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15 May 2026, Volume 23 Issue 5 Previous Issue   

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Applications of Artificial Intelligence in Research on Traditional Chinese Medicine Metabolomics LI Yaolei, CHENG Xianlong, LIN Yongqiang, LIU Jing, WEI Feng 2026, 23(5): 481-486.  DOI: 10.19803/j.1672-8629.20250880 Abstract ( 38 )   PDF (1222KB) ( 34 )   Objective To explore the applications of artificial intelligence (AI) in research on traditional Chinese medicine (TCM) metabolomics in order to upgrade the intelligent analysis of complex systems of TCM. Methods Following the metabolomics research workflow, this review outlined AI applications in such spheres as data processing, metabolite identification, interpretation of mechanisms, and quality control of TCM. Specific examples were cited to demonstrate the strengths and weaknesses of AI. Results AI enables high-throughput, automated preprocessing of metabolomic data so that quality control and feature screening are improved. Integrated with databases and molecular networking, AI can shed light on mapping relationships from vast data on mass spectrometry for intelligent metabolite predictions. By automatically identifying complex patterns in high-dimensional data and assessing feature contributions, AI facilitates differential metabolite selection via feature selection, deep relationship mining, and interpretability analysis. Network analysis, machine learning, and knowledge graphs can combine to offer insights into the mechanisms of TCM. Furthermore, AI can assist in identification of geographical origins and quality control by analyzing secondary metabolites. While AI enhances data processing efficiency, accuracy of predictions, and multi-dimensional integration, such challenges persist as the lack of data standardization, limited model interpretability, and insufficient domain-specific adaptation. Conclusion AI can empower TCM metabolomics research and contribute to the informatization and intellectualization of the analysis of complex mechanisms of TCM. References | Related Articles | Metrics

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Mutagenic Risk Prediction and Experimental Validation of Heterocyclic Nitroso Impurities WEN Hairuo, JIN Longlong, KOU Xiaoxuan, JIANG Chenchen, YE Xiao, ZHANG Ruiqiu, TIAN Ye, WU Xianfu 2026, 23(5): 487-493.  DOI: 10.19803/j.1672-8629.20260219 Abstract ( 28 )   PDF (1329KB) ( 38 )   Objective To evaluate the mutagenic risk of three drug-related heterocyclic nitroso impurities, and to provide data for setting regulatory limits. Methods Three (quantitative) structure-activity relationship [(Q)SAR] prediction software packages, namely Lhasa, Leadscope, and CASE Ultra, were used to predict the mutagenic risk of N-nitroso-paroxetine, N-nitroso-reboxetine, and N-nitroso-vortioxetine hydrobromide. Enhanced bacterial reverse mutation tests were conducted, involving Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and Escherichia coli strain WP2 uvrA (pKM101), both in the absence and presence of a 30% hamster S9 metabolic activation kit to evaluate their mutagenic potential. The benchmark dose (BMD) levels of these heterocyclic nitroso impurities were compared using the PROAST software (an R-based package) to study the correlations between the strength of mutagenic risk and structural modifications. Results As was predicted by (Q)SAR, Lhasa and Leadscope, based on structural characteristics, suggested a mutagenic risk for all the three heterocyclic nitroso impurities. In contrast, CASE Ultra, which relied on internal research data alone, predicted that N-nitroso-paroxetine posed no risk of bacterial reverse mutation. In the enhanced bacterial reverse mutation tests, all the test substances yielded negative results under non-metabolic activation. However, under metabolic activation with hamster S9, all the heterocyclic N-nitroso impurities, except N-nitroso-paroxetine, induced an increase in the number of revertant colonies, indicating a mutagenic risk. Based on BMDL values, N-nitroso-reboxetine was believed to be the most mutagenically potent for strain TA98, and N-nitroso-vortioxetine hydrobromide for strain TA100. Conclusion The three common heterocyclic nitroso impurities, except N-nitroso-paroxetine, demonstrate bacterial mutagenicity. Nitrosamine impurities containing a nitroso group within a six-membered ring are likely to induce frameshift mutations. These findings are expected to provide data for regulatory control of impurities in heterocyclic drugs and for risk prediction of nitrosamine impurities based on chemical structure-activity relationships. References | Related Articles | Metrics

