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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 Chinese Journal of Pharmacovigilance    2025, 22 (3): 349-356.   DOI: 10.19803/j.1672-8629.20240592 Abstract （1507）      PDF（pc） （1259KB）（4890）       Knowledge map    Save 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. Reference | Related Articles | Metrics | Comments（0）

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Pharmacovigilance for Traditional Chinese Patent Medicines for Orthopedics YANG Jingqi, XU Baohai, ZHANG Jing, JIANG Yang, SHI Fang Chinese Journal of Pharmacovigilance    2025, 22 (4): 436-441.   DOI: 10.19803/j.1672-8629.20240557 Abstract （377）      PDF（pc） （1232KB）（1814）       Knowledge map    Save 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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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A National Pharmacovigilance Management System in a New Era YANG Xuyun, SUN Yang, TIAN Chunhua, HU Zengyao Chinese Journal of Pharmacovigilance    2025, 22 (3): 276-281.   DOI: 10.19803/j.1672-8629.20240861 Abstract （926）      PDF（pc） （1478KB）（1471）       Knowledge map    Save 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. Reference | Related Articles | Metrics | Comments（0）

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One Case of Taste Disorders Caused by Cetylpridinium Chloride Gargle QIAN Xia, ZHENG Liguang, LI Tongtong, HE Yachun Chinese Journal of Pharmacovigilance    2025, 22 (5): 583-585.   DOI: 10.19803/j.1672-8629.20240804 Abstract （325）      PDF（pc） （1183KB）（1394）       Knowledge map    Save Objective To explore the therapeutic effect of cetylpirdinium chloride gargle while avoiding taste abnormalities and adverse reactions. Methods One case of taste disorder caused by cetylpirdinium chloride gargle was discussed. Based on a review of related reports at home and abroad, the cause of taste disorder and possible mechanisms were studied. Results Taste abnormalities caused by the use of cetylpirdinium chloride gargle were quite common globally. Early detection and interventions had to be carried out to restore taste. Conclusion The incidence of taste abnormalities caused by the use of cetylpirdinium chloride gargle remains relatively high. It is recommended that doctors and patients alike be aware of the likelihood of this adverse reaction. Once taste disorders occur, the drug should be discontinued quickly and symptomatic treatment initiated. Reference | Related Articles | Metrics | Comments（0）

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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 Chinese Journal of Pharmacovigilance    2025, 22 (3): 263-270.   DOI: 10.19803/j.1672-8629.20240945 Abstract （318）      PDF（pc） （2115KB）（1007）       Knowledge map    Save 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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Research Progress in the Pathogenesis and Medications of Trigeminal Neuralgia LI Shuran, XIE Rui, ZHAO Ronghua, BAO Lei, GENG Zihan, SUN Qiyue, CUI Xiaolan, GUO Shanshan, SUN Jing Chinese Journal of Pharmacovigilance    2025, 22 (5): 596-600.   DOI: 10.19803/j.1672-8629.20241020 Abstract （277）      PDF（pc） （1225KB）（988）       Knowledge map    Save Objective To summarize the findings of current research related to the pathogenesis of and drugs for trigeminal neuralgia (TN) so as to provide references for in-depth studies on TN. Methods Related literature published between the inception of the databases and December 29, 2024 was retrieved from such databases as CNKI, the National Science and Technology Library and PubMed before being analyzed. Results TN was likely associated with microvascular compression of the trigeminal nerve, dysfunction of ion channels, peripheral nerve injury leading to demyelination, and reactivation of herpes simplex virus type 1 (HSV-1) infection. The first-line drugs for TN included carbamazepine and oxcarbazepine. Additionally, traditional Chinese medicine (TCM) also demonstrated promising efficacy and unique advantages in the treatment of TN. Conclusion Research findings about the pathogenesis and medications of TN have been summarized so as to provide references for the clinical treatment and research and development of related drugs. Reference | Related Articles | Metrics | Comments（0）

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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 Chinese Journal of Pharmacovigilance    2025, 22 (3): 324-328.   DOI: 10.19803/j.1672-8629.20240704 Abstract （394）      PDF（pc） （1252KB）（964）       Knowledge map    Save 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. Reference | Related Articles | Metrics | Comments（0）

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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 Chinese Journal of Pharmacovigilance    2025, 22 (3): 282-285.   DOI: 10.19803/j.1672-8629.20240394 Abstract （873）      PDF（pc） （1207KB）（928）       Knowledge map    Save 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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Efficacy and Safety of Panax Quinquefolium Saponin in Adjuvant Treatment of Angina Pectoris of Coronary Heart Disease: a Meta-Analysis FAN Liping, LU Shu, SUN Huiyuan Chinese Journal of Pharmacovigilance    2025, 22 (5): 570-574.   DOI: 10.19803/j.1672-8629.20241011 Abstract （286）      PDF（pc） （1444KB）（815）       Knowledge map    Save Objective To evaluate the efficacy and safety of Panax quinquefolium saponin (Xinyue capsules) in treating angina pectoris of coronary heart disease. Methods Cochrane, PubMed, Embase, Web of Science, ClinicalTrials, SinoMed, CNKI, Wanfang and VIP Data Knowledge Service Platform were searched for literature on randomized controlled trials (RCTs) related to the efficacy and safety of Panax quinquefolium saponin in treating angina pectoris of coronary heart disease. Literature bias risk was assessed using the Cochrane risk of bias 2.0 tool (RoB 2.0) from the inception to Feb 28, 2025. RevMan 5.3 software was used for Meta-analysis and sensitivity analysis while GRADE was employed for quality evaluation of outcome indicators. Results A total of 11 articles were included in this study. Meta-analysis results showed that the clinical effective rate[RR=1.24, 95%CI(1.16, 1.32), P<0.000 01], improvement of angina symptoms(duration of angina pectoris[MD=-2.45, 95%CI(-3.54, -1.37), P<0.000 01] and frequency of angina pectoris[MD=-1.22, 95%CI(-1.80, -0.65), P<0.000 1], myocardial injury indexes{BNP[MD=-52.36, 95%CI(-87.35,-17.37), P=0.003]、CK-MB[MD=-4.56, 95%CI(-0.74,-0.08), P=0.000 7]、cTnI[MD=-0.41, 95%CI(-87.35,-17.37), P=0.01] and H-FABP[MD=-1.86, 95%CI (-3.35,-0.37), P=0.01]} in the panax quinquefolium saponin (Xinyue capsule) group were better than in the Western medicine group. However, there were no significant differences between the two groups in incidence of adverse reactions, such as dizziness, headache, flushing or those involving the digestive tract, liver function and kidney function. Conclusion Panax quinquefolium saponin (Xinyue capsules) can effectively improve the curative effect, symptoms and myocardial injury indexes in the treatment of angina pectoris of coronary heart disease without increasing adverse reactions. However, due to the limitation of the number, sample size and quality of the included studies, more high-quality studies are needed. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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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 Chinese Journal of Pharmacovigilance    2025, 22 (3): 241-248.   DOI: 10.19803/j.1672-8629.20240899 Abstract （919）      PDF（pc） （2553KB）（729）       Knowledge map    Save 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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Guidelines for the Use of Antiepileptic Drugs in the Periconception Period: Interpretations and Research Progress WANG Ran, FENG Xin Chinese Journal of Pharmacovigilance    2025, 22 (3): 357-360.   DOI: 10.19803/j.1672-8629.20240436 Abstract （352）      PDF（pc） （1225KB）（722）       Knowledge map    Save 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. Reference | Related Articles | Metrics | Comments（0）

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Adverse Event Signals of Liraglutide and Semaglutide Based on the FAERS Database ZHONG Ling, ZENG Huiyan, YUAN Xin, WANG Yingyan Chinese Journal of Pharmacovigilance    2025, 22 (3): 305-312.   DOI: 10.19803/j.1672-8629.20240753 Abstract （474）      PDF（pc） （1399KB）（671）       Knowledge map    Save 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. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Research Progress in Drug-Induced Hypotension NI Wenqi, ZHU Feng, ZHOU Shuang, CUI Yimin Chinese Journal of Pharmacovigilance    2025, 22 (4): 475-480.   DOI: 10.19803/j.1672-8629.20240733 Abstract （419）      PDF（pc） （1310KB）（670）       Knowledge map    Save 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. Reference | Related Articles | Metrics | Comments（0）

