中国药物警戒 ›› 2011, Vol. 8 ›› Issue (12): 755-758.

• 药品不良反应监测 • 上一篇    下一篇

宝山区405例新的/严重的药品不良反应报告分析

李?1, 盛红彬2,*   

  1. 1 上海市食品药品监督管理局宝山分局 上海 200439;
    2 上海交通大学医学院附属第三人民医院,上海 201900
  • 收稿日期:2011-01-30 出版日期:2011-12-10 发布日期:2015-07-30
  • 通讯作者: 盛红彬,男,主管药师,医院药学。E-mail：shenghongbin2005@126.com
  • 作者简介:李?,女,药师,药品监督管理。

Analysis On the 405 New/Serious ADR Cases' Adverse Reaction in Baoshan District

LI Qing1, SHENG Hong-bin2, *   

  1. 1 Shanghai Food and Drug Administration Baoshan Subadministration, Shanghai 200439, China;
    2 No.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 201900, China
  • Received:2011-01-30 Online:2011-12-10 Published:2015-07-30

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摘要： 目的 通过药品不良反应(ADR)报告的统计分析,发掘警戒信号,提高药品不良反应监测工作质量,促进临床用药安全。方法 选取上海市宝山区2010年1~6月份上报的新的严重的ADR报告表405例,采用EXCEL电子表格和手工筛选方法,从多个维度进行统计分析。结果 405例ADR中,60岁以上患者192例（47.1%）;引起ADR的药品主要是中药制剂156例（37.8%）,抗微生品药140例（33.9%）;用药途径中静脉注射239例（57.7%）;ADR主要累及消化系统、皮肤和神经系统,分别占34.1%、22.3%和20.9%。结论 ADR的发生与诸多因素相关,包括患者年龄、药品种类和给药途径等,特别要重视中药制剂和抗微生物药品的不良反应监测,临床表现也呈现多元化,应加强ADR的监测,科学合理用药,确保用药的安全、有效。

关键词: 药品不良反应（ADR）, 药物警戒, 合理用药

Abstract: Objective To explore the warning signal, improve the quality of adverse drug reaction(ADR) supervision and promote clinical drug safety through the statistical analysis of adverse drug reaction(ADR). Methods Choose the new & serious 405 ADRs cases in Baoshan District from January to June in 2010 as a sample, on which do statistical analysis in various ways by EXCEL and manual screening. Results In the 405 cases, including 192 cases who are over 60a(47.1%), ADRs are mainly caused by Chinese patent medicines(37.8%), anti-microbiology medicine(33.9%) and intravenous injection(57.7%). ADRs mainly affects the digestive system, skin and nervous system ,which respectively accounted for 34.1%,22.3% and 20.9%. Conclusion ADRs are caused by many factors, including patient`s age, drug types and the way of use, It must pay great attention to Chinese patent medicines and anti-microbiology medicine. The clinical manifestation is also becoming more and more pluralistic. Therefore, we should strengthen the monitoring method and rational use of drugs to ensure medication safety and efficiency.

Key words: ADR, pharmacovigilance, rational drug use

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