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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 （1772）      PDF（pc） （1259KB）（9571）       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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Research progress in methods for toxicity-decreasing processing of toxic herbal traditional Chinese medicines HE Jia, JIN Yan, ZHAO Yuyang, ZHOU Junhui, LI Xiaolin, YUAN Yuan, FU Lu Chinese Journal of Pharmacovigilance    2023, 20 (9): 1064-1070.   DOI: 10.19803/j.1672-8629.20220624 Abstract （374）      PDF（pc） （1386KB）（5067）       Knowledge map    Save Objective To summarize the current studies on processing methods to decrease toxicity of toxic herbal TCM in China so as to provide reference for subsequent studies. Methods Toxicity-decreasing processing methods and similarities and differences between these methods when used in a variety of medicinal parts were analyzed via literature review. Results The commonly used processing methods for toxic Chinese herbal medicines included JingZhiFa, ChaoZhiFa, FuLiaoGongZhiFa, QuYouZhiShuangFa. Medicinal parts could be divided into three parts: root and rhizome drugs, fruit and seed drugs and resin drugs. Processing methods varied depending on the medicinal parts. For example, steaming and boiling were used for root and rhizome drugs, while oil removal was employed to reduce toxicity in fruit and seed drugs rich in oil. Conclusion The main objective of processing for toxicity reduction is to remove toxic components and reduce adverse reactions of drugs. However, the toxicity and active components of most of the toxic Chinese herbal medicines are not clear, throwing doubt on the feasibility of these processing methods. The mechanism by which toxicity is minimized should be clarified, processing conditions should be optimized, and the relationships between toxicity and efficacy should be balanced. Reference | Related Articles | Metrics | Comments（0）

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Safety and Efficacy of Chinese Herbal Patent Medicines for COVID-19: an Umbrella Review LI Bo, XU Liu, XIE Yuqing, WANG Yiying, DONG Shuai, LIAN Jie, LI Guodong, CAO Huijuan Chinese Journal of Pharmacovigilance    2025, 22 (2): 155-161.   DOI: 10.19803/j.1672-8629.20240011 Abstract （508）      PDF（pc） （1467KB）（3345）       Knowledge map    Save Objective To summarize the current systematic review evidence for evaluating the efficacy and safety of Chinese herbal patent medicines (CHPMs) for the treatment of novel coronavirus pneumonia, assess the safety and efficacy of CHPMs as an intervention for the treatment of COVID-19, and to evaluate the quality of related evidence. Methods PubMed, Cochrane, Embase, Sinomed, China National Knowledge Infrastructure (CNKI), Wanfang database, and VIP were searched for systematic reviews of CHPMs in the treatment of COVID-19 that were published from the inception to June 15, 2023. Revman 5.3 software was used to conduct a secondary meta-analysis, AMSTAR-II was adopted to assess the methodological quality of articles, and the GRADE system was employed to evaluate the level of evidence before the results of evaluation were presented in the form of a bubble chart. Results Finally, 13 systematic reviews involving a total of 17 053 cases were included. Meta-analysis results showed that CHPMs combined with STs with Western medicine enjoyed advantages over STs with Western medicine alone in multiple outcome indicators, including the all-cause mortality (RR=0.26, 95%CI=0.09~0.81,P=0.02, I 2= 0%), viral clearance rate (RR=1.12, 95%CI=1.01~1.23, P=0.03, I 2= 44 %), rate of conversion to severe cases (RR=0.49, 95%CI=0.37~0.64, P<0.000 01, I 2= 0%), improvement in pulmonary imaging, clinical symptom recovery rate (including fever, cough, fatigue and shortness of breath) and recovery time of clinical symptoms (especially fatigue). There was no significant difference between the two groups in terms of adverse events or therapeutic efficacy against sore throat and diarrhea. Bubble chart results showed that there was extremely low-level evidence suggesting the effectiveness of Reyaning compounds. Jinhuaqinggan granules, Lianhuaqingwen granules, Shenhuag granules, Shufeng Jiedu capsules, Lianhuaqingwen capsules, Xuebijing injection, and Lianhuaqingke granules could make a big difference to nucleic acid conversion to negative, the incidence of severe cases, and to the recovery rate of pulmonary imaging, respectively. Conclusion CHPMs combined with conventional STs show better efficacy in treating novel coronavirus pneumonia compared to ST alone. However, the overall quality of evidence in these studies is generally low, and high-quality clinical trials are needed to validate these findings. Reference | 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 （1040）      PDF（pc） （1478KB）（2655）       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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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 （483）      PDF（pc） （1252KB）（2587）       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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Risks of Calcium Dobesilate Preparations to Safety MENG Kangkang, TANG Ren Chinese Journal of Pharmacovigilance    2024, 21 (11): 1288-1292.   DOI: 10.19803/j.1672-8629.20240539 Abstract （443）      PDF（pc） （1384KB）（2404）       Knowledge map    Save Objective To analyze the safety information of oral preparations of Calcium Dobesilate and provide reference for rational clinical drug use. Methods Individual cases of adverse drug reactions reported in China adverse drug reaction (ADR) database between January 1, 2004 and March 31, 2023, domestic and international literature published from January 1, 2000 to March 31, 2023, domestic and international drug specifications were analyzed. Results From January 1, 2004 to March 31, 2023, there were a total of 3 815 ADR reports of Calcium Dobesilate preparations in the database, involving 182 serious cases.in the reports of severe cases, skin damage was reported more frequently; Toxic epidermal necrolysis is more prominent in the literature, and the patients were accompanied by renal impairment. Conclusion Calcium Dobesilate oral preparation may cause serious skin damage, especially in patients with renal impairment requiring dialysis, and Medical institutions should pay attention to this risk. Marketing authorization holders should strengthen the monitoring of adverse reactions and update the information on safety in drug labels in time. Reference | Related Articles | Metrics | Comments（0）

