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Chinese Journal of Pharmacovigilance
15 March 2025, Volume 22 Issue 3

Orginal Article
15 March 2025, Volume 22 Issue 3 Previous Issue   
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Orginal Article
Identification of Druggable Targets for Intervertebral Disc Degeneration Based on Multi-Omics Data-Driven Mendelian Randomization and Prediction of Traditional Chinese Medicine Interventions
GUO Dongqi, WANG Hao, BAI Xin, BAI Jianqi, SU Hongmei, ZHANG Jingru, GUO Xiaofei, ZHAO Xiaoqi, WANG Min, WANG Yuan, ZHANG Ping
2025, 22(3): 241-248. 
DOI: 10.19803/j.1672-8629.20240899

Abstract ( 168 )   PDF (2553KB) ( 149 )  
Objective To identify druggable targets for the treatment of intervertebral disc degeneration (IDD), evaluate their safety, and to predict the traditional Chinese medicines (TCMs) that can regulate these druggable targets for IDD. Methods Data on expression quantitative trait loci of druggable genes was retrieved from the eQTLGen Consortium as exposures, while data on IDD genome-wide association study was downloaded from the GWAS Catalog to serve as outcomes for Mendelian randomization analysis intended to identify potential IDD therapeutic targets. Enrichment analyses were conducted on druggable genes related to IDD. The data on protein quantitative trait loci of druggable genes related to IDD was retrieved from the FinnGen database to validate the efficacy of these genes. A phenome-wide association study (PheWAS) via the PheWAS Portal was conducted to assess drug safety. The BATMAN-TCM 2.0 and ETCM 2.0 platforms were used to mine TCM components and analyze medication patterns. Potential lead compounds were identified through molecular docking of targets and TCM components on the CB-Dock 2 platform. Results 35 TCMs, including Corydalis yanhusuo W. T. Wang., Morinda officinalis How., and Artemisia argyi Lévl. et Vant., were found to treat IDD by regulating three druggable targets-ZP3, RRM2B, and CCL4, through their 20 active components. Gene expression MR indicated that 248 druggable genes were causally related to IDD, and enrichment analyses showed that these genes were associated with cytokine activities and cellular senescence. Protein MR validated six of these genes as druggable targets for IDD. PheWAS revealed no significant adverse effects associated with the aforementioned druggable targets. Molecular docking results showed good binding activity between the TCM components and the druggable targets, with the best binding energy of -10.2 kcal·mol-1. Conclusion Such genes as ZP3, RRM2B, and CCL4 are potential therapeutic targets for IDD with good safety profiles. TCMs like Morinda officinalis How., Corydalis yanhusuo W. T. Wang., and Artemisia argyi Lévl. et Vant. can treat IDD through these druggable targets, and their active components, such as Xanthosine, are potential compounds for new drug development.
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Interventions of Bushen Huoxue Decoction in Lumbar Intervertebral Disc Degeneration of Kidney Deficiency and Blood Stasis Type in Rats
KANG Jiaqi, GUO Xiaofei, SU Hongmei, BAI Jianqi, ZHU Hongwei, BAI Xin, CHEN Xin, WANG Hao, ZHAO Xiaoqi, GUO Dongqi, WANG Yuan, ZHANG Ping
2025, 22(3): 249-257. 
DOI: 10.19803/j.1672-8629.20240939

Abstract ( 90 )   PDF (7022KB) ( 111 )  
Objective To explore the effect of interventions of Bushen Huoxue decoction in lumbar intervertebral disc degeneration with kidney deficiency and blood stasis in rats. Methods Thirty-six SD rats were randomly divided into the sham operation group, model group, meloxicam group (0.135 mg·kg-1), and low, medium and high dose groups of Bushen Huoxue decoction (2.97、5.94、11.88 g·kg-1), with 6 rats in each group. A lumbar disc degeneration model was established via lumbar dynamic and static imbalance while the model of kidney deficiency and blood stasis was established via intramuscular injection of hydrocortisone and subcutaneous injection of epinephrine. The pathomorphological changes of the lumbar intervertebral disc were observed by X-ray and safranine O-fast green (SO/FG) staining. The expressions of collagen typeⅡ (COL2A1), aggrecan (ACAN) and other proteins in the cartilage endplate of intervertebral discs of rats were observed by immunohistochemical(IHC) staining. The contents of serum glutamic oxalic aminotransferase (AST), alanine aminotransferase (ALT), urea nitrogen(BUN) and creatinine (CREA) were detected, the organ coefficients of the liver and kidney were calculated, and the pathological changes of liver and kidney tissues were observed by hematoxylin-eosin (HE) staining. Results Bushen Huoxue decoction could delay the degeneration of the intervertebral disc in rats, increase the expressions of COL2A1, ACAN, BCL-2 and RGCC in the cartilage endplate, and decrease the expression of BAX. The contents of serum ALT, AST, BUN and CREA as well as the organ coefficients and HE staining of the liver and kidney remained normal. Conclusion Bushen Huoxue decoction can not only help improve lumbar degeneration with kidney deficiency and blood stasis in rats, but delay the degeneration of the cartilage endplate of the intervertebral disc. This decoction can promote the expressions of collagen type II and aggrecan in the cartilage endplate, inhibit apoptosis and regulate cell cycle. It is safe for long-term interventions in lumbar intervertebral disc degeneration of kidney deficiency and blood stasis type.
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Traditional Chinese Medicine Used in the Treatment of Gout Complicated with Osteoarthritis
BAI Xin, WANG Min, WANG Yuan, BAI Jianqi, SU Shuang, LIU Guanghui, GUO Xiaofei, KANG Jiaqi, GUO Dongqi, ZHANG Yimeng, WANG Hao, ZHAO Xiaoqi, ZHANG Ping
2025, 22(3): 258-262. 
DOI: 10.19803/j.1672-8629.20240910

Abstract ( 106 )   PDF (1250KB) ( 126 )  
Objective To study the way in which traditional Chinese medicine is used in treating gout complicated with osteoarthritis. Methods Cases of gout complicated with osteoarthritis were retrieved from the HIS system of Wangjing Hospital of China Academy of Chinese Medical Sciences collected between January 2022 and September 2024. Information about medications was retrieved before a database was established using Microsoft Excel 2016. Statistical analysis and association rule mining were conducted on the information using the Ancient and Modern Medical Records Cloud PlatformV 2.3.7 and SPSS Modeler 18.0. Results A total of 200 cases were included, with a male preponderance and a peak incidence in the 40-49 age group. Achyranthes bidentata and Lycopodium japonicum were the most frequently used oral and external Chinese herbal medicines, respectively. Medications with warm, neutral, and cold properties as well as sweet, bitter, and pungent flavors were preferred. The meridians most frequently targeted were the liver, kidney, and spleen. Both oral and external herbs were primarily used for clearing heat, promoting diuresis, and strengthening muscles and bones. The most commonly used herbal pairs were Cortex Phellodendri-Atractylodes Rhizoma and Erythrina Bark-Lycopodium japonicum, and Tongzhi Surunjiang capsules were the most frequently used combination drug. Conclusion Classical prescriptions such as Simiao powder and Sanhuang decoction play a crucial role in the TCM treatment of gout complicated with osteoarthritis. The concurrent use of proprietary medicines in TCM treatment provides a reference for rational drug use in clinical practice.
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Interventions of Guizhi Fuling Pills in Properties of Ovarian Cancer Stem Cells
BU Zixuan, XUE Mengwei, TIAN Jiawei, KE Kaile, WANG Ziying, LI Xiao, LU Tiangong
2025, 22(3): 263-270. 
DOI: 10.19803/j.1672-8629.20240945

Abstract ( 87 )   PDF (2115KB) ( 117 )  
Objective To investigate the potential pharmacology of Guizhi Fuling pills in intervening in stem cells of ovarian cancer. Methods UPLC-MS was adopted to analyze the active ingredients of Guizhi Fuling pills while network pharmacology was used to predict the potential targets and pathways through which Guizhi Fuling pills might intervene in ovarian cancer stemness. In vitro sphere formation assay was performed to observe the sphere-forming ability of ovarian cancer cells. Immunofluorescence was used to detect the expression of p-STAT3 in cells. qRT-PCR and protein immunoblotting were performed to detect the mRNA and protein levels of stemness markers, respectively. Results Ninety-five active ingredients and 350 targets were obtained from Guizhi Fuling pills that might intervene in the stemness of ovarian cancer by regulating such signaling pathways as PI3K/AKT1 and STAT3. Pharmacological studies showed that Guizhi Fuling pills inhibited the spheroid formation of ovarian cancer cells, intervened in STAT3 activation and nuclear expression, and regulated the expressions of stemness genes CD44 and ALDH1 family. Conclusion Guizhi Fuling pills suppress ovarian cancer stemness through multi-targets and multi-pathways. The mechanism by which Guizhi Fuling pills inhibits stemness markers ALDH1 and CD44 is closely related to STAT3.
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Big Data Analysis of Liver Adverse Reactions Monitoring of Chinese and Western Medicines Based on Age Correction and Risk Warning for Dermatologic Drugs
LONG Minjuan, ZHAO Xu, GUO Longxin, CAI Yuhan, LIN Li, ZHU Shengkai, LIU Wenlong, SONG Haibo, XIAO Xiaohe
2025, 22(3): 271-275. 
DOI: 10.19803/j.1672-8629.20240720

