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Implication of EU Pharmacovigilance System to China ZHANG Gui-ju, CHU Xiao-yi, TIAN Yue-jie, HUANG Lin, LI Yu-ji Chinese Journal of Pharmacovigilance    2015, 12 (10): 593-596.   Abstract （1273）      PDF（pc） （568KB）（47812）       Knowledge map    Save Objective To draw experience from pharmacovigilance system construction in EU, provide reference for pharmacovigilance system in China. Methods Introduce the organization structure and pharmacovigilance processes of EU pharmacovigilance system, compare the differences in regulations, directives and pharmacovigilance processes between China and EU, and provide advice on the improvement of drug adverse reaction monitoring and reporting in China. Results and Conclusion There are many differences between the drug adverse reaction monitoring and reporting system in China and EU pharmacovigilance system, such as the basement of regulation, the system design and the working mechanism. It is helpful for us to reform the drug adverse reaction monitoring and reporting in China borrowing the EU pharmacovigilance and enhance the interaction between drug administration and drug safety monitoring after drug approval. It would encourage the pharmaceutical enterprises taking responsibility of drug safety, promote the policy coordination of drug regulation, and improve the administration efficiency. Reference | Related Articles | Metrics | Comments（0）

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Characteristics of Clinical Combination with Yinzhihuang Granules in the Real World ZHANG Lidan, XIE Yanming, XIE Yuting Chinese Journal of Pharmacovigilance    2021, 18 (8): 705-709.   DOI: 10.19803/j.1672-8629.2021.08.02 Abstract （295）      PDF（pc） （1102KB）（3730）       Knowledge map    Save Objective To analyze the way Yinzhihuang granules for injection are used in the real world in order to provide reference for rational drug use. Methods Based on the real world electronic medical record system (hospital information system, HIS), the data on diagnosis and treatment of patients treated with Yinzhihuang granules was retrieved while the basic information of patients and diagnosis was analyzed descriptively. The combined use of related drugs was mined using association rules of the Apriori algorithm to explore how Yinzhihuang granules were used in clinical practice. Results A total of 5310 patients treated with Yinzhihuang granules for injection in 21 tertiary hospitals between June 2010 and June 2016 were included in the study. Male patients outnumbered female ones. Most of them were aged 45 to 65. The common diseases treated with Yinzhihuang injection were neonatal hyperbilirubinemia, pulmonary tuberculosis and viral hepatitis B. The common drug regimens were Yinzhihuang granules plus Kuhuang injection / Chaihu injection plus glycyrrhizic acid and pyrazinamide combined with rifampicin and ethambutanol. Conclusion The indications and dosage related to Yinzhihuang granules are basically in line with the relevant guidelines. Two common clinical treatment schemes have been found, which are of referential value in promoting the rational use of Yinzhihuang granules. Reference | Related Articles | Metrics | Comments（0）

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Research on the Differences and Correlation Between‘Serious’ and ‘Severe’ Adverse Drug Reactions/Events YUAN Li, YANG Yue Chinese Journal of Pharmacovigilance    2016, 13 (8): 484-488.   Abstract （1740）      PDF（pc） （1045KB）（3455）       Knowledge map    Save Objective To ravel out the concept,connotation and significance of ‘serious’ and ‘severe’ adverse drug reactions (ADRs) /adverse events (AEs), clear out the differences and correlation between the two concepts, and lay a foundation for accurate use in the actual work. Methods Literature research and comparative analysis were introduced to compare and summarize the differences and relationship between the concepts and connotation. Results ‘Serious’ ADR/AE is based on outcome, it is a guidance in determining responsibility in drug safety monitoring, ‘severe’ adverse drug reaction/event is a class of ADR/ADE marked as ‘severe’. Conclusion ‘Serious’ and ‘severe’ ADRs/AEs are not the same and often confused in use, the former is more likely a concept of administration, and the latter is more likely a technical concept. The existence of the two plays a different role, it should be paid attention when use. Reference | 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 （1388）      PDF（pc） （1259KB）（3353）       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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Analysis of Ketoacidosis Induced by Dapagliflozin Tablets YUAN Menghu, QIAN Fengdan Chinese Journal of Pharmacovigilance    2020, 17 (3): 157-160.   DOI: 10.19803/j.1672-8629.2020.03.06 Abstract （2277）      PDF（pc） （781KB）（3218）       Knowledge map    Save Objective To explore the safety of dapagliflozin tablets in clinical application. Methods This article summarizes two cases which have been diagnosed with ketoacidosis after using dapagliflozin tablets from Shanghai General Hospital in November 2018. In addition, relevant literatures at home and abroad are reviewed. Results The two diabetic patients began to show symptoms of tolerance, nausea and vomiting without obvious inducement on the 6th and 1st day after taking dapagliflozin tablets respectively. On the 7th and 6th day after taking the tablets, they were diagnosed with ketoacidosis through laboratory examination. Their symptoms improved after drug withdrawal, fluid rehydration, low-dose insulin intravenous drip, electrolyte correction and other treatments. Conclusion Dapagliflozin tablets may cause ketoacidosis. Medical personnel should pay attention and use carefully in high-risk groups. Reference | Related Articles | Metrics | Comments（0）