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Exploring the scientific connotation of Mongolian Medicine pharmacovigilance based on ancient Mongolian Medical literature ALATENG Hua, GAO Lei, ZHANG Xiaomeng, ZHANG Bing Chinese Journal of Pharmacovigilance    2024, 21 (6): 677-682.   DOI: 10.19803/j.1672-8629.20230743 Abstract （247）      PDF（pc） （1282KB）（2266）       Knowledge map    Save Objective To study the ancient Mongolian Medical literature from the perspective of pharmacovigilance, explain the theoretical connotation of Mongolian Medicine pharmacovigilance, and provide a reference for further research on the safety evaluation and pharmacovigilance of Mongolian Medicine. Methods By combing through over 40 classic works of Mongolian Medicine and historical documents since the 4th century, the content related to pharmacovigilance was excavated, and the toxicity theory and characteristics of safe and rational drug use in Mongolian Medicine were analyzed. Results The study found that Mongolian Medicine attaches great importance to the duality of drugs, which means that drugs can bring harm to the human body while treating diseases. The Mongolian Medicine pharmacovigilance is mainly reflected in the following aspects: the understanding of toxicity, detoxification of poisoning, dietary taboos, living taboos, physical taboos, disease taboos, and other medication taboos; methods of reducing toxicity such as compatibility and processing; principles for controlling drug dosage and treatment duration; as well as the characteristics of dosage forms. Conclusion Mongolian people have a long history of understanding and using “toxicity”, coupled with the theoretical characteristics of Mongolian Medicine and clinical medication differences, the practice of safe and rational drug use is rich and unique. Exploring the scientific connotation of Mongolian Medicine pharmacovigilance has practical and far-reaching significance for guiding the rational use of Mongolian Medicine in modern clinical practice and inheriting traditional medicine. 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 （387）      PDF（pc） （1183KB）（2133）       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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Rationality of compound drug components against hypertension GUO Shushu, JIANG Haiyan, FAN Xiaoyu, LI Wanfang, BAO Jie, MA Enlong, JIN Hongtao Chinese Journal of Pharmacovigilance    2024, 21 (9): 973-977.   DOI: 10.19803/j.1672-8629.20240278 Abstract （397）      PDF（pc） （1336KB）（2031）       Knowledge map    Save Objective To analyze the marketed combination antihypertensive drugs and the rationality of their components, explore their composition and assess their efficacy so as to provide references for the development and innovation of combination antihypertensive drugs. Methods The marketed compound drug combinations and approved drug combination therapy regimens were analyzed and summarized by searching domestic and foreign literature. Results With multiple mechanisms of action, compound antihypertensive drugs could improve drug compliance, reduce cardiovascular risks, and lower overall treatment cost. Conclusion Compound antihypertensive drugs have unique advantages in the treatment of hypertension. Compound drugs are also the best choice for the treatment of hypertension and concomitant diseases, which will provide a new impetus for the development of compound drugs in the future. Reference | Related Articles | Metrics | Comments（0）