Abstract ( 93 )   PDF (1309KB) ( 137 )  
Objective To explore the relationship between age and the risk of drug-induced liver injury (DILI), and to study the impact of age on the risk of adverse reactions induced by Chinese and Western medicines. Methods Reports about adverse drug reactions related to DILI were retrospectively analyzed, and the number of ADR reports was adjusted demographically based on the data of a census. The way in which the risk of DILI changed with age, the usage of categorized drugs and the characteristics of drugs of special varieties were analyzed. Results After age correction, the incidence of liver injury was found to increase with the age of users of traditional Chinese medicines and Western medicines in particular. Analysis by drug category showed that the risk of DILI increased with age, except for Western medicines used for the nervous system, traditional Chinese medicines and Western medicines for skin diseases. DILI due to traditional Chinese medicines for dermatologic diseases caused a larger number of serious adverse reactions than Western medicines. The underlying diseases of patients were mostly vitiligo, psoriasis and alopecia. Preparations involving Dictamni cortex, Polygonum multiflorum, Psoralea corylifolia were high-risk drugs. Conclusion The risk of DILI is positively correlated with age for most drugs. The risk posed by drugs for DILI and by traditional Chinese medicines for skin diseases deserves more attention so as to prevent the occurrence of serious adverse reactions.
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A National Pharmacovigilance Management System in a New Era
YANG Xuyun, SUN Yang, TIAN Chunhua, HU Zengyao
2025, 22(3): 276-281. 
DOI: 10.19803/j.1672-8629.20240861

Abstract ( 224 )   PDF (1478KB) ( 283 )  
Objective To analyze what pharmacovigilance is about in the new era and under new circumstances and summarize related experience in order to provide a reference for the construction of a national pharmacovigilance management system. Methods Based on related laws and regulations as well as the construction of systems and mechanisms, the achievements and downsides of pharmacovigilance in China were analyzed in terms of the evolution of pharmacovigilance, and ways to improve pharmacovigilance were recommended. Results Pharmacovigilance runs through the whole life cycle of drugs and focuses on risk management, providing strong technical support for regulation of pharmaceuticals. Since the implementation of pharmacovigilance, the legal system, regulatory system, organizational system, and professionalism have been gradually established and improved, but there is also much room for improvement. Conclusion It is recommended that more efforts be made to make pharmacovigilance more scientific, standard and legalized, and that a solid bottom line for drug safety be established to promote the high-quality development of pharmacovigilance and the pharmaceutical industry.
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Methods for Assessment of MAH Compliance with GVP
LIU Ying, XIONG Shunyu, XIONG Huiyu, CAI Fei, XU Mengdan, WANG Qing, REN Wei, XU Yan
2025, 22(3): 282-285. 
DOI: 10.19803/j.1672-8629.20240394

Abstract ( 285 )   PDF (1207KB) ( 288 )  
Objective To explore the methods for assessment of marketing authorization holders’ (MAHs) compliance with Good Pharmacovigilance Practice (GVP) and to design an informatized assessment tool according to applications in businesses so as to provide a reference for regulators’ efficient assessment of pharmacovigilance and for self-assessment by MAHs. Methods A system of indexes for assessment of MAHs’ compliance with GVP was developed as required by pharmacovigilance and related assessment. An informatized profiling model for MAHs’ pharmacovigilance was established via data analysis technology before the assessment methods were developed that were to be designed into assessment tools used across the province on a trial basis. Results Two hundred and ninety-nine key points of indexes for assessment and rating standards were identified, so the system and methods for assessment evaluation were established. Based on the actual operations, an informazed tool was devised and an informatized profiling model for assessment was established. Conclusion The establishment of methods for assessment of GVP compliance and informatized tools provides an innovative approach by which MAHs can improve their pharmacovigilance.
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Adverse Reactions to Antihypertensive and Hypoglycaemic Drugs Based on Spontaneous Presentation Systems
LIAO Mengfan, ZHONG Liling, XU Yan, LIU Ying, ZHANG Yexiang, CHEN Qingsong, LIU Xudong
2025, 22(3): 286-291. 
DOI: 10.19803/j.1672-8629.20240675

