中国药物警戒 ›› 2023, Vol. 20 ›› Issue (11): 1273-1278.
DOI: 10.19803/j.1672-8629.20230204

• 安全与合理用药 • 上一篇    下一篇

2018~2022年某院新型抗肿瘤药物消化系统不良反应分析

姚鑫1, 葛秋格1, 李亚敏1, 王一帆1, 李媛媛2, 刘志强2,*   

  1. 1济源市人民医院药剂科,河南 济源 459000;
    2河南理工大学医学院,河南 焦作 454000
  • 收稿日期:2023-04-10 出版日期:2023-11-15 发布日期:2023-11-13
  • 通讯作者: *刘志强,男,博士,副教授,医学。E-mail:zqliu@hpu.edu.cn
  • 作者简介:姚鑫,女,硕士,主管药师,临床药学。
  • 基金资助:
    国家自然科学基金资助项目(82100745); 河南省科技攻关计划项目(212102310642); 河南省高校基本科研业务费专项资金资助(NSFRF210320)

Adverse drug reactions caused by new anti-tumor drugs from 2018 to 2022 in one hospital

YAO Xin1, GE Qiuge1, LI Yamin1, WANG Yifan1, LI Yuanyuan2, LIU Zhiqiang2,*   

  1. 1Department of Pharmacy, People’s Hospital of Jiyuan, Jiyuan Henan 459000, China;
    2School of Medicine, Henan Polytechnic University, Jiaozuo Henan 454000, China
  • Received:2023-04-10 Online:2023-11-15 Published:2023-11-13

摘要: 目的 为新型抗肿瘤药品不良反应(ADR)监测以及针对消化系统ADR提供风险信号预警和药学监护的参考依据。方法 对2018年1月1日至2022年12月31日济源市人民医院上传至国家药品不良反应监测中心的91例新型抗肿瘤药物ADR报告,按照患者年龄、性别、体重指数(BMI)、原发疾病、ADR累及系统-器官、合并用药和转归等维度进行回顾性统计分析。结果 新型抗肿瘤药物ADR主要累及系统-器官为皮肤及其附属系统32例(35.16%),消化系统20例(21.98%);消化系统ADR临床表现以腹泻(25.00%)最为常见。多元Logistic回归方法显示消化系统ADR的独立危险因素是合并用药和低BMI,其中免疫检查点抑制剂相关消化系统ADR转归时间较长(2周~1个月)。结论 临床应关注合并用药和低BMI患者的新型抗肿瘤药物ADR监测工作,针对免疫检查点抑制剂不良反应处理进行药学监护。

关键词: 新型抗肿瘤药物, 药品不良反应, 危险因素, 联合用药, 药学监护, 消化系统, 免疫检查点抑制剂

Abstract: Objective To provide data for the monitoring of adverse drug reactions (ADR) induced by new anti-tumor drugs and for early warning of danger signals and pharmaceutical monitoring of ADR. Methods Ninety-one reports of ADR of new anti-tumor drugs submitted to the National Adverse Drug Reaction Monitoring Center by Jiyuan People’s Hospital between 2018 and 2022 were retrospectively analyzed according to the patients’ age, gender, BMI, primary diseases, systems-organs involved, usage of drugs and outcomes. Results ADR of new anti-tumor drugs mainly affected the skin and its accessory systems in 32 cases (35.16%), and the digestive system in 20 cases (21.98%), with diarrhea (25.00%)as the most common type of ADR in the digestive system. Multiple logistic regression analysis showed that the independent risk factors for ADR of the digestive system were lower BMI and concomitant medication. Patients with ADR of the digestive system related to immune checkpoint inhibitors took a longer time to recover (2 weeks to 1 month). Conclusion Clinical pharmacists are to be alert to ADR of new anti-tumor drugs among patients under concomitant medication or with lower BMI and manage adverse reactions caused by immune checkpoint inhibitors.

Key words: new anti-tumor drugs, adverse drug reactions, risk factors, concomitant medication, pharmaceutical care, digestive system, immune checkpoint inhibitors

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