2013—2016年西安地区抗菌药物不良反应报告分析
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摘要
目的了解西安地区抗菌药物不良反应的发生情况,分析不良反应的特点及规律,指导临床安全合理用药。方法采用回顾性研究方法,收集西安市不良反应监测中心2013年1月1日至2016年10月20日抗菌药物不良反应报告,对报告表中的患者年龄、性别、引起不良反应的药品类别等指标进行描述性分析。结果共收集12 049例抗菌药物不良反应报告,其中8 815例(73. 20%)来源于医疗机构;患者男女比例为1∶1. 36,平均年龄为37岁;引起不良反应的主要抗菌药物为头孢菌素类、氟喹诺酮类和β内酰胺类,分别占29. 74%(3 583例)、16. 13%(1 944例)、12. 55%(1 512例);累及器官的不良反应中,皮肤及其附件损害占比最高为28. 13%(3 276例)。结论西安地区抗菌药物不良反应发生频率有逐年上升趋势,应宣传抗菌药物与合理用药使用原则,必要时进行药学干预,以保证抗菌药物安全合理用药。
Objective To understand the situation of adverse drug reaction of antimicrobial in Xi'an area,and analyze the characteristics and rules so as to guide the clinical use of drugs safely and reasonably. Methods A retrospective study was conducted to collect adverse drug reaction reports of antimicrobial from Jan. 1 st,2013 to Oct. 20 th,2016 in Xi' an Adverse Reaction Monitoring Center. The patient age,gender,adverse drug reaction-causing drug category and other indicators were descriptively analyzed. Results A total of 12 049 antimicrobial adverse drug reaction reports were collected,including 8 815( 73. 20%) reports from the medical institutions; the male to female ratio was 1∶1. 36; the average age of the patients was 37 years old; the main antimicrobials that caused adverse drug reaction were Cephalosporins( 29. 74%,3 583 cases),Fluoroquinolone( 16. 13%,1 944 cases) and β-Lactam( 12. 55%,1 512 cases); the proportion of skin structure disorders was the highest( 28. 13%,3 276 cases) among the organs involved in adverse drug reaction. Conclusion The frequency of adverse reactions of antibacterial drugs in Xi' an area has been increasing year by year. To ensure safe and rational use of antimicrobial drugs,the principles of using antibiotics and rational drug use should be propagated and pharmacy intervention should be carried out when necessary.
Objective To understand the situation of adverse drug reaction of antimicrobial in Xi'an area,and analyze the characteristics and rules so as to guide the clinical use of drugs safely and reasonably. Methods A retrospective study was conducted to collect adverse drug reaction reports of antimicrobial from Jan. 1 st,2013 to Oct. 20 th,2016 in Xi' an Adverse Reaction Monitoring Center. The patient age,gender,adverse drug reaction-causing drug category and other indicators were descriptively analyzed. Results A total of 12 049 antimicrobial adverse drug reaction reports were collected,including 8 815( 73. 20%) reports from the medical institutions; the male to female ratio was 1∶1. 36; the average age of the patients was 37 years old; the main antimicrobials that caused adverse drug reaction were Cephalosporins( 29. 74%,3 583 cases),Fluoroquinolone( 16. 13%,1 944 cases) and β-Lactam( 12. 55%,1 512 cases); the proportion of skin structure disorders was the highest( 28. 13%,3 276 cases) among the organs involved in adverse drug reaction. Conclusion The frequency of adverse reactions of antibacterial drugs in Xi' an area has been increasing year by year. To ensure safe and rational use of antimicrobial drugs,the principles of using antibiotics and rational drug use should be propagated and pharmacy intervention should be carried out when necessary.
引文
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[11]张雪梅,李昱,贾倩倩,等. 2012—2014年驻陕药品生产企业不良反应报告分析与评价[J].药物流行病学杂志,2017,26(4):263-267.
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[14]乐文清,袁以凯,朱灿.我院2007—2009年药品不良反应报告分析[J].安徽医药,2011,15(3):387-388.
[15]储洁琼,刘俊,汪魏平. 400例抗菌药物不良反应报告分析[J].安徽医药,2013,17(6):1076-1078.
[16]沈陈军,宁萍,胡秀萍,等.滁州市第一人民医院209例抗菌药物不良反应报告及相关因素分析[J].中国医院用药评价与分析,2016,16(3):396-399.
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[19]彭评志,蒙光义,庞家莲,等. 206例抗菌药物不良反应报告分析[J].中国药业,2015,24(8):82-85.
[20]王槐芾,龙恩武,童荣生. 293例抗菌药物不良反应相关因素分析[J].四川医学,2011,32(1):35-38.