Abstract ( 141 )   PDF (1404KB) ( 157 )  
Objective To analyze the reports of adverse drug reactions(ADR) caused by antihypertensive and hypoglycemic drugs so as to provide a reference for rational clinical use of drugs. Methods The ADR reports related to commonly-used antihypertensive and hypoglycemic drugs collected by the Guangdong ADR self-reporting system between September 1, 2020 and August 31, 2022 were analyzed, and the influential factors for the occurrence of severe ADR were identified. Results A total of 6 113 ADR reports involving 9 207 clinical cases were included. Females and middle-aged and elderly patients accounted for a large proportion. Mild ADR and severe ones accounted for 90.22% and 9.78% respectively. In addition, there were 844 new ADR (13.81%). ADR mostly involved the gastrointestinal system and the skin and its accessories or were systemic, with calcium channel blocker drugs and biguanides as the leading cause. ADR caused by different drugs varied. Most of these ADR occurred 2 to 7 days (29.45%) and 30 days (40.95%) after medication, and the majority of the patients improved (58.23%) or recovered (35.25%). Patients with two or more types of primary diseases, smoking history, and ADR induction time of over 7 days were at higher risk of severe ADR. Conclusion The ADR caused by commonly-used drugs for diabetes and hypertension vary, depending on age, gender, organs involved and types of drugs. It is recommended that clinicians take precautions, monitor and assess patients at critical time points after medication in order to detect potential ADR quickly to keep patients safe.
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Effect of Compound Paracetamol Tablets on Plasma Concentrations of Risperidone in Patients with Schizophrenia Complicated with a Cold
LUO Jianchao, YANG Rong, FU Qiong, LI Jixian
2025, 22(3): 292-296. 
DOI: 10.19803/j.1672-8629.20240513

Abstract ( 118 )   PDF (1371KB) ( 95 )  
Objective To analyze the effect of compound paracetamol tablets on plasma concentrations of risperidone in patients with schizophrenia who had a cold. Methods The clinical data of 424 cold patients who received risperidone treatment in a hospital between June 1, 2019 and June 1, 2024 was retrospectively collected, 296 of whom had taken compound paracetamol alkane tablets while they had a cold and were assigned to the medication group. The rest of the patients who received no medication for their cold were included in the non-intervention group. The effects of colds and compound paracetamol tablets on high-level plasma concentrations of risperidone in these patients were analyzed. Results ①In the medication group, plasma concentrations of risperidone increased to varying degrees compared with the baseline (P <0.05).②The plasma concentrations of risperidone in both groups increased to varying extents compared with the baseline (P <0.05), especially in the medication group (P <0.05).③There was little difference in levels of risperidone between male and female patients ages 18 to 45 in the medication group (P >0.05), but the plasma concentrations of risperidone were higher in females than in males aged 46 to 60 (P <0.05).④There was no significant difference in the incidence of adverse reactions related to risperidone between the two groups (P >0.05), but more than half of the cases of adverse reactions occurred among patients with high concentrations of risperidone. Conclusion Colds may increase the plasma concentration of risperidone in patients with schizophrenia. Using compound paracetamol tablets can make matters worse among patients with a cold. It is recommended that blood concentrations be monitored and medication plans be adjusted when necessary.
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Disproportionality of Adverse Events to KRAS G12C Inhibitors Based on the FAERS Database
ZHU Zhipeng, LYU Qiang, YE Xiaofei, GUO Xiaojing
2025, 22(3): 297-304. 
DOI: 10.19803/j.1672-8629.20240841

