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Chinese Journal of Pharmacovigilance
15 October 2025, Volume 22 Issue 10

15 October 2025, Volume 22 Issue 10 Previous Issue   
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Changes and Digital Characterization of Cross-Section Characters of Polygonum Multiflorum Thunb. Grown for Different Years and Harvested at Different Times
YANG Yanrong, SHI Jia, WANG Qi
2025, 22(10): 1081-1086. 
DOI: 10.19803/j.1672-8629.20250455

Abstract ( 40 )   PDF (1554KB) ( 65 )  
Objective To explore the characteristics of Polygonum multiflorum Thunb. grown for 1 to 6 years and harvested in spring and autumn and to study the correlations between years of growth and its properties. Methods The Sapphire dual-mode multispectral laser imaging system was used to scan the sections of Polygonum multiflorum Thunb. pieces harvested in spring and autumn and grown for 1 to 6 years. By measuring the number, surface area, central vascular area and total area of abnormal vascular bundles on the sections of Polygonum multiflorum Thunb., the properties of Polygonum multiflorum Thunb. harvested in spring and autumn and grown 1 to 6 years were analyzed. Results ① The number of abnormal vascular bundles decreased with the years of growth, and the number of samples collected in the spring and grown for 1 to 6 years ranged from 8-16 to 8-15, compared with 9-20 to 9-16 for those collected in autumn. ② The cross-sectional surface area of Polygonum multiflorum Thunb. samples collected in spring and autumn increased with the years of growth, ranging from 3.92-5.26 cm2 to 10.14-15.37 cm2 for those collected in spring and from 4.84-5.37 cm2 to 12.29-17.32 cm2 for those harvested in autumn. ③ The central vascular bundle areas of Polygonum multiflorum Thunb. harvested in spring and autumn increased with the years of growth, with the samples harvested in spring ranging from 0.31-0.49 cm2 to 0.61-0.88 cm2 and from 0.27-0.42 cm2 to 0.58-0.77 cm2 for those collected in autumn.④ The areas of abnormal vascular bundles of Polygonum multiflorum Thunb. harvested in spring and autumn increased with the years of growth, with the samples harvested in spring ranging from 0.45-0.74 cm2 to 0.97-1.62 cm2 and from 0.58-0.77 cm2 to 1.55-2.14 cm2 for those harvested in autumn.⑤ The ratio of the central vascular bundle area to the cross-sectional area of decoction pieces collected in spring and autumn and grown for different years trended downward with the years, and ranged from 0.06-0.11 cm2 to 0.05-0.06 cm2 and from 0.05-0.08 cm2 to 0.04-0.06 cm2 respectively.⑥ The ratio of the total area of abnormal vascular bundles to the cross-sectional surface area of samples collected in spring and autumn and grown for different years became smaller with the years. The ratio decreased significantly in samples grown for 1-3 years, but gradually stabilized in those grown for over 3 years. The ratio ranged from 0.09-0.18 cm2 to 0.07-0.16 cm2 in samples collected in spring and from 0.07 to 0.16 for those collected in autumn. Conclusion The way in which the properties of Polygonum multiflorum Thunb. change in the process of growth has been elucidated, and the properties of Polygonum multiflorum Thunb. pieces are basically stable after three years of growth. Two important characteristics, namely, the cross-sectional surface area and the total area of abnormal vascular bundles, are larger in those collected in autumn and of the same age, so harvesting Polygonum multiflorum Thunb. in autumn is preferable.
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Process of Cutting Polygonum multiflorum Slices Based on Chemical Composition
WANG Qi, LI Yanyi, YANG Yanrong, SHI Jia
2025, 22(10): 1087-1093. 
DOI: 10.19803/j.1672-8629.20250369

Abstract ( 28 )   PDF (1555KB) ( 44 )  
Objective To investigate the differences in the distribution of main chemical components in different medicinal parts of Polygonum multiflorum decoction pieces, and to explore the applicability of processing techniques for removing the two ends of the plant. Methods A liquid chromatography-mass spectrometry system was used to find out about the differences in the content distribution of eleven chemical components in the middle and at both ends of Polygonum multiflorum decoction pieces sold in four areas of production. Results The distribution of the eleven chemical components measured in Polygonum multiflorum was higher at both ends than in the middle. Among these components, the content of 2,3,5,4 '- tetrahydroxystilbene-2-O-β-D-glucoside (trans-THSG) at either end was twice that of the middle. In addition, the contents of emodin-8-O-β-D-glucoside and quercetin-8-O-β-D-glucoside at either end of the samples from three of the areas of production were almost twice those of the middle. In Polygonum multiflorum decoction pieces of different origins, the distribution of trans-THSG, emodin-8-O-β-D-glucoside and quercetin-8-O-β-D-glucoside was considerably different. Conclusion The processing method-removing both ends of Polygonum multiflorum-can reduce the contents of trans-THSG, emodin-8-O-β-D-glucoside, and quercetin-8-O-β-D-glucoside in the decoction pieces to some extent, thereby lowering the risk of hepatotoxicity of Polygonum multiflorum.
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Components of Polygonum multiflorum Thunb. Leaves and Methods of Steaming Based on High-Resolution Q-Exactive-Orbitrap MS
WANG Yan, ZHANG Kai, NIU Chuang, LIU Wei, JIN Haina, WANG Qi
2025, 22(10): 1094-1099. 
DOI: 10.19803/j.1672-8629.20250370

