Chinese Journal of Pharmacovigilance

Volume 23, Issue 6 Table of Contents

2026, 23(6): 0-0.

Abstract ( 91 )

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Molecular Mechanisms of Mitochondrial Dynamics and Endoplasmic Reticulum Stress in Tumor Chemoresistance

GAO Zhichao, ZHAO Chenguang, FAN Youning, XUE Wenhan, LIANG Jingwei, WANG Lin, MENG Fanhao

2026, 23(6): 601-606.
DOI: 10.19803/j.1672-8629.20260249

Abstract ( 33 )

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Objective To explore the mechanisms of mitochondrial dynamics and endoplasmic reticulum stress in tumor chemoresistance so as to provide references for the development of clinical strategies for reversing drug resistance. Methods The key regulators of mitochondrial dynamics (fission and fusion) and their roles in drug resistance as well as the relationships between the three key pathways of the unfolded protein response (UPR) in endoplasmic reticulum stress (IRE1α, PERK, and ATF6) and chemoresistance were summarized based on literature review. Results Pharmacotherapy was one of the leading approaches to malignant tumors. However, the therapeutic efficacy was strongly limited by drug resistance. Mitochondria could regulate cellular metabolism, oxidative phosphorylation, and apoptotic thresholds through dynamic remodeling while endoplasmic reticulum stress could activate UPR pathways, collectively contributing to drug resistance. Conclusion Mitochondrial dynamics and endoplasmic reticulum stress are important mechanisms that mediate tumor chemoresistance, with close interactions between the two organelles through mitochondria-associated endoplasmic reticulum membranes (MAMs). Targeting key proteins involved in mitochondrial dynamics or modulating endoplasmic reticulum stress signaling pathways promises to be a novel strategy for reversing tumor drug resistance and improving chemotherapy efficacy.

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Research Progress in Roles of Extracellular Vesicles in Thromboinflammation in Ischemic Cardio-Cerebrovascular Diseases Treated with Traditional Chinese Medicine

BAI Xue, LI Xueli

2026, 23(6): 607-612.
DOI: 10.19803/j.1672-8629.20250695

Abstract ( 32 )

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Objective To investigate the mechanisms of extracellular vesicles (EVs) in Traditional Chinese Medicine (TCM) against “thromboinflammation” in ischemic cardio-cerebrovascular diseases, analyze the way TCM reshapes EV communication networks, and challenges to clinical translation. Methods Literature regarding TCM regulation of EVs was reviewed to summarize strategies for “addressing the root cause of problems” and “precision loading” that affected the biogenesis and delivery of EVs. Constraints imposed by in vivo metabolic complexity and EV heterogeneity on evaluation of clinical efficacy were analyzed. Results TCM remodeled the thromboinflammatory microenvironment primarily through two strategies: ① “addressing the root cause of problems”, which could help improve mitochondrial metabolism in parent cells to enhance protective EVs and curb pro-thrombotic EV generation while interpreting the biological basis of “Qi-boosting” (Yiqi), and ② “precision loading”, which meant physically blocking pathogenic miRNAs from loading into EVs, severing the inflammation-coagulation cascade and embodying “blood-activating” (Huoxue) signal decoupling. However, the “black box” of in vivo metabolism and high background noise of blood EVs remained technical barriers to translation. Conclusion EVs are crucial mediators for TCM interventions in thromboinflammation. TCM can not only optimize endogenous EV activity, but also use engineered EVs for precise delivery. It is recommended that evaluation standards be established for specific EVs based on single-particle analysis so as to promote the transition of TCM research toward precise “cell communication remodeling”.

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Effects of Deer Velvet Antler on Cardiomyocyte Apoptosis and Expressions of Bcl-2, Bax, and Caspase Proteins in a Rat Model of Myocardial Infarction

WANG Ziwei, LI Yanjun, HUANG Li, LIU Chengxiang, XIAO Xiang, YANG Deshuang, WANG Jinping, QIAO Jiajun, BAI Xue, LI Lin

2026, 23(6): 613-620.
DOI: 10.19803/j.1672-8629.20260141

Abstract ( 27 )