Abstract ( 75 )   PDF (1347KB) ( 113 )  
Objective To analyze the adverse event signals of KRAS G12C inhibitors, sotorasib and adagrasib, so as to provide a reference for clinical safety. Methods Data on adverse events reported from Q3 2021 to Q2 2024 was retrieved from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database before related signals were mined using the reporting odds ratio (ROR), the comprehensive standard method of the Medicines and Healthcare Products Regulatory Agency (MHRA), the Information Component (IC) method, and the Empirical Bayes Geometric Mean (EBGM) method. Results Sotorasib was primarily associated with adverse reactions related to hepatobiliary disorders (n=329, IC025=3.06), with the strongest signal for hepatotoxicity (n=76, IC025=5.14) while adagrasib was associated with surgical and medical procedures (n=102, IC025=1.65) and metabolism and nutrition disorders (n=76, IC025=0.97), with the strongest signal for electrocardiogram QT prolonged (n=11, IC025=2.87). Rare reactions included pulmonary embolism for sotorasib and status epilepticus for adagrasib. Gender and cumulative doses made a big difference to the incidence of adverse reactions. Conclusion In clinical application, it is necessary to strengthen the monitoring of adverse reactions of sotorasib and adaglasib, especially rare and serious adverse reactions, to improve drug safety.
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Adverse Event Signals of Liraglutide and Semaglutide Based on the FAERS Database
ZHONG Ling, ZENG Huiyan, YUAN Xin, WANG Yingyan
2025, 22(3): 305-312. 
DOI: 10.19803/j.1672-8629.20240753

Abstract ( 98 )   PDF (1399KB) ( 165 )  
Objective To mine and compare signals of post-marketing adverse events of liraglutide and semaglutide in order to provide references for safe and rational use. Methods Data on adverse events reported by the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between January 1, 2010 and March 31, 2024 was mined using the reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, information component (IC) method, and the muti-item gamma poisson shrinker (MGPS) method. Positive signals and tumor related signals were screened out and compared. Results 175 positive signals related to liraglutide were mined, involving 20 systems organs class (SOC), compared with 231 for semaglutide, involving 21 SOC. The adverse events manifested themselves as gastrointestinal disorders, metabolism and nutrition disorders. In terms of tumors, thyroid and pancreatic related tumors were dominating and onset of symptoms in most of the cases was after 360 days. Liraglutide was more significantly correlated with such adverse events as thyroid tumors, pancreatic tumors, and pancreatitis while semaglutide was likely to cause adverse events related to eyes and the skin. Conclusion Liraglutide and semaglutide can cause similar adverse drug reactions, so clinicians are advised to opt for personalized medications while warnings about the possibility of pancreatic tumors should be given in related instructions.
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Applicability of 99mTc-Ethyl Cysteinate Dimer in the Examination of Ischemic Cerebrovascular Diseases
YANG Shuzhen, ZHU Chuanming, LI Yan, LIU Tingting, WANG Hongxing, ZHENG Xiaofeng
2025, 22(3): 313-315. 
DOI: 10.19803/j.1672-8629.20240858

Abstract ( 38 )   PDF (1187KB) ( 75 )  
Objective To explore the applicability of 99mTc-ECD cerebral perfusion SPECT/CT fusion imaging in ischemic cerebrovascular diseases. Methods The clinical data of 112 patients clinically diagnosed with ischemic cerebrovascular diseases was collected. Computed tomography angiography (CTA) of the head and neck revealed varying degrees of vascular stenosis. All the patients underwent 99mTc-ECD cerebral perfusion SPECT/CT imaging within 5 days of onset. The detection rate, range, and positive rate of lesions were compared and analyzed between SPECT/CT fusion images, pure SPECT perfusion images, and CT images. The positive rates of different imaging methods were analyzed using the McNemar test, with P <0.05 indicating statistical significance. Results None of the 112 patients experienced significant discomfort during 99mTc-ECD imaging. The positive rate of SPECT/CT fusion imaging was 100%, with 381 ischemic or infarct lesions detected, compared with 98.21%, and 316 for SPECT perfusion imaging and 67.86% and 192 for CT imaging. Statistical analysis showed no significant difference in the diagnostic positive rate between SPECT/CT fusion images and pure SPECT images. However, both SPECT/CT fusion images and pure SPECT images had significantly higher diagnostic positive rates than CT images (P <0.05). Conclusion 99mTc-ECD cerebral perfusion imaging is safe and convenient. SPECT/CT fusion imaging is superior to SPECT cerebral perfusion imaging and CT imaging in terms of the detection range, number, and positive rate of lesions in patients with ischemic cerebrovascular disease.
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Kanglaite Combined with Gefitinib for Mid-Late Stage Lung Cancer:a Meta-Analysis and Trial Sequential Analysis
FAN Liping, LU Shu, CAI Yueping, WAN Yuxiang, SUN Huiyuan
2025, 22(3): 316-323. 
DOI: 10.19803/j.1672-8629.20241012