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Evaluation methods for aerodynamic particle size distribution of fine particles in inhaled products JIA Yinyin, ZHANG Caishu, ZHOU Ying, LIU Li, GENG Ying, WEI Ningyi, NIU Sijing, CHEN Hua, XU Hui Chinese Journal of Pharmacovigilance    2024, 21 (2): 141-146.   DOI: 10.19803/j.1672-8629.20230411 Abstract （640）      PDF（pc） （1447KB）（2026）       Knowledge map    Save Objective To improve the quality, safety, and effectiveness of drugs by evaluating the aerodynamic particle size distribution (APSD) of inhaled formulations. Methods The methods and related standards for detecting APSD specified in different national pharmacopoeias were compared and contrasted. APSD was characterized using multiple econometric parameters. The size of the fine particle dose and its proportion in the total collected dose were used as the key indicators for evaluating inhaled products. Results The Anderson cascade impactor (ACI) and the next generation impactor (NGI) were currently the most widely used and included in the US Pharmacopoeia. The Chinese Pharmacopoeia also included a glass twin impinger while the European Pharmacopoeia also included a multi-stage liquid impactor. The mass median aerodynamic diameter (MMAD) was an important variable to control the deposition position of particles in the lung. The geometric standard deviation (GSD) represented the shape of the drug particle size distribution curve. The closer to 1 the distribution curve, the narrower the distribution of particles. The changes in APSD could be detected by measuring both the ratio of the large particle mass (LPM) to the small particle mass (SPM) and the impactor-sized mass (ISM) in effective data analysis (EDA). The size and distribution of drug particles largely determined the location and amount of particle deposition in the respiratory system, thereby affecting the efficacy of drugs. The delivery of active pharmaceutical ingredients (APIs) in the inhaled formulations to the lungs through the respiratory system required that the aerodynamic particle size of aerosols range from 1 to 5 μm. Conclusion Appropriate testing methods can ensure the quality, safety, and effectiveness of inhaled products. Well-designed dosages and drug particle sizes are the key indicators that determine the performance of inhaled formulations. Therefore, successive improvement of testing methods for fine particles and in-depth research on the correlation between in vitro and in vivo use can facilitate the research and development of inhaled products. Reference | Related Articles | Metrics | Comments（0）

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Research progress in pharmacogenic cardiotoxicity ZHANG Bing, SA Rina, ZHANG Xiaomeng, ZHANG Dan, LIN Zhijian, WANG Yu Chinese Journal of Pharmacovigilance    2023, 20 (8): 841-847.   DOI: 10.19803/j.1672-8629.20230293 Abstract （1136）      PDF（pc） （1257KB）（1999）       Knowledge map    Save Pharmacogenic cardiotoxicity is one of the severe adverse reactions triggered by drugs, the severity of which ranges from mild electrocardiographic changes to fatal arrhythmias. Pharmacogenic cardiotoxicity is characterized by multiple sources, high incidence, insidiousness, susceptibility to special populations, diversity of clinical manifestations, and complexity of mechanisms. In recent years, research on pharmacogenic cardiotoxicity has received much attention. This paper reviews the research progress in pharmacogenic cardiotoxicity in terms of its clinical manifestations, mechanisms of occurrence and preventive measures to provide reference for clinical prevention of pharmacogenic cardiotoxicity. 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 （446）      PDF（pc） （1232KB）（1976）       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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Interpretation and insights from the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications” LU Zhenkai, YANG Dingquan, XIE Zhennian, WANG Lianxin, LI Yuanyuan, WANG Zhifei, CUI Xin, XIE Yanming Chinese Journal of Pharmacovigilance    2024, 21 (9): 1029-1033.   DOI: 10.19803/j.1672-8629.20240349 Abstract （470）      PDF（pc） （1296KB）（1966）       Knowledge map    Save Objective To guide the “Guidelines for Pharmacovigilance of Topical Traditional Chinese Medicines in Clinical Applications” (referred to as the “Guidelines”), providing a reference for standardizing pharmacovigilance activities and clinical practices related to topical traditional Chinese medicines (TCMs) in China. Methods Summarize the traditional formulations of topical TCMs mentioned in the “Guidelines”, and provide a detailed interpretation of the potential risks and control measures in the clinical application of topical TCMs. Results The Guidelines highlight the safety of medications containing mineral Chinese medicinal materials, toxic Chinese medicinal materials, and the use of TCMs in special populations such as pediatric, elderly, and pregnant patients. Comprehensive risk assessment and control measures are provided. Conclusion The irrational clinical application of topical TCMs increases the risk of medication-related adverse events. The guidelines offers valuable reference and guidance for better standardizing pharmacovigilance activities in the clinical application of topical TCMs. Reference | Related Articles | Metrics | Comments（0）

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Research Progress of Epimedium in the Treatment of Male Infertility TANG Tian, TAN Tianyang, LIU Zhejun, BAI Xue Chinese Journal of Pharmacovigilance    2024, 21 (11): 1238-1242.   DOI: 10.19803/j.1672-8629.20240638 Abstract （1091）      PDF（pc） （1246KB）（1905）       Knowledge map    Save Objective To assess the potential of Epimedium and its active components in the treatment of male infertility and to explore their prospects in traditional Chinese medicine therapy. Methods A systematic literature review was conducted to analyze the significant effects of Epimedium and its main active components on improving spermatogenesis, protecting the testicular microenvironment, regulating sex hormone levels, combating oxidative stress, and alleviating sexual dysfunction. Results Epimedium demonstrated the potential to protect germ cells by modulating key signaling pathways and improving apoptosis, and it also showed positive effects in improving sexual dysfunction. Conclusion The active components of Epimedium have significant potential in the treatment of male infertility. Future research should further verify their clinical efficacy to promote their application in the field of male reproductive health. Reference | Related Articles | Metrics | Comments（0）

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Chinese Patent Medicines for Preventing Myelosuppression in Adjuvant Treatment of Malignant Tumors: a Systematic Review and Network Meta-Analysis WANG Han, WANG Cunxuan, LYU Xuehaiyue, ZHANG Lining, SUO Yusi, GU Zhi'en, WANG Ping, JIN Xuejing Chinese Journal of Pharmacovigilance    2025, 22 (2): 169-176.   DOI: 10.19803/j.1672-8629.20240803 Abstract （673）      PDF（pc） （1515KB）（1899）       Knowledge map    Save Objective To conduct a network Meta-analysis of eight Chinese patent medicines (CPMs) that are commonly used in clinical practice, have a large market share, and are relatively affordable for patients in order to assess their protective effects against myelosuppression in adjuvant radiotherapy and chemotherapy for malignant tumors. Methods CNKI, Wanfang Database, Chinese Science and Technology Journal Database, SinoMed, Cochrane Library, PubMed, and Embase were searched for related literature published from inception to April 9, 2024. Randomized controlled trials (RCTs) in which CPMs were used to prevent myelosuppression during radiotherapy in patients with solid tumors were enrolled. Two researchers independently screened the literature, retrieved the data, and evaluated the quality of the literature using the risk of bias assessment tool. Stata software was used for network Meta-analysis. Results The number of RCTs included was 48 involving a total of 4 204 patients and eight CPMs, namely, Diyu Shengbai tablets, Qijiao Shengbai capsules, compound E Jiao Jiang, compound Zaofan pills, Zhenqi Fuzheng granules (capsule and punch), Shengxuebao mixture, Shenqi Shiyiwei granules and Shiyiwei Shenqi capsules. The results showed that Diyu Shengbai tablets, Qijiao Shengbai capsules, and Fufang Zaofan pills could reduce the incidence of myelosuppression while compound E Jiao Jiang, Diyu Shengbai tablets, and Zhenqi Fuzheng granules could reduce the incidence of leukopenia. Conclusion CPMs of the “buqi shengxue” category can reduce the incidence of myelosuppression and leukopenia during adjuvant treatment of malignant tumors, among which Shenqi Shiyiwei granules, Zhenqi Fuzheng granules (capsule and punch), and compound E Jiao Jiang have the better protective effect against myelosuppression. Reference | Related Articles | Metrics | Comments（0）