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In vitro PIG-A Gene Mutation Assay for Evaluation of N-nitrosamine Impurities KOU Xiaoxuan, TIAN Ye, SHAO Zixuan, NIU Qianyi, JIANG Hua, WEN Hairuo 2026, 23(5): 494-499.  DOI: 10.19803/j.1672-8629.20260220 Abstract ( 23 )   PDF (1914KB) ( 26 )   Objective To explore the reliability and sensitivity of an in vitro PIG-A gene mutation assay based on TK6 cells, and establish an experimental system for evaluating N-nitrosamine impurities. Methods Immunomagnetic bead separation was used to eliminate the spontaneous mutation rate of the PIG-A gene in TK6 cells. As required by the in vitro metabolic activation for mutagenicity assessment of nitrosamine impurities, the assay was performed with hamster liver S9 metabolic activation. DMSO served as the negative control, and NDEA (31.25-2 000 μg·mL-1) as the positive control. High-throughput flow cytometry was used to detect changes in the CD55 and CD59 phenotypes of TK6 cells. Under the established conditions, two nitrosamine impurities related to pharmaceutical structures were tested: 1-cyclopentyl-4-nitrosopiperazine (CPNP, 50-300 μg·mL-1) and N-nitrosobumetanide (250-2 000 μg·mL-1). Results The spontaneous mutation frequency decreased to 0.007 2% after the final elimination. In the absence of metabolic activation, no significant differences were observed in any of the NDEA groups compared with the negative control. In the presence of hamster S9, the PIG-A gene mutation frequency was significantly increased at NDEA concentrations of 500 μg·mL-1 and above. Under S9 activation, the mutation frequency was significantly elevated in the 150 and 300 μg·mL-1 CPNP groups, but no significant differences were found in any of the N-nitrosobumetanide groups. Without metabolic activation, neither CPNP nor N-nitrosobumetanide showed significant differences at any dose compared with the negative control. Conclusion The in vitro PIG-A gene mutation assay based on TK6 cells can effectively detect the mutagenic risk of N-nitrosamine impurities. In the future, it can be combined with next-generation sequencing technology to conduct genotoxicity evaluation of nitrosamine compounds. References | Related Articles | Metrics

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Research Progress in Nitrosamine Drug Substance-Related Impurity Synthesis JIN Longlong, WEN Hairuo, YANG Huiying, WANG Qing, SHAO Changjun, WU Xianfu 2026, 23(5): 500-505.  DOI: 10.19803/j.1672-8629.20260290 Abstract ( 27 )   PDF (3090KB) ( 29 )   Objective To introduce the synthetic methods of various nitrosamine drug substance-related impurities (NDSRIs) in order to provide a reference for the preparation of their reference standards for the development of analytical methods, evaluation of genetic toxicity, and for setting better limits. Methods The synthetic methods of and research progress in NDSRIs were outlined based on related literature and synthetic experiments. Results There were relatively few literature reports on the synthetic methods of NDSRIs, and many technological difficulties and challenges persisted. In this article, direct and indirect synthetic methods as well as multiple synthetic strategies were classified and summarized while solutions to the synthesis of some of the difficult-to-synthesize NDSRIs were recommended. Conclusion The technical challenges facing the synthesis of some NDSRIs require the availability of reference standards needed for the inspection and testing of the corresponding APIs and their preparations so as to facilitate the regulation of drugs. References | Related Articles | Metrics

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Research Progress in Detection Methods of Nitrosamine Drug Substance-Related Impurities JIN Longlong, WEN Hairuo, CHEN Zhonglan, YANG Huiying, WANG Qing, SHAO Changjun, WU Xianfu 2026, 23(5): 506-512.  DOI: 10.19803/j.1672-8629.20260288 Abstract ( 23 )   PDF (1241KB) ( 31 )   Objective To summarize the recent advancements in methods used to detect the nitrosamine drug substance-related impurities (NDSRIs) in order to provide a reference for quality control of drug products potentially containing NDSRIs. Methods By reviewing the recommendations issued by international drug regulatory authorities and the analytical methods for NDSRIs reported in the literature over the past five years, the related detection approaches and their applications were summarized. Results Due to the unique structure of NDSRIs and the stringent AI limit requirements set by regulatory agencies, there are relatively few literature reports on the detection methods of NDSRIs. The existing detection methods mainly rely on (U)HPLC-MS/MS, which has been widely applied in the detection of NDSRIs due to its high sensitivity, specificity and accuracy. Conclusion The detection of some NDSRIs still facing many technical challenges, more analytical methods for such impurities remains urgently developing. References | Related Articles | Metrics

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Evaluation of Anaphylactoid Reactions Induced by Traditional Chinese Medicine Injections Based on in vitro and in vivo Models YAO Ziying, SHEN Mengting, MA Congyu, HU Zhaoliang, ZHAO Yi, MENG Changhong, KANG An, WANG Yuxin 2026, 23(5): 513-518.  DOI: 10.19803/j.1672-8629.20250873 Abstract ( 22 )   PDF (1508KB) ( 20 )   Objective To establish in vivo and in vitro screening models for anaphylactoid reactions to evaluate the potential risk of anaphylactoid reactions to commonly used traditional Chinese medicine injections. Methods Based on the RBL-2H3 cell degranulation model and using the β-hexosaminidase (β-Hex) release rate as the index for evaluation, two dose groups (0.05 and 0.01 mL·mL-1) were established to screen for the in vitro anaphylactoid reaction risk of five traditional Chinese medicine injections, including Bozhi glycopeptide, Toad venom, Danshen, Shengmai and Xingnaojing. An experimental model of ear blue staining in mice was also established, where the rate of blue staining and that of increase of Evans Blue (EB) were used as indicators. Bozhi glycopeptide (3.2 mL·kg-1), Toad venom (16 mL·kg-1), Danshen (16 mL·kg-1), Shengmai (25 mL·kg-1) and Xingnaojing (16 mL·kg-1) were given at the maximum clinical dose before the possibility that the above injections could induce anaphylactoid reactions in vivo was evaluated. Results In vitro experiments showed that Danshen injection and Shengmai injection could induce the release of β-Hex at doses of 0.05 and 0.01 mL·mL-1, so the difference was statistically significant compared with the negative control group (P<0.01). The results of in vivo mouse ear blue staining tests suggested that EB increased more significantly at the dose of 25 mL·kg-1 in the Shengmai injection group than in the negative control group. Conclusion The RBL-2H3 cell model and the mouse ear blue staining model have proved to be well correlated and complementarity in the risk screening of anaphylactoid reactions to traditional Chinese medicine injections. The combination of the two models can provide a reference for research on post-marketing safety and for rational use of traditional Chinese medicine injections. References | Related Articles | Metrics

