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Chinese Journal of Pharmacovigilance
15 April 2025, Volume 22 Issue 4

15 April 2025, Volume 22 Issue 4 Previous Issue   
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Research Progress in Detection Methods of Pyrogen and Bacterial Endotoxin
LIU Sihan, PEI Yusheng, TAN Dejiang, SUN Huimin, ZHANG Heng, LIU Tao, WANG Dongmei, HE Qing
2025, 22(4): 361-367. 
DOI: 10.19803/j.1672-8629.20240821

Abstract ( 59 )   PDF (1324KB) ( 62 )  
Objective To introduce the detection methods of pyrogen and bacterial endotoxin in order to provide a reference for establishing a standardized detection system. Methods The characteristics, research progress and developments related to pyrogen detection in vivo, pyrogen detection in vitro and other detection methods were outlined based on related literature. Results The rabbit pyrogen method was being phased out globally while non-animal pyrogen and bacterial endotoxin detection methods became more popular. However, each in vivo method had its own technical limitations. Conclusion The limitations of each in vivo detection method make it necessary to ensure the safety of drugs for injection and medical devices.
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Testing Methods for Bacterial Endotoxin in a Pharmaceutical Excipient of Trimethyl-Phloroglucinol
ZHAO Yuxin, CAI Tong, SUN Huimin, LIU Tao, PEI Yusheng, XU Huarong
2025, 22(4): 368-371. 
DOI: 10.19803/j.1672-8629.20240820

Abstract ( 33 )   PDF (1172KB) ( 54 )  
Objective To establish a detection method for bacterial endotoxin in trimethyl-phloroglucinol. Methods According to the General Requirements of the Chinese Pharmacopoeia(2020 Edition),three methods were adopted to establish one for detection of bacterial endotoxin.①The test sample was dissolved in dimethyl sulfoxide(DMSO) to a concentration of 10 mg·mL-1, diluted 200-fold with BET water, and tested using the gel method with Limulus amebocyte lysate at a sensitivity of 0.03 EU·mL-1.②The test sample was dissolved in 70% ethanol to a concentration of 5 mg·mL-1, diluted 30-fold with BET water, and tested using the gel method with Limulus amebocyte lysate at a sensitivity of 0.25 EU·mL-1. ③The test sample was dissolved in methanol to a concentration of 100 mg·mL-1. The test solution was diluted to 10 mg·mL-1 with 20% Tween 80 solution before being diluted 40-fold with BET water and tested using the gel method with Limulus amebocyte lysate at a sensitivity of 0.03 EU·mL-1. Results After the tested products were dissolved with the three methods, the interference of the solvent and test sample with endotoxin detection was eliminated. The results of the interference test met the requirements. Conclusion Three test methods for bacterial endotoxin in trimethyl-phloroglucinol have been established, which can provide a reference for the establishment of detection methods for bacterial endotoxin in insolvable samples.
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Detection of Bacterial Endotoxin in Recombinant Follicle-Stimulating Hormone β Injection Using Gel-Clot Method and Recombinant C-Factor Method
CHEN Chen, ZHAO Xiaoyan, CAI Tong, PEI Yusheng
2025, 22(4): 372-376. 
DOI: 10.19803/j.1672-8629.20240685

Abstract ( 27 )   PDF (1284KB) ( 63 )  
Objective To establish a method for detecting bacterial endotoxins in recombinant follicle-stimulating hormone β injection in order to ensure clinical safety. Methods As required by the pharmacopoeia, the detection limit of bacterial endotoxin for recombinant follicle stimulating hormone β injection was established. The methodology of bacterial endotoxin detection was studied by using the gel method and two recombinant C factor kits made at home and abroad respectively before the two detection methods were compared. Results Interference testing showed that after an 80-fold dilution, both the gel-clot method and the recombinant C-factor method met the specified criteria, with no interference detected. The endotoxin levels in three batches of the test samples were less than 0.25 EU·IU-1. Results from the two recombinant C-factor kits were consistent with those obtained using the gel-clot method. Conclusion Both the gel-clot method and the recombinant C-factor method established in this study are applicable to the detection of bacterial endotoxins in recombinant follicle-stimulating hormone β injection.
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Determination of Linezolid Concentrations in Plasma with HPLC-MS/MS Method
WANG Jiaqing, WANG Qi, LIU Tongtong, ZHANG Dongjie, CHEN Qi, MEI Shenghui, NING Xiao
2025, 22(4): 377-380. 
DOI: 10.19803/j.1672-8629.20240848