Abstract ( 27 )   PDF (1735KB) ( 70 )  
Objective To analyze the chemical constituents of Polygonum multiflorum Thunb. Leaves, observe the changes in chemical constituents steaming, and to explore the effect of steaming on the chemical constituents. Methods The Waters Acquity UPLC BEH-C18 column (100 mm×2.1 mm, 1.7 μm) was used, and the mobile phase was composed of 0.1% formic acid water solution (A) - acetonitrile (B) under gradient elution. Q-Exactive-Orbitrap MS was used for data acquisition and analysis. The chemical constituents were qualitatively and relatively quantitatively analyzed by using standard products, and the results were compared with what was reported in literature. Results Thirty components were identified in Polygonum multiflorum Thunb. leaves and their steamed products. The relative contents of characteristic components changed significantly after steaming. The contents of stilbene glycosides and anthraquinones decreased, especially the former, whose content plummeted by more than 50%, while that of tannins increased. Conclusion Polygonum multiflorum Thunb. leaves contain such components as stilbene glycosides, anthraquinones and flavonoids, which are consistent with the characteristic components in the roots. The contents of components change after steaming. This study is expected to provide data for the tapping of its medicinal value and ensuring the safety of the drug for internal use.
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A Method for Determination of Polymers in Desmopressin Acetate
SUN Yue, LUO Shuqing, PAN Xiaoran, HU Xinyue, DING Xiaoli, LI Jing
2025, 22(10): 1100-1103. 
DOI: 10.19803/j.1672-8629.20250392

Abstract ( 20 )   PDF (1417KB) ( 44 )  
Objective To establish a method for the determination of polymers in desmopressin acetate using size exclusion chromatography. Methods A size exclusion chromatography method was employed, using a TSKgel G2000SWXL column (TSKgel G2000SWXL, 7.8 mm×300 mm, 5μm) with a mobile phase consisting of phosphoric acid-acetonitrile-methanol-water (0.2∶15∶5∶80) (with pH adjusted to 2.5 by disodium hydrigenphosphate buffer) at the flow rate of 0.3 mL·min-1. The column temperature was 25℃, the detection wavelength 210 nm, and the injection volume was 50 µL. Results The peaks of the parallel-dimer and desmopressin acetate were well separated with a good specificity, durability and precision. The parallel-dimer, cross-dimer and desmopressin acetate showed a good linear relationship within the concentration ranges of 0.01-21.6 μg·mL-1, 0.01-22.9 μg·mL-1 and 0.01-25.6 μg·mL-1, respectively (r>0.99). The limits of detection and quantification for the parallel-dimer, cross-dimer and desmopressin acetate were 0.14, 0.31, 0.17ng and 0.43, 0.46, 0.51 ng, respectively. The average recovery (n=9) of the parallel-dimer and cross-dimer ranged from 95% to 105%, indicating good accuracy. Conclusion This method is operable, accurate and sensitive, making it desirable for the determination of polymers in desmopressin acetate.
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Establishment of a High-Performance Liquid Chromatography-Fluorescence Micelle Assay for Determination of Polysorbate 80 in Human Papillomavirus Vaccines
LU Qiong, WANG Feiyu, YU Xiaojuan, ZHANG Jie, LIANG Haoyu, HUANG Weijin, NIE Jianhui
2025, 22(10): 1104-1108. 
DOI: 10.19803/j.1672-8629.20250492

Abstract ( 22 )   PDF (1302KB) ( 55 )  
Objective To evaluate the applicability of a high-performance liquid chromatography-fluorescence micelle assay (HPLC-FMA) for quantitative determination of polysorbate 80 in human papillomavirus (HPV) vaccines. Methods A SupelcoKnitted Reactor Coil (5 m×0.50 mm ID) was used as the reaction coil for HPLC-FMA analysis. The mobile phase was a tris (hydroxymethyl) aminomethane mixed solution at a flow rate of 1.5 mL·min-1. The detection wavelength was set at an excitation of 350 nm and an emission of 420 nm while the acquisition time was 2.5 minutes. The contents of polysorbate 80 were calculated using the fluorescence intensity (peak area). Results The method proved to be highly specific. Polysorbate 80 showed a good linear relationship at concentrations ranging from of 50 to 250 µg·mL-1, with an R2 value of 0.999 8. The instrument precision of RSD was 0.223%, and the intermediate precision of RSD was 1.269%. The average value from six replicate measurements was 91.123 µg·mL-1 with an RSD of 0.399%. Recovery rates at different concentrations ranged from 98.725% to 99.866%, with RSD values between 0.321% to 1.636%. The contents of polysorbate 80 in eight batches were determined as 96.500, 95.850, 94.940, 96.049, 91.847, 92.147, 102.060 and 84.667µg·mL-1, respectively. Conclusion This HPLC-FMA method requires no toxic chemicals or chromatographic columns, and can complete the assay within minutes, which can facilitate rapid, accurate, and reliable quantification of polysorbate 80 in HPV vaccines.
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An HPLC-MS/MS Method for Determination of Ceftazidime and Avibactam Concentrations in Human Plasma
LIU Tongtong, GUO Xingchen, ZHANG Dongjie, CHEN Qi, ZHAO Zhigang, MEI Shenghui, NING Xiao, YUAN Jinghua
2025, 22(10): 1109-1113. 
DOI: 10.19803/j.1672-8629.20240847