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Hypothyroidism Caused by Terepril and Literature Analysis ZHAO Shuang, MIAO Qiuli, SONG Yanqing, LI Yue Chinese Journal of Pharmacovigilance    2021, 18 (7): 697-699.   DOI: 10.19803/j.1672-8629.2021.07.22 Abstract （382）      PDF（pc） （874KB）（2991）       Knowledge map    Save Objective To analyze the clinical characteristics, risk factors, diagnosis and therapeutic strategy of hypothyroidism caused by terepril monoclonal antibody based on the cases. Methods A case of hypothyroidism induced by rectal cancer treated with terepril monoclonal antibody was analyzed, and the related literature was summarized. Results In this case, a 44 year old male patient with multiple metastases of rectal cancer after two or three lines of chemotherapy was treated with terepril monoclonal antibody 240 mg intravenously. This patient presented with symptoms such as decreased levels of FT3 and FT4 and elevated levels of TSH . Left thyroxine sodium tablet was given 12.5 μg orally once a day. Blood routine showed that there was no significant abnormality in the three normal values of thyroid function. The patient did not stop the treatment of terepril monoclonal antibody. Conclusion During the treatment of terepril monoclonal antibody, we should pay attention to the clinical symptoms and imaging characteristics of the patients, identify the immune-related hypothyroidism that may be caused by terepril monoclonal antibody. The patients with immune-related adverse reactions should be given corresponding treatment according to their severity, and at the same time, we should be alert to the risk of recurrence after re administration. Reference | Related Articles | Metrics | Comments（0）

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Common Signal Detection Methods of Adverse Drug Reaction REN Jing-tian, WANG Sheng-feng, HOU Yong-fang, DU Xiao-xi, LI Li-ming Chinese Journal of Pharmacovigilance    2011, 8 (5): 294-298.   Abstract （1372）      PDF（pc） （667KB）（2685）       Knowledge map    Save This paper aims to give some references for adverse drug reaction(ADR) signal detection in China, by summarizing the common used signal detection Methods and rationale, such as the Reporting Odd Ratio, Proportional Reporting Ratio, Information Component and Gamma-Poisson Shrinker. Reference | Related Articles | Metrics | Comments（0）

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The Drug Interactions with Warfarlin and the Traditional Chinese Medicines ZHANG Yan-li, WANG Jing-hong, GU Yuan-yuan, GUI Yue Chinese Journal of Pharmacovigilance    2011, 8 (1): 41-45.   Abstract （569）      PDF（pc） （602KB）（2619）       Knowledge map    Save Objective To summarize the drug interactions with warfarlin and the traditional chinese medicines at home and abroad, it provided reference for clinical medication. Methods The related articles in recent years on the development and the occurrence mechanism of drug interactions with warfarlin and the traditional chinese medicines are extensively reviewed． Results Some traditional chinese medicines can alter the anticoagulation effect of warfarlin such as angelica sinensis, pyrola, garlic, et al. Conclusion The drug interactions were existed between warfarlin and the traditional chinese medicines. Pay attention to the effect of the traditional chinese medicines with the prescription of warfarlin, in order to improve the safety and effectiveness for clinical medication. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2014, 11 (2): 122-122.   Abstract （540）      PDF（pc） （560KB）（2369）       Knowledge map    Save Reference | Related Articles | Metrics | Comments（0）