Abstract ( 40 )   PDF (1771KB) ( 75 )  
Objective To evaluate the clinical efficacy and safety of kanglaite combined with gefitinib in the treatment of mid-late stage lung cancer. Methods Randomized controlled trials(RCTS) involving kanglaite combined with gefitinib in the treatment of mid-late stage lung cancer that were published between the inception and January 11, 2025 were retrieved from Cochrane, PubMed, EMbase, Web of Science, CNKI, WANFANG and VIP database. Literature bias risk assessment was performed using the Cochrane Collaboration’s Risk of Bias 2.0 tool (ROB 2.0). RevMan 5.3 software was used for Meta-analysis. STATA12.0 software was used for sensitivity analysis and Egger's test. TSA 0.9.5.10 beta software was used for the trial sequential analysis (TSA). GRADE was used for quality evaluation of outcome indicators. Results Twelve trials involving 1 050 patients were included. ROB 2.0 results of all the studies included revealed some concerns. The results of Meta-analysis showed that the combination of Kanglaite and gefitinib in the treatment of mid-late stage lung cancer had significant advantages over gefitinib alone in clinical efficacy. Subgroup analysis showed that different dosage forms of kanglaite affected the heterogeneity of the disease control rate. Egger's test exhibited less publication bias. TSA indicated the possibility of false-positive results in the disease response rate, and more high-quality RCTs were needed to validate the efficacy. The results of the GRADE evaluation showed that the evidence quality of the outcome indicators in this study was low or exceedingly low. Conclusion Kanglaite combined with gefitinib in the treatment of advanced lung cancer is superior to the control group in improving efficacy, reducing gastrointestinal adverse reactions, improving quality of life, and the activity of immune cells, but more randomized controlled trials are needed for efficacy and safety evaluations .
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Safety of Children’s Traditional Chinese Medicine Decoction Pieces in Clinical Application and Children’s Drug Development
JIA Zhichao, HU Siyuan, LI Ruiben, XU Yaqian
2025, 22(3): 324-328. 
DOI: 10.19803/j.1672-8629.20240704

Abstract ( 76 )   PDF (1252KB) ( 97 )  
Objective To give tips about the clinical application and development of traditional Chinese medicine decoction pieces for children based on the 2020 edition of the Pharmacopoeia of the People's Republic of China (ChP 2020). Methods The children’s decoction pieces specified in the ChP 2020 were categorized before safety risks were analyzed. Results The ChP 2020 covered a total of 616 types of traditional Chinese medicine decoction pieces, 26 of which were specifically related to children. Among them, one type had both indications and dosage for children, 23 had indications for children only, one had only dosage for children, and one was prohibited for children. Among the 24 herbal medicines with indications for children, the most commonly used indication was infantile malnutrition, and a total of 3 drugs were labeled as “toxic” and 2 as “slightly toxic”. Conclusion It is recommended that basic research on pharmacy and toxicology related to indications and TCM decoction pieces, adverse drug reactions in children be reported, and related standards be improved so as to facilitate safe medication and drug development.
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Words of Warning and Preventive Measures in Labels of Antidepressants
ZOU Yuanlei, XIA Qingrong, LIANG Jun, HE Kongliang, MO Daming, WU Wenning
2025, 22(3): 329-333. 
DOI: 10.19803/j.1672-8629.20240826

Abstract ( 79 )   PDF (1284KB) ( 103 )  
Objective To analyze the warning statements and preventive measures in the instructions of antidepressants in a tertiary mental health hospital in order to provide references for standardized wording in the instructions of antidep-ressants. Methods The frequency at which warning statements and preventive measures appeared in the instructions of antidepressants in the Affiliated Mental Hospital of Anhui Medical University from September 1 to September 30, 2022 was statistically analyzed. Results A total of 19 antidepressant instructions were included in the statistics. The total frequency of warning statements was 33, so was the total frequency of corresponding preventive measures. Among the 3 types of warning statements, the total frequency of instructions without corresponding warning statements was 10. The total frequency of complete warning statements was 17, compared with 22 for complete preventive meas-ures. Such warning statements as "Suicidal tendencies and antidepressants" appeared 30 times (90.91%), "Prohibited for patients with hepatitis B virus, hepatitis C virus, liver function impairment, or elevated transaminase levels above the normal upper limit" was used twice (6.06%), and "Prohibited for patients with epilepsy, glaucoma, urinary retention, recent history of myocardial infarction, or allergy to this product" turned up once (3.03%). The frequency of preventive measures corresponding to warning statements was 30 (90.91%) for preventive measures against "Suicidal tendencies and antidepressants", 2 (6.06%) for preventive measures related to Prohibited for patients with hepatitis B virus, hepatitis C virus, liver function impairment, or elevated transaminase levels above the normal upper limit", and 1(3.03%) for preventive measures relating to "Prohibited for patients with epilepsy, glaucoma, urinary retention, recent history of myocardial infarction, or allergy to this product". Conclusion There are inadequacies in the warning statements and preventive measures specified in instructions for antidepressants. It is recommended that related enterprises supplement the missing warning statements and preventive measures. As for the warning statements and preventive measures concerning "Suicidal tendencies and antidepressants", the age range of young patients prone to suicide should be clearly defined, and the contents of preventive measures should be improved.
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One Case of Anemia Caused by Finerenone Tablets
LIU Chenpei, DU Yupeng, LIN Yan
2025, 22(3): 334-336. 
DOI: 10.19803/j.1672-8629.20240411