Abstract ( 17 )   PDF (1341KB) ( 56 )  
Objective To establish an LC-MS/MS method for the determination of ceftazidime (CAZ) and avibactam (AVI) in human plasma and apply the method to detection of clinical samples. Methods Plasma samples were deproteinized via methanol precipitation, with CAZ-d6 and AVI-13C5 as internal standards (IS), respectively. Chromatographic separation was performed on a ProChrom300 C18 column (Pusheng Technology, 2.1 mm×50 mm, 3 μm particle size) using gradient elution with 0.1% formic acid in water and in methanol respectively. The flow rate was 0.3 mL·min-1 and the column temperature was 40°C. For CAZ under the ESI+ mode, the qualitative and quantitative ion pairs were m/z 547.0>467.7 and m/z 547.0>396.0, respectively while the corresponding ion pairs for its IS were m/z 553.0>402.0 and m/z 553.0>473.7, compared with m/z 263.7>79.8 and m/z 263.7>96.0 respectively and m/z 268.7>79.8 and m/z 268.7>96.0 respectively for AVI-under ESI-. Results CAZ showed good linearity over the range of 2.00 μg·mL-1 to 200.30 μg·mL-1. The intra-day and inter-day accuracies were -5.64% to 3.79% and -7.10% to -1.83%, respectively while the intra-day and inter-day precisions (RSD%) were 1.06% to 3.34% and 1.45% to 6.36%, respectively, compared with 0.21 μg·mL-1 to 20.50 μg·mL-1, -5.22% to 13.39% and -3.46% to 5.06%, and 2.39% to 3.88% and 2.41% to 6.23% for AVI. The recovery rates of CAZ at low, medium and high concentrations ranged from 95.00% to 98.50%, compared with 96.50% to 105.10% for AVI. Samples remained stable under all tested conditions. Conclusion The established LC-MS/MS method for the determination of plasma CAZ and AVI is accurate, stable, simple, and suitable for clinical monitoring of therapeutic drugs.
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In vitro Evaluation of Mutagenicity Risk by N-nitroso Bumetanide
JIANG Chenchen, JIN Longlong, KOU Xiaoxuan, SONG Jie, SHI Haokun, HUANG Qin, WEN Hairuo
2025, 22(10): 1114-1119. 
DOI: 10.19803/j.1672-8629.20250436

Abstract ( 16 )   PDF (1513KB) ( 57 )  
Objective To evaluate the mutagenicity risk of N-nitroso bumetanide in vitro and provide data for its safety assessment. Methods Structure-activity relationships were analyzed using Derek Nexus and Sarah Nexus software to predict mutagenicity and structural alerts. An enhanced bacterial reverse mutation test was conducted according to EMA guidelines using Salmonella typhimurium TA98, TA100, TA1535, TA1537, and Escherichia coli WP2 uvrA(pKM101) strains in the absence of post-mitochondrial fraction (S9), and also in the presence of 30% rat liver s9, as well as 30% hamster liverS9,followed by 30 min of pre-incubation. Additionally, a mouse lymphoma assay (MLA) was performed to detect cytotoxicity and mutation frequency under different treatment. Results In terms of structure-activity, Derek Nexus predicted the bacterial mutagenicity risk (rated as “plausible”) due to the N-nitroso structure while Sarah Nexus rated it as “ambiguous”. In the enhanced bacterial reverse mutation test, no obvious increase in revertant colonies of any strain was observed at doses of 125-5 000 μg per plate. In the MLA, the relative total growth (RTG) pointed to no obvious toxicity at concentrations of 312.5-2 500 μg·mL-1, and the mutation frequencies did not differ significantly from those of the negative control, with all the results being negative. Conclusion N-nitroso bumetanide does not pose any mutagenicity risk when tested in vitro.
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Clinical Medications and Safety of Traditional Chinese Medicine for Osteoporosis Complicated with Lumbar Disc Herniation
KANG Jiaqi, BAI Jianqi, CAI Mingyang, WANG Yuan, ZHANG Ping
2025, 22(10): 1120-1126. 
DOI: 10.19803/j.1672-8629.20250476

