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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 （1504）      PDF（pc） （1259KB）（4872）       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 （376）      PDF（pc） （1232KB）（1810）       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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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 （255）      PDF（pc） （2408KB）（1637）       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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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 （924）      PDF（pc） （1478KB）（1468）       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 （324）      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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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 （842）      PDF（pc） （1293KB）（1388）       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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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 （585）      PDF（pc） （1297KB）（1367）       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）

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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 （421）      PDF（pc） （1296KB）（1358）       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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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 （205）      PDF（pc） （1282KB）（1245）       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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Research Progress in Quality Evaluation of Polygonum multiflorum Thunb. Based on Features of Traditional Identification YANG Yanrong, KANG Shuai, LI Yanyi, MA Shuangcheng, WEI Feng, WANG Fang, WANG Qi Chinese Journal of Pharmacovigilance    2024, 21 (12): 1357-1362.   DOI: 10.19803/j.1672-8629.20240343 Abstract （443）      PDF（pc） （1454KB）（1215）       Knowledge map    Save Objective To clarify the correlation between the characters and microscopic characteristics of Polygonum multiflorum Thunb. and its quality, and establish a method to evaluate the quality. Methods The history and basal traits of Polygonum multiflorum Thunb. were studied based on related literature and books. The correlations between the trait characteristics of “red and white” Polygonum multiflorum Thunb., cloudy pattern, wood center and its quality were explored. Results The authentic basal root of Polygonum multiflorum Thunb. should be Polygonum multifonum Thunb. of the family Polygonaceae. The wood center of Polygonum multiflorum Thunb. referred to the round-shaped central part or the central formation of the layer ring in the cross-section of the herb. There was a correlation between the cloudy pattern and wood center and the quality of Polygonum multiflorum Thunb. Herbs with an obvious cloudy pattern but no wood center had higher contents of effective ingredients while those with a small or no cloud pattern but with a wood center had lower contents. Conclusion The categorization of Polygonum multiflorum Thunb. into “red and white” types remains controversial.Studies are so far insufficient to definitively correlate traits with the quality of Polygonum multiflirum Thunb., so in-depth research is needed in this area. 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 （421）      PDF（pc） （1467KB）（1044）       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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Risks of piracetam preparations to safety LIU Cuili, WU Chen, WANG Tao Chinese Journal of Pharmacovigilance    2024, 21 (5): 563-566.   DOI: 10.19803/j.1672-8629.20230381 Abstract （321）      PDF（pc） （1414KB）（1040）       Knowledge map    Save Objective To analyze the risk of piracetam preparations in order to provide reference for clinical rational 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 literature published from January 1, 2000 to March 31, 2023 and risk control measures taken in China were analyzed. Results Between January 1, 2004 and March 31, 2023, there were a total of 40 675 ADR reports of piracetam preparations in the database, involving 1 922 serious cases (4.7%). There were 5 360 ADR reports of oral preparations, including 55 serious adverse reactions and 429 unexpected adverse reactions. There were 35 315 cases of ADR reports of injection preparations, including 1 865 serious cases (5.3%). Conclusion Piracetam preparations can cause serious adverse reactions such as anaphylactic shock. Clinicians should be alert to these serious adverse reactions and take preventions when prescribing piracetam preparations. Marketing authorization holders should assume more responsibility for monitoring and evaluation of adverse drug reactions and update the information on safety in drug labels in time. Reference | Related Articles | Metrics | Comments（0）

