首页|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

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

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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.
The Development of Liver Toxicity as well as the Abnormal Lipid Metabo-lism after Therapy with Prednisone and Vincristine
OBJECTIVE To investigate the risk factors for the development of liver toxicity as well as the ab-normal lipid metabolism after therapy with prednisone and vincristine.METHODS Adverse event associated with cholesterol and transaminases levels was classified and graded by Common Terminology Criteria for Adverse Events(CTCAE)Version 6.0.We obtained the adverse event reports and medication error reports using FDA Adverse E-vent Reporting System(FAERS).Multivariate Logistic regression was performed to determine the association between vincristine/prednisone and liver toxicity as well as the abnormal lipid metabolism.RESULTS Combination of vin-cristine and prednisone 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 of abnormal lipid metabolism(OR=0.347,P=0.000).CONCLU-SION When vincristine is used in combination with prednisone,children may experience serious liver injury.

VincristinePrednisoneTransaminaseHypercholesterolemiaFAERS database

宋颖、王幼鸿、吴秀萍

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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

长春新碱 强的松 转氨酶 高胆固醇血症 FAERS数据库

厦门市自然科学基金项目国家自然科学基金项目

3502Z2022714582204535

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(9)