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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.  
    Abstract1341)      PDF(pc) (568KB)(47910)       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.
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    Oxycodone and Acetaminophen Dependence and Abuse Risk Analysis
    MA Jun-li, PANG Li-yan, ZHOU Li-xin, ZHANG Li-ming
    Chinese Journal of Pharmacovigilance    2012, 9 (8): 476-478.  
    Abstract425)      PDF(pc) (525KB)(12231)       Save
    Oxycodone hydrochloride is a derivative of morphine. The pharmacological effects of the oxycodone hydrochloride is similar to morphine. There has been animal experiments show that oxycodone and morphine are similar in strengthening effect, and they have the same potential for psychological dependence. In the United States and Australia, oxycodone products are one of the most common drugs being diverted and abused. Although the single and compound preparations of oxycodone hydrochloride are both likely to cause abuse, In China, oxycodone acetaminophen(oxycodone hydrochloride compound) is managed in accordance with prescription drug, so it is more likely to be lossed and abused compared to the single preparation of oxycodone hydrochloride which is managed in accordance with narcotic drugs. Medical institutions and drug regulatory departments shall strengthen the management and monitoring of oxycodone acetaminophen to prevent loss and abuse.
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    Research and reflection on regulatory science developments of U.S. FDA
    SHA Mingquan, LI Nannan, XIA Wenjing, WEI Qun, WEN Baoshu
    Chinese Journal of Pharmacovigilance    2022, 19 (10): 1055-1059.   DOI: 10.19803/j.1672-8629.20220453
    Abstract525)      PDF(pc) (1239KB)(11485)       Save
    Objective To introduce the regulatory developments of U.S. Food and Drug Administration (FDA), so as to provide reference for the drug regulation in China. Methods New initiatives and their latest progress in FDA are introduced by translation and research on related regulations and documents, and the correlation to the reform of drug review and approval in China is analyzed. Results and Conclusion According to the drug regulation in China, it is suggested that experiences of drug regulation from FDA should be overviewed and classified into regulatory methods and regulatory tools, providing methodological reference to regulators, so as to improve the quality and efficiency of drug regulation, as well as the internationalization of regulatory capacities.
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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
    Abstract1753)      PDF(pc) (1259KB)(8590)       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.
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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
    Abstract371)      PDF(pc) (1102KB)(6377)       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.
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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.  
    Abstract540)      PDF(pc) (638KB)(4785)       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.
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    Research progress in methods for toxicity-decreasing processing of toxic herbal traditional Chinese medicines
    HE Jia, JIN Yan, ZHAO Yuyang, ZHOU Junhui, LI Xiaolin, YUAN Yuan, FU Lu
    Chinese Journal of Pharmacovigilance    2023, 20 (9): 1064-1070.   DOI: 10.19803/j.1672-8629.20220624
    Abstract357)      PDF(pc) (1386KB)(4538)       Save
    Objective To summarize the current studies on processing methods to decrease toxicity of toxic herbal TCM in China so as to provide reference for subsequent studies. Methods Toxicity-decreasing processing methods and similarities and differences between these methods when used in a variety of medicinal parts were analyzed via literature review. Results The commonly used processing methods for toxic Chinese herbal medicines included JingZhiFa, ChaoZhiFa, FuLiaoGongZhiFa, QuYouZhiShuangFa. Medicinal parts could be divided into three parts: root and rhizome drugs, fruit and seed drugs and resin drugs. Processing methods varied depending on the medicinal parts. For example, steaming and boiling were used for root and rhizome drugs, while oil removal was employed to reduce toxicity in fruit and seed drugs rich in oil. Conclusion The main objective of processing for toxicity reduction is to remove toxic components and reduce adverse reactions of drugs. However, the toxicity and active components of most of the toxic Chinese herbal medicines are not clear, throwing doubt on the feasibility of these processing methods. The mechanism by which toxicity is minimized should be clarified, processing conditions should be optimized, and the relationships between toxicity and efficacy should be balanced.
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    Analysis of the Irrational Factors of Parenteral Nutrition Prescriptions
    WANG Rui,ZHOU Wei,ZHANG Si-xi,SONG Yan-qing
    Chinese Journal of Pharmacovigilance    2015, 12 (2): 102-105.  