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Objective To investigate the effects of deer velvet antler on cardiomyocyte apoptosis and expressions of apoptosis-related proteins Bcl-2, Bax, and caspases in a rat model of myocardial infarction. Methods A rat model of myocardial infarction was established via ligation of the left anterior descending coronary artery. The sham-operated group (n=10) was sutured without ligation. Twenty rats in the myocardial infarction model were randomly divided into the model group and the deer antler velvet group, with 10 rats in each. The deer antler velvet group received 400 mg·kg^-1·d^-1deer antler velvet powder via gastric intubation while the shamoperated and model groups received an equal volume of 0.5% sodium carboxy-methylcellulose daily. After one week of intervention, cardiac function was evaluated via echocardiography. HE staining was used to examine the pathology of myocardial tissues while immunofluorescence was adopted to detect the expression of F-actin. ELISA was used to detect levels of serum tumor necrosis factor-α (TNF-α). TUNEL assay was employed to determine the myocardial cell apoptosis rate in the infarct border zone. Bcl-2 and Bax expressions in this zone were detected via immunohistochemistry, and Bcl-2, Bax, Caspase-3, and Caspase-9 protein expressions via Western blotting. Results Compared with the sham-operated group, the left ventricular short-axis fraction shortening (FS) and left ventricular ejection fraction (EF) of rats in the model group were significantly reduced (P<0.01) while theeft ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), end-systolic volume (ESV), and end-diastolic volume (EDV) were significantly increased (P<0.01). Hematoxylin and eosin (HE) staining revealed marked pathological changes in myocardial tissues, including disorderly F-actin and dissolution of the myocardial cytoskeleton. Serum TNF-α levels and myocardial cell apoptosis rates were significantly elevated (P<0.01). Immunohistochemistry and Western blotting both pointed to decreased Bcl-2 expressions and increased Bax expressions in the model group. Western blotting suggested significantly elevated Caspase-9 and Caspase-3 protein expressions (P<0.05, P<0.01). Compared with the model group, rats in the deer antler velvet group showed significantly increased EF and FS (P<0.01) but significantly decreased LVEDD, LVESD, EDV, and ESV (P<0.01). Hematoxylin and eosin staining indicated reduced sizes of myocardial lesions and effective repair of myocardial F-actin structure in the deer antler velvet group. Serum TNF-α levels and myocardial cell apoptosis rates decreased in the deer antler velvet group (P<0.05). Bcl-2 protein expressions increased while Bax, Caspase-9 and Caspase-3 protein expressions decreased in the deer antler velvet group P<0.05, P<0.01). Conclusion Deer antler velvet may target the balance between Bcl-2/Bax apoptosis-related proteins, block the Caspase-9/Caspase-3 cascade activation mediated through the mitochondrial pathway, reduce myocardial cell apoptosis in rats with acute myocardial infarction, and exert cardioprotective effects.

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Roles of Butu Decoction in Improving Heart Failure in Rats by Activating AKT/Bcl-2 Signaling Axis and Inhibiting Cardiomyocyte Apoptosis

LI Yanjun, LIU Chengxiang, TANG Bo, LIU Yi, ZHANG Jiuliang, JIANG Guochen, BAI Xue

2026, 23(6): 621-629.
DOI: 10.19803/j.1672-8629.20260430

Abstract ( 28 )

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Objective To explore the effect of Butu decoction on cardiac function of SD rats with heart failure (HF) and its molecular mechanism against cardiomyocyte apoptosis via the AKT/Bcl-2 signaling pathway. Methods Left anterior descending branch ligation was performed on male SD rats to establish an HF model. The surviving model rats were randomly divided into a model group (n=10), a Butu decoction group (n=10), and an enalapril maleate group (n=10). A sham surgery group was also established (n=10). Four weeks after intragastric administration, the cardiac function was detected via ultrasound. HE staining was used to observe myocardial histopathological changes, and Masson staining the degree of myocardial fibrosis. ELISA was employed to detect BNP contents in serum. Network pharmacology combined with molecular docking was used to identify the potential core targets and active components of Butu decoction against HF. TdT-mediated dUTP Nick-End Labeling (TUNEL) was adopted to determine the apoptosis rate of cells in regions bordering the infarction in rats. The protein expression levels of AKT1, pAKT1, Bax, Bcl-2 and Caspase-3 in these regions were detected via Western Blot. Results Results of animal experiments showed that the levels of LVESD and LVEDD in the Butu decoction group significantly decreased compared with the model group (P<0.01), while those of LVEF and LVFS significantly increased (P<0.01). HE staining suggested that the pathomorphology of rats in the Butu decoction group improved compared to the model group. The degree of myocardial fibrosis and the serum levels of BNP in the Butu decoction group were significantly reduced (P<0.01). Network pharmacology and molecular docking found that the main active components of Butu decoction, such as luteolin and quercetin, showed strong binding activity to AKT1, a core target regulating cell apoptosis and growth. Mechanistic studies suggested that Butu decoction significantly reduced the apoptosis rate of cardiomyocytes in regions bordering the infarction (P<0.01). This decoction had no obvious effect on the total protein level of AKT1, but markedly upregulated the expression of pAKT1 (P<0.05) and the anti-apoptotic protein Bcl-2 (P<0.01) while downregulating the pro-apoptotic proteins Bax (P<0.05) and Caspase-3 (P<0.01). Meanwhile, the Bcl-2/Bax ratio was significantly increased (P<0.05). Conclusion Butu decoction can improve ventricular remodeling and cardiac function in rats with heart failure, possibly by activating the AKT pathway, regulating Bcl-2/Bax proteins and inhibiting cardiomyocyte apoptosis.

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Research Progress in Active Ingredients of Ginseng and Salvia Miltiorrhiza and Its Therapeutic Effect against Coronary Heart Disease

BAI Xue, LI Xueli

2026, 23(6): 630-635.
DOI: 10.19803/j.1672-8629.20250705

Abstract ( 37 )

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Objective To summarize the recent advancements in the treatment of coronary artery disease (CAD) with the active ingredients and formulations of Ginseng-Salvia Miltiorrhiza in order to facilitate subsequent research and clinical applications. Methods Relate literature on treating CAD with the active ingredients and formulations of Ginseng-Salvia Miltiorrhiza was retrieved before the theories concerned, pharmacological effects, and molecular mechanisms of TCM were analyzed. Results CAD was regarded as “chest impediment and heart pain in TCM”, and its pathogenesis was characterized by qi deficiency and blood stasis. Ginseng and Salvia Miltiorrhiza were classic herbs for “invigorating qi and promoting blood circulation” with consistent efficacy and broad clinical applicability. The primary active ingredients of Ginseng responsible for cardiovascular protection were ginsenosides (such as Rg₁, Rb₁, etc), while those of Salvia Miltiorrhiza were tanshinones and phenolic acids. Active ingredients and formulations of Ginseng-Salvia Miltiorrhiza (including herbal pairs, combination of active ingredients, and compound formula) could exert significant cardioprotective effects against myocardial injury caused by ischemia, reperfusion injury, and microcirculatory dysfunction during the progression of CAD by improving myocardial energy metabolism, repairing damaged mitochondria, inhibiting inflammatory factor expressions, and counteracting oxidative stress. Conclusion By “invigorating qi and promoting blood circulation”, the active ingredients and formulations of Ginseng-Salvia Miltiorrhiza can synergistically improve cardiac function and attenuate myocardial injury in CAD.

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Effects of Ethanol on the in vitro Release Behavior of Aspirin Enteric-Coated Tablets by HPLC

ZHUANG Jie, QI Mengjie, YANG Shijie, ZHAI Chenfei, NIU Jianzhao, XU Fengguo, LIU Qian

2026, 23(6): 636-642.
DOI: 10.19803/j.1672-8629.20260172

Abstract ( 22 )

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Objective To compare the ethanol dose-dumping risk between generic and reference formulations of aspirin enteric-coated tablets from different manufacturers in accordance with the guidelines issued by the National Medical Products Administration (NMPA). Methods The gastric environment was simulated using 0.1 moL·L^-1 hydrochloric acid containing 0% to 40% ethanol. The in vitro release of aspirin was determined by high-performance liquid chromatography (HPLC). Dissolution profiles were generated, and the similarity of in vitro release between formulations was evaluated by calculating the similarity factor (f₂). Results In media containing 5% and 20% ethanol, the acid resistance of all the tested formulations proved satisfactory, with a cumulative release of ≤10% within 120 min. The in vitro release from the generic and reference formulations hardly changed. When the ethanol concentration was raised to 40%, the integrity of the enteric coating of all the formulations was disrupted, resulting in dose dumping (>90%) accompanied by drug degradation. Conclusion Ethanol at the concentration of 40% can induce dose dumping of aspirin enteric-coated tablets. The enteric coating material is believed to be the leading contributor to ethanol-induced dose dumping, which suggests a safety risk once these tablets are co-administered with alcoholic beverages.

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Determination of Contents of Monoester Alkaloids and Limit Test of Diester Alkaloids in Fupian (Heishunpian) Formula Granules by HPLC

WANG Minshu, CHENG Ding, WU Chengfeng, ZHANG Chunyan, YANG Yuqin, ZHANG Zhiguo

2026, 23(6): 643-648.
DOI: 10.19803/j.1672-8629.20260284

Abstract ( 20 )

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Objective To establish a high performance liquid chromatography (HPLC) method for simultaneous determination of three monoester alkaloids and for the limit test of three diester alkaloids so as to offer a feasible detection approach to quality control of related samples. Methods Using Fupian (Heishunpian) formula granules as the subject, the contents of three monoester alkaloids and three diester alkaloids were determined by HPLC-tandem mass spectrometry (HPLC-MS/MS) before an HPLC method was established to determine the contents of the three monoester alkaloids, the limit test of diester alkaloids and those of multiple batches of samples of Fupian (Heishunpian) formula granules. Results The HPLC-MS/MS results showed that 1 g of the test sample contained a total of 1.5 mg of monoester alkaloids and a total of 2.5 μg of diester alkaloids, which met the national standard. Using the established HPLC method, the three monoester alkaloids were highly linear within the range of tested concentrations (correlation coefficient R²>0.999), The total content of monoester alkaloid in 1 g of Fupian (Heishunpian) formula granules was 1.3 mg·g^-1, and no diester alkaloids were detected. Based on the instrumental quantitation limit and the national standard limit, the contents of diester alkaloids were believed to comply with the limit requirement. In multiple batches of samples detected by HPLC, the contents of monoester alkaloids all met the related standard and no diester alkaloids were detected. Conclusion The HPLC method established in this study is user-friendly and has excellent universality. Within the linear range, it can be used for the determination of monoester alkaloids and the limit test of diester alkaloids in Fupian (Heishunpian) formula granules as a complementary detection approach.

