中国药物警戒 ›› 2015, Vol. 12 ›› Issue (1): 45-48.

• 药械安全性研究 • 上一篇    下一篇

409例注射用单磷酸阿糖腺苷不良反应报告分析

王丽1,李强2   

  1. 1河南省食品药品评价中心，河南 郑州 450004
    2河南省郑州市食品药品检验所，河南 郑州 450006
  • 收稿日期:2014-07-30 出版日期:2015-01-08 发布日期:2015-07-28
  • 作者简介:王丽，女，硕士，药师，药品安全性监测。

Analysis of 409 Reports of Adverse Drug Reactions Caused by Vidarabine Monophosphate Injection

WANG Li1,LI Qiang2   

  1. 1Food and Drug Reevaluation Center of Henan Province, Henan Zhengzhou 450004, China;
    2Zhengzhou Institute of Food and Drug Control of Henan Province, Henan Zhengzhou 450006, China
  • Received:2014-07-30 Online:2015-01-08 Published:2015-07-28

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摘要： 目的 通过分析注射用单磷酸阿糖腺苷不良反应发生的一般规律及特点，为临床合理用药提供参考。方法 采用回顾性研究方法 ，对河南省药品不良反应监测中心报告数据库中2004年1月～2014年7月10日注射用单磷酸阿糖腺苷不良反应报告进行统计和分析；对国内2个厂家的药品说明书进行对比分析。结果 本组资料中14岁以下儿童（88.02%）居多，但说明书中却无儿童用药信息；联合用药215例，联用品种以抗生素为主（68.38%）；不良反应以皮肤及其附件损害（56.55%）为主，表现为皮疹（44.40%）和瘙痒（5.69%）等，但说明书中却无相关风险提示。结论 重视注射用单磷酸阿糖腺苷引发的不良反应，完善药品说明书，提高临床合理用药水平，确保临床用药安全。

关键词: 注射用单磷酸阿糖腺苷, 不良反应/事件, 分析

Abstract: Objective To study the general pattern and characteristics of adverse drug reactions induced by vidarabine monophosphate injection to provide references for clinical rational use of drug. Methods 409 cases of ADR related to the vidarabine monophosphate injection from January 2004 to July 2014 in Henan province were analyzed using retrospective study method.The drug instructions of two domestic pharmaceutical enterprises were compared. Results Among 409 reports, children aged 14 years old accounted for 88.02%, but there was no children informations in the drug instructions. 215 cases of drug combination accounted for 52.57%, and the combination species were focused on antibiotics(68.38%). The main ADR was damage to skin and its attachment(56.55%), and the major clinical manifestations were skin rashs(44.40%), itching(5.69%), etc, and there was no warning of these in the drug instructions. Conclusion It's important to pay attention to the ADR caused by vidarabine monophosphate injection, and perfect drug instuctions, in order to improve rational use of medicines in clinic, ensure clinical medication safety.

Key words: vidarabine monophosphate injection, adverse drug reaction/event, analysis

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