中国药物警戒 ›› 2013, Vol. 10 ›› Issue (2): 111-113.

• 药械安全性研究 • 上一篇    下一篇

我院参麦注射液应用情况及不良反应分析

朱玲琦12,周昕2,杜蕾3,王宏敏3,金慧琳3,许丽雯2   

  1. 1.复旦大学药学院,上海 201203；
    2.上海中医药大学附属龙华医院药剂科,上海 200032；
    3.上海市药品不良反应监测中心,上海 200233
  • 收稿日期:2012-05-02 修回日期:2016-03-09 出版日期:2013-02-08 发布日期:2016-03-09
  • 作者简介:朱玲琦,女,主管药师,医院临床药学。

Analysis of Shenmai Injection Application and Adverse Reaction at Our Hospital

ZHU Ling-qi1,2, ZHOU Xin2 ,Du Lei3 ,Wang Hong-min3, Jin Hui-lin3, XU Li-wen2   

  1. 1.School of Pharmacy, Fudan University, Shanghai 201203, China;
    2.Department of Pharmacy, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China;
    3.Shanghai Center for ADR Monitoring, Shanghai 200233, China
  • Received:2012-05-02 Revised:2016-03-09 Online:2013-02-08 Published:2016-03-09

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摘要： 目的 对我院参麦注射液应用情况及不良反应进行分析,为临床应用和药品监管部门决策提供参考。方法 采用医院集中监测的方法,对2011年 1月～10月期间我院应用参麦注射液的住院患者病历,进行回顾性调查,并进行统计。结果 共收集到468份应用参麦注射液的住院患者病历,85.5%为 50岁以上老年患者；适应证、用法用量和疗程均比较规范,基本符合药品说明书规定；不良反应发生率为 1.7%,属常见范畴；主要表现为头晕、乏力、胸闷、不适等,临床表现多样,无明显特异性,且多为一过性,停药即可,不需特别处理。结论医院集中监测法是对自发性呈报系统良好的补充,其得出的不良反应发生率具有可参考性,但需要进行多中心的研究,使数据更具代表性。

关键词: 参麦注射液, 不良反应, 医院集中监测

Abstract: Objective To analyze the clinical application and adverse reaction of Shenmai injection at our hospital, and provide reference for medical staff and regulators. Methods By the method of hospital intensive monitoring, we reviewed the medical records of all patients who ever used Shenmai injection from January to October 2011 at our hospital, and statistically analyzed the ADR of Shenmai injection. Results We collected 468 cases, 85.5% patients are over 50 years old. In most cases, indications, dosage and duration of treatment of Shenmai injection are consistent with the drug instruction. The incidence of ADR is 1.7%, belonging toa common category.The symptoms of adverse reactions are relatively light and transient, such as dizziness, fatigue, chest pain and discomfort. Conclusion Hospital intensive monitoring method isa good supplement of spontaneous reporting system, which can get a referential incidence rate of ADR, but multicenter studies are needed to make the data more representative.

Key words: Shenmai injection, adverse reaction, hospital intensive monitoring

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