Abstract ( 115 )   PDF (1196KB) ( 206 )  
Objective To analyze anemia caused by finerenone based on a case report in order to provide a reference for rational use of finerenone. Methods The treatment process, risk factors, possible mechanism and treatment regimens related to a diabetic kidney disease (DKD) patient with hemoglobin decline that was believed to have been caused by finerenone were analyzed based on research currently available. Results A DKD patient experienced hemoglobin decline after taking finerenone for four months. With an increase in drug dosage, the patient’s hemoglobin continued to decrease. With a Naranjo’s score of 8, the patient’s anemia was considered to have been caused by finerenone. After the patient discontinued the drug, hemoglobin gradually recovered during follow-up. Conclusion Clinicians should be alert to finerenone-induced anemia. Early identification and immediate interventions are crucial to preventing serious adverse drug reactions.
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One Case of Bone Marrow Suppression Caused by Azathioprine Tablets in a Patient with TPMT Heterozygous Mutation
HU Kun, HUANG Weiguo, LEI Lili, PANG Xiaocong, ZHOU Ying, CUI Yimin
2025, 22(3): 337-340. 
DOI: 10.19803/j.1672-8629.20240451

Abstract ( 71 )   PDF (1209KB) ( 115 )  
Objective To analyze the cause of bone marrow suppression in a patient with a TPMT gene mutation after treatment with azathioprine. Methods By using pyrophosphate sequencing genetic testing, international guidelines and literature review, the etiology of one case of bone marrow suppression was studied. Results The patient was identified as a heterozygote for the *1/*3C allele at the TPMT gene locus, which was associated with an elevated risk of azathioprine-induced bone marrow suppression. The patient was recommended to reduce the dosage of azathioprine and undergo vigilant monitoring. Upon cessation of azathioprine and initiation of symptomatic treatment, the bone marrow suppression of the patient improved after 27 days. Conclusion Mutations in TPMT can predispose individuals to heightened risks of adverse reactions to azathioprine. During azathioprine therapy, it is imperative to closely monitor hematological indices and other clinical parameters. When feasible, genetic testing should be conducted to preemptively gauge the risk of adverse reactions, thereby facilitating personalized medication adjustments to enhance treatment safety.
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One Case of Anaphylactic Shock Caused by Multiple Oral Cephalexin Capsules Combined with Oolong Tea
FU Xiaoyan, GOU Yu, LUO Xianhai, HU Qiaozhi
2025, 22(3): 341-342. 
DOI: 10.19803/j.1672-8629.20240677

Abstract ( 115 )   PDF (1154KB) ( 166 )  
Objective To explore the possible causes of anaphylactic shock after repeated use of cephalexin and to provide a reference for safe clinical use. Methods The possible causes of anaphylactic shock in a 37-year-old woman who had taken cephalexin capsules orally several times and then used the drug together with oolong tea one month later were analyze based on related literature. Results The cause of anaphylactic shock in this patient was unclear, which might be related to hypersensitivity caused by cephalexin and interactions between foods. Conclusion The use of cephalosporin antibiotics demands close attention to adverse drug reactions. Clinicians ought to monitor patients who have used this drug but have developed no adverse reactions.
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One Case of Acute Hepatic Injury Caused by Ioversol Injection
YU Li, TAN Xiying
2025, 22(3): 343-345. 
DOI: 10.19803/j.1672-8629.20240464