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One case of severe systemic rash caused by atorvastatin calcium tablets LI Fang, LONG Xiuying, BAI Na, WEI Jingxia Chinese Journal of Pharmacovigilance    2024, 21 (8): 939-942.   DOI: 10.19803/j.1672-8629.20240094 Abstract （572）      PDF（pc） （1234KB）（1035）       Knowledge map    Save Objective To analyze the clinical characteristics and potential allergenic mechanisms of atorvastatin induced severe generalized rash in patients with chronic diseases, providing a warning for future polypharmacy and reference for early clinical management. Methods A retrospective study was conducted on a patient with cerebral infarction who developed a generalized rash after polypharmacy (amlodipine, aspirin, atorvastatin, urinary kallidinogenase and edaravone dexborneol) was conducted. The rash worsened even after discontinuing urinary kallidinogenase and edaravone dexborneol and switching aspirin to clopidogrel. The rash subsided only after discontinuing all medications except for antiallergic drugs. When clopidogrel and amlodipine were reintroduced, the rash did not recur. The Naranjo score and literature review were used to analyze the potential allergenic drug. Results Based on the clinical presentation of the rash and its relationship with the timing of medication, combined with the Naranjo score of 5 for atorvastatin, it is very likely that atorvastatin is the drug causing the patient’s rash. Conclusions Clinicians should be aware that atorvastatin can cause severe generalized rash in chronic diseases patients a few days after administration during polypharmacy. 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 （1000）      PDF（pc） （1246KB）（1023）       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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Standards for Drug Safety Signal Detection Using Individual Case Safety Reports in Pharmacovigilance LIANG Jizhou, CHEN Chenxin, BAI Wangyang, GUO Xiaojing, XU Jinfang, HE Jia, YE Xiaofei Chinese Journal of Pharmacovigilance    2024, 21 (11): 1280-1283.   DOI: 10.19803/j.1672-8629.20240471 Abstract （1103）      PDF（pc） （1223KB）（1017）       Knowledge map    Save Objective To analyze and interpret the READUS-PV standard for drug safety signal detection based on individual safety reports in pharmacovigilance so as to provide references for related research in China. Methods The reporting of a disproportionality analysis for drug safety signal detection using individual case safety reports in pharmacovigilance (READUS-PV) jointly delivered by experts in pharmacovigilance worldwide was analyzed and interpreted. Results READUS-PV included 14 items concerning the title, introduction, methods, results, discussion, declaration and abstracts. Conclusion In actual drug safety signal detection research, READUS-PV can be consulted to improve research quality. 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）（1004）       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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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 （538）      PDF（pc） （1515KB）（995）       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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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 （276）      PDF（pc） （1225KB）（987）       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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Rational Use of Traditional Chinese Medicine Decoction Pieces in Outpatient Clinic of a Hospital LI Yiwen, CAO Keming, LAN Yuze, SU Shuang, MA Hongliang, ZHANG Lili, CHANG Xiaohong, LI Bo Chinese Journal of Pharmacovigilance    2024, 21 (11): 1293-1298.   DOI: 10.19803/j.1672-8629.20240410 Abstract （535）      PDF（pc） （1383KB）（983）       Knowledge map    Save Objective To investigate the applications of PDCA cycle management method in the review of prescriptions for traditional Chinese medicine decoction pieces and to analyze its role in improving the rate of standard prescriptions and promoting the rational use of medicines. Methods A total of 645 prescriptions for traditional Chinese medicine decoction pieces given by the outpatient clinic between October and December 2023 were selected as the control group while the prescriptions after the first and second rounds of PDCA cycle management from January to March 2024 (612 prescriptions) and from April to June 2024 (615 prescriptions) were selected for the intervention group. The results of review of prescriptions before and after the PDCA cycle was carried out were compared to evaluate the utility of the method in improving the qualified rate of Chinese medicine prescriptions. Results After two PDCA cycles, the qualified rate of prescriptions for traditional Chinese medicine decoction pieces was significantly improved. In the first stage study group, the qualified rate of outpatient Chinese medicine prescriptions was significantly increased from 70.54% to 81.69%(P<0.05), but it did not reach the intended goal. In the second stage study group, the qualified rate of outpatient Chinese medicine prescriptions was increased to 91.87% (P<0.05). In case of diagnostic absence, lack of Chinese medicine diagnosis, lack of labeling of special decoctions, and in terms of rational use of toxic sips, the qualified rate of the second stage study group was significantly higher than that of the control group and the first stage study group(P<0.05). Conclusion The PDCA cycle management method can effectively improve the quality and rationality of traditional Chinese medicine decoction pieces. Reference | Related Articles | Metrics | Comments（0）

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Adverse events of abemaciclib in breast cancer patients based on US FAERS database SU Xiaohan, ZENG Jiao, LI Xue, LIU Lixin, HOU Lingmi, LI Jinsui Chinese Journal of Pharmacovigilance    2024, 21 (5): 580-586.   DOI: 10.19803/j.1672-8629.20240131 Abstract （234）      PDF（pc） （1492KB）（960）       Knowledge map    Save Objective To analyze adverse drug events (ADE) of abemaciclib used in breast cancer patients that were reported in FAERS (FDA Adverse Event Reporting System) database in order to provide clinical data for rational use of this drug among breast cancer patients. Methods Adverse event reports of breast cancer patients using abemaciclib between October 1, 2017 and September 30, 2023 were retrieved from the FAERS before being categorized based on the Medical Dictionary for Regulatory Activities (MedDRA), System Organ Class (SOC), and Preferred Term (PT). Suspected risk signals were analyzed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence interval neural propagation network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). Results After duplicates were excluded, a total of 5 579 ADE of abemaciclib were retrieved. Following screening and analysis, 46 valid signals were identified that were of 16 SOC. The top three ADE were diarrhea, drug ineffectiveness, and dehydration. The top three signal strengths were treatment response loss, milk intolerance, and subcutaneous emphysema. Additionally, 19 suspicious signals, including renal tubular necrosis, kidney injury, sleep disorders (insomnia type), mediastinal emphysema, erythema multiforme, disseminated intravascular coagulation, and transient ischemic attack not mentioned in the product label deserved attention. Conclusion When this medication is adopted, clinicians should also watch for potential ADEs such as renal tubular necrosis and kidney injury that are not listed in the instructions to ensure the safety of the patients. Reference | Related Articles | Metrics | Comments（0）