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Intestinal Inflammation Induced by Kai-Xin-San through NF-κB-IL-6 Pathway LIU Siyu, YANG Yifei, ZHANG Haijing, ZHANG Guozhuang, GONG Ping, YANG Yun, LIU Ting, XIA Bing 2026, 23(5): 519-526.  DOI: 10.19803/j.1672-8629.20260134 Abstract ( 14 )   PDF (2399KB) ( 21 )   Objective To investigate the molecular mechanism through which Kai-Xin-San induces intestinal inflammation in mice in order to ensure its long-term clinical safety. Methods C57BL/6J mice were randomly assigned to the control group and the groups treated with doses of 0.5, 1.0, 2.0 and 4.0 g·kg-1 before the small intestinal transit rate was determined via an intestinal propulsion test. After 3 or 8 days of administration (The control group and the groups treated with doses of 0.5, 1.0, and 1.5 g·kg-1), hematological parameters were measured using an automated hematology analyzer. Histopathological injury was examined by hematoxylin and eosin (HE) staining. The expression and distribution of MUC2 were evaluated by immunofluorescence staining. Protein expression levels of NF-κB p65, p-IκB, NLRP3, NLRC4, ASC, and pro-Caspase-1 in intestinal tissues were analyzed by Western blotting. Cytokine levels of IL-1β, TNF-α, IL-6, and IL-22 in the small intestine after 8 days of administration were determined by Luminex multiplex assay while IL-6 levels were measured by ELISA. Results After 3 days of oral Kai-Xin-San administration, the small intestinal transit rate was significantly reduced in a dose-dependent manner. After 8 days of administration, pathological injuries were observed in the jejunum and ileum, including villus atrophy, mucosal architectural disruption, and luminal dilatation. MUC2 fluorescence kept decreasing with the increase in Kai-Xin-San doses. At 1.5 g·kg-1, Kai-Xin-San markedly upregulated protein expressions of pro-Caspase-1, NF-κB p65, and p-IκB in the small intestine, but no obvious changes were detected in the colon. After 3 days of treatment, these markers did not change significantly in either the small intestine or colon. Luminex and ELISA results both showed a significant increase in IL-6 levels in the 1.5 g·kg-1 dose group. Conclusion Three-day intragastric administration of Kai-Xin-San at 0.5 g·kg-1 can induce bloating and intestinal dysmotility in mice. Kai-Xin-San may activate the NF-κB pathway, promote IL-6 transcription, and trigger downstream inflammatory responses. The small intestine, particularly the jejunum and ileum, is the principal target organ, suggesting site-specific intestinal toxicity. References | Related Articles | Metrics

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Therapeutic Effects of Camellia petelotii (Merrill) Sealy against Ulcerative Colitis: a Study Based on Network Pharmacology, Molecular Docking, and Animal Experiments MO Yuhuan, PEI Yusheng, ZHANG Zan, LI Keyu, XIE Peng, ZHAO Yue, NING Ling 2026, 23(5): 527-532.  DOI: 10.19803/j.1672-8629.20250874 Abstract ( 19 )   PDF (1671KB) ( 22 )   Objective To explore the effect of the extract of [Camellia petelotii (Merrill) Sealy, CPS] on ulcerative colitis (UC) by combining network pharmacology, molecular docking technology and animal experiments. Methods The active components and targets of CPS were screened using the network pharmacology method before the “component-target-disease” network and protein interaction network were constructed. Gene Ontology (GO) function and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis were conducted. Molecular docking technology was adopted to test the binding ability of core components to core targets. A UC mouse model was induced by 2% dextran sodium sulfate. A normal control group, model group, CPS low-and high-dose groups (2.5, 5 g·kg-1) and sulfasalazine positive normal control group (500 mg·kg-1) were set up to evaluate the disease activity index (DAI) and pathological changes of colon tissues. The levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and matrix metalloproteinase-2 (MMP-2) in colon tissues were detected via enzyme-linked immunosorbent assay (ELISA).The expressions of IL-6 and Messenger RNA (mRNA) of B-cell lymphoma-2 (BCL-2) were detected via polymerase chain reaction (PCR). Results Using network pharmacology, such components as kaempferol and quercetin were screened as the core components of CPS in the treatment of UC while IL-6 and v-akt murine thymoma viral oncogene homolog 1 (AKT1) were the key targets, which were significantly enriched in biological processes such as inflammatory response and apoptosis. Molecular docking showed that the core components had a strong binding ability with the core targets (binding energy< -5.0 kcal·mol-1). Animal experiments suggested that CPS could significantly reduce the DAI score of UC mice (P<0.05), improve the pathological damage to colon tissues, inhibit the release of pro-inflammatory factors IL-6, TNF-α and MMP-2 (P<0.05), down-regulate the expression of IL-6 mRNA and up-regulate the expression of BCL-2 mRNA (P<0.05). Conclusion The CPS extract can combat ulcerative colitis by regulating IL-6, MMP-2 and BCL-2, inhibiting inflammatory response, apoptosis and tissue remodeling. References | Related Articles | Metrics