Abstract ( 114 )   PDF (1131KB) ( 146 )  
Objective To analyze one case of hepatic injury caused by ioversol injection in order to provide a reference for clinical use. Methods The clinical data of a 70-year-old male patient who experienced persistent elevation of liver enzymes after receiving ioversol injection was analyzed. The correlations between hepatic injury and ioversol injection were studied, and a literature review was conducted to identify cases of contrast agent-induced hepatic injury and potential causes. Results Based on correlation assessment, the severe liver injury in this patient was believed to have been caused by administration of ioversol injection. The patient’s liver function gradually improved after hepatoprotective treatment. Conclusion Ioversol injection may cause adverse reactions that lead to hepatic dysfunction. Clinicians should be aware of the risk of adverse drug reactions associated with ioversol injection and enhance monitoring.
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One Case of Neurotoxicity Caused by Fluorouracil Injection in a Patient with Metastatic Colorectal Cancer
MIN Qiong, LI Peng, DAI Xiaoyan, FAN Chunling, YOU Haisheng
2025, 22(3): 346-348. 
DOI: 10.19803/j.1672-8629.20240473

Abstract ( 78 )   PDF (1188KB) ( 123 )  
Objective To analyze one case of neurotoxicity caused by fluorouracil. Methods One case of acute neurotoxicity was investigated. The cause of neurotoxicity was identified by analyzing the diagnosis and treatment of the patient while the suspected drug was evaluated via causality assessment of adverse event. Results Neurotoxicity in this patient was considered to have been caused by the rising dose of fluorouracil. After subsequent treatment at a reduced dose of fluorouracil, the patient did not experience any more adverse reactions. Conclusion Toxicity can be increased when fluorouracil is used in intraperitoneal perfusion chemotherapy and intravenous chemotherapy at the same time. In order to decrease the risk of toxicity, clinicians ought to prescribe a lower dosage or choose a different drug.
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Progress in Clinical and Pharmacological Research of Angong Niuhuang Pills
BAI Xue, CHEN Yafei, TANG Tian, LIU Zhejun, WANG Guoyu, TAN Tianyang
2025, 22(3): 349-356. 
DOI: 10.19803/j.1672-8629.20240592

Abstract ( 103 )   PDF (1259KB) ( 123 )  
Objective To evaluate the clinical efficacy of Angong Niuhuang pills in the past three years and explore their pharmacological mechanisms in order to provide a reference for subsequent research. Methods By analyzing the latest data on clinical research, the therapeutic effects of Angong Niuhuang pills against such diseases as cerebral hemorrhage, cerebral infarction, craniocerebral injury, heatstroke, sepsis, viral encephalitis and pneumonia were summerized. Additionally, current pharmacological research was reviewed to analyze the mechanisms of action of Angong Niuhuang pills. Results The study found that Angong Niuhuang pills were highly effective in treating the aforementioned diseases. Pharmacological research suggested that they worked through multiple mechanisms, including anti-inflammation, antioxidation, anti-apoptosis, regulation of autophagy and mitochondrial dysfunction, inhibition of pyroptosis and ferroptosis, and regulation of metabolic products and gut microbiota. Conclusion This study has evaluated the clinical efficacy and pharmacological mechanism of Angong Niuhuang pills in the treatment of various diseases and confirmed their therapeutic effect and multi-target characteristics, providing data for subsequent research and clinical applications.
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Guidelines for the Use of Antiepileptic Drugs in the Periconception Period: Interpretations and Research Progress
WANG Ran, FENG Xin
2025, 22(3): 357-360. 
DOI: 10.19803/j.1672-8629.20240436

Abstract ( 67 )   PDF (1225KB) ( 86 )  
Objective To investigate the impact of antiepileptic drugs on mothers and fetuses during the periconceptional period in order to provide a reference for obstetricians and pharmacists. Methods Research progress in the correlations between various antiepileptic drugs and major congenital malformations, adverse perinatal outcomes, and neurodevelopment, as well as the effects of folic acid supplementation during the periconceptional period on maternal and fetal health was summarized and recommendations were offered. Results Antiepileptic drugs were correlated with congenital malformations, adverse perinatal outcomes and neurodevelopment. During the periconceptional period, epileptic seizures needed to be brought under effective control via medications while the potential impact of these drugs on the fetus had to be assessed. Conclusion The rational use of antiepileptic drugs combined with folic acid supplementation is crucial to the health of mothers with epilepsy and fetuses.
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