中国药物警戒 ›› 2019, Vol. 16 ›› Issue (3): 174-178.

• 安全性评价与合理用药 • 上一篇    下一篇

93例依达拉奉注射液药品不良反应报告分析

刘琛1, 褚燕琦1, 闫素英1,*, 金超1,2, 刘彤1, 邢丽秋3, 张晓3   

  1. 1 首都医科大学宣武医院药剂科,北京 100053;
    2 首钢矿山医院药剂科,河北 唐山 064400;
    3 北京市药品不良反应监测中心,北京 100024
  • 收稿日期:2018-11-14 修回日期:2020-06-28 出版日期:2019-03-20 发布日期:2019-04-17
  • 通讯作者: 闫素英,女,本科,主任药师,临床药学和药事管理。E-mail：yansuying10@sina.cn
  • 作者简介:刘琛,女,硕士,药师,临床药学。

Analysis of 93 Reports of Adverse Drug Reactions Induced by Edaravone Injection

LIU Chen1, CHU Yanqi1, YAN Suying1,*, JIN Chao1,2, LIU Tong1, XING Liqiu3, ZHANG Xiao3   

  1. 1 Department of Pharmacy, Xuanwu Hospital, Capital Medical University, Beijing 100053, China;
    2 Department of Pharmacy, Shougang Mining Hospital, Hebei Tangshan 064400, China;
    3 Beijing Adverse Drug Reaction Monitoring Center, Beijing 100035, China
  • Received:2018-11-14 Revised:2020-06-28 Online:2019-03-20 Published:2019-04-17

PDF (PC)

235

摘要： 目的 对依达拉奉注射液的药品不良反应报告进行分析,为该药的临床合理应用提供参考。方法 采用回顾性研究方法,对2012年1月至2016年12月期间北京市药品不良反应监测中心收到的依达拉奉药品不良反应报告进行统计,分析患者的性别与年龄分布、原患疾病情况、用药方案、ADR发生的时间、累及系统及临床表现、严重程度、结局等。结果 共收到93例依达拉奉药品不良反应报告,其中9例（9.68%）为严重药品不良反应。老年人有49例,占52.69%。药品不良反应主要累及系统为皮肤及其附件、肝胆系统和神经系统疾病等。67例（72.04%）药品不良反应发生在用药当天及用药后5天以内。23例（24.73%）存在超说明书适应证用药问题,1例（1.07%）存在禁忌用药问题,29例（31.18%）存在治疗过量或治疗不足的情况,3例（3.23%）存在超疗程用药问题。结论 严格按照药品说明书中规定的适应证和用法用量用药,在用药起始阶段应密切观察患者情况,一旦发生药品不良反应,需立即停药并采取对症治疗措施。

关键词: 依达拉奉, 药品不良反应, 用药错误, 药物警戒

Abstract: Objective To analyze the adverse drug reactions (ADR) reports induced by edaravone injection,so as to provide reference for rational drug use. Methods Reports from Beijing Adverse Drug Reaction Monitoring Center about adverse drug reaction induced by edaravone from January 2012 to December 2016 were analyzed. Patients' age, gender, disease, primary diseases, medication regimen, occurrence time, systems involved and clinical manifestations, severity and prognosis were collected. Results A total of 93 cases of adverse drug reaction reports induced by edaravone were collected, in which 9 cases (9.68%) were serious adverse drug reactions. There were 49 cases of elderly patients, accounting for 52.69%. Clinical manifestations involved skin and appendages disorders, liver and biliary system disorders ,nervous system disorders. 67 cases(72.04%) happened from the day starting edaravone to the fifth day. 23 cases(24.73%) have off-label use in indication. 1 case(1.07%) have contraindication. 29 cases(31.18%) have overuse or underuse of edaravone. 3 cases(3.23%) have a longer treatment time than that indicated in the label. Conclusion Medication regimen should be made in accordance to indication and dosage in drug labels. Patients should be under close attention so that adverse drug reactions could be detected as soon as possible. Once adverse drug reaction occurred, strategies such as stopping the medication and treatment should be quickly undertaken.

Key words: edaravone, adverse drug reaction(ADR), medication error, pharmacovigilance

中图分类号: