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新型冠状病毒肺炎大流行期间药物的超说明书、同情性和不合理使用、健康后果及伦理问题。

Off label, compassionate and irrational use of medicines in Covid-19 pandemic, health consequences and ethical issues.

作者信息

Paumgartten Francisco José Roma, Oliveira Ana Cecilia Amado Xavier de

机构信息

Escola Nacional de Saúde Pública, Fiocruz, Rio de Janeiro, RJ, Brazil,

出版信息

Cien Saude Colet. 2020 Sep;25(9):3413-3419. doi: 10.1590/1413-81232020259.16792020. Epub 2020 Aug 28.

Abstract

When Covid-19 emerged in December last year, there was no vaccine nor was there specific effective treatment for this fast-spreading and life-threatening viral respiratory infection. Clinical trials were planned and are in progress to investigate whether drugs used for influenza, HIV and other viruses, and also anthelmintics (ivermectin, nitazoxanide, niclosamide), and antimalarials (chloroquine, hydroxychloroquine) showing antiviral activity in in vitro assays, are effective and safe for Covid-19. So far there is no convincing evidence that these antiviral and antiparasitic drugs are of any benefit for Covid-19. Notwithsanding the absence of evidence of clinical efficacy, these drugs are widely used outside of clinical trials (off label) for prophylaxis and treatment of this viral infection. The rationale behind the prescription of macrolide antibiotics (azithromycin) for Covid-19 is obscure as well. The widespread prescription and use of drugs of unproven efficacy and safety for Covid-19 is at odds with the rational use of medicines, a cornerstone principle of pharmacotherapy advanced by WHO in 1985. This irrational use of drugs is cause for concern because some of them are associated with serious heart disorders and deaths.

摘要

去年12月新冠病毒病出现时,既没有疫苗,也没有针对这种快速传播且危及生命的病毒性呼吸道感染的特效治疗方法。当时计划并正在开展临床试验,以研究用于治疗流感、艾滋病毒及其他病毒的药物,以及在体外试验中显示出抗病毒活性的驱虫药(伊维菌素、硝唑尼特、氯硝柳胺)和抗疟药(氯喹、羟氯喹)对新冠病毒病是否有效且安全。到目前为止,没有令人信服的证据表明这些抗病毒和抗寄生虫药物对新冠病毒病有任何益处。尽管缺乏临床疗效证据,但这些药物在临床试验之外被广泛用于(未按药品说明书)预防和治疗这种病毒感染。使用大环内酯类抗生素(阿奇霉素)治疗新冠病毒病的理由也不明朗。对新冠病毒病使用未经证实疗效和安全性的药物进行广泛处方和应用,与合理用药背道而驰,合理用药是世界卫生组织在1985年提出的药物治疗的一项基本原则。这种不合理用药令人担忧,因为其中一些药物与严重的心脏疾病和死亡有关。

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