Abstract ( 48 )   PDF (1652KB) ( 68 )  
Objective To analyze the clinical medications and safety of oral traditional Chinese medicine (TCM) in the treatment of osteoporosis (OP) combined with lumbar disc herniation (LDH). Methods Medical records of outpatients diagnosed with OP combined with LDH and treated with oral administration of TCM in Wangjing Hospital between January 2023 and April 2025 were collected. Data on their medications was statistically analyzed via the Ancient and Modern Medical Cases Cloud Platform (V2.3.9), including high-frequency herbs, compatibility of herb pairs, and core prescriptions for OP complicated with LDH. The safety of these medications was assessed based on clinical data and literature review. Results A total of 250 cases were included. Most of the patients were middle-aged or elderly, accounting for 87.2%. 236 types of TCM herbs were used, with a total frequency of medication use of 3,378. High-frequency herbs included Ligusticum chuanxiong Hort., Achyranthes bidentata Bl., and Paeonia lactiflora Pall. The properties of these herbs were predominantly warm, neutral or slightly warm and the flavors were mainly sweet, bitter or pungent. The meridian tropisms involved the liver, spleen, and kidney. The efficacies included tonifying the liver and kidney, strengthening tendons and bones, and dispelling wind-dampness. Association analysis showed that high-frequency herb pairs were Ligusticum chuanxiong Hort.- Achyranthes bidentata Bl., Ligusticum chuanxiong-Paeonia lactiflora Pall., and Paeonia lactiflora Pall.- Achyranthes bidentata Bl. The core prescriptions for OP combined with LDH consisted of 15 types of herbs. The most commonly used Western medicines were calcium carbonate D3 tablets, mecobalamin tablets and calcitriol soft capsules, and the Chinese patent medicines included Danlu Tongdu tablets, Gutong plaster and Jintiange capsules. Safety assessment indicated that TCM was safe in treating OP combined with LDH. Conclusion The basic principle by which TCM treats OP combined with LDH is to regulate the liver, spleen, and kidney in order to tonify the liver and kidney, strengthen tendons and bones, and dispel wind-dampness. These medications have proved to be safe clinically.
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Interpretations of Revised Guidelines for Bacterial Endotoxin Testing in Chinese Pharmacopoeia 2025
PEI Yusheng, GAO Hua, ZHU Ran, LIU Tao, CAI Tong
2025, 22(10): 1127-1131. 
DOI: 10.19803/j.1672-8629.20250396

Abstract ( 44 )   PDF (1375KB) ( 91 )  
Objective To interpret the revised guidelines for bacterial endotoxin testing (9251) in Chinese Pharmacopoeia 2025 in order to help make the related testing more precise and feasible. Methods The modifications in the guidelines for bacterial endotoxin testing specified in Chinese Pharmacopoeia 2025 were analyzed. The background for the revision and implications were studied in depth. Results The major revisions included① specifications of endotoxin limits for ophthalmic medications; ②refined limit-setting requirements for raw materials, excipients, and packaging materials; ③ common interferents and ways of removal; ④ detailed descriptions of pretreatment methods for poorly soluble samples and packaging materials; ⑤ descriptions of low endotoxin recovery; ⑥ the specification of the recombinant factor C method as a complementary approach. Conclusion These revisions reflect better standards for pharmaceutical quality control in China and provide more practical technical guidance for professionals, which are of vital importance for quality control of pharmaceuticals.
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Interpretations of Revised Bioassay of Follicle-Stimulating Hormone in Chinese Pharmacopoeia 2025
WU Yanlin, WEN Miao, YANG Ze'an, ZHANG Yuan, HE Qing
2025, 22(10): 1132-1136. 
DOI: 10.19803/j.1672-8629.20250537

Abstract ( 19 )   PDF (1386KB) ( 58 )  
Objective To interpret the newly added and revised bioassay methods for the determination of bioactivity of follicle-stimulating hormone (FSH) in the Chinese Pharmacopoeia (2025 edition), and to conduct a comparative study on the refinement and standardization of these methods so as to facilitate the understanding and implementation of these standards. Methods An overview of the revisions of and additions to FSH bioassay methods was given. By elaborating on the process of drafting the additions of and revisions to the methods, the necessity and feasibility of the newly added methods were explained. Results The newly added methods in the Chinese Pharmacopoeia (2025 Edition), namely Method Two of 1216 FSH Biological Activity Determination and Method 3536 for Human FSH Biological Activity Determination, were both cell response methods. They were characterized by a high sensitivity, good specificity, high accuracy, and good consistency with the current standards. Conclusion The newly added methods for the determination of the FSH biological activity in the Chinese Pharmacopoeia (2025 Edition) is the first of its kind globally in the field of FSH activity determination. The progress in methods for FSH biological activity determination will help improve quality control of FSH products.
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Adverse Event Signals of Basiliximab after Liver and Kidney Transplantation Based on FAERS Database
CHENG Saisai, ZHOU Bi
2025, 22(10): 1137-1142. 
DOI: 10.19803/j.1672-8629.20240646