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Clinical characterization and mechanism exploration of Fructus Psoraleae-induced hepatotoxicity in zebrafish AO Ting, WANG Ningning, ZHOU Lei, DENG Huifang, YANG Xingxin, ZHOU Wei, SHEN Pan, GAO Yue Chinese Journal of Pharmacovigilance    2024, 21 (6): 611-616.   DOI: 10.19803/j.1672-8629.20240317 Abstract （311）      PDF（pc） （2408KB）（1879）       Knowledge map    Save Objective To investigate the effects of Fructus Psoraleae (FP) in accordance with clinical medicinal characteristics on the liver of zebrafish based on the proteome and its potential hepatotoxic mechanism. Methods Adult zebrafish were continuously treated with low, medium, and high concentrations of FP decoction (0.025, 0.050, 0.100 mg·mL-1) for 21 days. Changes in zebrafish body weight, liver histopathology, and levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the serum detected by enzyme-linked immunosorbent assay (ELISA) were compared. Potential hepatotoxic mechanisms were studied based on identified liver proteome through cluster and pathway enrichment analysis, and molecular docking was used to explore potential toxic targets of the main hepatotoxic components of FP. Results Zebrafish treated with FP decoction showed a significant decrease in body weight compared to the control group, with a more pronounced weight loss as the concentration increased. The levels of ALT and AST were significantly elevated in the Angelica sinensis treated group, with a dose-dependent effect (P < 0.05). Hematoxylin-eosin (HE) staining results showed disordered arrangement of liver cells, increased gaps, and phenomena such as steatosis and immune cell infiltration in the liver tissues of the FP-treated group compared to the control group, with the severity of the lesions worsening with increasing concentration. Cluster and functional enrichment analysis of the proteome indicated that FP affected the expression of lipid and energy metabolism-related proteins, including acetyl-CoA acetyltransferase 1 (acat1), 3-hydroxyacyl-CoA dehydrogenase (ehhadh), succinate dehydrogenase (sdha) and succinate dehydrogenase (sdhb) in the zebrafish liver, and molecular docking revealed the potential of the main hepatotoxic components in FP to bind to these proteins. Conclusion Long-term Fructus Psoraleae administration causes hepatic lipid metabolism disorders, ultimately resulting in hepatotoxicity characterized by steatosis, with the potential toxicity mechanism involving abnormal expression of lipid and energy metabolism-related proteins induced by main hepatotoxic compounds in FP. Reference | Related Articles | Metrics | Comments（0）

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Medications and Adverse Reaction in Children and Adolescents with Depressive Disorders ZHANG Longying, LOU Lifeng, YOU Qian, WEI Yubing, CAI Yan, LI Bin Chinese Journal of Pharmacovigilance    2024, 21 (12): 1419-1424.   DOI: 10.19803/j.1672-8629.20240664 Abstract （645）      PDF（pc） （1421KB）（1817）       Knowledge map    Save Objective To examine the real-world clinical medications for pediatric and adolescent patients with depressive disorders, analyze the usage of drugs, and provide references for rational prescriptions. Methods The demographic characteristics, types of drugs used, treatment regimens, and adverse drug reactions among pediatric and adolescent patients with depressive disorders treated at psychological clinic of Fujian Energy General Hospital between 2019 and 2023 were analyzed. Results A total of 2 550 prescriptions for pediatric and adolescent depression patients were collected, involving 14 597 prescriptions for Western medicines and 46 583 drug entries. The majority of patients were aged 16 to 18, who far outnumbered those in groups ages 10 to 12 and 13 to 15. The average age of patients declined over time, with females outnumbering males. The five most commonly prescribed psychiatric medications were sertraline, alprazolam, quetiapine, olanzapine, and aripiprazole. The treatment approach primarily involved polypharmacy (more than 80%), with the most common regimens being antidepressant + antipsychotic (30.81%), and antidepressant + antipsychotic + sedative-hypnotic or anxiolytic (26.69%). Adverse drug reactions included gastrointestinal disorders, metabolic and nutritional disturbances, and psychiatric symptoms. Conclusion Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), are the mainstay of treatments for pediatric and adolescent depression in outpatient settings. Sertraline is the most commonly prescribed despite its declining usage. The typical treatment regimen involves a single antidepressant, often combined with benzodiazepine sedative-hypnotics and atypical antipsychotics. Reference | Related Articles | Metrics | Comments（0）

