中国药物警戒 ›› 2023, Vol. 20 ›› Issue (10): 1159-1162.
DOI: 10.19803/j.1672-8629.20230062

• 安全与合理用药 • 上一篇    下一篇

327例新的药品不良反应报告分析

张露新1, 孟璐2, 张虹2,*   

  1. 1河南中医药大学,河南 郑州 450046;
    2河南省洛阳正骨医院,河南省骨科医院,河南 洛阳 471002
  • 收稿日期:2023-02-07 出版日期:2023-10-15 发布日期:2023-10-16
  • 通讯作者: *张虹,女,主任药师·硕导,医院学科建设与药事管理。E-mail: lyzgzh2008@163.com
  • 作者简介:张露新,女,硕士,药事管理与法规。
  • 基金资助:
    2022年河南省中医药科学研究专项课题（2022ZY 1137、2022ZY2054）

Analysis of 327 reports of new adverse drug reactions

ZHANG Luxin1, MENG Lu2, ZHANG Hong2,*   

  1. 1Henan University of Traditional Chinese Medicine, Zhengzhou Henan 450046, China;
    2Henan Luoyang Bone Setting Hospital/Henan Orthopaedic Hospital, Luoyang Henan 471002, China
  • Received:2023-02-07 Online:2023-10-15 Published:2023-10-16

PDF (PC)

515

摘要： 目的 研究新的药品不良反应特点,为临床有效防范新的药品不良反应提供参考。方法 对某院2019年1月1日至2022年12月31日上报的856例药品不良反应报告中筛选出的327例新的药品不良反应报告进行分析。结果 327例新的药品不良反应中245例（74.92%）发生于41岁及以上的中老年人;药物种类中西药241例（73.70%）、中成药86例（26.30%）,导致新的药品不良反应数量前3位的药品为银杏达莫注射液、复方血栓通片、盐酸左氧氟沙星注射液;涉及药物剂型21种,前3位为注射液、粉针剂、片剂;涉及用药途径13种,以静脉滴注195例（59.63%）、口服90例（27.52%）为主;累及系统-器官以皮肤及其附件损伤为主,其次为消化系统损伤、神经系统损伤。结论 新的药品不良反应有其自身发生规律,针对性地加强新的药品不良反应监测,可以提高临床合理用药水平,有效规避用药风险。

关键词: 新的药品不良反应, 特点, 银杏达莫注射液, 复方血栓通片, 盐酸左氧氟沙星注射液, 皮肤及其附件损伤, 消化系统损伤, 神经系统损伤

Abstract: Objective To study the characteristics of new adverse drug reactions so as to provide reference for effective prevention of new adverse drug reactions. Methods Three hundred and twenty-seven reports of new adverse drug reactions were screened from 856 reports submitted by a hospital between 2019 and 2022. Results Among the 327 new ADR, 245 cases (74.92%) involved people aged 41 or older. In terms of types of drugs, 241 cases (73.70%) were associated with Western drugs and 86 cases (26.30%) with proprietary Chinese medicines. The top three drugs responsible for new ADR were Ginkgo Biloba injection, compound thromboxane tablets, and levofloxacin hydrochloride injection. There were twenty-one drug dosage forms involved, and the top three were injection, powder injection and tablets. Thirteen routes of administration were involved, including 195 cases of intravenous injection (59.63%) and 90 cases of oral administration (27.52%). The systems-organs involved were mainly skin and its accessory injury, followed by injuries to the digestive system and nervous system. Conclusion New adverse drug reactions have their own patterns of occurrence, and targeted monitoring of new adverse drug reactions can improve the level of rational clinical use of drugs and effectively avoid the risk that arises from drug use.

Key words: new adverse drug reactions, characteristic, Ginkgo Biloba injection, compound thromboxane tablets, levofloxacin hydrochloride injection, skin and its accessory injury, digestive system injury, nervous system injury

中图分类号: