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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 （744）      PDF（pc） （1327KB）（713）       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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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 （558）      PDF（pc） （1600KB）（541）       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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Evaluation index system of MAH pharmacovigilance work JIA Jinsheng, WANG Qing, LIU Hongliang, HOU Yongfang Chinese Journal of Pharmacovigilance    2023, 20 (10): 1090-1094.   DOI: 10.19803/j.1672-8629.20230508 Abstract （527）      PDF（pc） （2882KB）（662）       Knowledge map    Save Objective To explore methods to quantitatively evaluate the pharmacovigilance evaluation work of marketing authorization holder(MAH) and support the development of scientific supervision work based on big data. Methods The analytic hierarchy process(AHP) method was used to decompose and detail ADR/ADE monitoring and reporting, risk identification and evaluation, post-market safety research, drug safety risk control and other related aspects, forming the MAH pharmacovigilance work evaluation index system. A data analysis information platform based on this index system was designed. Results 6 indicators of the criterion layer, 25 indicators of the sub-criterion layer and 85 indicators of the lowest layer are selected, and the weight values of each indicator of the evaluation system are determined. Based on the actual business situation and real world data, an information platform for MAH pharmacovigilance work evaluation was explored and designed. Conclusion The evaluation index system and information platform of holder pharmacovigilance laid the foundation for the intelligent evaluation of MAH pharmacovigilance work. Reference | Related Articles | Metrics | Comments（0）

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Implementation of periodic benefit risk evaluation reports in China TIAN Chunhua, WU Guizhi Chinese Journal of Pharmacovigilance    2023, 20 (12): 1382-1384.   DOI: 10.19803/j.1672-8629.20230579 Abstract （460）      PDF（pc） （1254KB）（576）       Knowledge map    Save Objective To elaborate on the revision of PSUR in the Adverse Drug Reaction Reporting and Monitoring Management(Order 81) in combination with the current regulation of drugs in China. Methods The revision and implementation of the ICH E2C guideline system and related requirements in China were introduced. The status quo, problems and challenges related to the transformation and implementation of ICH E2C were outlined before recommendations were offered. Results Compared with PSUR, PBRER was more comprehensive and detailed, which could better reflect the overall situation of product benefits and risks. However, the adoption of PBRER also faced many challenges, such as a lack of knowledge of PBRER on the part of drug marketing authorization holders, the need for more professional participation in PBRER writing, and the difficulty in obtaining complete data for mature products. Conclusion The full adoption of PBRER can promote the accountability of holders and help the national and provincial adverse drug reaction monitoring agencies to supervise holders. It is recommended that PBRER be fully adopted following the revision of Order 81. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2023, 20 (11): 0-0.   Abstract （348）      PDF（pc） （474KB）（358）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Updates and reflections on expedited reporting of safety information during drug clinical trials LIU Min, CHEN Yan, LIU Wendong, WANG Haixue Chinese Journal of Pharmacovigilance    2024, 21 (1): 98-101.   DOI: 10.19803/j.1672-8629.20230624 Abstract （331）      PDF（pc） （1324KB）（469）       Knowledge map    Save Objective To advance our understanding of the requirements on implementation of expedited reporting of safety information. Methods The background and changes of FAQ 2.0, including the scope, time limit, and method of expedited reporting, were interpreted and analyzed. Results and Conclusion In order to improve the quality of safety information reports, the applicant, as the main responsible person, should fulfil his responsibility, communicate willingly with all the parties involved in the clinical trial, and collect as much information as possible. The drug regulatory authority should continue to elevate the level of pharmacovigilance during the clinical trial, improve the system of standards and codes for practice, enhance the ability to assess risks, and upgrade informatization so as to protect the safety, rights and interests of the subjects. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2024, 21 (5): 0-0.   Abstract （326）      PDF（pc） （461KB）（283）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2024, 21 (4): 0-0.   Abstract （324）      PDF（pc） （473KB）（669）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Exploring new risk signals and susceptibility factors of traditional Chinese medicine-induced hepatotoxicity based on big data from adverse reaction monitoring GUO Longxin, GAO Yunjuan, WU Chengzhao, LONG Minjuan, ZHU Shengkai, SONG Haibo, ZHAO Xu, XIAO Xiaohe Chinese Journal of Pharmacovigilance    2024, 21 (1): 15-19.   DOI: 10.19803/j.1672-8629.20230779 Abstract （323）      PDF（pc） （1290KB）（326）       Knowledge map    Save Objective To explore the method of discovering signals of hepatotoxicity risk in traditional Chinese medicine (TCM) based on national adverse reaction monitoring big data, preliminarily screen risky varieties, and analyze the susceptible factors of liver damage based on the “ Trielement Injury Hypothesis ” theory. Methods Retrospective analysis of adverse drug reaction (ADR) reports related to TCM-induced drug-induced liver injury (DILI) collected between 2012 and 2016. Identify suspicious TCM varieties and predict the susceptible factors for liver damage in these varieties. Results A total of 1 901 ADR reports（1 719 patients) of TCM-induced DILI were collected, and 237 suspicious TCM varieties were newly discovered. Traditional Chinese medicine used for anti-tumor purposes had the highest incidence of DILI. The oral route of administration accounted for the largest proportion (71.70%), with a median latency period of 13.00 days, and the majority of cases had a latency period of 0 to 7 days (34.46%). Analysis based on the “ Trielement Injury Hypothesis ”theory revealed that the TCM varieties suspected of causing DILI were related to the body’s state, the drugs themselves, and the medication environment. Conclusion Discovery of a series of TCM risk signals requires further confirmation of the risk and analysis of the causal mechanisms. Reference | Related Articles | Metrics | Comments（0）

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Current applications of artificial intelligence in pharmacovigilance in the USA and implications WANG Tao, ZHENG Mingjie, LIU Hongliang, WANG Qing, SHEN Chuanyong Chinese Journal of Pharmacovigilance    2023, 20 (10): 1129-1133.   DOI: 10.19803/j.1672-8629.20230224 Abstract （310）      PDF（pc） （1536KB）（375）       Knowledge map    Save Objective To study the current applications of artificial intelligence in pharmacovigilance in the United States in order to provide reference for the supervision of China's postmarketing drugs. Methods Based on literature review, from the perspective of drug regulation, this article outlined the concepts and performance indicators related to artificial intelligence, the background of application, FDA's experience and challenges to pharmacovigilance from the perspective of monitoring of postmarketing drugs. Results In the past decade, FDA was extensively exploring the applications of artificial intelligence in pharmacovigilance. Currently, FDA focused on the applications of artificial intelligence in handling and evaluating individual safety reports submitted to the FDA adverse event reporting system, and major progress had been made in the retrieval and analysis of key information about ICSRs, as well as in causality assessment for ICSRs. Conclusion Based on the experience of FDA, it is recommended that we accelerate the introduction of artificial intelligence technologies, strengthen training of professionals, establish a social technology and management system for artificial intelligence and promote international exchanges and cooperation in this field. Reference | Related Articles | Metrics | Comments（0）

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Safe doses of Lingyang Ganmao oral liquid for children based on the multi-animal model SUN Qiyue, ZHAO Ronghua, BAO Lei, GUO Shanshan, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing Chinese Journal of Pharmacovigilance    2024, 21 (2): 121-126.   DOI: 10.19803/j.1672-8629.20230388 Abstract （309）      PDF（pc） （1550KB）（736）       Knowledge map    Save Objective To determine the effectiveness and range of optimal dosages of Lingyang Ganmao oral liquid for children, and to provide reference for medication in children. Methods Based on multi-animal models, five corresponding young animal models that targeted the major properties were used, including the mouse pneumonia model caused by influenza A (H1N1) virus infection, the mouse acute inflammation model for increased permeability of abdominal capillaries caused by glacial acetic acid, the mouse cough model caused by ammonia nebulization, the mouse pain model caused by glacial acetic acid and the rabbit fever model caused by lipopolysaccharide (LPS). To observe the antiviral, anti-inflammatory, antitussive, analgesic and antipyretic efficacy of Lingyang Ganmao oral liquid in six dosage groups, namely 0.1, 0.2, 0.4, 0.6, 0.8 and 1.0 mL·kg-1·d-1 for human use (children's dosage).The animal dosages were calculated using the body surface area conversion formula, based on the human dose. For mice, the dosages were 1, 2, 4, 6, 8, and 10 mL·kg-1·d-1, while for rabbits, the dosages were 0.3, 0.6, 1.2, 1.8, 2.4, and 3.0 mL·kg-1·d-1. The results are used to determine the optimal dose range for children. Results Lingyang Ganmao oral liquid could reduce lung indexes, inhibit capillary permeability, reduce the number of times mice coughed and writhed and help lower the body temperature of rabbits. The doses of stable efficacy ranged from 4.0 to 8.0 mL·kg-1·d-1 and from 1.2 to 2.4 mL·kg-1·d-1, respectively, which were equivalent to 0.4-0.8 mL·kg-1·d-1 for human use. Conclusion Lingyang Ganmao oral liquid produces stable and effective antiviral, anti-inflammatory, anti-cough, analgesic and antipyretic effects within the dose range of 0.4 to 0.8 mL·kg-1·d-1. The recommended dosage is 5mL each time and 1-2 times daily for children ages 1 to 3, 5mL each time and 1-3 times daily for those ages 4 to 6, and 5mL each time and 2-4 times daily for those between 7 and 12. Reference | Related Articles | Metrics | Comments（0）

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Adverse drug reaction induced by antineoplastic drugs in a cancer hospital: an analysis of 613 cases HUANG Huanjun, MAI Jiaheng, ZHANG Yunhui, GUO Chenchen, LIANG Weiting Chinese Journal of Pharmacovigilance    2024, 21 (3): 324-328.   DOI: 10.19803/j.1672-8629.20230467 Abstract （293）      PDF（pc） （1321KB）（374）       Knowledge map    Save Objective To analyze the characteristics and patterns of adverse drug reactions (ADR) induced by antineoplastic medications, and to provide reference for ensuring the safety of ambulatory chemotherapy. Methods A total of 613 reports about ADR caused by antineoplastic drugs between 2021 and 2022 in our hospital were collected and analyzed. Results Among the 613 cases of ADR, 60.03% occurred inside the hospital. Male patients outnumbered female ones and most of the patients ranged from 51 to 70 in age (51.23%). ADR were caused by intravenous infusion in 72.49% of these cases, 14.68% were severe ones, and 4.24% failed to improve after medication withdrawal or treatment. Cytotoxic anti-tumor medicines were responsible for 81.23% of these ADR, with oxaliplatin accounting for 18.65%. The blood or hematopoietic system was responsible for the largest number of ADR (17.68%). Conclusion ADR induced by cytotoxic anticancer drugs should be monitored, with particular attention to special populations and key drugs. When anticancer drugs are used in an ambulatory chemotherapy center, the risk of ADR should be assessed and corresponding treatment plans should be made to ensure the safety of patients. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2024, 21 (6): 0-0.   Abstract （292）      PDF（pc） （482KB）（664）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Classification of anti-tumor active ingredients of Paridis Rhizoma and research progress in mechanisms of action XIN Lingyi, YANG Yang, ZHU Jing, HE Na, ZHANG Jingmei, WANG Hangtian, CHEN Qinhua, YANG Guangyi Chinese Journal of Pharmacovigilance    2024, 21 (2): 235-240.   DOI: 10.19803/j.1672-8629.20230494 Abstract （283）      PDF（pc） （1390KB）（100）       Knowledge map    Save Paridis Rhizoma is a traditional Chinese medicine for clearing away heat and toxic materials. Polyphyllin, as the most important anti-tumor active ingredient of Paridis Rhizoma, contains more than 50 types of compounds, among which the ingredients with anti-tumor effects are polyphyllin I, II, VI, VII. It is effective in treating many types of tumor cancers, such as liver cancer, colon cancer, brain tumor, colorectal cancer, esophageal cancer, lung cancer and nasopharyngeal carcinoma. These ingredients are mostly isospirostanol saponins, dominated by polyphyllin I, followed by polyphyllin II, diosgenin, polyphyllin A, gracillin, polyphyllin VI, polyphyllin VII, polyphyllin H and polyphyllin E. In recent years, the anti-tumor effects of polyphyllin have been gradually discovered and applied in clinic, but the adverse effects of Paris saponins have also been reported, such as the toxic damage of polyphyllin I to the liver. In this paper, the saponin components in Paridis Rhizoma are classified while the latest progress in research on the anti-tumor mechanism of isospirostanol saponins is reviewed in order to summarize the active components and mechanism of action of the anti-tumor effect of Paris saponins and to provide reference for studies on anti-tumor effects of polyphyllin and the safety of medication. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2023, 20 (12): 0-0.   Abstract （280）      PDF（pc） （466KB）（284）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Revision of safety information in instructions of traditional Chinese patent medicines and simple preparations LEI Chao, QIAO Meng, CHEN Zijia, ZHANG Qiang, XIE Yanming, WANG Zhifei Chinese Journal of Pharmacovigilance    2023, 20 (12): 1396-1400.   DOI: 10.19803/j.1672-8629.20230315 Abstract （275）      PDF（pc） （1361KB）（347）       Knowledge map    Save Objective To study how to revise the safety information items in instructions for traditional Chinese patent medicines and simple preparations. Methods With reference to the Technical Guidelines for the Revision of Safety Information Items in the Instructions of Listed Traditional Chinese Medicine (Trial) (No. 1 in 2022), this paper analyzed the contents of such warnings as “taboos”, “adverse reactions”, “precautions” and “medications for special groups” in the instructions for traditional Chinese patent medicines and simple preparations, and offered recommendations in combination with the practical experience associated with the revision of safety information items in these instructions. Results and Conclusion Marketing authorization holders can improve the safety information items in the instructions by supplementing the missing items, standardizing related terminology, and correctly labeling safety information. During the process of revision, marketing authorization holders are to conduct exhaustive search of safety information by different means, and sort out and analyze the retrieved information as items of evidence that underlie any revision. The safety information items in the instructions for traditional Chinese patent medicines and simple preparations should be revised on this basis so as to provide more accurate guidance for clinical use of traditional Chinese patent medicines and simple preparations. Reference | Related Articles | Metrics | Comments（0）

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Adverse drug reaction/ event caused by oral antidiabetic drugs WEI Anhua, QI Jianjun, WANG Lu, ZENG Lu, GONG Xuepeng, JIANG Ying Chinese Journal of Pharmacovigilance    2023, 20 (12): 1415-1420.   DOI: 10.19803/j.1672-8629.20230077 Abstract （266）      PDF（pc） （1230KB）（285）       Knowledge map    Save Objective To study the characteristics and regularity of adverse drug reaction / adverse drug event (ADR/ADE) caused by oral antidiabetic drugs, and to provide reference for rational use of these drugs in clinic. Methods A retrospective study was conducted to retrieve all ADR/ADE reports involving 10 types of oral antidiabetic drugs from the database of Wuhan ADR/ADE spontaneous reporting system that were submitted between 2012 and 2022. The demography of the users, usage of drugs, organs and systems involved in ADR/ADE and clinical manifestations were analyzed using the descriptive statistical methods. Results A total of 953 ADR/ADE reports and 1 405 cases related to oral antidiabetic drugs were included in this study. The number of reports trended up. Mild cases and serious ones accounted for 88.67% and 11.33% respectively. The most common ADR/ADE were gastrointestinal, skin, and metabolic disorders while drugs involved most frequently were α-glycosidase inhibitors, thiazolidinediones (TZD) and biguanide combined with TZD. Meanwhile, the ADR/ADE caused by different types of oral antidiabetic drugs varied in terms of system -organ distribution and clinical manifestations. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) were most likely to induce urinary tract damage and genital pruritus, dipeptidyl peptidase-IV inhibitors (DPP4i) tended to lead to skin or skin accessory disorders, glinides were mainly associated with hypoglycemia, and other drugs were mainly linked to gastrointestinal damage. Conclusion The ADR/ADE due to oral antidiabetic drugs involve a wide range of systems and keep increasing each year. The ADR/ADE caused by new oral antidiabetic drugs deserve more attention. In order to ensure the safety of oral antidiabetic drugs in clinical use, potential risks need to be prevented, users need to improve their self-control, and related ADR/ADE have to be detected and handled quickly. Reference | Related Articles | Metrics | Comments（0）

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Research progress in roles of ginseng combined with Radix Aconiti Carmichaeli in reducing toxicity and increasing efficiency in myocardial cells LI Hongchang, GE Yunxuan, WANG Ningning, ZHOU Wei, WANG Yuguang, MA Zengchun, GAO Yue Chinese Journal of Pharmacovigilance    2024, 21 (6): 601-605.   DOI: 10.19803/j.1672-8629.20230681 Abstract （262）      PDF（pc） （1494KB）（104）       Knowledge map    Save Objective To study the mechanisms by which ginseng combined with Radix Aconiti Carmichaeli can reduce toxicity while improving efficacy in terms of chemistry, pharmacokinetics, drug metabolism, interactions between components and biological mechanisms. Methods The “dose- toxicity-time-effect” relationship was established based on drug dosage and molecular pathways. Energy metabolism and calcium overload were studied to find out whether they were involved in pharmacological and toxic effects, respectively. The toxicity conversion window of aconitine was analyzed while the toxicity threshold was predicted using physiologically based pharmacokinetic models (PBPK) and in vivo reverse dosimetry. The early toxicity dose of traditional Chinese medicine, impacts of drug metabolic enzymes and transporters on the in vivo disposal process of drugs, and drug interactions were explored. Results It was found that the combination of ginseng with Radix Aconiti Carmichaeli could reduce the concentration of aconitine through pharmacological mechanisms and antagonize toxic targets through toxicological mechanisms, thus acting as both a threat and a killer in the compatibility theory of “seven emotions and harmony”. Conclusion The study has shed light on the role of ginseng combined with Radix Aconiti Carmichaeli in reducing toxicity and increasing efficiency, and contributed to the compatibility theory about the “seven emotions and harmony”. Reference | Related Articles | Metrics | Comments（0）

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One case of acute transient depression caused by clarithromycin YANG Xueting, HE Bo, YAN Hongli, LI Dongmei Chinese Journal of Pharmacovigilance    2024, 21 (3): 352-354.   DOI: 10.19803/j.1672-8629.20230698 Abstract （261）      PDF（pc） （1253KB）（445）       Knowledge map    Save Objective To analyze the adverse reactions-acute transient depression-caused by a quadruple anti-Helicobacter pylori regimen, and to provide reference for early detection and prompt clinical interventions in such cases. Methods Analysis was made of the clinical data on a 29-year-old female patient who underwent a quadruple regimen (amoxicillin, clarithromycin, pantoprazole, and bismuth potassium citrate) because of acute transient depression caused by Helicobacter pylori infection. Results The transient acute depression was considered to have been triggered by the combined use of four anti-Helicobacter pylori drugs. Evidence-based medicine suggested that clarithromycin was the drug most likely to induce acute transient depression. Conclusion Healthcare providers should vigilantly observe patients for emotional fluctuations during the administration of pharmaceutical interventions for the complete eradication of H. pylori infection. In the event of acute transient depression, it is imperative to promptly discontinue the medication to forestall the worsening of symptoms. Reference | Related Articles | Metrics | Comments（0）

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Diagnosis and treatment of mycoplasma pneumoniae pneumonia in children and rational administration of related drugs JIA Zhaoguang, XU Wenshuai, JI Li’na, WANG Linlin, ZHAO Li’na, ZHAO Jingquan, MU Xiangdong Chinese Journal of Pharmacovigilance    2023, 20 (12): 1391-1395.   DOI: 10.19803/j.1672-8629.20230739 Abstract （257）      PDF（pc） （1401KB）（300）       Knowledge map    Save Objective To study the clinical diagnosis and treatment of Mycoplasma pneumoniae pneumonia (MPP) in children and the safe and reasonable use of related drugs. Methods Review from the perspectives of epidemiology, clinical and imaging manifestations, treatment methods, and side effects. Results Since the autumn of 2023, there has been a significant increase in MPP in children in China, with clinical manifestations such as fever and cough, which are generally mild and have a good prognosis; A few may develop into severe illness. For children with MPP, macrolides should be the preferred drug, but drug resistance is relatively common in China; Tetracyclines can be substituted and resistance is rare, but they are required for children more than 8 years; Quinolone drugs under the age of 18 belong to the category of over-the-counter medication and are not necessary; Severe MPP can also receive short-term symptomatic anti-inflammatory treatment with glucocorticoids. For children with complications such as extensive lung consolidation, atelectasis, and plastic bronchitis, early bronchoalveolar lavage treatment is recommended, and it is recommended to implement it under general anesthesia, which can significantly improve the outcome and prognosis. Conclusion For mild MPP, the application of anti-mycoplasma drugs and symptomatic treatment generally achieves good therapeutic effects; For severe MPP, on the basis of effective anti-infection, short-term treatment with glucocorticoids can be added, and if necessary, bronchoscopic alveolar lavage can significantly improve the outcome and prognosis. Reference | Related Articles | Metrics | Comments（0）