中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 441-443.
DOI: 10.19803/j.1672-8629.20220007

• 安全与合理用药 • 上一篇    下一篇

基于医疗机构信息系统的卡培他滨致手足综合征不良反应主动监测

郑宇静1, 赵紫楠1, 金鹏飞1, 赵飞2, 胡欣1, 张亚同1,*   

  1. 1北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室,北京 100730;
    2北京医院临床试验研究中心,北京 100730
  • 收稿日期:2022-02-11 出版日期:2023-04-15 发布日期:2023-04-20
  • 通讯作者: *张亚同,男,硕士,副主任药师,临床药学和风险管理。E-mail: zyt2002888@foxmail.com
  • 作者简介:郑宇静,女,本科,主管药师,医院药学。
  • 基金资助:
    国家重点研发计划（2020YFC2009001）

Active monitoring of adverse reactions of capecitabine-induced hand-foot syndrome based on the hospital information system

ZHENG Yujing1, ZHAO Zinan1, JIN Pengfei1, ZHAO Fei2, HU Xin1, ZHANG Yatong1,*   

  1. 1Department of Pharmacy, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Science, Beijing Key Laboratory of Assessment for Clinical Risk and Individual Application of Drugs, Beijing 100730, China;
    2Clinical Trial Center, Beijing Hospital, Beijing 100730, China
  • Received:2022-02-11 Online:2023-04-15 Published:2023-04-20

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摘要： 目的 探索卡培他滨致手足综合征主动监测方法。方法 对2020年10月1日至2021年9月30日北京医院住院并使用卡培他滨的患者进行回顾性风险信号挖掘。对可疑卡培他滨致手足综合征病例进行人工因果关系评价与筛选,并对获得的卡培他滨致手足综合征阳性病例的临床特点、治疗药物、处理及转归进行分析。结果 设定时间内共有257例住院患者使用了卡培他滨,经主动监测系统的信号挖掘,检出35例患者存在手足综合征的风险信号。通过人工筛选及因果关系评价,最终得到卡培他滨致相关性药源性手足综合征患者14例。卡培他滨致手足综合征发生率为5.45%,主动监测系统识别正确率为40.0%。结论 主动监测可有效提高药品不良反应监测的敏感性,早期发现轻症不良反应。

关键词: 卡培他滨, 手足综合征, 主动监测, 风险信号, 药品不良反应, 医疗机构信息系统

Abstract: Objective To explore active monitoring methods of capecitabine-induced hand-foot syndrome. Methods Retrospective risk signal mining was performed on patients who had been hospitalized in Beijing Hospital and taken capecitabine between October 1, 2020 and September 30, 2021 using the PASS ADR. Manual causality evaluation and screening were performed on suspected cases of capecitabine-induced hand-foot syndrome, and the clinical characteristics, therapeutic drugs, treatments and outcomes of the positive cases of capecitabine-induced hand-foot syndrome were analyzed. Results A total of 257 inpatients were treated with capecitabine in the course of monitoring, 35 of whom had risk signals of hand-foot syndrome detected through PASS ADR. Through manual screening and causality evaluation, 14 patients with capecitabine-related drug-induced hand-foot syndrome were finally obtained. The incidence of capecitabine-induced hand-foot syndrome was 5.45%, and the correct rate of identification by the active monitoring system was 40.0%. Conclusion Active monitoring can effectively improve the sensitivity of ADR monitoring and early detection of mild adverse reactions.

Key words: capecitabine, hand-foot syndrome, active monitoring, risk signal, adverse drug reaction, medical institution information system

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