法匹拉韦输注治疗新冠肺炎住院患者的有效性和安全性

L. Balykova, K. Zaslavskaya, V. Pavelkina, N. Pyataev, N. Selezneva, N. V. Kirichenko, A. Ivanova, G. V. Rodoman, K. Kolontarev, K. S. Skrupsky, E. Simakina, O. A. Mubarakshina, A. Taganov, D. Pushkar
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引用次数: 4

摘要

研究开发具有广泛抗病毒活性和产生耐药性能力较低的新治疗剂,仍然是抗击对公众健康的全球威胁的主要方面。为了提高COVID-19住院患者的治疗效果,需要使用非注射形式的法匹拉韦。这种剂型扩大了住院患者药物治疗的可能性,对他们来说,加速治疗效果和使用药物的高安全性尤为重要。本文的目的是在病原和对症治疗的背景下,评价含有法匹拉韦的药物用于肠外给药的有效性和安全性,并与住院COVID-19患者的标准治疗进行比较。材料和方法。在俄罗斯联邦的6个研究中心开展了一项开放、随机、多中心的比较研究,以评估favipiravir的有效性和安全性。favipiravir是一种冻干液,用于制备COVID-19住院患者输注液的浓缩物。217例患者完成了筛选程序和随机化,其中209例按照方案完成了研究。在研究组之间,已经发现了统计学上显著的差异,这使得有可能考虑药物Areplivir (favipiravir)在肠外给药方面优于标准治疗的假设,标准治疗包括favipiravir (p. o.)和remdesivir。一项对比分析显示,一个疗程的非肠外favipiravir药物治疗可显著改善COVID-19患者的病情,显著改善患者临床状况的速度和频率,缩短住院时间。经证实,使用含法匹拉韦的药物进行肠外给药治疗,对临床和生化血液检查、尿液分析、凝血图、生命体征和心电图等参数均无不良影响,表明治疗是安全的。该研究药物具有较高的安全性和耐受性。RNA依赖性RNA聚合酶的多功能性和对突变的抗性使其有可能被视为对抗引起ARVI的最常见RNA病毒的主要靶标,这决定了需要进一步研究favipiravir以扩大其适应症范围。
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EFFECTIVENESS AND SAFETY OF FAVIPIRAVIR INFUSION IN PATIENTS HOSPITALIZED WITH COVID-19
Research in the development of new therapeutic agents with a wide spectrum of the antiviral activity and a low ability to develop resistance remains the main dimension in combating the global threat to public health. The need for a parenteral form of favipiravir was dictated by the necessity to increase the efficacy of therapy in COVID-19 inpatients. This dosage form has expanded the possibilities of drug therapy in the inpatients, for whom a therapeutic effect acceleration and a high safety profile of the drugs used are especially important.The aim of the article is the evaluation of the efficacy and safety of a medicinal product containing favipiravir for the parenteral administration against the background of pathogenetic and symptomatic therapy, in comparison with standard therapy in hospitalized COVID-19 patients.Materials and methods. An open, randomized, multicenter comparative study was conducted in 6 research centers in the Russian Federation to evaluate the efficacy and safety of favipiravir, a lyophilisate for the preparation of a concentrate for the infusion solution administrated to the patients hospitalized with COVID-19. Screening procedures and randomization were completed in 217 patients, 209 of which had completed the study in accordance with the protocol.Results. Between the study groups, statistically significant differences have been found out, making it possible to consider the hypothesis of the drug Areplivir (favipiravir) superiority for the parenteral administration over the standard therapy, which included favipiravir (p. o.) and remdesivir. A comparative analysis has shown that a course of therapy with the parenteral favipiravir drug leads to a significant improvement in the condition of patients with COVID-19, significant benefits in terms of the speed and frequency of improvement in the clinical status of patients, as well as a reduction in the hospital stay length. It has been proven that therapy with a drug containing favipiravir for the parenteral administration does not adversely affect the parameters of clinical and biochemical blood tests, urinalysis, coagulograms, vital signs and ECG, which indicates the therapy safety. The study drug is characterized by a high safety profile and tolerability.Conclusion. The versatility and resistance to mutations of RNA-dependent RNA polymerase make it possible to consider it as the main target for combating the most common RNA viruses that cause ARVI, that determines the need  further studies of favipiravir to expand the range of its indications.
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