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188例药品不良反应报告分析
引用本文:张灵,程娟,赵黎明,吴华.188例药品不良反应报告分析[J].药物流行病学杂志,2014(11):670-684.
作者姓名:张灵  程娟  赵黎明  吴华
作者单位:合肥市滨湖医院药学部(合肥 230601);合肥市滨湖医院药学部;合肥市滨湖医院药学部;合肥市滨湖医院药学部
摘    要:目的:探讨我院药品不良反应(ADR)的发生情况、发生特点及相关因素,为临床合理用药提供依据。方法:采用回顾性分析方法,对我院2012年2月-2014年2月上报于国家药品不良反应监测中心的188例ADR报告中相关因素进行统计分析。结果:188例药品ADR报告中61岁以上患者所占比例最大(35.64%),男:女比例为0.79∶l。涉及的药品中,抗微生物药、中药制剂、循环系统药、维生素及营养制剂所占比例较高;ADR表现中,皮肤及附件损害最高(占42.55%)、其次为消化系统反应、循环系统反应、神经系统反应;静脉给药引发ADR的比例最高、其次为口服给药;新的、严重的ADR共计28例,占ADR总数的14.89%;我院ADR报告率偏低,存在漏报现象;新的、严重的ADR报告数较少;8例严重ADR中存在明显不合理用药。结论:加大ADR监测和报告力度,做好ADR知识宣传,加强对特殊人群、静脉给药方式及重点品种的用药监管与监测,加强对国家《药品不良反应信息通报》学习,提高合理用药水平,减少ADR的发生,尤其是严重ADR的重复发生。

关 键 词:药品不良反应  监测  合理用药

Analysis of 188 Cases of Adverse Drug Reaction Reports
Zhang Ling,Cheng Juan,Zhao Liming and Wu Hua.Analysis of 188 Cases of Adverse Drug Reaction Reports[J].Chinese Journal of Pharmacoepidemiology,2014(11):670-684.
Authors:Zhang Ling  Cheng Juan  Zhao Liming and Wu Hua
Affiliation:(Department of Pharmacy, Hefei Municipal Hospital of Binhu, Hefei 230601, China)
Abstract:Objective:To investigate the occurrence, characteristics and related factors of adverse drug reactions (ADR) in our hospital, So as to promote the rational using of drug in clinic. Methods:During the period from 2012 Febru ary to 2014 February, 188 ADR were reported to the National Center for ADR monitoring network platform in our hospital. These data were classified and analyzed statistically in relevant factors. Results:The report showed that the majority of the 188 cases are patient who over 61 years old(35. 64% ) ; the incidence of ADR was higher in women with the ratio of male to female was 0.79:1 ; in the related drugs, antimicrobial drugs, traditional Chinese medicine preparation, circulation sys tem drugs, vitamins and nutrition preparations had higher rates of ADR. In the clinical manifestations of ADR , the lesions of skin and its adnexa was most(42.55 % ), followed by the digestive system, circulatory system and nervous system. Intra venous drip caused the highest percentage of ADR , followed by oral administration. The new and serious ADR were 28 ca ses, accounting for 14.89% of the total number of ADR. In our hospital , ADR reporting rate was low, because some cases were missing; The number of new, serious ADR was less. 8 cases of serious adverse reactions had obviously irrational us age of drug. Conclusion:ADR monitoring and reporting should be strengthened. The work on the ADR knowledge propa gate shall be properly done.. The supervision and monitoring should be pay more attention to the special groups, intravenous administration and intensive safety monitoring varieties. Strengthen the national "adverse drug reaction reporting'of informa tion" to improve the level of rational drug using, and reduce the incidence of ADR, especially the repeated occurrence of se rious ADR.
Keywords:Adverse drug reaction  Monitoring  Rational drug use
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