中国药物警戒 ›› 2025, Vol. 22 ›› Issue (12): 1399-1403.
DOI: 10.19803/j.1672-8629.20250511

• 安全与合理用药 • 上一篇    下一篇

470例新的和严重的抗肿瘤药不良反应报告分析

杨佳丽1, 董心仪2, 黄焕均1, 陈浩云1, 钟陆华1, 张云惠1, 张文茜2, 曹怀瑾2, 梁蔚婷1*   

  1. 1中山大学肿瘤防治中心药学部,华南恶性肿瘤防治全国重点实验室,广东省恶性肿瘤临床医学研究中心,广东 广州 510060;
    2中山大学药学院,广东 广州 510006
  • 收稿日期:2025-08-01 发布日期:2025-12-19
  • 通讯作者: *梁蔚婷,女,硕士,副主任药师,抗肿瘤药物临床研究。E-mail: liangwt@sysucc.org.cn
  • 作者简介:杨佳丽,女,本科,静脉用药配置。
  • 基金资助:
    白求恩“2024耀动神州-药学科研能力建设基金”项目（Z04J2023E095）

470 Reports of New and Serious Adverse Drug Reactions Induced by Antineoplastic Drugs

YANG Jiali1, DONG Xinyi2, HUANG Huanjun1, CHEN Haoyun1, ZHONG Luhua1, ZHANG Yunhui1, ZHANG Wenqian2, CAO Huaijin2, LIANG Weiting1*   

  1. 1State Key Laboratory of Oncology in South China, Department of Pharmacy, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-Sen University Cancer Center, Guangzhou Guangdong 510060, China;
    2School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou Guangdong 510006, China
  • Received:2025-08-01 Published:2025-12-19

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摘要： 目的 探讨新的和严重的抗肿瘤药不良反应（ADR）,为临床用药安全提供参考。方法 收集2022年1月1日至2024年12月31日某院新的和严重的抗肿瘤药ADR报告共470例,并对报告类型及关联性,患者性别、年龄、原患疾病、给药途径,ADR发生时间、转归、怀疑用药、临床表现进行分析。结果 470例报告中,新的ADR 173例（36.81%）,其中新的一般的ADR 132例,新的严重的ADR 41例;严重的ADR 297例（63.19%）。ADR发生率男性略高于女性,不同年龄段的性别分布有差异,高发年龄主要集中在51~70岁。给药途径以静脉滴注为主（587例次,82.10%）。报告中发生在给药后1 d内的ADR有245例（52.13%）,转归结果为好转及痊愈的ADR共440例（93.62%）。涉及怀疑药品共715个,涉及63个品种,其中新型抗肿瘤药物共144个（20.14%）,涉及30个品种,传统抗肿瘤药物共571个（79.86%）,涉及33个品种,以铂类占比最多,共213个（37.3%）。新的ADR主要累及系统-器官是全身性疾病及给药部位各种反应,主要临床表现为胸闷（34例次）;严重ADR主要累及系统-器官系统是血液及淋巴系统疾病,主要的临床表现为中性粒细胞减少（122例次）。结论 新的和严重的ADR与患者的性别年龄、原患疾病、给药途径及怀疑用药相关,对于易发生新的和严重的ADR的患者和药品临床应密切关注。

关键词: 抗肿瘤药, 新的药品不良反应, 严重药品不良反应, 安全用药, 输液反应, 老年患者

Abstract: Objective To analyze the characteristics of new and serious adverse drug reactions (ADR) associated with antineoplastic agents, and to provide a reference for safe medication. Methods A total of 470 reports of new and serious ADR associated with antineoplastic agents were collected from a hospital in 2022-2024. The types of reports, causality assessments, gender of patients, age, primary diseases, routes of administration, time to ADR onset, outcomes, suspected drugs, and clinical manifestations were statistically analyzed. Results Among the 470 cases, 173 (36.81%) were new ADR, including 132 new and mild ADR and 41 that were both new and serious. There were 297 (63.19%) cases of serious ADR. The incidence of ADR was slightly higher in males than in females, with gender distribution varying across age-groups. The highest incidence occurred in the group ages 51 to 70. Intravenous infusion was the most common route of administration (587 instances, 82.10%). There were 245 reported cases of ADR (52.13%) that had occurred within one day of drug administration, and a total of 440 cases of ADR (93.62%) improved and completely recovered. A total of 715 suspected drugs involving 63 varieties were reported, including 144 (20.14%) novel antineoplastic drugs of 30 varieties, and 571 (79.86%) traditional antineoplastic drugs of 33 varieties. Platinum-based agents were the most frequently involved (213, 37.3%). The most commonly affected organs and systems by new ADR were systemic disorders and conditions at administration sites, with chest tightness being the predominant clinical manifestation (34 instances). For serious ADR, the most frequently affected systems were blood and lymphatic system disorders, with neutropenia as the main clinical presentation (122 instances). Conclusion New and serious ADR are associated with patients’ gender, age, underlying diseases, routes of administration, and suspected medications. Close monitoring is recommended for patients prone to such ADR in clinical practice.

Key words: Antineoplastic Agents, New Adverse Drug Reaction, Serious Adverse Drug Reaction, Medication Safety, Infusion Reaction, Elderly Patients

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