基于案例分析和FAERS数据库挖掘的长春新碱/强的松药品不良反应风险信号研究  

The Development of Liver Toxicity as well as the Abnormal Lipid Met abolism after Therapy with Prednisone and Vincristine

作　　者：宋颖 王幼鸿 吴秀萍 SONG Ying;WANG You-hong;WU Xiu-ping(Department of Pharmacy,Xiamen Children′s Hospital(Children′s Hospital of Fudan University at Xiamen),Xiamen 361006,China)

机构地区：[1]厦门市儿童医院(复旦大学附属儿科医院厦门医院)药学部,福建厦门361006

出　　处：《海峡药学》2024年第9期101-104,共4页Strait Pharmaceutical Journal

基　　金：厦门市自然科学基金项目(No.3502Z20227145);国家自然科学基金项目(No.82204535)。

摘　　要：目的探讨长春新碱/强的松与肝损伤、脂代谢异常发生风险的相关性。方法基于案例与FAERS数据库,采用关联性分级评价标准及Logistics回归法分析。结果强的松、长春新碱联合用药增加儿童患者肝损伤(ROR=2.109,P=0.000)风险信号、单用长春新碱的患者发生脂代谢异常的风险信号较强的松低(ROR=0.347,P=0.000)。结论强的松联合长春新碱增加儿童患者肝损伤风险信号。OBJECTIVE To investigate the risk factors for the development o f liver toxicity as well as the abnormal lipid metabolism after therapy with pre dnisone and vincristine.METHODS Adverse event associated with cholesterol and transaminases levels was classified and graded by Common Termino logy Criteria for Adverse Events(CTCAE)Version 6.0.We obtained the adverse e vent reports and medication error reports using FDA Adverse Event Reporting Syst em(FAERS).Multivariate Logistic regression was performed to determine the asso ciation between vincristine/prednisone and liver toxicity as well as the abnorma l lipid metabolism.RESULTS Combination of vincristine and pred nisone had a 2-fold increased risk of liver injury(OR=2.109,P=0.000)in children.Compared with prednisone,vincristine had a lower risk o f abnormal lipid metabolism(OR=0.347,P=0.000).C ONCLUSION When vincristine is used in combination with prednisone,chil dren may experience serious liver injury.

关 键 词：长春新碱 强的松 转氨酶 高胆固醇血症 FAERS数据库 

分 类 号：R969.3[医药卫生—药理学]