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Research progress of sustained and controlled release preparations of Chinese medicine SUN Li, XIE Bin, XU Yanqin Chinese Journal of Pharmacovigilance    2024, 21 (8): 949-954.   DOI: 10.19803/j.1672-8629.20240249 Abstract （1015）      PDF（pc） （1293KB）（1801）       Knowledge map    Save Objective To summarize the research progress on the slow and controlled release preparations of traditional Chinese medicine, and provide a basis for understanding the preparation process, prescription and quality evaluation of slow and controlled release preparations of traditional Chinese medicine. Methods Through literature search,the advantages and disadvantages, preparation process, and quality evaluation system was summarized from different new types of sustained and controlled release formulations. Results The new types of sustained and controlled release formulations involve solid lipid nanoparticles sustained and controlled release formulations, oral osmotic pump sustained and controlled release formulations, gastric retention delivery sustained and controlled release formulations, bioadhesive microspheres, and solid dispersions, and the preparation process uses multiple screening methods to arrive at the optimal process, and the quality evaluation methods for the sustained and controlled release formulations of traditional Chinese medicines include in vitro release studies, in vivo release, and in vitro and in vivo correlation studies. Conclusion The research on slow and controlled release preparations of traditional Chinese medicine mainly focuses on the single component of traditional Chinese medicine, traditional Chinese medicine extracts or active parts, and combination of several single components of traditional Chinese medicine, and the quality evaluation system mainly includes in vivo release, in vitro release and in vitro and in vivo correlation studies, which can provide reference basis for the future development of slow and controlled release preparations of traditional Chinese medicine. Reference | Related Articles | Metrics | Comments（0）

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Chinese patent medicines for recurrent spontaneous abortion: a scoping review of clinical evidence YU Xin, GONG Leilei, YAO Weijie, YUAN Sisi, FENG Xin Chinese Journal of Pharmacovigilance    2024, 21 (4): 361-365.   DOI: 10.19803/j.1672-8629.20240057 Abstract （422）      PDF（pc） （2126KB）（1743）       Knowledge map    Save Objective To systematically sort out the drug information and current status of clinical research on the treatment of Recurrent Spontaneous Abortion (RSA) with Chinese patent medicines, so as to provide reference evidence for the rational use of medicines in the clinic, and a basis for the decision-making in the clinical practice and healthcare. Methods We carried out Chinese and English database document retrieval to review the clinical studies on Chinese patent medicines for the treatment of RSA. Relevant software was used to manage the literature, extract the basic information of the drugs and studies, and carry out visual comparative analyses in the form of textual descriptions and charts. Results A total of 95 research articles on Chinese patent medicines were screened out, including 2 systematic reviews and 93 clinical studies. 11 types of Chinese patent medicines were involved, including 1 Chinese medicine injection. The drugs with a higher number of clinical studies were Zishenyutai pills, Gushenantai pills, and Baotailing preparation. Since 2005, the number of related studies has been on an overall elevated trend, and has been carried out in 24 regions of China, the largest number of studies with sample sizes of 51~100 cases included 67 (72.04%); the type of comparison with the largest number of studies was the comparison of Chinese patent medicines in combination with Western medicines versus Western medicines, with a total number of studies amounted to 75 (80.65%). At present, there is no uniform clinical treatment protocol and efficacy judgement standard, and some studies (43.01%) recorded the occurrence of adverse reactions during drug administration in patients. Conclusion Chinese patent medicines have good suitability for the treatment of RSA, and their effectiveness in combination with western medicines is clear. However, there are problems such as lack of content in the drug instruction, timing and duration of medication and outcome evaluation indexes are not standardised, insufficient attention to medication safety, insufficient embodiment of Chinese medicine characteristics , which needs to be improved in the future. Reference | Related Articles | Metrics | Comments（0）

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Current Progress and Considerations in Updating the Safety Information in Labels of Chinese Traditional Patent Medicines ZHU Lan, SHAO Bo, ZHU Yan, DAI Jie, ZHONG Shiqi Chinese Journal of Pharmacovigilance    2025, 22 (2): 188-192.   DOI: 10.19803/j.1672-8629.20240621 Abstract （649）      PDF（pc） （1297KB）（1711）       Knowledge map    Save Objective To review Current status of updating safety information in labels of Chinese traditional patent medicines. Methods To analyze the guidelines and requirements for the updating of information on adverse reactions, contraindications, precautions and warnings information in the labels of Chinese traditional patent medicines, and to make suggestions based on working experience. Results For some historical reasons, safety information is missing from some Chinese traditional patent medicine labels and should be added to provide guidance to healthcare professionals and patients on the use of medicines. Conclusion Revision of labeling and updating of safety information is one of the risk management measures, after solving the problem of missing safety information, there is still a need for continuous monitoring of adverse reactions, post-marketing research to identify drug risks, and to control the risks by revising labels and other measures. Reference | Related Articles | Metrics | Comments（0）