    Abstract366)      PDF(pc) (608KB)(4263)       Save
    Objective To avoid medication risk and ensure the safety and effectiveness of parenteral nutrition treatment, through checking the total parenteral nutrition prescriptions and intervening unreasonable prescriptions of surgical department. Methods At PIVAS (pharmacy intravenous admixture service), pharmacists audited parenteral nutrition prescriptions of 24 surgical departments from January to June 2014 and recorded the unreasonable prescriptions to classify and analyze. Results Based on the analysis of 4 012 unreasonable parenteral nutrition prescriptions in our hospital, the irrational factors involved in deficiency or excess of nutritional components, overproof electrolyte ion concentration, inappropriate use of special nutritional supplements, unreasonable glycolipid proportion, repeated use of nutritional components, and etc. Conclusion The audit and intervention on parenteral nutrition prescriptions by the pharmacists were critical to ensure the safe,effective and economical nutritional treatment.
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    Research Progress in Anti-tumor Effect of Polysaccharides
    QIAN Zhen,JIANG Guo-rong*
    Chinese Journal of Pharmacovigilance    2015, 12 (2): 96-98.  
    Abstract467)      PDF(pc) (609KB)(3728)       Save
    Polysaccharides, widely exist in the higher plants, fungi, algae, bacteria and cell membranes of animal, is one of the four basic substance of life. In recent years, numerous studies have showed that polysaccharides have immuno-regulation and anti-tumor effect. Polysaccharides are used on the adjuvant treatment of cancer, since it can directly kill tumor cells, activate immune receptors and improve immune function. This paper aims to review the study on anti-tumor of polysaccharides.
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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.  
    Abstract1480)      PDF(pc) (667KB)(3519)       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.
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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.  
    Abstract1839)      PDF(pc) (1045KB)(3491)       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.
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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
    Abstract2457)      PDF(pc) (781KB)(3432)       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.
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    Analysis of 652 Cases of Adverse Drug Reactions Induced by Lithium Carbonate
    ZHANG Shu, LIN Qiang, SUN Li-wei, WU Li-ling, ZHANG Long-ying, WU Xu-chen, HONG Shan
    Chinese Journal of Pharmacovigilance    2018, 15 (4): 234-239.  
    Abstract489)      PDF(pc) (812KB)(3372)       Save
    Objective To investigate the general characteristics and relative factors of the adverse drug reactions caused by lithium carbonate, so as to provide references for clinical rational and safe use of drug. Methods By retrospective study method, 652 cases of adverse drug reactions/events by lithium carbonate from the adverse reaction network platform of Pan-Pearl River Delta during 2003-2016 were analyzed. We analyzed the patient's age, gender, past history, the purpose of drug use, occurrence time, symptoms of adverse drug reactions, the systems-organs involved etc. Results 652 cases were collected that involved 1 002 cases of clinical manifestation. Multiple systems were affected by lithium carbonate including the damage to digestive system, nervous system, and general disorders etc. Conclusion Adverse reactions of lithium carbonate were correlated with individual differences, strictly controlled the indications, the rational drug use, monitoring lithium concentration in blood, in order to ensure drug safety.
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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
    Abstract456)      PDF(pc) (874KB)(3333)       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.
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    Analysis of the Community Elderly Medication Compliance and Influencing Factors
    SHI Xiu-hua, JIANG Chang-ying
    Chinese Journal of Pharmacovigilance    2015, 12 (7): 434-438.  
    Abstract369)      PDF(pc) (686KB)(3311)       Save
    Objective To find out the elderly medication compliance and its influencing factors in a community of Shanghai, so as to provide the benefits for ensuring drug safety and improving efficacy. Methods Extracting the survey from the elderly aged 60 years old or older in a community, evaluated them with the homemade scale of medication compliance. Results Among the 300 investigated elderly, the meam score of medication compliance is 15.63± 2.18, 31.33% of the elderly showed higher compliance. The elderly who are younger, with higher education and to participate in the basic medical insurance for urban workers, family doctors contracted, medication compliance is higher. While the compliance is lower for the elderly living alone and suffering from multiple chronic diseases, taking many kinds of medication. Conclusion The level of medication compliance of the elderly in community depends on the basic situation of older persons, physiological function, drugs, family and social support cases. So when we develop individualized regimen for elderly patients, ensure therapeutic efficacy and drug safety, it needs to participate and cooperate with the medical staff, patients and their families.
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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.  
    Abstract561)      PDF(pc) (384KB)(3229)       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.
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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
    Abstract504)      PDF(pc) (1467KB)(3191)       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.
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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.  
    Abstract621)      PDF(pc) (602KB)(3100)       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.
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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.  
    Abstract643)      PDF(pc) (581KB)(2745)       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.
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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.  
    Abstract793)      PDF(pc) (819KB)(2695)       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.
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