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20 June 2019, Volume 16 Issue 6 Previous Issue    Next Issue

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Study on the Quantitative Structure-genetic Toxicity Relationships of Pyrrolizidine Alkaloids LIU Kaili, LIANG Jingwei, WANG San, LI Zuojing, YAN Xinli, MENG Fanhao 2019, 16(6): 321-324.  Abstract ( 442 )   PDF (748KB) ( 146 )   Objective To establish a model using genotoxicity data (exposure level, CI) as the independent variable and predict the genetic toxicity of pyrrolizidine alkaloids using the model. Methods The partial least squares method was adopted to conduct a predictive study on the genetic toxicity of pyrrolizidine alkaloids. Results Partial least squares method (PLS) was applied to reduce the dimension, 8 components were extracted and a model was built using the 8 components. The prediction model of genetic toxicity of pyrrolizidine alkaloids is obtained through quantitative structure activity relationships (QSAR) analysis. The model is as follows: Log(toxi)=SAA*0.790049-SAG*0.141402-VOL*0.0830882+LogP*1.75971-RE*0.345487-POLAR*0.369259-TE*0.119995-BE*0.0987964-IAE*0.849541-EE*0.129214+CCI*0.0239072-HOF*0.097627-DIPOLE*0.0134722. Conclusion The QSAR model established in this study has good prediction ability for toxicity. References | Related Articles | Metrics

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Effects of Fulvestrant Inducing Apoptosis of Pituitary Adenoma Cells and the Acute Toxicity Study LI Zhenzong, LI Dan, WANG Hongyun, GONG Lei, GAO Hua, LIU Qian 2019, 16(6): 325-328.  Abstract ( 418 )   PDF (890KB) ( 160 )   Objective To investigate the effects of fulvestrant inducing apoptosis of pituitary adenoma GH3 cells and the acute toxicity of fulvestrant on mice. Methods After treated with fulvestrant for 72 h, the proliferative activity of pituitary adenoma GH3 cells was determined by MTS assay and 50% inhibitory concentration (IC50). Simultaneously, the apoptosis ratios of pituitary adenoma GH3 induced by fulvestrant were detected by Annexin V-FITC/PI. The acute oral toxicity of fulvestrant in mice was used by the maximum limit method. The mice were observed daily to record the number of death and body weight, then 50% lethal dose (LD50) was counted. Pathological examination was competed at the end of the 14 d observation period. Results The IC50 of fulvestrant on pituitary adenoma GH3 cells was 361.9 nM. Fulvestrant could induce apoptosis of GH3 cells dose-dependently. There were no death mice in the 14 d acute oral toxicity test which means the LD50 was greater than 2 000 mg·kg-1. The fetal tissue of mice was found that there was no significant difference between the blank group and the fulvestrant treatment group according to the histopathology observation. Conclusion Fulvestrant induces apoptosis of pituitary adenoma GH3 cells. The acute toxicity of fulvestrant is low and the LD50 was greater than 2 000 mg·kg-1 which indicates that fulvestrant is safe. References | Related Articles | Metrics

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Study on Applicability of ICH Guideline M1 Mapping Feasibility of National Adverse Drug Reaction Terminology MA Danhua, LIU Hongliang, WANG Dan, LI Ming, TIAN Chunhua 2019, 16(6): 329-332.  Abstract ( 590 )   PDF (810KB) ( 357 )   Objective To study the feasibility of mapping National Adverse Drug Reaction Terminology with MedDRA. Methods The applicability of MedDRA in China is studied through comparative analysis, questionnaire survey and expert interview. Result sand Conclusion It is feasible to establish the mapping relationship between National Adverse Drug Reaction Terminology and MedDRA, which is a powerful measure to implement the ADR Direct Reporting System. References | Related Articles | Metrics

