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    20 July 2019, Volume 16 Issue 7 Previous Issue    Next Issue

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    Hepatotoxicity Evaluation of Polygonum Multiflorum Based on 2D and 3D Hepatocyte Models In Vitro
    YAN Yujing, DAN Mo, WANG Qi, WEN Hairuo
    2019, 16(7): 385-392. 
    Abstract ( 457 )   PDF (1194KB) ( 139 )  
    Objective To evaluate the hepatotoxicity of PMEE and THSG on 2D and 3D hepatocyte models in vitro and compare the differences between them. Methods 2D and 3D hepatocyte models were dealt with different concentrations of PMEE and THSG for 24 h, 48 h and 144 h, then the cell viability, DNA damage and cell apoptosis were detected. Results PMEE could inhibit the proliferation of HepaRG in 2D model notably, but the effect on 3D model was not like this. Compared with 3D model, PMEE also had a stronger DNA damage effect on 2D model. The inhibitory effect of THSG on HepaRG in 3D model was greater than that in 2D model. What' s more, the frequency of apoptosis cells of high-dose THSG group was increased notably compared with control group in the alkaline comet assay of 3D model (P <0.01). Conclusion 3D model was greater than 2D model in sensitivity. Both PMEE and THSG had hepatotoxicity and the hepatotoxicity of PMEE was attenuated after being metabolized by 3D hepatocyte models, THSG was the opposite.
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    Study on Skin Safety and Vaginal Mucosal Irritation of Shenju Lotion
    ZHANG Guangqiu, ZHANG Meixiang, TAN Lu
    2019, 16(7): 393-398. 
    Abstract ( 873 )   PDF (806KB) ( 182 )  
    Objective To observe the sensitization of guinea pig skin and the irritation of rabbit skin and vaginal mucosa of Shenju lotion, so as to provide scientific basis for clinical application. Methods Skin sensitization experiments were carried out using guinea pigs as model, and intact, damaged skin and vaginal mucosal irritation experiments were performed using rabbits as model. Results Shenju lotion had no allergic reactions such as erythema or edema in guinea pig skin; 50% Shenju lotion was not irritating to the intact and damaged skin of rabbits, while the Shenju lotion solution was not irritating to the intact skin of rabbits, with mild and reversible irritation to damaged skin; no obvious irritation to rabbit vaginal mucosa. Conclusion Shenju lotion is safe for external use.
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    Study on Use of Drug Toxicity in Pharmacovigilance Thought of the Compendium of Materia Medica
    SHI Lin, LIU Xin, ZHANG Bing
    2019, 16(7): 399-403. 
    Abstract ( 461 )   PDF (779KB) ( 258 )  
    Objective To study the Compendium of Materia Medica from the perspective of pharmacovigilance, mine and reorganize pharmacovigilance thought of Chinese medicine and practical experiences in it. Methods By using traditional literature and data mining research methods, the contents of more than 1.9 million words in the Compendium of Materia Medica were filtered. We summarized the contents of use of drug toxicity in pharmacovigilance. Results There are a lot of records and methods in the Compendium of Materia Medica, which are about how to safely use the drugs and avoid adverse drug reactions in different links of drug use. Conclusion Use of drug toxicity in pharmacovigilance thought of the Compendium of Materia Medica is mainly embodied in the following aspects: paying attention to the compatibility and dietary taboos, promoting rational drug toxicity use, paying attention to the choice of dosage form and decocting method, emphasizing the factor of person and following the rule of drug for four seasons.
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    Study on Prevention of Drug Toxicity in Pharmacovigilance Thought of the Compendium of Materia Medica
    SHI Lin, LIU Xin, ZHANG Bing
    2019, 16(7): 404-410. 
    Abstract ( 331 )   PDF (902KB) ( 184 )  
    Objective To study the Compendium of Materia Medica from the perspective of pharmacovigilance, mine and reorganize the pharmacovigilance thought of Chinese medicine and practical experiences in it. Methods By using traditional literature research methods, contents of prevention of drug toxicity in pharmacovigilance of the Compendium of Materia Medica, such as source and distinguishing, origin and harvest, processing, and prevention of adverse drug reactions etc. were summed up. Results Ideological system of prevention of drug toxicity of the Compendium of Materia Medica was formed. Conclusion There are mainly three aspects of prevention of drug toxicity in pharmacovigilance thought of the Compendium of Materia Medica, which are attaching great importance to species and distinguishing, processing and records of adverse drug reactions.
