Favipiravir治疗印度中轻度新冠肺炎的现实世界经验

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2022-05-27 eCollection Date: 2022-01-01 DOI:10.2147/POR.S364066
Shashank Joshi, Agam Vora, K Venugopal, Pramod Dadhich, Anil Daxini, Sagar Bhagat, Saiprasad Patil, Hanmant Barkate
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引用次数: 3

摘要

Favipiravir是一种RNA依赖性RNA聚合酶抑制剂(RdRp),是一种广谱口服抗病毒药物,在印度获得紧急使用授权,用于治疗轻中度冠状病毒病(COVID-19)。本研究旨在评估法匹拉韦在实际临床实践中的有效性和安全性。材料和方法这是一项多中心、回顾性、单臂研究,在获得独立伦理委员会的许可后,在印度的四个中心进行。分析医疗记录以评价处方法匹拉韦患者的有效性和安全性。结果共有360例患者的病历符合纳入标准,其中358例可供最终分析。男性占研究人群的58.46%。入组患者平均年龄为51.80±16.45岁。最常见的症状是发烧、咳嗽和肌痛-疲劳。临床治愈和发热缓解的中位时间分别为5天和4天。平均住院时间为6天。总的来说,8%的患者出现了不良事件。肝酶升高、腹泻、食欲下降、头痛、疲劳和头晕是常见症状。在我们的现实世界研究中,发现favipiravir对轻至中度COVID-19患者的临床治愈率超过90%。这支持使用法匹拉韦治疗COVID-19。Favipiravir耐受性良好,副作用很小,而且是短暂的。
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Real-World Experience with Favipiravir for the Treatment of Mild-to-Moderate COVID-19 in India.

Background: Favipiravir, an RNA-dependent RNA polymerase inhibitor (RdRp), is a broad-spectrum oral antiviral agent approved in India under emergency use authorization, for the treatment of mild-to-moderate coronavirus disease (COVID-19). The present study was planned to evaluate the effectiveness and safety of favipiravir in real-world clinical practice.

Materials and methods: This was a multicentric, retrospective, single-arm study conducted across four centres in India, after obtaining permission from the independent ethics committee. Medical records were analysed to evaluate effectiveness and safety of patients who were prescribed favipiravir.

Results: The medical records of a total of 360 patients met the inclusion criteria, with 358 of them available for the final analysis. Males made up 58.46% of the study population. The average age of enrolled patients was 51.80 ± 16.45 years. The most common symptoms were fever, cough, and myalgia-fatigue. The median time to clinical cure and fever relief was five and four days, respectively. The average length of stay in the hospital was six days. In total, 8% of the patients experienced adverse events. Hepatic enzyme elevation, diarrhoea, decreased appetite, headache, fatigue, and giddiness were the common symptoms.

Conclusion: In our real-world study, favipiravir was found to have a clinical cure rate of more than 90% in mild-to-moderate COVID-19 patients. This supports the use of favipiravir in the treatment of COVID-19. Favipiravir was well tolerated, with only minimal side effects, which were transient in nature.

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Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
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期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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