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Identification of Chemical Constituents and Determination of Multi-Component Content of Lianpo Drinking Water Decoction Based on LC-MS/MS Technology CHEN Siyuan, ZHANG Yan, FENG Xue, ZHANG Caijuan, WANG Dunfang, LIU Haifan, LIU Bin, ZHU Lin, LIU Jianyao, LI Tao, YANG Weipeng Chinese Journal of Pharmacovigilance    2025, 22 (5): 554-559.   DOI: 10.19803/j.1672-8629.20240971 Abstract （225）      PDF（pc） （1504KB）（653）       Knowledge map    Save Objective To identify the chemical constituents of Lianpo decoction, and to establish a method for simultaneous determination of the contents of 11 active substances in the decoction using HPLC-QQQ MS/MS. Methods The ACQUITY UPLC BEH C18 column (2.1 mm×100 mm, 1.7 µm) with 0.1% aqueous formic acid (A)-acetonitrile (B) as the mobile phase and under gradient elution was used for the identification and quantification of the chemical components. Results Fifty chemical components were identified from the Lianpo decoction, including 15 organic acids, 10 alkaloids, 6 terpenes and 5 flavonoids. Among them, 11 components such as coptisine, trigonelline and genistein were confirmed through a comparison with reference standards. An HPLC-QQQ MS/MS method was developed for simultaneous quantification of coptisine, trigonelline, genistein, palmatine, berberine, ferulic acid, geniposide, honokiol, magnolol, daidzein, and succinic acid in the decoction. The concentration ranges of the components showed a good linearity (R>0.999), the average spiked recoveries ranged from 90.78% to 115.10%, and the relative standard deviations (RSDs) of the repeatability tests were all less than 4%. Conclusion The study has identified the chemical constituents of Lianpo decoction, and established a method for simultaneous determination of 11 components. This method is sensitive, accurate and rapid, which can help establish more methods for quality control of Lianpo decoction. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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One Case of Anemia Caused by Finerenone Tablets LIU Chenpei, DU Yupeng, LIN Yan Chinese Journal of Pharmacovigilance    2025, 22 (3): 334-336.   DOI: 10.19803/j.1672-8629.20240411 Abstract （335）      PDF（pc） （1196KB）（653）       Knowledge map    Save 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. Reference | Related Articles | Metrics | Comments（0）

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Effect of Shufeng Jiedu Capsules on the Production of Specific Antibodies against Influenza A H1N1 Virus and the Mechanisms LI Xinying, BAO Lei, LI Shuran, ZHAO Ronghua, SUN Jing, XIE Dan, BAO Yanyan, GUO Shanshan, CUI Xiaolan, GENG Zihan Chinese Journal of Pharmacovigilance    2025, 22 (8): 841-850.   DOI: 10.19803/j.1672-8629.20250170 Abstract （325）      PDF（pc） （3192KB）（653）       Knowledge map    Save Objective To explore the effects of Shufeng Jiedu capsules (SFJD) on the humoral immune response in mice with non-lethal influenza A virus (H1N1) infection and the mechanisms using an in vitro model. Methods A mouse model of non-lethal H1N1 infection was established. Mice were randomly divided into the normal, PR8 model, positive drug oseltamivir-phosphate (27.5 mg·kg-1·d-1), SFJD medium-dose (1.144 g·kg-1·d-1), and SFJD high-dose groups (2.288 g·kg-1·d-1). Each group was then divided into five time-point subgroups: Days 0, 2, 4, 6, and 8. The drug was administered by gavage from day 0 to day 4. At each time point, the mice were euthanized for sample collection. Lung and body weights were measured to calculate the lung index. Total IgA, IgM, and IgG in bronchoalveolar lavage fluid were detected using a high-throughput liquid phase protein chip multiplex assay. H1N1-specific IgA, IgM, and IgG were measured via enzyme-linked immunosorbent assay (ELISA). On day 8, viral loads in lung tissues were assessed by real-time fluorescence quantitative PCR (Real-time PCR). Lung images were obtained using Micro-CT. The percentage of B cells in peripheral blood and bronchoalveolar lavage fluid was analyzed by flow cytometry. Human bronchi epithelial cells (BEAS-2B) were allocated into 6 groups: normal control, virus infection, positive drug (62.5 μmol·L-1), SFJD high-dose (15.6 μg·mL-1) and SFJD medium-dose (7.8 μg·mL-1). Murine lung epithelial-12 cells (MLE12) were divided into five groups: normal control, virus infection, positive drug (250 μmol·L-1), SFJD high-dose (62.5 μg·mL-1) and SFJD medium-dose (31.3 μg·mL-1). Western blot was employed to evaluate the impact of SFJD on expression levels of B cell activating factor (BAFF) in respiratory epithelial cells. Results SFJD reduced the lung index of H1N1 infected mice from day 4 to day 8 (P<0.05), viral load on day 8 (P<0.01), and alleviated inflammatory lesions. It increased the proportion of B cells in peripheral blood and lung tissues (P<0.01, P<0.001), decreased total IgA levels in bronchoalveolar lavage fluid on day 8, increased total IgM levels (P<0.01), and reduced specific IgA secretion on day 4 (P<0.0001) while promoting specific IgM (P<0.0001) and IgG (P<0.0001) secretion on day 8. SFJD also inhibited BAFF expression in respiratory epithelial cell lines (P<0.05, P<0.001). Conclusion Early administration of SFJD in case of H1N1 infection can restore the peripheral blood B cell proportion, promote their infiltration into lung tissues, enhance specific IgM and IgG secretion, and exert antiviral effects. Additionally, SFJD regulates the humoral immune response post-infection by inhibiting BAFF expression in respiratory epithelial cells and by preventing excessive B cell activation. Reference | Related Articles | Metrics | Comments（0）