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    Study on Use and Prevention of Pediatric Drug Toxicity in the Compendium of Materia Medica
    WANG Xiao, SHI Lin, ZHANG Bing
    2019, 16(7): 411-415. 
    Abstract ( 386 )   PDF (730KB) ( 156 )  
    Objective To provide some reference for pediatric drug toxicity based on thoughts of use and prevention of pediatric drug toxicity from the Compendium of Materia Medica. Methods To extract factors such as smell and prescriptions of pediatric drug toxicity from the Compendium of Materia Medica, to establish a database of pediatric application of traditional Chinese medicine(TCM) toxicity with Excel 2016. With the database then its indications, processing, compatibility and application were statistically analyzed. Results There are 71 different kinds of TCM toxicity were used in pediatrics. Most of the drug toxicities are with mediocre or little poison. The majority of the prescriptions, 136 in total, are oral drugs which were processed first and then put into the prescriptions. The dosages were mostly measured with "Yi Zi" and "Ban Qian", and they were often used with vinegar or liquids which were made of rice. During the process, the compatibility of reducing toxicity should be focused. Conclusion The pediatric drug toxicity in the Compendium of Materia Medica contains rich clinical practice of pharmacovigilance, especially on its thoughts of use and prevention drug toxicity, which should be a good guidance for rational drug use in modern pediatrics.
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    Enlightenment of Market Share Liability on Compensation System for Delayed Drug Injury in China
    JU Mengqi, YUAN Lijia, LV Xufeng, YANG Lina, YANG Yue
    2019, 16(7): 416-419. 
    Abstract ( 393 )   PDF (675KB) ( 171 )  
    Objective To introduce the Market Share Liability in Europe and America, so as to provide reference to our country. Methods By the methods of jurisprudence analysis and case study, this paper analyzed the definition, background and application of Market Share Liability, and made suggestions on its application in the field of drug infringement in China. Results The application of the Market Share Liability was based on the premise that the product was "alternative" and defective. At the same time, it was a special rule, mainly to solve the problem that the victims were unable to identify infringer due to the delayed drug injury. Conclusion Before we learnt from the European and American experiences to establish the Market Share Liability, we should clarify the definition of "alternative" and "defective", and establish a statistical mechanism for market share of enterprises, so as to provide a reasonable and feasible reference for the compensation system for delayed drug injury cases in China.
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    Data Analysis of Oseltamivir Adverse Reactions in 55 Cases
    ZHOU Hong, XU Ning, ZHANG Xiao, CHEN Gang, LIU Yanjie, YU Xiaojia, GONG Lili, LIU Lihong
    2019, 16(7): 420-424. 
    Abstract ( 797 )   PDF (811KB) ( 293 )  
    Objective To analyze the reported data of oseltamivir ADRs and understand the post-marketing adverse reaction features of the drug in China, so as to provide references for clinical rational use and active monitoring in medical institutions. Methods The oseltamivir-related adverse reaction reports collected from Beijing Center for ADR Monitoring during 2003~2018 were organized and analyzed. Results A total of 55 reports were included in the analysis. Since 2016, the number of reported adverse reactions has increased significantly, mainly in children ≤15 years old (41 cases, 74.55%), and the involved systems-organs were mainly manifested as gastrointestinal system damage and nervous disorders. Conclusion The post-marketing safety of oseltamivir in China should be monitored actively in order to detect the drug risk signals in time and ensure medication safety of patients.
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    Pharmaceutical Practice of One Case of Severe Hypokalemia Induced by Glucocorticoid in Patient with Minimal Change Nephropathy
    YANG Hong, YIN Donghong
    2019, 16(7): 425-429. 