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Study on Applicability of ICH Guideline M1 Mapping Practice of National Adverse Drug Reaction Terminology HOU Yongfang, TIAN Chunhua, LIU Hongliang, LIU Cuili, LI Ming, WANG Xinmin 2019, 16(6): 333-337.  Abstract ( 869 )   PDF (777KB) ( 263 )   Objective To map and transform the "National Adverse Drug Reaction Terminology" to MedDRA. Methods Based on "National Adverse Drug Reaction Terminology" "MedDRA version 21.0" "UMC-Bridge" and so on, using"one term three codes" technological route to map and match the "national adverse drug reaction terminology" to MedDRA. If the codes found by different routes were the same, then mapping relationship was almost determined. If the codes found by different routes were different or only one code was found, then mapping relationship need to be reviewed artificially. If no code was found, the term needed to be coded by external experts. Results Of the 6 717 terms, 2 733 terms were basically determined, 3 175 terms need to be manually reviewed, and 809 terms needed to be manually coded by external experts. Conclusion The mapping and transformation of "National Adverse Drug Reaction Terminology" to MedDRA can be realized by adopting this technological route. In order to promote the application of MedDRA in China and facilitate the implementation of the direct reporting system, it is suggested to establish a coordination mechanism with MSSO to improve the accuracy of the Chinese version, establish the Chinese glossary of adverse drug reactions (C-ART) and guide for the filling of adverse drug reaction terms, etc. References | Related Articles | Metrics

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Current Status of Drug Abuse Epidemic and Intervention Research in China WAN Kaihua, WEI Yu, XU Yuming, ZHOU Juan 2019, 16(6): 338-341.  Abstract ( 572 )   PDF (606KB) ( 295 )   Objective To understand the prevalence and intervention status of drug abuse in China, and to provide a reference for effectively controlling the prevalence of drug abuse in China. Methods Through the review of relevant literature and information, the prevalence and major trends of drug abuse in China, and the main Methods of drug abuse intervention can be understood. Results At present, drug abuse in China mainly presented the following trends: the situation of synthetic drug abuse was severe; the lower age trend in drug abuse was becoming increasingly prominent; the situation of multiple drug abuse was widespread; the abuse of psychoactive drugs was increased, and the harm was serious; Currently, the intervention studies on drug abuse mainly included drug addiction interventions and preventive interventions in China. Conclusion We hope that the state will strengthen supervision, reduce blind spots in monitoring, combine preventive interventions for drug abuse and drug-detoxification interventions, and change from single passive intervention to the active one to effectively control the drug abuse. References | Related Articles | Metrics

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Design Normalization of Drug Labels and Its Clinical Significance JIN Hong, FU Lina, XU Jingyu, TAO Qiaofeng* 2019, 16(6): 342-346.  Abstract ( 506 )   PDF (624KB) ( 295 )   Objective To improve the design normalization of drug labels in our country and promote publishing the guideline of label design, provide foundation for accurate clinical medication. Methods By comparing the difference between provisions of drug labels published by drug administration department in China, Europe and America, analyze the gap between our country and Europe and America as well as possible risk to patients. Result sand Conclusion The design of drug labels in our country is similar with the West in design layout, label information, format of generic name and so on, but the text formatting, color, content requirement and other aspects are not explicitly stipulated. So it's recommended to formulate and issue the guideline of drug label design for strengthening guidance to drug label, so as to facilitate the safety of clinical medication. References | Related Articles | Metrics

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Study on Recognition of Drug Toxicity in Pharmacovigilance Thought of the Compendium of Materia Medica SHI Lin, LIU Xin, ZHANG Bing 2019, 16(6): 347-351.  Abstract ( 388 )   PDF (765KB) ( 144 )   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 classified and reorganized. We summarized the ideological connotation of recognition of drug toxicity, and researched the correlation between drug property and toxicity in grass classification, which has the most toxic drugs. Results Recognition of drug toxicity in pharmacovigilance thought of the Compendium of Materia Medica is mainly reflected in understanding of drug property, and the literatures are concentrated at QI WEI entry. The core of the pharmacovigilance thought is to explore the toxicity and interrelationship of drugs. Conclusion Understanding of drug property in the Compendium of Materia Medica pays great attention to drug toxicity and emphasizes the interaction between drugs. We used association rule algorithms in data mining to analyze the drugs in grass classification, it was found that XIN WEI was closely related to toxicity, and drugs of KU Han were easier experienced interactions such as JIN JI FAN WU and detoxification with other drugs. References | Related Articles | Metrics

