中国药物警戒 ›› 2022, Vol. 19 ›› Issue (3): 287-291.
DOI: 10.19803/j.1672-8629.2022.03.12

• 安全与合理用药 • 上一篇    下一篇

162例注射用奥美拉唑钠不良反应报告分析

张茜1, 李鹏飞1, 赵杰2, 刘丽宏1,*   

  1. 1首都医科大学附属北京朝阳医院药事部,北京 100020;
    2北京市药品不良反应监测中心, 北京 100000
  • 收稿日期:2020-08-21 出版日期:2022-03-15 发布日期:2022-03-16
  • 通讯作者: *刘丽宏,女,博士,主任药师,分子药理学。E-mail：hongllh@126.com
  • 作者简介:张茜,女,硕士,主管药师,临床药学。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017ZX09101001-002-045）

162 reports of adverse drug reactions induced by omeprazole sodium for injection

ZHANG Xi1, LI Pengfei1, ZHAO Jie2, LIU Lihong1,*   

  1. 1Department of Pharmacy, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100020, China;
    2Beijing ADR Monitoring Center, Beijing 100000, China
  • Received:2020-08-21 Online:2022-03-15 Published:2022-03-16

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摘要： 目的 分析注射用奥美拉唑钠药品不良反应（ADR）发生特点,为临床合理用药提供依据。方法 收集2015年1月1日至2020年3月31日国家药品不良反应监测系统中北京市收集到疑似注射用奥美拉唑钠ADR/事件报告共162例。将报告中的字段进行规范,利用世界卫生组织（WHO）药品不良反应术语集对ADR 症状进行提取。采用回顾性分析方法,对病例报告中患者性别、年龄、ADR累及系统- 器官、ADR发生时间、药物配制、给药途径、给药剂量、联合用药、ADR严重程度及转归情况进行分析。结果 60岁以上老年患者ADR病例报告数较高,共有82例,占50.62%。注射用奥美拉唑钠ADR/事件主要表现为皮疹、转氨酶升高、瘙痒、寒战等,其中皮肤及其附件损害（32.18%）、全身性损害（14.37%）占比较高,且多于输液开始或用药初期出现;肝胆系统损害占比为13.79%,多于用药数天后发生。病例报告中存在多例用药不合理及超说明书用药情况。结论 临床应加强注射用奥美拉唑钠用药管理,对用药过程严密监测,减少ADR 发生。生产企业应及时修订和完善药品说明书安全性信息,确保患者用药安全。

关键词: 注射用奥美拉唑钠, 药品不良反应, 安全性分析, 病例报告

Abstract: Objective To study the features of adverse drug reactions (ADR) induced by omeprazole sodium injection, and provide a basis rational usage of drugs in clinic. Methods 162 cases of ADR reports caused by omeprazole sodium injection were collected from January 1, 2015 to March 31, 2020 from Beijing ADR monitoring system. The field in each case report was standardized, and the ADR symptoms were extracted and standardized by WHO adverse reaction terminology. In addition, genders, ages, and ADR involved organs/systems, adverse reaction time, drug dispensing, administration route, dosage of administration, drug combination, severity and outcome of adverse reactions in ADR were retrospectively analyzed. Results 82 patients over 60 years old were reported to have ADR, accounting for 50.62% of all cases reported. Adverse reactions/events related to omeprazole sodium injection were mainly rashes, elevated transaminases, pruritus, chills, etc. to the percentage of skin damage (32.18%) and systemic damage (14.37%) were relatively high. Most of these adverse reactions occurred in the initial stage of drug administration. Hepatobiliary system damage accounted for 13.79%. Such adverse reactions usually occurred after a few days of drug administration. There were many cases of unreasonable drug usage and off-label drug usage. Conclusion Clinical management of omeprazole sodium injection should be strengthened, and the process of drug administration should be closely observed to reduce the occurrence of ADR. Production enterprises should promptly revise and improve the safety information of drug instructions to ensure the safety of drug usage for patients.

Key words: omeprazole sodium for injection, adverse drug reaction, safety analysis, case report

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