    Abstract ( 362 )   PDF (787KB) ( 265 )  
    Objective To introduce the pharmaceutical practice in a minimal change nephropathy patient with severe hypokalemia induced by glucocorticoid in clinical setting. Methods For a specific case, the clinical pharmacists participated in the individualized design of immunosuppressive therapy for a patient with glucocorticoid-induced hypokalemia, and put forward suggestions for pharmaceutical intervention to ensure safe and effective medication for patients. Results Clinical pharmacists participated in deciding the treatment and strengthened pharmaceutical care by playing their strengths, thus the therapeutic effect of the patient was ensured. Conclusion The safety, effectiveness and rationality of the drug use can be improved by strengthening the pharmaceutical care for minimal change nephropathy patients with severe hypokalemia induced by glucocorticoids.
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    Literature Review of 157 Cases of Adverse Drug Reactions Induced by Irinotecan
    MO Beilei, WANG Tao, YUAN Heng
    2019, 16(7): 430-435. 
    Abstract ( 481 )   PDF (771KB) ( 388 )  
    Objective To explore the characteristics and regularity of adverse reactions of irinotecan, so as to provide reference for preventing adverse reactions and rational clinical use. Methods Using "irinotecan"、"campto"、"adverse reaction"and "to"as key words, the articles in the CNKI and Wanfang database from January 2000 to January 2019 were searched and retrieved. Thirty-eight references which met the inclusion and exclusion criteria were extracted and analyzed. Results 157 cases were extracted. There were more middle-aged and elderly patients. The primary diseases were colon cancer, rectal cancer, lung cancer and cervical cancer. Systems and organs mainly involved in adverse reactions were blood, digestion, skin and its appendages, and systemic damage. The main clinical manifestations were myelosuppression, cholinergic syndrome, nausea, diarrhea and other digestive tract reactions. Conclusions trengthen the monitoring and guidance of drug use, pay attention to the quality of clinical nursing, and continuously improve the level of rational drug use.
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    Retrospective Analysis of Adverse Reactions and Prognosis of Six Contrast Agents from 2011 to 2018
    LI Xiaodan, ZHANG Yangxin, LIU Chen, BAI Xiangrong, YAN Suying
    2019, 16(7): 436-441. 
    Abstract ( 483 )   PDF (790KB) ( 247 )  
    Objective To find problems of contrast agents used in clinic and the characteristics of contrast agent-induced adverse drug reactions (ADRs), providing baseline data and strategies for rational use of contrast agents. Methods The study retrospectively analyzed the adverse drug reaction(ADR) reports of gadolinium and iodine contrast agents from January 2011 to June 2018 in Xuanwu Hospital. It estimated the incidence of contrast-related ADR. It also described ADR-related patients' gender, age, severity, organs and occurrence time. Results In our hospital, there were 177 cases of adverse drug reactions related to gadolinium and iodine contrast agents from January 2011 to June 2018. In 177 cases of contrast agent-induced ADRs, there were 106 males (59.9%) and 71 females (40.1%). There were 8 cases of severe ADRs. Clinical manifestations were skin and appendages disorders, gastrointestinal disorders, nervous system disorders and allergic reaction.72 (40.7%) cases of ADRs happened in 10 minutes after medication. Conclusion The adverse reaction incidence of gadolinium contrast agents is significantly higher than that of iodine contrast agents. Patients should be under close attention during and after medication period. Once adverse drug reaction occurred, strategies such as stopping the medication and treatment should be quickly undertaken.
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    One Case of Epidermolysis Bullosa Eruption Induced by Clopidogrel Hydrogen Sulfate Tablets
    HU Tingting, XU Ting
    2019, 16(7): 442-443. 
    Abstract ( 410 )   PDF (593KB) ( 180 )  
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    One Case of Dysuria Induced by Chinese Medicine Dispensing Granules Containing Ephedra
    ZHANG Yanli , CHEN Lu, GUI Yue
    2019, 16(7): 444-446. 
    Abstract ( 464 )   PDF (612KB) ( 492 )  
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    One Case of Exfoliative Keratosis Induced by Vancomycin Hydrochloride for Injection
    ZHAO Ruiping, LI Chengmin ,DU Yanhong
    2019, 16(7): 447-448. 
    Abstract ( 343 )   PDF (600KB) ( 141 )  
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