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Non-Clinical Safety Evaluation of Qingyi Capsules in Rats

QIN Zhaoheng, LI Zhendi, LI Yajuan, YIN Jiye

2026, 23(6): 649-655.
DOI: 10.19803/j.1672-8629.20250398

Abstract ( 20 )

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Objective To assess the safety of Qingyi capsules for clinical use by evaluating the acute toxicity in a single-dose administration test and the subchronic toxicity in a 4-week repeated-dose administration test in SD rats. Methods The maximum tolerated dose (MTD) and no observed adverse effect level (NOAEL) were determined via single-dose gavage toxicity tests and repeated-dose 4-week toxicity tests in SD rats before the toxicology and target organs were identified. The highest single dose for toxicity testing was 21g·kg^-1, and clinical observation, measurement of body weight changes, and pathological examination were conducted. For the 4-week repeated-dose toxicity test, the three doses were set at 1.5, 4.5 and 10.5 g·kg^-1, respectively, along with a vehicle control group. The examination indicators involved the rats’ external signs, body weight, food intake, ophthalmology, hematology, biochemistry, immune indicators, weight of major organs, gross necropsy, and histopathological examination. Results In the toxicity test, no death occurred, and no abnormality related to drug administration was observed in the gross pathological examination. There were no significant abnormalities in organ weights. In the repeated-dose toxicity test, food consumption was decreased and body weight gain retarded in the 10.5 g·kg^-1 dosing group, accompanied by reductions in red blood cell count, hemoglobin levels and an increase in reticulocyte count. These abnormalities were possibly associated with long-term high-dose administration of the test substance, and all the above changes were reversible after drug withdrawal. No abnormality related to the test substance was observed in the histopathological examination. Conclusion The MTD of Qingyi capsules in SD rats by single intragastric administration is 21 g·kg^-1 (equivalent to 183.12 g·kg^-1 of the crude drug). The NOAEL in the 4-week repeated-dose toxicity test in SD rats is 4.5 g·kg^-1(equivalent to 39.24 g·kg^-1 of the crude drug). Under the conditions used in this test, Qingyi capsules show no obvious toxicity in the tested animals. Long-term oral administration is safe within the intended dosages and courses of treatment.

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Safety Assessment of Haoqin Nasal Drops

HE Tao, WANG Xintang, YAN Yuwen, LIU Yan, CHENG Jiangnan, GU Zhengyi, MAO Yan

2026, 23(6): 656-662.
DOI: 10.19803/j.1672-8629.20260238

Abstract ( 26 )

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Objective To assess the safety of Haoqin nasal drops and provide a reference for safe clinical medications for allergic rhinitis (AR). Methods In single-dose toxicity test, SD rats were administered with the maximum tolerated dose (0.4 mL·kg^-1) of Haoqin nasal drops, which was equivalent to 1440 mg crude drug/kg. The overall state, body weight, food intake, toxic symptoms, and mortality of these rats were observed over a period of 14 days, followed by histopathological examination of major tissues and organs. In the repeated dose toxicity test, SD rats were divided into high-dose(270.0 mg·kg^-1), medium-dose (135.0 mg·kg^-1), low-dose(67.5 mg·kg^-1) groups and a control group, with 30 rats in each. The rats were administered with this drug for 13 weeks, followed by 4 weeks of recovery. The overall state of these rats was observed daily while their body weight was measured weekly. Such indexes were recorded as parameters of hematology, coagulation and blood biochemistry, urine indexes, organ coefficients and results of histopathological examination. Results In the single-dose toxicity test, the overall state, body weight, food intake and other indicators of rats were normal. In the repeated-dose toxicity test, some of the indicators of the medication group, such as red blood cell count and the average hemoglobin concentration of red blood cells, reticulocytes, hemoglobin, hematocrit and urea at the end of the dosing period, were statistically different from those of the control group, but within the normal range of fluctuation. In the high-dose group, there was one case of male hepatocyte vacuolation and one case of a slight decrease in female bone marrow hematopoietic stem cells. The two cases were considered a spontaneous disease in rats based on blood biochemical indicators. Conclusion The MTD of Haoqin nasal drops is 1440 mg crude drug/kg (equivalent to 400 times the intended clinical dose) for a single administration, and the NOAEL for the 13-week repeated doses is 270 mg crude drug/kg (equivalent to 75 times the intended clinical dose). Haoqin nasal drops show no significant toxicity and prove quite safe at therapeutic dosages.