[21]杜毅,徐彦贵,朱立勤,等. 3869人次静脉输液不良事件的相关性分析[J].中国医院药学杂志,2012,32(9):731-733.
[22]杨忠慧.伊曲康唑致不良反应184例文献分析[J].抗感染药学,2011,8(3):216-219.
[23]汪慧芳,赵心同,江佳,等.我院310例抗菌药物不良反应相关影响因素分析[J].中国药事,2014,28(6):669-673.
[24]蒙光义,廖国胜,王冬晓,等.抗菌药物致不良反应231例分析[J].中国药房,2014,25(10):923-925.
[2]Classen DC,Pestotnik SL,Evans RS,et al. Adverse drug events in hospitalized patients. Excess length of stay,extra costs,and attributable mortality[J]. JAMA,1997,277(4):301-306.
[3]Edwards IR,Aronson JK. Adverse drug reactions:Definitions,diagnosis,and management[J]. Lancet,2000,356(9237):1255-1259.
[4]肖永红,侯芳,王进,等.抗菌药物不良反应的社会与经济后果调查[J].中国卫生经济,2010,29(5):94-96.
[5]姚志红,刘英,詹煦旭,等.我院2012—2015年抗菌药物不良反应分析[J].中国当代医药,2016,23(17):136-138.
[6]王冬晓,蒙光义,罗雪兰,等. 431例抗菌药物不良反应报告分析[J].中国药业,2015,24(6):55-58.
[7]盛垚,冯华,李景云.中山市某三甲医院2013-2015年抗菌药物不良反应发生状况调查分析[J].广州医药,2017,48(2):82-86.
[8]徐冠,禹建春,吴昌枝.基层医院药品不良反应的综合分析与对策[J].中医药管理杂志,2018,26(1):79-80.
[9]Health Canada. Regulation of Health Product Advertising in Canada-Overview for Physicians EB/OL. Ottawa:Government of Canada,Health Canada,Health Products and Food Branch,Marketed Health Products Directorate.(2011-04-27)[2018-06-26].https://www. canada. ca/en/health-canada/services/drugshealth-products/regulatory-requirements-advertising/policiesguidance-documents/regulation-health-product-advertising-canadaphysicians. html
[10]朱磊,黄萍,李颖.我国药品不良反应监测现状及存在问题[J].中国药事,2016,30(7):729-734.
[11]张雪梅,李昱,贾倩倩,等. 2012—2014年驻陕药品生产企业不良反应报告分析与评价[J].药物流行病学杂志,2017,26(4):263-267.
[12]Dimri D,Raina RS,Thapliyal S,et al. Retrospective analysis of pattern of cutaneous adverse drug reactions in tertiary hospital of Pauri Garhwal[J]. J Clin Diagn Res,2016,10(5):FC01-FC06.
[13]谢小菊. 246例药品不良反应报告回顾性分析[J].安徽医药,2011,15(12):1633-1635.
[14]乐文清,袁以凯,朱灿.我院2007—2009年药品不良反应报告分析[J].安徽医药,2011,15(3):387-388.
[15]储洁琼,刘俊,汪魏平. 400例抗菌药物不良反应报告分析[J].安徽医药,2013,17(6):1076-1078.
[16]沈陈军,宁萍,胡秀萍,等.滁州市第一人民医院209例抗菌药物不良反应报告及相关因素分析[J].中国医院用药评价与分析,2016,16(3):396-399.
[17]Gallagher RM,Bird KA,Mason JR,et al. Adverse drug reactions causing admission to a paediatric hospital:A pilot study[J].J Clin Pharm Ther,2011,36(2):194.
[18]De Cock RF,Piana C,Krekels EH,et al. The role of population PK-PD modelling in paediatric clinical research[J]. Eur J Clin Pharmacol,2011,67(1):5-16.
[19]彭评志,蒙光义,庞家莲,等. 206例抗菌药物不良反应报告分析[J].中国药业,2015,24(8):82-85.
[20]王槐芾,龙恩武,童荣生. 293例抗菌药物不良反应相关因素分析[J].四川医学,2011,32(1):35-38.
[21]杜毅,徐彦贵,朱立勤,等. 3869人次静脉输液不良事件的相关性分析[J].中国医院药学杂志,2012,32(9):731-733.
[22]杨忠慧.伊曲康唑致不良反应184例文献分析[J].抗感染药学,2011,8(3):216-219.
[23]汪慧芳,赵心同,江佳,等.我院310例抗菌药物不良反应相关影响因素分析[J].中国药事,2014,28(6):669-673.
[24]蒙光义,廖国胜,王冬晓,等.抗菌药物致不良反应231例分析[J].中国药房,2014,25(10):923-925.