Abstract ( 25 )   PDF (1330KB) ( 44 )  
Objective To establish an HPLC-MS/MS method for determining the concentration of linezolid in plasma. Methods Linezolid-D3 was used as the internal standard. The sample release agent containing the internal standard was added. Protein was precipitated with methanol before the supernatant was injected for detection. Results Linezolid showed good linearity within the range of 0.42-28 μg·mL-1. The average recovery was 106.7% for the low concentration, 104.9% for the medium concentration, and 105.9% for the high concentration. The intra-day and inter-day precision was 2.38 %-6.74 % and 1.37 %-2.78 %, respectively, and the precision ranged from 1.37 % to 2.78 %. Conclusion This method is simple and fast, which can be used for rapid clinical monitoring of blood drug concentrations.
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Uncertainty Evaluation for Determination of Ambroxol in Rat Plasma by UPLC-MS/MS Method
JIN Shaoming, NING Xiao
2025, 22(4): 381-385. 
DOI: 10.19803/j.1672-8629.20240851

Abstract ( 25 )   PDF (1419KB) ( 46 )  
Objective To develop a method for the determination of ambroxol in rat plasma using ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS/MS), and to analyze the uncertainty associated with this method. Methods The sources of uncertainty in the process of establishing the UPLC-MS/MS method for determining ambroxol in rat plasma were analyzed and synthesized. Results The extended uncertainties at a low concentration (20 ng·mL-1) and at a high concentration (400 ng·mL-1) of ambroxol in rat plasma were 1.25 ng·mL-1 and 20.82 ng·mL-1, respectively (P=95%, k=2). Conclusion The uncertainty that arises from the determination of concentrations of ambroxol in rat plasma using the UPLC-MS/MS method is primarily introduced by standard curve fitting, solution preparation, and repeatability at low concentrations, and by the plasma recovery rate and matrix effects at high concentrations.
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Uncertainty Evaluation for the Determination of Tacrolimus Content in Human Whole Blood by UPLC-MS/MS Method
WANG Jiaqing, WANG Qi, LIU Tongtong, ZHANG Dongjie, NING Xiao
2025, 22(4): 386-390. 
DOI: 10.19803/j.1672-8629.20240850

Abstract ( 33 )   PDF (1418KB) ( 53 )  
Objective To evaluate the uncertainty of human whole blood tacrolimus (TAC) by ultra-performance liquid chromatography-mass spectrometry coupled with immunosuppressant kits. Methods The source of uncertainty in the concentration of TAC in human whole blood was analyzed and synthesized by UPLC-MS/MS. Results The extended uncertainty of a low concentration (3.54 mg·L-1) and a high concentration (14.89 mg·L-1) of TAC in human whole blood was 0.177 8 mg·L-1 and 0.7 mg·L-1, respectively (P=95%, k=2). Conclusion In this study, we have explored the establishment of a systematic evaluation standard for applications of uncertainty evaluation methods to immunosuppre-ssant kits,which can effectively identify the key error sources in the measurement process and provide a reference for the improvement and optimization of the kits.
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Determinants of Microscopic Identification between Ophiopogonis Radix and Liriopes Radix
YU Kunzi, KANG Shuai, ZHANG Nanping, CHANG Yan, CHENG Xianlong, WEI Feng
2025, 22(4): 391-396. 
DOI: 10.19803/j.1672-8629.20240528

Abstract ( 42 )   PDF (1818KB) ( 63 )  
Objective To summarize the factors that make a difference to the results of microscopic identification between Ophiopogonis Radix and Liriopes Radix and potential risks in order to enhance the ability of related laboratories to test Chinese medicinal materials microscopically and improve the quality control system. Methods Methods for microscopic identification between Ophiopogonis Radix and Liriopes Radix were outlined to analyze the causes of undesirable results. The original records were reviewed to find the problems in common before the determinants of the accuracy of microscopic detection were identified. Results A good knowledge of microscopic characteristics of Ophiopogonis Radix and Liriopes Radix, proper microscopic sections and sound judgment could make a big difference to the test results. Conclusion To enhance the ability of laboratories to conduct microscopic detection and improve the quality control system, it is important that testers gain insights into key microscopic characteristics, experimental procedures be standardized, and the ability to exercise good judgment be strengthened.
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Zebrafish Toxicity of Trimethylsilanol: an Introduced Impurity in Fludeoxyglucose [18F] Injection
MENG Xianghui, SUN Jiabei, Li Wenlong, JIA Juanjuan, CHENG Ming, HUANG Haiwei, SHI Yaqin
2025, 22(4): 397-402. 
DOI: 10.19803/j.1672-8629.20240571

