026, 23(2): 162-166. 
DOI: 10.19803/j.1672-8629.20250760

Abstract ( 3 )   PDF (1273KB) ( 1 )  
Objective To investigate the clinical characteristics of and risk factors for liver injury induced by anaplastic lymphoma kinase (ALK) inhibitors in patients with non-small cell lung cancer (NSCLC). Methods The clinical data of NSCLC patients treated with ALK inhibitors at the First Affiliated Hospital of Soochow University between January 2019 and July 2024 was collected. Patients were divided into a liver injury group and a non-liver injury group based on the occurrence of liver injury. Demographics, disease diagnosis, baseline biochemical indicators of livers, and other clinical data were compared between the two groups. Univariate and multivariate logistic regression analyses were used to identify risk factors for liver injury. Results A total of 75 NSCLC patients treated with ALK inhibitors were included in this study, with an overall incidence of liver injury of 42.7% (32/75). There were no significant differences in clinical characteristics such as demographic information, lung cancer stage, or baseline biochemical indicators of the liver between the two groups. Logistic regression analysis revealed that pre-existing diseases [P=0.047, hypertension P=0.006, 95%CI (1.691, 21.312)] and concomitant medications [P=0.008, concomitant use of proton pump inhibitors P=0.022, 95%CI (1.274, 23.761)] might be independent risk factors for ALK inhibitor-induced liver injury. Conclusion The results of this study suggest that the risk of liver injury in NSCLC patients receiving ALK inhibitor treatment is potentially associated with comorbid underlying diseases such as hypertension, or concurrent use of drugs like proton pump inhibitors during treatment. For such patients, close monitoring of liver function is essential in clinical practice to ensure the safe and rational use of ALK inhibitors.
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Usage and Safety of Traditional Chinese Medicine in Clinical Treatment of Lumbar Disc Herniation Complicated with Knee Osteoarthritis
GUO Xiaofei, FAN Weiming, KANG Jiaqi, BAI Jianqi, WANG Yiming, GUO Dongqi, ZHANG Ping, WANG Yuan, BAI Xuezhu
2026, 23(2): 167-173. 
DOI: 10.19803/j.1672-8629.20250950

Abstract ( 5 )   PDF (1809KB) ( 2 )  
Objective To explore the way traditional Chinese medicine (TCM) is used in the treatment of lumbar disc herniation (LDH) complicated with knee osteoarthritis (KOA). Methods Data on Chinese herbal medicine prescriptions and information about patients diagnosed concurrently with LDH and KOA between November 2023 and November 2025 were collected from the hospital information system database of Wangjing Hospital of China Academy of Chinese Medical Sciences and compiled into a unified Excel file. The safety of medications for these patients was assessed based on their medical records following drug administration and in conjunction with the Pharmacopoeia of the People’s Republic of China, drug package inserts and related literature. Results A total of 239 patients were included, with women ages 40 and older accounting for 68.20% of the cohort. Among the 193 TCM herbs, the most frequently used ones included Poria cocos(Schw.)Wolf (143 instances, 4.70%), and Glycyrrhiza uralensis Fisch. (121 instances, 3.98%). The properties of these herbs were predominantly warm (1 124 instances, 36.97%) and neutral (788 instances, 25.92%). In terms of flavor, sweet (1 638 instances, 53.88%) and bitter (1 260 instances, 41.45%) were dominating. The meridian tropisms involved the liver (1 666 instances, 54.80%) and spleen (1 207 instances, 39.70%). The efficacies included dispelling wind-dampness (296 instances, 9.74%) and tonifying the liver and kidney (275 times, 9.05%). Panax notoginseng(Burk.)F. H. Chen-Ligusticum chuanxiong Hort. (confidence 0.93, support 0.22) and Cornus officinalis Sieb. et Zucc.- Poria cocos(Schw.)Wolf (confidence 0.92, support 0.23) were identified as core drug pairs via association analysis. Cluster analysis revealed a total of five drug combinations. Safety evaluation indicated that the treatment of LDH combined with KOA with traditional Chinese medicine was safe. Conclusion The pathogenesis of patients with LDH combined with KOA is basically characterized by underlying deficiency and superficial excess. Clinical treatment is to focus on addressing the root cause by tonifying qi and nourishing blood to strengthen tendons and bones while treating the superficial manifestations by promoting blood circulation, unblocking meridians to relieve pain, dispelling wind, dispersing cold, and eliminating dampness.
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Key Technologies for Research on Speciation and Valence of Elements in Traditional Chinese Medicine
LI Yaolei, CHENG Xianlong, LIN Yongqiang, LIU Jing, WEI Feng
2026, 23(2): 174-180. 
DOI: 10.19803/j.1672-8629.20250907