Abstract ( 37 )   PDF (1342KB) ( 74 )  
Objective To explore the adverse event signals of basiliximab after kidney transplantation and liver transplantation, and to assess the safety of its clinical applications by finding some new suspicious signals of adverse events. Methods By adopting two signal mining methods-the information component (IC) method and the reporting odds ratio (ROR) method- and based on the proportion imbalance approach, the adverse events of basiliximab collected between January 1, 2004 and June 30, 2024 were retrieved from the FDA's Adverse Event Reporting System (FAERS) database. Results A total of 92 suspicious positive signals were identified for basiliximab after kidney transplantation, involving 26 system-organ classes (SOCs), compared with 27 after liver transplantation, involving 23 SOCs. Increased serum creatinine, fever, anemia, decreased platelet count, increased blood glucose, decreased blood pressure and other adverse reactions were consistent with the conditions specified in the instructions of basiliximab. After excluding the adverse reactions related to kidney transplantation itself, decreased lymphocyte count, increased white blood cell count and neutrophil count, elevated alanine aminotransferase, higher levels of blood lactate dehydrogenase, higher aspartate aminotransferase, abnormal liver function, lymphocyte infiltration, chest discomfort, diffuse intravascular coagulation, neurotoxicity after renal transplantation and other new suspicious signals of adverse events not mentioned in drug labels were found. New suspicious signals of adverse events after liver transplantation, such as shock, pleural effusion and elevated C-reactive protein, were detected after the possible adverse reactions of liver transplantation itself were excluded. Conclusion Rigorous monitoring is critical when basiliximab is used clinically. Special attention needs to be paid not only to suspicious adverse event signals that are left unmentioned in instructions, such as nervous system diseases, ocular diseases and thrombotic diseases caused by hypercoagulability after kidney transplantation, but also to new and serious suspected adverse event signals such as shock and pleural effusion after liver transplantation.
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179 Cases of Drug Eruptions Related to Antiepileptic Drugs
REN Liuli, LYU Fengwen, XIA Quan
2025, 22(10): 1143-1147. 
DOI: 10.19803/j.1672-8629.20250405

Abstract ( 40 )   PDF (1397KB) ( 59 )  
Objective To analyze the clinical characteristics of drug eruptions caused by antiepileptic drugs (AEDs), and provide a reference for the prevention and treatment of related adverse drug reactions. Methods Retrospective analysis was conducted of the basic data, sensitizing drugs, incubation periods, clinical features, treatments, and outcomes of patients with AEDs-related drug eruptions and admitted to a tertiary hospital in 2015-2024. Results Among the 179 hospitalizations, carbamazepine was the most common causative drug (48.04%), with a median incubation period of 19.00 (10.00, 25.25) days, followed by lamotrigine (27.37%), with a median incubation period of 14.00 (9.25, 30.00) days. The primary approaches to AEDs included epilepsy management, neuropathic pain treatment, and mood stabilization. The median age of the patients (105 females and 74 males) was 48 (30, 64) years. The median incubation period of drug eruptions was 17.00 (10.00, 26.00) days. Thirty-three patients were diagnosed with severe drug eruptions, including 26 cases of Stevens-Johnson syndrome and 7 cases of toxic epidermal necrolysis. In addition to skin manifestations, common findings included elevated CRP levels (63.69%), abnormal liver function (54.75%), fever (48.60%), and elevated peripheral blood eosinophil counts (23.46%). Primary treatments involved discontinuation of the causative drugs and administration of glucocorticoids (98.32%) and antihistamines (60.35%). Intravenous immunoglobulin was administered to some patients with severe drug eruptions (42.42%). All the 179 patients improved and were discharged after treatment, with a median hospital stay of 10.00 (8.00, 13.00) days. Conclusion Multiple AEDs can cause drug eruptions, with maculopapular eruptions being the most common. These eruptions are often accompanied by elevated CRP, abnormal liver function, and fever. Vigilance for the development of severe drug eruptions is crucial. The prognosis is generally favorable with timely diagnosis and appropriate treatment.
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160 Cases of Adverse Reactions to Novel Antitumor Drugs
MENG Xianqi, ZHU Weinan, ZHANG Yinyin
2025, 22(10): 1148-1153. 
DOI: 10.19803/j.1672-8629.20240856

Abstract ( 42 )   PDF (1307KB) ( 65 )  
Objective To analyze the characteristics and patterns of adverse reactions caused by new anti-tumor drugs in a hospital in order to provide references for rational clinical use of drugs. Methods The reports of adverse reactions induced by novel anti-cancer drugs submitted to the National Drug Adverse Reaction Monitoring System between 2021 and 2024 by our hospital were retrieved before the patients' age, gender, usage of drugs, types of adverse reactions, systems (organs) affected and clinical manifestations were analyzed. Results Among the 160 cases of adverse reactions, 78 involved male patients (48.75%) and 82 involved female ones (51.25%). The age of the patients ranged from 36 to 99, with an average age of (63.74 ± 11.50) years. The adverse reactions mostly affected the skin and its appendages (31.38%) and the digestive system (29.29%). The common clinical manifestations were diarrhea (22 cases), nausea (20 cases), hand-foot syndrome (18 cases), rash (18 cases), and pruritus (15 cases). Conclusion The adverse reactions related to new anti-tumor drugs involve patients across age groups and affect multiple systems and organs, including the skin and its appendages, the digestive system, systemic damage, and the circulatory system. When patients use new anti-tumor drugs, special attention should be paid to such adverse reactions as diarrhea, nausea, hand-foot syndrome, rash, and itching, and effective prevention and treatment measures should be taken.
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148 Case of Drug-Induced Liver Adverse Reactions
TUO Kangxiu, YANG Chengli, LI Ming, JIANG Man
2025, 22(10): 1154-1158. 
DOI: 10.19803/j.1672-8629.20250482