Abstract ( 22 )   PDF (1742KB) ( 44 )  
Objective To explore the toxicity of trimethylsilanol, which is an impurity introduced into fludeoxyglucose [18F] injection, on zebrafish embryos and larvae. Methods The development of zebrafish embryos and larvae exposed to different concentrations of trimethylsilanol was observed by stereomicroscopy, involving teratogenic and lethal detection. The trajectory tracking system for zebrafish behavior was used to analyze the influence of trimethylsilanol on autonomous behavior of larvae. Results Trimethylsilanol led to a dose-dependent decrease of survival of zebrafish embryos and larvae, induced an increase in deformity and edema of pericardial sac in both embryos and larvae, inhibited embryo yolk sac absorption and larvae floating growth, and activated the behavior of larvae. Conclusion Trimethylsaline has not only significant developmental and cardiac toxicity on the embryos and larvae of zebrafish, but also some neural toxicity on the larvae.
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Screening of Biomarkers of Skin Toxicity of Ioxanol and Its Potential Targets Based on Lipidomics
RAO Ling, XU Tiantian, HE Chunyuan, WANG Fang, WANG Facai
2025, 22(4): 403-409. 
DOI: 10.19803/j.1672-8629.20240615

Abstract ( 22 )   PDF (2097KB) ( 54 )  
Objective To explore lipid biomarkers and potential intervention targets for skin toxicity caused by iodixanol. Methods Forty-eight patients using iodixanol in our hospital were selected and divided into a no rash group and a rash group, with 24 cases in each group. Lipid mass spectrometry was adopted to detect the serum of patients with skin toxicity of iodixanol, differentially expressed lipid molecules were analyzed using Metaboanalyst 6.0 software, and the receiver operating characteristic curve (ROC) was drawn. Subsequently, lipid metabolism related genes and transcriptome sequencing results related to skin toxicity were downloaded from the molecular signatures database (MSigDB) and the National Center for Biotechnology Information (NCBI) in the United States, and the intersections of the above two datasets were examined to identify potential lipid metabolism targets associated with iodixanol induced rash. Results Compared with patients without rash, the lipid profile results showed that a total of 198 lipids were identified. After the screening of differential lipid components, 67 lipid components with significant differences were finally identified, including diacylglycerol (DG), triacylglycerol (TG), bis-monoacylglycerol-phosphate (BMP), cholesterol esters (CE), and phosphatidylethanolamine (PE). Compared with patients without rash, the levels of DG, TG, BMP, CE, and PE in the serum of patients with rash were significantly increased while the levels of alkyl-phosphatidylcholine [PC (O)], plasmenyl-phosphatidylcholine [PC (P)], and ether-linked phosphatidylethanolamine [PE (O)] were significantly decreased. Among the top 20 differentially expressed lipid molecules, lipid molecules of TG were dominating, accounting for 55% (11/20). ROC analysis showed that the screened differential lipid components had good predictability (AUC>0.800). Further analysis revealed that among the top 20 differentially expressed genes, proteolipid protein2 (PLP2) showed the most significant increase. Conclusion Levels of lipid TG may be a potential biomarker mediating the occurrence of skin rash caused by iodixanol, and the mechanism may be related to the abnormal upregulation of lipid metabolism gene PLP2 expression.
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Clinical Features and Risk Factors of Liver Injury Induced by Atypical Antipsychotic Drugs
CHEN Huan, LIANG Jun, ZHAO Wei, XIA Qingrong
2025, 22(4): 410-414. 
DOI: 10.19803/j.1672-8629.20240870