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Revision of the Provisions for Adverse Drug Reactions Reporting and Monitoring TIAN Chunhua Chinese Journal of Pharmacovigilance    2025, 22 (11): 1253-1257.   DOI: 10.19803/j.1672-8629.20250657 Abstract （704）      PDF（pc） （1267KB）（611）       Knowledge map    Save Objective To review the evolution of the Provisions for Adverse Drug Reaction Reporting and Monitoring and analyze the significant revisions and considerations in order to provide references for revisions. Methods The background and highlights of revisions and the role played by Provisions for the Monitoring of Adverse Drug Reaction (trial) in 1999 and the two revisions in 2004 and 2011 in enhancing the monitoring of adverse drug reactions were reviewed. The priorities of the current revision were analyzed, and the considerations were outlined from a technical perspective. Results The revisions of the provisions fully reflected the current needs of regulation, aligned with the reality in monitoring and evaluation of ADR, and served as a strong force behind related monitoring. The central purpose of this revision was to meet the requirement that “the state establish a pharmacovigilance system” stipulated in the “Drug Administration Law”. Importance was attached to the compatibility between related regulations and guidelines, and efforts were made to ensure inheritance and innovation of the provisions. Revisions involved delimiting the range of reporting, optimizing the requirements for reporting, highlighting risk control, and strengthening supervision and management. Conclusion The revisions of the provisions have a long way to go, but are of great significance for pharmacovigilance in China for some time to come, and will usher China's pharmacovigilance into a new stage of development. Reference | Related Articles | Metrics | Comments（0）

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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 Chinese Journal of Pharmacovigilance    2025, 22 (3): 292-296.   DOI: 10.19803/j.1672-8629.20240513 Abstract （339）      PDF（pc） （1371KB）（554）       Knowledge map    Save 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. Reference | Related Articles | Metrics | Comments（0）

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Doxorubicin-Induced Cardiotoxicity Related to Regulation of Mitochondrial-Associated Membranes by PDK4 SHI Yanlei, ZHANG Bing, WANG Yu, XU Zhuoxin, TIAN Min, MENG Min, SA Rina Chinese Journal of Pharmacovigilance    2025, 22 (8): 863-868.   DOI: 10.19803/j.1672-8629.20250272 Abstract （1052）      PDF（pc） （1785KB）（553）       Knowledge map    Save Objective To analyze the molecular mechanism through which PDK4 regulates Mitochondria-Associated Membranes(MAMs) and explore its potential association with anthracycline-induced cardiotoxicity in order to provide data for developing cardioprotective strategies. Methods By reviewing recent literature, the role of PDK4 in MAMs and its potential involvement in anthracycline-induced cardiotoxicity was explored. Results There were complicated interactions between PDK4, MAMs, and anthracycline-induced cardiotoxicity, primarily manifested as energy metabolism disorders, oxidative stress, apoptosis, and calcium homeostasis imbalance. These interactions played a significant role in the progression of anthracycline-induced cardiotoxicity. Conclusion Overexpression of PDK4 can, above all, disrupt calcium homeostasis mediated by MAMs, leading to mitochondrial calcium overload and consequently exacerbating anthracycline-induced cardiotoxicity. This study can offer novel insights and help identify potential therapeutic targets for developing protective strategies against anthracycline-associated cardiotoxicity. Reference | Related Articles | Metrics | Comments（0）

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Uncertainty Evaluation for Determination of Ambroxol in Rat Plasma by UPLC-MS/MS Method JIN Shaoming, NING Xiao Chinese Journal of Pharmacovigilance    2025, 22 (4): 381-385.   DOI: 10.19803/j.1672-8629.20240851 Abstract （154）      PDF（pc） （1419KB）（518）       Knowledge map    Save 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. Reference | Related Articles | Metrics | Comments（0）