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Alternative Methodologies for Determination of Active Components in Posterrior Pituitary ZHANG Yuan, GUO Longjing, YANG Zean, HE Qing, WANG Hongyu, WU Yanlin, NA Tao 2026, 23(5): 533-538.  DOI: 10.19803/j.1672-8629.20250858 Abstract ( 20 )   PDF (1315KB) ( 20 )   Objective To establish HPLC methods for the determination of active components—vasopressin and oxytocin—in posterior pituitary and to investigate the correlation and equivalence between the newly developed methods and those specified in the pharmacopoeia. Methods For vasopressin, a C18 column (4.6 mm×25 cm, 3.5 μm) was used. Mobile phase A consisted of 0.1 mol·L-1 diammonium hydrogen phosphate (pH=6.0) while mobile phase B was composed of a 1∶1 mixture of acetonitrile and water. The flow rate was 1.0 mL·min-1, detection wavelength 220 nm, and column temperature was 40°C. For oxytocin, a C18 column (4.6 mm×25 cm, 5 μm) was adopted. Mobile phase A was 0.1 mol·L-1 sodium dihydrogen phosphate solution (pH=4.5) while mobile phase B was a 1∶1 mixture of acetonitrile and water under the same conditions as vasopressin. Results Using either method, the resolution between the main peaks of vasopressin/oxytocin and adjacent impurity peaks met the required standard. A good linear relationship was observed between the concentration and chromatographic peak area: within the range of 0.21-13.33 IU·mL-1 for vasopressin (r=0.999 9), and 0.26-21 IU·mL-1 for oxytocin (r=0.999 9). The average recovery (n=9) was 100.3% and 99.8%, respectively. The RSD of repeatability precision was 0.09% and 0.44%, and that of reproducibility precision was 2.85% and 1.9%, respectively. Statistical analysis indicated good result equivalence and performance equivalence between the HPLC methods and the bioassay. Conclusion The established methods are user-friendly, accurate, reproducible, and equivalent to the bioassay, which can be used for determination of vasopressin and oxytocin contents in posterior pituitary. References | Related Articles | Metrics

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Evaluation of Allergic Reactions Caused by Indicator Components of Shuanghuanglian Injection WU Yanlin, YU Sisi, WEN Miao, LI Huimin, YANG Zean, ZHANG Yuan, HE Qing 2026, 23(5): 539-546.  DOI: 10.19803/j.1672-8629.20250899 Abstract ( 24 )   PDF (1396KB) ( 26 )   Objective To evaluate the pseudo-allergic reactions of Shuanghuanglian injection and its indicator components using an in vitro cell degranulation assay combined with molecular docking. Methods The indicator components of Shuanghuanglian injection were characterized using high-performance liquid chromatography. With the MrgprX2 receptor as the target protein and with four characteristic monomeric components—chlorogenic acid, caffeic acid, baicalin, and forsythin—as ligands, molecular docking was performed using AutoDock Vina and PyMOL software to screen for potentially anaphylactoid-inducing active ingredients. In vitro anaphylactoid testing was conducted using RBL-2H3 and P815 cells. The maximum non-toxic dose of Shuanghuanglian injection and four indicator components (chlorogenic acid, caffeic acid, baicalin, and forsythin) at 4, 2, 1, and 0.5-fold doses were used respectively, where the ingredients of the four indicator components at 1-fold dose were 0.097 mg·mL⁻¹ for chlorogenic acid, 0.032 mg·mL⁻¹ for caffeic acid, 0.25 mg·mL⁻¹ for baicalin, and 0.07 mg·mL⁻¹ for forsythin. By measuring the levels of histamine and β-hexosaminidase in the cell supernatant, the sensitization potential of the potential allergenic components of Shuanghuanglian injection was evaluated. Results The screening model established based on the MrgprX2 receptor could be used for preliminary screening of potential anaphylactoid components of the drug HPLC results showed that Shuanghuanglian injection contained four indicator components: chlorogenic acid, caffeic acid, baicalin, and forsythin. Baicalin, the main component identified from Shuanghuanglian injection screened by molecular docking, had high affinity for the MrgprX2 receptor, suggesting that chlorogenic acid, caffeic acid, baicalin, and forsythin carried potential anaphylactoid risks. Subsequent in vitro anaphylactoid activity assays using RBL-2H3 and P815 cells indicated that chlorogenic acid, caffeic acid, and baicalin were likely to increase the risk of anaphylactoid reactions. Conclusion Anaphylactoid reactions induced by Shuanghuanglian injection may result from the interactions between its indicator components. References | Related Articles | Metrics