Abstract ( 84 )   PDF (713KB) ( 106 )  
Objective To investigate the characteristics of drug-induced liver injury and provide references for related medications and prevention. Methods The case reports of drug-induced liver adverse reactions submitted to the National Adverse Drug Reaction Monitoring System by the Affiliated Hospital of Guizhou Medical University in 2021-2024 were collected and analyzed. Results A total of 148 cases of drug-induced liver adverse reactions were collected. Using the RUCAM scale, 109 cases were scored 6 to 8, and 39 cases 3 to 5. Among the 59 cases of liver injury whose detection indicators met the classification criteria, hepatocyte injury was the dominating type (44 cases), followed by the cholestatic type (10 cases) and the mixed type (5 cases). There were 55 grade Ⅰ cases and 4 grade Ⅱ cases. The top three drug categories responsible for live injury were antineoplastic drugs (41.58%), anti-infective drugs (36.63%) and drugs for the cardiovascular system (13.86%). The time from drug administration to the first detection of abnormal liver biochemical indicators was 2 to 15 days. Clinically, hepatoprotective drugs were used by 137 patients (92.57%) with drug-induced liver adverse reactions, 129 of whom provided detailed reports on their usage of hepatoprotective drugs. The types of hepatoprotective agents used ranged from 1 to 3 types: 73 cases (56.59%) took one type of hepatoprotective agent, 43 cases (33.33%) received two types of hepatoprotective agents, and 13 cases (10.08%) were given three types of hepatoprotective agents. Conclusion A wide range of drugs can cause drug-induced liver adverse reactions, with those causing hepatocellular injury as the dominating type. In clinical practice, high-risk drugs for liver injury should be monitored more rigorously. When formulating liver-protecting treatment plans, clinicians are advised to weigh the advantages and disadvantages of combined medications.
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Pharmaceutical Care to a Hypokalemia Elderly Patient with Pulmonary Mucormycosis Induced by Amphotericin B Cholesteryl Sulfate Complex
LI Bing, LIU Shuo
2025, 22(10): 1159-1161. 
DOI: 10.19803/j.1672-8629.20250125

Abstract ( 19 )   PDF (1197KB) ( 66 )  
Objective To analyze the pharmaceutical care given by a clinical pharmacist for an elderly patient with pulmonary mucormycosis who developed severe hypokalemia in order to provide references for safe clinical use. Methods A clinical pharmacist was involved in the pharmaceutical care for a patient who had underlying hypokalemia and experienced more decline in serum potassium levels during ABCD treatment for pulmonary mucormycosis. During the pharmaceutical care, the pharmacist assessed the rationality of the ABCD dosage and administration route, investigated the causes of recurrent hypokalemia, calculated the required potassium supplementation dose, and adjusted the potassium correction regimen. Results With the help of the clinical pharmacist, the patient received systemic and local ABCD treatment for pulmonary mucormycosis, along with oral and intravenous potassium supplementation to address hypokalemia. Following active antifungal therapy, the patient's condition stabilized, with negative results on follow-up fungal tests, and serum potassium levels were promptly corrected. Conclusion The clinical pharmacist has played a proactive role in the geriatric treatment team by analyzing the rationality of individualized, multi-route ABCD administration for pulmonary mucormycosis in elderly patients. The pharmacist has showed a keen ability to identify adverse reactions associated with ABCD-induced hypokalemia and assisted physicians in formulating scientific potassium supplementation regimens, effectively reducing adverse drug reactions while achieving favorable therapeutic outcomes.
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One Case of Acute Drug-Induced Liver Injury Caused by Cyclophosphamide for Injection in a Patient with Relapsing Polychondritis
LIU Hong, WANG Qian, CHENG Yongjing, CHEN Yingjuan
2025, 22(10): 1162-1164. 
DOI: 10.19803/j.1672-8629.20240830

Abstract ( 28 )   PDF (1233KB) ( 63 )  
Objective To analyze the acute drug-induced liver injury caused by low-dose cyclophosphamide for injection in a patient with relapsing polychondritis so as to provide a reference for clinicians. Methods The clinical data of a patient with relapsing polychondritis who developed acute drug-induced liver injury after the first low-dose intravenous application of cyclophosphamide was analyzed. The related literature was reviewed. Results The patient presented with acute liver injury after the first low-dose intravenous application of cyclophosphamide. After correlation analysis and multidisciplinary consultation, the patient was diagnosed with acute cyclophosphamide-induced liver injury. Cyclophosphamide was discontinued, and liver protection therapy was initiated, which led to a good prognosis. Conclusion Individual differences in adverse reactions deserve attention among patients who use cyclophosphamide for the first time. This drug should be used with caution. It is critical to identify the risk factors and assess the type and severity of cyclophosphamide induced liver injury so as to adjust the treatment in time.
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One Case of Multi-Organ Immune Injury Caused by Serplulimab in an Elderly Patient with Colon Tumor
LI Xiaomei, WANG Honggui, SUN Jiajing
2025, 22(10): 1165-1167. 
DOI: 10.19803/j.1672-8629.20241005