Abstract ( 3 )   PDF (1301KB) ( 1 )  
Objective To explore the key technologies for speciation and valence analysis of elements in traditional Chinese medicine (TCM) in order to provide data for risk assessment and regulation of exogenous harmful substances in TCM. Methods Based on research by our group and related studies worldwide, this study focused on TCM varieties with high risks of pollution. Key technologies for such processes as extraction, separation, and detection related to the speciation and valence of such elements as arsenic, mercury, and selenium were summarized. Strategies for characterizing unknown binding forms and methodological challenges to this field were also discussed. Results Speciation and valence analysis was critical to accurate evaluation of the safety and biological effectiveness of elements in TCM. Studies on the exposure of element speciation and valence in high-risk TCM categories, such as minerals, plants, animals, and fungi, attracted much attention. There were various extraction methods available, including acid extraction, enzyme extraction, and solvent extraction, tailored to the matrix characteristics of arsenic, mercury, and selenium, which could effectively minimize species transformation. The combination of high-performance liquid chromatography/ion chromatography with inductively coupled plasma mass spectrometry enabled highly sensitive and simultaneous analysis of inorganic and organic forms of elements. For unknown binding forms, high-resolution mass spectrometry and other technologies could help identify the binding forms of elements with organic components in TCM. However, challenges persisted, including interference from complex matrices, weak correlations between in vitro and in vivo bioavailability, and insufficient standardization and practical applications. Conclusion The exploration and application of technologies for studying the speciation and valence of harmful elements in TCM can inspire new technologies, methods and tools for risk prevention and control, and for effective regulation of inorganic pollutants in TCM.
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Safety Risks of Ranitidine Hydrochloride Injection Preparations
WANG Chunting, ZHANG Ruifang, CHEN Yafei
2026, 23(2): 181-184. 
DOI: 10.19803/j.1672-8629.20250814

Abstract ( 4 )   PDF (1502KB) ( 2 )  
Objective To analyze the safety risks of ranitidine hydrochloride injection preparations and provide a reference for safe medication. Methods Related data from the National Adverse Drug Reaction Monitoring Database (collected in 2004-2023), foreign databases (collected from inception to October 2025), domestic and foreign literature (published from inception to October 2025), and from drug inserts was compared while precautions against risks taken by drug regulators were analyzed. Results The number of reports about adverse reactions related to ranitidine hydrochloride injection preparations had trended upward since 2021. Patients ages 45 to 64 were a high-risk group. The dosage had to be adjusted for patients with renal insufficiency and patients with liver dysfunction had to use it with caution. Reports of serious reactions accounted for 12.63% of the total, with systemic diseases and reactions at the site of administration dominating. Reports about anaphylactic shock accounted for 10.86% of the total of reports on serious reactions. Rapid administration could induce serious adverse reactions like arrhythmia. Meanwhile, there were differences in information about safety between domestic and foreign drug inserts. Conclusion Marketing authorization holders of drugs should devote more effort to the monitoring of adverse reactions of the drug while offering guidance. Clinicians ought to take into consideration the patient’s age and liver and kidney function when giving prescriptions. The concentration and speed of administration should be under rigorous control to prevent serious adverse reactions such as anaphylactic shock.
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Evolution and Living Heritage Transmission of Beijing-School Processing Techniques
GUO Yueshan, WEI Yalei, HE Ting, GU Yuanyuan, LIU Wenjing, ZHAO Wei, MA Lina, CAO Junling
2026, 23(2): 185-191. 
DOI: 10.19803/j.1672-8629.20250770