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Analysis of 445 Reports of Severe Adverse Drug Reactions to Bevacizumab Injection LIU Ying, XUE Hongwei, PANG Nan, YANG Zhongyi, KE Wenyuan, LIU Ling 2026, 23(5): 547-552.  DOI: 10.19803/j.1672-8629.20250843 Abstract ( 34 )   PDF (761KB) ( 36 )   Objective To explore the characteristics of serious adverse drug reactions (ADRs) induced by bevacizumab injection and provide references for safe medications. Methods A total of 445 reports of serious ADRs induced by bevacizumab injection collected in 2019-2025 were retrieved from the Adverse Drug Reaction Monitoring System of Henan Province. Statistical analysis was conducted of the patients' age, gender, outcomes and severity of serious ADRs, primary diseases, routes and dosages of administration, systems-organs involved and clinical manifestations, grading of ADRs, and combined medications. Results Among the 445 reports of serious ADRs, female patients outnumbered male ones at a ratio of 1.75∶1. The incidence was high among patients ages 51 to 60. In terms of patient outcomes, a total of 586 cases (84.69%) recovered or improved. Intravenous drip was the dominating administration route (422 cases, 94.83%), with the dosages ranging from 25 mg to 1,100 mg. The primary diseases were indications that were not recorded in package inserts in 45 patients (10.11%). Combined medications included antimetabolites, platinum compounds, and paclitaxel-based agents (130 cases, 72.22%). Serious ADRs primarily involved the circulatory and lymphatic system and the gastrointestinal system. The common clinical manifestations were bone marrow suppression (115 cases, 18.31%), decreased white blood cell count (68 cases, 10.83%), nausea (45 cases, 7.17%), hypertension (33 cases, 5.25%), vomiting (30 cases, 4.78%), and decreased platelet count (29 cases, 4.62%). The severity of serious ADRs was predominantly grade 1 to 3, with no fatal cases reported. Conclusion Serious ADRs induced by bevacizumab injection are more common in middle-aged and elderly patients, especially in females. Most of the patients have favorable outcomes after clinical interventions. Improper administration routes and off-label drug use may occur in clinical practice. Severe ADRs involve multiple systems and organs. Clinicians should be well aware of the characteristics of related ADRs and effectively manage common serious ADRs. References | Related Articles | Metrics

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Analysis of 121 Reports of Adverse Drug Reactions to PD-1/PD-L1 Inhibitors DU Yan, YANG Chunlan, SUN Xuqun, FANG Ling 2026, 23(5): 553-557.  DOI: 10.19803/j.1672-8629.20250928 Abstract ( 39 )   PDF (1272KB) ( 32 )   Objective To investigate the characteristics and influencing factors of adverse drug reactions (ADRs) induced by PD-1/PD-L1 inhibitors in order to contribute to rational medication. Methods ADR reports related to PD-1/PD-L1 inhibitors and collected by a tertiary hospital in Anhui Province in 2024-2025 were analyzed in terms of the patients' gender, age, weight, underlying diseases, systems and organs involved in ADRs, and clinical manifestations. Results A total of 121 ADR reports were included, involving 86 males (71.07%) and 35 females (28.93%). Most of the patients were aged 51 to 80 (110 cases, 90.91%), and weighed 41 to 80 kg (113 cases, 93.39%). The underlying diseases included stomach, esophagus, lung and liver malignancies. The systems involved were damage to hematological and lymphatic systems (53 cases, 39.85%), the skin and its appendages (27 cases, 20.30%), and the endocrine system (10 cases, 7.52%). The clinical manifestations included leukopenia, neutropenia, thrombocytopenia, bone marrow suppression, rash, and abnormal thyroid and adrenal functions. Damage to hematological and lymphatic systems induced by PD-1/PD-L1 inhibitors was significantly associated with age (>70 years) and underlying diseases (gastric, esophageal and cardia digestive system tumors) (P<0.05). Conclusion During the treatment of tumor patients with PD-1/PD-L1 inhibitors, the prevalence of ADRs varies by gender, age, body weight, and underlying disease. Clinicians should be better informed of PD-1/PD-L1 inhibitors, and look out for risk indicators to prevent and reduce the occurrence of severe ADRs. References | Related Articles | Metrics

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Signal Analysis of Adverse Drug Reactions of Statins Based on Real-World Data LI Xingqiao, MA Sijia 2026, 23(5): 558-563.  DOI: 10.19803/j.1672-8629.20250823 Abstract ( 43 )   PDF (712KB) ( 40 )   Objective To analyze the adverse drug reaction (ADR) signals of statins and to provide a reference for rational clinical use of drugs. Methods The ADR reports of seven statins received by the Database of Chengdu Institute for Drug Control in 2011-2024 were collected. The reporting odds ratio (ROR) method was used to analyze patients' basic information, system organ classes involved, and detection results of ADR signals. Results A total of 1223 ADR reports with statins as suspected drugs were retrieved, involving more male patients than female ones, and most of the patients range from 56 to 70 in age. These reports involved 18 system organ classes, including diseases of the hepatobiliary system, diseases of the gastrointestinal system, diseases of the skin and subcutaneous tissue, musculoskeletal and connective tissue diseases, andneurological diseases. Twenty-one ADR signals were identified for atorvastatin, manifested in elevated blood creatinekinase (CK), rhabdomyolysis, increased blood myoglobin, myalgia and increased transaminase. Six ADR signals were mined for rosuvastatin, manifested in elevated blood CK and transaminase, myalgia. Twelve ADR signals were detected for simvastatin, manifested in rhabdomyolysis, elevated blood CK, hair loss, liver injury and myalgia and one ADR signal was identified for pravastatin, manifested in abnormal liver function. ADR signals were not detected for fluvastatin, lovastatin or pitavastatin due to the small number of collected reports. ADR signals common to most of the statins were abnormal liver function, elevated blood CK, myalgia and abdominal discomfort. Conclusion Statins can generate ADR signals with strong correlation strength in both the hepatobiliary and muscular systems, so clinicians should be alert to severe ADRs such as rhabdomyolysis and liver injury. A suspected ADR signal of hyperglycemia is identified for atorvastatin. Additionally, several new ADR signals, including constipation, regurgitation, abdominal pain, facial edema and asthenia, also merit attention. Regular monitoring of bilirubin, blood CK and blood glucose levels is critical when statins are used clinically. Risks should be identified as early as possible. Medications have to be adjusted and genetic screening is conducted when necessary to ensure rational clinical use of drugs. References | Related Articles | Metrics

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Visualization of Real-World Adverse Drug Reaction Based on a Traditional Chinese Medicine Preparation as Empirical Evidence WEI Wei, QUAN Qinbo, WANG Linghua, TIAN Yuejie, HUANG Lin, LI Na, WANG Weibo 2026, 23(5): 564-568.  DOI: 10.19803/j.1672-8629.20260022 Abstract ( 41 )   PDF (1745KB) ( 46 )   Objective To visualize the characteristics of and relationships between adverse drug reactions (ADR) so as to provide methodological support for revision of package inserts of drugs, safety research, and safe medication. Methods Different analytic methods for information visualization were used to display the distribution of and correlations between ADR based on 1 898 adverse reaction reports of a preparation from reports collected in Shandong Province in 2020-2024. Results As confirmed by multiple visualization maps and indicators, ADR fell into four types. Gastrointestinal ADR were the core cluster. The intragroup connections between ADR were much stronger than the intergroup ones. Allergic, neurological, and cardiovascular ADR were peripheral clusters around the core cluster. “Hepatic dysfunction” was independent of any cluster that required special attention. Conclusion Marketing authorization holders should strengthen proactive collection of ADR reports and signal detection for “hepatic dysfunction”, and conduct safety research on unexpected ADR in “neurological” and “cardiovascular” groups to improve the instructions about ADR in drugs' package inserts. Medical institutions can prevent and treat ADR according to their characteristics displayed in visualization maps. References | Related Articles | Metrics

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One Case of Myasthenia Gravis with Acute Myocarditis Caused by Toripalimab Injection ZOU Rui, WU Yutong, ZHOU Yue, LI Qin, MENG Zhaoyou 2026, 23(5): 569-571.  DOI: 10.19803/j.1672-8629.20250832 Abstract ( 21 )   PDF (1094KB) ( 26 )   Objective To investigate the clinical features, causality, and management strategies of myasthenia gravis (MG) combined with acute myocarditis induced by toripalimab injection so as to provide references for safe clinical use of the drug. Methods The diagnosis and treatment process of a patient with clear cell renal cell carcinoma (ccRCC) who developed MG and acute myocarditis after receiving toripalimab injection was analyzed. The correlation of adverse reactions was determined, related literature was reviewed, and the pathogenesis, clinical features, and major interve-ntions were discussed. Results Both causality assessment tools indicated a “probable” association. Upon discontinuation of toripalimab, the patient received methylprednisolone pulse therapy, intravenous immunoglobulin, tacrolimus, and pyridos-tigmine, leading to complete symptom resolution. There was no recurrence during the 6-month follow-up. Conclusion MG combined with acute myocarditis induced by toripalimab injection is a rare but fatal immune-related adverse events (irAEs). Monitoring is required during medication. Early identification and quick interventions can improve prognosis. References | Related Articles | Metrics

