211例新型抗肿瘤药品不良反应报告分析

doi:10.19803/j.1672-8629.20241003

摘要/Abstract

摘要： 目的回顾性分析新型抗肿瘤药品不良反应（ADR）报告,为临床安全用药提供参考。方法提取2022年1月1日至2024年10月31日医院上报的新型抗肿瘤药物ADR报告,分析患者基本特征、药品类别、累及系统-器官、主要临床表现、超说明书用药。结果 211例ADR报告中,男女比例为1.03∶1,60岁以上患者占70.62%。一般ADR报告106例（50.24%）,严重ADR报告105例（49.76%）。累及系统-器官最多为血液系统及造血系统,共129例（61.14%）。超说明书用药相关ADR报告18例,严重报告13例（72.22%）。结论新型抗肿瘤药物ADR报告中严重报告比例较高,临床应尽早识别干预;医疗机构需加强其超说明书用药管理,确保患者用药安全。

关键词: 新型抗肿瘤药物, 免疫检查点抑制剂, 药品不良反应, 免疫相关不良事件, 血液系统, 造血系统

Abstract: Objective To analyze reports of adverse drug reactions (ADR) caused by new antineoplastic drugs in a hospital in order to provide a reference for safe clinical use of drugs. Methods ADR reports related to new antineoplastic drugs submitted by a hospital between January 1, 2022 and October 31, 2024 were retrieved. The demographic data of patients, categories of drugs, affected systems and organs, clinical manifestations and off-label drug use were analyzed. Results Among the patients involved in the 211 ADR reports, the male-to-female ratio was 1.03∶1, and those over 60 years old accounted for 70.62%. There were 106 reports of mild cases (50.24%) and 105 reports of severe ones (49.76%). The blood system and hematopoietic system were the most frequently involved, accounting for 61.14% (129 cases). There were 18 ADR reports related to off-label drug use, including 13 severe cases (72.22%). Conclusion The proportion of reports of severe cases among ADR reports caused by new antineoplastic drugs is relatively high, pointing to the need for early clinical identification and intervention. It is imperative for medical institutions to enhance the regulation of off-label drug use in order to ensure patients’ safety.

Key words: New Antineoplastic Drugs, Immune Checkpoint Inhibitor, Adverse Drug Reaction, Immune-Related Adverse Events, Blood System, Hematologic System

中图分类号:

R951
R994.11

谢加力, 荀艳, 陶云松, 章圣朋. 211例新型抗肿瘤药品不良反应报告分析[J]. 中国药物警戒, 2025, 22(9): 1029-1033.

XIE Jiali, XUN Yan, TAO Yunsong, ZHANG Shengpeng. 211 Reports of Adverse Drug Reactions Induced by New Antineoplastic Drugs[J]. Chinese Journal of Pharmacovigilance, 2025, 22(9): 1029-1033.

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