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奥司他韦与急性肝炎,是真实关联还是巧合?

Oseltamivir and acute hepatitis, reality association or coincidence?

作者信息

Mastroianni Antonio, Vangeli Valeria, Greco Sonia, Urso Filippo, Greco Francesca, Chidichimo Luciana, Mauro Maria Vittoria

机构信息

UOC Malattie Infettive e Tropicali, 220599Azienda Ospedaliera di Cosenza, Cosenza, Italy.

UOC Farmacia Ospedaliera, 220599Azienda Ospedaliera di Cosenza, Cosenza, Italy.

出版信息

Antivir Ther. 2021 May;26(3-5):87-92. doi: 10.1177/13596535211041494. Epub 2021 Sep 17.

DOI:10.1177/13596535211041494
PMID:35485329
Abstract

Oseltamivir is an orally administered antiviral medication that selectively inhibits the influenza neuraminidase enzymes that are essential for viral replication and it is active against both influenza A and B viruses. Oseltamivir is indicated for therapy or post-exposure prevention of influenza A and B. Side effects are uncommon and include mild nausea, gastrointestinal upset, dizziness, and headache. Despite widespread use, oseltamivir has not been associated with clinically apparent liver injury; however, there is growing evidence of possible toxic liver involvement during oseltamivir therapy. To the best of our knowledge, this is the first reported case in Italy linking the development of acute hepatitis and oseltamivir therapy, in a patient suffering from influenza H1N1 infection. We also present a review of the literature on cases of oseltamivir hepatotoxicity, through the consultation of PubMed database, the bibliographical references of various articles and an extensive search using Google. In view of the analyzed results, we suggest that experts should carefully consider the need for inclusion of potential serious liver reactions be added to the oseltamivir product label.

摘要

奥司他韦是一种口服抗病毒药物,它能选择性抑制对病毒复制至关重要的流感神经氨酸酶,对甲型和乙型流感病毒均有活性。奥司他韦适用于甲型和乙型流感的治疗或暴露后预防。副作用不常见,包括轻度恶心、胃肠道不适、头晕和头痛。尽管广泛使用,但奥司他韦尚未与临床上明显的肝损伤相关联;然而,越来越多的证据表明在奥司他韦治疗期间可能存在肝脏毒性。据我们所知,这是意大利首例报告的在甲型H1N1流感感染患者中,将急性肝炎的发生与奥司他韦治疗联系起来的病例。我们还通过查阅PubMed数据库、各篇文章的参考文献以及使用谷歌进行广泛搜索,对有关奥司他韦肝毒性病例的文献进行了综述。鉴于分析结果,我们建议专家应仔细考虑是否需要在奥司他韦产品标签中增加潜在严重肝脏反应的内容。

相似文献

1
Oseltamivir and acute hepatitis, reality association or coincidence?奥司他韦与急性肝炎,是真实关联还是巧合?
Antivir Ther. 2021 May;26(3-5):87-92. doi: 10.1177/13596535211041494. Epub 2021 Sep 17.
2
First case of acute cholestatic hepatitis attributed to oseltamivir in a young girl with ah1n1 influenza.首例甲型 h1n1 流感患儿因奥司他韦致急性胆汁淤积性肝炎。
Ann Ig. 2021 May-Jun;33(3):205-208. doi: 10.7416/ai.2021.2427.
3
Possible neuropsychiatric reaction to high-dose oseltamivir during acute 2009 H1N1 influenza A infection.急性 2009 年 H1N1 流感感染期间大剂量奥司他韦可能引起的神经精神性反应。
Clin Infect Dis. 2010 Apr 1;50(7):e47-9. doi: 10.1086/651166.
4
Neuraminidase inhibitor resistance after oseltamivir treatment of acute influenza A and B in children.儿童甲型和乙型流感急性感染经奥司他韦治疗后的神经氨酸酶抑制剂耐药性。
Clin Infect Dis. 2009 Feb 15;48(4):389-96. doi: 10.1086/596311.
5
Effect of aloin on viral neuraminidase and hemagglutinin-specific T cell immunity in acute influenza.芦荟素对急性流感病毒神经氨酸酶和血凝素特异性 T 细胞免疫的影响。
Phytomedicine. 2019 Nov;64:152904. doi: 10.1016/j.phymed.2019.152904. Epub 2019 Apr 4.
6
Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis.用于预防和治疗健康成年人流感的神经氨酸酶抑制剂:系统评价与荟萃分析
BMJ. 2009 Dec 8;339:b5106. doi: 10.1136/bmj.b5106.
7
Long-acting neuraminidase inhibitor laninamivir octanoate (CS-8958) versus oseltamivir as treatment for children with influenza virus infection.长效神经氨酸酶抑制剂奥司他韦辛酸酯(CS-8958)与奥司他韦治疗儿童流感病毒感染的比较。
Antimicrob Agents Chemother. 2010 Jun;54(6):2575-82. doi: 10.1128/AAC.01755-09. Epub 2010 Apr 5.
8
Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial.奥司他韦对比麻杏石甘银翘散治疗 H1N1 流感:一项随机试验。
Ann Intern Med. 2011 Aug 16;155(4):217-25. doi: 10.7326/0003-4819-155-4-201108160-00005.
9
Neuraminidase inhibitors for influenza: a systematic review and meta-analysis of regulatory and mortality data.用于流感的神经氨酸酶抑制剂:对监管和死亡率数据的系统评价与荟萃分析
Health Technol Assess. 2016 May;20(42):1-242. doi: 10.3310/hta20420.
10
Safety of oseltamivir in pregnancy: a review of preclinical and clinical data.奥司他韦在妊娠期间的安全性:临床前和临床数据的综述。
Drug Saf. 2010 Aug 1;33(8):631-42. doi: 10.2165/11536370-000000000-00000.

引用本文的文献

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Hepatic involvement in major respiratory viral infections.肝脏在主要呼吸道病毒感染中的受累情况。
Clin Exp Hepatol. 2025 Jun;11(2):121-128. doi: 10.5114/ceh.2025.151800. Epub 2025 Jun 9.
2
Oseltamivir-induced hepatotoxicity: A retrospective analysis of the FDA adverse event reporting system.奥司他韦引起的肝毒性:对美国食品药品监督管理局不良事件报告系统的回顾性分析。
PLoS One. 2025 Feb 25;20(2):e0314970. doi: 10.1371/journal.pone.0314970. eCollection 2025.
3
Safety analysis of Oseltamivir and Baloxavir Marboxil after market approval: a pharmacovigilance study based on the FDA adverse event reporting system.
奥司他韦和玛巴洛沙韦上市后的安全性分析:基于 FDA 不良事件报告系统的药物警戒研究。
BMC Infect Dis. 2024 May 9;24(1):446. doi: 10.1186/s12879-024-09339-4.
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Pathophysiological effects of Tamiflu on liver and kidneys of male rats.达菲对雄性大鼠肝脏和肾脏的病理生理影响。
Beni Suef Univ J Basic Appl Sci. 2022;11(1):15. doi: 10.1186/s43088-021-00189-6. Epub 2022 Jan 25.