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One Case of Drug-Induced Liver Injury Caused by Linezolid Injection TANG Liu, LI Yang, LUO Guangwen, BAO Yindi 2026, 23(5): 572-574.  DOI: 10.19803/j.1672-8629.20250733 Abstract ( 29 )   PDF (535KB) ( 36 )   Objective To analyze one case of drug-induced liver injury (DILI) caused by linezolid injection, and to provide references for safe medications. Methods One case of DILI caused by linezolid combined with imipenem/cilastatin sodium for anti-infection in a patient with twin pregnancy after second-trimester induction of labor was analyzed. The causal relationship between the administered drugs and DILI was quantitatively evaluated using the Roussel Uclaf Causality Assessment Method(RUCAM) scale. Additionally, related literature was reviewed to summarize the clinical characteristics of and therapeutic strategies for such cases. Results Three days after the patient received anti-infection treatment with linezolid combined with imipenem/cilastatin sodium, liver enzymes increased significantly, with alanine aminotransferase (ALT) reaching 212.24 U·L-1 and aspartate aminotransferase (AST) reaching 222.76 U·L-1. According to the score by the RUCAM scale, the causality between DILI and linezolid in this patient was determined as “probable”. After linezolid was immediately discontinued and hepatoprotective therapy was initiated, liver enzymes decreased significantly. Conclusion Clinicians should be alert for the risk of DILI induced by linezolid in special physiological populations such as those during the post-pregnancy and postpartum period. Liver function indicators and related symptoms of patients should be monitored closely to detect DILI early and reduce the risk. References | Related Articles | Metrics

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One Case of Agranulocytosis Caused by Tiopronin Enteric-Coated Capsules DAI Biao, ZHANG Song, DENG Yiyun, CAO Yin, ZHANG Yuanyuan, LI Peipei, LIANG Jun 2026, 23(5): 575-577.  DOI: 10.19803/j.1672-8629.20250724 Abstract ( 21 )   PDF (1102KB) ( 26 )   Objective To investigate the adverse drug reaction of agranulocytosis caused by tiopronin enteric-coated capsules and provide a reference for safe medication in clinical practice. Methods One case of agranulocytosis induced by tiopronin enteric-coated capsules in a schizophrenia patient with liver injury was analyzed. Related literature was also reviewed and summarized. Results The patient developed liver injury after treatment with paliperidone extended-release tablets. Agranulocytosis accompanied by persistent fever occurred 8 days after combination therapy with tiopronin enteric-coated capsules (0.6 g·d⁻¹) for hepatoprotection. The granulocyte count returned to normal after discontinuation of the suspected drug and symptomatic treatment with anti-infectives, the human granulocyte colony-stimulating factor, and Diyu Shengbai capsules. Conclusion Potential hematologic toxicity, such as agranulocytosis, deserves attention during treatment with tiopronin enteric-coated capsules. When tiopronin is combined with antipsychotics, special attention should be paid to the patient's clinical manifestations and blood routine results. References | Related Articles | Metrics

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One Case of Acute Hepatic Injury Caused by Pregabalin Capsules WANG Aming, WEI Xiao, WU Hui, ZHANG Linlin, YANG Li 2026, 23(5): 578-580.  DOI: 10.19803/j.1672-8629.20250614 Abstract ( 33 )   PDF (1223KB) ( 31 )   Objective To explore the characteristics of acute hepatic injury caused by pregabalin capsules in order to provide a reference for safe clinical use and management of adverse reactions. Methods One case of acute hepatic injury caused by oral pregabalin capsules was analyzed. The correlations between hepatic injury and pregabalin were investigated, and the pathogenesis of acute hepatic injury caused by pregabalin was analyzed based on related literature before ways of prevention and treatment were recommended. Results The patient experienced hepatic injury after using pregabalin for 12 days. Clinical pharmacists traced the patient's medications, referred to the drug instructions and reviewed related literature before they concluded that hepatic injury was related to pregabalin. Therefore, they recommended that the drug be discontinued. The patient's liver function returned close to normal following hepatoprotective treatment ten days after discontinuation. Conclusion Clinicians are to be alert to the risk of such adverse reactions as hepatic injury caused by pregabalin. In case of hepatic injury, related drugs should be discontinued promptly and symptomatic treatment should be given to ensure safe medication. References | Related Articles | Metrics

