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Annual report of national adverse drug reaction monitoring (2022) Chinese Journal of Pharmacovigilance    2023, 20 (6): 712-719.   DOI: 10.19803/j.1672-8629.20230168 Abstract （1721）      PDF（pc） （3455KB）（1529）       Knowledge map    Save Objective To analyze the amount of monitoring of adverse drug reactions/events(ADR/AE) in depth in China in 2022, and to remind the public of the need to use drugs safely and properly. Methods Work related to nation-wide monitoring of adverse drug reactions in 2022 was summarized. Reports of ADRs/AEs received by the National Adverse Drug Reaction Monitoring System in 2022 were statistically analyzed and interpreted. Results A total of 2.023 million reports of ADR/AE were received in 2022, 642 000 of which were new and serious reports. 2.185 million reports involved suspected drugs, 82.3% of which were chemical drugs, 2.6% were biological products, and 12.8% were Chinese medicines. There were 942 000 reports of ADR/AE that involved essential drugs. The risks of adverse reactions of anti-infective drugs, cardiovascular system drugs, anti-metabolic drugs, and drugs for children were given much attention. Conclusion Adverse drug reaction monitoring should continue to be strengthened to ensure safe use of drugs and offer better protection for the public. Related Articles | Metrics | Comments（0）

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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 （1171）      PDF（pc） （1259KB）（1508）       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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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 （478）      PDF（pc） （1297KB）（1286）       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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Chinese Journal of Pharmacovigilance    2024, 21 (2): 0-0.   Abstract （245）      PDF（pc） （430KB）（1226）       Knowledge map    Save 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 （178）      PDF（pc） （2408KB）（1211）       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 （678）      PDF（pc） （1478KB）（1163）       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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Applicability of evaluation standards for use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis ZHANG Jian, FANG Huihua Chinese Journal of Pharmacovigilance    2024, 21 (2): 185-189.   DOI: 10.19803/j.1672-8629.20230140 Abstract （138）      PDF（pc） （1543KB）（1098）       Knowledge map    Save Objective To establish the standard for evaluation of clinical use of traditional Chinese medicine injections for promoting blood circulation and removing blood stasis. Methods According to the National Pharmacopoeia of the People’s Republic of China (2020 edition), the Drug Catalogues for National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2021), the Guidelines for Clinical Application of Proprietary Chinese Medicine for Coronary Heart Disease (2020 edition) and the Guidelines for Clinical Application of Proprietary Chinese Medicine for Heart Failure (2021), all TCM injections for promoting blood circulation and removing blood stasis were sorted out. According to drug instructions, guidelines and clinical use, the indicators for evaluation were identified, and the standard for evaluation was established using the Delphi method. Data on TCM injections for promoting blood circulation and removing blood stasis used in the Department of Cardiology between January 1 and June 30, 2022 was collected. The Technique for Order Preference by Similarity to an Ideal Solution was used for evaluation. Results A total of 21 indications of TCM injections for promoting blood circulation and removing blood stasis were included before primary and secondary evaluation indexes were established in terms of indications, solvents, usage and dosage, excipients, compatibility and special populations. According to the results of evaluation, 107 patients (89.17%) with Ci≥60% were identified from among 120 patients receiving TCM injections for promoting blood circulation and removing blood stasis, indicating that the usage of these TCM injections in the Department of Cardiology was generally proper. Conclusion The establishment of a standard for evaluation can help improve the rationality of the way in which TCM injections for promoting blood circulation and removing blood stasis are used. 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 （588）      PDF（pc） （1293KB）（1080）       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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Discovery and identification strategy for drug safety risks based on big data monitoring of adverse reactions GAO Yunjuan, ZHAO Xu, BAI Tiankai, BAI Zhaofang, WANG Jiabo, SONG Haibo, XIAO Xiaohe Chinese Journal of Pharmacovigilance    2024, 21 (1): 1-5.   DOI: 10.19803/j.1672-8629.20230772 Abstract （805）      PDF（pc） （1327KB）（1058）       Knowledge map    Save Objective To explore how to quickly discover and accurately identify drug safety risks from a vast number of adverse reaction reports from domestic and foreign Chinese and Western medicines. The aim is also to make scientific and effective predictions and control measures for these risks. Methods Drug-induced liver injury data was taken as an example, and the process of discovering, evaluating, confirming, and controlling risks associated with drugs were discussed. Results A preliminary exploration was conducted, leading to the establishment of an integrated strategy and method system for “large-scale adverse reaction monitoring and discovery - multi-model recognition and analysis- disease-symptom-toxicology verification.” This system has been successfully applied in identifying and analyzing drug-induced liver injury. Conclusion This strategy offers a fresh perspective for the continuous development and innovation of drug safety evaluation. It also provides technical support for ensuring public safety in medication and promoting the healthy development of the Chinese and Western medicine industry. 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 （461）      PDF（pc） （1234KB）（986）       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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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 （436）      PDF（pc） （1383KB）（974）       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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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 （845）      PDF（pc） （1246KB）（963）       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 （931）      PDF（pc） （1223KB）（929）       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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Management of individual adverse drug reaction reports LI Xiaozhu, WANG Qiang, PANG Yu, ZHANG Yijing Chinese Journal of Pharmacovigilance    2023, 20 (9): 975-977.   DOI: 10.19803/j.1672-8629.20230264 Abstract （727）      PDF（pc） （1185KB）（921）       Knowledge map    Save Objective To summarize and analyze the key points of ways in which individual case safety reports (ICSRs) are managed by referring to domestic and overseas laws and regulations in order to assist marketing authorization holders (MAHs) in handling ICSRs. Methods Based on a review of related literature and regulations at home and abroad, the whole process of ICSR management was introduced. Speaking from experience, we discussed the problems that were worthy of attention in the course of ICSR management. Results and Conclusion ICSRs underline pharmacovigilance by MAHs, who should collect, process, and submit ICSRs in accordance with related laws and regulations. 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 （349）      PDF（pc） （1296KB）（901）       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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Analysis of 327 reports of new adverse drug reactions ZHANG Luxin, MENG Lu, ZHANG Hong Chinese Journal of Pharmacovigilance    2023, 20 (10): 1159-1162.   DOI: 10.19803/j.1672-8629.20230062 Abstract （596）      PDF（pc） （1600KB）（890）       Knowledge map    Save Objective To study the characteristics of new adverse drug reactions so as to provide reference for effective prevention of new adverse drug reactions. Methods Three hundred and twenty-seven reports of new adverse drug reactions were screened from 856 reports submitted by a hospital between 2019 and 2022. Results Among the 327 new ADR, 245 cases (74.92%) involved people aged 41 or older. In terms of types of drugs, 241 cases (73.70%) were associated with Western drugs and 86 cases (26.30%) with proprietary Chinese medicines. The top three drugs responsible for new ADR were Ginkgo Biloba injection, compound thromboxane tablets, and levofloxacin hydrochloride injection. There were twenty-one drug dosage forms involved, and the top three were injection, powder injection and tablets. Thirteen routes of administration were involved, including 195 cases of intravenous injection (59.63%) and 90 cases of oral administration (27.52%). The systems-organs involved were mainly skin and its accessory injury, followed by injuries to the digestive system and nervous system. Conclusion New adverse drug reactions have their own patterns of occurrence, and targeted monitoring of new adverse drug reactions can improve the level of rational clinical use of drugs and effectively avoid the risk that arises from drug use. Reference | Related Articles | Metrics | Comments（0）

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Key points of investigation and report of suspected death of adverse drug reaction LIU Saiyue, LYU Xiaoqin, ZHOU Yun Chinese Journal of Pharmacovigilance    2023, 20 (9): 971-974.   DOI: 10.19803/j.1672-8629.20230307 Abstract （654）      PDF（pc） （1263KB）（872）       Knowledge map    Save Objective To guide the drug marketing authorization holder (MAH) to standardize the investigation and report of death cases, so as to provide a basis for in-depth evaluation of drug safety. Methods This paper refers to the requirements of domestic and foreign regulatory guidelines, elaborated the key points of field investigation and internal investigation of suspected death cases of adverse drug reactions known to MAH, as well as the comprehensive analysis of death cases. Results Field investigation includes basic information of cases, drug use, adverse reactions, diagnosis and treatment of patients, and medical institutions. Internal investigation and evaluation can be carried out from the whole process of production and quality control. In addition to the investigation and disposal, the investigation report can provide comprehensive analysis and evaluation combined with the previous safety analysis of the variety. Within the prescribed time limit, the investigation content should be summarized and analyzed to form the investigation report, and submitted as required. Conclusion To standardize the investigation and report of death cases, MAH needs to improve the pharmacovigilance system, and multi-department interaction and efficient disposal, so as to provide reliable basis for risk assessment and risk control, and better guide clinical safe drug use. 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 （263）      PDF（pc） （2126KB）（808）       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 Descriptions of Functions in Package Inserts of Chinese Herbal Patent Medicines ZHANG Meiwei, LI Keqian, YAO Keyu, ZHU Yan Chinese Journal of Pharmacovigilance    2025, 22 (2): 193-196.   DOI: 10.19803/j.1672-8629.20240666 Abstract （328）      PDF（pc） （1309KB）（804）       Knowledge map    Save Objective To analyze the current descriptions of functions in package inserts of Chinese herbal patent medicines and propose corresponding countermeasures in order to provide a reference for marketing authorization holders (MAHs). Methods The information about package inserts of Chinese herbal patent medicines was retrieved from the official website of the National Medical Products Administration, the Pharmacopoeia of the People's Republic of China (2020 edition), and from standards for pharmaceuticals at each level. A standard for determining descriptions of functions and retrieving terms of functions was established before a manual review and analysis of the results of retrieval were conducted. Results and Conclusion The descriptions of functions and indications in most of the package inserts of Chinese herbal patent medicines meet the current standards. However, the descriptions should be standardized and made more consistent with the targeted indications. 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 （724）      PDF（pc） （1207KB）（797）       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）