L. Balykova, V. Pavelkina, N. V. Shmyreva, N. Pyataev, N. Selezneva, O. Shepeleva, R. Z. Almyasheva
{"title":"几种致病因治疗方案治疗新型冠状病毒感染(covid-19)的疗效和安全性","authors":"L. Balykova, V. Pavelkina, N. V. Shmyreva, N. Pyataev, N. Selezneva, O. Shepeleva, R. Z. Almyasheva","doi":"10.19163/2307-9266-2020-8-3-150-159","DOIUrl":null,"url":null,"abstract":"The aim of the study is to assess the efficacy and safety of the Favipiravir (Areplivir) drug, compared to the standard etiotropic therapy in the patients hospitalized with COVID-19.Material and methods. The research was conducted as a part of an open, randomized, multicenter comparative study of the efficacy and safety of Areplivir, 200 mg film-coated tablets (“PROMOMED RUS” LLC, Russia), in the patients hospitalized with COVID-19. The dosing regimen of Favipiravir was 1600 mg twice a day on the 1st day and 600 mg twice a day on days 2–14. Thirty nine patients were enrolled into the study with a laboratory-established diagnosis of a new type of Coronavirus infection caused by SARS-CoV-2 (confirmed) of moderate severity, with pneumonia. The group of comparison (22 patients) received standard etiotropic therapy, prescribed in accordance with the current version of the temporary guidelines for the diagnosis and treatment of COVID-19, represented mainly by Hydroxychloroquine with the dosage regimen of 800 mg on the 1st day, then 400 mg on days 2–7, and Azithromycin 500 mg once a day for 5 days. The main group (17 patients) received Favipiravir (Areplivir) as etiotropiс therapy.Results. In the main group, the time period until fever disappeared was found to be 1.36 days shorter than in the group of comparison (p<0.05); there was a higher rate of the reduction of inflammatory changes in the lungs according to the computer tomography data (38.4% vs 14.9%, p<0.05). By the end of the treatment, there was also a lower lactate level in the blood (27.1%, p<0.05) than in the patients of the group of comparison. The evaluation of the drug efficacy ассording to the Categorical Ordinal Scale of Clinical Improvement and measurements of oxygen saturation in the blood, manifested similar positive dynamics in the patients treated ассording to various etiotropic therapy regimens. By the end of the treatment, the RNA SARS-CoV-2 tests were also negative in all the patients. As for the overall frequency of adverse events (AEs), no relevant distinctions were found between the groups. A greater part of AEs was related to hepatotoxicity, with a predominantly clinically relevant increase in alanine aminotransferase (ALT). A clinically relevant prolongation of the corrected QT interval on the standard ECG was found to occur in the standard-therapy group on day 5, while no serious AEs were registered in the main group. No serious adverse reactions were registered in patients of the main group.Conclusion. The efficacy of the Favipiravir (Areplivir) therapy for the novel coronavirus infection has proved to be superior to the efficacy of the standard etiotropic therapy in a number of aspects. Basing on the obtained findings, Favipiravir (Areplivir) drug can be recommended for treating patients with the novel coronavirus infection of moderate severity.","PeriodicalId":20025,"journal":{"name":"Pharmacy & Pharmacology","volume":"35 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2020-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"8","resultStr":"{\"title\":\"EFFICACY AND SAFETY OF SOME ETIOTROPIC THERAPEUTIC SCHEMES FOR TREATING PATIENTS WITH NOVEL CORONAVIRUS INFECTION (COVID-19)\",\"authors\":\"L. Balykova, V. Pavelkina, N. V. Shmyreva, N. Pyataev, N. Selezneva, O. Shepeleva, R. Z. Almyasheva\",\"doi\":\"10.19163/2307-9266-2020-8-3-150-159\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The aim of the study is to assess the efficacy and safety of the Favipiravir (Areplivir) drug, compared to the standard etiotropic therapy in the patients hospitalized with COVID-19.Material and methods. The research was conducted as a part of an open, randomized, multicenter comparative study of the efficacy and safety of Areplivir, 200 mg film-coated tablets (“PROMOMED RUS” LLC, Russia), in the patients hospitalized with COVID-19. The dosing regimen of Favipiravir was 1600 mg twice a day on the 1st day and 600 mg twice a day on days 2–14. Thirty nine patients were enrolled into the study with a laboratory-established diagnosis of a new type of Coronavirus infection caused by SARS-CoV-2 (confirmed) of moderate severity, with pneumonia. The group of comparison (22 patients) received standard etiotropic therapy, prescribed in accordance with the current version of the temporary guidelines for the diagnosis and treatment of COVID-19, represented mainly by Hydroxychloroquine with the dosage regimen of 800 mg on the 1st day, then 400 mg on days 2–7, and Azithromycin 500 mg once a day for 5 days. The main group (17 patients) received Favipiravir (Areplivir) as etiotropiс therapy.Results. In the main group, the time period until fever disappeared was found to be 1.36 days shorter than in the group of comparison (p<0.05); there was a higher rate of the reduction of inflammatory changes in the lungs according to the computer tomography data (38.4% vs 14.9%, p<0.05). By the end of the treatment, there was also a lower lactate level in the blood (27.1%, p<0.05) than in the patients of the group of comparison. The evaluation of the drug efficacy ассording to the Categorical Ordinal Scale of Clinical Improvement and measurements