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In Vitro Tests for Pyrogens in the Pharmacopoeia of the People’s Republic of China (2025 Edition)

LI Tiantian, PEI Yusheng, LIU Tao, WANG Can, HE Qing

2026, 23(6): 663-666.
DOI: 10.19803/j.1672-8629.20260140

Abstract ( 39 )

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Objective To interpret General Requirement 3309 In Vitro Pyrogen Test (a Reporter Gene Assay) in the Pharmacopoeia of the People’s Republic of China (Chinese Pharmacopoeia, ChP) (2025 Edition) so as to provide guidance and references for the application of pyrogen testing methods. Methods By reviewing pharmacopoeias and literature at home and abroad, pyrogen testing methods included in the Chinese Pharmacopoeia (2025 Edition), the European Pharmacopoeia (Ph. Eur. 12.2), and the United States Pharmacopeia (USP-NF 2026 Issue 2) were compared. Furthermore, the scope of application, interference testing, considerations for sample measurement, and system suitability testing specified in General Requirement 3309 In Vitro Pyrogen Test (a Reporter Gene Assay) of the Chinese Pharmacopoeia (2025 Edition) were analyzed. Results The In Vitro Pyrogen Test (a Reporter Gene Assay) stipulated in the Chinese Pharmacopoeia (2025 Edition) was the first to be included in a pharmacopoeia worldwide. The In Vitro Pyrogen Test (a Reporter Gene Assay) filled the gap in reporter gene-based pyrogen testing methods within the regulatory standard system. Conclusion In Vitro Pyrogen Test (a Reporter Gene Assay) is simple to operate, short in experimental cycles (3-6 hours), and able to detect a wide range of pyrogens.However, this method needs to be constantly revised in light of advancements across the globe and domestic practices.

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Relationships between Risk Levels and Categories of Keywords for Drug Inspection Defects

LI Conghui, GAO Zhenyu, ZHANG Jingmei

2026, 23(6): 667-671.
DOI: 10.19803/j.1672-8629.20260062

Abstract ( 93 )

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Objective To generate a keyword library for drug inspection defects and analyze classifications and risk levels of the defects based on the keywords and their combinations in different settings. Methods The keywords were retrieved from reports about GMP inspection delivered by the Center for Food and Drug Inspection of NMPA using a large language model. Highly automated methods, including traversal algorithms and VBA functions, were employed to calculate the proportions of defect keywords and keyword groups within their respective classification. Results A detailed keyword database for GMP inspection defects was established, along with a risk level table involving defect keywords, keyword groups, their classifications, and risk levels ranked from the highest to the lowest. Conclusion This research has established a model that integrates artificial intelligence technologies with traditional on-site drug inspections, which can significantly reduce the labor and time required for data compilation and analysis. It pioneers a novel paradigm of intelligent regulatory oversight based on large language models, facilitating a shift from experience-based inspections to data-driven decision-making.

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Adverse Reactions Induced by Iron Dextran Injection

WANG Chunting, ZHANG Ruifang, DENG Bin, ZOU Zhenlei, WANG Kun

2026, 23(6): 672-676.
DOI: 10.19803/j.1672-8629.20250815

Abstract ( 40 )

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Objective To analyze the data on monitoring of post-marketing adverse reactions of Iron Dextran injection, explore the risk factors, recommend risk control measures, and provide a reference for clinical safe medication. Methods The adverse reaction reports retrieved from the National Adverse Drug Reaction Monitoring System (from January 1, 2004 to May 31, 2024) and foreign databases, literature (published from the inception to December 26, 2025), as well as drugs’ package inserts were systematically analyzed. Data was analyzed in terms of demographics, systems and organs involved, manifestations and outcomes before the revision of drug instructions was proposed. Results Among the 2 173 reports, Severe cases accounted for 21.91% of the adverse reactions of Iron Dextran injection from the National Adverse Drug Reaction Monitoring System. Adverse reactions were dominating among adults ages 45 to 64, especially in female patients. The systems and organs involved included general disorders and reactions at the sites of administration, the skin and subcutaneous tissues, the gastrointestinal system, respiratory, thoracic and mediastinal disorders, and the immune system. The allergic shocks caused by this drug were mostly immediate. The adverse reaction profiles reported in databases and literature were basically consistent with those in China. There was a lack of information on safety in the sections of precautions, contraindications and special populations in drug instructions. Conclusion Iron Dextran injection can cause severe adverse reactions such as anaphylactic shock. Marketing authorization holders are to monitor adverse reactions and quickly improve drug instructions based on feedback. Health care providers should inquire about patients’ medication history and allergy history before administration, administer Iron Dextran injection with caution, and control the infusion rate to ensure safe medication.