Abstract ( 22 )   PDF (1137KB) ( 58 )  
Objective To investigate such adverse reactions as multi-organ immune injury induced by serplulimab, and to provide a reference for safe clinical practice. Methods One case of multi-organ immune injury induced by serplulimab in an elderly patient with colon tumors was analyzed, and a summary was made after literature review. Results Based on the patient's clinical manifestations, results of laboratory tests, and the temporal association with drug administration,the patient's multi-organ immune injury was considered to have been caused by serplulimab. The patient improved and was discharged after glucocorticoid therapy. However, the adverse reactions progressed because the patient failed to take the prescribed drugs or monitor for adverse reactions after discharge. Conclusion The incidence of ICIs-associated multi-organ immune injury is relatively low, but the fatality is exceedingly high. Clinicians should assess the risk before administering serplulimab, closely monitor patients during treatment, and remain alert to the risk of serplulimab-induced multi-organ immune injury.
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One Case of Acute Laryngeal Edema Caused by Acetylcysteine Solution for Inhalation
YUAN Meng, WEI Chunyan, CHEN Yao
2025, 22(10): 1168-1170. 
DOI: 10.19803/j.1672-8629.20241000

Abstract ( 40 )   PDF (1136KB) ( 64 )  
Objective To analyze the clinical characteristics of acute laryngeal edema induced by inhalation of acetylcysteine solution and to devise corresponding diagnostic approaches and therapeutic strategies in order to provide evidence-based references for safe medications. Methods One clinical case that presented with acute laryngeal edema following inhalation of acetylcysteine solution administration was analyzed before management protocols were formulated based on literature and evidence. Results A patient was treated for endoleaks in a stented abdominal aortic aneurysm. One hour and 47 minutes after acetylcysteine inhalation, the patient developed acute laryngeal edema, with clinical manifestations of dyspnea and hoarseness. The temporal correlation between drug administration and the symptom onset strongly suggested acute laryngeal edema due to acetylcysteine solution. Immediate discontinuation of the suspected agent combined with adrenaline therapy resulted in complete resolution of clinical manifestations and stabilization of vital signs. Conclusion Clinicians should remain vigilant against the risk of acute laryngeal edema associated with inhalation of acetylcysteine solution. This condition has a rapid onset and is potentially life-threatening. Enhanced clinical monitoring, comprehensive assessment, prompt withdrawal of suspected agents and adrenaline therapy when necessary are crucial to optimizing patient outcomes.
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One Case of Severe Diarrhea Caused by Semaglutide Injection
WEI Jinfei, JI Liwei
2025, 22(10): 1171-1173. 
DOI: 10.19803/j.1672-8629.20240655

Abstract ( 52 )   PDF (1222KB) ( 76 )  
Objective To analyze one case of severe diarrhea induced by semaglutide injection and to provide clinical physicians with references for its rational use. Methods Based on findings of research currently available, the diagnostic and therapeutic process, risk factors, potential mechanisms and treatment strategies related to a patient with severe diarrhea that was considered to have been caused by semaglutide injection were analyzed. Results During hospitalization, the patient experienced severe diarrhea after receiving two doses of semaglutide injection (0.5 mg). The symptoms were alleviated following symptomatic treatment. After discharge, severe diarrhea recurred when the patient was readministered with semaglutide injection (0.5 mg). The symptoms abated after discontinuation of medication. Conclusion Clinicians should initiate semaglutide injection at a low dose as instructed. Particular attention should be paid to such adverse reactions as diarrhea induced by semaglutide injection. Prompt interventions are warranted once such adverse events occur.
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One Case of Tremor Caused by Esketamine Injection
SU Su, WANG Moyi, MA Yiyi, LI Xiaoling, CHU Yanqi, ZHANG Lan
2025, 22(10): 1174-1176. 
DOI: 10.19803/j.1672-8629.20250096

Abstract ( 32 )   PDF (1216KB) ( 59 )  
Objective To study the characteristics of esketamine-induced tremors and to provide references for safe medications. Methods One case of tremor caused by esketamine was studied. The adverse reactions and pathogenesis of tremors caused by esketamine were analyzed based on correlation evaluation and literature review. Recommendations about treatment and the priorities of pharmaceutical care were outlined. Results After the drug instructions and related literature were reviewed, the correlation between esketamine and tremors was determined as “possible”. The symptoms were gradually improved after discontinuation of esketamine. Conclusion Clinicians should be aware of the risk of tremors caused by esketamine and monitor for adverse reactions of esketamine to ensure the safety of patients.
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Characterization of Higher-Order Structures in Protein Pharmaceuticals: a Study of Methods and Advances
MENG Hexin, WANG Yue, LIU Youping, LIU Bo
2025, 22(10): 1177-1182. 
DOI: 10.19803/j.1672-8629.20250615

Abstract ( 35 )   PDF (1484KB) ( 58 )  
Objective To summarize the recent advancements in methods used to characterize the higher-order structures of protein drugs in order to address the challenges to quality control and to provide references for structural analysis of related drugs. Methods By reviewing related literature, the principles and applications of and limitations to mass spectrometry, cryo-electron microscopy, and artificial intelligence prediction in the characterization of protein drug higher-order structures were synthesized. Results There were distinct advantages to different characterization techniques in terms of resolution, throughput, and dynamic information capture. Mass spectrometry excelled in analyzing conformational dynamics, cryo-electron microscopy provided near-atomic-level static structures, while the integration of multiple techniques and computational modeling significantly improved the integrity and reliability of structural information about complex protein systems. Conclusion Despite the progress that has been made in protein drug structure research, currently-used analytical methods are far from perfect. More research and the development of new methods are required to achieve more precise structural analysis, which are expected to provide technical support for the development and quality control of biological drugs.
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Advances in Pharmacological Research on Oligoasthenozoospermia
TANG Tian, TAN Tianyang, LIU Zhejun, BAI Xue
2025, 22(10): 1183-1187. 
DOI: 10.19803/j.1672-8629.20250248

