Center for Clinical Pharmacology, Military Medical Academy, Belgrade, Serbia.
Faculty of Medicine, Military Medical Academy, University of Defence, Belgrade, Serbia.
Int J Clin Pract. 2021 Mar;75(3):e13825. doi: 10.1111/ijcp.13825. Epub 2020 Nov 22.
At present, neither specific antiviral drugs, nor vaccine is recommended for coronavirus disease 2019 (COVID-19) treatment. In this review we discuss the drugs suggested as therapy for COVID-19 infection, with a focus on chloroquine and hydroxychloroquine. The list of drugs used for COVID-19 treatment includes a combination of lopinavir and ritonavir, remdesivir, favipiravir, alpha-interferon, ribavirin, atazanavir, umifenovir, and tocilizumab. As their efficacy and safety are under investigation, none of the regulatory agencies approved them for the treatment of COVID-19 infection. Although chloroquine and hydroxychloroquine possess antiviral and immunomodulatory effects, in practice benefit of their use for COVID-19 treatment is controversial. Several studies investigating hydroxychloroquine were stopped and the French national medicines regulator suspended its use in clinical trials because of safety concerns. The results from the double-blind, randomised clinical trials, including large number of participants, will add better insight into the role of these two drugs as already available and affordable, antimalarial therapy. The ethical issue on emergency use of chloroquine and hydroxychloroquine in the settings of COVID-19 should be carefully managed, with adherence to the "monitored emergency use of unregistered and experimental interventions" (MEURI) framework or be ethically approved as a trial, as stated by the WHO. Potential shortage of chloroquine/hydroxychloroquine on the market can be overbridged with regular prescriptions by medical doctors and national drug agency should ensure sufficient quantities of these drugs for standard indications.
目前,针对 2019 冠状病毒病(COVID-19),既没有推荐特定的抗病毒药物,也没有推荐疫苗。在本次综述中,我们讨论了建议用于 COVID-19 感染治疗的药物,重点关注氯喹和羟氯喹。用于 COVID-19 治疗的药物包括洛匹那韦和利托那韦、瑞德西韦、法匹拉韦、α干扰素、利巴韦林、阿扎那韦、乌米酚韦和托珠单抗。由于其疗效和安全性正在研究中,监管机构均未批准这些药物用于 COVID-19 感染的治疗。虽然氯喹和羟氯喹具有抗病毒和免疫调节作用,但在实践中,它们在 COVID-19 治疗中的应用获益仍存在争议。由于安全性问题,一些研究羟氯喹的临床试验被停止,法国国家药品监管局暂停了其在临床试验中的使用。包括大量参与者的双盲、随机临床试验的结果,将为这两种药物作为现有且负担得起的抗疟治疗药物的作用提供更好的了解。在 COVID-19 背景下,紧急使用氯喹和羟氯喹的伦理问题应谨慎管理,应遵循“监测未注册和试验性干预措施的紧急使用”(MEURI)框架,或按照世卫组织的规定,作为试验获得伦理批准。氯喹/羟氯喹在市场上的潜在短缺可以通过医生开具常规处方来弥补,国家药物管理局应确保这些药物有足够数量用于标准适应证。