of oxygen saturation in the blood, manifested similar positive dynamics in the patients treated ассording to various etiotropic therapy regimens. By the end of the treatment, the RNA SARS-CoV-2 tests were also negative in all the patients. As for the overall frequency of adverse events (AEs), no relevant distinctions were found between the groups. A greater part of AEs was related to hepatotoxicity, with a predominantly clinically relevant increase in alanine aminotransferase (ALT). A clinically relevant prolongation of the corrected QT interval on the standard ECG was found to occur in the standard-therapy group on day 5, while no serious AEs were registered in the main group. No serious adverse reactions were registered in patients of the main group.Conclusion. The efficacy of the Favipiravir (Areplivir) therapy for the novel coronavirus infection has proved to be superior to the efficacy of the standard etiotropic therapy in a number of aspects. Basing on the obtained findings, Favipiravir (Areplivir) drug can be recommended for treating patients with the novel coronavirus infection of moderate severity.\",\"PeriodicalId\":20025,\"journal\":{\"name\":\"Pharmacy & Pharmacology\",\"volume\":\"35 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-12-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"8\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacy & Pharmacology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.19163/2307-9266-2020-8-3-150-159\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacy & Pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.19163/2307-9266-2020-8-3-150-159","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 8
摘要
该研究的目的是评估Favipiravir (Areplivir)药物与标准致病因治疗在COVID-19住院患者中的疗效和安全性。材料和方法。该研究是一项开放、随机、多中心比较研究的一部分,该研究旨在研究200mg Areplivir薄膜包衣片(“promed RUS”LLC,俄罗斯)对COVID-19住院患者的疗效和安全性。Favipiravir给药方案为1600mg / d,第1天;600mg / d,第2-14天。39名患者被纳入研究,实验室诊断为由SARS-CoV-2引起的新型冠状病毒感染(确诊),严重程度中等,伴有肺炎。对照组(22例)接受标准致病因治疗,按照新版新冠肺炎临时诊疗指南处方,主要为羟氯喹,给药方案为第1天800 mg,第2-7天400 mg,阿奇霉素500 mg,每天1次,连用5天。主要组(17例)采用Favipiravir (Areplivir)治疗。主组发热消失时间比对照组短1.36 d (p<0.05);计算机断层扫描数据显示,肺部炎症改变的减少率更高(38.4% vs 14.9%, p<0.05)。治疗结束时,血乳酸水平也低于对照组(27.1%,p<0.05)。根据临床改善的分类顺序量表和血氧饱和度的测量对药物疗效进行评估,在根据各种致病因治疗方案治疗的患者中表现出类似的积极动态。在治疗结束时,所有患者的RNA SARS-CoV-2检测也呈阴性。至于不良事件(ae)的总体频率,两组间无相关差异。大部分ae与肝毒性有关,主要与临床相关的丙氨酸转氨酶(ALT)升高有关。标准治疗组在第5天出现标准心电图校正QT间期的临床相关延长,而主治疗组未出现严重不良事件。主组患者未见严重不良反应。Favipiravir (Areplivir)治疗新型冠状病毒感染的疗效已被证明在多个方面优于标准致病因治疗的疗效。基于上述发现,Favipiravir (Areplivir)药物可推荐用于治疗中度新型冠状病毒感染患者。
EFFICACY AND SAFETY OF SOME ETIOTROPIC THERAPEUTIC SCHEMES FOR TREATING PATIENTS WITH NOVEL CORONAVIRUS INFECTION (COVID-19)
The aim of the study is to assess the efficacy and safety of the Favipiravir (Areplivir) drug, compared to the standard etiotropic therapy in the patients hospitalized with COVID-19.Material and methods. The research was conducted as a part of an open, randomized, multicenter comparative study of the efficacy and safety of Areplivir, 200 mg film-coated tablets (“PROMOMED RUS” LLC, Russia), in the patients hospitalized with COVID-19. The dosing regimen of Favipiravir was 1600 mg twice a day on the 1st day and 600 mg twice a day on days 2–14. Thirty nine patients were enrolled into the study with a laboratory-established diagnosis of a new type of Coronavirus infection caused by SARS-CoV-2 (confirmed) of moderate severity, with pneumonia. The group of comparison (22 patients) received standard etiotropic therapy, prescribed in accordance with the current version of the temporary guidelines for the diagnosis and treatment of COVID-19, represented mainly by Hydroxychloroquine with the dosage regimen of 800 mg on the 1st day, then 400 mg on days 2–7, and Azithromycin 500 mg once a day for 5 days. The main group (17 patients) received Favipiravir (Areplivir) as etiotropiс therapy.Results. In the main group, the time period until fever disappeared was found to be 1.36 days shorter than in the group of comparison (p<0.05); there was a higher rate of the reduction of inflammatory changes in the lungs according to the computer tomography data (38.4% vs 14.9%, p<0.05). By the end of the treatment, there was also a lower lactate level in the blood (27.1%, p<0.05) than in the patients of the group of comparison. The evaluation of the drug efficacy ассording to the Categorical Ordinal Scale of Clinical Improvement and measurements of oxygen saturation in the blood, manifested similar positive dynamics in the patients treated ассording to various etiotropic therapy regimens. By the end of the treatment, the RNA SARS-CoV-2 tests were also negative in all the patients. As for the overall frequency of adverse events (AEs), no relevant distinctions were found between the groups. A greater part of AEs was related to hepatotoxicity, with a predominantly clinically relevant increase in alanine aminotransferase (ALT). A clinically relevant prolongation of the corrected QT interval on the standard ECG was found to occur in the standard-therapy group on day 5, while no serious AEs were registered in the main group. No serious adverse reactions were registered in patients of the main group.Conclusion. The efficacy of the Favipiravir (Areplivir) therapy for the novel coronavirus infection has proved to be superior to the efficacy of the standard etiotropic therapy in a number of aspects. Basing on the obtained findings, Favipiravir (Areplivir) drug can be recommended for treating patients with the novel coronavirus infection of moderate severity.