Abstract ( 52 )   PDF (1308KB) ( 59 )  
Objective To investigate the clinical characteristics and risk factors of drug-induced liver injury (DILI) induced by atypical antipsychotic drugs (AAPs) in our hospital in order to provide a reference for safe drug use. Methods The medical records of 122 patients who had received AAPs treatment for DILI at Hefei Fourth People’s Hospital between 2020 to and 2023 were retrospectively analyzed, including gender, age, disease history, medication history, blood routine, blood glucose, liver and kidney function, initial medication and indexes of combined medications. The control group was randomly matched at a ratio of 1∶1, and the risk factors for liver injury were studied logistic regression analysis. Based on the results of analysis, the receiver operating curve (ROC) was drawn to analyze the ability of risk factors to predict DILI. Results Among the 122 patients with AAPs induced DILI, the male to female ratio was 1∶1.22, and the average age was (32.98 ± 14.04) years. Olanzapine caused the largest number of cases of DILI during treatment (52 cases, 42.62%), and the proportion of hepatocyte injury in the clinical classification of DILI was the highest (87 cases, 71.31%). The degree of liver injury was mostly mild (121 cases, 99.18%), and most of the patients improved after symptomatic treatment (62 cases, 50.82%) or liver function returned to normal (43 cases, 35.25%). Logistic regression analysis showed that total bilirubin (TBIL), drug dose, fatty liver and combination of drugs were risk factors for liver injury caused by AAPs (P<0.05). The AUC value of the ROC curve for the combined application of the above risk factors was 0.809, with a sensitivity of 75.40% and a specificity of 76.00%, suggesting good predictability. Conclusion DILI caused by APPs occurs mostly in adult patients, and olanzapine is the biggest contributor. The clinical manifestations are primarily hepatocyte damage. Total bilirubin, drug dose, fatty liver and drug combination are important risk factors. The risk assessment of drug use should be assessed, liver function closely monitored, and adverse drug reactions reduced.
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Bleeding Induced by Rivaroxaban Combined with PK-DDI in Patients with Nonvalvular Atrial Fibrillation and Renal Insufficiency:a Retrospective Cohort Study
WU Shiqi, SU Su, YAN Suying, ZHANG Qingxia
2025, 22(4): 415-419. 
DOI: 10.19803/j.1672-8629.20240399

Abstract ( 31 )   PDF (1332KB) ( 76 )  
Objective To screen the drugs that increase the bleeding risk of pharmacokinetic drug-drug interactions (PK-DDIs) related to rivaroxaban in patients with non-valvular atrial fibrillation (NVAF) and renal insufficiency [15<creatinine clearance(CLcr)≤60 mL·min-1] in the real world, and to promote the rational use of drugs in clinical practice. Methods The rivaroxaban PK-DDI catalogue was summarized by searching for the related literature from databases (PubMed, Web of Science, CNKI, Wanfang and VIP), instructions, 2021 European Heart Rhythm Association guidelines, and Lexicomp database. A retrospective cohort study was conducted to investigate NVAF patients with renal insufficiency who were admitted to Xuanwu Hospital of Capital Medical University and took rivaroxaban from November 2022 to October 2023. The patients were divided into the PK-DDI group and non-PK-DDI group. PK-DDI drugs were limited to P-gp and/or CYP3A4 inhibitors, the patients were followed up for 3 months, and the efficacy and safety outcomes of the two groups were compared. Results Sixty-five types of drugs had to be prohibited or used with caution while another 76 types of drugs did not need to be adjusted in dosage. A total of 143 patients were included in the study. The incidence of hemorrhage in the PK-DDI group was higher than in the non-PK-DDI group (P<0.05), but there was no significant difference in the incidence of ischemic stroke between the two groups (P>0.05). The common bleeding event in the PK-DDI group was clinically relevant non-major bleeding (8 cases, 61.5%), and the incidence of bleeding 30 days after treatment was 38.7%. The drugs included amiodarone, ginkgo biloba extract, fluconazole, voriconazole and ocitinib. Conclusion PK-DDIs of rivaroxaban involve a variety of drugs, and the chief targets are P-gp and CYP3A4. The combination of P-gp and/or CYP3A4 inhibitors may increase the risk of bleeding among patients with renal insufficiency who take rivaroxaban, which should never be used in combination with ginkgo biloba extract or voliconazole. When rivaroxaban is used in combination with amiodarone, fluconazole or ocitinib, such parameters should be monitored as prothrombin time (PT), anti-factor Xa levels, or blood concentrations of rivaroxaban.
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Trough Steady-State Concentration/Dose Ratio and Contributors to Adverse Drug Reactions of Sulpiride
LAN Xiaoqian, GUO Wei
2025, 22(4): 420-423. 
DOI: 10.19803/j.1672-8629.20240825