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243 Reports of Adverse Drug Reactions Associated with Olanzapine

PAN Yanjuan, YUE Kexin, LIU Weijie, WANG Lingjun, WANG Chuansheng

2026, 23(6): 677-680.
DOI: 10.19803/j.1672-8629.20250557

Abstract ( 55 )

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Objective To investigate the patterns of adverse drug reactions (ADRs) associated with olanzapine, and to provide a reference for rational clinical drug use. Methods ADR reports related to olanzapine and collected in 2021-2025 were retrieved from the spontaneous reporting system database of The Second Affiliated Hospital of Henan Medical University. The basic data, demographics of patients, medications, system-organ classes involved and clinical manifestations were analyzed. Results A total of 243 reports on ADRs of olanzapine were included, 32.10% of which (78/243) were classified as “new/serious.” The most common systems involved were the nervous system (37.45%), hepatobiliary system (15.64%), cardiovascular system (15.64%), hematological system (11.52%), and gastrointestinal system (5.76%). Conclusion The ADRs of olanzapine can involve multiple systems and organs. Damage to the nervous system is the most common. Most of these ADRs occur at conventional doses of 5 mg·d^-1 and 10 mg·d^-1. Olanzapine is likely to induce a marked increase in transaminase levels in early treatment, and female patients are more susceptible to hematologic system damage. The safety of olanzapine needs to be monitored in clinical practice, especially in terms of liver function and routine blood tests.

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Reports of Adverse Reactions of Immune Checkpoint Inhibitor-Related Colitis

WANG Yuting, LYU Xinge, PAN Chen, WU Yi, CUI Xiangli

2026, 23(6): 681-685.
DOI: 10.19803/j.1672-8629.20260039

Abstract ( 29 )

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Objective To analyze the clinical characteristics of enteritis associated with immune checkpoint inhibitors (ICIs), and to provide a reference for rational clinical medications and management of such immune-related adverse reactions. Methods The clinical data of patients with ICIs-related enteritis admitted to our hospital between January 2020 and August 2025 was collected before the baseline demographics, medications, clinical features of enteritis, treatment regimens and clinical outcomes of these patients were statistically analyzed. Results A total of 29 patients were enrolled in this study, 24 of whom were male (82.76%) with a median age of 65. The overall incidence of ICIs-related enteritis was 0.92% (29/3 153). The median onset time of enteritis was 16 days after the first administration of ICIs. The dominating primary tumors were lung cancer in 9 cases (31.03%), gastric cancer in 6 cases (20.69%), and esophageal cancer in 5 cases (17.24%). Programmed cell death protein 1 (PD-1) inhibitors were the major ICIs used in patients with enteritis (28 cases, 96.55%), among which sintilimab was responsible for the largest number of cases (10 cases). Twenty-one of these patients (72.41%) were treated with ICIs combined with chemotherapy. There were 26 cases (89.66%) of grade 1-2 adverse reactions and 3 cases (10.34%) of grade 3-4 adverse reactions. The main treatments included symptomatic and supportive care (22 cases, 75.86%) and glucocorticoid therapy (6 cases, 20.69%), and 28 patients (96.55%) improved. Conclusion ICIs-related enteritis is more prevalent in elderly male patients with malignant tumors. The incidence of enteritis is relatively low in patients receiving PD-1 inhibitor monotherapy, but ICIs combined with chemotherapy can elevate the risk. Patients with ICIs-related enteritis have a favorable prognosis following quick interventions, and clinicians should monitor gastrointestinal symptoms within 3 months of ICIs administration.

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Two Cases of Acute Generalized Exanthematous Pustulosis Caused by Clindamycin Hydrochloride Injection during the Perinatal Period

WEN Ranmiao, CHEN Yue, YANG Caihua

2026, 23(6): 686-689.
DOI: 10.19803/j.1672-8629.20250427

Abstract ( 38 )

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Objective To investigate the clinical correlations between the use of clindamycin during the perinatal period and acute generalized exanthematous pustulosis (AGEP). Methods Two cases of pregnant women who developed AGEP after using clindamycin hydrochloride injection were reviewed. Based on related literature, methods for evaluation of adverse drug reactions were adopted to analyze the correlations between clindamycin and AGEP as well as the clinical characteristics, sensitization mechanisms and risks posed by perinatal medication. Results The two pregnant women, who had a history of penicillin allergy and lincomycin allergy respectively, developed typical symptoms of AGEP after using clindamycin as usual. Correlation analysis found that AGEP was likely associated with intravenous clindamycin infusion in the two women. After discontinuation of clindamycin and anti-allergic treatment, the symptoms were relieved. Conclusion The adverse drug reactions are related to T-cell-mediated immune responses, HLA-B*51:01 and IL36RN gene polymorphisms, and perinatal immune changes. Clindamycin used during the perinatal period, especially in individuals with specific drug allergies, carries a potential risk of inducing AGEP. It is recommended that the risks be assessed before medication and monitoring be enhanced to ensure the safety of both the mother and the fetus.

