[基于抗体的复方抗病毒药物治疗成人急性呼吸道病毒感染的疗效和安全性评估]

[Evaluation of the efficacy and safety of a complex antiviral drug based on antibodies in the treatment of adult patients with acute respiratory viral infection].

作者信息

Khamitov R F, Nikiforov V V, Zaytsev A A, Tragira I N

机构信息

Kazan State Medical University.

Pirogov Russian National Research Medical University.

出版信息

Ter Arkh. 2022 Jan 15;94(1):83-93. doi: 10.26442/00403660.2022.01.201345.

DOI:10.26442/00403660.2022.01.201345

PMID:36286922

Abstract

AIM

To evaluate the efficacy and safety of Raphamin, containing technologically processed affinity-purified antibodies to interferon , CD4 receptor, 1 domain of the major histocompatibility complex class II and 2 microglobulin major histocompatibility complex class I in the treatment of acute respiratory viral infection (ARVI), including influenza, in adults.

MATERIALS AND METHODS

240 patients 1870 years old with ARVI were included in a phase III (20192020), randomized, double-blind, placebo-controlled trial. Pregnant women, patients with suspected bacterial infections were excluded from the study. Raphamin/placebo was prescribed for 5 days within 24 hours of the illness onset. Primary endpoint was a time to resolution of ARVI (Polymerase chain reaction PCR-confirmed). Additionally, the severity of ARVI, proportion of patients with ARVI resolution/worsening/complications, frequency of antipyretics prescription, and time to resolution of symptoms of ARVI (including PCR non confirmed) were assessed.

RESULTS

The average time to resolution of ARVI (PCR-confirmed) was 4.11.9 [4.01.9] and 5.02.5 [5.02.5] days in the Raphamin/placebo groups (ITT and [PP] analysis, р=0.0155 and [р=0.0114], respectively). The duration of ARVI decreased by 0.892.23 [0.932.25] days. Superiority of Raphamin was shown during therapy period according to the ARVI resolution criterion (р=0.0014 [р=0.0005]). There were no statistically significant difference in the severity of ARVI and frequency of antipyretics prescription. The proportion of patients with worsening/complications was 0 [0]% and 2.5 [2.8]% in the Raphamin and placebo groups, respectively. Favorable safety profile of Raphamin (including the incidence and severity of adverse events) and high compliance were shown.

CONCLUSION

Raphamin promotes significant decrease, practically by a day, the duration of ARVI, including influenza.

摘要

目的

评估瑞法明（Raphamin）治疗成人急性呼吸道病毒感染（ARVI）（包括流感）的疗效和安全性。瑞法明含有经过技术处理的、对干扰素、CD4受体、主要组织相容性复合体II类1结构域以及主要组织相容性复合体I类β2微球蛋白具有亲和纯化作用的抗体。

材料与方法

240例年龄在18至70岁的ARVI患者纳入一项III期（2019 - 2020年）随机双盲安慰剂对照试验。孕妇、疑似细菌感染患者被排除在研究之外。在发病24小时内给予瑞法明/安慰剂，疗程5天。主要终点是ARVI症状缓解时间（经聚合酶链反应（PCR）确认）。此外，评估了ARVI的严重程度、ARVI症状缓解/加重/出现并发症的患者比例、退烧药的使用频率以及ARVI症状缓解时间（包括PCR未确认的情况）。

结果

瑞法明/安慰剂组中，ARVI（PCR确认）症状缓解的平均时间分别为4.1±1.9 [4.0±1.9]天和5.0±2.5 [5.0±2.5]天（意向性分析（ITT）和符合方案分析（PP），p分别为0.0155和0.0114）。ARVI病程缩短了0.89±2.23 [0.93±2.25]天。根据ARVI缓解标准，在治疗期间瑞法明显示出优越性（p = 0.0014 [p = 0.0005]）。ARVI严重程度和退烧药使用频率无统计学显著差异。瑞法明组和安慰剂组中病情加重/出现并发症的患者比例分别为0 [0]%和2.5 [2.8]%。瑞法明显示出良好的安全性（包括不良事件的发生率和严重程度）以及高依从性。