Abstract ( 28 )   PDF (1383KB) ( 50 )  
Objectives To identify the determinants of the trough steady-state concentration/dose ratio (Cmin/D) of sulpiride, and detect the risk factors for hyperprolactinemia(HPRL) as well as extra pyramidal symptoms (EPS) after sulpiride administration based on therapeutic drug monitoring(TDM). Methods Hospitalized patients who underwent TDM in Beijing Anding Hospital between September 1, 2018 and February 28, 2023 were included. Such basic information as gender, age, body mass index (BMI), history of smoking and serum creatine levels was retrieved from the medical record system. Data on dosage, comedication and adverse drug reactions was also recorded. SPSS 26.0 was used for statistical analysis. Results One hundred and thirteen patients with steady-state concentrations determined by TDM were included. The daily dosage of sulpiride was 0.4 (0.3, 0.8) g·d-1, trough steady-state concentration (Cmin) 374.80 (210.64, 656.58) ng·mL-1,and the trough steady-state concentration/dose ratio (Cmin/D) was 0.83 (0.59, 1.10) ng·mL-1·mg-1·d. Multiple linear regression analysis suggested that gender and age had significant effects on Cmin/D (P<0.05). The most common adverse reactions were HPRL and EPS. The combination of TCAs/SSRIs increased the risk of EPS (P<0.05), and gender was identified as a risk factor for HPRL(P<0.05). Conclusion The Cmin of sulpiride is dose related, and Cmin/D is higher among females than among males, and higher among minors than among adults and geriatric patients. Concomitant use of TCAs/SSRIs with sulpiride requires caution due to the EPS risk, and prolactin levels should be closely monitored when sulpiride is administered to female patients.
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Determinants of Blood Drug Concentration / Dose Ratio of Antipsychotics
MEI Liping, BAI Fuchen, YU Jie, ZHANG Chunjie, WANG Yajun, AN Limei
2025, 22(4): 424-428. 
DOI: 10.19803/j.1672-8629.20240744

Abstract ( 35 )   PDF (1270KB) ( 53 )  
Objective To analyze the effects of gender, age and dosage on serum concentrations of antipsychotics, and to provide a reference for clinical applications of drug concentration monitoring. Methods The clinical data of outpatients who received antidepressant treatment in 2023, such as gender, age, dosage, and serum drug concentrations, was collected before being analyzed statistically using SPSS 26.0 ResultsThe data on serum concentration monitoring was collected from a total of 2 055 patients, involving 11 antipsychotics. The rate of compliance with the recommended range for treatment was the highest with haloperidol (82.35%) and lowest with clozapine (14.41%). According to the multiple linear regression equation, gender, age and dosage could do nothing more than account for some of the changes in serum drug concentrations. Except for aripiprazole and quetiapine, the C/D value of antipsychotic drugs was higher among females than among males, but there was a statistically significant difference in the case of risperidone, that is, the steady-state trough concentration of female patients was higher at the same dosage as males. There was no significant correlation between age and the C/D value of antipsychotic drugs, and the difference was not statistically significant. Conclusion There is considerable difference between individuals using antipsychotics, and there are many factors that affect serum drug concentrations. Dosage, gender, and age may all cause fluctuations in serum drug concentrations that should be monitored more rigorously when antidepressants are used.
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Establishment and Evaluation of Apatinib-Induced Hypertension Prediction Model Based on Real-World Data
WANG Shuan, HUANG Can, QI Lamei
2025, 22(4): 429-435. 
DOI: 10.19803/j.1672-8629.20240579

Abstract ( 28 )   PDF (1327KB) ( 57 )  
Objective To analyze the risk factors for hypertension induced by apatinib, establish a prediction model and verify its accuracy. Methods The data of 168 inpatients treated with apatinib in Anqing Municipal Hospital between 2020 and 2023 was retrospectively analyzed. In addition, 121 of these cases treated between 2020 and 2022 were used as the training set while another 47 cases treated in 2023 were selected as the validation set. The independent risk factors for apatinib-induced hypertension were screened using the clinical information of patients in the training set. A prediction model was established and evaluated by the ROC curve. The accuracy of the model was verified using the information of patients in the validation set. Results A total of 51 patients (42.15%) in the training set developed hypertension. Compared with the non-hypertensive group, there was statistically significant difference in gender, age, rates of complications with hypertension, dose and the adoption of immunization and chemotherapy in the hypertension group (P <0.05). Binary logistic regression analysis showed that age, gender, complications with hypertension, and the combination of immunization and chemotherapy were independent risk factors for apatinib-induced hypertension. The area under the ROC curve of the prediction model was 0.850, the sensitivity was 72.50%, and the specificity was 84.30%. The 47 patients in the validation set were selected for cross-validation, and the accuracy of the prediction model was 87.23%. Conclusion Age, gender, complications with hypertension, and the combination of immunization and chemotherapy are independent risk factors for apatinib-induced hypertension. The fitting model can help predict the incidence of apatinib-induced hypertension.
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Pharmacovigilance for Traditional Chinese Patent Medicines for Orthopedics
YANG Jingqi, XU Baohai, ZHANG Jing, JIANG Yang, SHI Fang
2025, 22(4): 436-441. 
DOI: 10.19803/j.1672-8629.20240557

