摘要
目的:利用中国医院药物警戒系统(CHPS),评估动脉灌注奥沙利铂的安全性情况,分析发生不良反应的影响因素。方法:依托CHPS系统,对2021年1月至2023年6月某三级甲等医院使用奥沙利铂的人群进行回顾性分析。比较静脉滴注与动脉灌注奥沙利铂人群的特征,从血液系统毒性、肝毒性、肾毒性、神经毒性4个方面比较两种给药方式下的不良反应发生率,对不良反应发生率最高的肝毒性进行影响因素分析。结果:回顾性监测了1731例使用奥沙利铂的患者,其中动脉灌注810例,静脉滴注921例。动脉灌注奥沙利铂的患者血小板减少、肝损伤的发生率高于静脉滴注奥沙利铂的患者,差异均有统计学意义(P<0.05)。多因素Logistic回归分析显示,剂量增加、原发疾病为肝癌的人群是动脉灌注奥沙利铂导致肝损伤的独立影响因素。结论:动脉灌注奥沙利铂需重点关注血小板减少及肝损伤的风险。针对肝癌患者,控制给药剂量有助于降低奥沙利铂临床用药风险。CHPS系统对监护真实世界的用药情况有重要意义。
OBJECTIVE:To explore the safety of arterial infusion of oxaliplatin and analyze the risk factors of adverse drug reactions based on Chinese Hospital Pharmacovigilance System(CHPS).METHODS:According to the CHPS,retrospective analysis was performed on patients with oxaliplatin in a Grade Ⅲ,Level A hospital from Jan.2021 to Jun.2023.Characteristics of populations with intravenous drip and arterial infusion of oxaliplatin were compared.The incidence of adverse drug reactions was compared from four aspects:hematological toxicity,hepatotoxicity,nephrotoxicity and neurotoxicity.The influential factors of hepatotoxicity with the highest incidence of adverse drug reactions were analyzed.RESULTS:Totally 1731 cases of oxaliplatin were analyzed retrospectively,including 810 cases in artery infusion group,and 921 cases in intravenous drip infusion group.The incidence of thrombocytopenia and liver injury in patients with arterial infusion of oxaliplatin was higher than that in patients with intravenous drip of oxaliplatin,the differences were statistically significant(P<0.05).Multivariate Logistic regression analysis showed that dose increase and primary disease of liver cancer were independent factors of liver injury induced by arterial infusion of oxaliplatin.CONCLUSIONS:Artery infusion of oxaliplatin need to be focused on the risk of thrombocytopenia and liver injury.For patients with liver cancer,controlling the dose of oxaliplatin is helpful to reduce the risk of clinical use.The CHPS systems are important for monitoring real-world drug use.
作者
董思喆
覃忠于
蓝晓步
DONG Sizhe;QIN Zhongyu;LAN Xiaobu(Dept.of Pharmacy,the First People’s Hospital of Nanning,Nanning 530022,China;Guangxi Adverse Drug Reaction Monitoring Center,Nanning 530029,China)
出处
《中国医院用药评价与分析》
2024年第9期1145-1148,共4页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
广西药品安全科研项目(No.桂药科〔2022〕自选10号)。
关键词
奥沙利铂
中国医院药物警戒系统
动脉灌注化疗
药物安全性
Oxaliplatin
Chinese Hospital Pharmacovigilance System
Transcatheter arterial infusion
Drug safety