Abstract ( 2 )   PDF (1792KB) ( 1 )  
Objective To propose a systematic strategy to boost the living inheritance and modernization Beijing-School traditional processing methods (BTPM). Methods By means of literature review, analysis of evolution, and systematic induction, the origins, core tools (such as the Gao’an knife and the copper stewing pot), characteristic adjuvants (including licorice water and bile), and representative processed products (nine-processed Arisaema Cum and wine-stewed rhubarb) were summarized. Based on tiered planning and route design, a multi-stage and multi-dimensional inheritance system was constructed. Results A systematic and dynamic inheritance route involving short-term, medium-term, and long-term objectives was proposed. The short term (1-3 years) objective was to document the related techniques and literature as soon as possible and to establish a digital archive. The medium term (3-5 years) objective was to study the principles of processing, and establish a three-level standard system. As for the long term (more than 5 years), efforts should be devoted to promoting the collaborated inheritance by universities, enterprises and society and broaden the three leading applications of “characteristic decoction pieces-classic prescriptions-health products” so that an integrated inheritance ecosystem of “research-education-production-application” could be created. Conclusion The systematic inheritance scheme proposed in this article not only elucidates clear phases and feasible routes for the survival of BTPM, but also helps promote its sustainable transformation from an endangered heritage to an active resource in modern traditional Chinese medicine.
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Pyrexia Syndrome Caused by Dabrafenib Capsules Combined with Trametinib Tablets
TIAN Chunyu, XIA Yuchao, ZHANG Yanhua, YIN Yue
2026, 23(2): 192-196. 
DOI: 10.19803/j.1672-8629.20250603

Abstract ( 3 )   PDF (1283KB) ( 1 )  
Objective To analyze the patterns and characteristics of pyrexia syndrome induced by dabrafenib combined with trametinib in order to provide references for safe medication. Methods A total of 23 patients with BRAF V600-Mutant melanoma were collected, who had received dabrafenib plus trametinib, either as postoperative adjuvant therapy or for unresectable advanced diseases. Meanwhile, other case reports published between inception and June 30, 2024 were retrieved from CNKI, Wanfang, Web of Science, Elsevier and PubMed databases before being analyzed. Results A total of 33 patients were enrolled in our study, including 18 males and 15 females ages 35 to 77. The median duration of the first fever was 16.5(1-240) d. Three of the patients with fever improved without treatment while the rest were treated until fever was gone. Twenty of these patients resumed treatment with single-agent dabrafenib or dabrafenib combined with trametinib at the original dose or at a reduced dose, but fever recurred in 18 of them. Twenty of these patients experienced two or more febrile episodes and medication was permanently discontinued in three of them due to serious adverse drug reactions. Conclusion Dabrafenib combined with trametinib is likely to cause fever within 30 days of medication (69.69%), and 60.60% of patients experience two or more febrile episodes. Discontinuation of treatment, reduced drug dosage, and the use of non-steroidal anti-inflammatory drugs or steroids are key management strategies against pyrexia syndrome.
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One Case of Acute Liver Failure Caused by Amiodarone Injection
JIANG Wenhao, XU Hongbing, ZHANG Xiaogang, WU Jiangping
2026, 23(2): 197-199. 
DOI: 10.19803/j.1672-8629.20250359

Abstract ( 5 )   PDF (1208KB) ( 3 )  
Objective To investigate the causes and clinical characteristics of acute liver failure induced by amiodarone in order to provide a reference for safe clinical medications. Methods One case of acute liver failure following administration of amiodarone hydrochloride injection was analyzed while the association, causes, and clinical features regarding acute liver failure caused by this drug were explored based on related literature. Results Correlation analysis showed that acute liver failure was strongly associated with amiodarone in this patient. Liver enzyme levels improved after discontinuing the medication and initiating therapy, but treatment was ultimately discontinued due to worsening condition. Conclusion Despite the low incidence of acute liver failure induced by amiodarone, the consequent adverse reactions can be severe. Clinicians should be alert to adverse drug reactions, adhere to rational and standardized prescriptions, and ensure early identification and interventions to improve the prognosis of patients.
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One Case of Immune-Related Myocardial Injury Caused by Glofitamab Injection
YU Lingzi, HE Jiajie, PING Nana, ZHU Qian, ZHANG Xiao, LI Junhong, ZOU Rui, HE Siyun, XIA Fan, JIN Zhengming, QU Changju
2026, 23(2): 200-202. 
DOI: 10.19803/j.1672-8629.20250696

