苯溴马隆与药物性肝损伤的获益-风险分析和思考

doi:10.19803/j.1672-8629.2022.02.16

摘要/Abstract

摘要： 目的分析苯溴马隆引起药物性肝损伤的获益风险,为其安全使用提供参考。方法对国家药品不良反应监测数据库（建库至2020年6月30日）和乌普萨拉监测中心数据库中（建库至2020年8月9日）苯溴马隆相关肝损伤报告及相关文献进行整理与分析。结果 2个数据库共收到来自真实世界的苯溴马隆不良反应自发报告874份,均检索到药物性肝损伤,患者多为18~64岁的男性,不良反应描述主要为肝功能异常、氨基转移酶升高等,国内患者转归结果良好。结论苯溴马隆存在导致药物性肝损伤的风险,应加强干预和肝功能生化指标监测,避免严重药物性肝损伤的发生。

关键词: 苯溴马隆, 药物性肝损伤, 不良反应监测, 获益-风险

Abstract: Objective To analyze the benefit-risk of DILI caused by benzbromarone and to provide reference for its safe use. Methods The adverse reactions to benzbromarone recorded in the National ADR Database from building to June 30, 2020 and the UMC database from building to August 9, 2020 and related literature were collected and analyzed. Results A total of 874 reports of DILI were retrieved from spontaneous reports of adverse reactions to benzbromarone received from the real world in both domestic and international adverse reaction monitoring databases. Patients were mostly males aged 18 to 64. Adverse reactions were mostly described as abnormal liver function and elevated aminotransferase. The outcome of domestic patients was good. Conclusion There is the risk of DILI from benzbromarone. Strengthening intervention and monitoring of liver function can effectively help prevent serious DILI.

Key words: benzbromarone, drug-related liver injury, ADR monitoring, benefit-risk

中图分类号:

R994.11

王轶, 任经天. 苯溴马隆与药物性肝损伤的获益-风险分析和思考[J]. 中国药物警戒, 2022, 19(2): 189-192.

WANG Yi, REN Jingtian. Evaluation and significance of benefit-risk analysis of benzbromarone-induced liver injury[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 189-192.

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