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Advances in the Study on Extraction of Polysaccharides from Traditional Chinese Medicine QIN Yan, WU Chun-ying, FU Rong-geng, Huang Li, ZHANG Hong-gang, LU Man-xia, YANG Yan-tao Chinese Journal of Pharmacovigilance    2012, 9 (11): 670-673.   Abstract （558）      PDF（pc） （581KB）（2339）       Knowledge map    Save This paper summarized the extracting methods of polysaccharides discovered in recent years, and reviewed the applications including enzyme extraction, two aqueous phase extraction, ultrasonic extraction, microwave-assisted extraction, supercritical fluid extraction, high pressure extraction, molecular distillation technique in extraction of polysaccharides from Traditional Chinese Medicine in detail, respectively. The principles and characteristics of these techniques were described, and their future developments were prospected, which aims at providing some useful information for further study on the extraction of polysaccharides. Reference | Related Articles | Metrics | Comments（0）

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Brief Introduction on the Guideline for the Pharmacovigilance Delegation Agreement (Pilot Version) YANG Le, TIAN Chunhua, XIA Dongsheng, WANG Dan, LIU Cuili, TANG Ren, YU Hongli PENG Lili, WANG Gang Chinese Journal of Pharmacovigilance    2021, 18 (6): 510-513.   DOI: 10.19803/j.1672-8629.2021.06.04 Abstract （766）      PDF（pc） （1105KB）（2299）       Knowledge map    Save Objective To provide an important reference for drug marketing authorization holders and consignee to carry out pharmacovigilance commission. Methods From the perspective of drafters, the regulation is related with the drafting background, the status of post marketing pharmacovigilance Commission, guidelines and key points were introduced. Results and Conclusion The guidelines for the Pharmacovigilance delegation agreement (pilot version) has been officially released on June 4, 2020. As the first normative documentation on how to carry out pharmacovigilance delegation for drug marketing authorization holders in China in the new era, it aims to provide guide and enlightenment for relevant parties, and will be continuously adjusted and improved in practice. Reference | Related Articles | Metrics | Comments（0）

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Literature Analysis of Clinical Application and Adverse Drug Reaction/Event of Lianhua Qingwen Capsule PENG Li-li, LI Lan, SHEN Lu, LI Xing-ling Chinese Journal of Pharmacovigilance    2015, 12 (12): 753-755.   Abstract （9120）      PDF（pc） （642KB）（2259）       Knowledge map    Save ObjectiveTo investigate and analyze the literatures on clinical application and ADR/ADE induced by Lianhua Qingwen Capsule to provide reference for its rational use in clinic. MethodsThe literatures for ADR/ADE of Lianhua Qingwen Capsule were retrieved in the databases of CNKI、Wangfang data for the last 10 years, which were screened out and analyzed by evidence-based medicine method and bibliometric statistical method. ResultsThirty-eight literatures were included and toltal 122 adverse drug reaction cases were collected. Most drug adverse reactions occurred after first use, primarily involved gastrointestinal system(73.9%), skin and its appendaes (9.6%), including nausea, vomiting, abdominal distention, diarrhea, skin rashes, itching, etc. ConclusionWe should reinforce the clinical application of Lianhua Qingwen Capsule, standardize and improve the drug package inserts, promote the rational use of drug and guarantee the safety of patients. Reference | Related Articles | Metrics | Comments（0）

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Research Progress in Chemical Constituents, Pharmacology and Toxicology of Volatile Oil in Asarum QIAN Shensi, LIU Meiyi, RONG Rong, YANG Yong Chinese Journal of Pharmacovigilance    2021, 18 (4): 388-395.   DOI: 10.19803/j.1672-8629.2021.04.21 Abstract （451）      PDF（pc） （1211KB）（2238）       Knowledge map    Save The clinical application of Asarum in traditional Chinese medicine is very extensive. Volatile oil, as a main active ingredient of Asarum, has a series of pharmacological effects such as anesthesia, antipyretic action, analgesia, anti-inflammation. However, Asarum volatile oil is also generally considered the material basis of its toxic and side effects, and improper use may lead to serious toxic reactions. In this study, the main components of Asarum volatile oil and recent research on their pharmacological and toxicological effects were categorized, analyzed and summarized by reviewing literature published over the past ten years. There is the need to carry out targeted pharmacodynamic and toxicological research on the main components of Asarum volatile oil in order to provide reference for the rational and effective application of Asarum and ensure the safety of clinical medication. Reference | Related Articles | Metrics | Comments（0）