Abstract ( 60 )   PDF (1232KB) ( 85 )  
Objective To trace medications with traditional Chinese patent medicines used in orthopedics departments in three locations of Beijing Jishuitan Hospital in 2024 and analyze the information related to pharmacovigilance so as to ensure rational and safe medications. Methods Data on usage of drugs was analyzed based on reports on adverse drug reactions, the hospital information management system and drug instructions. Cases of ADR caused by traditional Chinese patent medicines for orthopedics, data on drug contraindications, and toxic ingredients were statistically analyzed. Results ADR due to Traditional Chinese patent medicines in the orthopedics department were more prevalent in females or middle-aged and elderly people. The systems-organs involved were mostly the skin, nerves and the digestive system. Information about drug contraindications involved special populations, disease syndromes, diet and combined medications. Traditional Chinese patent medicines containing toxic components used by the orthopedics department accounted for 45.31% of the total, with aconitum as the dominating toxic component. Conclusion Traditional Chinese patent medicines are frequently used in orthopedics. There is a wide range of contraindications, and most of the drugs for orthopedics contain toxic ingredients, so pharmacovigilance is required.
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159 Cases of Adverse Reactions to Immune Checkpoint Inhibitors
ZHANG Yunhui, CHEN Haoyun, ZHONG Luhua, FANG Caifu, HUANG Huanjun, GUO Chenchen, DONG Xinyi, SHI Feng, LIANG Weiting
2025, 22(4): 442-446. 
DOI: 10.19803/j.1672-8629.20240795

Abstract ( 43 )   PDF (1250KB) ( 63 )  
Objective To analyze the incidence and clinical characteristics of adverse drug reactions (ADR) associated with immune checkpoint inhibitors (ICIs) in order to provide a reference for safe clinical use of ICIs. Methods One hundred and fifty-nine ICIs-related ADR reports submitted between June 1, 2018 and August 31, 2024 in a cancer hospital were collected before the patients’ age, gender, severity of ADR, occurrence times, system organs involved, and clinical manifestations were analyzed. Results According to the 159 ADR reports, the age of most of the patients ranged from 41 to 70 (74.84%), and there were 1.94 times as many male patients as female ones. There were 11 types of ICIs medicines involved. 28.93% of these ADR were serious and 80.63% occurred in the first five cycles of ICIs therapy. ADR involved a wide range of system organ classes, particularly the skin and subcutaneous tissues. Six types of ICIs caused ADR that were not mentioned in drug inserts. Conclusion The spectrum of ADR caused by ICIs is extensive and complicated. The implementation of personalized risk-based surveillance strategies for early identification and intervention is critical to effective management of ICIs-related ADR.
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Adverse Event Signals for Osimertinib-Induced Muscle Toxicity Based on FAERS Database
CHEN Lingbin, HUANG Zhixiong, ZHENG Cailin, WU Jinneng, CHEN Zhou
2025, 22(4): 447-451. 
DOI: 10.19803/j.1672-8629.20240587

Abstract ( 38 )   PDF (1339KB) ( 79 )  
Objective To analyze adverse event (AE) signals related to osimertinib-induced muscle toxicity so as to provide a reference for safe clinical use of this drug. Methods All the data on AE related to osimertinib and collected between the 4th quarter of 2015 and the 4th quarter of 2023 was retrieved from the FDA Adverse Event Reporting System (FAERS) database. Data mining of positive signals of AE related to osimertinib-induced muscle toxicity was performed using the reporting odds ratio (ROR) method and the proportional reporting ratio (PRR) method. Results A total of 616 AE related to muscle toxicity were reported, with osimertinib as the primary suspect (PS). The male-to-female ratio was 2.87. Muscle spasms and myositis met the criteria for positive signals based on both ROR and PRR. Conclusion In clinical use of osimertinib, adverse reactions mentioned in drug instructions, the risk of muscle toxicity and gender differences deserve attention. It is recommended that key indicators be monitored within 30 days of medications with osimertinib to ensure the safety of patients.
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One Case of Dermatitis Medicamentosa in a Paediatric Epilepsy Patient Caused by Lacosamide Oral Solution
LUO Wen, WU Jing, HE Dake, YANG Rui
2025, 22(4): 452-455. 
DOI: 10.19803/j.1672-8629.20240461

Abstract ( 30 )   PDF (1161KB) ( 53 )  
Objective To analyze dermatitis medicamentosa caused by lacosamide oral solution so as to provide references for safe and rational drug use. Methods A retrospective study was conducted on a pediatric epilepsy patient who experienced dermatitis medicamentosa after oral administration of lacosamide oral solution. The potential cause of the adverse drug reaction and overall safety were explored. Results The Naranjo scale suggested that lacosamide was likely associated with the adverse drug reaction. Following discontinuation of lacosamide oral solution and symptomatic treatment, the symptoms of dermatitis medicamentosa disappeared gradually. Conclusion It is recommended that lacosamide be administered at a small dose that should be increased gradually in children under 4 years old. The blood concentration should be monitored to ensure the safety.
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One Case of Hematological Abnormalities Caused by Lipoic Acid Injection
LIU Ying, GUO Hongye, YANG Yiheng, JIN Rui
2025, 22(4): 456-459. 
DOI: 10.19803/j.1672-8629.20240658

