抗疱疹病毒药物安全性的差异:基于 FAERS 数据库的真实世界药物警戒研究。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-10 DOI:10.1080/14740338.2024.2412235
Dan He, Dexuan Kong, Yanbin Zeng, Meifen Han, Shunguo Zhang, Zhiling Li
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引用次数: 0

摘要

背景:抗疱疹病毒药物的安全性尚未进行系统比较。了解不良事件(AEs)的变化可为临床合理用药提供参考:我们从美国食品药品管理局不良事件报告系统(FAERS)数据库中收集了 2004 年第一季度至 2023 年第三季度期间阿昔洛韦、更昔洛韦、伐昔洛韦和福斯康定的数据。结果显示,所有药物都与血液病有显著关联:结果:所有药物都与血液毒性有明显相关性,其中更昔洛韦和福沙奈特的骨髓抑制作用更强。与肾功能损害的相关性排序如下:福斯卡尼、更昔洛韦、伐昔洛韦和阿昔洛韦(ROR 分别为 16.72、7.06、3.51 和 2.02)。在肝脏毒性方面,更昔洛韦与急性-慢性肝功能衰竭有关(ROR = 52.83),而福沙耐特与暴发性肝炎有关(ROR = 49.91)。在神经系统中,阿昔洛韦的神经毒性最强(ROR = 14.95)。在中毒性脑病方面,伐昔洛韦排名第一(ROR = 64.70)。Foscarnet 的癫痫状态强度最高(ROR = 6.45)。此外,阿昔洛韦与严重皮肤不良反应(SCARs)的关联性最强:我们的研究揭示了四种抗疱疹病毒药物在安全性方面的差异。更昔洛韦显示出最高的血液毒性风险,但在癫痫发作和 SCAR 方面似乎相对安全。与其他药物相比,Foscarnet 更容易引起肾毒性、癫痫发作和电解质失衡。阿昔洛韦和伐昔洛韦与浆细胞增多症、神经毒性和 SCAR 密切相关。
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Differences in safety profiles of anti-herpesvirus medications: a real-world pharmacovigilance study based on the FAERS database.

Background: Anti-herpesvirus drug safety profiles have not been systematically compared. Understanding variations in adverse events (AEs) could provide reference for rational clinical use.

Methods: We collected data on acyclovir, ganciclovir, valaciclovir, and foscarnet from the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q3 2023. Disproportionality analyses were conducted to evaluate the risk of AEs.

Results: All drugs exhibited significant associations with hematotoxicity, with ganciclovir and foscarnet being more myelosuppressive. The correlation with renal impairment ranked as follows: foscarnet, ganciclovir, valaciclovir, and acyclovir (ROR = 16.72, 7.06, 3.51, and 2.02, respectively). Regarding hepatotoxicity, ganciclovir was associated with acute-on-chronic liver failure (ROR = 52.83), and foscarnet was associated with fulminant hepatitis (ROR = 49.91). In the nervous system, acyclovir showed the highest intensity of neurotoxicity (ROR = 14.95). Valaciclovir ranked first in toxic encephalopathy (ROR = 64.70). Foscarnet showed the highest intensity of status epilepticus (ROR = 6.45). Besides, acyclovir showed the strongest association with severe cutaneous adverse reactions (SCARs).

Conclusions: Our study revealed differences in safety profiles of four anti-herpesvirus medications. Ganciclovir exhibited the highest risk of hematotoxicity but appeared relatively safe in seizures and SCARs. Foscarnet was more likely to induce nephrotoxicity, seizures, and electrolyte imbalances than others. Acyclovir and valaciclovir were strongly associated with plasmacytosis, neurotoxicity, and SCARs.

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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
期刊最新文献
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