基于美国FAERS数据库的拉米夫定肾脏及泌尿系统不良事件信号挖掘

doi:10.19803/j.1672-8629.20230666

摘要/Abstract

摘要： 目的利用美国食品药品监督管理局不良事件报告系统（FAERS）挖掘拉米夫定肾脏及泌尿系统不良事件相关信号,为临床安全用药提供参考。方法收集FAERS数据库2004年1月1日至2023年3月31日的不良事件,根据首要怀疑药物,以替诺福韦、奈韦拉平、齐多夫定、阿德福韦为对照组,采用报告比值比法（ROR）结合压缩估计算法对拉米夫定肾脏及泌尿系统（含各类检查中肾脏、泌尿道检查及尿液分析）不良事件进行信号挖掘,并分别对人类免疫缺陷病毒（HIV）患者、乙型肝炎病毒（HBV）患者进行亚组信号挖掘。结果拉米夫定组和对照组发生的肾脏及泌尿系统（含各类检查中肾脏、泌尿道检查及尿液分析）不良事件分别为1 165、2 713例次。与对照相比,拉米夫定的肾功能损害风险更高。除肾功能损害外,HIV组肾衰、HBV组中毒性肾病风险均较对照更高。HIV合并HBV感染是拉米夫定引起肾功能损害的影响因素。结论提示拉米夫定存在肾脏及泌尿系统损害的风险,该发现可为长期应用拉米夫定提供参考。

关键词: 拉米夫定, 核苷（酸）类, 肾脏, 泌尿系统, 肾功能损害, 人类免疫缺陷病毒, 乙型肝炎病毒, 药品不良事件, 美国食品药品监督管理局不良事件报告系统

Abstract: Objective To mine the risk signals related to lamivudine-caused adverse events (AE) of the kidney and urinary system based on the Food and Drug Administration Adverse Event Reporting System (FAERS), and provide references for clinical safe drug use. Methods AE in the FAERS database collected between the first quarter of 2004 and the second quarter of 2023 were retrieved. According to the primary suspected drugs, the method of the reporting odds ratio (ROR) and compression estimation algorithm were used to identify the risk signals of AE associated with lamivudine in the kidney and urinary system by taking tenofovirdisoproxil, nevirapine, zidovudine and adefovirdipivoxil as control. Subgroup signal mining was performed on HIV and HBV patients respectively. Results There were 1 165 AE related to the kidney and the urinary system with lamivudine as the primary suspected drug and 2 713 cases in the control group. The risk of renal impairment by lamivudine was higher than in the control group, so was the risk of renal failure in the HIV group and toxic nephropathy in the HBV group. HIV complicated with HBV infection was a risk factor for renal impairment by lamivudine. Conclusion The AE signals of the kidney and urinary system based on FAERS point to the risk of lamivudine-caused damage to the kidney and urinary system, which could provide references for long-term use of lamivudine.

Key words: lamivudine, nucleoside/nucleotide analogues, kidney, urinary system, renal impairment, HIV, HBV, adverse drag event, FAERS

中图分类号:

R994.11
R978

李金洋. 基于美国FAERS数据库的拉米夫定肾脏及泌尿系统不良事件信号挖掘[J]. 中国药物警戒, 2024, 21(10): 1154-1158.

LI Jinyang. Mining of adverse event signals of lamivudine in the kidney and urinary system based on FAERS[J]. Chinese Journal of Pharmacovigilance, 2024, 21(10): 1154-1158.

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