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Using Global Trigger Tool to Monitor Adverse Drug Events in Inpatients with Psychiatric Disorders XU Jiayue, HU Qiaozhi, XU Ting 2019, 16(6): 352-359.  Abstract ( 406 )   PDF (781KB) ( 117 )   Objective To use the global trigger tool (GTT) to monitor adverse drug events (ADEs) of inpatients with psychiatric disorders and evaluate the applicability of the tool. Methods Medical record informations of adult inpatients discharged from the Mental Health Center of West China Hospital, Sichuan University from January 1, 2015 to December 31, 2015 were randomly selected, with a total of 600 cases (50 cases per month). Medical records were reviewed using 31 triggers for ADE monitoring in patients with psychiatric disorders to determine ADE and grade its severity. At the same time, the trigger tool was preliminarily revised according to the Results of the medical record search. Results A total of 600 patients were included in this study, only 15 of the 31 triggers were positive, with a positive frequency of 776 times. Among them, 379 times were effective triggers involving ADE, and a total of 281 ADEs were detected after repeated removal, of which only 25 ADEs were considered to be preventable. ADE/1 000 patients days were 26.96, ADE/100 patients were 46.83%, and 243 patients had ADE at least once, accounting for 40.50% of the total number of patients. Based on the above Results, it is recommended to add two new triggers to the original trigger tool and localize one trigger. Conclusion The global trigger tool has a strong applicability in monitoring adverse drug events of patients with psychiatric disorders, and can provide reference for preventing drug risks. It is worthy to be popularized in medical institutions related to mental health diseases in China, but the tool still needs to be improved to adapt to the monitoring of adverse drug events in patients with psychiatric disorders in this region. References | Related Articles | Metrics

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Analysis of Safety and Risk of the Mixed Use of Ceftriaxone and Dexamethasone FENG Yanan1, LIU Xinxin1, WU Guizhi2*, ZHAO Li1, LI Yonghui1* 2019, 16(6): 360-363.  Abstract ( 630 )   PDF (657KB) ( 322 )   Objective To study the safety and risk of mixed ceftriaxone and dexamethasone given in patients, and provide more information of safe and rational drug use in clinic. Methods To analyze 1 124 ADR case reports of ceftriaxone mixed with dexamethasone for injection. Results Mixing ceftriaxone with dexamethasone for use mainly took place in primary health care institutions. Mixed use of these two drugs tends to cause more serious allergic reactions, including anaphylactic shock. Most of cases mixed using dexamethasone is lack of clear indications. Conclusion Mixing ceftriaxone with dexamethasone for use tends to cause more serious allergic reactions. Ceftriaxone should be avoided to mix with dexamethasone for clinical use. References | Related Articles | Metrics

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Analysis of Adverse Drug Reactions During Therapy in 186 AIDS Patients in Our Hospital WANG Jia, MENG Xianmin, DONG Ping 2019, 16(6): 364-366.  Abstract ( 472 )   PDF (645KB) ( 176 )   Objective To explore the feature and regularity of adverse drug reactions (ADRs) in acquired immune deficiency syndrome (AIDS) patients, and to provide reference for clinical pharmcovigilance and rational drug use. Methods A retrospective analysis was performed on 186 AIDS patients with all ADR reports which were reported to the National Drug Adverse Reaction Monitoring System from January 2016 to December 2018. Results Among the 186 cases of adverse drug reactions, there were 169 males and 17 females, and the majority (26.34%) were patients aged from 31 to 40 years old. A total of 61 drugs were involved, anti-infective drugs had the highest drug composition ratio (81.72%), among which sulfonamides caused the most ADR cases (46.05%). Skin and local lesion were the major clinical manifestations (40.76%). Conclusion The occurrence of ADR in AIDS patients may be associated with age, classes of drugs, and the frequency of use. Communicate and feedback the regularity and characteristics of ADR, which is beneficial for the clinicians to strengthen their vigilance against ADR and optimize treatment. References | Related Articles | Metrics