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One Case of Scrotal Inflammation with Local Necrosis Caused by Dapagliflozin Tablets

LI Hualong, WANG Lingfeng, LU Qian

2026, 23(6): 690-692.
DOI: 10.19803/j.1672-8629.20250377

Abstract ( 56 )

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Objective To analyze the clinical characteristics and treatments of scrotal inflammation with local necrosis induced by dapagliflozin so as to provide a reference for safe clinical practice. Methods One case of scrotal inflammation with local necrosis induced by dapagliflozin was analyzed and the possible mechanism, clinical characteristics, and treatment regimens were investigated based on literature. Results After 4 months of taking dapagliflozin, the patient developed epididymo-orchitis. Related literature and time correlations of medication suggested that this symptom might have been caused by dapagliflozin. The patient was discharged after right testicular epididymis resection under intraspinal anesthesia. Conclusion When dapagliflozin is used in clinic, clinicians need to alert to adverse reactions in the urogenital system, which may lead to surgery or even threaten life if left untreated.

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One Case of Vulvar Ulcer Caused by Recombinant Human Papillomavirus Quadrivalent Vaccine

GAO Xin

2026, 23(6): 693-695.
DOI: 10.19803/j.1672-8629.20250415

Abstract ( 32 )

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Objective To investigate one case of vulvar ulcer suspected to be caused by the recombinant human papillomavirus quadrivalent (types 6,11,16,18) vaccine (4v hpv vaccine) so as to provide a reference for safe vaccination. Methods The clinical data of one patient who developed vulvar ulcer after receiving the 4v hpv vaccine was analyzed while related literature was reviewed to identify the possible causes and manage this adverse reaction. Results The patient used to be healthy with no related medical history. Vulvar ulcer was considered to be an adverse reaction associated with the 4v hpv vaccine. After anti-infection treatment, the patient improved and was discharged. Conclusion After vaccination with the 4v hpv vaccine, monitoring of vaccine-related adverse reactions is essential, and immediate therapeutic interventions are recommended in the event of vulvar ulcers.

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One Case of Autoimmune Hemolytic Anemia Caused by Camrelizumab for Injection

LAN Zhihui, BU Lijia, NING Jie, JIANG Jiemei, YANG Yanbiao

2026, 23(6): 696-698.
DOI: 10.19803/j.1672-8629.20250180

Abstract ( 30 )

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Objective To explore such adverse reactions as autoimmune hemolytic anemia (AIHA) caused by camrelizumab for injection in order to provide a reference for safe medications. Methods One case of severe anemia following the use of an immune checkpoint inhibitor (ICI) in a patient with parotid gland carcinoma was analyzed based on related literature. Results Based on the patient’s medical history, results of laboratory tests, and the timing of drug administration, the patient’s AIHA was considered an adverse reaction caused by camrelizumab for injection. Conclusion AIHA caused by ICI is very rare because it is difficult to detect at an early stage. Once detected, anemia is usually severe. Therefore, immune related adverse reactions should be monitored and identified when ICI is used clinically, especially among chronic users.

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One Case of Lower Limb Edema Caused by Fuzhiqing Ointment

WANG Hao, PAN Peng, QIN Haijun, WANG Jianping

2026, 23(6): 699-701.
DOI: 10.19803/j.1672-8629.20260104

Abstract ( 37 )

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Objective To explore the adverse reactions induced by Fuzhiqing ointment and provide a reference for its clinical application. Methods One case of a patient with cerebral infarction complicated with mixed hemorrhoids, thrombotic external hemorrhoids, constipation, and chronic anorectal inflammation was analyzed. The patient developed bilateral lower limb edema after 12 days of topical application of Fuzhiqing ointment. The possible causes, as well as corresponding prevention and treatment measures, were explored. Results The lower limb edema in this patient was likely associated with the prolonged topical use of Fuzhiqing ointment. The symptoms of the patient improved significantly 2 days after drug withdrawal and completely disappeared one week after drug withdrawal. Conclusion Clinicians should be alert to the risk of lower limb edema among patients who chronically use Fuzhiqing ointment, and ensure its rational use.

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Research Progress on Reducing Toxicity and Controlling Toxicity in the Traditional Chinese Medicine Dichroae Radix

MA Lina, GU Yuanyuan, LIU Wenjing, HE Ting, ZHAO Wei, CAO Junling

2026, 23(6): 702-706.
DOI: 10.19803/j.1672-8629.20260130

Abstract ( 19 )

