中国药物警戒 ›› 2025, Vol. 22 ›› Issue (6): 645-648.
DOI: 10.19803/j.1672-8629.20240799

• 安全与合理用药 • 上一篇    下一篇

983例奥沙利铂不良反应报告分析

赵玉芳1,2, 世伟3, 杨胜男1,2, 刘治恩1,2, 雷雯朴1,2, 张亚男1,2, 赵科1,2, 郭浩1,2*   

  1. 1内蒙古自治区人民医院药学处,内蒙古 呼和浩特 010017;
    2内蒙古自治区基本药物监测与临床综合评价中心,内蒙古 呼和浩特 010017;
    3内蒙古自治区药物警戒中心,内蒙古 呼和浩特 010010
  • 收稿日期:2024-10-17 发布日期:2025-06-18
  • 通讯作者: *郭浩,男,博士,副主任药师,循证药学。E-mail: guohao851@163.com
  • 作者简介:赵玉芳,女, 硕士,主管药师,医院药学。
  • 基金资助:
    中国研究型医院药学专项课题项目（Y2024FH-YWPJ02）

983 Adverse Reaction Reports of Oxaliplatin

ZHAO Yufang1,2, SHI Wei3, YANG Shengnan1,2, LIU Zhien1,2, LEI Wenpu1,2, ZHANG Yanan1,2, ZHAO Ke1,2, GUO Hao1,2*   

  1. 1Department of Pharmacy, Inner Mongolia Autonomous Region People’s Hospital, Hohhot Inner Mongolia 010017, China;
    2Center for Essential Medicine Monitoring and Clinical Comprehensive Evaluation of Inner Mongolia Autonomous Region, Hohhot Inner Mongolia 010017, China;
    3Center for Pharmacovigilance of Inner Mongolia Autonomous Region, Hohhot Inner Mongolia 010010, China
  • Received:2024-10-17 Published:2025-06-18

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摘要： 目的 分析奥沙利铂不良反应特征,为临床安全用药提供参考。方法 收集某省2022年1月1日至2023年12月31日上报至国家药品不良反应监测系统的奥沙利铂不良反应（ADR）病例报告,利用比值失衡测量法中的报告比值比（ROR）法与英国药品和健康产品管理局（MHRA）的综合标准法进行信号挖掘并分析。结果 983例奥沙利铂ADR报告中,患者年龄主要集中在45~65岁,大部分ADR发生在用药24 h内,严重ADR 275例（27.98%）。阳性信号累及9个系统-器官（SOC）,ADR报告频数前3位的首选术语（PT）依次为恶心、呕吐和骨髓抑制;信号强度前3位的PT依次为多汗、呼吸困难和瘙痒。结论 奥沙利铂发生严重ADR和明显影响原疾病ADR的概率较低,但在输注过程中或结束后,出现的多汗、呼吸困难及瘙痒等应引起特别警惕,鉴别是否属于过敏反应并及时干预。

关键词: 奥沙利铂, 恶心, 呕吐, 骨髓抑制, 多汗, 呼吸困难, 瘙痒, 药品不良反应

Abstract: Objective To analyze the characteristics of adverse reactions caused by oxaliplatin in order to provide a reference for clinical safe drug use. Methods The ADR of oxaliplatin reported to the National Adverse Drug Reaction Monitoring System by a province between 2022 and 2023 were collected before signals were mined and analyzed using the reported odds ratio (ROR) method and the Medicines and Healthcare Products Regulatory Agency (MHRA) method. Results According to the 983 ADR reports of oxaliplatin, the age of the patients mostly ranged from 45 to 65, and most of the ADR occurred within 24 hours of medication. There were 275 cases (27.98%) serious ADR. The positive signals involved 9 systems-organs (SOC), and the top three preferred terms (PTs) were nausea, vomiting and bone marrow suppression. The top three PT signals were hyperhidrosis, dyspnea and itching. Conclusion Oxaliplatin has little chance of causing serious ADR or obvious ADR that affect preexisting diseases, but during or after infusion, hyperhidrosis, dyspnea and itching deserve special attention. There is the need to find out whether the ADR are allergies in order to offer quick interventions.

Key words: Oxaliplatin, Nausea, Vomiting, Bone Marrow Suppression, Hyperhidrosis, Dyspnea, Itching, Adverse Drug Reaction

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