[应用 HS221GI 治疗成人流感和 ARVI：一种新方法--控制病毒引起的炎症。双盲、随机、安慰剂对照、多中心临床试验结果]。

IF 0.3 4区医学 Q3 MEDICINE, GENERAL & INTERNAL Terapevticheskii Arkhiv Pub Date : 2023-12-28 DOI:10.26442/00403660.2023.12.202554

A G Malyavin, M I Bagaeva, O V Kalyuzhin

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引用次数: 0

摘要

目的：评估药物Aterixen®（XC221GI，1-[2-(1-甲基咪唑-4-基)-乙基]全氢嗪-2,6-二酮）治疗成人无并发症型流感和其他ARVI的疗效和安全性：该 III 期临床试验共招募了 260 名年龄在 18-65 岁之间、患有轻度和中度流感或其他急性呼吸道感染的患者。患者被随机分配到两组：第1组（n=130）的患者服用Aterixen®片剂，每次100毫克，每天2次，连续服用5天；第2组（n=130）的患者服用与该药物相对应的安慰剂，疗程相同。疗效评估的主要终点是首次用药到临床症状改善的时间（小时）。主要疗效分析的对象是根据方案完成研究的 PCR 确诊流感或 ARVI 患者（按方案感染）。此外，还在 ITT 和 PP 群体中进行了疗效评估，包括已发现和未发现病原体的患者。安全性分析人群包括所有至少接触过一次研究药物或安慰剂的患者，无一例外：结果：在所有研究人群的主要分析和附加分析中，Aterixen®药物在主要终点上均明显优于安慰剂：与安慰剂组相比，研究药物组的临床改善快24小时。对次要终点有效性的评估证实，在缓解卡他症状和中毒症状方面，Aterixen® 比安慰剂更有优势。结论：该药物具有良好的安全性：结论：在门诊治疗中使用该药物具有良好的安全性。Aterixen® 是治疗成人流感和其他急性呼吸道感染的一种有效而安全的药物。

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[Application of HS221GI in treatment of influenza and ARVI in adults: a new approach - managing virus-induced inflammation. Results of a double-blind, randomized, placebo-controlled, multicenter clinical trial].

Aim: Evaluation of the efficacy and safety of the drug Aterixen^® (XC221GI, 1-[2-(1-methylimidazole-4-yl)-ethyl]perhydroazine-2,6-dione), in the treatment of uncomplicated forms of influenza and other ARVI in adults.

Materials and methods: The phase III clinical trial enrolled 260 people aged 18-65 years with mild and moderate forms of influenza or other ARVI. Patients were randomly assigned to two groups: in group 1 (n=130), patients were prescribed the drug Aterixen® in tablets of 100 mg 2 times a day for 5 days; in group 2 (n=130) - a placebo corresponding to the drug, in the same regimen. The primary endpoint of the efficacy assessment was the time in hours from the first administration of the drug to clinical improvement. The main efficacy analysis was performed in a population of patients with PCR-confirmed influenza or ARVI who completed the study according to the protocol (per protocol infected). Additionally, efficacy was evaluated in ITT and PP populations, including patients with both identified and undetected pathogen. The population for safety analysis included all patients, without exception, who were exposed to at least one exposure to the study drug or placebo.

Results: A statistically significant superiority of the drug Aterixen^® over placebo in primary endpoint was revealed in both the main and additional analysis in all studied populations: clinical improvement in the group of the studied drug occurred 24 hours faster compared with the placebo group. The evaluation of the effectiveness of secondary endpoints confirmed the superiority of the drug Aterixen^® over placebo in terms of relief of catarrhal symptoms and symptoms of intoxication. A favorable safety profile of the drug has been demonstrated.

Conclusion: The drug has demonstrated a favorable safety profile for use in outpatient practice. Aterixen^® is an effective and safe treatment for influenza and other ARVI in adults.

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来源期刊

Terapevticheskii Arkhiv 医学-医学：内科

CiteScore

1.40

自引率

33.30%

发文量

171

审稿时长

3-8 weeks

期刊介绍： Терапевтический архив The journal was founded by the prominent Russian therapists M.P. Konchalovsky and G.F. Lang in 1923. Then its editors-in-chief were Professors V.N. Vinogradov and A.G. Gukasyan. Since 1972, E.I. Chazov, Academician of the Russian Academy of Sciences, has been heading the editorial board of the journal. Over 90 years, there have been more than 1000 issues where the authors and editorial staff have done their best for readers to keep abreast of current advances in medical science and practice and for physicians to master the advanced principles of recognition and treatment of a wide spectrum of visceral diseases. The papers published in the journal (editorials, original articles, lectures, reviews, etc.) cover both current scientific achievements and practical experience in diagnosing, treating, and preventing visceral diseases. The authors of publications are not only Russian, but also foreign scientists and physicians. All papers are peer-reviewed by highly qualified Russian specialists. The journal is published monthly. Traditionally, each issue has predominantly certain thematic areas covering individual therapy specializations. Every year, one of the issues is devoted to related problems in practical medicine (allergology and immunology, neurology and psychiatry, obstetrics, oncology, etc.). This all draws the attention of the reading public to the journal. The journal is indexed in RSCI (Russian Science Citation Index), PubMed/Medline, Index Medicus, Scopus/EMBASE, Web of Science Core Collection (Science Citation Index Expanded), Web of Science (Russian Science Citation Index - RSCI, Current Contents Connect, BIOSIS Previews), Google Scholar, Ulrich''s Periodicals Directory. The journal is included in the list of periodicals recommended by the Higher Attestation Committee for publishing the papers containing the basic materials of doctoral and candidate dissertations. By the decision of the Presidium of the Russian Academy of Medical Sciences, the “Therapevticheskiy Arkhiv” was awarded the Botkin medal. It was admitted to the European Association of Sciences Editors (EASE). The journal was honored with the Golden Press Fund decoration at the 13th International Press Professional Exhibition.