44例抗肿瘤药物严重药品不良反应报告分析

Analysis in reports of 44 serious adverse drug reaction cases induced by antineoplastic drugs

目的分析海口地区抗肿瘤药物严重药品不良反应(ADR)的特点,为抗肿瘤药物的安全性再评价提供科学依据。方法检索2017—2019年海口市ADR监测中心接收的抗肿瘤药物严重ADR报告信息,分析抗肿瘤药物严重ADR的特点。结果2017—2019年,海口地区抗肿瘤药物严重ADR报告数呈逐年上升趋势;44例严重ADR报告显示,患者性别分布均衡,ADR主要发生于年龄≥60岁患者;严重ADR最主要的给药途径为静脉滴注,且多在用药1 h内发生;44例严重ADR共涉及8类26个品种抗肿瘤药(其中金属铂类药物比率最高),严重ADR主要为过敏性休克、严重过敏样反应、骨髓抑制及高热等;44例严重ADR中,21例为药品说明书上未载明的新的ADR。结论临床医生应熟知抗肿瘤药物的ADR和联合用药原则,充分做好严重ADR的应对措施,以最大程度保护患者的生命安全。

Objective To analyze the characteristics of serious adverse drug reactions(ADR)associated with antineoplastic drugs in Haikou area,and provide scientific basis for the safety re-evaluation of antineoplastic drugs.Methods Serious ADR reports induced by antineoplastic drugs occurred in ADR Monitoring Center in Haikou City from 2017 to 2019 were retrieved,characteristics of ADR induced by antineoplastic drugs were analyzed.Results The number of serious ADR reports induced by antineoplastic drugs in Haikou area was increased from 2017 to 2019.Serious ADR reports of 44 cases showed that the sex ratio was balanced,ADR usually concentrated in patients aged≥60 years by way of intravenous administration,and mainly occurred within 1 h after medication.There were 8 categories of antineoplastic drugs with a total of 26 types in the 44 ADR reports,in which the top one category was platinum antineoplastic drugs.The main adverse reactions caused by antineoplastic drugs were anaphylactic shock,severe anaphylactic reaction,myelosuppression,high fever and so on.There were 21 patients with new and serious ADR unrecorded in medicine specification.Conclusion It is necessary to know the ADR of antineoplastic drugs and principles of combined medication in clinical practice for physicians,and take adequate measures to deal with ADS,so as to protect the safety and health of the patients.