Abstract ( 30 )   PDF (1186KB) ( 49 )  
Objective To investigate the adverse drug reactions relating to lipoic acid induced hematological abnormalities so as to provide a reference for its safe clinical applications. Methods One case of hematological abnormalities after injections of lipoic acid was analyzed, and related literature was retrieved to help find the proper medication. Results Fourteen days after lipoic acid injection, blood routine examination results of the patient showed decreased levels of white blood cells, red blood cells and hemoglobin. The lipoic acid injection was discontinued and replaced by leucogen tablets. Three days after treatment, levels of the three indicators mentioned above improved. Conclusion Clinicians should be alert to the potential adverse effects of lipoic acid on the hematological system, particularly in cases with longer disease durations and multiple medications, whose risk of adverse drug reactions may increase.
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One Case of Vitiligo Caused by Sintilimab Injection in a Patient with Advanced Long-Term Survival Lung Adenocarcinoma
LIU Yalan, LIU Yanxiang, CHEN Peng
2025, 22(4): 460-462. 
DOI: 10.19803/j.1672-8629.20240760

Abstract ( 27 )   PDF (1148KB) ( 62 )  
Objective To investigate the relationship between the occurrence of vitiligo and the clinical benefits of programmed cell death-1(PD-1)/ programmed cell death-ligand 1(PD-L1) inhibitors in order to provide a reference for clinical safety and monitoring of Adverse Drug Reactions. Methods One case of vitiligo induced by sintilimab in a patient with pulmonary adenocarcinoma was analyzed. Case reports of vitiligo caused by PD-1/PD-L1 inhibitors collected between January 1, 2000 and September 1, 2024 were retrieved from PubMed, Web of Science and CNKI full-text databases. Descriptive statistical analysis was performed. Results The patient developed vitiligo 33 months after usingPD-1 inhibitors. The correlation between clinical manifestations and the duration of medication suggested that vitiligo was likely to be caused by sintilimab. Based on the literature review, a total of 20 patients were included in the analysis. The earliest onset was one month after immunotherapy with PD-1/PD-L1 inhibitors, and the longest one 20 months later. Fifteen cases occurred within 3 to 8 months of immunotherapy. Conclusion Clinicians who prescribe PD-1/PD-L1 inhibitors should be alert to the risk of vitiligo. The occurrence of vitiligo may be closely related to the good prognosis of immunotherapy.
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One Case of Interstitial Pneumonia Caused by Imatinib Mesylate Tablets during the Treatment of Gastric Stromal Tumor
CHEN Qi, ZHANG Mingqiang, GUO Jun
2025, 22(4): 463-465. 
DOI: 10.19803/j.1672-8629.20240503

Abstract ( 30 )   PDF (1111KB) ( 56 )  
Objective To analyze the clinical manifestations, severity grading, management, and prognosis of interstitial pneumonitis that occurred during the treatment of gastric stromal tumors with imatinib mesylate tablets so as to provide guidance for clinicians. Methods The clinical data of a patient who developed interstitial pneumonitis during the treatment of her gastric stromal tumor with oral imatinib mesylate was analyzed. Additionally, the related literature was reviewed and summarized. Results The patient developed cough and sputum while she was treated with imatinib mesylate. After correlation analysis and multidisciplinary consultation, the patient was diagnosed with imatinib-induced interstitial pneumonia. Imatinib mesylate was discontinued, and glucocorticoid therapy was initiated. The patient’s clinical symptoms and imaging findings gradually improved. Literature review showed that imatinib mesylate could cause interstitial pneumonia, with such common clinical symptoms as dyspnea, cough, sputum production and shortness of breath. Chest CT often showed ground-glass opacities and reticular fibers. The clinical severity of the condition could be classified into four grades, and immediate treatment led to a good prognosis. Conclusion Clinicians should be alert to the risk of adverse drug reactions and conduct a safety assessment before using imatinib mesylate. In case of respiratory symptoms during treatment, a range of examinations is recommended. If imatinib-induced interstitial pneumonitis is considered likely, the multidisciplinary team should carry out an all-round assessment and adopt the right treatment regimen according to the severity grade to improve the patient’s prognosis.
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One Case of Laryngeal Edema Caused by Shuganning Injection
YAO Linqing, YANG Lining, XIANG Rong
2025, 22(4): 466-468. 
DOI: 10.19803/j.1672-8629.20240687

Abstract ( 31 )   PDF (1104KB) ( 69 )  
Objective To draw attention to serious allergic reactions caused by drugs and to provide a reference for clinical use of Shuganning injection. Methods One case of laryngeal edema in a patient with chronic viral hepatitis B was reported within 2 minutes of intravenous infusion of Shuganning injection. The causes and precautions were studied. Results The patient’s laryngeal edema was probably related to Shuganning injection. Symptoms improved after one hour of rescue. Conclusion Clinicians need to pay attention to severe allergic reactions caused by Shuganing injection, and early detection and treatment are crucial.
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One Case of Allergic Shock Caused by Pentoxifylline Injection in a Patient with Chronic Renal Failure
CHEN Fen, WANG Suping
2025, 22(4): 469-471. 
DOI: 10.19803/j.1672-8629.20240611

Abstract ( 34 )   PDF (1153KB) ( 67 )  
Objective To analyze the characteristics of anaphylactic shock caused by pentoxifylline injection and provide a reference for rational drug use in clinic. Methods One case of anaphylactic shock caused by pentoxifylline in an adult with chronic kidney disease was reported. Related literature was reviewed to find out more about pentoxifylline-caused anaphylactic shock before the causes and prevention measures were analyzed. Results Based on the patient’s manifestations and the correlations between medication and time of administration, pentoxifylline was considered to have caused anaphylactic shock. After effective anti-allergic treatment, the patient’s symptoms of anaphylactic shock were relieved. Conclusion Pentoxifylline injection may increase the risk of anaphylactic shock in patients with chronic kidney disease. Adverse reactions should be monitored during medication to promote safe and rational drug use in clinical practice.
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One Case of Rash Caused by Apalutamide Combined with Goserelin
ZENG Ji, ZHANG Jinke, WANG Li, CHEN Jun, MENG Xudong, NING Jing, HUANG Cheng
2025, 22(4): 472-474. 
DOI: 10.19803/j.1672-8629.20240510

Abstract ( 30 )   PDF (1064KB) ( 59 )  
Objective To investigate a case of drug-induced rash during treatment with apalutamide tablets combined with goserelin acetate sustained-release implant in order to provide data for safe and rational medications. Methods After analysis of one case of rash caused by the combined use of apalutamide tablets and goserelin acetate sustained-release implant, an individualized plan for pharmacotherapeutic monitoring was developed based on related literature and clinical experience. Additionally, recommendations for new medications were provided. Results In-depth analysis of the patient’s medication history, prescriptions and relevant literature identified apalutamide tablets and goserelin acetate sustained-release implant as the suspected cause of the adverse reaction. Apalutamide was promptly discontinued, and antihistamine therapy was initiated. Concurrently, the statin regimen was adjusted to mitigate potential drug interactions, with close monitoring of lipid profiles. The patient’s systemic rash and pruritus showed marked improvement within about three weeks. Conclusion Potential rash-related adverse reactions may occur when apalutamide is administered in combination with goserelin acetate sustained-release implants. Quick regimen adjustments and proactive monitoring are critical to medication compliance and patient safety.
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Research Progress in Drug-Induced Hypotension
NI Wenqi, ZHU Feng, ZHOU Shuang, CUI Yimin
2025, 22(4): 475-480. 
DOI: 10.19803/j.1672-8629.20240733

Abstract ( 60 )   PDF (1310KB) ( 76 )  
Objective To investigate the research progress in drug-induced hypotension and provide clinical references for its prevention. Methods The categories drugs of associated with increased hypotension risk and their mechanisms of action were analyzed, the impact of pharmacogenetic polymorphisms on hypotension risk were evaluated, and the current prevention and treatment strategies were summarized by reviewing literature and searching PharmGKB database. Results Over 250 types of drugs were identified that could induce hypotension, with cardiovascular drugs and neurological drugs as the primary high-risk categories. Drugs could induce hypotension through such mechanisms as vasodilation, cardiac suppression, and blood volume reduction. Pharmacogenetic polymorphisms could significantly influence drug metabolism and hypotensive risk. Effective prevention strategies included personalized medications, genetic testing-guided dosage adjustment, avoidance of inappropriate drug combinations, and symptomatic treatment. Conclusion Drug-induced hypotension requires increased clinical attention. Future research should prioritize the development of predictive models and targeted intervention protocols for high-risk populations.
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