中国药物警戒 ›› 2024, Vol. 21 ›› Issue (10): 1137-1142.
DOI: 10.19803/j.1672-8629.20240139

• 安全与合理用药 • 上一篇    下一篇

141例靶向抗肿瘤口服药品不良反应分析

郭益俊1, 陈霞1,*, 孟萍2   

  1. 1南通市第一人民医院药剂科,江苏 南通 226000;
    2南通市食品药品监督检验中心,南通市药品不良反应监测中心,江苏 南通 226000
  • 收稿日期:2024-02-27 出版日期:2024-10-15 发布日期:2024-10-14
  • 通讯作者: *陈霞,女,本科,主任药师,医院药学。E-mail: cxia66@126.com
  • 作者简介:郭益俊,男,硕士,主管药师,医院药学。
  • 基金资助:
    南通市卫生健康委员会科研课题专项（MSZ2022015）

Adverse drug reaction reports in 141 cases of orally administered targeted anti-tumor drugs

GUO Yijun1, CHEN Xia1,*, MENG Ping2   

  1. 1Pharmacy Department of Nantong First People's Hospital, Nantong Jiangsu 226000, China;
    2Nantong Food and Drug Supervision and Inspection Center, Nantong Adverse Drug Reaction Monitoring Center, Nantong Jiangsu 226000, China
  • Received:2024-02-27 Online:2024-10-15 Published:2024-10-14

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摘要： 目的 研究靶向抗肿瘤口服药品不良反应（adverse drug reaction,ADR）发生特点和数量,挖掘其ADR可疑信号,为临床安全用药提供借鉴。方法 对某市药品不良反应监测中心2018年1月1日至2022年12月31日收到的141例靶向抗肿瘤药所致ADR报告中的患者年龄、性别、原患疾病、ADR发生时间、ADR严重程度及转归、ADR累及系统-器官、ADR临床表现及发生例次等进行分析,并运用报告比值比（reporting odds ratio,ROR）法挖掘ADR信号。结果 141例中共涉及23个药品,共发生164例次ADR,累及13个系统-器官。发生例次排名前3位的ADR为皮疹（28例次, 17.07%）、高血压（16例次, 9.76%）、腹泻（14例次, 8.54%）。共挖掘到8个药物的13个可疑ADR信号。其中安罗替尼的可疑信号为3个：高血压、口腔溃疡、手足综合征;阿帕替尼的可疑信号为3个：高血压、手足综合征、蛋白尿;奥希替尼的可疑信号为2个：皮疹、腹泻;阿法替尼、达可替尼、吉非替尼和伊马替尼的可疑信号均为1个：皮疹;瑞戈非尼的可疑信号为1个：腹泻。结论 在患者使用靶向抗肿瘤口服药期间,应重点监护老年人群等特殊群体;重点关注首次用药1个月内的患者;重点监测皮疹、高血压、腹泻、手足综合征、口腔溃疡、蛋白尿等ADR并做好防治工作。

关键词: 口服药物, 抗肿瘤治疗, 靶向药物, 药品不良反应, 报告分析, 信号挖掘, 报告比值比法

Abstract: Objective To study the characteristics and number of reports of oral adverse drug reaction (ADR), and to explore suspicious ADR signals, so as to provide references for clinical safe drug use. Methods Due to the research needs of the project, statistical analysis was conducted on 141 ADR reports caused by oral targeted anti-tumor drugs received by a drug adverse reaction monitoring center in a certain city from January 1, 2018 to December 31, 2022, including patient age, gender, underlying disease, ADR occurrence time, Severity and outcome of ADR, ADR involvement of system organs, ADR clinical manifestations, and occurrence cases. The reporting odds ratio (ROR) method was used to mine ADR signals. Results The 141 cases of ADR involved a total of 23 drugs, with a total of 164 ADR symptoms affecting 13 systemic organs. The top three ADR occurrences were rash (28 cases, 17.07%), hypertension (16 cases, 9.76%), and diarrhea (14 cases, 8.54%). A total of 8 suspected ADR signals related to drugs were identified. Three signals of hypertension, oral ulcers, and hand foot syndrome were identified from anlotinib. Three signals of hypertension, hand foot syndrome, and proteinuria were identified from Apatinib. Two signals of rash and diarrhea were identified from osimertinib. One signal of rash was detected from afatinib, one signal of rash was detected from dacotinib, and one signal of rash was detected from gefitinib. One signal of rash was identified from imatinib. Dig out one signal of diarrhea from Regorafenib. Conclusion During the use of oral targeted anti-tumor drugs by patients, special groups such as the elderly should be closely monitored. Focus on patients within the first month of taking medication. Focus on monitoring ADR such as rash, hypertension, diarrhea, hand foot syndrome, oral ulcers, proteinuria, and take preventive and treatment measures.

Key words: oral medication, antitumor therapy, targeted drugs, adverse drug reaction(ADR), report analysis, signal mining, ROR

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