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Research Progress of Clinical Applications and Adverse Reactions of Herba Leonuri FENG Qun, ZHAO Hong, SUN Rong Chinese Journal of Pharmacovigilance    2014, 11 (2): 74-76.   Abstract （481）      PDF（pc） （384KB）（2186）       Knowledge map    Save ObjectiveThe clinical applications and adverse reactions of Herba Leonuri were determined and the correlation of its efficacy and toxic and side effect were discussed. The literature evidence and research ideas were provided for making safety standards, and studying its safety based on its efficacious substance basis. MethodsAncient books, literature in past dynasties and references in the last decades at home and abroad about the efficacy and adverse reactions of Herba Leonuri were collated, analyzed and summarized. ResultsHerba Leonuri, which has the efficacy of promoting blood flowing, regulating menstruation, diuresis and detumescence, is a commonly used traditional Chinese gynecological medicine. It is always used to diseases of gynecology and diseases caused by immune system and circulatory system. A number of adverse reactions caused by Herba Leonuri and its preparations were reported. The adverse reactions of Herba Leonuri came down to urinary system, reproductive system, etc. And the most common organs damaged by Herba Leonuri were liver and kidney during conventional or excessive dose. ConclusionOnly under the process of efficacy-expression and conferring to the toxicological experiment of Herba Leonuri, can basement be provided for consummating safety standards and putting forward early-warning scheme of adverse reaction that can be referred in clinic. In this way Herba Leonuri can be ensured to be used safely. Reference | Related Articles | Metrics | Comments（0）

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Literation Research on the Incompatibility of Ambroxol Hydrochloride Injection JIANG La-Mei, TIAN Yue-jie Chinese Journal of Pharmacovigilance    2011, 8 (11): 672-674.   Abstract （317）      PDF（pc） （543KB）（2184）       Knowledge map    Save Objective To research the incompatibility of :Ambroxol Hydrochloride Injection in clinical treatments for guiding clinical rational drug use. Methods To retrieve the incompatibility of: Ambroxol Hydrochloride Injection reported in domestic journals of medicine from 2005 to 2011, to analyze and summarize by drug systematics. Results There are incompatibilities between Ambroxol Hydrochloride Injection and many kinds of drugs, especially for some respiration medication. Conclusion we should be care of the incompatibility in the usage of Ambroxol Hydrochloride Injection to avoid adverse clinical event occurred. Reference | Related Articles | Metrics | Comments（0）

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Research Development on Efficacy of Prepared Aconite Root Related to Chemical Material Basis and Pharmacological Effects YU Qing-min, LUAN Yong-fu, LI Xiao-jiaoyang,SUN Rong Chinese Journal of Pharmacovigilance    2012, 9 (11): 674-678.   Abstract （467）      PDF（pc） （638KB）（2157）       Knowledge map    Save ObjectiveTo introduce the research development on the chemical composition, pharmacological effects and efficacy of Prepared Aconite Root, and provide literature evidences and research ideas of the clinical practice study of Prepared Aconite Root. MethodsReferences in old days and in the last decades both at home and abroad about Prepared Aconite Root were collated, analyzed and summarized. ResultsPrepared Aconite Root can turn around lifes, tonify fire and helping yang and dispel the wind and cold-dampness. The causes and influencing factors of Prepared Aconite Root 's adverse reactions are mainly related to concocted drugs, TCM drugs, drug dose, drug compatibility, the boiling method, individual differences and medication methods. ConclusionPrepared Aconite Root is a medicine with strong pharmacodynamic action and largely clinical practice, and has a very vast prospect on clinical practice with the further research on its chemical composition, pharmacological effects and efficacy. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2020, 17 (8): 548-548.   DOI: 10.19803/j.1672-8629.2020.08.21 Abstract （740）      PDF（pc） （845KB）（2106）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Analysis of 631 Reports of ADR/ADE Caused by Xuesaitong Injection LI Wen-wu ,ZHANG Hui-xia, YANG Sha-sha ,LIU Chao Chinese Journal of Pharmacovigilance    2010, 7 (11): 690-693.   Abstract （297）      PDF（pc） （627KB）（2045）       Knowledge map    Save Objective To study the general pattern and characteristics of adverse drug reactions induced by Xuesaitong injection to provide references for clinical rational use of drug. Methods 631 ADR/ADE reports of Xuesaitong injection collected by Henan center for ADR monitoring from 2004 to 2009 were analyzed using retrospective study method. Results 259 cases of patients over the age of 60 accounted for 41.05% ;233 cases of patients with ADR/ADE occurred within 30 minutes accounted for 36.93%; 186 cases of drug overdose accounted for 29.48%;125 cases of combination therapy accounted for 19.81%; ADR/ADE mainly were skin allergies. Conclusion ADR monitoring should be strengthened to improve the rational use of drug and reduce the occurrence of ADR/ADE. Reference | Related Articles | Metrics | Comments（0）

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Analysis of Granulocytopenia Induced by Thiamazole WEN Xiaoling, GAO Yunjuan, ZHANG Hailang, YANG Jie, LAN Shan, LI Yamei, LI Lan Chinese Journal of Pharmacovigilance    2018, 15 (7): 398-403.   Abstract （755）      PDF（pc） （819KB）（2027）       Knowledge map    Save Objective To analyze the characteristics of granulocytopenia induced by thiamazole, so as to provide reference for clinical safe and rational drug use. Methods Retrospective study was conducted on the statistical analysis of granulocytopenia induced by thiamazole that received by the national adverse drug reactions monitoring database from January 1, 2004 to June 30, 2016. Results Among 1 358 cases of granulocytopenia induced by thiamazole, the proporation of the serious adverse drug reactions(ADRs) was 48.53%, female patients were 3.93 times that of male patients, the most of patients were 15 to 44 years old, it occurred within 12 weeks accounting for 87.56%, and there may be a dose correlation in the occurrence of ADRs. Clinical manifestations were mainly the blood system damage, systemic damage and respiratory damage. Conclusion Granulocytopenia induced by thiamazole can't be ignored. The clinic should pay attention to usage and dosage. The education of patients, the blood monitoring before and after treatment should be strengthened. Doctors should actively take treatment measures to reduce the injury if it happened, so as to prevent or reduce the occurrence of serious adverse drug reactions. Reference | Related Articles | Metrics | Comments（0）

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Clinical Use and Safety of Oseltamivir Phosphate LI Sheng, ZHENG Lei Chinese Journal of Pharmacovigilance    2021, 18 (3): 250-255.   DOI: 10.19803/j.1672-8629.2021.03.09 Abstract （455）      PDF（pc） （1119KB）（1901）       Knowledge map    Save Objective To investigate the clinical use and safety of oseltamivir phosphate, analyze the characteristics of its adverse drug reactions (ADR), and provide reference for rational use of drugs. Methods Data on the use of oseltamivir phosphate in our hospital between February 2016 and February 2018 was retrospectively analyzed in terms of indications, use of drugs, usage and dosage, combined use of drugs and adverse reactions. The rationality and safety of drug use was highlighted. The relationships between adverse reactions and age, allergy history, underlying diseases and combined medication were explored to identify the risk factors. Results There were a total of 1 795 adult patients and 3 199 children who took oseltamivir phosphate. As far as the therapeutic use was concerned, there were 1 481 cases (82.5%) in the adult group, and 2 602 cases (81.3%) in the child group. This drug was prescribed mainly for upper respiratory tract infections, bronchitis and pneumonia, but 767 of these cases were diagnosed with influenza virus infection via virology examination, and the rest were suspected influenza cases or clinically diagnosed cases of influenza. As for preventive medication: the adult group consisted of 314 cases (17.5%), compared with 597 cases (18.7%) in the child group. A lack of indications related to preventive medication was found. Administration started within 48 hours of onset of influenza symptoms, with 109 cases (79.0%) in the child group, and 169 cases (60.1%) in the adult group, Drug usage and dosage, courses of treatment were up to standards, but combined medication was not well-grounded. There were 106 cases of adverse drug reactions, but there was no case of serious adverse drug reactions. Statistical analysis showed that the rate of adverse drug reactions was related to the age of patients and the number of types of combined drugs. Conclusion Excessive use of preventive drugs and inappropriate indications have been found in the clinical use of oseltamivir phosphate. This drug is quite safe and the main adverse reactions involve the digestive system, but the age of patients, combination of drugs and allergy may be regarded as the main risk factors for adverse reactions. The safety of drug use in elderly patients and children has become a concern. Reference | Related Articles | Metrics | Comments（0）