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Objective To collate the ancient and modern toxicity reduction methods of Dichroa Radix, explore the regularities and effective strategies for toxicity reduction, thereby providing a reference for establishing a toxicity-reduction and control process for Dichroa Radix based on its unique “toxicity-efficacy”characteristics. Method By collating the toxicity-reducing methods for Dichroa Radix recorded in ancient medical classics, including processing, compatibility, and syndrome-based medication, as well as, combining them with modern processing techniques, studies on the toxicity efficacy relationship, and combination drug toxicity reduction research, the relevant data were analyzed. Results The toxicity-reducing methods recorded in ancient texts primarily involved processing and compatibility. The processing methods gradually evolved from wine-processing to the combined use of multiple excipients. Modern studies have clearly indicated that quinazolinone alkaloids are not only the active components responsible for the antimalarial and other therapeutic effects of Dichroa Radix, but also the main toxic substrates, exhibiting a typical characteristic of “integration of toxicity and efficacy.” Experimental evidence has confirmed that processing can reduce the content of febrifugine, while compatibility can alleviate adverse reactions such as vomiting, and the related toxicity-reducing mechanisms have been elucidated. Conclusion The methods for reducing the toxicity of Dichroa Radix have a long history and diverse forms. The integration of traditional experience with modern research has laid a foundation for its safe clinical application. A thorough elucidation of the molecular basis and target underlying the reduction of toxicity and enhancement of efficacy in active ingredients characterized by the “integration of toxicity and efficacy”, combined with modern formulation technologies to optimize manufacturing processes, is helpful for advancing the modern development and precise application of Dichroa Radix.

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Research Progress in Medicinal of Leeches

WANG Xueni, LIU Wenping, ZHANG Yunan, NI Zhexin, HUANGFU Chaoji, ZHOU Wei, GAO Yue

2026, 23(6): 707-713.
DOI: 10.19803/j.1672-8629.20250927

Abstract ( 28 )

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Objective To review the current taxonomy, morphology, physiological adaptation mechanisms and pharmacological effects of leeches as well as research progress in repellency and control measures in order to provide a reference for basic research, development of pharmaceuticals, and efficient use of leech resources. Methods Such databases as CNKI, Wanfang Medicine, PubMed, Web of Science, and the China Species Library were searched for related literature. Studies on the taxonomy, anatomy, physiology, pharmacology, and control technologies of leeches were summarized and analyzed. Results The taxonomic system of leeches was not made uniform in China, and the actual species of leeches might have been underestimated. Leeches possessed a specialized morphology, anatomy, and mechanism for physiological adaptation, whose salivary gland secretions were rich in bioactive components and important pharmacologically due to their anticoagulant, antithrombotic, anti-inflammatory, and wound-healing-promoting properties. However, the mechanisms of action and structure-activity relationships remained to be elucidated. Despite the constant advances in research on repellency, control, and resource utilization of leeches, the related technological systems still needed to be improved. Conclusion Considerable progress has been made in research on the taxonomy, morphological structure, and pharmacological effects of leeches. However, the taxonomic revision, diversity surveys, and development and application of active components leave much to be desired. Traditional taxonomy should be used in combination with molecular systematics. More effort needs to be devoted to the functional analysis, applications and development of pharmacologically active substances derived from leeches so as to promote the valid evaluation, rational use, and sustainable development of leech resources.

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Research Progress in the Pathogenesis of Acute Lung Injury and Interventions with Traditional Chinese Medicine

NIU Yuanfei, LIU Meiting, RONG Wenshuang, MA Lina, GU Yuanyuan, ZHANG Lichun, HOU Hongping, YANG Mengyuan, ZHENG Changhui, FU Yao, HE Ting, ZHAO Wei, WANG Lianmei, CAO Junling

2026, 23(6): 714-719.
DOI: 10.19803/j.1672-8629.20250593

Abstract ( 31 )

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Objective To explore the advancements in research on interventions by traditional Chinese medicine and its active ingredients in acute lung injury (ALI) so as to provide a reference for the development of novel TCM-based pharma-cotherapies and for precision clinical strategies for the prevention and treatment of ALI. Methods The pathophysiological mechanisms underlying ALI were summarized. Recent research progress in mitigating ALI via TCM and its active components by modulating key pathways, including inflammation, oxidative stress, and the gut-lung axis was analyzed. Results ALI and its more severe form, acute respiratory distress syndrome (ARDS), were leading causes of respiratory failure in critically ill patients and were associated with high morbidity and mortality. The pathogenesis of ALI was complex, involving multiple interconnected pathological processes, including dysregulated inflammation, oxidative stress, apoptosis, and disruption of the alveolar-capillary barrier. These factors were intertwined to form a sophisticated pathological network. Current clinical management of ALI primarily relied on organ support and anti-inflammatory therapies, and specific and effective interventions were lacking. Conclusion TCM, characterized by a holistic regulatory approach through multi-target and multi-pathway mechanisms, is well-aligned with this intricate pathological network and offers unique therapeutic advantages. This compatibility suggests that TCM promises to be an adjunctive approach to ALI, so more research is needed.

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FDA is Requiring Warning about Vitamin B₆ Deficiency and Associated Seizures for Drug Products Containing Carbidopa/Levodopa

2026, 23(6): 720-720.
DOI: 10.19803/j.1672-8629.20269906

Abstract ( 48 )

PDF (657KB) ( 56 )

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