基于中国医院药物警戒系统的动脉灌注奥沙利铂的 安全性特征分析.

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 1 731 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. [ABSTRACT FROM AUTHOR]