Abstract ( 38 )   PDF (1207KB) ( 56 )  
Objective To summarize the recent research advances in the mechanisms of action and therapeutic effects of drugs for oligoasthenospermia in combination with research findings from corresponding animal models in order to provide more targeted references for the selection of drugs, in-depth studies on mechanisms, and development of new drugs for prevention and treatment of oligoasthenospermia. Methods PubMed, CNKI, and other databases were searched particularly for literature on research progress in antioxidant stress drugs, anti-apoptosis drugs, metabolism-regulating drugs, targeted drugs, hormone-regulating drugs, and multi-target regulatory drugs of TCM using oligoasthenospermia models. The action of and research data on a range of drugs were elaborated. Results Antioxidant stress, anti-apoptosis, metabolism-regulating, targeted, hormone-regulating drugs, and multi-target regulatory drugs of TCM could all deliver distinct therapeutic effects. Some of these drugs were unusually effective at addressing critical pathological abnormalities such as oxidative stress, mitochondrial dysfunction, and apoptotic imbalance, thus significantly enhancing sperm quality. Conclusion More effort should be made to gain insights into the action mechanisms of drugs, promote the transition of more efficient and safe drugs from basic research to clinical applications in order to facilitate the prevention and treatment of oligoasthenospermia.
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Research Advances in Phosphodiesterase Inhibitors for the Treatment of Depression
LIU Meng, FANG Ke, ZHANG Yuan, ZHANG Zhen, WEI Liangbing
2025, 22(10): 1188-1193. 
DOI: 10.19803/j.1672-8629.20250626

Abstract ( 35 )   PDF (1490KB) ( 63 )  
Objective To review the mechanisms of action, advances in research, and clinical potential of phosphodiesterase inhibitors (PDEIs) for the treatment of depression. Methods Such databases as PubMed, Web of Science, and the China National Knowledge Infrastructure (CNKI) were searched for related literature. The retrieved studies were screened and analyzed to summarize the classification of PDEs, their neuroregulatory mechanisms, and preclinical and clinical findings related to depression. Results PDEIs were found to produce antidepressant effects in various animal models primarily by modulating cyclic adenosine monophosphate (cAMP)/cyclic guanosine monophosphate (cGMP) signaling pathways. These effects involved enhancement in neuronal plasticity, regulation of neurotransmitter release, and attenuation of neuroinflammatory responses. Inhibitors targeting specific subtypes, such as phosphodiesterase-4 (PDE4) and phosphodiesterase-5 (PDE5), showed such potential advantages as rapid onset of action and cognitive improvement in preclinical and some clinical studies. However, challenges persisted, including gastrointestinal side effects and variable blood-brain barrier penetration efficiency. Conclusion PDEIs are promising as an emerging class of therapeutic agents for depression. Subsequent research should focus on optimizing subtype selectivity, developing advanced drug delivery systems, and exploring rational combination therapies to maximize their clinical utility.
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WHODrug Global: a Validated, Regularly Updated and Standardised Drug Dictionary for Medicinal Information Coding
STRESE Sara, LAGERLUND Olof, SHEN Ling, AHNFELT Emelie, YUE Qunying, FLADVAD Malin
2025, 22(10): 1194-1200. 
DOI: 10.19803/j.1672-8629.20250092

Abstract ( 62 )   PDF (1427KB) ( 101 )  
The WHODrug Global (WHODrug in short) medicinal information dictionary aim to facilitate the coding of medications in clinical trials as well as identification of medication-related problems in post-marketing surveillance, and thereby supporting the development and usage of effective and safe medications. WHODrug is a product provided by the Swedish foundation Uppsala Monitoring Centre (UMC). WHODrug contains individual product names, active ingredients and additional information such as marketing authorisation holder, country of sale, pharmaceutical form and strength, available in an English and a Chinese version. All related medications are linked using a structured WHODrug alphanumeric code, connecting product names and variations of the ingredient with the active moiety of the active ingredient s, including the International Nonproprietary Name (INN). Medications in WHODrug are classified using the ATC system and clustered into Standardised Drug Groupings, to allow for grouping of medications with one or more properties in common. The different information levels in WHODrug are used to explore the relationship between a medication or a class of medications and an adverse event. Using WHODrug in clinical trials and post-marketing safety work enables the use of accurate standardised medication nomenclature and other information that supports easier global information exchange. The ISO standards for Identification of Medicinal Products (IDMP) global Pharmaceutical Product Identifier (PhPID) is currently being added to WHODrug Global. To meet the demands of WHODrug users from the pharmaceutical industry, academia and regulatory authorities, it is essential to keep the dictionary comprehensive, validated and constantly updated on a global scale. This article introduces the application of WHODrugin practice, its data structure and applications of the structure, as well as uses of other products within the product portfolio, with the aim of supporting the effective and safe development and use of drugs.
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