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One Case of Joint Pain and Muscle Weakness Caused by Dupilumab Injection ZHANG Qin, ZHENG Xiaoyuan 2026, 23(5): 581-584.  DOI: 10.19803/j.1672-8629.20250622 Abstract ( 20 )   PDF (1154KB) ( 26 )   Objective To investigate such adverse reactions as joint pain and muscle weakness induced by dupilumab, and to explore the possible mechanisms in order to provide a reference for safe use of the drug. Methods One case of a patient with severe asthma who developed joint pain and muscle weakness after using dupilumab was analyzed. The correlation of these adverse events with dupilumab was studied. Furthermore, related literature was reviewed and summarized. Results After the drug instructions and literature were reviewed and the time of administration was analyzed, other combination drugs were excluded. The correlation between dupilumab and the adverse reactions of joint pain and muscle weakness was determined as “probable”. These symptoms gradually improved after drug discontinuation and supportive treatment. Conclusion Clinicians should be alert to the adverse reactions of joint pain and muscle weakness associated with dupilumab. When treatment with this drug is restarted, the risks and benefits should be weighed and monitored. References | Related Articles | Metrics

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Research Progress in Effects of Traditional Chinese Medicine on Neural Stem Cells PENG Lili, FAN Yan, TIAN Chunhua, XIAO Suping 2026, 23(5): 585-589.  DOI: 10.19803/j.1672-8629.20260203 Abstract ( 23 )   PDF (1319KB) ( 24 )   Objective To review the recent advances in research on the effects of traditional Chinese medicines (TCMs) on the proliferation, differentiation, apoptosis and neuroprotection of neural stem cells (NSCs) and on related molecular mechanisms made since 2017 so as to provide data for the prevention and treatment of such neurological diseases as cerebral ischemia, Alzheimer's disease and Parkinson's disease with TCMs. Methods CNKI, Wanfang, VIP, PubMed were searched for related literature published in 2017-2025 by using “neural stem cells, traditional Chinese medicine, proliferation, differentiation, apoptosis, neuroprotection, signaling pathway” as key words. The effects of TCM monomers, effective parts, extracts, single prescriptions and compound preparations on NSCs were summarized and analyzed. Results TCMs with kidney-tonifying, spleen-strengthening, blood-activating, intellect-enhancing, and heat-clearing/detoxifying properties could regulate core signaling pathways—including Shh, Wnt/β-catenin, PI3K/Akt, Notch, ERK, JAK2/STAT3, and Nrf2. They could also improve the neurogenic microenvironment, reduce oxidative stress and inflammatory response, inhibit apoptosis of NSCs, promote the proliferation of endogenous NSCs and their directional differentiation into neurons, and exert neuroprotective effects. So TCM formulas had better overall regulatory effects than monomeric components, which was attributed to their synergistic actions involving multi-component, multi-target, and multi-pathway mechanisms. Conclusion TCMs can exert distinct and stable regulatory effects on the biological behaviors of neural stem cells (NSCs). The past few years have witnessed significant advancements in research in this field in terms of mechanistic depth, target specificity, and translational value. However, studies on clinical translation remain relatively limited. Subsequent research should integrate artificial intelligence, bio-imaging, and nano-delivery systems to conduct more in-depth mechanistic investigations and clinical trials so as to facilitate the clinical applications of TCMs in neural repair. References | Related Articles | Metrics

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Research Progress in the Treatment of Thyroid Dysfunction Associated with Immune Checkpoint Inhibitors LYU Xinge, PAN Chen, WU Yi, WANG Yuting, CUI Xiangli 2026, 23(5): 590-594.  DOI: 10.19803/j.1672-8629.20260073 Abstract ( 15 )   PDF (1169KB) ( 23 )   With the increasing use of immune checkpoint inhibitors (ICIs), immune-related adverse events (irAEs) have become a major clinical challenge. Thyroid dysfunction associated with ICIs (ICIs-TD) is one of the most common endocrine irAEs. ICIs-TD varies in terms of both time to onset and clinical features. This review summarizes the epidemiology, underlying mechanisms, biomarkers, risk factors, diagnosis and management of ICIs-TD in the hope of providing a reference for the subsequent development of clinical prediction models for ICIs-TD and for early identification and precise interventions. References | Related Articles | Metrics

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Research Progress in the Role of Molecular Hydrogen in the Treatment of Periodontal Diseases YU Fengxin, DAI Chunli, JIA Sen 2026, 23(5): 595-599.  DOI: 10.19803/j.1672-8629.20250937 Abstract ( 21 )   PDF (1188KB) ( 21 )   Objective To explore the mechanisms and administration methods of molecular hydrogen (H2) and to summarize the research progress in the treatment of periodontal diseases with H2. Methods Related literature was reviewed to summarize the molecular mechanisms and routes of administration of H2 as well as the current applications and therapeutic effects of H2 in the treatment of periodontal diseases. Results H2 possessed significant antioxidant, antiinflammatory, and anti-apoptotic properties. Clinically, the consumption of hydrogen-rich water could effectively facilitate the treatment of periodontal diseases. Conclusion H2 promises good potential in the prevention and treatment of periodontal disease. However, more in-depth studies are required to establish its efficacy and safety. References | Related Articles | Metrics

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FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos 2026, 23(5): 600-600.  DOI: 10.19803/j.1672-8629.20269905 Abstract ( 34 )   PDF (672KB) ( 40 )   Related Articles | Metrics