Abstract ( 1 )   PDF (1282KB) ( 1 )  
Objective To investigate immune-related myocardial injury induced by glofitamab in order to provide a reference for safe clinical use. Methods Immune-related myocardial injury induced by glofitamab in a patient with diffuse large B-cell lymphoma was analyzed while related literature was summarized. Results Based on the patient’s clinical manifestations, results of laboratory tests, and the temporal association with drug administration, the immune-related myocardial injury was considered to be strongly associated with glofitamab. After comprehensive management involving dexamethasone, tocilizumab, continuous renal replacement therapy, trimetazidine, rosuvastatin, and isosorbide mononitrate, the patient improved and was discharged. Conclusion Despite the seemingly low incidence of glofitamab-induced immune-related myocardial injury, the associated mortality can be exceedingly high. Prior to glofitamab therapy, potential risks should be assessed, and during treatment, patients should be closely monitored for the risk of immune-related myocardial injury.
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One Case of Severe Mental Disorders Caused by Injection of Meropenem and Voriconazole
LIU Tiantian, JIN Mengya, ZHAO Xue, GONG Ying, ZHANG Yanli, CAO Junling
2026, 23(2): 203-206. 
DOI: 10.19803/j.1672-8629.20250280

Abstract ( 8 )   PDF (1179KB) ( 4 )  
Objective To explore the risk factors, clinical characteristics, and treatment strategies related to severe psychiatric disorders induced by the combination of meropenem and voriconazole so as to provide a reference for safe medications. Methods One case of psychiatric abnormality after the combined use of meropenem and voriconazole was analyzed, and the possible mechanism and management strategies for the adverse reactions were explored with reference to literature. Results A patient with postoperative rectal cancer complicated by pulmonary infection, abdominal infection and bloodstream infection developed severe psychiatric disorders after the combined use of meropenem and voriconazole. These two drugs were considered to be the likely cause of the adverse reaction. After discontinuation of the drugs and symptomatic treatment with antipsychotic medications, the patient’s psychiatric symptoms disappeared. Conclusion Clinical use of meropenem and voriconazole demands attention to risk factors related to neurotoxicity. In case of adverse reactions involving the central nervous system, prompt drug discontinuation and symptomatic management are required.
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One Case of Severe Interstitial Lung Disease Caused by Tegafur Gimeracil Oteracil Potassium Capsules for the Treatment of Gastric Cancer
MENG Dehui, WANG Chao, LI Hua, DING Chunlei
2026, 23(2): 207-209. 
DOI: 10.19803/j.1672-8629.20250469

Abstract ( 1 )   PDF (1192KB) ( 1 )  
Objective To analyze such adverse reactions as severe interstitial lung disease (ILD) caused by S-1 (tegafur gimeracil oteracil potassium) capsules in a patient with gastric cancer, and to provide a reference for clinicians. Methods The clinical data of a patient who developed ILD during the treatment of her gastric cancer with oral S-1 was analyzed. The related literature was reviewed and summarized. Results The patient developed fever accompanied by nausea and vomiting three days into the re-treatment with S-1. Chest CT showed that ILD symptoms worsened compared with the previous week. After multidisciplinary consultation and correlation analysis, the patient was diagnosed with S-1-induced ILD. S-1 was discontinued before methylprednisolone and ventilator-assisted ventilation were used. The patient’s clinical symptoms and chest CT findings gradually improved. Conclusion Although S-1-induced ILD is rare, it may lead to severe respiratory failure and is even life-threatening. Clinicians should be alert to the risk of adverse drug reactions and conduct a safety assessment before prescribing S-1. Related examinations should be completed soon after patients develop such symptoms as fever or dyspnea. If S-1-induced ILD is considered likely, clinicians should adopt the right treatment regimen according to the ILD grade to improve the patient’s prognosis.
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One Case of Peripheral Neuropathy Caused by Combination of Moxifloxacin Hydrochloride Tablets and Voriconazole Tablets
WU Xiaoping, ZHANG Yongliang
2026, 23(2): 210-212. 
DOI: 10.19803/j.1672-8629.20250527

Abstract ( 5 )   PDF (1170KB) ( 4 )  
Objective To explore the adverse reaction-peripheral neuropathy-induced by the combination of moxifloxacin hydrochloride tablets and voriconazole tablets so as to provide a reference for rational clinical drug use. Methods The process of diagnosis and treatment, risk factors, possible mechanisms, and therapeutic strategies for peripheral neuropathy in an elderly patient following the combination of moxifloxacin and voriconazole were analyzed. Results Based on the correlation assessment, peripheral neuropathy was considered to have been caused by the combined use of moxifloxacin and voriconazole. After discontinuation of medication and symptomatic treatment, the patient's lower limb activity improved enough to enable him to walk on his own. Conclusion While moxifloxacin is commonly combined with voriconazole for pulmonary aspergillosis, the present case suggests that their concurrent use may induce peripheral neuropathy. It is recommended that this combination be avoided if possible. Prudence and pharmacovigilance are essential to safe medication.
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Research Progress in Applications of MAT
WU Hao, HE Qing, CAI Tong, PEI Yusheng, LIU Tao, WANG Dongmei
2026, 23(2): 213-218. 
DOI: 10.19803/j.1672-8629.20250672

Abstract ( 3 )   PDF (1296KB) ( 6 )  
Objective To develop a more sensitive, broad-spectrum, three-R (replacement, reduction and refinement) and non-animal in vitro platform in order to address ethical concerns, species-specific variations, and limited ranges of detection inherent in conventional methods for detection of pyrogens. Methods By reviewing the related literature, the characteristics, research progress and developments concerning the monocyte activation test (MAT) were summarized. Results The MAT technology proved capable of sensitive and broad-spectrum detection of endotoxins and non-endotoxin pyrogens (NEPs) In addition, this technology could be used entirely in vitro and without using any animal. Conclusion This study has validated the MAT as a robust and ethically-feasible technology for ensuring the safety and efficacy of drugs.
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Research Progress in the “6+1” Framework for Evaluation & Selection of Proprietary Chinese Medicines Based on Clinical Needs
LIU Wenjing, GU Yuanyuan, HE Ting, CAO Junling, ZHAO Wei, BA Na, YUE Xiaoni, WANG Jingli, CHEN Hongnan, MA Lina
2026, 23(2): 219-223. 
DOI: 10.19803/j.1672-8629.20250751

Abstract ( 3 )   PDF (1296KB) ( 2 )  
As a vital component of traditional Chinese medicine, proprietary Chinese medicines have to be properly selected to ensure rational clinical use. Based on the conventional evaluation of safety, effectiveness, economy, innovation, suitability, and accessibility, the incorporation of the “heritability” dimension, which shows the distinct features of traditional Chinese medicine, has resulted in a “6+1” selection framework that has become a widely-used approach to evaluating the clinical value of proprietary Chinese medicines. This paper is intended to interpret the core connotations of each dimension within the “6+1” selection framework, analyze the challenges to its practical applications, and recommend ways of implementation from a unique perspective. A dynamic weighting mechanism is proposed that can flexibly adjust weights based on such factors as disease profiles, stages of treatment, and health care policies so that a gateway to decision-making is grounded on real-world evidence and clinical needs, thereby improving the adaptability and applicability of the evaluation framework. This study is expected to offer a reference for optimizing drug directories in medical institutions, improving the quality of TCM services, and for formulating better guidelines.
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Research Advances in Antifungal Agents for Coccidioidomycosis
DING Shuwen, MA Ruize, CHEN Zhihai
2026, 23(2): 224-228. 
DOI: 10.19803/j.1672-8629.20250787

Abstract ( 1 )   PDF (1284KB) ( 1 )  
Objective To summarizes the current efficacy of and recent advances in antifungal agents for coccidioidomycosis so as to provide data for drug development and guidance for clinical practice. Methods Literature was retrieved from such databases as CNKI, Wanfang Data, PubMed, and Elsevier. The pharmacological profiles, clinical efficacy, and adverse reaction spectra of commonly used antifungal drugs were summarized. Additionally, the mechanisms of action and clinical trial data of novel antifungal agents were outlined. Results Fluconazole and itraconazole were currently first-line clinical treatments. However, both required prolonged administration, hence a need for vigilance on potential neurological, gastrointestinal, hepatic, and renal toxicities. Amphotericin B had potent antifungal activity but significant nephrotoxicity, limiting its use to critically ill patients or salvage treatment. Novel antifungal agents, such as olorofim, were still undergoing clinical validation. While their adverse effects involved multiple organ systems, the overall incidence was relatively low and symptoms were not severe. Conclusion No specific antifungal agent targeting Coccidioides infection is currently available. Future research should prioritize the development of new antifungal agents with lower toxicity and greater target specificity to provide safer and more effective therapeutic options.
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Advances in Medications for Breast Cancer Leptomeningeal Metastases
YE Ling, XU Rui, RUAN Cong, QIAN Jiajia, HU Weiqiong, WANG Qiru, LIU Jiyong, LI Gang
2026, 23(2): 229-234. 
DOI: 10.19803/j.1672-8629.20250786

Abstract ( 3 )   PDF (1279KB) ( 2 )  
Objective To summarize the latest research advances in precision detection, biomarkers, and treatment strategies for breast cancer leptomeningeal metastasis (BCLM) in order to provide references for improving the clinical efficacy and prognosis of patients. Methods An in-depth analysis of the mechanisms underlying BCLM was conducted based on the molecular diagnostic techniques, prognostic biomarkers, as well as therapeutic strategies. Current challenges to diagnostic approaches and treatment strategies were also studied. Results Based on advancements in novel detection technologies, individualized treatment strategies guided by biomarkers promised wide applications. Furthermore, new targeted drugs and delivery technologies offered more opportunities to improve patients’ prognosis. Conclusion The clinical management of BCLM should integrate precision testing, biomarker-guided approaches, and multimodal treatment strategies. High-quality clinical studies are essential to optimizing therapeutic frameworks and prolonging patients’ survival.
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Research Progress in Lipid-Lowering Drugs
WANG Li, WU Jing, LI Min, YUAN Jiaxin, YU Wenwen, QI Yingmei
2026, 23(2): 235-240. 
DOI: 10.19803/j.1672-8629.20250788

Abstract ( 1 )   PDF (1267KB) ( 3 )  
Objective To investigate the research progress in lipid-lowering drugs so as to provide new insights for developing clinical lipid management strategies and promoting rational drug use. Methods Such databases as CNKI, PubMed, and Web of Science were searched for literature published between the inception of each database and December 31, 2025. Based on their mechanisms of action, lipid-lowering drugs were categorized into classic agents (statins, cholesterol absorption inhibitors, fibrates, niacin, bile acid sequestrants, and polyunsaturated fatty acids) and novel agents (proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors, angiopoietin like protein 3 (ANGPTL3) inhibitors, apolipoprotein C3 (ApoC3) inhibitors, apolipoprotein B (ApoB) synthesis inhibitors, microsomal triglyceride transfer protein (MTP) inhibitors, and ATP citrate lyase (ACLY) inhibitors. Their mechanisms of action, indications, adverse drug reactions (ADR), and information on medication monitoring were summarized. Results Classic lipid-lowering drugs, primarily working by inhibiting cholesterol synthesis or absorption, underlay lipid management. However, their risks, such as myotoxicity and hepatotoxicity, required rigorous monitoring. Novel lipid-lowering drugs mostly targeted specific pathways and characterized by potent efficacy and easy administration. Their safety profiles were generally favorable, with such common ADR as injection site reactions. Conclusion Lipid-lowering drugs have evolved from broad-spectrum regulation to precise targeting. Drug selection in clinical practice should be individualized, with emphasis on monitoring and preventing typical ADR associated with different drug classes in order to ensure precise and safe medication.
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