84例新型抗肿瘤药品不良反应报告分析

doi:10.19803/j.1672-8629.20220188

摘要/Abstract

摘要： 目的研究我院新型抗肿瘤药物引起的药品不良反应（adverse drug reaction, ADR）发生特点及规律,为临床合理用药提供参考。方法收集我院 2020年1月1日至2021年12月31日上报至国家药品不良反应监测系统的新型抗肿瘤药物ADR,对 ADR 类型、患者年龄和疾病类型、药品种类、累及系统-器官、严重 ADR 的主要药品及临床表现等方面进行分析。结果 84例新型抗肿瘤药物ADR中,中老年患者居多;累及系统-器官主要是消化系统和皮肤及其附件系统;严重ADR占比34.52%。9例患者存在超说明书用药的问题。结论临床医师和药师应重视新型抗肿瘤药物致ADR,加强患者药学监护,为临床用药安全以及药品上市后再评价提供参考依据。

关键词: 药品不良反应, 新型抗肿瘤药, 靶向药物, 免疫检查点抑制剂, 药学监护

Abstract: Objective To analyze the characteristics and regularity of adverse drug reactions (ADR) caused by novel anti-tumor drugs in Anhui Chest Hospital so as to provide reference for rational use of drugs. Methods A total of 84 cases of ADR of novel anti-tumor drugs reported by our hospital to the national ADR Monitoring System from January 1, 2020 to December 31, 2021 were collected. These ADR were analyzed in terms of types, age and diseases of patients, types of drugs used, organs and/or systems involved, main drugs and clinical manifestations of severe ADR. Results Most of these patients were middle-aged and elderly ones (≥45 years old). The organs and/or systems at the highest risk of ADR were the digestive system and the skin and its accessory system. 34.52% of the cases were serious ADR and there were 9 cases of off-label drug use. Conclusion Clinicians and pharmacists should be alert to ADR caused by novel anti-tumor drugs, and the course of medication should be rigorously monitored so as to provide data for clinical drug safety and re-evaluation of drugs after marketing.

Key words: adverse drug reaction, novel anti-tumor drugs, targeted medicine, immunocheckpoint inhibitor, pharmaceutical care

中图分类号:

R994.11

杨岩, 周德喜, 吴欣俐, 薛淑雅, 丁海华, 张泉, 张云玲. 84例新型抗肿瘤药品不良反应报告分析[J]. 中国药物警戒, 2023, 20(3): 334-338.

YANG Yan, ZHOU Dexi, WU Xinli, XUE Shuya, DING Haihua, ZHANG Quan, ZHANG Yunling. Eighty-four cases of adverse drug reactions caused by novel anti-tumor drugs[J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 334-338.

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