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Clinical and Literature Analysis of 107 Cases of Adverse Drug Reactions Induced by Pegaspargase MIAO Wenjuan, TIAN Jixin, Yu Yaqing, ZHANG Ping 2019, 16(6): 367-373.  Abstract ( 493 )   PDF (732KB) ( 168 )   Objective To analyze the occurrence and clinical characteristics of adverse drug reactions induced by pegaspargase, so as to provide reference for clinical safe medication. Methods ADR cases induced by pegaspargase in the Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences from July 2013 to March 2019 were collected. In addition, case reports of adverse drug reactions induced by pegaspargase were retrieved from the CNKI database, VIP database, Wanfang database and Pubmed database. Then patients information such as gender, age, original disease, medication and the occurrence of adverse reactions was summarized and analyzed. Results Totally 107 patients were retrieved, including 30 clinical cases in our hospital and 77 literature cases. Among them, 67(62.62%) were males and 40(37.38%) were females, and 55(51.40%) were children under 10 years old. Adverse reactions occurred in 3 minutes to 44 days after administration of pegaspargase. The main clinical manifestations were gastrointestinal damage, blood system damage and cardiovascular damage. Conclusion Clinicians and pharmacists should pay attention to the occurrence characteristics of adverse reactions of pegaspargase. When using chemotherapy regimens containing pegaspargase, it should be closely observed the clinical symptoms and monitored related indicators such as coagulation function and liver function, in order to minimize the adverse drug reactions damage caused by pegaspargase. References | Related Articles | Metrics

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Analysis of 1189 Cases of Adverse Drug Relations Induced by Carboprost Methylate ZHANG Shu, LIN Qiang, DENG Wen, CHEN Shen 2019, 16(6): 374-378.  Abstract ( 434 )   PDF (788KB) ( 171 )   Objective To investigate the general characteristics and relative factor of the adverse drug reactions induced by carboprost methylate, so as to provide reference of clinical rational and safe use of drug. Methods By retrospective study method, we analyzed the 1 189 cases of adverse drug relations/events induced by carboprost methylate in the adverse reaction network platform of Pan-Pearl River Delta from 2005 to 2017. By retrospective study method, we analyzed the patient's age, gender, past history, the purpose of drug use,occurrence time, symptoms of adverse drug reactions, the system involved etc. Results The adverse drug reactions of carboprost methylate mainly occurred on the day of medication. The systems involved of adverse drug reactions include the gastrointestinal system damage, systemic damage,skin and its accessories damage etc.Serious adverse drug reactions mostly occurred in half an hour after the drug use. Conclusion Clinic should pay attention to the drug adverse reactions of carboprost methylate, especially to the serious adverse reactions.Drug manufacturers should promptly revise and improve the safety information of drug instructions,so as to ensure the safety of drug use. References | Related Articles | Metrics

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One Case of Cytopenia Induced by Piperacillin Sodium and Tazobactam Sodium for Injection WANG Aming, WU Hui, WANG Hongxia, ZHANG Linlin, BIAN Hailin 2019, 16(6): 379-380.  Abstract ( 412 )   PDF (531KB) ( 180 )   References | Related Articles | Metrics

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One Case of Peripheral Neuropathy Induced by Telbivudine Tablets LIU Mengxiao, SONG Jie, ZHANG Chuanhui, JIA Shengnan, SHAO Xue, JIN Zhenjin 2019, 16(6): 381-382.  Abstract ( 293 )   PDF (526KB) ( 96 )   References | Related Articles | Metrics

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Two Cases of Acute Pulmonary Embolism Induced by Antipsychotic Drugs YANG Jiyang, CUI Xiangli, Wu Xinan 2019, 16(6): 383-384.  Abstract ( 336 )   PDF (527KB) ( 289 )   References | Related Articles | Metrics